Healthcare Express-Moore

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/13/2022. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the technical consultant and laboratory operations director at the conclusion of the survey. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant and laboratory operations director, the laboratory failed to perform quality control as stated in the IQCP for CKMB and Troponin I testing for two of 16 months. Findings include: (1) On 05/13/2022 at 09:30 am, the laboratory operations director stated the following: (a) CKMB and Troponin I testing were performed using the Quidel Triage Meter; (b) Two levels of QC (quality control) materials were tested monthly, according to the laboratory IQCP (Individualized Quality Control Plan). (2) A review of QC records for testing performed from January 2021 through April 2022 revealed there was no documentation to prove QC had been performed for two of 16 months as follows: (a) Between 04/04/2021 and 06/01/2021 (b) Between 07/01/2021 and 09/01 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- /2021 (3) The records were reviewed with the technical consultant and laboratory operations director. Both stated on 05/13/2022 at 10:17 am, although the QC had been performed the records had not been maintained. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 12/08/2020. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the director of laboratory operations and the technical consultant at the conclusion of the survey. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the director of laboratory operations and the technical consultant, the laboratory failed to perform maintenance procedures as required by the manufacturer. Findings include: (1) On 12/08/2020 at 10:20 am, the director of laboratory operations stated to the surveyor CBC (Complete Blood Count) testing was performed on the Sysmex XP300 analyzer; (2) The surveyor reviewed the manufacturer's weekly maintenance requirement for the analyzer, as stated on the manufacturer's maintenance log titled "XP-300 Maintenance Log", which was: (a) Clean SRV Tray (3) Maintenance records were reviewed by the surveyor for 11 months (January 2020 through November 2020). The weekly maintenance had not been documented as performed between: (a) 01/23/2020 and 02/03/2020 (b) 06/29/2020 and 07/14/2020 (c) 07/27/2020 and 08/10 /2020 (d) 09/21/2020 and 10/05/2020 (e) 10/26/2020 and 11/10/2020 (4) The surveyor reviewed the records with the director of laboratory operations and the technical consultant. Both stated on 12/08/2020 at 12:15 pm, there was no evidence the above maintenance had been performed as required. 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 D0000 The findings were reviewed with the technical consultant and testing person #1 at the conclusion of the survey. The initial survey was performed on 09/12/18. The laboratory was found to be in compliance with standard-level deficiencies cited. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant and testing person #1, the laboratory failed to thoroughly review and evaluate proficiency testing results. Findings include: (1) At the beginning of the survey, the surveyor reviewed 2018 proficiency testing records and identified the following failure, in which