Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on October 7, 2020 through October 9, 2020, Coatesville Dialysis was found to be in compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services-Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on October 7, 2020 through October 9, 2020, Coatesville Dialysis, was identified to have the following standard level deficiency, that was determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.
Plan of Correction:
494.30(b)(2) STANDARD
IC-ASEPTIC TECHNIQUES FOR IV MEDS
Name - Component - 00
[The facility must-]
(2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and
Observations:
Based on review of facility policy and procedure, observation, and an interview with the facility Administrator, it was determined the facility failed to ensure opened Medication vials to be labeled with the medication expiration date for one (1) of one (1) observation (Observation #1), failed to ensure opened Medication vials to be labeled with nurse initials for three (3) out of three (3) observations (Observation #1-Observation #3), and failed to ensure expired medications to be disposed of for two (2) of two (2) observations (Observation #4 and Observation #5).
Findings include:
A review was conducted of facility policy and procedure on October 7, 2020, at approximately 2:00 PM revealing the following: Policy:1-06-01 'Medication Policy' states " ...#28 Medications containing a preservative must be discarded 28 days after opening or accessed ..... . Each vial is labeled with the initials of the person opening the vial and the expiration date .....30. Medications are ordered and replaced prior to expiration. Unless an exact expiration date is specified, medications with an expiration of month/year are considered expired the last day of the stated month....."
Observations conducted in the patient treatment area on October 7. 2020 between 9:30 AM and 12:30 PM revealed the following:
Observation #1: One (1) 30 ml (milliliter) open, not in use, vial of Heparin \ was observed in the nursing station medication preparation area that was not labeled with the initials of the nurse who had previously opened the vial.
Observation #2: One (1) 2 ml open vial of Epogen \ was observed in medication fridge #1 in the nursing station medication preparation area and was not labeled with the initials of the nurse who had previously opened the vial.
Observation #3: One (1) 1 ml open vial of Tubersol \ was observed in medication fridge #1 in the nursing station medication preparation area and was not labeled with the initials of the nurse who had previously opened the vial.
Observation #4: Eight (8) 10 ml vials of Sterile Water, was observed in the emergency cart in the peritoneal dialysis nursing station area, all vials had an expiration date of 9/2020.
Observation #5: Two (2) 1000 ml bags of Normal Saline Solution, was observed in the emergency cart in the peritoneal dialysis nursing station area, and had an expiration date of 10/1/2020.
An interview with the facility Administrator on October 9, 2020 at approximately 11:15 AM confirmed the above findings.
Plan of Correction:Coatesville PA 11482 CMS Recert POC 100920
V0143
The FA will hold mandatory in-service(s) for all Clinical Teammates (TMs) starting on 10/09/2020. Audits will begin 10/12/2020. Surveyor observations will be reviewed. Education included but will not limited to a review of Policy #1-06-01 Medication Policy with the emphasis on but not limited to: 1) Each vial is labeled with the initials of the person opening the vial and the expiration date. 2) All medications in the facility are checked monthly for expiration dates. 3) Medications are ordered and replaced prior to expiration date. 4) Expired medications are removed from the treatment and inventory areas.
Verification of attendance at in-service will be evidenced by TMs signature on in-service sheet. Any TMs absent will receive in-service training upon return to work schedule. The FA or designee will conduct medication audits in the ICHD and PD departments daily for one (1) week, every other day for one (1) week, twice weekly for one (1) week, once weekly for two (2) weeks, then monthly. The results of the audits will be reviewed with the TMs during homeroom meetings and the Medical Director during the monthly Facility Health Meeting (FHM-QAPI) with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.
Completion date: 11/14/2020
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