PRINTED: 03/15/2013 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 051511 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 4311 THIRD AVENUE SAN DIEGO HOSPICE & THE INSTITUTE FOR PALLIATIVE M (X4) ID PREFIX TAG 03/18/2012 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) L 000 INITIAL COMMENTS SAN DIEGO, CA 92103 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE L 000 The following represents the findings of the California Department of Public Health during the investigation of a self reported event from 3/12/12 through 3/18/12. Event #CA00302549 Representing the Department of Public Health: Health Facilities Evaluator Nurse #29361 and Pharmaceutical Consultant II #25053. On 3/9/12 the hospice reported to the Department, an adverse patient event, which occurred on 3/4/12. The event involved a caregiver who administered 20 times the prescribed amount of oral morphine (Roxanol) to Patient A. The patient died approximately one hour following the orally administered dose. The hospice pharmacy did not have a system in place to ensure the safe administration of medications in the patients' homes. The pharmacy dispensed medication kits to patients' homes that contained different sized syringes not clearly identified for use with a specific medication. Patient A's caregiver used the wrong syringe to administer Roxanol to Patient A. The interdisciplinary group (IDG) failed to ensure that a caregiver in Patient A's home was identifed, assessed, and trained to administer medications safely. The hospice's Quality Assessment and Performance Improvement program (QAPI) failed to implement preventive actions following the adverse patient event. LABORATORY DIRECTOR'S OR PROVIDER/SUPPLIER REPRESENTATIVE'S SIGNATURE (X6) DATE TITLE Any deficiency statement ending with an asterisk (*) denotes a deficiency which the institution may be excused from correcting providing it is determined that other safeguards provide sufficient protection to the patients . (See instructions.) Except for nursing homes, the findings stated above are disclosable 90 days following the date of survey whether or not a plan of correction is provided. For nursing homes, the above findings and plans of correction are disclosable 14 days following the date these documents are made available to the facility. If deficiencies are cited, an approved plan of correction is requisite to continued program participation. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 8UKJ11 Facility ID: CA080000304 If continuation sheet Page 1 of 17 PRINTED: 03/15/2013 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 051511 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 4311 THIRD AVENUE SAN DIEGO HOSPICE & THE INSTITUTE FOR PALLIATIVE M (X4) ID PREFIX TAG 03/18/2012 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) L 000 Continued From page 1 SAN DIEGO, CA 92103 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE L 000 The hospice's governing body failed to investigate all related systems, which may have contributed to the adverse patient event. As a result, on 3/14/12 at 1:40 P.M., the Department called Immediate Jeopardy (IJ) and informed the hospice's Chief Clinical Officer and the Pharmacy Manager 1. The IJ was called under CFR 418.106(e)(2)(i) - L 694. The Immediate Jeopardy was abated on 3/18/12 at 2:51 P.M. after an acceptable plan of correction was received from the Chief Clinical Officer and the hospice staff. The plan of correction included the following: 1. The hospice identified all patients with e-kits (787). Patients were contacted by telephone or by home visits to remove the e-kit syringes or caution patients not to use the e-kit until the syringes were exchanged. 2. A "read receipt" e-mail was sent to all nurses, informing them of the syringe exchange, new morphine and syringe labeling and new patient teaching guides provided in the e-kits. 3. The hospice would immediately provide training for all triage nurses to include specified protocols for telephone directives, with step by step performance guidelines for directing the use of medication administration, over the telephone. 4. The hospice pharmacy would replace existing bottles of morphine and 1 milliliter syringes with new red labels. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 8UKJ11 Facility ID: CA080000304 If continuation sheet Page 2 of 17 PRINTED: 03/15/2013 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 051511 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 4311 THIRD AVENUE SAN DIEGO HOSPICE & THE INSTITUTE FOR PALLIATIVE M (X4) ID PREFIX TAG 03/18/2012 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) L 000 Continued From page 2 SAN DIEGO, CA 92103 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE L 000 5. The hospice developed a new teaching guide, with enlarged syringe illustrations, which demonstrated the reading and filling of medication syringes to be included in the patients' e-kits. Additional copies of the guide were included in the Patient and Family Handbook. 6. The hospice would maintain current and accurate medication profiles in the patient's home. 7. A system for tracking syringe replacements and patient notifications, would be coordinated and centralized, by using the hospice's Infusion Verification (telephone) Line. L 559 418.58 QUALITY ASSESSMENT & PERFORMANCE IMPROVEMENT L 559 This CONDITION is not met as evidenced by: Based on interview and record review, the hospice failed to ensure: 1. The Quality Assessment and Performance Improvement program (QAPI) analyzed and identified the causes of 1 of 1 adverse patient events reviewed, and immediately implement a course of action to prevent a reoccurrence. (Refer to L569). 2. The hospice pharmacy dispensed e-kit medications with syringes that were readily identified for specific medications. (Refer to L 694). 3. The Interdisciplinary Group (IDG), identified and acknowledged a caregiver in the home, and FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 8UKJ11 Facility ID: CA080000304 If continuation sheet Page 3 of 17 PRINTED: 03/15/2013 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 051511 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 4311 THIRD AVENUE SAN DIEGO HOSPICE & THE INSTITUTE FOR PALLIATIVE M (X4) ID PREFIX TAG 03/18/2012 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) L 559 Continued From page 3 SAN DIEGO, CA 92103 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE L 559 failed to determine the caregiver was trained and capable of administering medications to 1 of 1 sampled patients (Patient A). (Refer to L 692) The cumulative effect of these systemic problems resulted in the facility's failure to comply with the Condition of Participation, Quality Assessment and Performance improvement (QAPI). The failure of the facility to be in compliance with this Condition of Participation contributed to the Department calling an Immediate Jeopardy on 3/14/12 at 1:40 PM. L 569 418.58(c)(2) PROGRAM ACTIVITIES L 569 (2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospice. This STANDARD is not met as evidenced by: Based on interview and record review, the hospice Quality Assessment and Performance Improvement program, (QAPI) failed to: 1. Analyze the causes of 1 of 1 adverse patient events reviewed where a caregiver administered the wrong dose of liquid morphine(Roxanol) to Patient A. 2. Identify that pharmacy e-kits, dispensed to 787 patients' homes, contained syringes that could easily be confused by the caregiver and be used to administer the wrong dose of a medication. Findings: 1. On 3/04/12, a caregiver administered 20 times FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 8UKJ11 Facility ID: CA080000304 If continuation sheet Page 4 of 17 PRINTED: 03/15/2013 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 051511 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 4311 THIRD AVENUE SAN DIEGO HOSPICE & THE INSTITUTE FOR PALLIATIVE M (X4) ID PREFIX TAG 03/18/2012 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) L 569 Continued From page 4 SAN DIEGO, CA 92103 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE L 569 the prescribed amount of liquid morphine (Roxanol) to Patient A. The Roxanol was removed from an e-kit which was dispensed by the hospice pharmacy, for use in the patient's home. The patient died approximately one hour following the orally administered dose. On 3/12/12 at 12:35 P.M., Pharmacy Manager 1 (PM 1) was interviewed. PM 1 stated that the hospice pharmacy dispensed e-kits which contained medications for managing end of life symptoms. The e-kits typically contained Roxanol for pain management and shortness of breath, and glycopyrrolate for management of secretions. The e-kits also contained syringes for the administration of these medications. A 3 milliliter (ml) syringe was supplied, intended for use with the glycopyrrolate, and a 1 ml syringe was supplied for use with the Roxanol. According to PM 1, both syringes were clear plastic with black lettering and were not labeled for use with a specific medication. PM 1 stated the syringes may require, "repackaging" to prevent them from "getting mixed up." In addition, during the inspection of the e-kit, the syringe's black calibrations appeared to rub off with minimal handling. Eight days following the adverse patient event, in an effort to prevent further incidents, the QAPI program had failed to analyze or determine related causes to the adverse event. According to the Chief Clinical Officer, on 3/12/12 at 4 P.M., the hospice had not identified hospice policies, protocols, or systems, which may have contributed to the adverse event. 2. On 3/12/12 at 4:45 P.M., LN 2 was interviewed. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 8UKJ11 Facility ID: CA080000304 If continuation sheet Page 5 of 17 PRINTED: 03/15/2013 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 051511 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 4311 THIRD AVENUE SAN DIEGO HOSPICE & THE INSTITUTE FOR PALLIATIVE M (X4) ID PREFIX TAG 03/18/2012 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) L 569 Continued From page 5 SAN DIEGO, CA 92103 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE L 569 LN 2 stated that she visited Patient A's home on 3/04/12 at 10:20 A.M. LN 2 spoke with Caregiver 2 who explained how she administered 5 milliliters (ml) of Roxanol to Patient A, using a 3 ml syringe instead of a 1 ml syringe. Both syringes were clear plastic with black lettering and were not permanently attached to the bottles of medication for which they were intended, and could be easily switched. LN 2 was aware that Patient A's caregiver had used the incorrect syringe in the Roxanol administration on 3/04/12. On 3/09/12 the hospice Chief Clinical Officer reported the event to the Department, and on 3/12/12 at 1 P.M., PM 1 stated the syringes might need "repackaging " to prevent them from "getting mixed up." On 3/14/12, the hospice stated there were more than 600 e-kits with syringes in patients' homes, yet the QAPI had taken no measures to address the potential risk to other patients. On 3/18/12 the hospice stated that the number of e-kits in patient homes was revised to be 787. L 648 418.100 ORGANIZATIONAL ENVIRONMENT L 648 This CONDITION is not met as evidenced by: Based on staff interview and policy and procedure review, the hospice Governing Body failed to ensure: 1. The 787 e-kits dispensed by the pharmacy to patient homes were safe for patient and caregiver use. [L 694] 2. The Quality Assessment and Improvement program (QAPI), analyzed the causes of 1of 1 adverse patient events reviewed in order to FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 8UKJ11 Facility ID: CA080000304 If continuation sheet Page 6 of 17 PRINTED: 03/15/2013 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 051511 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 4311 THIRD AVENUE SAN DIEGO HOSPICE & THE INSTITUTE FOR PALLIATIVE M (X4) ID PREFIX TAG 03/18/2012 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) L 648 Continued From page 6 SAN DIEGO, CA 92103 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE L 648 implement preventive actions. [L 569] 3. The hospice staff determined the ability of caregivers in 1 of 1 sampled patient's homes (Patient A) to safely administer medications. [L 692] 4. The Governing Body notified the California Department of Public Health of an "unusual occurrence," in accordance with their policies. [Refer to L 651] The cumulative effect of these systemic problems resulted in the hospice's failure to comply with the Condition of Participation for Organization/Administration of services L 651 418.100(b) GOVERNING BODY AND ADMINISTRATOR L 651 A governing body (or designated persons so functioning) assumes full legal authority and responsibility for the management of the hospice, the provision of all hospice services, its fiscal operations, and continuous quality assessment and performance improvement. A qualified administrator appointed by and reporting to the governing body is responsible for the day-to-day operation of the hospice. The administrator must be a hospice employee and possess education and experience required by the hospice's governing body. This STANDARD is not met as evidenced by: Based on interview and record review, the hospice's Governing Body failed to report the death of 1 of 1 sampled patients (Patient A) determined to be an adverse patient event, to the Department, in accordance with the hospice policy. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 8UKJ11 Facility ID: CA080000304 If continuation sheet Page 7 of 17 PRINTED: 03/15/2013 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 051511 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 4311 THIRD AVENUE SAN DIEGO HOSPICE & THE INSTITUTE FOR PALLIATIVE M (X4) ID PREFIX TAG 03/18/2012 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) L 651 Continued From page 7 SAN DIEGO, CA 92103 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE L 651 Findings: On 3/8/12 the hospice verbally reported an adverse patient event, which occurred on 3/4/12, to a Department representative on site. The Department representative told the hospice to report the incident to the district office for investigation. The adverse patient event involved a caregiver who administered 20 times the prescribed amount of liquid morphine (Roxanol) to Patient A. The patient died approximately one hour following the orally administered dose. According to the hospice policy, dated 11/4/11, entitled, Reporting Unusual Occurrences to Department of Health-Hospice Program, the "Compliance Officer (or designee) will report an adverse event to the CDPH by the next CDPH workday either by telephone (confirmed in writing) or in person." Following the patient's death, on 3/4/12, the hospice's governing body, failed to notify the California Department of Public Health of an "unusual occurrence," in accordance with their policies L 686 418.106 DRUGS BIOLOGICALS MEDICAL SUPPLIES & DME L 686 This CONDITION is not met as evidenced by: Based on interview and record review, the facility failed to: 1. Provide oversight and direction for the management of 1 of 1 in-house hospice FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 8UKJ11 Facility ID: CA080000304 If continuation sheet Page 8 of 17 PRINTED: 03/15/2013 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 051511 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 4311 THIRD AVENUE SAN DIEGO HOSPICE & THE INSTITUTE FOR PALLIATIVE M (X4) ID PREFIX TAG 03/18/2012 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) L 686 Continued From page 8 SAN DIEGO, CA 92103 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE L 686 pharmacy systems. [L 694] 2. Ensure the Interdisciplinary Group (IDG), identified and assessed the training needs for a caregiver for 1 of 1 sampled patients (Patient A). [L 692] As a result, a caregiver in the patient's home administered an incorrect dose of liquid morphine, (Roxanol) to Patient A who died approximately one hour following the orally administered dose. The cumulative effect of these systemic problems resulted in the hospice's failure to comply with the Condition of Participation for Drugs/Biologicals/Medical Supplies/DME. The failure of the hospice to comply with this Condition of Participation contributed to the Department calling Immediate Jeopardy on 3/14/12 at 1:40 P.M. L 692 418.106(d) ADMINISTRATION OF DRUGS AND BIOLOGICALS L 692 (1) The interdisciplinary group, as part of the review of the plan of care, must determine the ability of the patient and/or family to safely self-administer drugs and biologicals to the patient in his or her home. (2) Patients receiving care in a hospice that provides inpatient care directly in its own facility may only be administered medications by the following individuals: (i) A licensed nurse, physician, or other health care professional in accordance with their scope of practice and State law; (ii) An employee who has completed a State-approved training program in medication administration; and FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 8UKJ11 Facility ID: CA080000304 If continuation sheet Page 9 of 17 PRINTED: 03/15/2013 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 051511 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 4311 THIRD AVENUE SAN DIEGO HOSPICE & THE INSTITUTE FOR PALLIATIVE M (X4) ID PREFIX TAG 03/18/2012 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) L 692 Continued From page 9 SAN DIEGO, CA 92103 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE L 692 (iii) The patient, upon approval by the interdisciplinary group. This STANDARD is not met as evidenced by: Based on interview, and record review, the hospice interdisciplinary group (IDG) failed to provide assessment, training, education, and oversight for a caregiver for 1 of 1 sampled patients (Patient A). As a result, a caregiver in the patient's home administered the incorrect dose of Roxanol (liquid morphine) to Patient A, who died approximately 1 hour following the orally administered dose. Findings: On 3/12/12, at 11:15 A.M., an investigation of an adverse patient event was conducted at the hospice. Patient A was admitted to hospice services on 10/17/11, with diagnoses to include dementia (loss of cognitive function) and Parkinson's disease (neurological deterioration), according to the Record of Admission. According to the Chief Clinical Officer (CCO), on 3/04/12, a private caregiver employed by Patient A's family, made an error administering liquid morphine,(Roxanol) from Patient A's e-kit. E-kits (emergency kits) were medications sealed in plastic bags, prescribed by the patients' physician, dispensed by the pharmacy, and delivered to the patients' homes. The medications were to be used for the treatment of emergent symptoms, commonly experienced in end of life care. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 8UKJ11 Facility ID: CA080000304 If continuation sheet Page 10 of 17 PRINTED: 03/15/2013 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 051511 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 4311 THIRD AVENUE SAN DIEGO HOSPICE & THE INSTITUTE FOR PALLIATIVE M (X4) ID PREFIX TAG 03/18/2012 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) L 692 Continued From page 10 SAN DIEGO, CA 92103 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE L 692 On 2/28/12, Patient A's physician prescribed Roxanol 2.5 to 5 mg (milligrams) for pain every hour as needed, and glycopyrrolate 2 ml (milliliter) every 4 hours, to manage increased secretions. According to the Roxanol bottle's label, provided in the patient's e-kit, the concentration of Roxanol was 20 mg/ml and the glycopyrrolate was 0.04 mg per 2 ml. According to Lexi-Comp's Geriatric Handbook 11th Edition, Roxanol was effective within 30 minutes, with peak effects in 1-2 hours, and had a duration of 4-12 hours. On 3/12/12 at 12:35 P.M., Pharmacy Manager 1 (PM 1) reviewed the contents of a sample e-kit containing two amber colored bottles, and two oral syringes. One of the syringes was marked 3 ml and the other was marked 1 ml. Both syringes were clear plastic and marked "for oral use only." There was no other identification, labeling, or instructions on the syringes. During the inspection of the e-kit, the syringe's black calibrations appeared to rub off with minimal handling. PM 1 stated that according to pharmacy records, bottles of Roxanol and glycopyrrolate and the specific size syringes to administer the medications, were dispensed by the hospice pharmacy to Patient A's home. . PM 1 explained the 1 ml syringe was notably thinner in appearance, and was intended for use with Roxanol, while the 3 ml syringe, was to be used to administer 2 ml of glycopyrrolate. According to PM 1, the syringes were packaged in the e-kit, and temporarily attached to each FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 8UKJ11 Facility ID: CA080000304 If continuation sheet Page 11 of 17 PRINTED: 03/15/2013 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 051511 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 4311 THIRD AVENUE SAN DIEGO HOSPICE & THE INSTITUTE FOR PALLIATIVE M (X4) ID PREFIX TAG 03/18/2012 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) L 692 Continued From page 11 SAN DIEGO, CA 92103 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE L 692 medication bottle, by a rubber band. PM 1 said once the syringe was removed from the rubber band and bottle, the two syringes could be "easily switched and replaced on the wrong bottle, confusing the caregiver." On 3/12/12 at 1:55 P.M., during an interview with the triage nurse (LN 1), LN 1 stated that on 3/4/12, at 9:45 A.M., she received a telephone message from the hospice's answering service. According to the answering service message, someone had called from Patient A's family and reported Patient A had "labored breathing." LN 1 called the hospice's central scheduler, and requested an urgent home visit for Patient A. LN 1 stated she returned the call to Patient A's home and, "spoke to a man," who identified himself as Patient A's caregiver, (Caregiver 1). According to LN 1 she was told that Patient A had received the last dose of Roxanol at 9:17 A.M., so she advised the caregiver to, "Administer 5 mg of Roxanol at 10:17 A.M." On 3/12/12 at 4:45 P.M., LN 2 was interviewed. According to LN 2, she was the nurse who made the requested visit to Patient A on 3/4/12 at 10:20 A.M. At that time, LN 2 found Patient A, "lying in bed, with irregular breathing, and a respiratory rate of 16." According to LN 2, upon arrival at Patient A's home, she found a woman present, who identified herself as Caregiver 2. LN 2 stated that according to LN 1's report, she believed Caregiver 2's identity was a man. LN 2 then asked Caregiver 2 if she had administered 5 mg of Roxanol as instructed by LN 1. According to LN 2, Caregiver FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 8UKJ11 Facility ID: CA080000304 If continuation sheet Page 12 of 17 PRINTED: 03/15/2013 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 051511 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 4311 THIRD AVENUE SAN DIEGO HOSPICE & THE INSTITUTE FOR PALLIATIVE M (X4) ID PREFIX TAG 03/18/2012 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) L 692 Continued From page 12 SAN DIEGO, CA 92103 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE L 692 2 stated, "I gave 5 milliliters of Roxanol." At LN 2 's request, Caregiver 2 explained how she administered the Roxanol to Patient A. LN 2 stated she observed Caregiver 2 demonstrate how she used the 3 ml syringe, intended for the glycopyrrolate, to draw up the Roxanol. According to LN 2, Caregiver 2 pulled back the plunger to the 3 ml mark on the syringe. Caregiver 2 repeated the demonstration a second time, pulling back the plunger to 2 ml, making the dose total, 5 ml. According to LN 2, the morphine strength and dose administered to Patient A, equaled 100 mg, or 20 times the physician's prescribed dose. On 3/13/12 at 9:05 A.M., LN 3, the primary nurse, was interviewed. As the primary nurse, LN 3 was the patient's case manager, and was responsible for the delivery of care. According to LN 3 she never met Caregiver 2, did not know her skill level, and was unaware of her previous training or experience. LN 3 stated she never attempted to determine Caregiver 2's full identity, or assess if she was competent to receive hospice directives, or administer medications safely to Patient A. LN 3 stated that the black markings on the syringes supplied in the e-kits, faded during handling. On 3/13/12 at 12:05 P.M., Certified Home Hospice Aide (CHHA) 1 was interviewed. According to CHHA 1, Caregiver 2 had been in the home assisting with Patient A's care for "2-3 weeks" and would assist CHHA 1 with the patient's bathing and dressing. CHHA 1 stated she had reported to LN 3 that Caregiver 2 was present in the patient's home, FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 8UKJ11 Facility ID: CA080000304 If continuation sheet Page 13 of 17 PRINTED: 03/15/2013 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 051511 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 4311 THIRD AVENUE SAN DIEGO HOSPICE & THE INSTITUTE FOR PALLIATIVE M (X4) ID PREFIX TAG 03/18/2012 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) L 692 Continued From page 13 SAN DIEGO, CA 92103 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE L 692 and that she had assisted with the patient's personal care. The hospice IDG failed to respond to CHHA 1's report that Caregiver 2 was present in Patient A's home, and was providing care to the patient. LN 3 did not assess Caregiver 2's role in the home, nor did she determine whether the caregiver had the ability to administer medications to the patient safely. The triage nurse, LN 1, who responded to the telephone call from Patient A's home on 3/4/12, failed to determine the identity of the caregiver who would administer the medication, and failed to determine if that person was competent and trained to do so. . L 694 418.106(e)(2)(i) LABEL DISPOSE STORAGE DRUGS L 694 (2) Disposing. (i) Safe use and disposal of controlled drugs in the patient's home. The hospice must have written policies and procedures for the management and disposal of controlled drugs in the patient's home. At the time when controlled drugs are first ordered the hospice must: This STANDARD is not met as evidenced by: Based on interview, and record review, the pharmacy failed to ensure that medications and syringes supplied in the e-kit delivered to 1 of 1 FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 8UKJ11 Facility ID: CA080000304 If continuation sheet Page 14 of 17 PRINTED: 03/15/2013 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 051511 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 4311 THIRD AVENUE SAN DIEGO HOSPICE & THE INSTITUTE FOR PALLIATIVE M (X4) ID PREFIX TAG 03/18/2012 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) L 694 Continued From page 14 SAN DIEGO, CA 92103 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE L 694 sampled patient's homes (Patient A), were dispensed in a manner to ensure the safe use of controlled medications. As a result, a caregiver in the patient's home administered 20 times the prescribed amount of liquid morphine, (Roxanol) to Patient A. The patient died approximately one hour following the orally administered dose. Findings: On 3/12/12, at 11:15 A.M., an investigation was conducted following an entity reported incident, described by the hospice's Chief Clinical Officer, (CCO) as an adverse event. According to the CCO, a private care giver, employed by the patient's family, made an error administering morphine (Roxanol) from Patient A's e-kit (emergency kit). According to the hospice policy, dated 4/4/08, entitled, Emergency Medication E-Kits Guideline, "E-Kits are prescribed to expedite the treatment of emergent symptoms commonly experienced in end of life care." According to the patient's medication list, dated 2/28/12, Patient A's physician prescribed,"Morphine Sulfate Oral Liquid, (Roxanol) 20 mg/ml (milligrams/milliliter) 2.5 mg to 5 mg, for pain. On 3/12/12 at 12 P.M., Pharmacy Manager 1 (PM1) was interviewed. A sample e-kit was requested for joint review. The e-kit packaging was a clear plastic bag with an orange label. According to PM 1, the concentration for the liquid morphine (Roxanol) was 20 mg/ml. In addition, glycopyrrolate 2 milliliters was FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 8UKJ11 Facility ID: CA080000304 If continuation sheet Page 15 of 17 PRINTED: 03/15/2013 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 051511 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 4311 THIRD AVENUE SAN DIEGO HOSPICE & THE INSTITUTE FOR PALLIATIVE M (X4) ID PREFIX TAG 03/18/2012 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) L 694 Continued From page 15 SAN DIEGO, CA 92103 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE L 694 prescribed for excess secretions. Both medications and their administration syringes, were provided by the hospice pharmacy, and were delivered to Patient A as part of the hospice e-kit. Each bottle of medication had a rubber band attached to the neck of the bottle to hold the syringe intended to be used to administer each medication. In the e-kit were two empty 30 ml bottles, representing the Roxanol, and glycopyrrolate. The written instructions on the bottle, labeled for Roxanol, read, "Use as Directed by SDHIPM (the hospice) Physician for Pain." In the same packaging, were 2 clear syringes with black calibrations on the syringe barrels. One syringe was a 1 ml [milliliter] syringe attached to the morphine bottle by the rubber band; the other, a 3 ml syringe, was attached to the glycopyrrolate with a rubber band. According to PM 1, she assumed families understood to use the smaller 1 ml syringe for the morphine, and the larger 3 ml syringe for the glycopyrrolate, as the dose required for the glycopyrrolate, was more than 1 ml. On 3/14/12 at 10:30 A.M., inspectors from the California Board of Pharmacy, and Pharmacy Consultant 1, from the California Department of Public Health, met with hospice PM 1 and the Chief Clinical Officer (CCO). Pharmacy Consultant 1, asked how the hospice nurse explained to the patients' families and caregivers the difference between milligrams and milliliters. Inspector 1 from the Board of Pharmacy, also questioned how the hospice FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 8UKJ11 Facility ID: CA080000304 If continuation sheet Page 16 of 17 PRINTED: 03/15/2013 FORM APPROVED DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES STATEMENT OF DEFICIENCIES AND PLAN OF CORRECTION (X1) PROVIDER/SUPPLIER/CLIA IDENTIFICATION NUMBER: OMB NO. 0938-0391 (X2) MULTIPLE CONSTRUCTION A. BUILDING ______________________ (X3) DATE SURVEY COMPLETED C 051511 B. WING _____________________________ NAME OF PROVIDER OR SUPPLIER STREET ADDRESS, CITY, STATE, ZIP CODE 4311 THIRD AVENUE SAN DIEGO HOSPICE & THE INSTITUTE FOR PALLIATIVE M (X4) ID PREFIX TAG 03/18/2012 SUMMARY STATEMENT OF DEFICIENCIES (EACH DEFICIENCY MUST BE PRECEDED BY FULL REGULATORY OR LSC IDENTIFYING INFORMATION) L 694 Continued From page 16 SAN DIEGO, CA 92103 PROVIDER'S PLAN OF CORRECTION (EACH CORRECTIVE ACTION SHOULD BE CROSS-REFERENCED TO THE APPROPRIATE DEFICIENCY) ID PREFIX TAG (X5) COMPLETION DATE L 694 would ensure the syringes would be correctly identified. At this time, the CCO had no response. PM 1 acknowledged the syringes currently provided in patients' e-kits had no labels to indicate the specific drug to be used in each syringe. PM 1 also stated the two syringe sizes and characteristics were confusing, and "possibly contributed to the incident." On 3/14/12, the Department understood that at least 620 hospice patients had the same or similar e-kits in their homes. The hospice provided the Department with a revised number of 787 on 3/18/12. The failure of the hospice to comply with this Standard contributed to the Department calling an Immediate Jeopardy on 3/14/12 at 1:40 PM. FORM CMS-2567(02-99) Previous Versions Obsolete Event ID: 8UKJ11 Facility ID: CA080000304 If continuation sheet Page 17 of 17