Summary:
Summary Statement of Deficiencies 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 record review and staff interview, the laboratory failed to test proficiency testing (PT) samples in the same manner as routine patient samples in the specialties of Chemistry and Hematology. Findings include: 1. Record review on 6/8/2022 of the laboratory's American Associates of Bioanylysts (AAB) 2020, 2021 and 2022 Hematology/Coagulation and Chemistry Cardiac Markers PT records revealed technical consultant (TC) 1 performed the proficiency testing for all of the Hematology/Coagulation and Chemistry Cardiac Markers PT events. 2. Interview with TC 1 on 6/8/2022 at 11:35 AM confirmed the above findings. 3. The laboratory performs 180 Chemistry and 18,000 Hematology tests annually. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- the PT event. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory director (LD) failed to attest that proficiency testing samples were performed in the same manner as patient specimens. Findings include: 1. Record review on 6/8/2022 of the 2020 American Associates of Bioanylysts (AAB) Chemistry Cardiac Markers events 2 and 3 attestation pages revealed the pages were not signed by the LD. 2. Record review on 6 /8/2022 of the 2020 AAB Hematology/Coagulation event 2 attestation page revealed the page was not signed by the LD. 3. Record review on 6/8/2022 of the 2021 AAB Chemistry Cardiac Markers events 1,2 and 3 attestation pages revealed the pages were not signed by the LD. 4. Record review on 6/8/2022 of the 2021 AAB Hematology /Coagulation events 1,2 and 3 attestation pages revealed the pages were not signed by the LD. 5. Record review on 6/8/2022 of the 2022 AAB Chemistry Cardiac Markers events 1 and 2 attestation pages revealed the pages were not signed by the LD. 6. Record review on 6/8/2022 of the 2022 AAB Hematology/Coagulation events 1 attestation pages revealed the pages were not signed by the LD. 7. Interview with technical consultant 1 on 6/8/2022 at 11:30 AM confirmed the above findings. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory director (LD) failed to have a policy in place to assess the competency of all laboratory personnel. Findings Include: 1. Record review of the laboratory's procedure manual on 6/8/2022 revealed the laboratory did not have a policy in place to assess the competency of the technical consultant (TC). 2. Record review of the laboratory's 2020 and 2021's competency records on 6/8/2022 revealed the laboratory failed to document competency for 2 of 2 TC's based on their CLIA responsibilities. 3. Staff Interview on 6/8/2022 at 10:30 AM with TC1 and TC2 confirmed the above findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on surveyor observation, record review and staff interview, the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1251 through 493.1283 for each specialty and -- 2 of 8 -- subspecialty of testing performed. The cumulative effect of this lack of oversight resulted in the laboratory's inability to ensure accuracy and reliability of patient test results in the specialtis of Hematology and Chemistry. Refer to D5403, D5415, D5445, and D5783. 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)