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 review of the Centers for Medicare and Medicaid Services (CMS) data system for proficiency testing, a lack of proficiency testing (PT) records, and confirmation by the lab director/technical consultant (LD/TC) as listed on the CMS- 209 personnel form, the laboratory failed to enroll in an HHS approved proficiency testing program for complete blood count testing (CBC) performed on the Sysmex XN-330. Testing began on January 28, 2022. Findings include: 1. Review of the CMS data system for proficiency testing revealed no documentation of the performance of proficiency testing for CBC testing on the Sysmex XN-330 since it was put into use on 1/28/22. 2. There was no documentation available for review on the day of survey for proficiency testing. 3. The LD/TC confirmed in an interview at 12:30 p.m. that the laboratory had not enrolled in proficiency testing for CBC's performed on the Sysmex XN-330. Approximately 81 CBC's had been performed between 1/28/22 and 8/16/22. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 review of quality control (QC) records for the Sysmex XN-330 hematology analyzer from 1/28/22 through 8/16/22 and manufacturer's assay sheets for the XN-L Check controls, the laboratory failed to retain the manufacturer's assay sheet for the lot number of XN-L Check controls, in use from 1/28/22 through 6/21/22, for at least 2 years. Findings include: 1) A quarterly QC report for lot #1351 (in use between 12 /16/21 and 3/29/22) was reviewed--no assay sheet was retained for this lot. 2) A quarterly QC report for lot #2070 (in use between 3/16/22 and 6/21/22) was reviewed-- no assay sheet was retained for this lot. 3) The laboratory director/technical consultant and TP #1 confirmed in an interview at 11:00 a.m. that no quality control assay sheets had been retained. 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 patient test logs, interview with the laboratory director/technical consultant (LD/TC) on 8/16/22 at 11:15 a.m., and lack of a written procedure manual, the laboratory failed to establish a written procedure manual for performing CBC (Complete Blood Count) testing with the Sysmex XN-330 Hematology analyzer, in use for patient testing from 1/28/2022 through 8/16/22 when a total of 81 patient specimens were tested. Findings include: 1. Review of patient test logs revealed approximately 81 patient CBC's were tested from 1/28/22 through 8/16/22. 2. There was no procedure manual available for review on 8/16/22 for performing patient CBC's on the Sysmex XN-330 Hematology analyzer. 3. The LD/TC confirmed in an interview on 8/16/22 at 11:00 a.m. that there was no written procedure for performing CBC's. 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)