Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted March 3, 2022 through March 4, 2022, Community Health Care was identified to be in compliance with the following requirements of of 42 CFR, Part 491.12, Subpart A, Conditions for Certification: Rural Health Clinics - Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an unannounced Medicare recertification survey conducted March 3, 2022 through March 4, 2022, Community Health Care was found the have the following standard level deficiency that was determined to be in substantial compliance with the following requirements of 42CFR, Part 405, Subpart X and 42CFR Part 491.1-491.11 Subpart A, Conditions for Certification: Rural Health Clinics.
Plan of Correction:
491.6(b) and (b)(1) STANDARD PHYSICAL PLANT AND ENVIRONMENT Name - Component - 00 491.6(b) Maintenance:
The clinic . . . has a preventive maintenance program to ensure that:
(1) All essential mechanical, electrical and patient-care equipment is maintained in safe operating condition;
Observations:
Based upon observations and interview with the facility administrator, it was determined that the facility failed to ensure proper disposal of expired drugs and biologicals (Observation#1-Observation #9). Findings include: Request for policy on 3/4/2022 at approximately 1:00PM revealed no specific policy.
On 3/3/22 between 9:50 AM-11:40 AM, observations revealed: Observation #1: Seven (7) fourteen (14) french urological catheters with expiration date of 2/2008. Observation #2: Empty oxygen tank with no identification that tank was empty. Observation #3: Seven (7) Rusch flo catheter latex free fourteen (14) french with expiration date of 12/2005. Observation #4: Ten (10) Eswab collection/Presentation of aerobic, anaerobic and fastidious bacteria with expiration date of 12/31/2021. Observation #5: Eight (8) BD vacutainer eclipse blood collection needle twenty two (22) gauge with expiration date of 9/2016. Observation #6: One (1) Surguard 2 twenty two (22) gauge safety hypodermic needle with expiration 1/2019. Observation # 7: Review of Emergency crash cart 1) Three (3) vials of Epinephrine one milligram per millimeter (1mg/ml) with expiration date of 7/1/2017. 2) Four (4) angiocath twenty (20) gauge by one and a quarter (1.25) inch needle with expiration date of 12/1999. Observation #8: Review of Lab room 1) Five (5) total Henry Schein staple remover--three (3) with expiration of 1/2014 and two (2) with expiration of 9/2019. Observation #9: Review of vaccine refrigerators 1) Three (3) Soliquan 100/33 Insulin pens with expiration of 10/31/21.
An interview with the Clinic Administrator on 3/4/2022 at approximately 1:30 PM confirmed the above findings. "I knew the catheters were expired, I was just keeping them in case I needed them in an emergency, I will get rid of them right now and No we really don't have a specific policy for expired items or inventory checks but I will develop one right now for you. We do usually check the supplies throughout the year."
Plan of Correction:Community Health Care, RHC LLC 550 W. Walnut St Shamokin, PA 17872 R394904 Facility ID 385512
The following is a Plan of Correction for the deficiencies found during the unannounced Medicare onsite recertification survey conducted on March 3 through March4, 2022:
Deficiencies: 491.3(b) and (b1) 1. Policy for Disposal of Expired Drugs, Biologicals and Lab/Patient Supplies- This policy has been created and placed into effect as of 3/17/2022
Policy for 'Review and Proper Disposal of Expired Drugs, Biologicals and Lab/Patient Supplies' Expired clinic items:
An inventory sheet will be placed in each room that houses lab supplies, patient supplies-- exam rooms 1,2,3,4,5 and lab supply room, lab draw room ( room 5). These rooms house supplies /items that have expiration dates. The inventory sheet of each room will be reviewed and initialed every month. The review will be conducted by the office staff designated by the Clinic Administrator. All items that will expire the following month after the review month will be discarded/removed from the room and the inventory sheet will be updated and initialed. All items brought into the rooms for inventory/stocking must be logged by the staff prior to placement ( item name, lot # if applicable and expiration date) . Any items that are removed for expiration reasons and may be used for "teaching" ( i.e, vacutainers, needles, syringes etc) will be placed out of the room into a box/bag labeled as "teaching" and will be exempt from patient use. The inventory sheets will be placed in a binder after they are reviewed and acting upon for that month.
The crash cart inventory sheet will be updated monthly after the inventory is checked for expired products. The expired products will be removed by the expiration date. The review will be performed by the staff and the inventory will be initialed at the time of rev. Expired products will be removed and disposed of via biohazard/biological waste or waste as appropriate. The inventory sheets will be kept in a binder within the crash cart.
All refrigerators /freezer housing samples, meds, vaccines will be reviewed monthly for expired items. Samples, meds will be discarded the month prior to their expiration dates. All vaccines will be discarded month of their expiration dates. Log sheets placed on each refrigerator/freezer device will be dated and initialed by the staff the day they are completing the review. Log sheets will be kept on the refrigerator/freezer and placed in a binder at the end of the year.
Oxygen tanks will be checked monthly and after each use . Tanks that are less than ¼ full will be labeled as such and reported to clinical Administrator. Tanks that are empty, will be removed by the staff from the exam room where they are stored and marked " empty". They will be given to the Clinical Administrator that same day. The empty tanks will be refilled /replaced by the Oxygen company in a timely fashion.
Observations continued
Observation 1- Expired French and urological catheters have been removed and discarded
Observation 2- oxygen tank has been marked as empty and removed from the room. It has been returned to the oxygen supply store and replaced.
Observation 3- Expired rusch flo catheters have been removed and discarded
Observation 4- Expired Eswabs have been removed and discarded
Observation 5-Expired vacutainer blood collection needs have been removed and discarded
Observation 6- Expired surgurard 22 gauge hypodermic needle has been removed and discarded
Observation 7-Expired emergency Crash cart epinephrine has been removed and discarded along with angiocath 20g needle has been removed and discarded
Observation 8-Lab Room- Expired staple removers have been removed and discarded.
Observation 9- Vaccine Refrigerator – Soliquan insulin pens have been removed and discarded.
- All expired items as per the Deficiency Listing from the Recertification Survey of 3/3-3/4/2022 including: urological catheters , rusch flo catheters and exp e-swabs/cultures, vacutainer collection needles, hypodermic needles, epinephrine, angio cath needles, staple removers, and insulin samples have been removed and disposed into biohaz/biological waste and waste as appropriate. The removal of these items was completed by staff during 3/7-3/17/22 - The Empty Oxygen tank was marked " empty" and removed by staff during 3/7-3/17/22
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