Centers for Medicare and Medicaid Services
Conditions of Participation (CoP)
Provider Plan of Correction
Provider Name

The University of Texas MD Anderson Cancer Center

Provider Identification #

450076

Survey Exit Date 05/17/19

Address

1515 Holcombe Blvd
Houston, TX 77030

Survey Type

Complaint

Tags

Tag

Tag A
000

Tag A
043
Governi
ng
Body
A
043(A)

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Through a collaborative effort of The University of Texas MD Anderson Cancer Center’s (Hospital) senior leadership, administration, nursing staff,
medical staff and the Governing Body, the Hospital has taken prompt and significant corrective actions to ensure compliance with the Centers for
Medicare and Medicaid Services (CMS) Conditions of Participation (CoPs) under Tags A043, A115, A131, A143, A144, A263, A385, A392, A397,
A409, and A576. Hospital has corrected all alleged deficiencies, has implemented training and monitoring and taken steps for sustained
compliance with the CoPs over time to ensure safe, quality care for patients. Accordingly, Hospital respectfully requests that CMS accept this PoC
as a credible allegation of compliance and evidence of current and long-term sustained compliance with the CoPs and to reinstate Hospital’s
deemed status.

All

Person
Responsible
Completion Date
President
Completion Date:
July 10, 2019

The Plans of Correction for Tags A043, A115, A131, A143, A144, A263, A385, A392, A397, A409, and A576 are incorporated by this reference.
Tag A 043. Hospital maintains an effective Governing Body that is legally responsible for the conduct of the Hospital. Alternatively, if Hospital
does not have an organized Governing Body, the persons legally responsible for the conduct of the Hospital carry out the functions specified in
this part that pertain to the Governing Body.

A. In accordance with Texas State law, the
President appointed by the Board of
Regents serves as the Governing Body of
the Hospital, and is legally responsible for
the conduct of the Hospital and carries out
the functions of the Governing Body
specified the CoPs.
A Governing Body Charter (which serves as
the Governing Body’s “Bylaws”) was
developed by the Governing Body and the

A. The Governing Body Charter was adopted by the
Governing Body to confirm the Governing Body’s
duties and responsibilities under the CoPs, including
specifically 42 C.F.R. 482.12, on June 18, 2019.
The Chief Operating Officer will ensure education for
the ELT, the Chair of the ECMS Committee, and
members of the President’s Advisory regarding their
reporting obligations to the Governing Body.

A. The President will monitor compliance
with reporting requirements of the ELT,
(including QAPI reporting), the ECMS
Committee, Chair of the ECMS
Committee, and other Hospital leaders
and committees to the Governing Body
for 6 months to ensure compliance with
reporting obligations.

President
Completion Date:
July 10, 2019

The Governing Body will address any
deficiencies in reporting with the Hospital

1

 Tag

Plan for correcting the cited deficiency

Executive Leadership Team (ELT), and
approved by the Governing Body on June
18, 2019.
The Governing Body Charter:
Reflects the designation of the President
as the Governing Body in accordance with
Texas State law;
Incorporates the responsibilities of the
President under Texas State law;
Incorporates the responsibilities of the
President as the Governing Body under the
CoPs, including without limitation the role
of the Governing Body for the Medical
Staff and Quality Assessment and
Performance Improvement (QAPI)
Program (See Plan of Correction for Tag A
263, QAPI)); and Requires maintenance of
minutes.

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

leader, Medical Staff leader or committee
chair, as applicable.
The Governing Body Charter will be
reviewed by the Governing Body and ELT
annually and revised if necessary to
reflect any changes to the CoPs,
applicable legal and accrediting
standards, any changes to the Hospital
leaders with direct reporting to the
Governing Body and any changes to the
committees reporting to the Governing
Body.

The Medical Staff Bylaws were revised to
clarify the role of the President as
Governing Body in accordance with 42
C.F.R. 482.12 and 482.22.

The Medical Staff Bylaws were
reviewed and recommended for
approval by the ECMS on or before
June 20, 2019.
The Medical Staff Bylaws will be approved
by the Medical Staff on or before July 8,
2019.
The Medical Staff Bylaws will be approved
by the Governing Body on or before July
10, 2019.

2

 Tag

Plan for correcting the cited deficiency

A
043(B)

B. The Governing Body has been actively
involved in the oversight and
implementation of the Plans of Correction
to ensure that blood component
transfusions are administered in
accordance with the Hospital’s policies and
procedures and acceptable nursing
standards.

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

Responsible
Person: President
Completion Date:
July 10, 2019

The Plans of Correction for Tags A 115,
144, 385, 409 are incorporated by this
reference.
A
043(C)

C. The Governing Body has been actively
involved in the oversight and
implementation of the Plans of Correction
to ensure that nurses continually assess
patients during transfusions of blood
components, and that vital signs are
monitored and any vital signs flagged as
abnormal are assessed or reassessed in
accordance with Hospital policy.

Responsible
Person: President
Completion Date:
July 10, 2019

The Plans of Correction for Tags A 115,
385, 409 are incorporate by this reference.
A
043(D)

D. The Governing Body has been actively
involved in the oversight and
implementation of this Plan of Correction
to ensure nurses notified the physician of
changes in vital signs and changes in the
condition of patients receiving transfusions
of blood components.

Responsible
Person: President
Completion Date:
July 10, 2019

The Plans of Correction for Tags A 115,
144, 409 are incorporated by this
reference.

3

 Tag

Plan for correcting the cited deficiency

A
043(E)

E. The Governing Body has been actively
involved in the oversight and
implementation of the Plans of Correction
to ensure Hand-Off Communication is
performed in transferring patients with
infectious disease within the facility, and
that isolation precautions for safe care are
implemented.

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

Responsible
Person: President
Completion Date:
July 10, 2019

The Plans of Correction for Tags A 115, 144
are incorporated by this reference.
A
043(F)

F. The Governing Body has been actively
involved in the oversight and
implementation of the Plans of Correction
to ensure patients are allowed to make
informed decisions regarding their care.

Responsible
Person: President
Completion Date:
July 10, 2019

The Plans of Correction for Tags A 115, 131
are incorporated by this reference.
A
043(G)

G. The Governing Body has been actively
involved in the oversight and
implementation of the Plan of Correction
to ensure the protection of patient’s
personal privacy and dignity.

Responsible
Person: President
Completion Date:
July 10, 2019

The Plans of Correction for Tags A 115, 143
are incorporated by this reference.
A
043(H)

H. The Governing Body has been actively
involved in the oversight and
implementation of the Plans of Correction
to ensure the development,
implementation and maintenance of an
effective, ongoing, hospital-wide, data
driven QAPI program. The Governing Body

Responsible
Person: President
Completion Date:
July 10, 2019

4

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

ensures that the quality program reflects
the complexity of the Hospital’s
organization and services, including
services furnished under contract or
arrangement, and focuses on indicators
related to improved health outcomes and
the prevention and reduction of medical
errors.
The Plans of Correction for Tags A 263 and
576 are incorporated by this reference.
TAG A
115
Patient
Rights

Tag A 115 Hospital protects and promotes each patient’s rights. Hospital ensures patient’s rights are protected. Specifically, Hospital ensures
that: A. blood component transfusions are administered in accordance with Hospital’s policies/procedures and acceptable nursing standards; B.
nurses continually assess patients during transfusions of blood components, in accordance with Hospital policy; C. nurses notify the physician of
changes in vital signs and condition of patients receiving transfusions of blood components, in accordance with Hospital policy; D. Hand-Off
Communication are performed in transferring a patient with orders for isolation precautions from one patient location to another patient
location, and Contact isolation precautions for safe care are implemented; E. patients are allowed to make informed decisions regarding their
care; and F. the patients’ personal privacy and dignity are protected by having a X-ray door/room not accessible to the public.

A
115(A)

A. Hospital ensures that blood component
transfusions are administered in
accordance with Hospital’s
policies/procedures and acceptable
nursing standards.
A transfusion reaction investigation was
completed regarding the Reference
Patient. An interdisciplinary team including
the CMS/CLIA Steering Committee,
members of the Transfusion and Patient
Blood Management Committee, the
Multidisciplinary Clinical Policies and
Procedures Task Force, Medical Staff and
Nursing reviewed the Hospital’s Blood
Component Administration and
Transfusion Reaction Policy CLN1115. As
part of this review over 6,000 patient
charts who received blood transfusions
were reviewed.

A. The Associate Director of G9 (Pediatrics)
implemented immediate individualized one on one
training for the two Pediatric RNs who cared for
Patient #34 as follows:
Nurse-Day Shift: Trained 12/7/18 and 12/31/18.
Training included:
• Coached on the escalation of concerns
• Coached on appropriate documentation of
escalation of concerns/provider notification
• Nursing practice when carrying out the plan
of care; prioritizing interventions
• Reviewed gaps in documentation related to
hand-off documentation when the patient
leaves the unit
Nurse- Night Shift- Trained 12/20/18. Training
included:
• Gaps in vital sign monitoring and
documentation for blood component
administration

A. A random sample of 93 blood
component transfusion records are
audited and analyzed retrospectively each
week by the Office of Performance
Improvement (OPI) to determine
adherence to Blood Component
Administration and Transfusion Reaction
Policy CLN1115 for vital signs and
monitoring, that orders specify the
duration for the transfusion, and the
actual duration of the transfusion. OPI
reviews the data with the Executive
Director of Nursing Quality, Safety and
Research, and the Laboratory Medicine
Quality and Safety Officer to develop
recommendations for improvement.

A. Chief Operating
Officer
Completion Date:
July 10, 2019

In collaboration with the Executive
Director of Nursing Quality, Safety and
Research and the Laboratory Medicine

5

 Tag

Plan for correcting the cited deficiency

A training program was developed by an
inter-disciplinary team, including a
transfusion medicine faculty member. This
team was led by the Executive Director of
Nursing, Professional Practice, Strategy
and Execution and the Chief Education and
Training Officer to develop curriculum and
implement training for Credentialed
Providers (Physicians, Advanced Practice
Nurses and Physician Assistants) who
obtain informed consent for, order,
administer or manage complications of
blood component transfusions and
registered nurses (RN) who administer
blood components pursuant to the Blood
Component Administration and
Transfusion Reaction Policy CLN1115,
which includes enhanced nursing
standards for administering and
monitoring blood components.
The hospital nurse training “Blood
Component Administration Competency”
has been updated to include the following
transfusion reaction symptoms: dry,
flushed skin, pain in the abdomen and
extremities, vomiting and bloody diarrhea.
The training also addresses signs and
symptoms of transfusion associated
circulatory overload. Completed May 17,
2019.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which was published on
May 19, 2019.

Procedure for implementing the acceptable plan of
correction
•
•
•

Reviewed signs and symptoms of reactions
Coached on appropriate documentation of
escalation of concerns/provider notification
Reviewed institutional policy (CLN1115).

RNs who administer blood components received
educational information delivered in person by unit
nursing leadership (Associate Directors, Nurse
Managers, or Clinical Nurse Leaders) starting May 16,
2019 and completed by May 24, 2019. The topics
addressed included adherence to Blood Component
Administration and Transfusion Reaction Policy
CLN1115, as supported by ATT1722, Guidelines for
Identifying and Reporting a Transfusion Reaction,
acceptable nursing standards for assessment,
recognition, responding, and reporting symptoms of
suspected transfusion reactions.
RNs who administer blood components completed
mandatory computer based training with knowledge
assessment starting May 17, 2019 to be completed by
July 10, 2019. The topics addressed within the
computer based training on the Blood Component
Administration and Transfusion Reaction Policy
CLN1115, which includes increased monitoring of vital
sign and patient assessment, recognizing, responding
and reporting transfusion reactions.
Material was also reviewed regarding delivering
patient education for participation in their care while
receiving blood components.

Follow-up/Monitoring

Person
Responsible
Completion Date

Quality and Safety Officer, OPI will submit
the information and recommendations
for improvement to the Transfusion and
Patient Blood Management Committee,
the ECMS, and the QAPI Council monthly
for at least 2 months.
After 2 months of data collection, the
QAPI Council will determine whether the
frequency of data collection should be
adjusted (up or down) based on
performance. The Transfusion and
Patient Blood Management Committee
and ECMS will review the determination
and may make recommendations for
further improvement to the QAPI Council.
The QAPI Council will provide a
summation to the ELT and the Governing
Body at least quarterly.
The Hospital will address any deficiencies
with the individual nursing staff member
through pertinent education and training,
re-education and/or disciplinary action, as
appropriate.
Any Credentialed Provider deficiencies
will be addressed through pertinent
education and training, re-education
and/or referral for confidential peer
review through the medical staff.

Additional training will be conducted regarding the
changes to the EHR Blood Component Order Sets, the
modifications to the Blood Component Administration
and Transfusion Reaction Policy CLN1115 (including
the use of volumetric pumps, orders to include the
duration of the transfusion, and definitions of
hypotension and fever, ATT1722, Guidelines for
Identifying and Reporting a Transfusion Reaction), and

Under the revised policy, nursing staff are

6

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

to take the patient’s vital signs prior to
initiating the transfusion, 15 minutes into
the transfusion, hourly from the start of
the transfusion through completion of the
transfusion, and at completion of the
transfusion. They are required to assess
the patient for signs and symptoms of
transfusion reaction and document their
observations hourly through completion of
the transfusion, and at completion of the
transfusion.

the Stop the Line for Patient Safety Policy CLN1185, by
July 10, 2019.

The Electronic Health Record (EHR)
includes a list of the symptoms of a
transfusion reaction. If the nurse selects
yes, the EHR generates a checklist of the
symptoms allowing the nurse to select the
symptoms that are present.
To ensure RNs administer blood
components in accordance with Hospital
policy and acceptable nursing standards:
(1) The Blood Component Administration
and Transfusion Reaction Policy CLN1115
was further modified to require that blood
components are administered via
volumetric pump to ensure the duration of
the transfusion is in accordance with
the physician’s orders. (Accordingly, blood
components will not be administered via
“gravity” flow).
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which was approved on
June 20, 2019.

Follow-up/Monitoring

Person
Responsible
Completion Date

RNs on leave who transfuse blood components must
complete training before attending patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 and the
enhanced nursing standards for administering and
monitoring blood component transfusions, and the
Stop the Line for Patient Safety Policy CLN1185 is
included in the on-boarding process for new RNs who
transfuse blood components.
Credentialed Providers who obtain informed consent
for, order, administer or manage complications of
blood component transfusions will complete the
computer based training as outlined above by July 10,
2019.
Credentialed Providers who obtain informed consent
for, order, administer or manage complications of
blood components and are on leave must complete
the computer based training before attending
patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 and the Stop
the Line for Patient Safety Policy CLN1185 is included
in the on-boarding process for new Credentialed
Providers.
A reminder communication will be sent to all nursing
staff who administer and monitor transfusions
regarding the process for reporting a suspected
transfusion reaction, by July 10, 2019.

(2) Based on the National Patient Safety

7

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

Network Biovigilance Component
Hemovigilance Module Surveillance
Protocol, published April 2018 by the
Centers for Disease Control the Blood
Component Administration and
Transfusion Reaction Policy CLN1115 will
be amended to include the definitions of
hypotension and fever, by July 10, 2019.
ATT1722, Guidelines for Identifying and
Reporting a Transfusion Reaction, which
supports CLN1115, will be revised to
address the hypotension and fever
parameters by July 10, 2019.
(3) EHR Physician Blood Component Order
Set was modified to require duration of
blood component transfusion. A
Credentialed Provider must specify the
duration of the blood component
transfusion in order to complete the blood
component order (hard stop). This change
will be effective by July 10, 2019.
(4) Stop the Line for Patient Safety Policy
CLN1185 was modified to permit anyone
to stop the line for an incomplete,
conflicting or unclear order or in the event
of a suspected transfusion reaction.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS
approved the updated Stop the Line for
Patient Safety Policy CLN1185, which was
approved on June 20, 2019.
Further training was developed on the EHR
Blood Component Order Sets, and the
modifications to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115 and the Stop the Line for

8

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

Patient Safety Policy CLN1185.
The hospital has developed a
Hemovigilance Unit that will track the vital
signs of each patient receiving transfusion
services. Phase 1 of the Hemovigilance
Unit’s activities consist of performing
retrospective chart reviews on patients
identified through the Unit monitoring
system as having a possible transfusion
reaction. Any patients identified as having
a definite reaction receive a written
consult, recorded in the EHR, from a
Transfusion Medicine Physician. May 20,
2019.
Following a 2-4 week prospective pilot in 3
areas where transfusions are administered
(Phase 2), the Hemovigilance Unit will
track the vital signs of each patient
receiving transfusion services in real time
(Phase 3). These vital signs will be
reviewed by an RN under the supervision
of an Advanced Practice Provider (APP) or
physician 24/7 to complement the
monitoring being provided at the bedside.
The real time monitoring will also weight
the vital signs and assign a risk number for
each patient that is updated in real time,
highlighting patients exhibiting potential
signs of a reaction. Signs of a reaction will
be referred to a member of the transfusion
medicine practice. In addition to the
monitoring being done by nursing under
this POC, the Hemovigilance Unit will also
review potential false negatives on an
ongoing basis and report to the
Transfusion and Patient Blood
Management Committee.
We are not formally submitting Phase 2

9

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

B. A random sample of 93 blood
component transfusion records are
audited and analyzed retrospectively each
week by the OPI to determine adherence
to Blood Component Administration and
Transfusion Reaction Policy CLN1115 for
the for vital signs and monitoring. OPI
reviews the data with the Executive
Director of Nursing Quality, Safety and
Research, and the Laboratory Medicine
Quality and Safety Officer to develop
recommendations for improvement.

B. Chief Operating
Officer

and 3 as part of our corrective action as
these require a significant time investment
to operationalize it across the hospital but
we wanted CMS to be aware of its
development as proof of our commitment
to being an industry leader in developing
new, innovative approaches to delivering
the highest level of care.

A
115(B)

This plan of correction is also addressed
under the Plans of Correction Tags A 043,
A 144, A 385, and A 409.
B. The Hospital ensures that nurses
continually assess patients during
transfusion of blood components.
A transfusion reaction investigation was
completed regarding the Reference
Patient. An interdisciplinary team including
the CMS/CLIA Steering Committee,
members of the Transfusion and Patient
Blood Management Committee, the
Multidisciplinary Clinical Policies and
Procedures Task Force, Medical Staff and
Nursing reviewed the Hospital’s Blood
Component Administration and
Transfusion Reaction Policy CLN1115. As
part of this review over 6,000 patient
charts who received blood transfusions
were reviewed.
A training program was developed by an
inter-disciplinary team, including a
transfusion medicine faculty member. This
team was led by the Executive Director of
Nursing, Professional Practice, Strategy
and Execution and the Chief Education and
Training Officer to develop curriculum and
implement training for Credentialed
Providers who obtain informed consent
for, order, administer or manage

B. The Associate Director of G9 (Pediatrics)
implemented immediate individualized one on one
training for the two Pediatric RNs who cared for
Patient #34 as follows:
Nurse-Day Shift: Trained 12/7/18 and 12/31/18.
Training included:
• Coached on the escalation of concerns
• Coached on appropriate documentation of
escalation of concerns/provider notification
• Nursing practice when carrying out the plan
of care; prioritizing interventions
• Reviewed gaps in documentation related to
hand-off documentation when the patient
leaves the unit
RNs who administer blood components received
educational information delivered in person by unit
nursing leadership (Associate Directors, Nurse
Managers, or Clinical Nurse Leaders) starting May 16,
2019 and completed by May 24, 2019. The topics
addressed included adherence to Blood Component
Administration and Transfusion Reaction Policy
CLN1115, as supported by the ATT1722, Guidelines for
Identifying and Reporting a Transfusion Reaction,
acceptable nursing standards for continual
assessment, recognition, responding, and reporting
symptoms of suspected transfusion reactions.

Completion Date:
July 10, 2019

In collaboration with the Executive
Director of Nursing Quality, Safety and
Research and the Laboratory Medicine
Quality and Safety Officer, OPI will submit
the information and recommendations
for improvement to the Transfusion and
Patient Blood Management Committee,
the ECMS, and the QAPI Council monthly
for at least 2 months.
After 2 months of data collection, the
QAPI Council will determine whether the
frequency of data collection should be
adjusted (up or down) based on
performance. The Transfusion and
Patient Blood Management Committee

10

 Tag

Plan for correcting the cited deficiency

complications of blood component
transfusions and registered nurses (RN)
who administer blood components
pursuant to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which includes enhanced
nursing standards for administering and
monitoring blood components.
The hospital nurse training “Blood
Component Administration Competency”
has been updated to include the following
transfusion reaction symptoms: dry,
flushed skin, pain in the abdomen and
extremities, vomiting and bloody diarrhea.
The training also addresses signs and
symptoms of transfusion associated
circulatory overload. Completed May 17,
2019.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which was published on
May 19, 2019.
Under the revised policy, nursing staff are
to take the patient’s vital signs prior to
initiating the transfusion, 15 minutes into
the transfusion, hourly from the start of
the transfusion through completion of the
transfusion, and at completion of the
transfusion. They are required to assess
the patient for signs and symptoms of
transfusion reaction and document their
observations hourly through completion of
the transfusion, and at completion of the
transfusion.

Procedure for implementing the acceptable plan of
correction

RNs who administer blood components completed
mandatory computer based training with knowledge
assessment starting May 17, 2019 to be completed by
July 10, 2019. The topics addressed within the
computer based training on the Blood Component
Administration and Transfusion Reaction Policy
CLN1115, which includes increased monitoring of vital
sign and patient assessment, recognizing, responding
and reporting transfusion reactions.
Material was also reviewed regarding delivering
patient education for participation in their care while
receiving blood components.
Additional training will be conducted regarding the
changes to the Blood Component Administration and
Transfusion Reaction Policy CLN1115 (including
definitions of hypotension and fever, as described in
ATT1722, Guidelines for Identifying and Reporting a
Transfusion Reaction), and the Stop the Line for
Patient Safety Policy CLN1185, by July 10, 2019.

Follow-up/Monitoring

Person
Responsible
Completion Date

and ECMS will review the determination
and may make recommendations for
further improvement to the QAPI Council.
The QAPI Council will provide a
summation to the ELT and the Governing
Body at least quarterly.
The Hospital will address any deficiencies
with the individual nursing staff member
through pertinent education and training,
re-education and/or disciplinary action, as
appropriate.
Any Credentialed Provider deficiencies
will be addressed through pertinent
education and training, re-education
and/or referral for confidential peer
review through the medical staff.

RNs on leave who transfuse blood components must
complete training before attending patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 and the
enhanced nursing standards for administering and
monitoring blood component transfusions, and the
Stop the Line for Patient Safety Policy CLN1185 is
included in the on-boarding process for new RNs who
transfuse blood components.
Credentialed Providers who obtain informed consent
for, order, administer or manage complications of
blood component transfusions will complete the
computer based training as outlined above by July 10,
2019.
Credentialed Providers who obtain informed consent

11

 Tag

Plan for correcting the cited deficiency

The Electronic Health Record (EHR)
includes a list of the symptoms of a
transfusion reaction. If the nurse selects
yes, the EHR generates a checklist of the
symptoms allowing the nurse to select the
symptoms that are present.
To ensure RNs administer blood
components in accordance with Hospital
policy and acceptable nursing standards:

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

for, order, administer or manage complications of
blood components and are on leave must complete
the computer based training before attending
patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 and the Stop
the Line for Patient Safety Policy CLN1185 is included
in the on-boarding process for new Credentialed
Providers.

(1) Based on the National Patient Safety
Network Biovigilance Component
Hemovigilance Module Surveillance
Protocol, published April 2018 by the
Centers for Disease Control the Blood
Component Administration and
Transfusion Reaction Policy CLN1115 will
be amended to include the definitions of
hypotension and fever, by July 10, 2019.
ATT1722, Guidelines for Identifying and
Reporting a Transfusion Reaction, which
supports CLN1115, will be revised to
address the hypotension and fever
parameters by July 10, 2019.
(2) Stop the Line for Patient Safety Policy
CLN1185 was modified to permit anyone
to stop the line for an incomplete,
conflicting or unclear order or in the event
of a suspected transfusion reaction.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS
approved the updated Stop the Line for
Patient Safety Policy CLN1185, which was
approved on June 20, 2019.
Further training was developed on the
modifications to the Blood Component

12

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

Administration and Transfusion Reaction
Policy CLN1115 and the Stop the Line for
Patient Safety Policy CLN1185.
The hospital has developed a
Hemovigilance Unit that will track the vital
signs of each patient receiving transfusion
services. Phase 1 of the Hemovigilance
Unit’s activities consist of performing
retrospective chart reviews on patients
identified through the Unit monitoring
system as having a possible transfusion
reaction. Any patients identified as having
a definite reaction receive a written
consult, recorded in the EHR, from a
Transfusion Medicine Physician. May 20,
2019.
Following a 2-4 week prospective pilot in 3
areas where transfusions are administered
(Phase 2), the Hemovigilance Unit will
track the vital signs of each patient
receiving transfusion services in real time
(Phase 3). These vital signs will be
reviewed by an RN under the supervision
of an APP or physician 24/7 to
complement the monitoring being
provided at the bedside. The real time
monitoring will also weight the vital signs
and assign a risk number for each patient
that is updated in real time, highlighting
patients exhibiting potential signs of a
reaction. Signs of a reaction will be
referred to a member of the transfusion
medicine practice. In addition to the
monitoring being done by nursing under
this POC, the Hemovigilance Unit will also
review potential false negatives on an
ongoing basis and report to the
Transfusion and Patient Blood
Management Committee.

13

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

C. A random sample of 93 blood
component transfusion records are
audited and analyzed retrospectively each
week by the OPI to determine adherence
to (1) Blood Component Administration
and Transfusion Reaction Policy CLN1115,
including reporting to and consulting with
the Credentialed Provider and the
Transfusion Medicine Physician for
suspected transfusion reactions, and (2)
Stop the Line for Patient Safety Policy
CLN1185, to stop the line in the event of a
suspected transfusion reaction or an
incomplete, conflicting or unclear order.

C. Chief Operating
Officer

We are not formally submitting Phase 2
and 3 as part of our corrective action as
these require a significant time investment
to operationalize it across the hospital but
we wanted CMS to be aware of its
development as proof of our commitment
to being an industry leader in developing
new, innovative approaches to delivering
the highest level of care.

A
115(C)

This plan of correction is also addressed
under the Plans of Correction Tags A 043,
A 144, A 385, and A 409.
C. Hospital ensures that nurses notify the
Credentialed Providers of changes in vital
signs and condition of patients receiving
transfusions of blood components as
required under the Hospital policy.
A transfusion reaction investigation was
completed regarding the Reference
Patient. An interdisciplinary team including
the CMS/CLIA Steering Committee,
members of the Transfusion and Patient
Blood Management Committee, the
Multidisciplinary Clinical Policies and
Procedures Task Force, Medical Staff and
Nursing reviewed the Hospital’s Blood
Component Administration and
Transfusion Reaction Policy CLN1115. As
part of this review over 6,000 patient
charts who received blood transfusions
were reviewed.
A training program was developed by an
inter-disciplinary team, including a
transfusion medicine faculty member. This
team was led by the Executive Director of
Nursing, Professional Practice, Strategy
and Execution and the Chief Education and

C. The Associate Director of G9 (Pediatrics)
implemented immediate individualized one on one
training for the two Pediatric RNs who cared for
Patient #34 as follows:
Nurse-Day Shift: Trained 12/7/18 and 12/31/18.
Training included:
• Coached on the escalation of concerns
• Coached on appropriate documentation of
escalation of concerns/provider notification
• Nursing practice when carrying out the plan
of care; prioritizing interventions
Reviewed gaps in documentation related to hand-off
documentation when the patient leaves the unit
Nurse- Night Shift- Trained 12/20/18. Training
included:
• Gaps in vital sign monitoring and
documentation for blood component
administration
• Reviewed signs and symptoms of reactions
• Coached on appropriate documentation of
escalation of concerns/provider notification
• Reviewed institutional policy (CLN1115).
RNs who administer blood components received

Completion Date:
July 10, 2019

OPI reviews the data with the Executive
Director of Nursing Quality, Safety and
Research, and the Laboratory Medicine
Quality and Safety Officer to develop
recommendations for improvement.
In collaboration with the Executive
Director of Nursing Quality, Safety and
Research and the Laboratory Medicine
Quality and Safety Officer, OPI will submit
the information and recommendations
for improvement to the Transfusion and

14

 Tag

Plan for correcting the cited deficiency

Training Officer to develop curriculum and
implement training for Credentialed
Providers who obtain informed consent
for, order, administer or manage
complications of blood component
transfusions and registered nurses (RN)
who administer blood components
pursuant to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which includes enhanced
nursing standards for administering and
monitoring blood components.
The hospital nurse training “Blood
Component Administration Competency”
has been updated to include the following
transfusion reaction symptoms: dry,
flushed skin, pain in the abdomen and
extremities, vomiting and bloody diarrhea.
The training also addresses signs and
symptoms of transfusion associated
circulatory overload. Completed May 17,
2019.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which was published on
May 19, 2019.
Under the revised policy, nursing staff are
to take the patient’s vital signs prior to
initiating the transfusion, 15 minutes into
the transfusion, hourly from the start of
the transfusion through completion of the
transfusion, and at completion of the
transfusion. They are required to assess
the patient for signs and symptoms of
transfusion reaction and document their
observations hourly through completion of

Procedure for implementing the acceptable plan of
correction
educational information delivered in person by unit
nursing leadership (Associate Directors, Nurse
Managers, or Clinical Nurse Leaders) starting May 16,
2019 and completed by May 24, 2019. The topics
addressed included adherence to Blood Component
Administration and Transfusion Reaction Policy
CLN1115, as supported by ATT1722, Guidelines for
Identifying and Reporting a Transfusion Reaction,
acceptable nursing standards for assessment,
recognition, responding, and reporting symptoms of
suspected transfusion reactions.
RNs who administer blood components completed
mandatory computer based training with knowledge
assessment starting May 17, 2019 to be completed by
July 10, 2019. The topics addressed within the
computer based training on the Blood Component
Administration and Transfusion Reaction Policy
CLN1115, included increased monitoring of vital sign
and patient assessment, recognizing, responding and
reporting transfusion reactions to and consulting with
the Credentialed Provider and the Transfusion
Medicine Physician, and clarifying physician orders.
Material was also reviewed regarding delivering
patient education for participation in their care while
receiving blood components.
Additional training will be conducted regarding the
changes to the Blood Component Administration and
Transfusion Reaction Policy CLN1115 (including
definitions of hypotension and fever, reporting
suspected transfusion reactions to and consulting with
the Credentialed Provider and the Transfusion
Medicine Physician), and the Stop the Line for Patient
Safety Policy CLN1185, by July 10, 2019.

Follow-up/Monitoring

Person
Responsible
Completion Date

Patient Blood Management Committee,
the ECMS, and the QAPI Council monthly
for at least 2 months.
After 2 months of data collection, the
QAPI Council will determine whether the
frequency of data collection should be
adjusted (up or down) based on
performance. The Transfusion and
Patient Blood Management Committee
and ECMS will review the determination
and may make recommendations for
further improvement to the QAPI Council.
The QAPI Council will provide a
summation to the ELT and the Governing
Body at least quarterly.
The Hospital will address any deficiencies
with the individual nursing staff member
through pertinent education and training,
re-education and/or disciplinary action, as
appropriate.
Any Credentialed Provider deficiencies
will be addressed through pertinent
education and training, re-education
and/or referral for confidential peer
review through the medical staff.

RNs on leave who transfuse blood components must
complete training before attending patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 and the

15

 Tag

Plan for correcting the cited deficiency

the transfusion and at completion of the
transfusion.
The Electronic Health Record (EHR)
includes a list of the symptoms of a
transfusion reaction. If the nurse selects
yes, the EHR generates a checklist of the
symptoms allowing the nurse to select the
symptoms that are present.
To ensure RNs notify the Credentialed
Providers of condition of patients receiving
transfusions of blood components as
required under the Hospital policy:
(1) Based on the National Patient Safety
Network Biovigilance Component
Hemovigilance Module Surveillance
Protocol, published April 2018 by the
Centers for Disease Control the Blood
Component Administration and
Transfusion Reaction Policy CLN1115 will
be amended to include the definitions of
hypotension and fever, by July 10, 2019.

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

enhanced nursing standards for administering and
monitoring blood component transfusions, Stop the
Line for Patient Safety Policy CLN1185 is included in
the on-boarding process for new RNs who transfuse
blood components.
Credentialed Providers who obtain informed consent
for, order, administer or manage complications of
blood component transfusions will complete the
computer based training as outlined above by July 10,
2019.
Credentialed Providers who obtain informed consent
for, order, administer or manage complications of
blood components and are on leave must complete
the computer based training before attending
patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 is included in
the on-boarding process for new Credentialed
Providers.

ATT1722, Guidelines for Identifying and
Reporting a Transfusion Reaction, which
supports CLN1115, will be revised to
address the hypotension and fever
parameters by July 10, 2019.
(2) The Blood Component Administration
and Transfusion Reaction Policy CLN1115
was further modified to require that the
Transfusion Medicine Physician is
consulted regarding suspected blood
component transfusion reactions.
(3) Stop the Line for Patient Safety Policy
CLN1185 was modified to permit anyone
to stop the line for an incomplete,

16

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

conflicting or unclear order or in the event
of a suspected transfusion reaction.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS
approved the updated Stop the Line for
Patient Safety Policy CLN1185, which was
approved on June 20, 2019.
Further training was developed on the
modifications to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115 and the Stop the Line for
Patient Safety Policy CLN1185.
The hospital has developed a
Hemovigilance Unit that will track the vital
signs of each patient receiving transfusion
services. Phase 1 of the Hemovigilance
Unit’s activities consist of performing
retrospective chart reviews on patients
identified through the Unit monitoring
system as having a possible transfusion
reaction. Any patients identified as having
a definite reaction receive a written
consult, recorded in the EHR, from a
Transfusion Medicine Physician. May 20,
2019.
The hospital has developed a
Hemovigilance Unit that will track the vital
signs of each patient receiving transfusion
services. Phase 1 of the Hemovigilance
Unit’s activities consist of performing
retrospective chart reviews on patients
identified through the Unit monitoring
system as having a possible transfusion
reaction. Any patients identified as having
a definite reaction receive a written
consult, recorded in the EHR, from a
Transfusion Medicine Physician. May 20,

17

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

2019.
Following a 2-4 week prospective pilot in 3
areas where transfusions are administered
(Phase 2), the Hemovigilance Unit will
track the vital signs of each patient
receiving transfusion services in real time
(Phase 3). These vital signs will be
reviewed by an RN under the supervision
of an APP or physician 24/7 to
complement the monitoring being
provided at the bedside. The real time
monitoring will also weight the vital signs
and assign a risk number for each patient
that is updated in real time, highlighting
patients exhibiting potential signs of a
reaction. Signs of a reaction will be
referred to a member of the transfusion
medicine practice. In addition to the
monitoring being done by nursing under
this POC, the Hemovigilance Unit will also
review potential false negatives on an
ongoing basis and report to the
Transfusion and Patient Blood
Management Committee.
We are not formally submitting Phase 2
and 3 as part of our corrective action as
these require a significant time investment
to operationalize it across the hospital but
we wanted CMS to be aware of its
development as proof of our commitment
to being an industry leader in developing
new, innovative approaches to delivering
the highest level of care.
This plan of correction is also addressed
under the Plans of Correction Tags A 043,
A 144, A 385, and A 409.

18

 Tag

Plan for correcting the cited deficiency

A
115(D)

D. Hand-Off Communications are
performed and documented in transferring
a patient with isolation precaution orders
from one patient location to another to
ensure that
isolation precautions for safe care are
implemented.
Nursing leadership reviewed Hand-Off
Communication Policy CLN0513 in relation
to transfers within Hospital, by June 19,
2019.
The Executive Director of Clinical
Informatics approved a modification to the
EHR Hand-Off Communication
documentation for nursing to include
isolation precautions. A new flow sheet
row will serve as the transferring RN’s
attestation that the isolation status was
communicated to the receiving health care
provider.
The Executive Director of Nursing,
Professional Practice, Strategy and
Execution in collaboration with the
Director of Education developed and will
implement educational training specifically
addressing hand-off communication and
documentation related to isolation
precautions for patient transfers within
Hospital in accordance with Hand-Off
Communication Policy CLN 0513 and the
new documentation.

Procedure for implementing the acceptable plan of
correction
D. RNs who provide hand-off communication for
patients transferring within Hospital will receive
education and training with nurse leadership
(Associate Director, nurse manager, clinical nurse
leaders and educators) to be completed by July 10,
2019. The topics addressed during the training will
emphasize isolation precaution information,
adherence to Hand-Off Communication Policy CLN
0513, and documentation and modification
enhancements to EHR to include attestation of
isolation precautions.
RNs on leave who provide hand-off communication for
patients transferring within Hospital must complete
the training before attending patients
Education regarding isolation precaution information,
adherence to Hand-Off Communication Policy CLN
0513, documentation and the EHR that includes
attestation of isolation precautions
will be included in the on-boarding process for new
RNs who provide hand-off communication for patients
transferring within Hospital.

Follow-up/Monitoring

D. The Hospital will prepare a report
reflecting all isolation inpatients with a
permanent or temporary hand-off to
assess whether the RN attestation of
hand-off and isolation precaution was
communicated and documented.

Person
Responsible
Completion Date
D. Chief Nursing
Officer
Completion Date:
July 10, 2019

The report is reviewed weekly by the
Executive Directors of Nursing team and
the Chief Nursing Officer, who may
recommend and implement any
appropriate changes.
The report will be submitted to the QAPI
Council monthly for the initial quarter.
After the first quarter, QAPI Council will
determine whether the frequency of data
collection should be adjusted (up or
down) based on performance.
Monitoring and reporting will continue
until 100% compliance is documented for
two consecutive months.
The QAPI Council will review the
information, and may make
recommendations for further
improvement, and provide at least a
summation to the ELT and the Governing
Body at least quarterly.
The Hospital will address any deficiencies
with the individual RN through pertinent
training, re-education and/or disciplinary
action, as appropriate.

This plan of correction is also addressed
under the Plans of Correction Tags A 043,
A 144.

19

 Tag

A
115(E)

Plan for correcting the cited deficiency

The Hospital has developed an
acceptable process to ensure that
patients are allowed to make informed
decisions regarding their care, including
current signed consent forms for
transfusion of blood components.
An ESC was convened following the CMS
hospital survey. The ESC included the
Chief Medical Executive, Chief Medical
Officer, Chief Operating Officer, Chief
Compliance Officer, and Chief Nursing
Officer. The ESC made a determination to
update the process for blood component
transfusions, to ensure patients who
receive blood component transfusions
receive information and disclosures
needed to make informed decisions.
An interdisciplinary team, led by the
Chief Medical Officer and including the
Chief Nursing Officer, Chief Compliance
Officer, Associate Vice President (AVP)
for Patient Experience, Medical Practice
leaders, Nursing leaders, and Information
Technology leaders developed a blood
component transfusion informed
consent policy. The Informed Consent for
Blood Component Transfusion Policy
CLN3276 requires that patients and/or
their representative receiving
transfusions of blood components have
current informed consents and receive
information and disclosures needed to
make informed decisions, including risks,
benefits and alternatives. Specifically, a
patient’s Informed Consent for Blood
Component Transfusion must be
renewed (i) every six months, (ii) when a
patient signs a consent to

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

The Electronic Health Record (EHR) System will be
updated to build the workflow for the new
informed consent process and will be fully tested by
July 10, 2019.

Following completion of training and
full implementation of the new
Informed Consent for Blood
Component Transfusion Policy
CLN3276 and the associated EHR
workflow, a random sample of 93
blood component transfusion records
will be audited and analyzed
retrospectively each week by OPI to
determine adherence to the Informed
Consent for Blood Component
Transfusion Policy CLN3276. OPI will
review the data with the Chief Medical
Officer and the Executive Director of
Nursing Quality, Safety and Research
to develop recommendations for
improvement.

The Chief Education Officer and Training Officer in
conjunction with the Chief Medical Officer will
develop computer-based training, with knowledge
assessment on the new Informed Consent for Blood
Component Transfusion Policy CLN3276 and the
Blood Component Administration and Transfusion
Reaction Policy CLN1115 for Credentialed Providers
(Physicians, Advanced Practice Nurses and Physician
Assistants) who obtain informed consent for, order,
administer or manage complications of blood
component transfusions, and registered nurses
(RNs) who administer blood components. The topics
to be addressed in this training will include:
adherence to Informed Consent for Blood
Component Transfusion Policy CLN3276, which
includes ensuring patients receiving transfusions of
blood components have current informed consents
and receive information and disclosures needed to
make informed decision, including risks, benefits and
alternatives, and are informed of the right to refuse
treatments through the opportunity to revoke their
consent. In addition, training will be provided on the
time frame and circumstances for expiration of blood
component transfusion consent thereby ensuring
patients will have repeated consent after
reassessment. Training will also address nursing
documentation to confirm the presence of a current
informed consent prior to each episode of blood
component administration, and to confirm that the
patient has not revoked the consent in accordance
with the Blood Component Administration and
Transfusion Reaction Policy CLN1115. The EHR
workflow will be incorporated into the training
program.
The training program will be developed by July 10,

Person
Responsible
Completion Date
Chief Medical
Officer
Completion Date:
July 16, 2019.

In collaboration with the Chief Medical
Officer and the Executive Director of
Nursing Quality, Safety and Research,
OPI will submit the information and
recommendations for improvement to
the ECMS and the QAPI Council
monthly for at least 2 months.
After 2 months of data collection, the
QAPI Council will determine whether the
frequency of data collection should be
adjusted (up or down) based on
performance. The ECMS will review the
determination and may make
recommendations for further
improvement to the QAPI Council. The
QAPI Council will provide a quarterly
summation to the ELT and the Governing
Body.
The Hospital will address any
deficiencies with the individual nursing

20

 Tag

Plan for correcting the cited deficiency

receive a new chemotherapy agent, (iii)
when a new primary cancer diagnosis is
assigned to the patient, and (iv) any
other time the Attending Physician or
Physician Designee determines that
there is a significant deviation from the
course of treatment originally discussed
with a patient, or there is a change in a
patient’s condition or diagnosis that
would reasonably be expected to alter
the original Informed Consent for Blood
Component Transfusion.
The Executive Owner of the Policy (the
Chief Medical Executive) and the
Executive Committee of the Medical Staff
(ECMS) approved the Informed Consent
for Blood Component Transfusion Policy
CLN3276 on June 20, 2019.
A training program will be developed by
an inter-disciplinary team, led by the
Chief Education and Training Officer and
the Chief Medical Officer, to develop
curriculum and implement training for
Credentialed Providers (Physicians,
Advanced Practice Nurses and Physician
Assistants) who obtain informed
consent for, order, administer or
manage complications of blood
component transfusions and registered
nurses (RNs) who administer blood
component transfusions. The training
program will be developed by
July 10, 2019.
The Blood Component Administration
and Transfusion Reaction Policy
CLN1115 was amended to require
nursing documentation to confirm the

Procedure for implementing the acceptable plan of
correction
2019.
Credentialed Providers who obtain informed consent
for, order, administer or manage complications of
blood component transfusions and RNs who
administer blood components will receive
mandatory computer-based training developed by
the Chief Education Officer and Training Officer in
conjunction with the Chief Medical Officer.

Follow-up/Monitoring

Person
Responsible
Completion Date

staff member through pertinent
education and training, re-education
and/or disciplinary action, as
appropriate.
Any Credentialed Provider deficiencies
will be addressed through pertinent
education and training, re- education
and/or referral for confidential peer
review through the medical staff.

Credentialed Providers who obtain informed
consent for, order, administer or manage
complications of blood components but are on leave
must complete the training before attending
patients.
Education regarding Informed Consent for Blood
Component Transfusion Policy CNL3276 and the
Blood Component Administration and Transfusion
Reaction Policy CLN1115 will be included in the onboarding process for new Credentialed Providers who
order blood components.
RNs who administer blood components and are on
leave must complete the computer based training
before attending patients. Education regarding
compliance with Informed Consent for Blood
Component Transfusion Policy CLN3276 and the
Blood Component Administration and Transfusion
Reaction Policy CLN1115 is included in new
employee orientation for all RN staff who administer
blood components.
Training for the new Informed Consent for Blood
Component Transfusion Policy 3276 for Hospital’s
approximately 4,300 Credentialed Providers and RNs
who obtain informed consent for, order, administer
or manage complications of blood component
transfusions will be initiated by July 10, 2019.
Hospital will complete the training by July 16, 2019.

21

 Tag

Plan for correcting the cited deficiency

presence of a current informed consent
and to confirm that the patient has not
revoked the consent.

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

The new Informed Consent for Blood Component
Transfusion Policy CLN3276 and the associated EHR
workflow will be fully implemented once training is
complete.

The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS
approved the Informed Consent for Blood
Component Transfusion Policy CLN1115 on
June 20, 2019.

A
115(F)

This plan of correction is also addressed
under the Plans s of Correction Tags A 043,
and A 131.
F. The Executive Director of Diagnostic
Imaging Administration performed a walkthrough of the imaging units in the
Hospital, including those on units P3 and
P4, and assessed their accessibility to the
public.
The Executive Director of Diagnostic
Imaging Administration evaluated needed
changes to physical environment to
provide personal privacy and dignity for all
patients
The Vice President of Ambulatory
Operations will perform a walk-through of
all ambulatory exam room in the Hospital,
and assess their accessibility to the public.
The Vice President of Ambulatory
Operations evaluated needed changes to
the physical environment to provide
personal privacy and dignity for all patients
The following plans of correction are
incorporated by reference into this plan:
Plan of Correction Tags A 043, and A 143.

F. Units P3 and P4 X-Ray rooms had privacy curtains
installed within hours of the CMS visit. Staff in
radiology was instructed by the Executive Director of
Diagnostic Imaging to use these privacy curtains
whenever a patient was present.
The Executive Director of Diagnostic Imaging
Administration conducted a gap analysis June 18, 2019
on every x-ray room throughout the organization to
identify those x-ray rooms that did not have privacy
curtains. A work order was created and all curtains will
be installed by July 10, 2019.
The Vice President of Ambulatory Operations
conducted a gap analysis June 18, 2019 on every
ambulatory exam room throughout the organization
to identify those exam rooms that did not have privacy
curtains. A work order was created and all curtains will
be installed by July 10, 2019.

F. 1 month and 3 months following
completion of the corrective action plan,
a second walk-through of all ambulatory
and Diagnostic Imaging areas of the
hospital will be conducted by the Vice
President of Ambulatory Operations &
Chief Facilities Officer.

F. Vice President
of Ambulatory
Operations &
Chief Facilities
Officer
Completion
Date:
July 10, 2019

Any rooms in need of action will be
identified, and work orders for correction
will be submitted and followed up to
ensure completion.
Ongoing, routine monitoring will be
performed by the Vice President of
Ambulatory Operations & Chief Facilities
Officer. Any rooms in need of action will
be identified, and work orders for
correction will be submitted and followed
up to ensure completion.

Ambulatory staff was instructed by the Vice President
of Ambulatory Operations to use these privacy
curtains whenever a patient was present.
Every Diagnostic Imaging and Ambulatory staff will
complete a Computer Based Training on patient
personal privacy by July 10, 2019

22

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

Ambulatory staff on leave must complete the
computer based training before attending patients.

Tag A
131
Patient
Rights:
Inform
ed
Consen
t
A 131

Education regarding patient personal privacy is
included in new employee orientation for all
ambulatory and Diagnostic Imaging staff.
Hospital has developed an acceptable process to ensure the patient’s right (or his or her representative as allowed under State law) to make
informed decisions regarding his or her care. Hospital ensures that patient’s rights include being informed of his or her health status, being
involved in care and planning and treatment, and being able to request or refuse treatment.

The Hospital has developed an
acceptable process to ensure that
patients are allowed to make informed
decisions regarding their care, including
current signed consent forms for
transfusion of blood components.
An ESC was convened following the CMS
hospital survey. The ESC included the
Chief Medical Executive, Chief Medical
Officer, Chief Operating Officer, Chief
Compliance Officer, and Chief Nursing
Officer. The ESC made a determination to
update the process for blood component
transfusions, to ensure patients who
receive blood component transfusions
receive information and disclosures
needed to make informed decisions.
An interdisciplinary team, led by the
Chief Medical Officer and including the
Chief Nursing Officer, Chief Compliance
Officer, Associate Vice President (AVP)
for Patient Experience, Medical Practice
leaders, Nursing leaders, and Information

The Electronic Health Record (EHR) System will be
updated to build the workflow for the new
informed consent process and will be fully tested by
July 10, 2019.
The Chief Education Officer and Training Officer in
conjunction with the Chief Medical Officer will
develop computer-based training, with knowledge
assessment on the new Informed Consent for Blood
Component Transfusion Policy CLN3276 and the
Blood Component Administration and Transfusion
Reaction Policy CLN1115 for Credentialed Providers
(Physicians, Advanced Practice Nurses and Physician
Assistants) who obtain informed consent for, order,
administer or manage complications of blood
component transfusions, and registered nurses
(RNs) who administer blood components. The topics
to be addressed in this training will include:
adherence to Informed Consent for Blood
Component Transfusion Policy CNL3276, which
includes ensuring patients receiving transfusions of
blood components have current informed consents
and receive information and disclosures needed to
make informed decision, including risks, benefits and
alternatives, and are informed of the right to refuse

Following completion of training and
full implementation of the new
Informed Consent for Blood
Component Transfusion Policy
CLN3276 and the associated EHR
workflow, a random sample of 93
blood component transfusion records
will be audited and analyzed
retrospectively each week by OPI to
determine adherence to the Informed
Consent for Blood Component
Transfusion Policy CLN3276. OPI will
review the data with the Chief Medical
Officer and the Executive Director of
Nursing Quality, Safety and Research
to develop recommendations for
improvement.

Chief Medical
Officer
Completion Date
for specified
corrective actions
and initiation of
training: July 10,
2019.

In collaboration with the Chief Medical
Officer and the Executive Director of
Nursing Quality, Safety and Research,
OPI will submit the information and
recommendations for improvement to
the ECMS and the QAPI Council
monthly for at least 2 months.

23

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Technology leaders developed a blood
component transfusion informed
consent policy. The Informed Consent for
Blood Component Transfusion Policy
CLN3276 requires that patients and/or
their representative receiving
transfusions of blood components have
current informed consents and receive
information and disclosures needed to
make informed decisions, including risks,
benefits and alternatives. Specifically, a
patient’s Informed Consent for Blood
Component Transfusion must be
renewed (i) every six months, (ii) when a
patient signs a consent to
receive a new chemotherapy agent, (iii)
when a new primary cancer diagnosis is
assigned to the patient, and (iv) any
other time the Attending Physician or
Physician Designee determines that
there is a significant deviation from the
course of treatment originally discussed
with a patient, or there is a change in a
patient’s condition or diagnosis that
would reasonably be expected to alter
the original Informed Consent for Blood
Component Transfusion.

treatments through the opportunity to revoke their
consent. In addition, training will be provided on the
time frame and circumstances for expiration of blood
component transfusion consent thereby ensuring
patients will have repeated consent after
reassessment. Training will also address nursing
documentation to confirm the presence of a current
informed consent prior to each episode of blood
component administration, and to confirm that the
patient has not revoked the consent in accordance
with the Blood Component Administration and
Transfusion Reaction Policy CLN1115. The EHR
workflow will be incorporated into the training
program.

The Executive Owner of the Policy (the
Chief Medical Executive) and the
Executive Committee of the Medical Staff
(ECMS) approved the Informed Consent
for Blood Component Transfusion Policy
CLN3276 on June 20, 2019.
A training program will be developed by
an inter-disciplinary team, led by the
Chief Education and Training Officer and
the Chief Medical Officer, to develop
curriculum and implement training for

The training program will be developed by July 10,
2019.
Credentialed Providers who obtain informed consent
for, order, administer or manage complications of
blood component transfusions and RNs who
administer blood components will receive
mandatory computer-based training developed by
the Chief Education Officer and Training Officer in
conjunction with the Chief Medical Officer.

Follow-up/Monitoring

Person
Responsible
Completion Date

After 2 months of data collection, the
QAPI Council will determine whether the
frequency of data collection should be
adjusted (up or down) based on
performance. The ECMS will review the
determination and may make
recommendations for further
improvement to the QAPI Council. The
QAPI Council will provide a quarterly
summation to the ELT and the Governing
Body.
The Hospital will address any
deficiencies with the individual nursing
staff member through pertinent
education and training, re-education
and/or disciplinary action, as
appropriate.
Any Credentialed Provider deficiencies
will be addressed through pertinent
education and training, re- education
and/or referral for confidential peer
review through the medical staff.

Credentialed Providers who obtain informed
consent for, order, administer or manage
complications of blood components but are on leave
must complete the training before attending
patients.
Education regarding Informed Consent for Blood
Component Transfusion Policy CNL3276 and the
Blood Component Administration and Transfusion
Reaction Policy CLN1115 will be included in the onboarding process for new Credentialed Providers who
order blood components.
RNs who administer blood components and are on
leave must complete the computer based training

24

 Tag

Plan for correcting the cited deficiency

Credentialed Providers (Physicians,
Advanced Practice Nurses and Physician
Assistants) who obtain informed
consent for, order, administer or
manage complications of blood
component transfusions and registered
nurses (RNs) who administer blood
component transfusions. The training
program will be developed by
July 10, 2019.
The Blood Component Administration
and Transfusion Reaction Policy
CLN1115 was amended to require
nursing documentation to confirm the
presence of a current informed consent
and to confirm that the patient has not
revoked the consent.

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

before attending patients. Education regarding
compliance with Informed Consent for Blood
Component Transfusion Policy CLN3276 and the
Blood Component Administration and Transfusion
Reaction Policy CLN1115 is included in new
employee orientation for all RN staff who administer
blood components.
Training for the new Informed Consent for Blood
Component Transfusion Policy CLN3276 for
Hospital’s approximately 4,300 Credentialed
Providers and RNs who obtain informed consent for,
order, administer or manage complications of blood
component transfusions will be initiated by July 10,
2019. Hospital will complete the training by July 16,
2019. The new Informed Consent for Blood
Component Transfusion Policy CLN3276 and the
associated EHR workflow will be fully implemented
once training is complete.

The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS
approved the Informed Consent for Blood
Component Transfusion Policy CLN1115 on
June 20, 2019.

Tag A
143
Patient
Rights:
Person
al
Privacy
A 143

This plan of correction is also addressed
under the Plans s of Correction Tags A 043,
and A 131.
Hospital ensures the patient’s right to personal personal privacy.

The Executive Director of Diagnostic
Imaging Administration performed a walkthrough of the imaging units in the
Hospital, including those on units P3 and
P4, and assessed their accessibility to the

Units P3 and P4 X-Ray rooms had privacy curtains
installed within hours of the CMS visit. Staff in
radiology was instructed by the Executive Director of
Diagnostic Imaging to use these privacy curtains
whenever a patient was present.

1 month and 3 months following
completion of the corrective action plan,
a second walk-through of all ambulatory
and Diagnostic Imaging areas of the
hospital will be conducted by the Vice

Vice President of
Ambulatory
Operations &
Chief Facilities
Officer

25

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

public.
The Executive Director of Diagnostic
Imaging Administration evaluated needed
changes to physical environment to
provide personal privacy and dignity for all
patients.
The Vice President of Ambulatory
Operations will perform a walk-through of
all ambulatory exam room in the Hospital,
and assess their accessibility to the public.
The Vice President of Ambulatory
Operations evaluated needed changes to
the physical environment to provide
personal privacy and dignity for all
patients.
The following plans of correction are
incorporated by reference into this plan:
Plan of Correction Tags A 043, and A
115(F).

The Executive Director of Diagnostic Imaging
Administration conducted a gap analysis June 18, 2019
on every x-ray room throughout the organization to
identify those x-ray rooms that did not have privacy
curtains. A work order was created and all curtains will
be installed by July 10, 2019.
The Vice President of Ambulatory Operations
conducted a gap analysis June 18, 2019 on every
ambulatory exam room throughout the organization
to identify those exam rooms that did not have privacy
curtains. A work order was created and all curtains will
be installed by July 10, 2019.

Follow-up/Monitoring

President of Ambulatory Operations &
Chief Facilities Officer.

Person
Responsible
Completion Date
Completion Date:
July 10, 2019

Any rooms in need of action will be
identified, and work orders for correction
will be submitted and followed up to
ensure completion.
Ongoing, routine monitoring will be
performed by the Vice President of
Ambulatory Operations & Chief Facilities
Officer. Any rooms in need of action will
be identified, and work orders for
correction will be submitted and followed
up to ensure completion.

Ambulatory staff was instructed by the Vice President
of Ambulatory Operations to use these privacy
curtains whenever a patient was present.
Every Diagnostic Imaging and Ambulatory staff will
complete a Computer Based Training on patient
personal privacy by July 10, 2019.
Ambulatory staff on leave must complete the
computer based training before attending patients.
Education regarding patient personal privacy is
included in new employee orientation for all
ambulatory and Diagnostic Imaging staff.

Tag A
144
Patient
Rights:
Care in
Safe
Setting
A
144(1)

Hospital ensures patients have the right to care in a safe setting. Specifically, Hospital ensures that: 1. blood component transfusions are
administered in accordance with Hospital’s policy/procedures and acceptable nursing standards; 1.A. nurses continually assess patients during
transfusions of blood components, in accordance with Hospital policy; 1.B. nurses notify the physician of changes in vital signs and condition of
patients receiving transfusions of blood components, in accordance with Hospital policy; and 2. Hand-Off Communication are performed in
transferring a patient with an infectious disease from a patient unit to the operating room, and Contact isolation precautions for safe care are
implemented.
Hospital ensures that blood component
transfusions are administered in
accordance with Hospital’s

The Associate Director of G9 (Pediatrics) implemented
immediate individualized one on one training for the
two Pediatric RNs who cared for Patient #34 as

A random sample of 93 blood component
transfusion records are audited and
analyzed retrospectively each week by

Chief Operating
Officer

26

 Tag

Plan for correcting the cited deficiency

policy/procedures and acceptable nursing
standards.
A transfusion reaction investigation was
completed regarding the Reference
Patient. An interdisciplinary team including
the CMS/CLIA Steering Committee,
members of the Transfusion and Patient
Blood Management Committee, the
Multidisciplinary Clinical Policies and
Procedures Task Force, Medical Staff and
Nursing reviewed the Hospital’s Blood
Component Administration and
Transfusion Reaction Policy CLN1115. As
part of this review over 6,000 patient
charts who received blood transfusions
were reviewed.
A training program was developed by an
inter-disciplinary team, including a
transfusion medicine faculty member. This
team was led by the Executive Director of
Nursing, Professional Practice, Strategy
and Execution and the Chief Education and
Training Officer to develop curriculum and
implement training for Credentialed
Providers who obtain informed consent
for, order, administer or manage
complications of blood component
transfusions and registered nurses (RN)
who administer blood components
pursuant to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which includes enhanced
nursing standards for administering and
monitoring blood components.
The hospital nurse training “Blood
Component Administration Competency”
has been updated to include the following
transfusion reaction symptoms: dry,

Procedure for implementing the acceptable plan of
correction
follows:
Nurse-Day Shift: Trained 12/7/18 and 12/31/18.
Training included:
• Coached on the escalation of concerns
• Coached on appropriate documentation of
escalation of concerns/provider notification
• Nursing practice when carrying out the plan
of care; prioritizing interventions
• Reviewed gaps in documentation related to
hand-off documentation when the patient
leaves the unit
Nurse- Night Shift- Trained 12/20/18. Training
included:
• Gaps in vital sign monitoring and
documentation for blood component
administration
• Reviewed signs and symptoms of reactions
• Coached on appropriate documentation of
escalation of concerns/provider notification
• Reviewed institutional policy (CLN1115).
RNs who administer blood components received
educational information delivered in person by unit
nursing leadership (Associate Directors, Nurse
Managers, or Clinical Nurse Leaders) starting May 16,
2019 and completed by May 24, 2019. The topics
addressed included adherence to Blood Component
Administration and Transfusion Reaction Policy
CLN1115, as supported by ATT1722, Guidelines for
Identifying and Reporting a Transfusion Reaction,
acceptable nursing standards for assessment,
recognition, responding, and reporting symptoms of
suspected transfusion reactions.
RNs who administer blood components completed
mandatory computer based training with knowledge
assessment starting May 17, 2019 to be completed by
July 10, 2019. The topics addressed within the
computer based training on the Blood Component

Follow-up/Monitoring

the OPI to determine adherence to Blood
Component Administration and
Transfusion Reaction Policy CLN1115 for
vital signs and monitoring, that orders
specify the duration for the transfusion,
and the actual duration of the
transfusion. OPI reviews the data with the
Executive Director of Nursing Quality,
Safety and Research, and the Laboratory
Medicine Quality and Safety Officer to
develop recommendations for
improvement.

Person
Responsible
Completion Date
Completion Date:
July 10, 2019

In collaboration with the Executive
Director of Nursing Quality, Safety and
Research and the Laboratory Medicine
Quality and Safety Officer, OPI will submit
the information and recommendations
for improvement to the Transfusion and
Patient Blood Management Committee,
the ECMS, and the QAPI Council monthly
for at least 2 months.
After 2 months of data collection, the
QAPI Council will determine whether the
frequency of data collection should be
adjusted (up or down) based on
performance. The Transfusion and
Patient Blood Management Committee
and ECMS will review the determination
and may make recommendations for
further improvement to the QAPI Council.
The QAPI Council will provide a
summation to the ELT and the Governing
Body at least quarterly.
The Hospital will address any deficiencies
with the individual nursing staff member
through pertinent education and training,
re-education and/or disciplinary action, as
appropriate.

27

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

flushed skin, pain in the abdomen and
extremities, vomiting and bloody diarrhea.
The training also addresses signs and
symptoms of transfusion associated
circulatory overload. Completed May 17,
2019.

Administration and Transfusion Reaction Policy
CLN1115, which includes increased monitoring of vital
sign and patient assessment, recognizing, responding
and reporting transfusion reactions.

The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which was published on
May 19, 2019.
Under the revised policy, nursing staff are
to take the patient’s vital signs prior to
initiating the transfusion, 15 minutes into
the transfusion, hourly from the start of
the transfusion through completion of the
transfusion, and at completion of the
transfusion. They are required to assess
the patient for signs and symptoms of
transfusion reaction and document their
observations hourly through completion of
the transfusion, and at completion of the
transfusion.
The Electronic Health Record (EHR)
includes a list of the symptoms of a
transfusion reaction. If the nurse selects
yes, the EHR generates a checklist of the
symptoms allowing the nurse to select the
symptoms that are present.
To ensure RNs administer blood
components in accordance with Hospital
policy and acceptable nursing standards:
(1) The Blood Component Administration
and Transfusion Reaction Policy CLN1115
was further modified to require that blood

Material was also reviewed regarding delivering
patient education for participation in their care while
receiving blood components.

Follow-up/Monitoring

Person
Responsible
Completion Date

Any Credentialed Provider deficiencies
will be addressed through pertinent
education and training, re-education
and/or referral for confidential peer
review through the medical staff.

Additional training will be conducted regarding the
changes to the EHR Blood Component Order Sets, the
modifications to the Blood Component Administration
and Transfusion Reaction Policy CLN1115 (including
the use of volumetric pumps, orders to include the
duration of the transfusion, and definitions of
hypotension and fever, as described in ATT1722,
Guidelines for Identifying and Reporting a Transfusion
Reaction), and the Stop the Line for Patient Safety
Policy CLN1185, by July 10, 2019.
RNs on leave who transfuse blood components must
complete training before attending patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 and the
enhanced nursing standards for administering and
monitoring blood component transfusions, and the
Stop the Line for Patient Safety Policy CLN1185 is
included in the on-boarding process for new RNs who
transfuse blood components.
Credentialed Providers who obtain informed consent
for, order, administer or manage complications of
blood component transfusions will complete the
computer based training as outlined above by July 10,
2019.
Credentialed Providers who obtain informed consent
for, order, administer or manage complications of
blood components and are on leave must complete
the computer based training before attending

28

 Tag

Plan for correcting the cited deficiency

components are administered via
volumetric pump to ensure the duration of
the transfusion is in accordance with
the physician’s orders. (Accordingly, blood
components will not be administered via
“gravity” flow).
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which was approved on
June 20, 2019.

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 and the Stop
the Line for Patient Safety Policy CLN1185 is included
in the on-boarding process for new Credentialed
Providers.
A reminder communication will be sent to all nursing
staff who administer and monitor transfusions
regarding the process for reporting a suspected
transfusion reaction, by July 10, 2019.

(2) Based on the National Patient Safety
Network Biovigilance Component
Hemovigilance Module Surveillance
Protocol, published April 2018 by the
Centers for Disease Control the Blood
Component Administration and
Transfusion Reaction Policy CLN1115 will
be amended to include the definitions of
hypotension and fever, by July 10, 2019.
ATT1722, Guidelines for Identifying and
Reporting a Transfusion Reaction, which
supports CLN1115, will be revised to
address the hypotension and fever
parameters by July 10, 2019.
(3) EHR Physician Blood Component Order
Set was modified to require duration of
blood component transfusion. A
Credentialed Provider must specify the
duration of the blood component
transfusion in order to complete the blood
component order (hard stop). This change
will be effective by July 10, 2019.
(4) Stop the Line for Patient Safety Policy
CLN1185 was modified to permit anyone

29

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

to stop the line for an incomplete,
conflicting or unclear order or in the event
of a suspected transfusion reaction.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS
approved the updated Stop the Line for
Patient Safety Policy CLN1185, which was
approved on June 20, 2019.
Further training was developed on the EHR
Blood Component Order Sets, and the
modifications to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115 and the Stop the Line for
Patient Safety Policy CLN1185.
The hospital has developed a
Hemovigilance Unit that will track the vital
signs of each patient receiving transfusion
services. Phase 1 of the Hemovigilance
Unit’s activities consist of performing
retrospective chart reviews on patients
identified through the Unit monitoring
system as having a possible transfusion
reaction. Any patients identified as having
a definite reaction receive a written
consult, recorded in the EHR, from a
Transfusion Medicine Physician. May 20,
2019.
Following a 2-4 week prospective pilot in 3
areas where transfusions are administered
(Phase 2), the Hemovigilance Unit will
track the vital signs of each patient
receiving transfusion services in real time
(Phase 3). These vital signs will be
reviewed by an RN under the supervision
of an Advanced Practice Provider (APP) or
physician 24/7 to complement the
monitoring being provided at the bedside.

30

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

The Associate Director of G9 (Pediatrics) implemented
immediate individualized one on one training for the
two Pediatric RNs who cared for Patient #34 as
follows:

A random sample of 93 blood component
transfusion records are audited and
analyzed retrospectively each week by
the OPI to determine adherence to Blood
Component Administration and
Transfusion Reaction Policy CLN1115 for
the for vital signs and monitoring. OPI
reviews the data with the Executive
Director of Nursing Quality, Safety and
Research, and the Laboratory Medicine
Quality and Safety Officer to develop
recommendations for improvement.

Person
Responsible
Completion Date

The real time monitoring will also weight
the vital signs and assign a risk number for
each patient that is updated in real time,
highlighting patients exhibiting potential
signs of a reaction. Signs of a reaction will
be referred to a member of the transfusion
medicine practice. In addition to the
monitoring being done by nursing under
this POC, the Hemovigilance Unit will also
review potential false negatives on an
ongoing basis and report to the
Transfusion and Patient Blood
Management Committee.
We are not formally submitting Phase 2
and 3 as part of our corrective action as
these require a significant time investment
to operationalize it across the hospital but
we wanted CMS to be aware of its
development as proof of our commitment
to being an industry leader in developing
new, innovative approaches to delivering
the highest level of care.

A
144(1)(
A)

This plan of correction is also addressed
under the Plans of Correction Tags A 043,
A 115, A 385, and A 409.
The Hospital ensures that nurses
continually assess patients during
transfusion of blood components.
A transfusion reaction investigation was
completed regarding the Reference
Patient. An interdisciplinary team including
the CMS/CLIA Steering Committee,
members of the Transfusion and Patient
Blood Management Committee, the
Multidisciplinary Clinical Policies and
Procedures Task Force, Medical Staff and
Nursing reviewed the Hospital’s Blood
Component Administration and

Nurse-Day Shift: Trained 12/7/18 and 12/31/18.
Training included:
• Coached on the escalation of concerns
• Coached on appropriate documentation of
escalation of concerns/provider notification
• Nursing practice when carrying out the plan
of care; prioritizing interventions
• Reviewed gaps in documentation related to

Chief Operating
Officer
Completion Date:
July 10, 2019

In collaboration with the Executive

31

 Tag

Plan for correcting the cited deficiency

Transfusion Reaction Policy CLN1115. As
part of this review over 6,000 patient
charts who received blood transfusions
were reviewed.

A training program was developed by an
inter-disciplinary team, including a
transfusion medicine faculty member. This
team was led by the Executive Director of
Nursing, Professional Practice, Strategy
and Execution and the Chief Education and
Training Officer to develop curriculum and
implement training for Credentialed
Providers who obtain informed consent
for, order, administer or manage
complications of blood component
transfusions and registered nurses (RN)
who administer blood components
pursuant to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which includes enhanced
nursing standards for administering and
monitoring blood components.
The hospital nurse training “Blood
Component Administration Competency”
has been updated to include the following
transfusion reaction symptoms: dry,
flushed skin, pain in the abdomen and
extremities, vomiting and bloody diarrhea.
The training also addresses signs and
symptoms of transfusion associated
circulatory overload. Completed May 17,
2019.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which was published on

Procedure for implementing the acceptable plan of
correction
hand-off documentation when the patient
leaves the unit
RNs who administer blood components received
educational information delivered in person by unit
nursing leadership (Associate Directors, Nurse
Managers, or Clinical Nurse Leaders) starting May 16,
2019 and completed by May 24, 2019. The topics
addressed included adherence to Blood Component
Administration and Transfusion Reaction Policy
CLN1115, as supported by ATT1722, Guidelines for
Identifying and Reporting a Transfusion Reaction,
acceptable nursing standards for continual
assessment, recognition, responding, and reporting
symptoms of suspected transfusion reactions.
RNs who administer blood components completed
mandatory computer based training with knowledge
assessment starting May 17, 2019 to be completed by
July 10, 2019. The topics addressed within the
computer based training on the Blood Component
Administration and Transfusion Reaction Policy
CLN1115, which includes increased monitoring of vital
sign and patient assessment, recognizing, responding
and reporting transfusion reactions.
Material was also reviewed regarding delivering
patient education for participation in their care while
receiving blood components.
Additional training will be conducted regarding the
changes to the Blood Component Administration and
Transfusion Reaction Policy CLN1115 (including
definitions of hypotension and fever, as described in
ATT1722, Guidelines for Identifying and Reporting a
Transfusion Reaction), and the Stop the Line for
Patient Safety Policy CLN1185, by July 10, 2019.

Follow-up/Monitoring

Person
Responsible
Completion Date

Director of Nursing Quality, Safety and
Research and the Laboratory Medicine
Quality and Safety Officer, OPI will submit
the information and recommendations
for improvement to the Transfusion and
Patient Blood Management Committee,
the ECMS, and the QAPI Council monthly
for at least 2 months.
After 2 months of data collection, the
QAPI Council will determine whether the
frequency of data collection should be
adjusted (up or down) based on
performance. The Transfusion and
Patient Blood Management Committee
and ECMS will review the determination
and may make recommendations for
further improvement to the QAPI Council.
The QAPI Council will provide a
summation to the ELT and the Governing
Body at least quarterly.
The Hospital will address any deficiencies
with the individual nursing staff member
through pertinent education and training,
re-education and/or disciplinary action, as
appropriate.
Any Credentialed Provider deficiencies
will be addressed through pertinent
education and training, re-education
and/or referral for confidential peer
review through the medical staff.

RNs on leave who transfuse blood components must
complete training before attending patients.

32

 Tag

Plan for correcting the cited deficiency

May 19, 2019.
Under the revised policy, nursing staff are
to take the patient’s vital signs prior to
initiating the transfusion, 15 minutes into
the transfusion, hourly from the start of
the transfusion through completion of the
transfusion, and at completion of the
transfusion. They are required to assess
the patient for signs and symptoms of
transfusion reaction and document their
observations hourly through completion of
the transfusion, and at completion of the
transfusion.

The Electronic Health Record (EHR)
includes a list of the symptoms of a
transfusion reaction. If the nurse selects
yes, the EHR generates a checklist of the
symptoms allowing the nurse to select the
symptoms that are present.
To ensure RNs administer blood
components in accordance with Hospital
policy and acceptable nursing standards:

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 and the
enhanced nursing standards for administering and
monitoring blood component transfusions, and the
Stop the Line for Patient Safety Policy CLN1185 is
included in the on-boarding process for new RNs who
transfuse blood components.
Credentialed Providers who obtain informed consent
for, order, administer or manage complications of
blood component transfusions will complete the
computer based training as outlined above by July 10,
2019.
Credentialed Providers who obtain informed consent
for, order, administer or manage complications of
blood components and are on leave must complete
the computer based training before attending
patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 and the Stop
the Line for Patient Safety Policy CLN1185 is included
in the on-boarding process for new Credentialed
Providers.

(1) Based on the National Patient Safety
Network Biovigilance Component
Hemovigilance Module Surveillance
Protocol, published April 2018 by the
Centers for Disease Control the Blood
Component Administration and
Transfusion Reaction Policy CLN1115 will
be amended to include the definitions of
hypotension and fever, by July 10, 2019.
ATT1722, Guidelines for Identifying and
Reporting a Transfusion Reaction, which
supports CLN1115, will be revised to
address the hypotension and fever

33

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

parameters by July 10, 2019.
(2) Stop the Line for Patient Safety Policy
CLN1185 was modified to permit anyone
to stop the line for an incomplete,
conflicting or unclear order or in the event
of a suspected transfusion reaction.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS
approved the updated Stop the Line for
Patient Safety Policy CLN1185, which was
approved on June 20, 2019.
Further training was developed on the
modifications to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115 and the Stop the Line for
Patient Safety Policy CLN1185.
The hospital has developed a
Hemovigilance Unit that will track the vital
signs of each patient receiving transfusion
services. Phase 1 of the Hemovigilance
Unit’s activities consist of performing
retrospective chart reviews on patients
identified through the Unit monitoring
system as having a possible transfusion
reaction. Any patients identified as having
a definite reaction receive a written
consult, recorded in the EHR, from a
Transfusion Medicine Physician. May 20,
2019.
Following a 2-4 week prospective pilot in 3
areas where transfusions are administered
(Phase 2), the Hemovigilance Unit will
track the vital signs of each patient
receiving transfusion services in real time
(Phase 3). These vital signs will be
reviewed by an RN under the supervision

34

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

The Associate Director of G9 (Pediatrics) implemented
immediate individualized one on one training for the
two Pediatric RNs who cared for Patient #34 as
follows:

A random sample of 93 blood component
transfusion records are audited and
analyzed retrospectively each week by
the OPI to determine adherence to (1)
Blood Component Administration and
Transfusion Reaction Policy CLN1115,
including reporting to and consulting with
the Credentialed Provider and the
Transfusion Medicine Physician for
suspected transfusion reactions, and (2)
Stop the Line for Patient Safety Policy

Person
Responsible
Completion Date

of an APP or physician 24/7 to
complement the monitoring being
provided at the bedside. The real time
monitoring will also weight the vital signs
and assign a risk number for each patient
that is updated in real time, highlighting
patients exhibiting potential signs of a
reaction. Signs of a reaction will be
referred to a member of the transfusion
medicine practice. In addition to the
monitoring being done by nursing under
this POC, the Hemovigilance Unit will also
review potential false negatives on an
ongoing basis and report to the
Transfusion and Patient Blood
Management Committee.
We are not formally submitting Phase 2
and 3 as part of our corrective action as
these require a significant time investment
to operationalize it across the hospital but
we wanted CMS to be aware of its
development as proof of our commitment
to being an industry leader in developing
new, innovative approaches to delivering
the highest level of care.

A
144(1)(
B)

This plan of correction is also addressed
under the Plans of Correction Tags A 115,
A 144, A 385, and A 409.
Hospital ensures that nurses notify the
Credentialed Providers of changes in vital
signs and condition of patients receiving
transfusions of blood components as
required under the Hospital policy.
A transfusion reaction investigation was
completed regarding the Reference
Patient. An interdisciplinary team including
the CMS/CLIA Steering Committee,
members of the Transfusion and Patient

Nurse-Day Shift: Trained 12/7/18 and 12/31/18.
Training included:
• Coached on the escalation of concerns
• Coached on appropriate documentation of
escalation of concerns/provider notification

Chief Operating
Officer
Completion Date:
July 10, 2019

35

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Blood Management Committee, the
Multidisciplinary Clinical Policies and
Procedures Task Force, Medical Staff and
Nursing reviewed the Hospital’s Blood
Component Administration and
Transfusion Reaction Policy CLN1115. As
part of this review over 6,000 patient
charts who received blood transfusions
were reviewed.

Nursing practice when carrying out the plan
of care; prioritizing interventions
Reviewed gaps in documentation related to hand-off
documentation when the patient leaves the unit

A training program was developed by an
inter-disciplinary team, including a
transfusion medicine faculty member. This
team was led by the Executive Director of
Nursing, Professional Practice, Strategy
and Execution and the Chief Education and
Training Officer to develop curriculum and
implement training for Credentialed
Providers who obtain informed consent
for, order, administer or manage
complications of blood component
transfusions and registered nurses (RN)
who administer blood components
pursuant to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which includes enhanced
nursing standards for administering and
monitoring blood components.
The hospital nurse training “Blood
Component Administration Competency”
has been updated to include the following
transfusion reaction symptoms: dry,
flushed skin, pain in the abdomen and
extremities, vomiting and bloody diarrhea.
The training also addresses signs and
symptoms of transfusion associated
circulatory overload. Completed May 17,
2019.

•

Nurse- Night Shift- Trained 12/20/18. Training
included:
• Gaps in vital sign monitoring and
documentation for blood component
administration
• Reviewed signs and symptoms of reactions
• Coached on appropriate documentation of
escalation of concerns/provider notification
• Reviewed institutional policy (CLN1115).
RNs who administer blood components received
educational information delivered in person by unit
nursing leadership (Associate Directors, Nurse
Managers, or Clinical Nurse Leaders) starting May 16,
2019 and completed by May 24, 2019. The topics
addressed included adherence to Blood Component
Administration and Transfusion Reaction Policy
CLN1115, as supported by ATT1722, Guidelines for
Identifying and Reporting a Transfusion Reaction,
acceptable nursing standards for assessment,
recognition, responding, and reporting symptoms of
suspected transfusion reactions.
RNs who administer blood components completed
mandatory computer based training with knowledge
assessment starting May 17, 2019 to be completed by
July 10, 2019. The topics addressed within the
computer based training on the Blood Component
Administration and Transfusion Reaction Policy
CLN1115, included increased monitoring of vital sign
and patient assessment, recognizing, responding and
reporting transfusion reactions to and consulting with
the Credentialed Provider and the Transfusion
Medicine Physician, and clarifying physician orders.
Material was also reviewed regarding delivering

Follow-up/Monitoring

Person
Responsible
Completion Date

CLN1185, to stop the line in the event of a
suspected transfusion reaction or an
incomplete, conflicting or unclear order.
OPI reviews the data with the Executive
Director of Nursing Quality, Safety and
Research, and the Laboratory Medicine
Quality and Safety Officer to develop
recommendations for improvement.
In collaboration with the Executive
Director of Nursing Quality, Safety and
Research and the Laboratory Medicine
Quality and Safety Officer, OPI will submit
the information and recommendations
for improvement to the Transfusion and
Patient Blood Management Committee,
the ECMS, and the QAPI Council monthly
for at least 2 months.
After 2 months of data collection, the
QAPI Council will determine whether the
frequency of data collection should be
adjusted (up or down) based on
performance. The Transfusion and
Patient Blood Management Committee
and ECMS will review the determination
and may make recommendations for
further improvement to the QAPI Council.
The QAPI Council will provide a
summation to the ELT and the Governing
Body at least quarterly.
The Hospital will address any deficiencies
with the individual nursing staff member
through pertinent education and training,
re-education and/or disciplinary action, as
appropriate.
Any Credentialed Provider deficiencies
will be addressed through pertinent

36

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which was published on
May 19, 2019.

patient education for participation in their care while
receiving blood components.

Under the revised policy, nursing staff are
to take the patient’s vital signs prior to
initiating the transfusion, 15 minutes into
the transfusion, hourly from the start of
the transfusion through completion of the
transfusion, and at completion of the
transfusion. They are required to assess
the patient for signs and symptoms of
transfusion reaction and document their
observations hourly through completion of
the transfusion and at completion of the
transfusion.
The Electronic Health Record (EHR)
includes a list of the symptoms of a
transfusion reaction. If the nurse selects
yes, the EHR generates a checklist of the
symptoms allowing the nurse to select the
symptoms that are present.
To ensure RNs notify the Credentialed
Providers of condition of patients receiving
transfusions of blood components as
required under the Hospital policy:
(1) Based on the National Patient Safety
Network Biovigilance Component
Hemovigilance Module Surveillance
Protocol, published April 2018 by the
Centers for Disease Control the Blood
Component Administration and
Transfusion Reaction Policy CLN1115 will
be amended to include the definitions of
hypotension and fever, by July 10, 2019.

Follow-up/Monitoring

Person
Responsible
Completion Date

education and training, re-education
and/or referral for confidential peer
review through the medical staff.

Additional training will be conducted regarding the
changes to the Blood Component Administration and
Transfusion Reaction Policy CLN1115 (including
definitions of hypotension and fever, reporting
suspected transfusion reactions to and consulting with
the Credentialed Provider and the Transfusion
Medicine Physician), and the Stop the Line for Patient
Safety Policy CLN1185, by July 10, 2019.
RNs on leave who transfuse blood components must
complete training before attending patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 and the
enhanced nursing standards for administering and
monitoring blood component transfusions, Stop the
Line for Patient Safety Policy CLN1185 is included in
the on-boarding process for new RNs who transfuse
blood components.
Credentialed Providers who obtain informed consent
for, order, administer or manage complications of
blood component transfusions will complete the
computer based training as outlined above by July 10,
2019.
Credentialed Providers who obtain informed consent
for, order, administer or manage complications of
blood components and are on leave must complete
the computer based training before attending
patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 is included in
the on-boarding process for new Credentialed
Providers.

37

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

ATT1722, Guidelines for Identifying and
Reporting a Transfusion Reaction, which
supports CLN1115, will be revised to
address the hypotension and fever
parameters by July 10, 2019.
(2) The Blood Component Administration
and Transfusion Reaction Policy CLN1115
was further modified to require that the
Transfusion Medicine Physician is
consulted regarding suspected blood
component transfusion reactions.
(3) Stop the Line for Patient Safety Policy
CLN1185 was modified to permit anyone
to stop the line for an incomplete,
conflicting or unclear order or in the event
of a suspected transfusion reaction.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS
approved the updated Stop the Line for
Patient Safety Policy CLN1185, which was
approved on June 20, 2019.
Further training was developed on the
modifications to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115 and the Stop the Line for
Patient Safety Policy CLN1185.
The hospital has developed a
Hemovigilance Unit that will track the vital
signs of each patient receiving transfusion
services. Phase 1 of the Hemovigilance
Unit’s activities consist of performing
retrospective chart reviews on patients
identified through the Unit monitoring
system as having a possible transfusion
reaction. Any patients identified as having

38

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

a definite reaction receive a written
consult, recorded in the EHR, from a
Transfusion Medicine Physician. May 20,
2019.
The hospital has developed a
Hemovigilance Unit that will track the vital
signs of each patient receiving transfusion
services. Phase 1 of the Hemovigilance
Unit’s activities consist of performing
retrospective chart reviews on patients
identified through the Unit monitoring
system as having a possible transfusion
reaction. Any patients identified as having
a definite reaction receive a written
consult, recorded in the EHR, from a
Transfusion Medicine Physician. May 20,
2019.
Following a 2-4 week prospective pilot in 3
areas where transfusions are administered
(Phase 2), the Hemovigilance Unit will
track the vital signs of each patient
receiving transfusion services in real time
(Phase 3). These vital signs will be
reviewed by an RN under the supervision
of an APP or physician 24/7 to
complement the monitoring being
provided at the bedside. The real time
monitoring will also weight the vital signs
and assign a risk number for each patient
that is updated in real time, highlighting
patients exhibiting potential signs of a
reaction. Signs of a reaction will be
referred to a member of the transfusion
medicine practice. In addition to the
monitoring being done by nursing under
this POC, the Hemovigilance Unit will also
review potential false negatives on an
ongoing basis and report to the
Transfusion and Patient Blood

39

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

Management Committee.
We are not formally submitting Phase 2
and 3 as part of our corrective action as
these require a significant time investment
to operationalize it across the hospital but
we wanted CMS to be aware of its
development as proof of our commitment
to being an industry leader in developing
new, innovative approaches to delivering
the highest level of care.

A
144(2)

This plan of correction is also addressed
under the Plans of Correction Tags A 043,
A 115, A 385, and A 409.
Hand-Off Communications are performed
and documented in transferring a patient
with isolation precaution orders from one
patient location to another to ensure that
isolation precautions for safe care are
implemented.
Nursing leadership reviewed Hand-Off
Communication Policy CLN0513 in relation
to transfers within Hospital, by June 19,
2019.
The Executive Director of Clinical
Informatics approved a modification to the
EHR Hand-Off Communication
documentation for nursing to include
isolation precautions. A new flow sheet
row will serve as the transferring RN’s
attestation that the isolation status was
communicated to the receiving health care
provider.
The Executive Director of Nursing,
Professional Practice, Strategy and
Execution in collaboration with the
Director of Education developed and will

RNs who provide hand-off communication for patients
transferring within Hospital will receive education and
training with nurse leadership (Associate Director,
nurse manager, clinical nurse leaders and educators)
to be completed by July 10, 2019. The topics
addressed during the training will emphasize isolation
precaution information, adherence to Hand-Off
Communication Policy CLN 0513, and documentation
and modification enhancements to EHR to include
attestation of isolation precautions.
RNs on leave who provide hand-off communication for
patients transferring within Hospital must complete
the training before attending patients
Education regarding isolation precaution information,
adherence to Hand-Off Communication Policy CLN
0513, documentation and the EHR that includes
attestation of isolation precautions
will be included in the on-boarding process for new
RNs who provide hand-off communication for patients
transferring within Hospital.

The Hospital will prepare a report
reflecting all isolation inpatients with a
permanent or temporary hand-off to
assess whether the RN attestation of
hand-off and isolation precaution was
communicated and documented.

Chief Nursing
Officer
Completion Date:
July 10, 2019

The report is reviewed weekly by the
Executive Directors of Nursing team and
the Chief Nursing Officer, who may
recommend and implement any
appropriate changes.
The report will be submitted to the QAPI
Council monthly for the initial quarter.
After the first quarter, QAPI Council will
determine whether the frequency of data
collection should be adjusted (up or
down) based on performance.
Monitoring and reporting will continue
until 100% compliance is documented for
two consecutive months.
The QAPI Council will review the
information, and may make

40

 Tag

Plan for correcting the cited deficiency

implement educational training specifically
addressing hand-off communication and
documentation related to isolation
precautions for patient transfers within
Hospital in accordance with Hand-Off
Communication Policy CLN 0513 and the
new documentation.

Tag A
263
QAPI

A 263

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

recommendations for further
improvement, and provide at least a
summation to the ELT and the Governing
Body at least quarterly.
The Hospital will address any deficiencies
with the individual RN through pertinent
training, re-education and/or disciplinary
action, as appropriate.

This plan of correction is also addressed
under the Plans of Correction Tags A 043,
A 115.
Hospital has developed, has implemented and maintains an effective, ongoing, hospital-wide, data-driven Quality Assessment and Performance
Improvement (QAPI) program. The hospital's Governing Body ensures that the program reflects the complexity of the hospital's organization and
services; involves all hospital departments and services (including those services furnished under contractor arrangement); and focuses on
indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital maintains demonstrable
evidence of its QAPI program for review by CMS.
Hospital adopted a formal, effective,
The QAPI Program is supported by the Office of
The Chief Operating Officer and Chief
ongoing, hospital-wide and data-driven
Performance Improvement, which reports to the Chief Medical Executive will jointly monitor the
QAPI Program that reflects the complexity Operating Officer. The Office of Performance
QAPI Program on a monthly basis for the
of the Hospital’s structure and services.
Improvement provides support for the QAPI Program
initial 6 months to:
The QAPI Program includes all Hospital
through three separate departments (Patient Safety
i. Ensure the QAPI Council is meeting at
departments and services, including
and Accreditation; Quality Measurement; and
least 10 times per year,
services furnished under contract or
Healthcare Systems Engineering).
ii. Document meeting minutes
arrangement.
The Chief Patient Safety Officer, the Chief Value and
iii. Focus on the indicators as directed by
Quality Officer and the Chief Patient Experience
the Governing Body related to improved
The Chair of the ECMS, representatives of
Officer, covering the Hospital departments, will report health outcomes and prevention and
the ELT and Governing Body will approve
to the QAPI Council all quality assessment, quality
reduction of medical errors, and
the updated QAPI Program on June 27,
improvement, and other quality indicator data
otherwise complying with the QAPI
2019.
described in the QAPI Program in accordance with the Program.
QAPI Council meeting schedule. These officers will
iv. Ensure the QAPI program is hospitalThe Governing Body has established the
report immediate or significant quality concerns on an wide.
Quality Assessment and Performance
ad hoc basis to the QAPI Council. The QAPI Council
v. Ensure reporting to the Governing Body
Improvement Council (QAPI Council) on
Chairs will report immediately to the ELT and the
in accordance with the QAPI Program.
June 13, 2019, as the overall coordinating
Governing Body. Ad hoc meetings will be scheduled at
body for hospital-wide quality and safety
the request of the QAPI Council Chairs. The frequency This monitoring will occur until 100%
efforts across the organization. The QAPI
for each department, committee and contracted
compliance of the above noted criteria is
Council is responsible to provide regular
service is documented in the reporting cadence.
achieved for 6 consecutive months and
reports to the Governing Body and the ELT
annually thereafter. The results are
on the results and effectiveness of the
The QAPI Council reports to the ELT and the Governing reported to the ELT and the Governing
QAPI Program. The Governing Body
Body at least 10 times a year, as noted.
Body.

Chief Operating
Officer
Completion Date:
July 10, 2019

41

 Tag

Plan for correcting the cited deficiency

appointed the QAPI Council Chairs on June
13, 2019. The QAPI Council reviews quality
indicator data, identifies gaps, and is
accountable for successful implementation
of action plans to improve health
outcomes and prevent and reduce medical
errors from all clinical departments in the
Hospital.
The QAPI Council facilitates creating,
promoting and maintaining a culture of
safety and quality throughout the Hospital
as a result of its actions. The QAPI Council
provides the infrastructure for leaders to
use data and information to guide
decisions and to understand variation in
the performance of processes supporting
safety, quality/outcomes and patient
experience. The QAPI Program includes a
reporting cadence for the departments,
committees and contracted services that
report to the QAPI Council. The QAPI
Council meets at least 10 times per year,
takes minutes of all reviews and actions
and provides feedback to appropriate
committees. The QAPI Council reports to
the ELT and the Governing Body at least 10
times per year.

Procedure for implementing the acceptable plan of
correction

The Governing Body, ELT members, QAPI Council
members, QAPI Council Subcommittee members and
Patient Safety Quality Officers will receive mandatory
education on the QAPI Program directed by the Chief
Operating Officer, by July 10, 2019. Topics addressed
during the education include CMS and Hospital
expectations for QAPI activities, new responsibilities
for each individual and new quality-related reporting
structure.
Any ELT members, QAPI Council members, QAPI
Council Subcommittee members and Patient Safety
Quality Officers on leave (FMLA or vacation) must
complete the education before resuming quality
responsibilities.

Follow-up/Monitoring

Person
Responsible
Completion Date

The ELT as directed by the Governing
Body will address any deficiencies with
the QAPI Council, as appropriate.
The Governing Body has directed priority
measures for the QAPI Program, to
include blood component transfusion.
The Governing Body will perform periodic
evaluation of the metrics to ensure
meaningful and relevant measures
related to safety, quality/outcomes and
patient experience.

Education regarding the QAPI Program is included in
the on-boarding process for new ELT members, QAPI
Council members, QAPI Council Subcommittee
members and Patient Safety Quality Officers.

The QAPI Council provides support for the
hospital-wide systems to collect, analyze,
report and utilize meaningful, accurate
data throughout the Hospital. For
Performance Improvement, the QAPI
Council utilizes a dedicated focus on data
collection and reporting, and is
accountable for the successful
implementation of analysis and action
planning to impact areas and processes
that are high-risk, high-volume and
problem-prone throughout the Hospital.

42

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

The Governing Body has directed the ELT
to facilitate the oversight of the QAPI
Council and the evaluation of data and
actions taken to support safety,
quality/outcomes and patient experience.
The QAPI Council reports to the ELT at
least 10 times a year and the Governing
body chairs ELT to effectuate the goals of
the QAPI Program and ensure that the
QAPI Program reflects the complexity of
the Hospital's organization and services,
including services furnished under contract
or arrangement, and focus on indicators
related to improved health outcomes and
the prevention and reduction of medical
errors.
The Governing Body and the ELT provides
oversight and ensures that the QAPI
program reviews each of the alleged
deficiencies in the 2567 that impacts or
could impact quality of care.
The Hospital maintains and demonstrates
evidence of its QAPI Program for review by
CMS.

Tag A
385
Nursing
Service
s
A
385(A)

The following plan of correction is
incorporated by reference into this Plan:
Plan of Correction Tag A-043.
The Hospital has an organized nursing service that provides 24-hour nursing services. The nursing services are furnished or supervised by a
registered nurse.

A. Hospital ensures that blood component
transfusions are administered in
accordance with Hospital’s
policy/procedures and acceptable nursing

A. The Associate Director of G9 (Pediatrics)
implemented immediate individualized one on one
training for the two Pediatric RNs who cared for
Patient #34 as follows:

A. A random sample of 93 blood
component transfusion records are
audited and analyzed retrospectively each
week by the OPI to determine adherence

A. Chief Nursing
Officer
Completion Date:

43

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

standards.
A transfusion reaction investigation was
completed regarding the Reference
Patient. An interdisciplinary team including
the CMS/CLIA Steering Committee,
members of the Transfusion and Patient
Blood Management Committee, the
Multidisciplinary Clinical Policies and
Procedures Task Force, Medical Staff and
Nursing reviewed the Hospital’s Blood
Component Administration and
Transfusion Reaction Policy CLN1115. As
part of this review over 6,000 patient
charts who received blood transfusions
were reviewed.
A training program was developed by an
inter-disciplinary team, including a
transfusion medicine faculty member. This
team was led by the Executive Director of
Nursing, Professional Practice, Strategy
and Execution and the Chief Education and
Training Officer to develop curriculum and
implement training for Credentialed
Providers who obtain informed consent
for, order, administer or manage
complications of blood component
transfusions and registered nurses (RN)
who administer blood components
pursuant to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which includes enhanced
nursing standards for administering and
monitoring blood components.
The hospital nurse training “Blood
Component Administration Competency”
has been updated to include the following
transfusion reaction symptoms: dry,
flushed skin, pain in the abdomen and

Nurse-Day Shift: Trained 12/7/18 and 12/31/18.
Training included:
• Coached on the escalation of concerns
• Coached on appropriate documentation of
escalation of concerns/provider notification
• Nursing practice when carrying out the plan
of care; prioritizing interventions
• Reviewed gaps in documentation related to
hand-off documentation when the patient
leaves the unit
Nurse- Night Shift- Trained 12/20/18. Training
included:
• Gaps in vital sign monitoring and
documentation for blood component
administration
• Reviewed signs and symptoms of reactions
• Coached on appropriate documentation of
escalation of concerns/provider notification
• Reviewed institutional policy (CLN1115).
RNs who administer blood components received
educational information delivered in person by unit
nursing leadership (Associate Directors, Nurse
Managers, or Clinical Nurse Leaders) starting May 16,
2019 and completed by May 24, 2019. The topics
addressed included adherence to Blood Component
Administration and Transfusion Reaction Policy
CLN1115, as supported by ATT1722, Guidelines for
Identifying and Reporting a Transfusion Reaction,
acceptable nursing standards for assessment,
recognition, responding, and reporting symptoms of
suspected transfusion reactions.
RNs who administer blood components completed
mandatory computer based training with knowledge
assessment starting May 17, 2019 to be completed by
July 10, 2019. The topics addressed within the
computer based training on the Blood Component
Administration and Transfusion Reaction Policy

Follow-up/Monitoring

to Blood Component Administration and
Transfusion Reaction Policy CLN1115 for
vital signs and monitoring, that orders
specify the duration for the transfusion,
and the actual duration of the
transfusion. OPI reviews the data with the
Executive Director of Nursing Quality,
Safety and Research, and the Laboratory
Medicine Quality and Safety Officer to
develop recommendations for
improvement.

Person
Responsible
Completion Date
July 10, 2019

In collaboration with the Executive
Director of Nursing Quality, Safety and
Research and the Laboratory Medicine
Quality and Safety Officer, OPI will submit
the information and recommendations
for improvement to the Transfusion and
Patient Blood Management Committee,
the ECMS, and the QAPI Council monthly
for at least 2 months.
After 2 months of data collection, the
QAPI Council will determine whether the
frequency of data collection should be
adjusted (up or down) based on
performance. The Transfusion and
Patient Blood Management Committee
and ECMS will review the determination
and may make recommendations for
further improvement to the QAPI Council.
The QAPI Council will provide a
summation to the ELT and the Governing
Body at least quarterly.
The Hospital will address any deficiencies
with the individual nursing staff member
through pertinent education and training,
re-education and/or disciplinary action, as
appropriate.

44

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

extremities, vomiting and bloody diarrhea.
The training also addresses signs and
symptoms of transfusion associated
circulatory overload. Completed May 17,
2019.

CLN1115, which includes increased monitoring of vital
sign and patient assessment, recognizing, responding
and reporting transfusion reactions.

The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which was published on
May 19, 2019.
Under the revised policy, nursing staff are
to take the patient’s vital signs prior to
initiating the transfusion, 15 minutes into
the transfusion, hourly from the start of
the transfusion through completion of the
transfusion, and at completion of the
transfusion. They are required to assess
the patient for signs and symptoms of
transfusion reaction and document their
observations hourly through completion of
the transfusion, and at completion of the
transfusion.
The Electronic Health Record (EHR)
includes a list of the symptoms of a
transfusion reaction. If the nurse selects
yes, the EHR generates a checklist of the
symptoms allowing the nurse to select the
symptoms that are present.
To ensure RNs administer blood
components in accordance with Hospital
policy and acceptable nursing standards:
(1) The Blood Component Administration
and Transfusion Reaction Policy CLN1115
was further modified to require that blood
components are administered via

Material was also reviewed regarding delivering
patient education for participation in their care while
receiving blood components.

Follow-up/Monitoring

Person
Responsible
Completion Date

Any Credentialed Provider deficiencies
will be addressed through pertinent
education and training, re-education
and/or referral for confidential peer
review through the medical staff.

Additional training will be conducted regarding the
changes to the EHR Blood Component Order Sets, the
modifications to the Blood Component Administration
and Transfusion Reaction Policy CLN1115 (including
the use of volumetric pumps, orders to include the
duration of the transfusion, and definitions of
hypotension and fever, as described in ATT1722,
Guidelines for Identifying and Reporting a Transfusion
Reaction), and the Stop the Line for Patient Safety
Policy CLN1185, by July 10, 2019.
RNs on leave who transfuse blood components must
complete training before attending patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 and the
enhanced nursing standards for administering and
monitoring blood component transfusions, and the
Stop the Line for Patient Safety Policy CLN1185 is
included in the on-boarding process for new RNs who
transfuse blood components.
Credentialed Providers who obtain informed consent
for, order, administer or manage complications of
blood component transfusions will complete the
computer based training as outlined above by July 10,
2019.
Credentialed Providers who obtain informed consent
for, order, administer or manage complications of
blood components and are on leave must complete
the computer based training before attending
patients.

45

 Tag

Plan for correcting the cited deficiency

volumetric pump to ensure the duration of
the transfusion is in accordance with
the physician’s orders. (Accordingly, blood
components will not be administered via
“gravity” flow).
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which was approved on
June 20, 2019.

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 and the Stop
the Line for Patient Safety Policy CLN1185 is included
in the on-boarding process for new Credentialed
Providers.
A reminder communication will be sent to all nursing
staff who administer and monitor transfusions
regarding the process for reporting a suspected
transfusion reaction, by July 10, 2019.

(2) Based on the National Patient Safety
Network Biovigilance Component
Hemovigilance Module Surveillance
Protocol, published April 2018 by the
Centers for Disease Control the Blood
Component Administration and
Transfusion Reaction Policy CLN1115 will
be amended to include the definitions of
hypotension and fever, by July 10, 2019.
ATT1722, Guidelines for Identifying and
Reporting a Transfusion Reaction, which
supports CLN1115, will be revised to
address the hypotension and fever
parameters by July 10, 2019.
(3) EHR Physician Blood Component Order
Set was modified to require duration of
blood component transfusion. A
Credentialed Provider must specify the
duration of the blood component
transfusion in order to complete the blood
component order (hard stop). This change
will be effective by July 10, 2019.
(4) Stop the Line for Patient Safety Policy
CLN1185 was modified to permit anyone
to stop the line for an incomplete,

46

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

conflicting or unclear order or in the event
of a suspected transfusion reaction.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS
approved the updated Stop the Line for
Patient Safety Policy CLN1185, which was
approved on June 20, 2019.
Further training was developed on the EHR
Blood Component Order Sets, and the
modifications to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115 and the Stop the Line for
Patient Safety Policy CLN1185.
The hospital has developed a
Hemovigilance Unit that will track the vital
signs of each patient receiving transfusion
services. Phase 1 of the Hemovigilance
Unit’s activities consist of performing
retrospective chart reviews on patients
identified through the Unit monitoring
system as having a possible transfusion
reaction. Any patients identified as having
a definite reaction receive a written
consult, recorded in the EHR, from a
Transfusion Medicine Physician. May 20,
2019.
Following a 2-4 week prospective pilot in 3
areas where transfusions are administered
(Phase 2), the Hemovigilance Unit will
track the vital signs of each patient
receiving transfusion services in real time
(Phase 3). These vital signs will be
reviewed by an RN under the supervision
of an Advanced Practice Provider (APP) or
physician 24/7 to complement the
monitoring being provided at the bedside.
The real time monitoring will also weight

47

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

The Associate Director of G9 (Pediatrics) implemented
immediate individualized one on one training for the
two Pediatric RNs who cared for Patient #34 as
follows:

A random sample of 93 blood component
transfusion records are audited and
analyzed retrospectively each week by
the OPI to determine adherence to Blood
Component Administration and
Transfusion Reaction Policy CLN1115 for
the for vital signs and monitoring. OPI
reviews the data with the Executive
Director of Nursing Quality, Safety and
Research, and the Laboratory Medicine
Quality and Safety Officer to develop
recommendations for improvement.

Person
Responsible
Completion Date

the vital signs and assign a risk number for
each patient that is updated in real time,
highlighting patients exhibiting potential
signs of a reaction. Signs of a reaction will
be referred to a member of the transfusion
medicine practice. In addition to the
monitoring being done by nursing under
this POC, the Hemovigilance Unit will also
review potential false negatives on an
ongoing basis and report to the
Transfusion and Patient Blood
Management Committee.
We are not formally submitting Phase 2
and 3 as part of our corrective action as
these require a significant time investment
to operationalize it across the hospital but
we wanted CMS to be aware of its
development as proof of our commitment
to being an industry leader in developing
new, innovative approaches to delivering
the highest level of care.

A
385(A)(
1)

This plan of correction is also addressed
under the Plans of Correction Tags A 043,
A 144, A 115, and A 409.
The Hospital ensures that nurses
continually assess patients during
transfusion of blood components.
A transfusion reaction investigation was
completed regarding the Reference
Patient. An interdisciplinary team including
the CMS/CLIA Steering Committee,
members of the Transfusion and Patient
Blood Management Committee, the
Multidisciplinary Clinical Policies and
Procedures Task Force, Medical Staff and
Nursing reviewed the Hospital’s Blood
Component Administration and
Transfusion Reaction Policy CLN1115. As

Nurse-Day Shift: Trained 12/7/18 and 12/31/18.
Training included:
• Coached on the escalation of concerns
• Coached on appropriate documentation of
escalation of concerns/provider notification
• Nursing practice when carrying out the plan
of care; prioritizing interventions
• Reviewed gaps in documentation related to
hand-off documentation when the patient

Chief Nursing
Officer
Completion Date:
July 10, 2019

In collaboration with the Executive
Director of Nursing Quality, Safety and

48

 Tag

Plan for correcting the cited deficiency

part of this review over 6,000 patient
charts who received blood transfusions
were reviewed.

A training program was developed by an
inter-disciplinary team, including a
transfusion medicine faculty member. This
team was led by the Executive Director of
Nursing, Professional Practice, Strategy
and Execution and the Chief Education and
Training Officer to develop curriculum and
implement training for Credentialed
Providers who obtain informed consent
for, order, administer or manage
complications of blood component
transfusions and registered nurses (RN)
who administer blood components
pursuant to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which includes enhanced
nursing standards for administering and
monitoring blood components.
The hospital nurse training “Blood
Component Administration Competency”
has been updated to include the following
transfusion reaction symptoms: dry,
flushed skin, pain in the abdomen and
extremities, vomiting and bloody diarrhea.
The training also addresses signs and
symptoms of transfusion associated
circulatory overload. Completed May 17,
2019.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which was published on
May 19, 2019.

Procedure for implementing the acceptable plan of
correction
leaves the unit
RNs who administer blood components received
educational information delivered in person by unit
nursing leadership (Associate Directors, Nurse
Managers, or Clinical Nurse Leaders) starting May 16,
2019 and completed by May 24, 2019. The topics
addressed included adherence to Blood Component
Administration and Transfusion Reaction Policy
CLN1115, as supported by ATT1722, Guidelines for
Identifying and Reporting a Transfusion Reaction,
acceptable nursing standards for continual
assessment, recognition, responding, and reporting
symptoms of suspected transfusion reactions.
RNs who administer blood components completed
mandatory computer based training with knowledge
assessment starting May 17, 2019 to be completed by
July 10, 2019. The topics addressed within the
computer based training on the Blood Component
Administration and Transfusion Reaction Policy
CLN1115, which includes increased monitoring of vital
sign and patient assessment, recognizing, responding
and reporting transfusion reactions.
Material was also reviewed regarding delivering
patient education for participation in their care while
receiving blood components.
Additional training will be conducted regarding the
changes to the Blood Component Administration and
Transfusion Reaction Policy CLN1115 (including
definitions of hypotension and fever, as described in
ATT1722, Guidelines for Identifying and Reporting a
Transfusion Reaction), and the Stop the Line for
Patient Safety Policy CLN1185, by July 10, 2019.

Follow-up/Monitoring

Person
Responsible
Completion Date

Research and the Laboratory Medicine
Quality and Safety Officer, OPI will submit
the information and recommendations
for improvement to the Transfusion and
Patient Blood Management Committee,
the ECMS, and the QAPI Council monthly
for at least 2 months.
After 2 months of data collection, the
QAPI Council will determine whether the
frequency of data collection should be
adjusted (up or down) based on
performance. The Transfusion and
Patient Blood Management Committee
and ECMS will review the determination
and may make recommendations for
further improvement to the QAPI Council.
The QAPI Council will provide a
summation to the ELT and the Governing
Body at least quarterly.
The Hospital will address any deficiencies
with the individual nursing staff member
through pertinent education and training,
re-education and/or disciplinary action, as
appropriate.
Any Credentialed Provider deficiencies
will be addressed through pertinent
education and training, re-education
and/or referral for confidential peer
review through the medical staff.

RNs on leave who transfuse blood components must
complete training before attending patients.
Education regarding Blood Component Administration

49

 Tag

Plan for correcting the cited deficiency

Under the revised policy, nursing staff are
to take the patient’s vital signs prior to
initiating the transfusion, 15 minutes into
the transfusion, hourly from the start of
the transfusion through completion of the
transfusion, and at completion of the
transfusion. They are required to assess
the patient for signs and symptoms of
transfusion reaction and document their
observations hourly through completion of
the transfusion, and at completion of the
transfusion.
The Electronic Health Record (EHR)
includes a list of the symptoms of a
transfusion reaction. If the nurse selects
yes, the EHR generates a checklist of the
symptoms allowing the nurse to select the
symptoms that are present.
To ensure RNs administer blood
components in accordance with Hospital
policy and acceptable nursing standards:

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

and Transfusion Reaction Policy CLN1115 and the
enhanced nursing standards for administering and
monitoring blood component transfusions, and the
Stop the Line for Patient Safety Policy CLN1185 is
included in the on-boarding process for new RNs who
transfuse blood components.
Credentialed Providers who obtain informed consent
for, order, administer or manage complications of
blood component transfusions will complete the
computer based training as outlined above by July 10,
2019.
Credentialed Providers who obtain informed consent
for, order, administer or manage complications of
blood components and are on leave must complete
the computer based training before attending
patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 and the Stop
the Line for Patient Safety Policy CLN1185 is included
in the on-boarding process for new Credentialed
Providers.

(1) Based on the National Patient Safety
Network Biovigilance Component
Hemovigilance Module Surveillance
Protocol, published April 2018 by the
Centers for Disease Control the Blood
Component Administration and
Transfusion Reaction Policy CLN1115 will
be amended to include the definitions of
hypotension and fever, by July 10, 2019.
ATT1722, Guidelines for Identifying and
Reporting a Transfusion Reaction, which
supports CLN1115, will be revised to
address the hypotension and fever
parameters by July 10, 2019.

50

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

(2) Stop the Line for Patient Safety Policy
CLN1185 was modified to permit anyone
to stop the line for an incomplete,
conflicting or unclear order or in the event
of a suspected transfusion reaction.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS
approved the updated Stop the Line for
Patient Safety Policy CLN1185, which was
approved on June 20, 2019.
Further training was developed on the
modifications to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115 and the Stop the Line for
Patient Safety Policy CLN1185.
The hospital has developed a
Hemovigilance Unit that will track the vital
signs of each patient receiving transfusion
services. Phase 1 of the Hemovigilance
Unit’s activities consist of performing
retrospective chart reviews on patients
identified through the Unit monitoring
system as having a possible transfusion
reaction. Any patients identified as having
a definite reaction receive a written
consult, recorded in the EHR, from a
Transfusion Medicine Physician. May 20,
2019.
Following a 2-4 week prospective pilot in 3
areas where transfusions are administered
(Phase 2), the Hemovigilance Unit will
track the vital signs of each patient
receiving transfusion services in real time
(Phase 3). These vital signs will be
reviewed by an RN under the supervision
of an APP or physician 24/7 to
complement the monitoring being

51

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

The Associate Director of G9 (Pediatrics) implemented
immediate individualized one on one training for the
two Pediatric RNs who cared for Patient #34 as
follows:

A random sample of 93 blood component
transfusion records are audited and
analyzed retrospectively each week by
the OPI to determine adherence to Blood
Component Administration and
Transfusion Reaction Policy CLN1115 for
the for vital signs and monitoring and
documentation in accordance with
Nursing Documentation of Patient Care
Policy CLN0647. OPI reviews the data
with the Executive Director of Nursing
Quality, Safety and Research, and the
Laboratory Medicine Quality and Safety

Person
Responsible
Completion Date

provided at the bedside. The real time
monitoring will also weight the vital signs
and assign a risk number for each patient
that is updated in real time, highlighting
patients exhibiting potential signs of a
reaction. Signs of a reaction will be
referred to a member of the transfusion
medicine practice. In addition to the
monitoring being done by nursing under
this POC, the Hemovigilance Unit will also
review potential false negatives on an
ongoing basis and report to the
Transfusion and Patient Blood
Management Committee.
We are not formally submitting Phase 2
and 3 as part of our corrective action as
these require a significant time investment
to operationalize it across the hospital but
we wanted CMS to be aware of its
development as proof of our commitment
to being an industry leader in developing
new, innovative approaches to delivering
the highest level of care.
This plan of correction is also addressed
under the Plans of Correction Tags A 043,
A 144, A 115, and A 409.
A
385(A)(
2)

The Hospital ensures that RNs provide and
documented timely, complete and
accurate assessments on patients who
experienced transfusion reactions.
A transfusion reaction investigation was
completed regarding the Reference
Patient. An interdisciplinary team including
the CMS/CLIA Steering Committee,
members of the Transfusion and Patient
Blood Management Committee, the
Multidisciplinary Clinical Policies and

Nurse-Day Shift: Trained 12/7/18 and 12/31/18.
Training included:
• Coached on the escalation of concerns
• Coached on appropriate documentation of
escalation of concerns/provider notification
• Nursing practice when carrying out the plan
of care; prioritizing interventions

Chief Nursing
Officer
Completion Date:
July 10, 2019

52

 Tag

Plan for correcting the cited deficiency

Procedures Task Force, Medical Staff and
Nursing reviewed the Hospital’s Blood
Component Administration and
Transfusion Reaction Policy CLN1115. As
part of this review over 6,000 patient
charts who received blood transfusions
were reviewed.
A training program was developed by an
inter-disciplinary team, including a
transfusion medicine faculty member. This
team was led by the Executive Director of
Nursing, Professional Practice, Strategy
and Execution and the Chief Education and
Training Officer to develop curriculum and
implement training for Credentialed
Providers who obtain informed consent
for, order, administer or manage
complications of blood component
transfusions and registered nurses (RN)
who administer blood components
pursuant to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which includes enhanced
nursing standards for administering and
monitoring blood components.
The hospital nurse training “Blood
Component Administration Competency”
has been updated to include the following
transfusion reaction symptoms: dry,
flushed skin, pain in the abdomen and
extremities, vomiting and bloody diarrhea.
The training also addresses signs and
symptoms of transfusion associated
circulatory overload. Completed May 17,
2019.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component

Procedure for implementing the acceptable plan of
correction
•

Reviewed gaps in documentation related to
hand-off documentation when the patient
leaves the unit

RNs who administer blood components received
educational information delivered in person by unit
nursing leadership (Associate Directors, Nurse
Managers, or Clinical Nurse Leaders) starting May 16,
2019 and completed by May 24, 2019. The topics
addressed included adherence to Blood Component
Administration and Transfusion Reaction Policy
CLN1115, as supported by ATT1722, Guidelines for
Identifying and Reporting a Transfusion Reaction,
acceptable nursing standards for continual
assessment, recognition, responding, and reporting
symptoms of suspected transfusion reactions.
RNs who administer blood components completed
mandatory computer based training with knowledge
assessment starting May 17, 2019 to be completed by
July 10, 2019. The topics addressed within the
computer based training on the Blood Component
Administration and Transfusion Reaction Policy
CLN1115, which includes increased monitoring of vital
sign and patient assessment, recognizing, responding
and reporting transfusion reactions.
Material was also reviewed regarding delivering
patient education for participation in their care while
receiving blood components.

Follow-up/Monitoring

Person
Responsible
Completion Date

Officer to develop recommendations for
improvement.
In collaboration with the Executive
Director of Nursing Quality, Safety and
Research and the Laboratory Medicine
Quality and Safety Officer, OPI will submit
the information and recommendations
for improvement to the Transfusion and
Patient Blood Management Committee,
the ECMS, and the QAPI Council monthly
for at least 2 months.
After 2 months of data collection, the
QAPI Council will determine whether the
frequency of data collection should be
adjusted (up or down) based on
performance. The Transfusion and
Patient Blood Management Committee
and ECMS will review the determination
and may make recommendations for
further improvement to the QAPI Council.
The QAPI Council will provide a
summation to the ELT and the Governing
Body at least quarterly.
The Hospital will address any deficiencies
with the individual nursing staff member
through pertinent education and training,
re-education and/or disciplinary action, as
appropriate.

Additional training will be conducted regarding the
changes to the Blood Component Administration and
Transfusion Reaction Policy CLN1115 (including
definitions of hypotension and fever, as described in
ATT1722, Guidelines for Identifying and Reporting a
Transfusion Reaction), the Stop the Line for Patient
Safety Policy CLN1185, and the Nursing
Documentation of Patient Care Policy CLN0647 by July
10, 2019.

53

 Tag

Plan for correcting the cited deficiency

Administration and Transfusion Reaction
Policy CLN1115, which was published on
May 19, 2019.
Under the revised policy, nursing staff are
to take the patient’s vital signs prior to
initiating the transfusion, 15 minutes into
the transfusion, hourly from the start of
the transfusion through completion of the
transfusion, and at completion of the
transfusion. They are required to assess
the patient for signs and symptoms of
transfusion reaction and document their
observations hourly through completion of
the transfusion, and at completion of the
transfusion.

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

RNs on leave who transfuse blood components must
complete training before attending patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 and the
enhanced nursing standards for administering and
monitoring blood component transfusions, the Stop
the Line for Patient Safety Policy CLN1185, and
Nursing Documentation of Patient Care Policy
CLN0647is included in the on-boarding process for
new RNs who transfuse blood components.

The Electronic Health Record (EHR)
includes a list of the symptoms of a
transfusion reaction. If the nurse selects
yes, the EHR generates a checklist of the
symptoms allowing the nurse to select the
symptoms that are present.
blood component transfusion In addition,
the Hospital’s Nursing Documentation of
Patient Care Policy CLN0647 was modified
as follows: (i) to require nurses to
document assessment and reassessment
of the patient, prior to, during and after a
procedure or treatment as indicated,
within an appropriate time frame after the
intervention for an evaluation of
effectiveness and patient’s response to the
intervention, and appropriate follow up
with the Credentialed Provider; and (ii) to
require clear documentation for nursing
work flow in the EHR, to include
documentation of vital signs and
suspected transfusion reaction in

54

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

accordance with the Hospital’s Blood
Component Administration and
Transfusion Reaction Policy LN1115.
To ensure RNs document and detect
infusion reactions:
(1) Based on the National Patient Safety
Network Biovigilance Component
Hemovigilance Module Surveillance
Protocol, published April 2018 by the
Centers for Disease Control the Blood
Component Administration and
Transfusion Reaction Policy CLN1115 will
be amended to include the definitions of
hypotension and fever, by July 10, 2019.
ATT1722, Guidelines for Identifying and
Reporting a Transfusion Reaction, which
supports CLN1115, will be revised to
address the hypotension and fever
parameters by July 10, 2019.
(2) Stop the Line for Patient Safety Policy
CLN1185 was modified to permit anyone
to stop the line for an incomplete,
conflicting or unclear order or in the event
of a suspected transfusion reaction.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS
approved the updated Stop the Line for
Patient Safety Policy CLN1185, which was
approved on June 20, 2019.
Further training was developed on the
modifications to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115 and the Stop the Line for
Patient Safety Policy CLN1185.

55

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

The hospital has developed a
Hemovigilance Unit that will track the vital
signs of each patient receiving transfusion
services. Phase 1 of the Hemovigilance
Unit’s activities consist of performing
retrospective chart reviews on patients
identified through the Unit monitoring
system as having a possible transfusion
reaction. Any patients identified as having
a definite reaction receive a written
consult, recorded in the EHR, from a
Transfusion Medicine Physician. May 20,
2019.
Following a 2-4 week prospective pilot in 3
areas where transfusions are administered
(Phase 2), the Hemovigilance Unit will
track the vital signs of each patient
receiving transfusion services in real time
(Phase 3). These vital signs will be
reviewed by an RN under the supervision
of an APP or physician 24/7 to
complement the monitoring being
provided at the bedside. The real time
monitoring will also weight the vital signs
and assign a risk number for each patient
that is updated in real time, highlighting
patients exhibiting potential signs of a
reaction. Signs of a reaction will be
referred to a member of the transfusion
medicine practice. In addition to the
monitoring being done by nursing under
this POC, the Hemovigilance Unit will also
review potential false negatives on an
ongoing basis and report to the
Transfusion and Patient Blood
Management Committee.
We are not formally submitting Phase 2
and 3 as part of our corrective action as
these require a significant time investment

56

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

The Associate Director of G9 (Pediatrics) implemented
immediate individualized one on one training for the
two Pediatric RNs who cared for Patient #34 as
follows:

A random sample of 93 blood component
transfusion records are audited and
analyzed retrospectively each week by
the OPI to determine adherence to (1)
Blood Component Administration and
Transfusion Reaction Policy CLN1115,
including reporting to and consulting with
the Credentialed Provider and the
Transfusion Medicine Physician for
suspected transfusion reactions, and (2)
Stop the Line for Patient Safety Policy
CLN1185, to stop the line in the event of a
suspected transfusion reaction or an
incomplete, conflicting or unclear order.

Person
Responsible
Completion Date

to operationalize it across the hospital but
we wanted CMS to be aware of its
development as proof of our commitment
to being an industry leader in developing
new, innovative approaches to delivering
the highest level of care.
A
385(A)(
3)

Hospital ensures that nurses notify the
Credentialed Providers of changes in vital
signs and condition of patients receiving
transfusions of blood components as
required under the Hospital policy.
A transfusion reaction investigation was
completed regarding the Reference
Patient. An interdisciplinary team including
the CMS/CLIA Steering Committee,
members of the Transfusion and Patient
Blood Management Committee, the
Multidisciplinary Clinical Policies and
Procedures Task Force, Medical Staff and
Nursing reviewed the Hospital’s Blood
Component Administration and
Transfusion Reaction Policy CLN1115. As
part of this review over 6,000 patient
charts who received blood transfusions
were reviewed.
A training program was developed by an
inter-disciplinary team, including a
transfusion medicine faculty member. This
team was led by the Executive Director of
Nursing, Professional Practice, Strategy
and Execution and the Chief Education and
Training Officer to develop curriculum and
implement training for Credentialed
Providers who obtain informed consent
for, order, administer or manage
complications of blood component
transfusions and registered nurses (RN)
who administer blood components

Nurse-Day Shift: Trained 12/7/18 and 12/31/18.
Training included:
• Coached on the escalation of concerns
• Coached on appropriate documentation of
escalation of concerns/provider notification
• Nursing practice when carrying out the plan
of care; prioritizing interventions
Reviewed gaps in documentation related to hand-off
documentation when the patient leaves the unit
Nurse- Night Shift- Trained 12/20/18. Training
included:
• Gaps in vital sign monitoring and
documentation for blood component
administration
• Reviewed signs and symptoms of reactions
• Coached on appropriate documentation of
escalation of concerns/provider notification
• Reviewed institutional policy (CLN1115).
RNs who administer blood components received
educational information delivered in person by unit
nursing leadership (Associate Directors, Nurse
Managers, or Clinical Nurse Leaders) starting May 16,
2019 and completed by May 24, 2019. The topics
addressed included adherence to Blood Component
Administration and Transfusion Reaction Policy
CLN1115, as supported by ATT1722, Guidelines for

Chief Nursing
Officer
Completion Date:
July 10, 2019

OPI reviews the data with the Executive
Director of Nursing Quality, Safety and
Research, and the Laboratory Medicine
Quality and Safety Officer to develop
recommendations for improvement.
In collaboration with the Executive
Director of Nursing Quality, Safety and
Research and the Laboratory Medicine
Quality and Safety Officer, OPI will submit
the information and recommendations
for improvement to the Transfusion and
Patient Blood Management Committee,
the ECMS, and the QAPI Council monthly
for at least 2 months.
After 2 months of data collection, the
QAPI Council will determine whether the
frequency of data collection should be

57

 Tag

Plan for correcting the cited deficiency

pursuant to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which includes enhanced
nursing standards for administering and
monitoring blood components.
The hospital nurse training “Blood
Component Administration Competency”
has been updated to include the following
transfusion reaction symptoms: dry,
flushed skin, pain in the abdomen and
extremities, vomiting and bloody diarrhea.
The training also addresses signs and
symptoms of transfusion associated
circulatory overload. Completed May 17,
2019.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which was published on
May 19, 2019.
Under the revised policy, nursing staff are
to take the patient’s vital signs prior to
initiating the transfusion, 15 minutes into
the transfusion, hourly from the start of
the transfusion through completion of the
transfusion, and at completion of the
transfusion. They are required to assess
the patient for signs and symptoms of
transfusion reaction and document their
observations hourly through completion of
the transfusion and at completion of the
transfusion.
The Electronic Health Record (EHR)
includes a list of the symptoms of a
transfusion reaction. If the nurse selects
yes, the EHR generates a checklist of the

Procedure for implementing the acceptable plan of
correction
Identifying and Reporting a Transfusion Reaction,
acceptable nursing standards for assessment,
recognition, responding, and reporting symptoms of
suspected transfusion reactions.
RNs who administer blood components completed
mandatory computer based training with knowledge
assessment starting May 17, 2019 to be completed by
July 10, 2019. The topics addressed within the
computer based training on the Blood Component
Administration and Transfusion Reaction Policy
CLN1115, included increased monitoring of vital sign
and patient assessment, recognizing, responding and
reporting transfusion reactions to and consulting with
the Credentialed Provider and the Transfusion
Medicine Physician, and clarifying physician orders.
Material was also reviewed regarding delivering
patient education for participation in their care while
receiving blood components.
Additional training will be conducted regarding the
changes to the Blood Component Administration and
Transfusion Reaction Policy CLN1115 (including
definitions of hypotension and fever, reporting
suspected transfusion reactions to and consulting with
the Credentialed Provider and the Transfusion
Medicine Physician), and the Stop the Line for Patient
Safety Policy CLN1185, by July 10, 2019.

Follow-up/Monitoring

Person
Responsible
Completion Date

adjusted (up or down) based on
performance. The Transfusion and
Patient Blood Management Committee
and ECMS will review the determination
and may make recommendations for
further improvement to the QAPI Council.
The QAPI Council will provide a
summation to the ELT and the Governing
Body at least quarterly.
The Hospital will address any deficiencies
with the individual nursing staff member
through pertinent education and training,
re-education and/or disciplinary action, as
appropriate.
Any Credentialed Provider deficiencies
will be addressed through pertinent
education and training, re-education
and/or referral for confidential peer
review through the medical staff.

RNs on leave who transfuse blood components must
complete training before attending patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 and the
enhanced nursing standards for administering and
monitoring blood component transfusions, Stop the
Line for Patient Safety Policy CLN1185 is included in
the on-boarding process for new RNs who transfuse
blood components.
Credentialed Providers who obtain informed consent

58

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

symptoms allowing the nurse to select the
symptoms that are present.

for, order, administer or manage complications of
blood component transfusions will complete the
computer based training as outlined above by July 10,
2019.

To ensure RNs notify the Credentialed
Providers of condition of patients receiving
transfusions of blood components as
required under the Hospital policy:
(1) Based on the National Patient Safety
Network Biovigilance Component
Hemovigilance Module Surveillance
Protocol, published April 2018 by the
Centers for Disease Control the Blood
Component Administration and
Transfusion Reaction Policy CLN1115 will
be amended to include the definitions of
hypotension and fever, by July 10, 2019.

Follow-up/Monitoring

Person
Responsible
Completion Date

Credentialed Providers who obtain informed consent
for, order, administer or manage complications of
blood components and are on leave must complete
the computer based training before attending
patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 is included in
the on-boarding process for new Credentialed
Providers.

ATT1722, Guidelines for Identifying and
Reporting a Transfusion Reaction, which
supports CLN1115, will be revised to
address the hypotension and fever
parameters by July 10, 2019.
(2) The Blood Component Administration
and Transfusion Reaction Policy CLN1115
was further modified to require that the
Transfusion Medicine Physician is
consulted regarding suspected blood
component transfusion reactions.
(3) Stop the Line for Patient Safety Policy
CLN1185 was modified to permit anyone
to stop the line for an incomplete,
conflicting or unclear order or in the event
of a suspected transfusion reaction.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS
approved the updated Stop the Line for
Patient Safety Policy CLN1185, which was

59

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

approved on June 20, 2019.
Further training was developed on the
modifications to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115 and the Stop the Line for
Patient Safety Policy CLN1185.
The hospital has developed a
Hemovigilance Unit that will track the vital
signs of each patient receiving transfusion
services. Phase 1 of the Hemovigilance
Unit’s activities consist of performing
retrospective chart reviews on patients
identified through the Unit monitoring
system as having a possible transfusion
reaction. Any patients identified as having
a definite reaction receive a written
consult, recorded in the EHR, from a
Transfusion Medicine Physician. May 20,
2019.
The hospital has developed a
Hemovigilance Unit that will track the vital
signs of each patient receiving transfusion
services. Phase 1 of the Hemovigilance
Unit’s activities consist of performing
retrospective chart reviews on patients
identified through the Unit monitoring
system as having a possible transfusion
reaction. Any patients identified as having
a definite reaction receive a written
consult, recorded in the EHR, from a
Transfusion Medicine Physician. May 20,
2019.
Following a 2-4 week prospective pilot in 3
areas where transfusions are administered
(Phase 2), the Hemovigilance Unit will
track the vital signs of each patient
receiving transfusion services in real time

60

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

All RNs who administer blood components received
pertinent education and training with knowledge
assessment to be completed by July 10, 2019. The
topics addressed during the training included changes
to the EHR Blood Component Order Sets, adherence to
Blood Component Administration and Transfusion
Reaction Policy CLN1115, Patient Care Orders Policy
CLN1140, and Stop the Line for Patient Safety Policy
CLN1185, obtaining complete and accurate

A random sample of 93 blood component
transfusion records are audited and
analyzed retrospectively each week by
the OPI to determine adherence to Blood
Component Administration and
Transfusion Reaction Policy CLN1115, EHR
Credentialed Provider Order Sets, and
Stop The Line DCLN1185, specifically that
orders specify the duration for the

Person
Responsible
Completion Date

(Phase 3). These vital signs will be
reviewed by an RN under the supervision
of an APP or physician 24/7 to
complement the monitoring being
provided at the bedside. The real time
monitoring will also weight the vital signs
and assign a risk number for each patient
that is updated in real time, highlighting
patients exhibiting potential signs of a
reaction. Signs of a reaction will be
referred to a member of the transfusion
medicine practice. In addition to the
monitoring being done by nursing under
this POC, the Hemovigilance Unit will also
review potential false negatives on an
ongoing basis and report to the
Transfusion and Patient Blood
Management Committee.
We are not formally submitting Phase 2
and 3 as part of our corrective action as
these require a significant time investment
to operationalize it across the hospital but
we wanted CMS to be aware of its
development as proof of our commitment
to being an industry leader in developing
new, innovative approaches to delivering
the highest level of care.

A
385(A)(
4)

This plan of correction is also addressed
under the Plans of Correction Tags A 043,
A 144, A 115, and A 409.
The Hospital ensures that nurses have
complete and accurate orders prior to
initiating transfusions. Blood components
are infused at the duration specified in the
Credentialed Provider orders for
transfusion. Orders are clarified as
needed, and Credentialed Providers are
notified if the orders are not followed.

Chief
Officer

Nursing

Completion Date:
July 10, 2019

61

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

A transfusion reaction investigation was
completed regarding the Reference
Patient. An interdisciplinary team including
the CMS/CLIA Steering Committee,
members of the Transfusion and Patient
Blood Management Committee, the
Multidisciplinary Clinical Policies and
Procedures Task Force, Medical Staff and
Nursing reviewed the Hospital’s Blood
Component Administration and
Transfusion Reaction Policy CLN1115. As
part of this review over 6,000 patient
charts who received blood transfusions
were reviewed.

Credentialed Provider orders prior to initiating
transfusions, infusing blood components at the
duration specified in the Credentialed Provider order
for transfusion, clarifying orders as necessary,
notifying the Credentialed Provider if orders are not
followed, and procedures for stopping the line for
patient safety. July 10, 2019.
Any RN on leave who transfuses blood components
must complete the training before attending patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115, Patient Care
Orders Policy CLN1140, and Stop the Line for Patient
Safety Policy CLN1185, obtaining complete and
accurate Credentialed Provider orders prior to
initiating transfusions, infusing blood components at
the duration specified in the Credentialed Provider
order for transfusion, clarifying orders as necessary,
notifying the Credentialed Provider if orders are not
followed, and procedures for stopping the line for
patient safety is included in the on-boarding process
for new RNs who transfuse blood components.

The Hospital took the following actions to
ensure that RNs infuse blood components
at the duration specified in the order, that
orders are clarified as needed, and that
Credentialed Providers are notified if the
orders are not followed:
(1) The Blood Component Administration
and Transfusion Reaction Policy CLN1115
was further modified to require that blood
components are administered via
volumetric pump to ensure the duration of
the transfusion is in accordance with
the Credentialed Provider’s orders.
(Accordingly, blood components will not
be administered via “gravity” flow).
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which was approved on
June 20, 2019.

Follow-up/Monitoring

Person
Responsible
Completion Date

transfusion, and the actual duration of
the transfusion. OPI reviews the data
with the Executive Director of Nursing
Quality, Safety and Research, and the
Laboratory Medicine Quality and Safety
Officer to develop recommendations for
improvement.
In collaboration with the Executive
Director of Nursing Quality, Safety and
Research and the Laboratory Medicine
Quality and Safety Officer, OPI will submit
the information and recommendations
for improvement to the Transfusion and
Patient Blood Management Committee,
the ECMS, and the QAPI Council monthly
for at least 2 months.
After 2 months of data collection, the
QAPI Council will determine whether the
frequency of data collection should be
adjusted (up or down) based on
performance. The Transfusion and
Patient Blood Management Committee
and ECMS will review the determination
and may make recommendations for
further improvement to the QAPI Council.
The QAPI Council will provide a
summation to the ELT and the Governing
Body at least quarterly.
The Executive Director of Nursing,
Strategy, Practice and Execution and
Executive Director of Quality, Safety and
Research will address any deficiencies
with the individual nursing staff member
through pertinent education and training,
re-education and/or disciplinary action, as
appropriate.

(2) To ensure clarity of Credentialed
Provider orders, the Hospital’s Patient Care

62

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

Orders Policy CLN1140 was modified as
follows: (i) to require health care providers
to seek clarification of incomplete,
conflicting or unclear orders.
The Executive Owner of the Patient Care
Orders Policy CLN1140 (the Chief Medical
Officer) and the ECMS, approved the
updated Patient Care Orders Policy
CLN1140, which was published on June 20,
2019.
(3) Electronic Health Record (EHR)
Credentialed Provider Order Set was
modified to require duration of blood
component transfusion. A Credentialed
Provider must specify the duration of the
blood component transfusion in order to
complete the blood component order
(hard stop). This change will be effective
by July 10, 2019.
(4) Stop the Line for Patient Safety Policy
CLN1185 was modified to permit anyone
to stop the line for an incomplete,
conflicting or unclear order or in the event
of a suspected transfusion reaction.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Stop the Line for
Patient Safety Policy CLN1185, which was
approved on June 20, 2019.
Training was developed by the Executive
Director of Nursing, Professional Practice,
Strategy and Execution to develop
curriculum and implement training for
registered nurses (RN) who administer
blood components pursuant to the Blood
Component Administration and

63

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

All RNs who administer blood components received
pertinent education and training with knowledge
assessment to be completed by July 10, 2019. The
topics addressed during the training included changes
to the EHR Blood Component Order Sets, adherence to
Blood Component Administration and Transfusion
Reaction Policy CLN1115, Patient Care Orders Policy
CLN1140, and Stop the Line for Patient Safety Policy
CLN1185, obtaining complete and accurate
Credentialed Provider orders prior to initiating
transfusions, infusing blood components at the
duration specified in the Credentialed Provider order
for transfusion, clarifying orders as necessary,
notifying the Credentialed Provider if orders are not
followed, and procedures for stopping the line for
patient safety. July 10, 2019.
Any RN on leave who transfuses blood components
must complete the training before attending patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115, Patient Care
Orders Policy CLN1140, and Stop the Line for Patient
Safety Policy CLN1185, obtaining complete and
accurate Credentialed Provider orders prior to
initiating transfusions, infusing blood components at
the duration specified in the Credentialed Provider
order for transfusion, clarifying orders as necessary,
notifying the Credentialed Provider if orders are not
followed, and procedures for stopping the line for
patient safety is included in the on-boarding process
for new RNs who transfuse blood components.

A random sample of 93 blood component
transfusion records are audited and
analyzed retrospectively each week by
the OPI to determine adherence to Blood
Component Administration and
Transfusion Reaction Policy CLN1115, EHR
Credentialed Provider Order Sets, and
Stop The Line DCLN1185, specifically that
orders specify the duration for the
transfusion, and the actual duration of
the transfusion. OPI reviews the data
with the Executive Director of Nursing
Quality, Safety and Research, and the
Laboratory Medicine Quality and Safety
Officer to develop recommendations for
improvement.

Person
Responsible
Completion Date

Transfusion Reaction Policy CLN1115, the
Stop The Line for Patient Safety Policy CLN
1185, the Patient Care Orders Policy CLN
1140, and the EHR Order Set.
This plan of correction is also addressed
under Plan of Correction Tag A 409(D).
A
385(A)(
5)

The Hospital ensures that nurses follow
Credentialed Provider orders for
transfusion rates (duration) for patients.
A transfusion reaction investigation was
completed regarding the Reference
Patient. An interdisciplinary team including
the CMS/CLIA Steering Committee,
members of the Transfusion and Patient
Blood Management Committee, the
Multidisciplinary Clinical Policies and
Procedures Task Force, Medical Staff and
Nursing reviewed the Hospital’s Blood
Component Administration and
Transfusion Reaction Policy CLN1115. As
part of this review over 6,000 patient
charts who received blood transfusions
were reviewed.
The Hospital took the following actions to
ensure complete and accurate orders for
blood components, that RNs infuse blood
components at the duration specified in
the order, that orders are clarified as
needed, and that Credentialed Providers
are notified if the orders are not followed:
(1) The Blood Component Administration
and Transfusion Reaction Policy CLN1115
was further modified to require that blood
components are administered via
volumetric pump to ensure the duration of
the transfusion is in accordance with

Chief Nursing
Officer
Completion Date:
July 10, 2019

In collaboration with the Executive
Director of Nursing Quality, Safety and
Research and the Laboratory Medicine
Quality and Safety Officer, OPI will submit
the information and recommendations
for improvement to the Transfusion and
Patient Blood Management Committee,
the ECMS, and the QAPI Council monthly
for at least 2 months.
After 2 months of data collection, the
QAPI Council will determine whether the
frequency of data collection should be
adjusted (up or down) based on
performance. The Transfusion and
Patient Blood Management Committee

64

 Tag

Plan for correcting the cited deficiency

the Credentialed Provider’s orders.
(Accordingly, blood components will not
be administered via “gravity” flow).
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which was approved on
June 20, 2019.
(2) To ensure clarity of Credentialed
Provider orders, the Hospital’s Patient Care
Orders Policy CLN1140 was modified as
follows: (i) to require health care providers
to seek clarification of incomplete,
conflicting or unclear orders.

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

and ECMS will review the determination
and may make recommendations for
further improvement to the QAPI Council.
The QAPI Council will provide a
summation to the ELT and the Governing
Body at least quarterly.
The Executive Director of Nursing,
Strategy, Practice and Execution and
Executive Director of Quality, Safety and
Research will address any deficiencies
with the individual nursing staff member
through pertinent education and training,
re-education and/or disciplinary action, as
appropriate.

The Executive Owner of the Patient Care
Orders Policy CLN1140 (the Chief Medical
Officer) and the ECMS, approved the
updated Patient Care Orders Policy
CLN1140, which was published on June 20,
2019.
(3) Electronic Health Record (EHR)
Credentialed Provider Order Set was
modified to require duration of blood
component transfusion. A Credentialed
Provider must specify the duration of the
blood component transfusion in order to
complete the blood component order
(hard stop). This change will be effective
by July 10, 2019.
(4) Stop the Line for Patient Safety Policy
CLN1185 was modified to permit anyone
to stop the line for an incomplete,
conflicting or unclear order or in the event
of a suspected transfusion reaction.

65

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Nurse Staffing Policy and Plan, CLN1054 requires
adequate ( i.e., minimum) numbers of licensed
registered nurses, licensed practical (vocational)
nurses, and other personnel to provide nursing care to
all patients as needed.

The Chief Nursing Officer approved a new
staffing matrix format to ensure adequate
staffing for hospital-wide inpatient units
on June 20, 2019. The new matrix was
reviewed with the Nurse Staffing Advisory
Committee on June 20, 2019.

Person
Responsible
Completion Date

The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Stop the Line for
Patient Safety Policy CLN1185, which was
approved on June 20, 2019.
Training was developed by the Executive
Director of Nursing, Professional Practice,
Strategy and Execution to develop
curriculum and implement training for
registered nurses (RN) who administer
blood components pursuant to the Blood
Component Administration and
Transfusion Reaction Policy CLN1115, the
Stop The Line for Patient Safety Policy CLN
1185, the Patient Care Orders Policy CLN
1140, and the EHR Order Set.
This plan of correction is also addressed
under Plan of Correction Tag A 409(E).

A
385(B)

The Chief Nursing Officer reviewed
Hospital’s inpatient nurse staffing grid, and
hospital-wide inpatient staffing, including
on G9 Pediatrics SW&NE and G9 Pediatric
Intensive Care Services NW to ensure
adequate staffing.
The Nurse Staffing Advisory Committee
reviewed hospital-wide inpatient nurse
staffing grid. June 20, 2019.
This plan of correction is also addressed
under Plan of Correction Tag A 392.

This Policy was reviewed by the Chief Nursing Officer
and the Nurse Staffing Advisory Committee, but no
substantive changes were needed.
A new staffing matrix was created to reflect minimum
staffing in accordance with Nurse Staffing Policy and
Plan, CLN1054. The staffing matrix was approved by
the Chief of Nursing and the Nurse Staffing Advisory
Committee on June 20, 2019.

Chief Nursing
Officer
Completion Date:
July 10, 2019

The Division Administrator for Nursing
will educate clinical leaders for all
inpatient units on the use and
implementation of the new staffing
matrix, by July 10, 2019
Any nurse leader on leave will be
educated on the new staffing matrix upon
return to work.
The Division Administrator for Nursing
will review the staffing levels against the

66

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

staffing matrix monthly for the first two
months, and at least twice each year
thereafter.
The biannual assessment will be provided
to the Nurse Staffing Advisory Committee
and the Governing Body.

A
385(C)

The Chief Nursing Officer and the
Executive Director of Nursing, Professional
Practice, Strategy and Execution reviewed
the Hospital’s Nursing Staff Competency
Policy CLN0670 and the status of current
competencies in clinical areas.
The Hospital’s Nursing Staff Competency
Policy CLN0670 was revised to enhance
the annual assessment and validation of
the competence of nursing staff, and to
include effective monitoring of annual
competence assessment of nursing staff.
Changes to the Nursing Staff Competency
Policy CLN0670 were reviewed with the
Competency Steering Committee and
feedback was solicited on June 14, 2019.
The Chief Nursing Officer, and the
Executive Director of Nursing, Practice,
Strategy and Execution approved the
updated Nursing Staff Competency Policy
CLN0670 on June 18, 2019.

The Executive Director of Nursing, Professional
Practice, Strategy and Execution will develop training
on the Hospital’s Nursing Staff Competency Policy
CLN0670 for all clinical nursing personnel. The topics
addressed during the training will include:
•
•
•
•

Overview of policy changes
Annual needs assessment
Role of competency steering committee
Manager and Employee responsibilities

Training will be completed by July 10, 2019.
A competency matrix will be used to identify expected
competencies by area and role of nursing staff to
provide clarity regarding expected annual and
unit/area-specific competencies for clinical nursing
staff.
An annual competency validation summary will be
developed as a single source of competencies and
required educational activities for individual staff
members. The document will reside in the employee
personnel record.

This plan of correction is also addressed
under Plan of Correction Tag A 397.
The Executive Director of Nursing, Professional
Practice, Strategy and Execution in collaboration with
the Unit leadership, reviewed the personnel files of

The Executive Director of Nursing,
Professional Practice, Strategy and
Execution, in conjunction with the
Director of Nursing Education and the
Competency Steering Committee will
develop a process to monitor compliance
with the Hospital’s Nursing Staff
Competency Policy CLN0670, which
includes
• Annually perform review of the
annual needs assessment for
each area
• Oversight of all competency
content to ensure adherence to
evidence-based standards
• Standardization of forms and
reporting processes
• Annual review of educational
evaluations to ensure content
meets needs of identified
learners
• Quarterly review of nursing
quality metrics to identify areas
where competencies or further
education are needed.
• Quarterly review of new
processes or procedures to
identify areas where
competencies or further
education are needed.

Chief Nursing
Officer
Completion Date:
July 10, 2019

67

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction
Staff #1, Staff #47, and Staff #43, and ensured that
each of these staff members had an annual
competency validation before caring for patients in
accordance with the patients’ needs by July 10, 2019.
The revised process will be introduced to nursing
leaders (Directors of Nursing, Associate Directors,
Nurse Managers, Clinical Nurse Leaders, and
educators) by July 10, 2019.
Compliance is reinforced regularly by nursing
leadership.

Tag A
392
Staffing
and
Deliver
y of
Care
A 392

Follow-up/Monitoring

Person
Responsible
Completion Date

The revised process will be completed by
July 10, 2019. The updated process will
also be initiated by July 10, 2019.
Any nurse not in compliance with the
Hospital’s Nursing Staff Competency
Policy CLN0670, will be removed from
providing patient care until annual
competencies are completed.

Any clinical nursing personnel on leave (FMLA or
vacation) must complete the training before returning
to work.
Hospital nursing service has adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to
provide nursing care to all patients as needed. Hospital has supervisory and staff personnel for each department or nursing unit to ensure, when
needed, the immediate availability of a registered nurse for bedside care of any patient.

The Chief Nursing Officer reviewed
Hospital’s inpatient nurse staffing grid, and
hospital-wide inpatient staffing, including
on G9 Pediatrics SW&NE and G9 Pediatric
Intensive Care Services NW to ensure
adequate staffing.
The Nurse Staffing Advisory Committee
reviewed hospital-wide inpatient nurse
staffing grid. June 20, 2019.
This plan of correction is also addressed
under Plan of Correction Tag A 385.

Nurse Staffing Policy and Plan, CLN1054 requires
adequate ( i.e., minimum) numbers of licensed
registered nurses, licensed practical (vocational)
nurses, and other personnel to provide nursing care to
all patients as needed.
This Policy was reviewed by the Chief Nursing Officer
and the Nurse Staffing Advisory Committee, but no
substantive changes were needed.
A new staffing matrix was created to reflect minimum
staffing in accordance with Nurse Staffing Policy and
Plan, CLN1054. The staffing matrix was approved by
the Chief of Nursing and the Nurse Staffing Advisory
Committee on June 20, 2019.

The Chief Nursing Officer approved a new
staffing matrix format to ensure adequate
staffing for hospital-wide inpatient units
on June 20, 2019. The new matrix was
reviewed with the Nurse Staffing Advisory
Committee on June 20, 2019.

Chief Nursing
Officer
Completion Date:
July 10, 2019

The Division Administrator for Nursing
will educate clinical leaders for all
inpatient units on the use and
implementation of the new staffing
matrix, by July 10, 2019
Any nurse leader on leave will be
educated on the new staffing matrix upon
return to work.
The Division Administrator for Nursing

68

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

will review the staffing levels against the
staffing matrix monthly for the first two
months, and at least twice each year
thereafter.
The biannual assessment will be provided
to the Nurse Staffing Advisory Committee
and the Governing Body.

Tag A
397
Patient
Care
Assign
ments
A 397

Hospital ensures a registered nurse assigns the nursing care of each patient to other nursing personnel in accordance with the patient's needs
and the specialized qualifications and competence of the nursing staff available.

The Chief Nursing Officer and the
Executive Director of Nursing, Professional
Practice, Strategy and Execution reviewed
the Hospital’s Nursing Staff Competency
Policy CLN0670 and the status of current
competencies in clinical areas.
The Hospital’s Nursing Staff Competency
Policy CLN0670 was revised to enhance
the annual assessment and validation of
the competence of nursing staff, and to
include effective monitoring of annual
competence assessment of nursing staff.
Changes to the Nursing Staff Competency
Policy CLN0670 were reviewed with the
Competency Steering Committee and
feedback was solicited on June 14, 2019.
The Chief Nursing Officer, and the
Executive Director of Nursing, Practice,
Strategy and Execution approved the
updated Nursing Staff Competency Policy

The Executive Director of Nursing, Professional
Practice, Strategy and Execution will develop training
on the Hospital’s Nursing Staff Competency Policy
CLN0670 for all clinical nursing personnel. The topics
addressed during the training will include:
•
•
•
•

Overview of policy changes
Annual needs assessment
Role of competency steering committee
Manager and Employee responsibilities

Training will be completed by July 10, 2019.
A competency matrix will be used to identify expected
competencies by area and role of nursing staff to
provide clarity regarding expected annual and
unit/area-specific competencies for clinical nursing
staff.
An annual competency validation summary will be
developed as a single source of competencies and
required educational activities for individual staff

The Executive Director of Nursing,
Professional Practice, Strategy and
Execution, in conjunction with the
Director of Nursing Education and the
Competency Steering Committee will
develop a process to monitor compliance
with the Hospital’s Nursing Staff
Competency Policy CLN0670, which
includes
• Annually perform review of the
annual needs assessment for
each area
• Oversight of all competency
content to ensure adherence to
evidence-based standards
• Standardization of forms and
reporting processes
• Annual review of educational
evaluations to ensure content
meets needs of identified
learners
• Quarterly review of nursing
quality metrics to identify areas

Chief Nursing
Officer
Completion Date:
July 10, 2019

69

 Tag

Plan for correcting the cited deficiency

CLN0670 on June 18, 2019.

Procedure for implementing the acceptable plan of
correction
members. The document will reside in the employee
personnel record.

This plan of correction is also addressed
under Plan of Correction Tag A 385.

•
The Executive Director of Nursing, Professional
Practice, Strategy and Execution in collaboration with
the Unit leadership, reviewed the personnel files of
Staff #1, Staff #47, and Staff #43, and ensured that
each of these staff members had an annual
competency validation before caring for patients in
accordance with the patients’ needs by July 10, 2019.
The revised process will be introduced to nursing
leaders (Directors of Nursing, Associate Directors,
Nurse Managers, Clinical Nurse Leaders, and
educators) by July 10, 2019.
Compliance is reinforced regularly by nursing
leadership.

Tag A
409
Blood
Transfu
sions
and IV
Medica
tions
A 409

Follow-up/Monitoring

Person
Responsible
Completion Date

where competencies or further
education are needed.
Quarterly review of new
processes or procedures to
identify areas where
competencies or further
education are needed.

The revised process will be completed by
July 10, 2019. The updated process will
also be initiated by July 10, 2019.
Any nurse not in compliance with the
Hospital’s Nursing Staff Competency
Policy CLN0670, will be removed from
providing patient care until annual
competencies are completed.

Any clinical nursing personnel on leave (FMLA or
vacation) must complete the training before returning
to work.
Hospital ensures blood component transfusions and intravenous medications are administered in accordance with State law and approved
medical staff policies and procedures. If blood component transfusions and intravenous medications are administered by personnel other than
doctors of medicine or osteopathy, Hospital ensures the personnel have special training for this duty.

Hospital ensures that blood component
transfusions are administered in
accordance with Hospital’s
policy/procedures and acceptable nursing
standards.
A transfusion reaction investigation was
completed regarding the Reference
Patient. An interdisciplinary team including
the CMS/CLIA Steering Committee,

The Associate Director of G9 (Pediatrics) implemented
immediate individualized one on one training for the
two Pediatric RNs who cared for Patient #34 as
follows:
Nurse-Day Shift: Trained 12/7/18 and 12/31/18.
Training included:
• Coached on the escalation of concerns
• Coached on appropriate documentation of
escalation of concerns/provider notification

A random sample of 93 blood component
transfusion records are audited and
analyzed retrospectively each week by
the OPI to determine adherence to Blood
Component Administration and
Transfusion Reaction Policy CLN1115 for
vital signs and monitoring, that orders
specify the duration for the transfusion,
and the actual duration of the
transfusion. OPI reviews the data with the

Chief Operating
Officer
Completion Date:
July 10, 2019

70

 Tag

Plan for correcting the cited deficiency

members of the Transfusion and Patient
Blood Management Committee, the
Multidisciplinary Clinical Policies and
Procedures Task Force, Medical Staff and
Nursing reviewed the Hospital’s Blood
Component Administration and
Transfusion Reaction Policy CLN1115. As
part of this review over 6,000 patient
charts who received blood transfusions
were reviewed.
A training program was developed by an
inter-disciplinary team, including a
transfusion medicine faculty member. This
team was led by the Executive Director of
Nursing, Professional Practice, Strategy
and Execution and the Chief Education and
Training Officer to develop curriculum and
implement training for Credentialed
Providers who obtain informed consent
for, order, administer or manage
complications of blood component
transfusions and registered nurses (RN)
who administer blood components
pursuant to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which includes enhanced
nursing standards for administering and
monitoring blood components.
The hospital nurse training “Blood
Component Administration Competency”
has been updated to include the following
transfusion reaction symptoms: dry,
flushed skin, pain in the abdomen and
extremities, vomiting and bloody diarrhea.
The training also addresses signs and
symptoms of transfusion associated
circulatory overload. Completed May 17,
2019.

Procedure for implementing the acceptable plan of
correction
Nursing practice when carrying out the plan
of care; prioritizing interventions
• Reviewed gaps in documentation related to
hand-off documentation when the patient
leaves the unit
Nurse- Night Shift- Trained 12/20/18. Training
included:
• Gaps in vital sign monitoring and
documentation for blood component
administration
• Reviewed signs and symptoms of reactions
• Coached on appropriate documentation of
escalation of concerns/provider notification
• Reviewed institutional policy (CLN1115).
•

RNs who administer blood components received
educational information delivered in person by unit
nursing leadership (Associate Directors, Nurse
Managers, or Clinical Nurse Leaders) starting May 16,
2019 and completed by May 24, 2019. The topics
addressed included adherence to Blood Component
Administration and Transfusion Reaction Policy
CLN1115, as supported by ATT1722, Guidelines for
Identifying and Reporting a Transfusion Reaction,
acceptable nursing standards for assessment,
recognition, responding, and reporting symptoms of
suspected transfusion reactions.
RNs who administer blood components completed
mandatory computer based training with knowledge
assessment starting May 17, 2019 to be completed by
July 10, 2019. The topics addressed within the
computer based training on the Blood Component
Administration and Transfusion Reaction Policy
CLN1115, which includes increased monitoring of vital
sign and patient assessment, recognizing, responding
and reporting transfusion reactions.

Follow-up/Monitoring

Person
Responsible
Completion Date

Executive Director of Nursing Quality,
Safety and Research, and the Laboratory
Medicine Quality and Safety Officer to
develop recommendations for
improvement.
In collaboration with the Executive
Director of Nursing Quality, Safety and
Research and the Laboratory Medicine
Quality and Safety Officer, OPI will submit
the information and recommendations
for improvement to the Transfusion and
Patient Blood Management Committee,
the ECMS, and the QAPI Council monthly
for at least 2 months.
After 2 months of data collection, the
QAPI Council will determine whether the
frequency of data collection should be
adjusted (up or down) based on
performance. The Transfusion and
Patient Blood Management Committee
and ECMS will review the determination
and may make recommendations for
further improvement to the QAPI Council.
The QAPI Council will provide a
summation to the ELT and the Governing
Body at least quarterly.
The Hospital will address any deficiencies
with the individual nursing staff member
through pertinent education and training,
re-education and/or disciplinary action, as
appropriate.

Material was also reviewed regarding delivering
patient education for participation in their care while

71

 Tag

Plan for correcting the cited deficiency

The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which was published on
May 19, 2019.
Under the revised policy, nursing staff are
to take the patient’s vital signs prior to
initiating the transfusion, 15 minutes into
the transfusion, hourly from the start of
the transfusion through completion of the
transfusion, and at completion of the
transfusion. They are required to assess
the patient for signs and symptoms of
transfusion reaction and document their
observations hourly through completion of
the transfusion, and at completion of the
transfusion.
The Electronic Health Record (EHR)
includes a list of the symptoms of a
transfusion reaction. If the nurse selects
yes, the EHR generates a checklist of the
symptoms allowing the nurse to select the
symptoms that are present.
To ensure RNs administer blood
components in accordance with Hospital
policy and acceptable nursing standards:
(1) The Blood Component Administration
and Transfusion Reaction Policy CLN1115
was further modified to require that blood
components are administered via
volumetric pump to ensure the duration of
the transfusion is in accordance with
the physician’s orders. (Accordingly, blood
components will not be administered via
“gravity” flow).

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

receiving blood components.
Additional training will be conducted regarding the
changes to the EHR Blood Component Order Sets, the
modifications to the Blood Component Administration
and Transfusion Reaction Policy CLN1115 (including
the use of volumetric pumps, orders to include the
duration of the transfusion, and definitions of
hypotension and fever, as described in ATT1722,
Guidelines for Identifying and Reporting a Transfusion
Reaction), and the Stop the Line for Patient Safety
Policy CLN1185, by July 10, 2019.
RNs on leave who transfuse blood components must
complete training before attending patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 and the
enhanced nursing standards for administering and
monitoring blood component transfusions, and the
Stop the Line for Patient Safety Policy CLN1185 is
included in the on-boarding process for new RNs who
transfuse blood components.
Credentialed Providers who obtain informed consent
for, order, administer or manage complications of
blood component transfusions will complete the
computer based training as outlined above by July 10,
2019.
Credentialed Providers who obtain informed consent
for, order, administer or manage complications of
blood components and are on leave must complete
the computer based training before attending
patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 and the Stop
the Line for Patient Safety Policy CLN1185 is included
in the on-boarding process for new Credentialed
Providers.

72

 Tag

Plan for correcting the cited deficiency

The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which was approved on
June 20, 2019.

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

A reminder communication will be sent to all nursing
staff who administer and monitor transfusions
regarding the process for reporting a suspected
transfusion reaction, by July 10, 2019.

(2) Based on the National Patient Safety
Network Biovigilance Component
Hemovigilance Module Surveillance
Protocol, published April 2018 by the
Centers for Disease Control the Blood
Component Administration and
Transfusion Reaction Policy CLN1115 will
be amended to include the definitions of
hypotension and fever, by July 10, 2019.
ATT1722, Guidelines for Identifying and
Reporting a Transfusion Reaction, which
supports CLN1115, will be revised to
address the hypotension and fever
parameters by July 10, 2019.
(3) EHR Physician Blood Component Order
Set was modified to require duration of
blood component transfusion. A
Credentialed Provider must specify the
duration of the blood component
transfusion in order to complete the blood
component order (hard stop). This change
will be effective by July 10, 2019.
(4) Stop the Line for Patient Safety Policy
CLN1185 was modified to permit anyone
to stop the line for an incomplete,
conflicting or unclear order or in the event
of a suspected transfusion reaction.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS
approved the updated Stop the Line for

73

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

Patient Safety Policy CLN1185, which was
approved on June 20, 2019.
Further training was developed on the EHR
Blood Component Order Sets, and the
modifications to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115 and the Stop the Line for
Patient Safety Policy CLN1185.
The hospital has developed a
Hemovigilance Unit that will track the vital
signs of each patient receiving transfusion
services. Phase 1 of the Hemovigilance
Unit’s activities consist of performing
retrospective chart reviews on patients
identified through the Unit monitoring
system as having a possible transfusion
reaction. Any patients identified as having
a definite reaction receive a written
consult, recorded in the EHR, from a
Transfusion Medicine Physician. May 20,
2019.
Following a 2-4 week prospective pilot in 3
areas where transfusions are administered
(Phase 2), the Hemovigilance Unit will
track the vital signs of each patient
receiving transfusion services in real time
(Phase 3). These vital signs will be
reviewed by an RN under the supervision
of an Advanced Practice Provider (APP) or
physician 24/7 to complement the
monitoring being provided at the bedside.
The real time monitoring will also weight
the vital signs and assign a risk number for
each patient that is updated in real time,
highlighting patients exhibiting potential
signs of a reaction. Signs of a reaction will
be referred to a member of the transfusion
medicine practice. In addition to the

74

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

The Associate Director of G9 (Pediatrics) implemented
immediate individualized one on one training for the
two Pediatric RNs who cared for Patient #34 as
follows:

A random sample of 93 blood component
transfusion records are audited and
analyzed retrospectively each week by
the OPI to determine adherence to Blood
Component Administration and
Transfusion Reaction Policy CLN1115 for
the for vital signs and monitoring. OPI
reviews the data with the Executive
Director of Nursing Quality, Safety and
Research, and the Laboratory Medicine
Quality and Safety Officer to develop
recommendations for improvement.

Person
Responsible
Completion Date

monitoring being done by nursing under
this POC, the Hemovigilance Unit will also
review potential false negatives on an
ongoing basis and report to the
Transfusion and Patient Blood
Management Committee.
We are not formally submitting Phase 2
and 3 as part of our corrective action as
these require a significant time investment
to operationalize it across the hospital but
we wanted CMS to be aware of its
development as proof of our commitment
to being an industry leader in developing
new, innovative approaches to delivering
the highest level of care.

A
409(A)

This plan of correction is also addressed
under Plans of Correction Tags A 043, A
144, A 385, and A 115.
The Hospital ensures that nurses
continually assess patients during
transfusion of blood components.
A transfusion reaction investigation was
completed regarding the Reference
Patient. An interdisciplinary team including
the CMS/CLIA Steering Committee,
members of the Transfusion and Patient
Blood Management Committee, the
Multidisciplinary Clinical Policies and
Procedures Task Force, Medical Staff and
Nursing reviewed the Hospital’s Blood
Component Administration and
Transfusion Reaction Policy CLN1115. As
part of this review over 6,000 patient
charts who received blood transfusions
were reviewed.

A training program was developed by an

Nurse-Day Shift: Trained 12/7/18 and 12/31/18.
Training included:
• Coached on the escalation of concerns
• Coached on appropriate documentation of
escalation of concerns/provider notification
• Nursing practice when carrying out the plan
of care; prioritizing interventions
• Reviewed gaps in documentation related to
hand-off documentation when the patient
leaves the unit
RNs who administer blood components received
educational information delivered in person by unit
nursing leadership (Associate Directors, Nurse
Managers, or Clinical Nurse Leaders) starting May 16,

Chief Operating
Officer
Completion Date:
July 10, 2019

In collaboration with the Executive
Director of Nursing Quality, Safety and
Research and the Laboratory Medicine
Quality and Safety Officer, OPI will submit
the information and recommendations
for improvement to the Transfusion and
Patient Blood Management Committee,
the ECMS, and the QAPI Council monthly

75

 Tag

Plan for correcting the cited deficiency

inter-disciplinary team, including a
transfusion medicine faculty member. This
team was led by the Executive Director of
Nursing, Professional Practice, Strategy
and Execution and the Chief Education and
Training Officer to develop curriculum and
implement training for Credentialed
Providers who obtain informed consent
for, order, administer or manage
complications of blood component
transfusions and registered nurses (RN)
who administer blood components
pursuant to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which includes enhanced
nursing standards for administering and
monitoring blood components.
The hospital nurse training “Blood
Component Administration Competency”
has been updated to include the following
transfusion reaction symptoms: dry,
flushed skin, pain in the abdomen and
extremities, vomiting and bloody diarrhea.
The training also addresses signs and
symptoms of transfusion associated
circulatory overload. Completed May 17,
2019.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which was published on
May 19, 2019.
Under the revised policy, nursing staff are
to take the patient’s vital signs prior to
initiating the transfusion, 15 minutes into
the transfusion, hourly from the start of
the transfusion through completion of the

Procedure for implementing the acceptable plan of
correction
2019 and completed by May 24, 2019. The topics
addressed included adherence to Blood Component
Administration and Transfusion Reaction Policy
CLN1115, as supported by ATT1722, Guidelines for
Identifying and Reporting a Transfusion Reaction,
acceptable nursing standards for continual
assessment, recognition, responding, and reporting
symptoms of suspected transfusion reactions.
RNs who administer blood components completed
mandatory computer based training with knowledge
assessment starting May 17, 2019 to be completed by
July 10, 2019. The topics addressed within the
computer based training on the Blood Component
Administration and Transfusion Reaction Policy
CLN1115, which includes increased monitoring of vital
sign and patient assessment, recognizing, responding
and reporting transfusion reactions.
Material was also reviewed regarding delivering
patient education for participation in their care while
receiving blood components.

Follow-up/Monitoring

Person
Responsible
Completion Date

for at least 2 months.
After 2 months of data collection, the
QAPI Council will determine whether the
frequency of data collection should be
adjusted (up or down) based on
performance. The Transfusion and
Patient Blood Management Committee
and ECMS will review the determination
and may make recommendations for
further improvement to the QAPI Council.
The QAPI Council will provide a
summation to the ELT and the Governing
Body at least quarterly.
The Hospital will address any deficiencies
with the individual nursing staff member
through pertinent education and training,
re-education and/or disciplinary action, as
appropriate.

Additional training will be conducted regarding the
changes to the Blood Component Administration and
Transfusion Reaction Policy CLN1115 (including
definitions of hypotension and fever, as described in
ATT1722, Guidelines for Identifying and Reporting a
Transfusion Reaction), and the Stop the Line for
Patient Safety Policy CLN1185, by July 10, 2019.
RNs on leave who transfuse blood components must
complete training before attending patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 and the
enhanced nursing standards for administering and
monitoring blood component transfusions, and the
Stop the Line for Patient Safety Policy CLN1185 is
included in the on-boarding process for new RNs who
transfuse blood components.

76

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

transfusion, and at completion of the
transfusion. They are required to assess
the patient for signs and symptoms of
transfusion reaction and document their
observations hourly through completion of
the transfusion, and at completion of the
transfusion.

The Electronic Health Record (EHR)
includes a list of the symptoms of a
transfusion reaction. If the nurse selects
yes, the EHR generates a checklist of the
symptoms allowing the nurse to select the
symptoms that are present.
To ensure RNs administer blood
components in accordance with Hospital
policy and acceptable nursing standards:
(1) Based on the National Patient Safety
Network Biovigilance Component
Hemovigilance Module Surveillance
Protocol, published April 2018 by the
Centers for Disease Control the Blood
Component Administration and
Transfusion Reaction Policy CLN1115 will
be amended to include the definitions of
hypotension and fever, by July 10, 2019.
ATT1722, Guidelines for Identifying and
Reporting a Transfusion Reaction, which
supports CLN1115, will be revised to
address the hypotension and fever
parameters by July 10, 2019.
(2) Stop the Line for Patient Safety Policy
CLN1185 was modified to permit anyone
to stop the line for an incomplete,
conflicting or unclear order or in the event
of a suspected transfusion reaction.

77

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS
approved the updated Stop the Line for
Patient Safety Policy CLN1185, which was
approved on June 20, 2019.
Further training was developed on the
modifications to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115 and the Stop the Line for
Patient Safety Policy CLN1185.
The hospital has developed a
Hemovigilance Unit that will track the vital
signs of each patient receiving transfusion
services. Phase 1 of the Hemovigilance
Unit’s activities consist of performing
retrospective chart reviews on patients
identified through the Unit monitoring
system as having a possible transfusion
reaction. Any patients identified as having
a definite reaction receive a written
consult, recorded in the EHR, from a
Transfusion Medicine Physician. May 20,
2019.
Following a 2-4 week prospective pilot in 3
areas where transfusions are administered
(Phase 2), the Hemovigilance Unit will
track the vital signs of each patient
receiving transfusion services in real time
(Phase 3). These vital signs will be
reviewed by an RN under the supervision
of an APP or physician 24/7 to
complement the monitoring being
provided at the bedside. The real time
monitoring will also weight the vital signs
and assign a risk number for each patient
that is updated in real time, highlighting
patients exhibiting potential signs of a

78

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

reaction. Signs of a reaction will be
referred to a member of the transfusion
medicine practice. In addition to the
monitoring being done by nursing under
this POC, the Hemovigilance Unit will also
review potential false negatives on an
ongoing basis and report to the
Transfusion and Patient Blood
Management Committee.
We are not formally submitting Phase 2
and 3 as part of our corrective action as
these require a significant time investment
to operationalize it across the hospital but
we wanted CMS to be aware of its
development as proof of our commitment
to being an industry leader in developing
new, innovative approaches to delivering
the highest level of care.

A
409(B)

This plan of correction is also addressed
under the Plans of Correction Tags A 043,
A 144, A 385, and A 115.
The Hospital ensures that RNs provide and
documented timely, complete and
accurate assessments on patients who
experienced transfusion reactions.
A transfusion reaction investigation was
completed regarding the Reference
Patient. An interdisciplinary team including
the CMS/CLIA Steering Committee,
members of the Transfusion and Patient
Blood Management Committee, the
Multidisciplinary Clinical Policies and
Procedures Task Force, Medical Staff and
Nursing reviewed the Hospital’s Blood
Component Administration and
Transfusion Reaction Policy CLN1115. As
part of this review over 6,000 patient
charts who received blood transfusions

RNs who administer blood components received
educational information delivered in person by unit
nursing leadership (Associate Directors, Nurse
Managers, or Clinical Nurse Leaders) starting May 16,
2019 and completed by May 24, 2019. The topics
addressed included adherence to Blood Component
Administration and Transfusion Reaction Policy
CLN1115, as supported by ATT1722, Guidelines for
Identifying and Reporting a Transfusion Reaction,
acceptable nursing standards for continual
assessment, recognition, responding, and reporting
symptoms of suspected transfusion reactions.
RNs who administer blood components completed
mandatory computer based training with knowledge
assessment starting May 17, 2019 to be completed by
July 10, 2019. The topics addressed within the
computer based training on the Blood Component

A random sample of 93 blood component
transfusion records are audited and
analyzed retrospectively each week by
the OPI to determine adherence to Blood
Component Administration and
Transfusion Reaction Policy CLN1115 for
the for vital signs and monitoring and
documentation in accordance with
Nursing Documentation of Patient Care
Policy CLN0647. OPI reviews the data
with the Executive Director of Nursing
Quality, Safety and Research, and the
Laboratory Medicine Quality and Safety
Officer to develop recommendations for
improvement.

Chief Operating
Officer
Completion Date:
July 10, 2019

In collaboration with the Executive
Director of Nursing Quality, Safety and

79

 Tag

Plan for correcting the cited deficiency

were reviewed.
A training program was developed by an
inter-disciplinary team, including a
transfusion medicine faculty member. This
team was led by the Executive Director of
Nursing, Professional Practice, Strategy
and Execution and the Chief Education and
Training Officer to develop curriculum and
implement training for Credentialed
Providers who obtain informed consent
for, order, administer or manage
complications of blood component
transfusions and registered nurses (RN)
who administer blood components
pursuant to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which includes enhanced
nursing standards for administering and
monitoring blood components.
The hospital nurse training “Blood
Component Administration Competency”
has been updated to include the following
transfusion reaction symptoms: dry,
flushed skin, pain in the abdomen and
extremities, vomiting and bloody diarrhea.
The training also addresses signs and
symptoms of transfusion associated
circulatory overload. Completed May 17,
2019.

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Administration and Transfusion Reaction Policy
CLN1115, which includes increased monitoring of vital
sign and patient assessment, recognizing, responding
and reporting transfusion reactions.

Research and the Laboratory Medicine
Quality and Safety Officer, OPI will submit
the information and recommendations
for improvement to the Transfusion and
Patient Blood Management Committee,
the ECMS, and the QAPI Council monthly
for at least 2 months.

Material was also reviewed regarding delivering
patient education for participation in their care while
receiving blood components.
Additional training will be conducted regarding the
changes to the Blood Component Administration and
Transfusion Reaction Policy CLN1115 (including
definitions of hypotension and fever, as described in
ATT1722, Guidelines for Identifying and Reporting a
Transfusion Reaction), the Stop the Line for Patient
Safety Policy CLN1185, and the Nursing
Documentation of Patient Care Policy CLN0647 by July
10, 2019.
RNs on leave who transfuse blood components must
complete training before attending patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 and the
enhanced nursing standards for administering and
monitoring blood component transfusions, the Stop
the Line for Patient Safety Policy CLN1185, and
Nursing Documentation of Patient Care Policy
CLN0647is included in the on-boarding process for
new RNs who transfuse blood components.

Person
Responsible
Completion Date

After 2 months of data collection, the
QAPI Council will determine whether the
frequency of data collection should be
adjusted (up or down) based on
performance. The Transfusion and
Patient Blood Management Committee
and ECMS will review the determination
and may make recommendations for
further improvement to the QAPI Council.
The QAPI Council will provide a
summation to the ELT and the Governing
Body at least quarterly.
The Hospital will address any deficiencies
with the individual nursing staff member
through pertinent education and training,
re-education and/or disciplinary action, as
appropriate.

The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which was published on
May 19, 2019.
Under the revised policy, nursing staff are
to take the patient’s vital signs prior to

80

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

initiating the transfusion, 15 minutes into
the transfusion, hourly from the start of
the transfusion through completion of the
transfusion, and at completion of the
transfusion. They are required to assess
the patient for signs and symptoms of
transfusion reaction and document their
observations hourly through completion of
the transfusion, and at completion of the
transfusion.
The Electronic Health Record (EHR)
includes a list of the symptoms of a
transfusion reaction. If the nurse selects
yes, the EHR generates a checklist of the
symptoms allowing the nurse to select the
symptoms that are present.
In addition, the Hospital’s Nursing
Documentation of Patient Care Policy
CLN0647 was modified as follows: (i) to
require nurses to document assessment
and reassessment of the patient, prior to,
during and after a procedure or treatment
as indicated, within an appropriate time
frame after the intervention for an
evaluation of effectiveness and patient’s
response to the intervention, and
appropriate follow up with the
Credentialed Provider; and (ii) to require
clear documentation for nursing work flow
in the EHR, to include documentation of
vital signs and suspected transfusion
reaction in accordance with the Hospital’s
Blood Component Administration and
Transfusion Reaction Policy LN1115.
To ensure RNs document and detect
infusion reactions:
(1) Based on the National Patient Safety

81

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

Network Biovigilance Component
Hemovigilance Module Surveillance
Protocol, published April 2018 by the
Centers for Disease Control the Blood
Component Administration and
Transfusion Reaction Policy CLN1115 will
be amended to include the definitions of
hypotension and fever, by July 10, 2019.
ATT1722, Guidelines for Identifying and
Reporting a Transfusion Reaction, which
supports CLN1115, will be revised to
address the hypotension and fever
parameters by July 10, 2019.
EPIC parameters will be modified, based
on the above Network Biovigilance
Component Hemovigilance Module
Surveillance Protocol by July 10, 2019.
(2) Stop the Line for Patient Safety Policy
CLN1185 was modified to permit anyone
to stop the line for an incomplete,
conflicting or unclear order or in the event
of a suspected transfusion reaction.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS
approved the updated Stop the Line for
Patient Safety Policy CLN1185, which was
approved on June 20, 2019.
Further training was developed on the
modifications to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115 and the Stop the Line for
Patient Safety Policy CLN1185.
The hospital has developed a
Hemovigilance Unit that will track the vital
signs of each patient receiving transfusion

82

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

services. Phase 1 of the Hemovigilance
Unit’s activities consist of performing
retrospective chart reviews on patients
identified through the Unit monitoring
system as having a possible transfusion
reaction. Any patients identified as having
a definite reaction receive a written
consult, recorded in the EHR, from a
Transfusion Medicine Physician. May 20,
2019.
Following a 2-4 week prospective pilot in 3
areas where transfusions are administered
(Phase 2), the Hemovigilance Unit will
track the vital signs of each patient
receiving transfusion services in real time
(Phase 3). These vital signs will be
reviewed by an RN under the supervision
of an APP or physician 24/7 to
complement the monitoring being
provided at the bedside. The real time
monitoring will also weight the vital signs
and assign a risk number for each patient
that is updated in real time, highlighting
patients exhibiting potential signs of a
reaction. Signs of a reaction will be
referred to a member of the transfusion
medicine practice. In addition to the
monitoring being done by nursing under
this POC, the Hemovigilance Unit will also
review potential false negatives on an
ongoing basis and report to the
Transfusion and Patient Blood
Management Committee.
We are not formally submitting Phase 2
and 3 as part of our corrective action as
these require a significant time investment
to operationalize it across the hospital but
we wanted CMS to be aware of its
development as proof of our commitment

83

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

The Associate Director of G9 (Pediatrics) implemented
immediate individualized one on one training for the
two Pediatric RNs who cared for Patient #34 as
follows:

A random sample of 93 blood component
transfusion records are audited and
analyzed retrospectively each week by
the OPI to determine adherence to (1)
Blood Component Administration and
Transfusion Reaction Policy CLN1115,
including reporting to and consulting with
the Credentialed Provider and the
Transfusion Medicine Physician for
suspected transfusion reactions, and (2)
Stop the Line for Patient Safety Policy
CLN1185, to stop the line in the event of a
suspected transfusion reaction or an
incomplete, conflicting or unclear order.

Person
Responsible
Completion Date

to being an industry leader in developing
new, innovative approaches to delivering
the highest level of care.
A
409(C)

Hospital ensures that nurses notify the
Credentialed Providers of changes in vital
signs and condition of patients receiving
transfusions of blood components as
required under the Hospital policy.
A transfusion reaction investigation was
completed regarding the Reference
Patient. An interdisciplinary team including
the CMS/CLIA Steering Committee,
members of the Transfusion and Patient
Blood Management Committee, the
Multidisciplinary Clinical Policies and
Procedures Task Force, Medical Staff and
Nursing reviewed the Hospital’s Blood
Component Administration and
Transfusion Reaction Policy CLN1115. As
part of this review over 6,000 patient
charts who received blood transfusions
were reviewed.
A training program was developed by an
inter-disciplinary team, including a
transfusion medicine faculty member. This
team was led by the Executive Director of
Nursing, Professional Practice, Strategy
and Execution and the Chief Education and
Training Officer to develop curriculum and
implement training for Credentialed
Providers who obtain informed consent
for, order, administer or manage
complications of blood component
transfusions and registered nurses (RN)
who administer blood components
pursuant to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which includes enhanced

Nurse-Day Shift: Trained 12/7/18 and 12/31/18.
Training included:
• Coached on the escalation of concerns
• Coached on appropriate documentation of
escalation of concerns/provider notification
• Nursing practice when carrying out the plan
of care; prioritizing interventions
Reviewed gaps in documentation related to hand-off
documentation when the patient leaves the unit
Nurse- Night Shift- Trained 12/20/18. Training
included:
• Gaps in vital sign monitoring and
documentation for blood component
administration
• Reviewed signs and symptoms of reactions
• Coached on appropriate documentation of
escalation of concerns/provider notification
• Reviewed institutional policy (CLN1115).
RNs who administer blood components received
educational information delivered in person by unit
nursing leadership (Associate Directors, Nurse
Managers, or Clinical Nurse Leaders) starting May 16,
2019 and completed by May 24, 2019. The topics
addressed included adherence to Blood Component
Administration and Transfusion Reaction Policy
CLN1115, as supported by ATT1722, Guidelines for
Identifying and Reporting a Transfusion Reaction,
acceptable nursing standards for assessment,
recognition, responding, and reporting symptoms of

Chief Operating
Officer
Completion Date:
July 10, 2019

OPI reviews the data with the Executive
Director of Nursing Quality, Safety and
Research, and the Laboratory Medicine
Quality and Safety Officer to develop
recommendations for improvement.
In collaboration with the Executive
Director of Nursing Quality, Safety and
Research and the Laboratory Medicine
Quality and Safety Officer, OPI will submit
the information and recommendations
for improvement to the Transfusion and
Patient Blood Management Committee,
the ECMS, and the QAPI Council monthly
for at least 2 months.
After 2 months of data collection, the
QAPI Council will determine whether the
frequency of data collection should be
adjusted (up or down) based on
performance. The Transfusion and
Patient Blood Management Committee

84

 Tag

Plan for correcting the cited deficiency

nursing standards for administering and
monitoring blood components.
The hospital nurse training “Blood
Component Administration Competency”
has been updated to include the following
transfusion reaction symptoms: dry,
flushed skin, pain in the abdomen and
extremities, vomiting and bloody diarrhea.
The training also addresses signs and
symptoms of transfusion associated
circulatory overload. Completed May 17,
2019.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which was published on
May 19, 2019.
Under the revised policy, nursing staff are
to take the patient’s vital signs prior to
initiating the transfusion, 15 minutes into
the transfusion, hourly from the start of
the transfusion through completion of the
transfusion, and at completion of the
transfusion. They are required to assess
the patient for signs and symptoms of
transfusion reaction and document their
observations hourly through completion of
the transfusion and at completion of the
transfusion.
The Electronic Health Record (EHR)
includes a list of the symptoms of a
transfusion reaction. If the nurse selects
yes, the EHR generates a checklist of the
symptoms allowing the nurse to select the
symptoms that are present.

Procedure for implementing the acceptable plan of
correction
suspected transfusion reactions.
RNs who administer blood components completed
mandatory computer based training with knowledge
assessment starting May 17, 2019 to be completed by
July 10, 2019. The topics addressed within the
computer based training on the Blood Component
Administration and Transfusion Reaction Policy
CLN1115, included increased monitoring of vital sign
and patient assessment, recognizing, responding and
reporting transfusion reactions to and consulting with
the Credentialed Provider and the Transfusion
Medicine Physician, and clarifying physician orders.
Material was also reviewed regarding delivering
patient education for participation in their care while
receiving blood components.

Follow-up/Monitoring

Person
Responsible
Completion Date

and ECMS will review the determination
and may make recommendations for
further improvement to the QAPI Council.
The QAPI Council will provide a
summation to the ELT and the Governing
Body at least quarterly.
The Hospital will address any deficiencies
with the individual nursing staff member
through pertinent education and training,
re-education and/or disciplinary action, as
appropriate.

Additional training will be conducted regarding the
changes to the Blood Component Administration and
Transfusion Reaction Policy CLN1115 (including
definitions of hypotension and fever, reporting
suspected transfusion reactions to and consulting with
the Credentialed Provider and the Transfusion
Medicine Physician), and the Stop the Line for Patient
Safety Policy CLN1185, by July 10, 2019.
RNs on leave who transfuse blood components must
complete training before attending patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115 and the
enhanced nursing standards for administering and
monitoring blood component transfusions, Stop the
Line for Patient Safety Policy CLN1185 is included in
the on-boarding process for new RNs who transfuse
blood components.

85

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

To ensure RNs notify the Credentialed
Providers of condition of patients receiving
transfusions of blood components as
required under the Hospital policy:
(1) Based on the National Patient Safety
Network Biovigilance Component
Hemovigilance Module Surveillance
Protocol, published April 2018 by the
Centers for Disease Control the Blood
Component Administration and
Transfusion Reaction Policy CLN1115 will
be amended to include the definitions of
hypotension and fever, by July 10, 2019.
ATT1722, Guidelines for Identifying and
Reporting a Transfusion Reaction, which
supports CLN1115, will be revised to
address the hypotension and fever
parameters by July 10, 2019.
(2) The Blood Component Administration
and Transfusion Reaction Policy CLN1115
was further modified to require that the
Transfusion Medicine Physician is
consulted regarding suspected blood
component transfusion reactions.
(3) Stop the Line for Patient Safety Policy
CLN1185 was modified to permit anyone
to stop the line for an incomplete,
conflicting or unclear order or in the event
of a suspected transfusion reaction.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS
approved the updated Stop the Line for
Patient Safety Policy CLN1185, which was
approved on June 20, 2019.
Further training was developed on the

86

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

modifications to the Blood Component
Administration and Transfusion Reaction
Policy CLN1115 and the Stop the Line for
Patient Safety Policy CLN1185.
The hospital has developed a
Hemovigilance Unit that will track the vital
signs of each patient receiving transfusion
services. Phase 1 of the Hemovigilance
Unit’s activities consist of performing
retrospective chart reviews on patients
identified through the Unit monitoring
system as having a possible transfusion
reaction. Any patients identified as having
a definite reaction receive a written
consult, recorded in the EHR, from a
Transfusion Medicine Physician. May 20,
2019.
The hospital has developed a
Hemovigilance Unit that will track the vital
signs of each patient receiving transfusion
services. Phase 1 of the Hemovigilance
Unit’s activities consist of performing
retrospective chart reviews on patients
identified through the Unit monitoring
system as having a possible transfusion
reaction. Any patients identified as having
a definite reaction receive a written
consult, recorded in the EHR, from a
Transfusion Medicine Physician. May 20,
2019.
Following a 2-4 week prospective pilot in 3
areas where transfusions are administered
(Phase 2), the Hemovigilance Unit will
track the vital signs of each patient
receiving transfusion services in real time
(Phase 3). These vital signs will be
reviewed by an RN under the supervision
of an APP or physician 24/7 to

87

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

All RNs who administer blood components received
pertinent education and training with knowledge
assessment to be completed by July 10, 2019. The
topics addressed during the training included changes
to the EHR Blood Component Order Sets, adherence to
Blood Component Administration and Transfusion
Reaction Policy CLN1115, Patient Care Orders Policy
CLN1140, and Stop the Line for Patient Safety Policy
CLN1185, obtaining complete and accurate
Credentialed Provider orders prior to initiating
transfusions, infusing blood components at the
duration specified in the Credentialed Provider order

A random sample of 93 blood component
transfusion records are audited and
analyzed retrospectively each week by
the OPI to determine adherence to Blood
Component Administration and
Transfusion Reaction Policy CLN1115, EHR
Credentialed Provider Order Sets, and
Stop The Line DCLN1185, specifically that
orders specify the duration for the
transfusion, and the actual duration of
the transfusion. OPI reviews the data
with the Executive Director of Nursing

Person
Responsible
Completion Date

complement the monitoring being
provided at the bedside. The real time
monitoring will also weight the vital signs
and assign a risk number for each patient
that is updated in real time, highlighting
patients exhibiting potential signs of a
reaction. Signs of a reaction will be
referred to a member of the transfusion
medicine practice. In addition to the
monitoring being done by nursing under
this POC, the Hemovigilance Unit will also
review potential false negatives on an
ongoing basis and report to the
Transfusion and Patient Blood
Management Committee.
We are not formally submitting Phase 2
and 3 as part of our corrective action as
these require a significant time investment
to operationalize it across the hospital but
we wanted CMS to be aware of its
development as proof of our commitment
to being an industry leader in developing
new, innovative approaches to delivering
the highest level of care.

A
409(D)

This plan of correction is also addressed
under the Plans of Correction Tags A 043,
A 144, A 385, and A 115.
The Hospital ensures that nurses have
complete and accurate orders prior to
initiating transfusions. Blood components
are infused at the duration specified in the
Credentialed Provider orders for
transfusion. Orders are clarified as
needed, and Credentialed Providers are
notified if the orders are not followed.
A transfusion reaction investigation was
completed regarding the Reference
Patient. An interdisciplinary team including

Chief
Officer

Nursing

Completion Date:
July 10, 2019

88

 Tag

Plan for correcting the cited deficiency

the CMS/CLIA Steering Committee,
members of the Transfusion and Patient
Blood Management Committee, the
Multidisciplinary Clinical Policies and
Procedures Task Force, Medical Staff and
Nursing reviewed the Hospital’s Blood
Component Administration and
Transfusion Reaction Policy CLN1115. As
part of this review over 6,000 patient
charts who received blood transfusions
were reviewed.
The Hospital took the following actions to
ensure that RNs infuse blood components
at the duration specified in the order, that
orders are clarified as needed, and that
Credentialed Providers are notified if the
orders are not followed:
(1) The Blood Component Administration
and Transfusion Reaction Policy CLN1115
was further modified to require that blood
components are administered via
volumetric pump to ensure the duration of
the transfusion is in accordance with
the Credentialed Provider’s orders.
(Accordingly, blood components will not
be administered via “gravity” flow).
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which was approved on
June 20, 2019.

Procedure for implementing the acceptable plan of
correction
for transfusion, clarifying orders as necessary,
notifying the Credentialed Provider if orders are not
followed, and procedures for stopping the line for
patient safety. July 10, 2019.
Any RN on leave who transfuses blood components
must complete the training before attending patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115, Patient Care
Orders Policy CLN1140, and Stop the Line for Patient
Safety Policy CLN1185, obtaining complete and
accurate Credentialed Provider orders prior to
initiating transfusions, infusing blood components at
the duration specified in the Credentialed Provider
order for transfusion, clarifying orders as necessary,
notifying the Credentialed Provider if orders are not
followed, and procedures for stopping the line for
patient safety is included in the on-boarding process
for new RNs who transfuse blood components.

Follow-up/Monitoring

Person
Responsible
Completion Date

Quality, Safety and Research, and the
Laboratory Medicine Quality and Safety
Officer to develop recommendations for
improvement.
In collaboration with the Executive
Director of Nursing Quality, Safety and
Research and the Laboratory Medicine
Quality and Safety Officer, OPI will submit
the information and recommendations
for improvement to the Transfusion and
Patient Blood Management Committee,
the ECMS, and the QAPI Council monthly
for at least 2 months.
After 2 months of data collection, the
QAPI Council will determine whether the
frequency of data collection should be
adjusted (up or down) based on
performance. The Transfusion and
Patient Blood Management Committee
and ECMS will review the determination
and may make recommendations for
further improvement to the QAPI Council.
The QAPI Council will provide a
summation to the ELT and the Governing
Body at least quarterly.
The Executive Director of Nursing,
Strategy, Practice and Execution and
Executive Director of Quality, Safety and
Research will address any deficiencies
with the individual nursing staff member
through pertinent education and training,
re-education and/or disciplinary action, as
appropriate.

(2) To ensure clarity of Credentialed
Provider orders, the Hospital’s Patient Care
Orders Policy CLN1140 was modified as
follows: (i) to require health care providers
to seek clarification of incomplete,

89

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

conflicting or unclear orders.
The Executive Owner of the Patient Care
Orders Policy CLN1140 (the Chief Medical
Officer) and the ECMS, approved the
updated Patient Care Orders Policy
CLN1140, which was published on June 20,
2019.
(3) Electronic Health Record (EHR)
Credentialed Provider Order Set was
modified to require duration of blood
component transfusion. A Credentialed
Provider must specify the duration of the
blood component transfusion in order to
complete the blood component order
(hard stop). This change will be effective
by July 10, 2019.
(4) Stop the Line for Patient Safety Policy
CLN1185 was modified to permit anyone
to stop the line for an incomplete,
conflicting or unclear order or in the event
of a suspected transfusion reaction.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Stop the Line for
Patient Safety Policy CLN1185, which was
approved on June 20, 2019.
Training was developed by the Executive
Director of Nursing, Professional Practice,
Strategy and Execution to develop
curriculum and implement training for
registered nurses (RN) who administer
blood components pursuant to the Blood
Component Administration and
Transfusion Reaction Policy CLN1115, the
Stop The Line for Patient Safety Policy CLN
1185, the Patient Care Orders Policy CLN

90

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

All RNs who administer blood components received
pertinent education and training with knowledge
assessment to be completed by July 10, 2019. The
topics addressed during the training included changes
to the EHR Blood Component Order Sets, adherence to
Blood Component Administration and Transfusion
Reaction Policy CLN1115, Patient Care Orders Policy
CLN1140, and Stop the Line for Patient Safety Policy
CLN1185, obtaining complete and accurate
Credentialed Provider orders prior to initiating
transfusions, infusing blood components at the
duration specified in the Credentialed Provider order
for transfusion, clarifying orders as necessary,
notifying the Credentialed Provider if orders are not
followed, and procedures for stopping the line for
patient safety. July 10, 2019.
Any RN on leave who transfuses blood components
must complete the training before attending patients.
Education regarding Blood Component Administration
and Transfusion Reaction Policy CLN1115, Patient Care
Orders Policy CLN1140, and Stop the Line for Patient
Safety Policy CLN1185, obtaining complete and
accurate Credentialed Provider orders prior to
initiating transfusions, infusing blood components at
the duration specified in the Credentialed Provider
order for transfusion, clarifying orders as necessary,
notifying the Credentialed Provider if orders are not
followed, and procedures for stopping the line for
patient safety is included in the on-boarding process
for new RNs who transfuse blood components.

A random sample of 93 blood component
transfusion records are audited and
analyzed retrospectively each week by
the OPI to determine adherence to Blood
Component Administration and
Transfusion Reaction Policy CLN1115, EHR
Credentialed Provider Order Sets, and
Stop The Line DCLN1185, specifically that
orders specify the duration for the
transfusion, and the actual duration of
the transfusion. OPI reviews the data
with the Executive Director of Nursing
Quality, Safety and Research, and the
Laboratory Medicine Quality and Safety
Officer to develop recommendations for
improvement.

Person
Responsible
Completion Date

1140, and the EHR Order Set.
This plan of Correction is also addressed
under Plan of Correction Tag A385.
A
409(E)

The Hospital ensures that nurses follow
Credentialed Provider orders for
transfusion rates (duration) for patients.
A transfusion reaction investigation was
completed regarding the Reference
Patient. An interdisciplinary team including
the CMS/CLIA Steering Committee,
members of the Transfusion and Patient
Blood Management Committee, the
Multidisciplinary Clinical Policies and
Procedures Task Force, Medical Staff and
Nursing reviewed the Hospital’s Blood
Component Administration and
Transfusion Reaction Policy CLN1115. As
part of this review over 6,000 patient
charts who received blood transfusions
were reviewed.
The Hospital took the following actions to
ensure complete and accurate orders for
blood components, that RNs infuse blood
components at the duration specified in
the order, that orders are clarified as
needed, and that Credentialed Providers
are notified if the orders are not followed:
(1) The Blood Component Administration
and Transfusion Reaction Policy CLN1115
was further modified to require that blood
components are administered via
volumetric pump to ensure the duration of
the transfusion is in accordance with
the Credentialed Provider’s orders.
(Accordingly, blood components will not
be administered via “gravity” flow).

Chief Nursing
Officer
Completion Date:
July 10, 2019

In collaboration with the Executive
Director of Nursing Quality, Safety and
Research and the Laboratory Medicine
Quality and Safety Officer, OPI will submit
the information and recommendations
for improvement to the Transfusion and
Patient Blood Management Committee,
the ECMS, and the QAPI Council monthly
for at least 2 months.
After 2 months of data collection, the
QAPI Council will determine whether the
frequency of data collection should be
adjusted (up or down) based on
performance. The Transfusion and
Patient Blood Management Committee
and ECMS will review the determination
and may make recommendations for
further improvement to the QAPI Council.

91

 Tag

Plan for correcting the cited deficiency

The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Blood Component
Administration and Transfusion Reaction
Policy CLN1115, which was approved on
June 20, 2019.
(2) To ensure clarity of Credentialed
Provider orders, the Hospital’s Patient Care
Orders Policy CLN1140 was modified as
follows: (i) to require health care providers
to seek clarification of incomplete,
conflicting or unclear orders.

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

Person
Responsible
Completion Date

The QAPI Council will provide a
summation to the ELT and the Governing
Body at least quarterly.
The Executive Director of Nursing,
Strategy, Practice and Execution and
Executive Director of Quality, Safety and
Research will address any deficiencies
with the individual nursing staff member
through pertinent education and training,
re-education and/or disciplinary action, as
appropriate.

The Executive Owner of the Patient Care
Orders Policy CLN1140 (the Chief Medical
Officer) and the ECMS, approved the
updated Patient Care Orders Policy
CLN1140, which was published on June 20,
2019.
(3) Electronic Health Record (EHR)
Credentialed Provider Order Set was
modified to require duration of blood
component transfusion. A Credentialed
Provider must specify the duration of the
blood component transfusion in order to
complete the blood component order
(hard stop). This change will be effective
by July 10, 2019.
(4) Stop the Line for Patient Safety Policy
CLN1185 was modified to permit anyone
to stop the line for an incomplete,
conflicting or unclear order or in the event
of a suspected transfusion reaction.
The Executive Owner of the Policy (the
Chief Medical Officer) and the ECMS,
approved the updated Stop the Line for

92

 Tag

Plan for correcting the cited deficiency

Procedure for implementing the acceptable plan of
correction

Follow-up/Monitoring

All applicable Laboratory Directors, each of whom is
responsible for different portions of the 25 laboratory
sections/areas, will be educated on the revised and
renamed CLIA Laboratory Quality Management Plan
with a special emphasis on the monthly reporting of
quality data for each section/area to the ECMS and the
QAPI Council. July 10, 2019

Each Laboratory Director shall delegate
responsibility to the Pathology and
Laboratory Medicine Division Head for
reviewing the quality reports from all
laboratory sections/areas on a monthly
basis for 6 months to ensure consistent
reporting. In the event that any area or
section fails to timely report its quality
data, the responsible individuals will be
retrained and may be subject to discipline
in accordance with the hospital’s HR
policies. Monitoring will continue until all
sections/areas are timely reported for a
period of 6 months.

Person
Responsible
Completion Date

Patient Safety Policy CLN1185, which was
approved on June 20, 2019.
Training was developed by the Executive
Director of Nursing, Professional Practice,
Strategy and Execution to develop
curriculum and implement training for
registered nurses (RN) who administer
blood components pursuant to the Blood
Component Administration and
Transfusion Reaction Policy CLN1115, the
Stop The Line for Patient Safety Policy CLN
1185, the Patient Care Orders Policy CLN
1140, and the EHR Order Set.
This plan of correction is also addressed
under Plan of Correction Tag A385.
Tag A
576

A. The Division Quality Management Plan
(DIV QIP 0206) has been renamed CLIA
Laboratory Quality Management Plan and
has been revised to require that the
quality data from all 25 laboratory
sections/areas be reported to the ECMS
and the QAPI Council on a monthly basis.
June 14, 2019.

B. The Division Quality Management Plan
(DIV QIP 0206) has been renamed CLIA
Laboratory Quality Management Program
and has been revised to require that all
laboratory sections/areas are identified
and required to submit quality data to the
ECMS and the QAPI Council.

Laboratory
Director
Completion Date:
July 10, 2019

93

 94