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), interview with Testing Personnel (TP), the laboratory failed to ensure that all TP who perform Hematology testing participated in the American Proficiency Institute (API) PT in the calendar year 2022 and the 1st and 2nd events of 2023. The findings include: 1. A review of PT attestation records showed that 1 out of 10 TP performed PT in the aforementioned time frame. 2. TP #1 as listed on the CMS-209 form confirmed on 11/1/23 at 11:30 am that PT events were not rotated between all TP. 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. 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 -- This STANDARD is not met as evidenced by: Based on the surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to ensure that all attestation statements provided by the American Proficiency Institute (API) for Hematology testing in calendar year 2023 were signed by the Laboratory Director (LD). The findings include: 1. The attestation statement was not signed by the LD for API Hematology testing 2nd Event in 2023. 2. TP #1 as listed on the CMS-209 form confirmed on 11/1/23 at 11:00 am that the attestation statement for the aforementioned event was not signed. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of the Calibration Verification (CV) records and interview with the Testing Personnel (TP), the laboratory failed to retain all CV records for the Medonic M Series analyzer from 11/1/21 to 10/9/23. The finding includes: 1. The laboratory failed to retain all the Manufacturers Package Inserts (MPI) used for Calibration Verification for the Medonic M Series analyzer for 2 years. 2. The TP # 1 listed on the CMS-209 form confirmed on 11/1/23 at 11:45 am that the all CV records were not retained. D5781