Summary:
Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on American Association of Bioanalyst Proficiency Testing Program (AABPTP) records (since year 2017) and technical supervisor interview on June 19, 2019 at 10:35 AM, it was determined that the laboratory failed to enroll in an HHS approved Proficiency Testing Program for Complete Cell Count (CBC) tests and white blood cell (WBC) three parameters differential examination since January 2019. The findings include: 1. The laboratory performed the CBC tests and WBC three parameters differential examination by the Sysmex KX21N system and participated in the AABPTP since January 2017. 2. On June 19, 2019 at 10:35 AM, the AABPTP records showed that the laboratory did not participate in the proficiency testing program for the CBC tests and WBC three parameters differential examination for this year 2019. 3. The laboratory did not have records of the AABPTP enrollment for the year 2019. 4. The technical supervisor confirmed on June 19, 2019 at 10:35 AM, that the laboratory did not perform proficiency testing samples for CBC and WBC differential during this year. He stated that the laboratory performed the enrollment in AABPTP for the year 2019 but, the enrollment paid was accredited to another laboratory. 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 -- 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)