Sunharbor Manor
December 15, 2016 Complaint Survey

Standard Health Citations

FF09 483.60(a),(b):PHARMACEUTICAL SVC - ACCURATE PROCEDURES, RPH

REGULATION: The facility must provide routine and emergency drugs and biologicals to its residents, or obtain them under an agreement described in §483.75(h) of this part. The facility may permit unlicensed personnel to administer drugs if State law permits, but only under the general supervision of a licensed nurse. A facility must provide pharmaceutical services (including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals) to meet the needs of each resident. The facility must employ or obtain the services of a licensed pharmacist who provides consultation on all aspects of the provision of pharmacy services in the facility.

Scope: Isolated
Severity: Potential to cause more than minimal harm
Citation date: December 15, 2016
Corrected date: February 21, 2017

Citation Details

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on interview and record review during an abbreviated survey the facility did not ensure that the pharmaceutical services provided medications pursuant to a prescription/order. Specifically one of three residents reviewed for pharmacy services (Resident #1) had a physician's orders [REDACTED]. The medication was not delivered by pharmacy to the facility as per physician's orders [REDACTED]. Complaint ID# NY 693 The findings are: Resident #1 was admitted to the facility on [DATE] with [DIAGNOSES REDACTED]. The Minimum Data Set 3.0 (MDS-an assessment tool) dated documented 3/8/16 documented Resident #1's cognition status as intact. The Admission Physician order [REDACTED]. Nucynta 50 mg by oral route every four hours as needed for moderate pain. The Comprehensive Care Plan (CCP) dated 3/1/16 titled Analgesic Narcotic use documented: pain, resident utilizes Nucynta. Interventions included to administer medication as ordered, evaluate effectiveness of pain medication, and identify factors that increase pain and to monitor for side effects of the pain medication. The Medication Administration Record [REDACTED]. The pain level documented 5 and 3 respectively. During an interview with the 7:00 AM-3:00 PM Registered Nurse (RN #1) on 4/7/16 at 1:45 PM, RN #1 stated that she didn't recall Resident #1 in pain. RN #1 stated that Resident #1 was alert and oriented and was able to make her own decisions. RN #1 stated that Resident #1 did ask for pain medications. She had a Tylenol order for break through pain and after medication administration her pain level was down to zero. RN #1 stated that the pharmacy delivered medication at night or early morning. RN #1 stated that certain medications such as Nucynta 50 mg are in the emergency medication box available to be utilized for breakthrough pain for Resident #1. However, it cannot be used in place for Nucynta ER because the ER medication is extended release and stays in the system longer and manages chronic pain. The different versions of the medications are not interchangeable. During an interview with the Pharmacy Representative (PR) on 4/7/16 at 12:27 PM, the PR stated that Resident #1 was admitted on [DATE] and the order for Nucynta ER was faxed to the pharmacy at 7:19 PM on 3/1/16 by the facility. The PR stated that the physician was paged twice by the pharmacist, however the pharmacist did not hear back from the doctor that night. Since the doctor did not call back, the medication order could not be processed. The PR stated that the pharmacy did not call the facility to notify them of the doctor not calling back. The PR stated that the pharmacy did not get the prescription for Nucynta ER until two days later on 3/3/16 and that's when the order was processed. The PR stated that usually the physician calls back immediately and a verbal order is okay from the physician for emergency supply. The PR stated that the pharmacy did not have any documentation that the facility was notified or that the facility called the pharmacy to enquire about the medication. During an interview with the Director of Nursing (DON) on 4/07/16 at 2:27 PM, the DON stated that Nucynta ER was not available in the emergency box, however Nucynta 50 mg was administered as per physician's orders [REDACTED]. The DON stated that the medications should have been delivered by the pharmacy as directed by the physician. 415.18(a)

Plan of Correction: ApprovedJanuary 6, 2017

I. Immediate Corrective Actions:
? Resident #1 is no longer in the facility.
? The licensed staff who were unable to administer the med to resident #1 as ordered received an educational counseling on facility policy regarding Medication Unavailable.
II. Identification of other Residents:
? All New / Re-Admission's had the potential to be affected by the deficient practice.
? On 12/22 the Dir. of Nursing Services obtained a list of all New/Readmits to the facility over the past week. A Medical record review of 10 new / readmission's were conducted and completed for identification of any other resident's in need of corrective action. The audit included the review of MAR, and CCP to ensure medication(s) delivered and administered as per physician orders, and found to be compliant.
Accordingly, the facility respectfully states that no other residents were affected by this practice.

III. Systemic Changes:
The Administrator, DON and Medical Director reviewed & revised current P/P on:
? Medication Unavailable
The lesson plans will concentrate on the following:
? Contracted pharmacy to contact RN Supervisor or DNS/Designee if they are unable to reach a Physician to fill an order.
? The Pharmacy will be responsible to notify facility on each subsequent shift, daily, on inability to process an order. Pharmacy will also attempt to continue to reach physician on each subsequent shift and communicate with facility daily on such matters.
? All physician/physician extender's will be in-serviced on their responsibility to communicate with nursing that they are aware of the need for verbal approval to pharmacy to process a controlled substance order.
All Licensed Nursing staff, physician/physician extender's, and pharmacy rep., will be educated on the P/P regarding Medication Unavailable by the in-service coordinator/designee with emphasis on their respective role to safeguard the process.
IV. Quality Assurance Monitoring:
1. An audit tool will be developed to monitor and ensure the facility?s compliance regarding:
?Pharmaceutical Services and response to situations that prevent them from fulfilling a med order.
2. DNS/designee will conduct a random sampling of 10 new admissions monthly on pharmaceutical services for 3 months and then quarterly thereafter for compliance.
Upon each months review, any negative findings will be conveyed to pharmacy rep and investigated with required summary report of findings and interventions included at QA presentation. The pharmacy vendor will in-service and counsel their staff appropriately regarding any negative findings from the audit and provide a copy of implemented education/counsel or actions taken to the facility for it's review and maintained by the facility.
All audit findings will then be presented to the Administrator and the QA committee, quarterly for follow up and review.
V. Responsible Party for poc implementation:
Director of Nursing / designee in in conjunction with Medical Director.

FF09 483.25:PROVIDE CARE/SERVICES FOR HIGHEST WELL BEING

REGULATION: Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.

Scope: Isolated
Severity: Potential to cause more than minimal harm
Citation date: December 15, 2016
Corrected date: February 21, 2017

Citation Details

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on interview and record review during an abbreviated survey, the facility did not ensure that an accurate and complete assessment to provide the necessary care and services for pain management to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care, was conducted and that pain medications were provided as ordered for one of three residents reviewed for pain (Resident #1). Specifically, Resident #1 had physician's orders [REDACTED].#1 on admission to the facility or upon complaint of pain. The findings are: Complaint ID# NY 693 Resident #1 was admitted to the facility on [DATE] with [DIAGNOSES REDACTED]. The Minimum Data Set 3.0 (MDS-an assessment tool) dated 3/8/16 documented Resident #1's cognition status as intact. The undated facility policy titled Pain Management and Follow up Policy stated that in house residents who require pain medication will be assessed prior to the initiation of such medication by licensed personnel to determine appropriate interventions. Numeric pain scale is used to document medication effectiveness of regime in Electronic Medical Record (EMAR). The medical record lacked documented evidence of a complete pain assessment for Resident #1 on admission. The Comprehensive Care Plan (CCP) dated 3/1/16 titled, [MEDICATION NAME] Narcotic use, documented: pain. Interventions included to administer medication as ordered, evaluate effectiveness of pain medication, and identify factors that increase pain and to monitor for side effects of the pain medication. The CCP dated 3/2/16 titled, Pain Management, documented alteration in comfort: pain related to [MEDICAL CONDITIONS] Arthritis, and [MEDICATION NAME] compression fracture. Interventions included to evaluate effectiveness of pain medications, identify factors that increase pain and monitor side effects of pain medication. 1) The Admission physician's orders [REDACTED]. [MEDICATION NAME] 50 mg by oral route every four hours as needed for moderate pain. The Comprehensive Care Plan (CCP) dated 3/1/16 titled [MEDICATION NAME] Narcotic use documented: pain, resident utilizes [MEDICATION NAME]. Interventions included to administer medication as ordered, evaluate effectiveness of pain medication, and identify factors that increase pain and to monitor for side effects of the pain medication. The Medication Administration Record dated 3/1/16 and 3/2/16 documented [MEDICATION NAME] ER 100 was not administered due to unavailability of medication. The pain level documented 5 and 3 respectively. During an interview with the 7:00 AM-3:00 PM Registered Nurse (RN #1) on 4/7/16 at 1:45 PM, RN #1 stated that she didn't recall Resident #1 in pain. RN #1 stated that Resident #1 was alert and oriented and was able to make her own decisions. RN #1 stated that Resident #1 did ask for pain medications. She had a Tylenol order for break through pain and after medication administration her pain level was down to zero. RN #1 stated that the pharmacy delivered medication at night or early morning. RN #1 stated that certain medications such as [MEDICATION NAME] 50 mg are in the emergency medication box available to be utilized for breakthrough pain for Resident #1. However, it cannot be used in place for [MEDICATION NAME] ER because the ER medication is extended release and stays in the system longer and manages chronic pain. The different versions of the medications are not interchangeable. During an interview with the Pharmacy Representative (PR) on 4/7/16 at 12:27 PM, the PR stated that Resident #1 was admitted on [DATE] and the order for [MEDICATION NAME] ER was faxed to the pharmacy at 7:19 PM on 3/1/16 by the facility. The PR stated that the physician was paged twice by the pharmacist, however the pharmacist did not hear back from the doctor that night. Since the doctor did not call back, the medication order could not be processed. The PR stated that the pharmacy did not call the facility to notify them of the doctor not calling back. The PR stated that the pharmacy did not get the prescription for [MEDICATION NAME] ER until two days later on 3/3/16 and that's when the order was processed. The PR stated that usually the physician calls back immediately and a verbal order is okay from the physician for emergency supply. The PR stated that the pharmacy did not have any documentation that the facility was notified or that the facility called the pharmacy to enquire about the medication. During an interview with the Director of Nursing (DON) on 4/07/16 at 2:27 PM, the DON stated that [MEDICATION NAME] ER was not available in the emergency box, however [MEDICATION NAME] 50 mg was administered as per physician's orders [REDACTED]. The DON stated that the medications should have been delivered by the pharmacy as directed by the physician. 2) The Interim Physician order [REDACTED]. The Nursing Progress note dated 3/3/16 at 11:49 AM documented patient's (family member) requesting Tylenol order for mother; secondary to patient's back pain, verbal order received from physician. The MAR dated 3/3/16 lacked documented evidence of administration of Tylenol 1000 mg. The Nursing Progress note dated 3/3/16 at 11:26 PM documented complaint of back ache, Tylenol 500 mg given with fair effect. The Medical Record lacked documented evidence that a pain assessment was completed related to complaint of back pain on 3/3/16. The MAR dated 3/3/16 lacked documented evidence of administration of Tylenol 500 mg. During an interview with LPN #1 on 4/7/16 at 1:17 PM, LPN #1 stated that Resident #1's (family member) had requested Tylenol as Resident #1 complained of back pain. LPN #1 stated that Resident #1 was always complaining of pain due to surgery. LPN #1 stated that on 3/3/16 when Resident #1 came back from therapy she was complaining of back pain. LPN #1 stated that she had administered Tylenol 1000 mg after receiving an order from the physician. LPN #1 stated that she forgot to document same in the medical record. During an interview with the 7:00 AM-3:00 PM Certified Nursing Assistant (CNA #1) on 4/7/16 at 1:30 PM, CNA #1 stated that she was assigned to Resident #1 and that Resident #1 was alert and oriented and was able to make her needs known. CNA #1 stated that Resident #1 complained of pain to her back at times. CNA #1 stated that she would notify the nurses (don't recall who) on the unit. During an interview with the 3:00 PM-11:00 PM RN #3, on 4/7/16 at 1:30 PM, RN #3 stated that she had done the pain assessment on admission for Resident #1 however it must be a transcription error that it did not appear on the assessment form. RN #3 stated that she probably forgot to click the appropriate boxes on the assessment. RN #3 stated that she should have completed the assessment. During an interview with the Director of Nursing (DON) on 4/07/16 at 2:27 PM, the DON stated that the admission pain assessment for Resident #1 was not a complete assessment. The DON further stated that the pain assessment on admission should have been completed especially when a resident is coming from the hospital with pain medication orders. During a subsequent interview on 8/17/16 at 12:20 PM the DON stated that there is no documented pain assessment for Resident #1 on 3/3/16. The DON stated that the staff is expected to assess for pain level prior and after administering pain medications to ensure efficacy of pain medication. During an interview with the 3:00 PM-11:00 PM LPN #2 on 4/7/16 at 3:11 PM, LPN #1 stated that Resident #1 complained of pain on 3/3/16. LPN #1 administered Tylenol 500 mg, two tablets. LPN #1 stated that she did not sign the MAR (Medication Administration Record) and just wrote the note about administering Tylenol. LPN #1 stated that by error she wrote the wrong dose on the Nursing Progress Note. LPN #1 further stated that the medication was not given at the time it is documented in the progress note, I must have given it prior. I don't recall what time. 415.12

Plan of Correction: ApprovedJanuary 6, 2017

I. Immediate Corrective Actions:
1) A. Resident# 1 did receive the med as ordered when it became available in the facility.
B. A written educational counseling was issued to the 2 LPN?s who failed to administer medication as ordered.
C. Written education counseling was provided to the LPN who failed to document pain medication administration in the MAR.
2) Written educational counseling was provided to the RN who failed to properly document in medical record resident's completed pain assessment on resident's admission.
II. Identification of other Residents:
? All New / Re-Admission's had the potential to be affected by the deficient practices.
? On 12/22 the Dir. of Nursing Services obtained a list of all New/Readmits to the facility over the past week. Medical record review of 10 new / readmission's were conducted and completed for identification of other resident's in need of corrective action. The audit included the review of MAR, initial pain assessment and CCP, and found to be compliant.
Accordingly, the facility respectfully states that no other residents were affected by this practice.

III. Systemic Changes:
1&2) The Administrator, DON and Medical Director reviewed & revised current P/P on:
? Medication Unavailable
? Pain Management and follow up
? Medication administration/documentation
an in-service education will be provided to all Licensed Nursing staff and Physicians/Physician Extenders regarding the above policies.

The lesson plan will concentrate on the following updates:
Physician/physician extender's responsibility to communicate with nursing that they are aware of the need for verbal approval to pharmacy for a controlled substance. the Pharmacy will be responsible to notify facility on each subsequent shift daily on inability to process an order.
as well as review of:
? If medications unavailable, notify Supervisor, MD and Pharmacy Services
? Pain medication administered issued as ordered
? Documentation of medication administration and effectiveness in Electronic Medical Record
? Documentation actions & Orders in 24 hour report
2). The Electronic Medical Record's info-matics were programmed to prevent log out from the resident assessment admissions screen without documenting on the pain assessment category.

IV. Quality Assurance Monitoring:
1. An audit tool will be developed to monitor and ensure the facility?s compliance regarding:
? Medication administration and documentation in MAR
? Medication unavailable documentation
? Pain Management and Follow-Up
2. DNS/designee will conduct a random sampling of 5 new admissions monthly regarding pain assessment documentation and medication administration as ordered, for 3 months, and then quarterly thereafter to ensure compliance with resident's comprehensive care.
All audit findings will be presented to the Administrator and the QA committee, quarterly for follow up and review. Any negative findings will be subject to an investigation, education and progressive discipline monthly or at the time of discovery, with required summary report included at QA presentation.
V. Responsible Party for poc implementation:
Director of Nursing / designee.