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 review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (CMS-209), review of 2021 and 2022 Complete Blood Count (CBC) American Proficiency Institute (API) Proficiency Testing (PT) attestation sheets and upon interview with the lab liaison, the laboratory failed to ensure proficiency testing was performed by testing personnel (TP) who routinely perform patient testing in 2021 and 2022. The findings include: 1. Review of the form CMS 209 revealed four testing personnel who perform patient testing for CBC. 2. Review of 2021 and 2022 API PT attestation records for CBC testing revealed testing personnel two and four listed on the CMS-209 failed to participate in testing PT samples in 2021 and 2022. 3. Interview with the lab liaison on June 15, 2023, at 12:30 p.m. confirmed the laboratory failed to ensure proficiency testing was performed by TP who routinely perform patient testing for CBC in 2021 and 2022. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory procedure manual, document request, and interview with the lab liaison, the laboratory failed to follow the procedure for eyewash fountain maintenance from May 2021 through survey date (June 15, 2023). The findings include: 1. Observation of the laboratory on June 15, 2023, at 9 a.m. revealed an eyewash fountain attached to the laboratory sink faucet. 2. Review of the eyewash fountain procedure stated the following, "Test unit on a regular weekly basis". 3. Request made to the lab liaison on June 15, 2023, at 10:30 a. m. for documentation of weekly eyewash fountain maintenance revealed no documentation was available for surveyor review. 4. Interview with the lab liaison on June 15, 2023, at 12:30 p.m. confirmed the laboratory failed to follow their written procedure for weekly eyewash fountain maintenance from May 2021 through survey date (June 15, 2023). D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the manufacturer control package insert, and interview with the lab liaison, the laboratory failed to label three of three control vials used for performing quality control on the Sysmex XP 300 with corrected expiration date. The findings include: 1. Observation of the laboratory on June 15, 2023 at 9:10 a.m. revealed the Sysmex XP300 complete blood count (CBC) instrument (serial # B9735) in use for patient testing. Also observed were three levels of Sysmex Eightcheck-3WP X-TRA CBC controls (Lot 3080) that were not labeled with corrected expiration date. 2. Review of the manufacturer control package insert revealed the following, "Opened and recapped vials and vials whose caps have been pierced will retain stability for 14 days if stored at 2-8 degrees C after being re- capped". 3. Interview with the lab liaison on June 15, 2023 at 12:30 p.m. confirmed the laboratory failed to label CBC controls with corrected expiration date for three of three control vials observed on the date of the survey (June 15, 2023). Word key: degrees C = degrees Celsius D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CMS 209), the laboratory testing personnel competency assessment records, and interview with the lab liaison, the laboratory's technical consultant failed to document the six required criteria for assessing personnel competency for two of -- 2 of 3 -- four testing personnel (TP) in 2021 and 2022 and two of four TP in 2022. The findings include: 1. Review of the CMS 209 revealed four testing personnel who perform complete blood count patient testing. 2. Review of testing personnel competency assessment records for 2021 and 2022 failed to include documentation of the six required criteria of competency that include: direct observation of routine patient test performance; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results and preventative maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and, assessment of problem solving skills for the following testing personnel listed on the CMS 209; - TP one and four in 2021 and 2022 - TP two and three in 2022 3. Interview with the lab liaison on June 15, 2023 at 12:30 p.m. confirmed the laboratory's technical consultant failed to document the six required criteria for assessing personnel competency for two of four TP in 2021 and 2022 and two of four TP in 2022. -- 3 of 3 --