Summary:
Summary Statement of Deficiencies D0000 The laboratory was found not to be in compliance with the following CLIA conditions: D2000: 493.801 Condition: Enrollment and testing of samples D5024: 493.1215 Condition: Hematology D5200: 493.1230 Condition: General laboratory systems D6000: 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 observation of laboratory, lack of documentation, review of patient test records, and interview with the lead testing person, determined the laboratory failed to enroll in proficiency testing (PT) for the complete blood count (CBC) analytes in 2022 and 2023 with 36 patients reported since testing began on 07.15.2022. The findings include: 1. Observation of the laboratory at approximately 1:00 p.m. on 03.14.2023 revealed an Abbott Cell Dyn instrument on the laboratory counter in use for CBC patient testing. 2. Request for PT records at approximate 1:00 p.m. on 03.14.2023 revealed no PT records were available. The lead testing person stated the laboratory was not enrolled in PT for the CBC analytes. 3. Review of patient test reports revealed patient testing for CBCs began on 07.15.2022 until the date of survey (03.14.2023). 4. Interview with the lead testing person at approximately 2:00 p.m. on Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- 03.14.2023 confirmed the laboratory was not enrolled in PT for the CBC analytes in 2022 and 2023 with patient testing being performed. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation, lack of documentation, and interview with the lead testing person, the laboratory failed to meet the requirements for the hematology specialty as evidenced by: 1. The laboratory failed to establish written policies and procedures to assess employee competency in 2022 and 2023 for performance of complete blood counts (CBCs) (Refer to D5209) 2. The laboratory failed to establish general quality assessment (QA) policies and procedures in 2022 and 2023 for monitoring of moderately complex complete blood counts(CBCs) (Refer to 5291) 3. The laboratory failed to establish analytic quality assessment (QA) policies and procedures for the complete blood count (CBC) performed on the Abbott Cell Dyn in 2022 and 2023 (Refer to D5791) D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: The laboratory failed to establish testing personnel competency assessment policies (Refer to D5209) and failed to establish a general laboratory systems quality assessment policy in 2022. (Refer to D5291) D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on request for personnel records, lack of documentation, and interview with the lead testing person, the laboratory failed to establish written policies and procedures to assess employee competency in 2022 and 2023 for performance of complete blood count (CBC), with 36 patients reported since testing began on 07.15.2022. The findings include: 1. Request for testing personnel records revealed no documentation -- 2 of 9 -- of competency for all testing persons. 2. The testing personnel competency policies and procedures were requested from the lead testing person at approximately 2:00 p. m. on 03.14.2023. The lead testing person stated the laboratory did not have policies or procedures for assessing testing personnel competency. 3. Interview with the lead testing person at approximately 2:00 p.m. on 03.14.2023 confirmed the laboratory failed to establish written policies and procedures to assess employee competency since patient testing began 07.15.2022 through the survey date of 03.14.2023 with 36 patients had been reported since testing began on 07.15.2022. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on observation of the laboratory, lack of documentation, and interview with lead testing person, the laboratory failed to establish general quality assessment (QA) policies and procedures in 2022 and 2023 for monitoring of moderately complex complete blood counts(CBCs), with 36 patients reported since testing began on 07.15.2022. The findings include: 1. Observation of the laboratory at approximately 1: 00 p.m. on 03.14.2023 revealed an Abbott Cell Dyn instrument on the laboratory counter for CBC patient testing. 2. Request for QA policies and procedures from the lead testing person on 03.14.2023 at 1:00 p.m. revealed the laboratory had no general QA policies or procedures. 3. Interview with the lead testing person at approximately 2:00 p.m. on 03.14.2023 confirmed the laboratory did not have any general QA policies or procedures in 2022 and 2023, with 36 patient CBCs reported since testing began on 07.15.2022 through the date of survey (03.14.2023). 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)