Summary:
Summary Statement of Deficiencies 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: Through review of quality control (QC) results for October 2020, March 2021 and June 2021, lack of documentation, review of patient results and interview it was determined that the laboratory failed to document successful QC result prior to reporting complete blood count (CBC) patient results on four of ninety-two days reviewed. Findings follow: A) Review of QC results for CBC testing in October 2020 revealed that no QC results were presented for 10/22/20 through 10/26/20 inclusive. B) Upon request, the laboratory was unable to provide QC results for CBC testing for 10/22/20 through 10/26/20. C) Review of patient results revealed that CBC tests were performed and resulted on seventeen patients, identified as numbers one through seventeen on a separate patient identification list, between 10/22/20 and 10/26.20. D) In an interview on 8/24/21 at 01:00 PM the laboratory staff member, identified as number three on the CMS 209 form, confirmed that QC results for CBC testing were not available on the dates identified above and "it doesn't look like they were done". 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 --