Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on March 10, 2022 through March 11, 2022, Miller Donmoyer Family Health Center, Llc was determined 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 10, 2022 through March 11, 2022, Miller Donmoyer Family Health Center, Llc was found to 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 #13).
Findings include:
Request for policy on 3/11/2022 at approximately 12:50 PM revealed no specific policy.
On 3/10/22 between 10:00 AM-11:10 AM and 3/11/22 between 9:30 AM-10:30 AM observations of exam rooms, lab and surgical cart revealed:
Observation #1: Five (5) Hemoccult serial test for routine screening for fecal occult blood with expiration date of 12/2021
Observation #2: Three (3) Mckesson lubricating jelly with expiration date of 8/2020
Observation #3: Nine (9) Dyna Lube sterile jelly with expiration date of 8/2021
Observation #4: Three (3) Toujeo solostar insulin injection pens three hundred (300) units per millimeter with expiration date of 2/28/2022
Observation #5: Two (2) Basaglar Kwik pen insulin injection with expiration date of 2/2022
Observation #6: Soliquar insulin injection pen 100/33 with expiration date of 7/31/2021
Observation #7: Five (5) packs of 3M red dot electrodes with expiration date of 10/7/2021
Observation #8: Thirty (30) Povidone-iodine swabsticks with expiration date of 12/2021
Observation #9: One (1) central line dressing kit with expiration date of 12/31/2020
Observation #10: Two (2) Bovie hi temperature cautery loop tip with expiration date of 3/2018
Observation #11: Five (5) pairs of individually wrapped scissors with expiration date of 10/1/2020
Observation #12: Eight (8) Optima multitest swab specimen collection kit with expiration date of 2/28/2022
Observation #13: Two (2) Hologic Optima unisex swab specimen collection kit for endocervical and male urethral swab with expiration date of 10/31/2021
An interview with the Clinic Administrator on 3/11/2022 at approximately 12:50 PM confirmed the above findings.
"I am embarrassed because I do check my supplies, I just checked all the rooms recently and replaced all the hemoccult slides, those two (2) rooms must have been occupied when I was doing the room checks and forgot to go back to them. I knew that the Bovie's were expired but don't recall why they were still on the cart and I didn't even think about expiration dates on the EKG (electrocardiogram) machine electrodes."
Plan of Correction:Observation 1: The expired hemoccult serial tests were removed from exam room drawers and discarded. The current hemoccult serial tests are to be stored in the laboratory cabinet. An excel spreadsheet with the contents of the cabinet with their expiration dates will be hung on the inside of cabinet door to be reviewed by nurse manger monthly. Supplies that are to expire that month will be replaced and discarded prior to expiration date. New supplies will be available prior to expiration to prevent a disruption in patient care. This action went into effect March 11, 2022.
Observation 2: The expired McKesson lubricating jelly was removed from exam room drawers and discarded. One tube of lubricating jelly will be kept with the rectal thermometer and one tube to be stored with the hemoccult slides. Lubricating jelly tubes are to no longer be stored in each individual exam room. The expiration date of lubricating jelly tubes will be on a spreadsheet and kept with the nurse manager and will be reviewed every month. Tubes that are to expire in that month will be replaced prior to expiration. The close to expiration tube will be discarded. New supplies will be available prior to expiration to prevent a disruption in patient care. This action went into effect on March 11, 2022.
Observation 3: The expired Dyna Lube sterile jelly was removed from exam room drawers and discarded. One tube of lubricating jelly will be kept with the rectal thermometer and one tube to be stored with the hemoccult slides. Lubricating jelly tubes are to no longer be stored in each individual exam room. The expiration date of lubricating jelly tubes will be on a spreadsheet and kept with the nurse manager and will be reviewed every month. Tubes that are to expire in that month will be replaced prior to expiration. The close to expiration tube will be discarded. This action went into effect on March 11, 2022.
Observation 4: The expired Toujeo solostar insulin was removed from the refrigerator, the needle tips were removed from the packaging and discarded in a sharps container, the insulin pens were then discarded. A member of the clerical staff is to review insulins monthly and remove and discard any insulins to expire in that month. The member of the clerical staff will ensure those insulins closer to expiration date will be rotated to the front for timely distribution. A meeting between the nurse manager and clerical staff took place, to ensure the clerical staff completely understood the task. This plan was implemented March 14, 2022.
Observation 5: The expired Basaglar kwikpen insulin was removed from the refrigerator, the needle tips were removed from the packaging and discarded in a sharps container, the insulin pens were then discarded. A member of the clerical staff is to review insulins monthly and remove and discard any insulins to expire in that month. The member of the clerical staff will ensure those insulins closer to expiration date will be rotated to the front for timely distribution. A meeting between the nurse manager and clerical staff took place, to ensure the clerical staff completely understood the task. This plan was implemented March 14, 2022.
Observation 6: The expired Soloquar insulin pens were removed from the refrigerator, the needle tips were removed from the packaging and discarded in a sharps container, the insulin pens were then discarded. A member of the clerical staff is to review insulins monthly and remove and discard any insulins to expire in that month. The member of the clerical staff will ensure those insulins closer to expiration date will be rotated to the front for timely distribution. A meeting between the nurse manager and clerical staff took place, to ensure the clerical staff completely understood the task. This plan was implemented March 14, 2022.
Objection 7: The expired 3M red dot electrodes will be removed from the EKG cart discarded and replaced. The box containing the individual packages of electrodes is to be clearly marked with a marker of expiration date by the nurse manager, so to be clearly visible. The expiration date of the electrodes will also be on a spreadsheet. The spreadsheet will be kept with the nurse manager and reviewed monthly. Electrodes due to expire that month will be replaced and the close to expiration date electrodes will be discarded. New electrodes will be available prior to expiration to prevent a disruption in patient care. This plan will be implemented March 21, 2022.
Objection 8:The expired Povidone-iodine swabs were removed from the surgical cart and discarded. The swabs were immediately replaced. An excel spreadsheet with the contents of the surgical cart and their expiration dates will be kept on the surgical cart. The nurse manager will review and update spreadsheet monthly. Discarding any items and replacing them if due to expire that month. This plan went into effect March 11, 2022.
Objection 9: The expired Central line dressing kit was removed from the surgical cart and discarded. An excel spreadsheet with the contents of the surgical cart and their expiration dates will be kept on the surgical cart. The nurse manager will review and update spreadsheet monthly. Discarding any items and replacing them if due to expire that month. This plan went into effect March 11, 2022.
Objection 10: The expired Bovie hi temperature cautery loop was removed from surgical cart and discarded. An excel spreadsheet with the contents of the surgical cart and their expiration dates will be kept on the surgical cart. The nurse manager will review and update spreadsheet monthly. Discarding any items and replacing them if due to expire that month. This plan went into effect March 11, 2022.
Objective 11: The expired individually wrapped scissors were removed from the surgical cart and discarded. An excel spreadsheet with the contents of the surgical cart and their expiration dates will be kept on the surgical cart. The nurse manager will review and update spreadsheet monthly. Discarding any items and replacing them if due to expire that month. This plan went into effect March 11, 2022.
Objective 12: The expired Optima multitest swab specimen collection kits were removed from laboratory stock and discarded. A member of the clerical staff is to review laboratory supplies monthly and remove and discard any supplies to expire in that month. The member of the clerical staff will notify the phlebotomist of products set to expire a month prior to expiration to ensure the phlebotomist has ample time to replace supplies to not cause a disruption in patient service. A meeting between the nurse manager and clerical staff took place, to ensure the clerical staff completely understood the task. This plan was implemented March 14, 2022.
Objective 13: The expired Hologic Optima unisex swab specimen collection kit for endocervical and male urethral swabs were removed from laboratory stock and discarded. A member of the clerical staff is to review laboratory supplies monthly and remove and discard any supplies to expire in that month. The member of the clerical staff will notify the phlebotomist of products set to expire a month prior to expiration to ensure the phlebotomist has ample time to replace supplies to not cause a disruption in patient service. A meeting between the nurse manager and clerical staff took place, to ensure the clerical staff completely understood the task. This plan was implemented March 14, 2022.
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