Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on 4/8/2024, Budfield Street Home 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 completed 4/8/2024, Budfield Street Home Dialysis was found to have the following standard level deficiencies that were 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(a)(1)(i) STANDARD
IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK
Name - Component - 00
Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory.
Observations:
Based on review of facility policy and procedure, observations (OBV) and staff (EMP) interview the facility staff failed to use proper personal protective equipment (PPE) during a procedure for one (1) of two (2) observations conducted (OBV1).
Findings included:
Review of facility policy and procedures on 4/8/2024 at approximately 3:30 PM revealed, "TITLE: PERIPHERAL VENIPUNCTURE PROCEDURE Materials required ...*PPE-personal protective equipment (face protection, mask, gloves, fluid resistant/fluid impervious barrier garment) NOTES: Procedure 1. Dialysis Precautions and aseptic technique are used when performing this procedure. 2. Explain the procedure to the patient. Perform hand hygiene and gather supplies. Put on PPE ...Rationale 1. Dialysis Precautions, including the use of personal protective equipment, are used to prevent exposure to blood/body fluids. 2. Hand hygiene protects patient and teammate from cross contamination. PPE is worn for teammate protection ... "
Observations of patient care was conducted on 4/5/2024 at approximately 11:05 AM which revealed, EMP4 was conducting a venipuncture procedure with the patient. EMP4 completed the venipuncture procedure. EMP4 was not waring a mask during the procedure.
An exit interview with group facility administrators on 4/8/2024 at approximately 1:25 PM confirmed the findings.
Plan of Correction:V0115
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on
04/29/24. Surveyor observations were reviewed. Education included but was not limited to a review of
Procedure 5-10-01A "Peripheral Venipuncture Procedure" with emphasis on but not limited to: 1)
Materials required: PPE – personal protective equipment (face protection, mask, gloves, fluid
resistant/fluid impervious barrier garment). 2) Step 2: ...Perform hand hygiene and gather supplies.
Put on PPE. Rationale: Hand hygiene protects patient and teammate from cross contamination. PPE is
worn for teammate protection. Verification of attendance at in-service will be evidenced by teammate's
signature on the in-service sheets. Any staff member not present will review the in-service with the
Facility Administrator or designee upon returning to work.
The Facility Administrator or designee will conduct audits to verify teammates are wearing appropriate
PPE as required per policy: on twenty five percent (25%) of venipunctures daily for two weeks (2) then
weekly for two weeks. Ongoing compliance will be monitored with the Monthly Infection control eAudit
Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review audit results with teammates during homeroom
meetings, and with the Medical Director during monthly Quality Assessment and Performance
Improvement meetings known as Facility Health Meetings. The Facility Administrator will report
progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for
effectiveness and new plans developed when needed, until sustained compliance is achieved.
Supporting documentation will be included in the meeting minutes. The Facility Administrator is
responsible for compliance with this 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 the facility policy and procedures, observations (OBV) and staff (EMP) interview it was determined the facility failed to ensure labeling and disposal of expired medications for one (1) of one (1) facility tour.
Findings included:
Review of facility policy and procedures on 4/8/2024 at approximately 3:30 PM revealed, "TITLE: MEDICATION POLICY ...POLICY: 1. The Facility Administrator/designee is responsible for supervising the handling ,storing, disposing, administering, and controlling of medications and performs a monthly audit and inventory...12. All open or unopened medication packages (i.e. vials, ampules etc.) are stored according to the manufacturer's directions. Do not use any medication that has been stored improperly or has expired. k. Medications containing a preservative must be discarded 28 days after opening or accessed (e.g., needle punctured), unless the manufacturer specifies a different (shorter or longer) date or as directed by the manufacturer...l. All medications in the facility are checked monthly...n. Disposal of expired medications, including all over the counter and nutritional product samples are removed from the treatment and inventory areas and disposed of per state/local regulations..."
A tour was conducted with EMP1 on 4/5/2024 at approximately 10:05 AM, observation of clinic room 3 was conducted. The following medication vial was found opened without a date or initials labeled: Heparin 30,000 units Exp 04/2021 NDC 11288-402-30, Lot A6R3609M.
A tour was conducted with EMP1 on 4/5/2024 at approximately 10:21 AM, observation of clinic room 1 was conducted. The following medication vial was found opened with initial's and a date of 2/14/2024, 30 ml Multidose vial HEPARIN sodium Inj. USP 30,000 USP units/ml Exp Lot HH6290 Exp 01-Jul-2025.
An exit interview with group facility administrators on 4/8/2024 at approximately 1:25 PM confirmed the findings.
Plan of Correction:V0413
The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on
04/29/24. Surveyor observations were reviewed. Education included but was not limited to a review of
Policy 1-06-01 "Medication Policy" with emphasis on but not limited to: 1) The Facility Administrator /
designee is responsible for supervising the handling, storing, disposing, administering, and controlling of
medications and performs monthly audit and inventory. 2) Each vial is labeled with the initials of the
person opening the vial and the expiration date. 3) Medications containing a preservative must be
discarded 28 days after opening or accessed, unless the manufacturer specifies a different (shorter or
longer) date or as directed by the manufacturer. 4) All medications are checked monthly for expiration
dates. 5) Medications are ordered and replaced prior to expiration.
The Facility Administrator or designee immediately conducted a one hundred percent (100%) audit of all
medications with expiration dates. Any items identified as expired in the audit were immediately and
appropriately discarded, including items identified by the surveyor's observations.
Ongoing compliance will be monitored by Facility Administrator or designee per policy with the monthly
infection control audit. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review audit results with teammates during homeroom
meetings, and with the Medical Director during monthly Quality Assessment and Performance
Improvement meetings known as Facility Health Meetings. The Facility Administrator will report
progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for
effectiveness and new plans developed when needed, until sustained compliance is achieved.
Supporting documentation will be included in the meeting minutes. The Facility Administrator is
responsible for compliance with this plan of correction.
|