INVESTIGAIIGN BEFORE Facility: BRIGHAM 8 mum's HOSPITAL 75 FRANCIS STREET BOSTON, MA, 02115 Date Renaived: 12/03/2014 Date Investigated: 01/08/2015, o1/12/2015, 01/15/2015, 01/20/2015 n- in INVESTIGAIGRY SEEDS: 1. PERSONS INTERVIEWED Risk Manager Ass. Chief Nurse Ass. Chief Nurse Nursing Director Registered Nurse Registered Nurse #3 Registered Nurse #5 Chief Medical Officer Hospital Physician #1 Chief Financial Officer Pharmacist #1 Registered Nurse #8 Occupational Health Coordinator #1 #2 #2 #1 2. RECORDS REVIEWED Clinical Records (10) Controlled Substance Report 9/9/14 Personnel Files (4) Credential Files (5) List of Contract Services Governing Body Minutes urn-- Reference 14-1181 Pagai 01/13/2015, 01/14/2015, Director of Clinical Compliance Chief Nursing Officer Nursing Director #1 Nursing Director #3 Registered Nurse #2 Registered Nurse #4 Registered Nurse #6 Primary Care Physician Registered Nurse #7 Director of Pharmacy Infection Preventionist Registered Nurse #9 Policies/Procedures (3B The Joint Commission Report Drug MOnographs Personnel Health Files (2) Organizational Charts (2) Nurse Staff Schedules Medical Staff By Laws Facility? BRIGHAM HOSPIIAL INVESTIGAEION BEFORE Reference 14-1181 Page 2 3. PHYSICAL EVIDENCE REVIEWED Tour of Patient #4'5 Nursing Unit B. ISSUES FOR INVESTIGAIION 1. SYNOPSIS: 2. ISSUES: It was alleged that: 1) Patient #4 received inappropriate medical care because a physician prescribed and . that were not clinically indicated, 2) Patient #4 received poor quality of nursing care because those medications were not administered and monitored in accordance with Hospital policies and procedures or accepted standards of practice, 3) Patient #4 received routine medications by personal staff and 4) Infection control practices were not followed by medical and nursing staff. Based on record reviews and interviews the allegation of inappropriate medical care and poor nursing care was invalid because and were ordered, administered and monitored according to Hospital policies and procedures, allegation 3 and 4 were valid because personal private staff were administering medications and Hospital staff failed to follow infection prevention policies and procedures Deficiencies were cited. 1. Physician Services 2. Nursing Services 3. Nursing Services 4. Infection Control C. ISSUE 1 Physician Services BRIEF EXPLANATION OF FINDINGS It was alleged that Hospital Physician who managed Patient #4'3 prescribed ., and that were not clinically indicated and that the and . that were ordered based on Patient #4'5 specifications. Federal Hospital Regulations require the medical staff to be well organized and accountable to the governing body for the quality of the medical care provided to the patients. INVESTIGAEION BEFORE Facility: BRIG-HAM s. mum's HOSPITAL Reference 14-1181 Page 3 Based on interview and record review the allegation of inappropriate medical care was determined invalid because: 1) Patient #4?s medical record, dated /14, indicated that Patient #4 was admitted to the Hospital for with a that developed after 'zs, as well as other medications to address his/her which included . - and . The goal for Patient #4 was to given the need for - for Patient #4's 2) Patient #4'3 medical record indicated that during Patient #4's hospitalization from 1, a physician prescribed doses of that were within dose Monograph guidelines for 3) Pharmacist #1 said he reviewed Patient #4'5 medical record which indicated Patient #4 was diagnosed as I from resulting in the need for . . Pharmacist #1 said Patient #4's doses were ordered and administered within the Drug Monographs of the Hospital. VALIDITY: Invalid C. ISSUE 2 Nursing Services BRIEF EXPLANATION OF FINDINGS It was alleged that the nursing staff administered high doses of and medications to Patient #4 that were not administered according to policies and procedures or accepted standards of practice because: nurses administered divided doses of and administered doses of medications before the medication was due to be administered. Federal hospital regulations require that: (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient?s care as specified under and accepted standards of practice. Drugs and biologicals may be prepared and administered on the orders INVESTIGAIION REPORT Facility: womws HOSPITAL . Reference 14-1181 Page 4 of other practitioners not specified under i482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital'policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. Based on record review and interviews the allegation of poor quality of nursing care was invalid because: 1) Hospital Nursing Staff interview and review of electronic medication administration records indicated that Patient #4 received and as ordered by hospital physicians. 2) Record review and interview indicated there was no evidence of split doses or that early doses of were administered. VALIDITY: Invalid C. ISSUE 3 Nursing Services BRIEF EXPLANATION OF FINDINGS It was alleged that Patient #4's medications were sometimes administered by Patient #4'5 personal staff who were not licensed in the State of Massachusetts. Federal hospital regulations require that 1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient?s care as specified under and accepted standards of practice. Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under i482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and INVESTIGAEION BEFORE Facility: sarcasm Imam-a HOSPITAL . saferenaa 14?1181 Page 5 State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. Based on interview and record review, the allegation of poor quality of nursing care was determined valid because unauthorized persons administered routine medications to Patient #1 from a non-secure storage area. Deficiencies were cited. VALIDITY: Valid C. ISSUE 4 Infection Control BRIEF EXPLANATION OF FINDINGS It was alleged that Patient #4 was for a on Patient #4 did not allow Hospital staff to gown and glove, as required by the Hospital's policy because these made Patient #4 feel dirty. It was alleged that staff were not wearing . - and this placed other patients at risk for during Patient #4'8 six month hospitalization. Federal Hospital regulations require the Hospital to develop a system for controlling infections and communicable diseases of patients and personnel. Based on records reviewed and interviews, the allegation of poor infection control practices was determined to be valid because staff failed to use personal protective equipment with a patient diagnosed with . and placed the Infection Prevention program lacked policies to address private staff who provided care for Patient #4 during his/her prolonged hospitalization and because the Hospital failed to follow their policies for respirator fit testing. Deficiencies were cited. VALIDITY: Valid D. INVESTIGATION Facility: ERIGI-IAM s. mom's 30mm. Reference 14?1181 Page 6