Summary:
Summary Statement of Deficiencies D0000 During a recertification survey on 09/26/2023 the laboratory was found not be in compliance with the following CLIA conditions: 493.1250 Condition: Hematology 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency test (PT) records and staff interview, the laboratory director and testing personnel failed to sign the complete blood count (CBC) PT attestation statements for seven of seven events reviewed from 2021, 2022, and 2023. The findings include: 1. Review of the laboratory's API PT records for CBC testing revealed the attestation statements were maintained electronically on the API website on the date of the survey (09/26 /2023) as follows for seven of seven events reviewed: 2021 Events two and three 2022 Events one, two, and three 2023 Events one and two None of the attestation statements had been signed by either the laboratory director or testing personnel. 2. Interview on 09/26/2023 at 2:15 pm with the laboratory director, testing person one, and laboratory liaison confirmed the laboratory director and testing personnel did not sign the attestation statements that were submitted electronically on the API website for the PT events for CBC testing in 2021, 2022, and 2023. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of laboratory American Proficiency Institute (API) proficiency testing (PT) records, lack of policy, and staff interview, the laboratory failed to test PT samples the same number of times that patient samples were tested for complete blood count (CBC) testing for two API PT events (two of seven reviewed) in 2022 and 2023. The findings include: 1. Review of PT records for 2022 event one revealed PT samples were performed multiple times as indicated below: #01 03/28/2022 12:44 and 13:58 #02 03/28/2022 12:45 and 14:01 #03 03/28/2022 13:00 and 14:14 #04 03/28 /2022 14:06 and 03/29/2023 9:24 am 2. Review of PT records for 2023 event two revealed PT samples were performed multiple times as indicated below: #06 07/26 /2023 13:42, 13:44, 13:48, 15:58. #07 07/26/2023 13:52, 13:54, 13:57, 14:01. #08 07 /26/2023 14:15, 14:19, 14:21, 14:28. #09 07/26/2023 14:39, 14:43, 14:46, 14:49 #10 07/26/2023 14:52, 14:54, 14:57, 14:58. 3. There was no policy that required repeat testing of patient samples on the date of the survey (09/26/2023). 4. Interview on 09/26 /2023 at 2:15 pm with the laboratory director, testing person one, and laboratory liaison confirmed the laboratory did not test PT samples the same number of times that patient samples are routinely tested in 2022 and 2023. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including 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 observation of the laboratory, review of daily quality control records, lack of records, and staff interview, the laboratory failed to retain manufacturer package inserts for quality controls used for the Sysmex XN 330 CBC instrument in 2022 or 2023. The findings include: 1. Observation of the laboratory on 09/26/2023 at 9:22 am revealed a Sysmex XN 330 (serial # 12114) in use for patient CBC testing. 2. Review of daily quality control instrument printouts revealed the following: Lot 1351 in use on 01/04/2022 Lot 2070 in use on 06/01/2022 Lot 2322 in use on 01/10/2023 Lot 3041 in use on 05/18/2023 3. No manufacturer control assay sheets were available on the date of the survey for lots 1351, 2070, 2322, or 3041. 4. Interview on 09/26/2023 at 3:00 pm with the laboratory director testing person one, and laboratory liaison confirmed the laboratory failed to retain quality control manufacturer assay sheets for a period of two years for the Sysmex XN 330 CBC instrument in 2022 and 2023. 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: -- 2 of 8 -- Based on record request and staff interview the laboratory failed to establish a written policy or procedure to assess testing personnel competency (See D5209), failed to document review of PT performance evaluations (See D5221), failed to establish a written policy for Quality Assessment (See D5291), failed to have a complete procedure for the Sysmex XN 330 instrument (See D5403), failed to monitor and define environmental criteria for the use of the Sysmex XN 330 (See D5413), and failed to have control procedures in place for controls used for the Sysmex XN 330 (See D5441). 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 lack of records and staff interview, the laboratory failed to establish written policies and procedures to assess competency for personnel that perform CBC patient testing. The findings include: 1. There was no competency policy available on the date of the survey (09/26/2023). 2. Interview on 09/26/2023 at 3:00 pm with the laboratory director, testing person one, and laboratory liaison confirmed the laboratory did not have a personnel policy established to assess competency for personnel that perform CBC patient testing. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of laboratory PT records and staff interview, the laboratory failed to document review of the performance evaluation provided by API in 2021, 2022, and 2023. The findings include: 1. Review of the laboratory's API CBC PT records revealed no documented review or evaluation for six of seven events (2021 events two and three, 2022 events one and three, 2023 events one and two). 2. Interview on 09/26 /2023 at 2:15 pm with the laboratory director, testing person one, and laboratory liaison confirmed the laboratory did not document review of the performance evaluations provided by API for six of seven PT events in 2021, 2022, and 2023. 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 lack of policy and staff interview, the laboratory failed to establish a written -- 3 of 8 -- policy or procedure for quality assessment. The findings include: 1. A Quality assessment policy was not available on the date of the survey (09/26/2023). 2. Interview on 09/26/2023 at 3:00 pm with the laboratory director, testing person one, and laboratory liaison confirmed the laboratory did not have a written policy or procedure for quality assessment. 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)