Summary:
Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 11/15/2023 and concluded on 11/15/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on facility documentation, record review, and staff interview, the laboratory failed to ensure proficiency testing (PT) was rotated among 1 of 10 testing personnel (TP; TP #10) for PT events reviewed. Findings included: Review of an undated facility document titled "The Clinical Laboratory Quality Assurance Program" revealed, "Proficiency Testing: The Lab coordinator will be responsible for making certain that all laboratory personnel participate in Proficiency testing, and the Proficiency testing challenges are done, reported to the appropriate agency." Review of PT records on 11/15/2023 at 11:00 AM revealed TP #10 performed hematology PT for 2022 Event #3, 2023 Event #1, and 2023 Event #2. During an interview on 11/15 /2023 at 2:50 PM, TP #10 confirmed she performed all hematology PT for 2022 Event #3, 2023 Event #1, and 2023 Event #2. During an interview on 11/15/2023 at 3:00 PM, the Regional Laboratory Coordinator acknowledged the laboratory failed to ensure PT was rotated among all the TPs. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on facility document review, record review, and staff interview, the laboratory failed to ensure 1 of 10 testing personnel (TP; TP #10) completed and maintained documentation of competency assessment at least annually. Findings included: Review of an undated facility document titled "The Clinical Laboratory Quality Assurance Program" revealed, "The laboratory coordinator, or the designee, will document training and evaluate job performance of individuals responsible for laboratory testing semi-annually during the first year, and annually thereafter." Review of an employee document titled "Medonic CBC Basic" revealed the last employee competency for TP #10 occurred on 01/26/2022. During an interview on 11 /15/2023 at 3:00 PM, the Regional Laboratory Coordinator acknowledged the laboratory failed to ensure TP #10 completed and maintained documentation of competency assessment at least annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on document review and staff interview, the laboratory failed to ensure staff followed manufacturer maintenance recommendations regarding monthly clot prevention for 18 (January 2022 - August 2022 and January 2023 - October 2023) of 29 months reviewed for 1 (Medonic M-Series) of 1 hematology laboratory instrument. Findings included: A review of a hematology manufacturer's manual revealed a section titled, "8.2 Monthly Cleaning," which revealed, "This section describes the cleaning procedures to be used to secure the correct function of the instrument on a monthly basis" and, under "Clot Prevention," "This process will decrease the risk of debris material building up in the instrument system. This should be performed at least once a month or every 1000 samples." A review on 11/15/2023 at 11:00 AM of facility maintenance documents titled "Medonics M-Series Maintenance Schedule" revealed the laboratory failed to follow manufacturer maintenance recommendations regarding clot prevention. Further record review revealed the monthly clot prevention cleaning was not documented from January 2022 through August 2022 or January 2023 through October 2023. During an interview on 11/15/2023 at 3:00 PM, the Regional Laboratory Coordinator acknowledged the laboratory failed to ensure staff followed manufacturer maintenance recommendations regarding clot prevention cleaning for the hematology laboratory instrument. -- 2 of 2 --