Smh Sameday Health & Imaging

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: Based on review of the laboratory's individualized quality control plans (IQCP) and staff interview, the laboratory failed to have a system in place to evaluate the effectiveness of 3 out of 3 IQCPs (HemoCue, Piccolo Express, iSTAT) reviewed. The findings were: 1. Review of the laboratory's records showed an IQCP had been developed for the HemoCue analyzer which was last reviewed on 11/28/22; the IQCP for the Piccolo Express was put into effect on 3/1/24; and the IQCP for the iSTAT was approved on 12/2/24; however, the quality assessment plan for the IQCPs failed to include a method for how often the effectiveness of the IQCPs were to be evaluated. 2. Interview with the technical consultant on 12/17/24 at 10:28 AM revealed an evaluation of the IQCPs should occur on an annual basis. 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 D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation, review of the SARS-CoV-2 patient testing log, and staff interview, the laboratory failed to report 1,467 SARS-CoV-2 negative patient test results from 5/1/22 through 11/29/22. The findings were: 1. Observation of the laboratory showed testing for SARS-CoV-2 was performed using the Roche Cobas Liat and the Cue Covid-19 molecular test systems. 2. Review of the laboratory's SARS-CoV-2 patient testing log showed the laboratory performed a total of 2,094 molecular SARS-CoV-2 patient tests with 1,467 negative patient results. 3. Interview with the technical consultant on 11/29/22 at 3:30 PM confirmed the laboratory did not report the SARS-CoV-2 negative patient test results to the State Public Health Laboratory. 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 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 lack of documentation and staff interview, the labortory failed to have a written procedure for reporting SARS-CoV-2 positive and negative test results. The findings were: 1. Review of the laboratory's procedure manuals showed no evidence the laboratory had developed a policy and procedure for reporting SARS-CoV-2 positive and negative test results to the appropriate agencies. 2. Interview with the technical consultant and lead testing personnel on 7/22/21 at 11:30 AM confirmed the laboratory did not have a written procedure for reporting SARS-CoV-2 test results. 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)