Summary:
Summary Statement of Deficiencies D0000 An initial certification survey was completed on 11/13/2024. Immediate Jeopardy existed for the following condition level deficiencies: D2000 - 42 CFR 493.801 - Condition: Enrollment and testing of proficiency samples D5026 - 42 CFR 493.1217 - Condition: Immunohematology D6076 - 42 CFR 493.1441 - Condition: Laboratories performing high complexity testing; laboratory director D6108 - 42 CFR 493.1447 - Condition: Laboratories performing high complexity testing; technical supervisor D6141 - 42 CFR 493.1459 - Condition: Laboratories performing high complexity testing; general supervisor D6168 - 42 CFR 493.1487 - Condition: Laboratories performing high complexity testing; testing personnel The laboratory ceased testing on 11/14/2024 and Immediate Jeopardy was removed. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of laboratory records, American Proficiency Institute (API) proficiency testing (PT) records and interview with testing personnel (TP) #1; the laboratory failed to have PT samples tested by three of four TP who routinely perform Rhesus (Rh) factor slide method testing for four of four Rh factor events (See D2007) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- and failed to retain all documents related to proficiency testing for four of four Rhesus (Rh) factor testing events from the beginning of patient testing, 07/28/2023, to the date of the on-site survey, 11/13/2023 (See D2015). 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 review of laboratory records, American Proficiency Institute (API) proficiency testing (PT) records and interview with testing personnel (TP) #1; the laboratory failed to have PT samples tested by three of four TP who routinely perform Rhesus (Rh) factor slide method testing in the specialty of immunohematology for four of four events in 2023 through the on-site survey date, 11/13/2024. Findings include: 1. Review of the Laboratory Personnel Report (signed by the laboratory director on 11/10/2024) and laboratory competency documents revealed four TP authorized to perform Rh factor slide method testing. 2. Review of API PT attestation statements for four of four PT events from the beginning of patient testing, 07/28 /2023, to the date of the on-site survey, 11/13/2023, revealed TP #1 performed all four Rh factor testing events. Year: Event: TP: 2023 2 1 2023 3 1 2024 1 1 2024 2 1 3. Interview with TP #1 on 11/13/2024, at 11:51 am, confirmed the laboratory failed to have PT samples tested by three of four TP who routinely perform Rhesus (Rh) factor slide method testing in the specialty of immunohematology. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and interview with testing personnel (TP) #1; the laboratory failed to retain all documents related to proficiency testing for four of four Rhesus (Rh) factor testing events from the beginning of patient testing, 07/28/2023, to the date of the on-site survey, 11/13/2023. Findings include: 1. Review of four of four API PT events revealed the laboratory failed to retain the following: -Testing records, - Results/scores provided by API, -Documentation of laboratory director review of API scores, -Records of any