| 3631 |
MINNIE HAMILTON HEALTH CARE |
51A013 |
186 HOSPITAL DRIVE |
GRANTSVILLE |
WV |
26147 |
2019-08-07 |
761 |
E |
0 |
1 |
0WYC11 |
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, staff interview, review of the Center for Medicare & Medicaid Services (CMS) State Operations manual (SOM) Appendix PP (Guidance to Surveyors for Long Term Care Facilities requirements of Federal regulations and interpretive guidance), recommendations from the Centers of Disease Control (CDC), and the United States Pharmacopeia (USP) General Chapter 797, the facility failed to ensure durgs were stored and labeled in accordance with currently accepted professional principles. The facility failed to label resident's prescribed solution and various over the counter medications, as well as resident's multi-dose insulin vials with the date the medications was opened. The facility failed to ensure safety in the use of multi-dose vials of insulin by failing to track and monitor the date vials were accessed to assure its usage within the recommended time frame for safe use. This practice had the potential to affect more than an isolated number of residents. Resident identifier: R#2, R#4, R#9, #R12, R#16, R#19, R#20, and R#73. Facility census: 22. Findings included: a) Medication storage (refrigerator and cart) On 08/06/19 at 10:17 AM review of the medication refrigerator revealed a bottle of Acidophilus that was not dated when it was opened. Licensed practical nurse (LPN#66), upon seeing the bottle, stated it should have been dated when it was opened and did not know why it was not. Also observed was a bottle of prescribed [MEDICATION NAME] suspension 1 gm (gram)/10 ml (milliliter), for Resident R#16, that did not have the date the bottle was opened. On 08/06/19 at 11:18 AM review of the resident's insulin vials with licensed practical nurse (LPN#36) revealed the multi-use insulin vials were not dated when the nurse opened them. There were no dates hand-written on any of the insulin vials or boxes to indicate the date the nurse initially opened the vial to access it. Without the 'open' date, the staff would not know when to dispose of any vials of unused insulin. The only date on the vials and boxes was the manufacturers expiration date. LPN#36 confirmed the insulin vials and boxes should be dated when opened and were not. LPN#36 verified the standard of practice is to dispose of insulin twenty-eight (28) days after opening the vial if it was not all used. LPN#36 confirmed nurses were to mark on the vial the date the vial was opened so staff could track the 28 days after opening to dispose of the vial properly. The residents whose insulin vials where not labeled with the date staff opened the insulin vials were: Resident (R#2) who had 2 vials of [MEDICATION NAME]/Novalin insulin opened; R#4 who had Novalog opened; R#9's [MEDICATION NAME]/Humalog insulin; R#12's Novalog insulin; R#16 who had 2 vials of [MEDICATION NAME]/Novalin insulin opened; R#19 who had 2 vials of [MEDICATION NAME]/ Novalog insulin opened; R#20's Novalog insulin; and R#73's Humalog insulin. LPN#36 acknowledged the medications had not been stored according to professional standards. b) CMS SOM, Appendix PP (Guidance to Surveyors for Long Term Care Facilities requirements of Federal regulations and interpretive guidance) GUIDANCE 483.45(g) Labeling of Drugs and Biologicals and 483.45(h) Storage of Drugs and Biologicals Additionally, to minimize contamination, facility staff should date the label of any multi-use vial when the vial is first accessed and access the vial in a dedicated medication preparation area: - If a multi-dose vial has been opened or accessed (e.g., needle-punctured), the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. - If a multi-dose vial has not been opened or accessed (e.g., needle-punctured), it should be discarded according to the manufacturer's expiration date. c) Recommendations from the Centers of Disease Control (CDC) According to the CDC, the United States Pharmacopeia (USP) General Chapter 797 recommends the following for multi-dose vials of sterile pharmaceuticals: If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. If a multi-dose vial has not been opened or accessed (e.g., needle-punctured), it should be discarded according to the manufacturer's expiration date. The manufacturer's expiration date refers to the date after which an unopened multi-dose vial should not be used. The beyond-use-date refers to the date after which an opened multi-dose vial should not be used. The beyond-use-date should never exceed the manufacturer's original expiration date. |
2020-09-01 |