Beacon Health Alliance, Pc

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's Complete Blood Count (CBC) analyzer calibration procedure, review of the Beckman AcT Diff calibration records, observation of the laboratory and interview with the lead testing person, the laboratory failed to follow their written policy for CBC instrument calibration frequency in 2022. The findings include: 1. Review of the laboratory's AcT diff (CBC analyzer) procedure stated, "Calibrate at least once every six months or after replacing major components that involve the primary measurement characteristics (such as an aperture) or when control values are consistently out of expected assay range." 2. Review of the Beckman AcT diff calibration records revealed calibration was not performed from July 2021 until March 2023, resulting in the laboratory not following their calibration procedure. 3. Observation of the laboratory revealed a Beckman AcT CBC analyzer in use for CBC patient testing. 4. Interview with the lead testing person at approximately 2:00 pm on April 20, 2023 confirmed the laboratory failed to follow their written policy for CBC instrument calibration frequency in 2022. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 employee personnel records for 2020 and 2021 and interview with the lead testing person, the laboratory's technical consultant failed to document the six required criteria for assessing personnel competency for all testing personnel (TP). The findings include: 1) Review of employee personnel records for 2020 and 2021 did not reveal 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. 2) An interview with the lead testing person on September 21, 2021 at 10:00 a.m. confirmed all TP evaluated during 2020 and 2021 were not evaluated using the six criteria for competency required by Centers for Medicare and Medicaid (CMS). ================================== Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --