| 4664 |
RIVERSIDE HEALTH AND REHABILITATION CENTER |
515035 |
6500 MACCORKLE AVENUE SW |
SAINT ALBANS |
WV |
25177 |
2015-12-18 |
431 |
K |
0 |
1 |
5DCP11 |
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observations, medication administration pass observations, medical record review, review of facility policy, review of facility's investigations, and staff interviews, the facility, in coordination with the licensed pharmacist, failed to provide a narcotic storage system in which the resident's controlled substances were in permanently affixed compartments for storage of controlled drugs in one (1) of two (2) medication rooms, failed to ensure the proper labeling of medications to assure that they were stored safely and were provided to the residents accurately and in accordance with the prescriber's instructions, and failed to establish a system of medication records that enabled periodic accurate reconciliation, accounting for, and disposition of all controlled medications. The facility had no formal mechanisms in place to maintain accurate and timely medication records. The facility, in coordination with the pharmacist, failed to establish a means to ensure security and safeguarding of controlled medications. There was no system to account for the receipt, usage, disposition, and reconciliation of all controlled medications. The facility was not conducting periodic reconciliations of records of receipt, disposition, and inventory for controlled medications to prevent or identify loss or diversion of these medications. There was no evidence the pharmacist evaluated the facility's systems regarding controlled medications to ensure the facility maintained an accurate accounting of all controlled medications and completed periodic reconciliations. The facility failed to ensure/prevent misappropriation of controlled substances for 63 residents who resided in the facility for the time period of [DATE] through [DATE] who received controlled narcotics (pain medication). The facility's failure to follow a systematic approach for receipt and destruction of narcotics placed all residents receiving narcotics at risk for drug diversion and misappropriation of narcotics. The facility's failure to follow policy and procedure and have a systematic approach for receipt and destruction of narcotics constituted an Immediate Jeopardy. The facility was notified of the Immediate Jeopardy at 05:38 p.m. on [DATE] Resident identifiers for the original Immediate Jeopardy (all residents who were dispensed and delivered narcotics during [DATE] through [DATE]: Residents #49, #7, #67, #50, #20, #17, #77, #2, #85, #32, #57, #144, #105, #130, #12, #95, #70, #69, #65, #6, #82, #83, #43, #38, #39, #31, #10, #109, #47, #126, #3, #104, #111, #134, #15, #29, #131, #36, #81, #101, #120, #148, #19, #78, #72, #75, #149, #147, #133, #27, #61, #18, #59, #129, #11, #23, #51, #90, #143, #118, #141, #42, and #109. Resident sample identifiers: #32, #17, #32, and #47. On [DATE] at 6:18 p.m., the State agency confirmed the plan of correction had been implemented and the immediacy was removed. At that time, the scope and severity was reduced from a K to an E because of a remaining deficient practice. Injectable Ativan was not stored to include the appropriate accessory and cautionary instructions, did not include the prescriber's instructions, and were not stored in a permanently affixed locked container. This had the potential to affect Residents #81, #1, #85, and #97, and/or any resident residing in the facility with orders for injectable Ativan (a schedule IV benzodiazepine used for the treatment of [REDACTED]. Findings include: a) Residents #49, #7, #67, #50, #20, #17, #77, #2, #85, #32, #57, #144, #105, #130, #12, #95, #70, #69, #65, #6, #82, #83, #43, #38, #39, #31, #10, #109, #47, #126, #3, #104, #111, #134, #15, #29, #131, #36, #81, #101, #120, #148, #19, #78, #72, #75, #149, #147, #133, #27, #61, #18, #59, #129, #11, #23, #51, #90, #143, #118, #141, #42, and #109. Review of medical records throughout the afternoon and evening on [DATE], found discrepancies in the accounting for controlled narcotics (pain medication) for these 63 residents who resided in the facility for the time period of [DATE] through [DATE]. The following four (4) residents are a representative sample of the findings of the discrepancies in the accounting of controlled pain medication: 1. Resident #32 During observation of the medication administration pass on [DATE] at 10:13 a.m., Registered Nurse (RN) #12 administered Norco (pain) 7XXX,[DATE] mg (milligrams) 1 tablet by mouth to Resident #32. Medication reconciliation on [DATE] at 10:00 a.m., found RN #12 failed to document on Resident #32's MAR the Norco 7XXX,[DATE] mg 1 tablet given on [DATE] at 10:13 a.m. On [DATE] at 11:15 a.m., RN #12 and the surveyor reviewed the MAR for Resident #32. RN #12 confirmed the medication (Norco) was not documented. When asked for the Controlled Substance Accountability Sheet (CSAS) for [DATE], RN #12, could not locate the document. At 12:30 p.m. on [DATE], Resident #32's CSAS was requested from the director of nursing (DON) and the assistant director of nursing (ADON). On [DATE] at 5:00 p.m., the ADON and DON confirmed the CSAS sheet for Resident #32 could not be located. At that time, a request was made for the Monthly Controlled Drug Reports (MCDR) from the pharmacy for all narcotics (pain medications) dispensed and received from the pharmacy for the months of September, October, November, and (MONTH) (YEAR). The MCDR was provided on [DATE] at 8:00 a.m. Review of Resident #32's medical record found the Physician's Recapitulation Orders dated (MONTH) (YEAR), included orders for Hydrocodone (pain medication - same as Norco) 7XXX,[DATE]mg mg (milligram) every eight (8) hours as needed for pain. Review of the Medication Administration Records (MAR) dated September, October, November, and (MONTH) (YEAR) and the MCDRs from the pharmacy found: -- (MONTH) (YEAR) - 120 Hydrocodone tablets were received from the pharmacy and six (6) doses were documented on the MAR as administered. There were 118 Hydrocodone tablets unaccounted for. -- (MONTH) (YEAR) - 130 Hydrocodone tablets were received from the pharmacy and two (2) doses were documented on the MAR as administered, leaving 128 Hydrocodone tablets unaccounted for. -- (MONTH) (YEAR) - 60 Hydrocodone tablets were received from the pharmacy and zero (0) doses were documented on the MAR as administered, leaving 60 Hydrocodone tablets unaccounted for. -- (MONTH) (YEAR) - 60 Hydrocodone tablets were received from the pharmacy and one (1) dose was documented on the MAR as administered, leaving 59 Hydrocodone tablets unaccounted for. These findings prompted review of the narcotic medications of three (3) additional residents. 2. Resident #17 Medical record review of the Physician's Recapitulation Orders for Resident #17, dated (MONTH) (YEAR), revealed orders for Hydrocodone ,[DATE]mg mg (milligram) every four (4) hours as needed for pain. Review of the Medication Administration Records (MAR) dated September, October, November, and (MONTH) (YEAR) and the MCDRs from the pharmacy found: -- (MONTH) (YEAR) - 182 Hydrocodone tablets were received from the pharmacy and sixteen (16) doses were documented on the resident's MAR as administered. There were 166 Hydrocodone tablets unaccounted for. -- (MONTH) (YEAR) - 150 Hydrocodone tablets were received from the pharmacy and two (2) doses were documented on the MAR as administered, leaving 148 Hydrocodone tablets unaccounted for. -- (MONTH) (YEAR) - 120 Hydrocodone tablets were received from the pharmacy and four (4) doses were documented on the MAR as administered to the resident. That left 116 Hydrocodone tablets unaccounted for. -- (MONTH) (YEAR) - 60 Hydrocodone tablets were received from the pharmacy and six (6) doses were documented on the MAR as administered, leaving 54 Hydrocodone tablets unaccounted for. 3. Resident #129 Review of Resident #129's medical record found the Physician's Recapitulation Orders dated (MONTH) (YEAR), included an order for [REDACTED]. Review of the Medication Administration Records (MAR) dated September, October, November, and (MONTH) (YEAR) and the MCDRs from the pharmacy found: -- (MONTH) (YEAR) - 50 Hydrocodone tablets were received from the pharmacy, one (1) dose was documented on the MAR as administered, leaving 49 Hydrocodone tablets unaccounted for. -- (MONTH) (YEAR) - 30 Hydrocodone tablets were received from the pharmacy and nine (9) doses were documented on the MAR as administered. There were 21 Hydrocodone tablets unaccounted for. -- (MONTH) (YEAR) - 30 Hydrocodone tablets were received from the pharmacy and ten (10) doses were documented on the MAR as administered, leaving 20 Hydrocodone tablets unaccounted for. -- (MONTH) (YEAR) - 30 Hydrocodone tablets were received from the pharmacy and three (3) doses were documented on the MAR as administered - 27 Hydrocodone tablets were unaccounted for. 4. Resident #47 Review of the Physician's Recapitulation Orders for Resident #47, dated (MONTH) (YEAR), revealed orders for Hydrocodone ,[DATE]mg mg every 6 hours as needed for pain. Review of the Medication Administration Record (MAR) dated October, (MONTH) and (MONTH) (YEAR) and the MCDRs from the pharmacy found: -- (MONTH) (YEAR) - 52 Hydrocodone tablets were received from the pharmacy and one (1) dose was documented on the MAR as administered. There were 51 Hydrocodone tablets unaccounted for. -- (MONTH) (YEAR) - 30 Hydrocodone tablets were received from the pharmacy and 13 doses were documented on the MAR as administered, leaving 17 Hydrocodone tablets unaccounted for. -- (MONTH) (YEAR) - 30 Hydrocodone tablets were received from the pharmacy and 17 doses was documented in the MAR as administered, leaving 13 Hydrocodone tablets unaccounted for. b) Review of the facility's policy, Medication Storage in the Facility Controlled Substance Storage, dated ,[DATE], on [DATE] at 8:30 a.m., the policy directed: 4.2: CONTROLLED SUBSTANCE STORAGE. Policy: Medications included in the Drug Enforcement Administration (DEA) classification as controlled substances are subject to special handling, storage, disposal and record keeping in the facility in accordance with federal, state, and other applicable laws and regulations. A. The director of nursing, in collaboration with the consultant pharmacist, maintains the facility's compliance with federal and state laws and regulation in the handling of control substances. Only authorized licensed nursing and pharmacy personnel have access to controlled substances. B. Schedule (II-V) medications and other medications subject to abuse or diversion are stored in a permanently affixed, (double-locked) compartment separate from all other medications or per state regulation. Alternately, in a unit dose system, these medications may be kept with other medication(s) if the supply of the medication(s) is minimal and a shortage is readily detectable. The access system to controlled medications is not the same as the system giving access to other medication (the key that opens the compartment is different from the key that opens the medication cart). If a key system is used, the medication nurse on duty maintains possession of the key to controlled substances storage areas. Back-up keys to all medication storage areas, including those for controlled substances, are kept by the director of nursing or designee. C. Controlled-substances that require refrigeration are stored within a locked box within the refrigerator. This box must be attached to the inside of the refrigerator. D. A controlled substance accountability record is prepared by the pharmacy/facility for all Scheduled II, III, IV, and V medications (See 10.12: INDIVIDUAL RESIDENT'S CONTROLLED SUBSTANCE RECORD, although some states require a bound book with numbered pages), including those in the emergency supply. The following information is completed on the accountability form upon dispensing or receipt of a controlled substance or use of a controlled substance from the emergency supply: 1. Name of resident. If applicable. 2. Prescription number, if applicable. 3. Name, strength, and dosage form of medication. 4. Date received. 5. Quality received. 6. Name of person receiving medication supply. E. At each shift change, or when keys are transferred, a physical inventory of all controlled substance, including refrigerated items is conducted by two licensed nurses and is documented. (See 10.14: SHIFT VERIFICATION OF CONTROLLED SUBSTANCES COUNT). The emergency supply may be verified by assuring that the seal on the supply has not been broken. If the seal has been broke to the emergency narcotic supply, then a physical count of the contents must be conducted by two licensed nurses and paperwork must be present to account for any medication removed from the supply ( contents of the emergency narcotic supply is limited by individual state and federal laws). c) On [DATE] at 12:20 p.m., observations of the facility's East side medication room found 75 vials of Ativan 2 mg/ml (milligrams per milliliter) injectable throughout the refrigerator. A permanently affixed storage box was in the refrigerator, but the door was broken. On [DATE] at 12:20 p.m., with the assistance of RN #12 a physical count of the vials of Ativan stored in the refrigerator was completed. The results of this count found: 1. Resident #81 - There were twenty-five (25) vials of Ativan 2 mg/ml for this resident. The last dose was administered on [DATE]. The resident expired prior to the survey. 2. Resident #1 - Eighteen (18) vials of Ativan 2 mg/ml were found. The last documented dose was administered on [DATE]. 3. Resident #85 - Ten (10) vials of Ativan 2 mg/ml were found for this resident. Last documented dose was administered on [DATE] 4. Resident #97 - Eighteen (18) vials of Ativan 2 mg/ml were found and the last dose was administered on [DATE]. 5. Emergency supply - Four (4) vials of Ativan 2 mg/ml were found. The last dose was administered on [DATE]. All of the vials of Ativan were not properly labeled in packaging from the pharmacy. Some vials were loose with no name or directions on the vials and others were placed in plastic bags with just the resident's name on them. Following the observations of the medication room, reviews of the residents' medical records, progress notes, medication administration records, and individual sign out sheets were completed to ascertain when the last doses of Ativan were administered. Unlike the narcotics records, sign out sheets for Ativan were utilized. In an interview on [DATE] at 12:45 p.m., the DON said she was not aware the permanently affixed compartment of the refrigerator was broken. She also confirmed the labels on the vials were missing and the vials were being stored incorrectly. |
2019-08-01 |