Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on 7/10/2019, Portage Health Center RHC was found to be in compliance with the requirements 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 onsite unannounced Medicare recertification survey completed 7/10/2019, Portage Health Center RHC was found to have the following standard level deficiency that was determined to be in substantial compliance with the following requirement of 42 CFR, Part 405, Subpart X and 42 CFR, Part 491.1 - 491.12, Subpart A, Conditions for Certification: Rural Health Clinics.
Plan of Correction:
491.6(b)(2) STANDARD
MAINTENANCE
Name - Component - 00
Drugs and biologicals are appropriately stored; and
Observations:
Based on review of policy and procedure, observation tour of the facility (OBV) and staff (EMP) interview, the facility failed to appropriately store medications and supplies for (1) of one (1) facility observation tour.
Findings included:
Review of agency policy on 7/8/2019 at approximately 10:18 PM revealed: Policy "Rural Health Clinic Policy and Procedure Manual, Physical Plant and Environment Drug and Biological Storage Policy, Policy Drug samples, injectable's, and emergency drugs will be stored in the original manufacturer's packaging to ensure that proper labeling and packaging are maintained. Constantly monitored, secure areas will be used for all drug storage. These areas will not be accessible by clinic patients and visitors. Procedure, all drug samples will be marked with the expiration date. Pharmaceuticals will be checked monthly to assure they are not outdated or deteriorated. Clinic nursing staff will provide monthly inspection for expired material. The RN or MA will oversee all inspections to ensure that they occur in a timely, consistent manner. The monthly inspection will ensure that all expired drugs have been removed from the storage area. Lab Supplies and reagents will also be inspected to ensure that all expired material has been removed. All expired drug samples, lab supplies, reagents, and multi-use vials opened for more than thirty days will be discarded on a monthly basis...The handling of drugs and biologicals will be done in accordance with all state and federal OSHA guidelines..."
Review of agency policy on 7/8/2019 at approximately 10:18 PM revealed: "Job Title: Medical Assistant...Duties and Responsibilities...3. Prepares exam rooms and instruments for examination and testing. Stocks supplies. sterilized instruments..."
During a rural health clinic tour, observation of the facility's storage room area on 7/8/2019 at approximately 2:46 PM revealed multiple shelves of supplies. The following supplies were found to be expired upon review:
Blood glucose monitoring system found unused still packaged, Onetouch Ultra 2 Lot Y1204041X, Exp 08/2013
Blood glucose monitoring system found unused still packaged, Contour Blood Glucose Monitoring System Lot DWOBC3C51C Exp 2012-02 FAD 876944
Lot 1981 Exp 2012-05 FAD 7109B
During a rural health clinic tour, observation of the facility's medication storage and preparation area on 7/8/2019 at approximately 2:46 PM revealed, multiple cabinets with medications available for use. The following injectable multidose vials were opened and located in the cabinets of the medication prep area:
Xylocaine 20 ml 2% Lot 6118318 Exp 3/22, initialed and date opened was listed 4/4/19.
2% Xylocaine w/Epi 1:100,000 20 ml Lot 6116666 Exp 7/19, initialed and date opened was listed 6/4/2019.
2% Lidocaine 50 ml Lot 89-221-DK Exp 1/5/2020, Initialed and date opened was listed 6/4/2019.
During an exit interview with the director of clinical services and office coordinator on 7/9/2019 at approximately 3:30 PM confirmed the aforementioned findings.
Plan of Correction:J0023 – Maintenance
Portage Rural Health Clinic staff members failed to remove expired lab supplies. The Rural Health Clinic Policy and Procedure Manual, Physical Plant and Environment, Drug and Biological Storage Policy, states: The purpose of this policy is to ensure proper security, storage, and disposal of drugs and biologicals. Clinic nursing staff members will provide monthly inspection for expired material, including medical supplies with expiration dates. All storage areas, exam rooms, cabinets and lab areas will be inspected on the first working day of the month by all clinical staff. The monthly inspection will ensure lab supplies and reagents will also be inspected to ensure that all expired material has been removed. Any opened vials with expiration dates will be logged onto a form (when opened) to be sure they are disposed of within the 30 day time frame. The log will be reviewed at the time of inspection. A log will be kept for documentation of the monthly inspection. All out dated lab supplies and reagents will be disposed of (i.e. hazardous waste). To ensure that the inspection continues monthly all staff members will review this policy upon hire during their orientation period and then with the annual evaluation review in January of each year. The Office Manager or her designee will monitor that the inspections are completed on a monthly basis, and will audit monthly for four months, and then conduct a random audit quarterly to maintain compliance.
All appropriate staff members will be re-educated of our Rural Health Clinic Policy and Procedure Manual, Physical Plant and Environment, Drug and Biological Storage Policy by the Director of Clinical Services for Conemaugh Physician Group by 8/16/2019.
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