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 surveyor review of the Proficiency Testing (PT) records, Procedure Manual (PM) and interview with the Testing Personnel (TP) and the Laboratory Director (LD), the laboratory failed to ensure that all Testing Personnel (TP) who performed Hematology testing participated in all PT events from the American Proficiency Institute (API) in the calendar year of 2023. The findings include: 1. There were no signed attestation statements by TP that performed all PT events in 2023 2. During the interview with TP#1 and the LD, it was revealed that TP #1 performed all PT events in 2023. 3. TP#1 as listed on the CMS-209 form and the LD confirmed on 3/12/24 at 11:45 am that the laboratory failed to rotate all TP to participate in all Hematology PT events in 2023. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to maintain all work records and signed attestation records for Hematology tests from American Proficiency Institute Associates (API) in the calendar years 2022 and 2023. The findings include: 1. The laboratory failed to maintain a copy of the work records for the 2nd PT event in 2022 and the 3rd PT event in 2023. 2. The Laboratory Director and TP failed to sign the attestation statements for all PT events performed in 2022 and 2023. 3. TP #1 as listed on the CMS 209 form confirmed on 3/12/24 at 1:35 pm, the laboratory failed to maintain a copy of all work records and have signed attestation statements for the above mentioned PT events. 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 surveyor review of the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to follow its policies and procedures for assessing the competency of TP in calendar years 2022 and 2023. The findings include: 1. The laboratory CA policy stated "Annual competency evaluations shall be completed and filed for all employees." 2. There was no documented evidence CA was performed on Four out of Four TP listed on the CMS 209 form in calendar years 2022 and 2023. 3. TP #1 as listed on the CMS-209 form confirmed on 3 /12/24 at 1:45 pm, the laboratory failed to follow its policies and procedures for assessing the competency of TP in 2022 and 2023. 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)