Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing records, lack of documentation, and staff interview, the laboratory director or his designee failed to attest to the routine integration of the American Proficiency Institute (API) proficiency tests into the patient workload for 9 of 18 proficiency testing events reviewed from July 2021 through December 2022. The findings were: 1. Review of the proficiency testing records showed attestation statements with the following concerns: a. The 2022 API chemistry core event #2 was not signed by the laboratory director or his designee. b. The 2022 API chemistry core verification event #2 was not signed by the laboratory director or his designee. c. The 2022 API chemistry core event #3 was not signed by the laboratory director or his designee. d. The 2022 API hematology event #2 was not signed by the laboratory director or his designee. e. The 2022 API hematology event #3 was not signed by the laboratory director or his designee. f. The 2022 API microbiology event #2 was not signed by the laboratory director or his designee. g. The 2022 API microbiology event #3 was not signed by the laboratory director or his designee. h. The 2022 API immunology event #3 was not signed by the laboratory director or his designee. i. The 2022 API chemistry miscellaneous event #2 was not signed by the laboratory director or his designee. 2. Interview with the technical consultant on 3/8/23 at 12:52 PM revealed the previous technical consultant had resigned in June of 2022 and confirmed the attestation statements had not been signed. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the API (American Proficiency Institute) proficiency testing (PT) records, lack of documentation, and staff interview, the laboratory director (LD) failed to review and evaluate proficiency testing results for 11 of 18 testing events reviewed from July 2021 to December 2022. The findings were: 1. Review of the API proficiency testing records failed to include documentation the laboratory director had evaluated the proficiency test results. The following concerns were identified: a. Review of the API 2021 miscellaneous core event #2 showed no documentation the LD had reviewed the results. b. Review of the API 2022 chemistry core event #1 showed no documentation the LD had reviewed the results. This proficiency testing event showed lipase scored a 20%. c. Review of the API 2022 chemistry core event #2 showed no documentation the LD had reviewed the results. This proficiency testing event showed lipase scored a 20%. d. Review of the API 2022 chemistry core verification event #2 showed no documentation the LD had reviewed the results. e. Review of the API 2022 hematology event #1 showed no documentation the LD had reviewed the results. f. Review of the API 2022 hematology event #2 showed no documentation the LD had reviewed the results. g. Review of the API 2022 hematology event #3 showed no documentation the LD had reviewed the results. h. Review of the API 2022 microbiology event #1 showed no documentation the LD had reviewed the results. i. Review of the API 2022 microbiology event #2 showed no documentation the LD had reviewed the results. j. Review of the API immunology event #3 showed no documentation the LD had reviewed the results. k. Review of the API miscellaneous chemistry event #1 showed no documentation the LD had reviewed the results. 2. Interview with the technical consultant on 3/8/23 at 12:52 PM revealed the previous technical consultant had resigned in June of 2022 and confirmed the PT records did not show documentation of the LD's review of the results. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and staff interview, the laboratory failed to at least twice annually verify the accuracy of the lipase analyte for 1 of 2 years (2022) reviewed. The laboratory performed approximately 72 patient lipase tests per year. The findings were: 1. Review of the American Proficiency Institute (API) proficiency testing records showed the laboratory failed 3 consecutive testing events for lipase; 2021 event #3, 2022 event #1, and 2022 event #3. Further review showed the error which caused the failures was resolved on 7/20/22; however, there was no evidence patient test results had been evaluated for accuracy. 2. Interview with the technical consultant (TC) on 3/9/23 at 11:18 AM revealed the failure of the lipase analyte on the proficiency testing events was due to the failure of the laboratory to enter a correlation factor into the test system. The error was corrected in July of 2022. The TC confirmed patient results had not been evaluated for accuracy. -- 2 of 9 -- D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)