Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on December 12, 2022, Armstrong Primary Care Center - Leechburg was found 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 onsite unannounced Medicare recertification survey completed December 12, 2022, Armstrong Primary Care Center - Leechburg was found to have the following standard level deficiency that was determined to be in substantial compliance with the following requirement(s) of 42 CFR, Part 405, Subpart X and 42 CFR Part 491.1 - 491.11 Subpart A, Conditions for Certification: Rural Health Clinics.
Plan of Correction:
491.9(b)(3)(iii) STANDARD
PROVISION OF SERVICES
Name - Component - 00
491.9(b) Patient care policies.
(3) The policies include:
(iii) Rules for the storage, handling, and administration of drugs and biologicals.
Observations:
Based on review of policies/procedures, observations and interview with the clinic manager (EMP1) the clinic failed to ensure the disposal of expired drugs and to contain oxygen cylinders safely for two (2) of two (2) observations made. OBS #1 and OBS#2.
Findings include:
Review of facility policy #12368458 title: "Oxygen Safety" completed on December 12, 2022 approximately 10:30 AM revealed: "Store cylinders in a safe area indoors...All oxygen cylinders should be secured and stored upright in a designated oxygen cylinder carrier or properly secured to a wall in an upright position. ..."
OBS #1 conducted on December 12, 2022 at approximatly 10:00 AM revealed one (1) oxygen cylinder not secured in a designated oxygen cylinder carrier, not secured upright to a wall in the storage room.
Interview with EMP1 on December 12, 2022 at approximately 11:00 AM confirmed above findings regarding oxygen cylinder. "The delivery people take care of that and we don't usually have one not in a carrier."
Review of facility policy #11994668 title: "Medication Administration" completed December 12, 2022 at approximately 3:30PM revealed: "Multiple Dose Vials: All multiple dose vials may be used for no longer than 28 days from date of first use... Vials will be marked with an expiration date."
OBS# 2 conducted December 12, 2022 approximately 3:00 PM revealed the following:
One (1) vial of Xylocaine MPF inj 50mg/5ml - MDV (multi-dose vial), Lot # 6128223, Expiration date: 4/26 was observed with hand written date "11-4-22" on label in the patient supply of medication dispensory system for nurse to administer.
Interview with EMP1 on December 12, 2022 at approximately 4:30PM confirmed the above findings regarding Xylocaine medication. "That vial should not be in the patient supply of medications."
Plan of Correction:Based on the findings upon review of facility policy #12368458 title: "Oxygen Safety" completed on December 12, 2022 approximately 10:30 AM revealed: "Store cylinders in a safe area indoors...All oxygen cylinders should be secured and stored upright in a designated oxygen cylinder carrier or properly secured to a wall in an upright position. ..."
OBS #1 conducted on December 12, 2022 at approximately 10:00 AM revealed one (1) oxygen cylinder not secured in a designated oxygen cylinder carrier, not secured upright to a wall in the storage room.
Interview with EMP1 on December 12, 2022 at approximately 11:00 AM confirmed above findings regarding oxygen cylinder. "The delivery people take care of that and we don't usually have one not in a carrier."
Since the visit on December 12, 2022, the office manager ordered more oxygen storage carriers to maintain compliance with the current "Oxygen Safety" policy. Additionally, she or her designee, will assure that all tanks are properly stored after each delivery. Oxygen tanks and their storage will be checked regularly to ensure the "Oxygen Safety" policy is maintained at all times.
In response to the findings after the review of policy #11994668 title: "Medication Administration" completed December 12, 2022 at approximately 3:30PM revealed: "Multiple Dose Vials: All multiple dose vials may be used for no longer than 28 days from date of first use... Vials will be marked with an expiration date."
OBS# 2 conducted December 12, 2022 approximately 3:00 PM revealed that One (1) vial of Xylocaine MPF inj 50mg/5ml - MDV (multi-dose vial), Lot # 6128223, Expiration date: 4/26 was observed with hand written date "11-4-22" on label in the patient supply of medication dispensary system for nurse to administer. In the interview with EMP1 on December 12, 2022 at approximately 4:30PM confirmed the above findings regarding Xylocaine medication. "That vial should not be in the patient supply of medications."
In order to mitigate any further "medication administration" policy violations, the office will order color coded stickers and label all medications based off of expiration date. There will be a color coded chart added to the already existing log sheet with double nurse signoff. When a multi-dose vial is used, the expiration data will be reassigned using the appropriate color coded sticker and include the revised expiration date. This will be signed off by two nurses. Color coded stickers have been ordered and this procedure will be implemented upon delivery. The office manager will assure the process is being followed on a weekly basis for a period of three months, then review monthly.
|