Ghc East Clinic

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on surveyor review of Certification and Surveyor Provider Enhanced Reporting (CASPER) records and proficiency testing (PT) records and interview with the Technical Consultant, the laboratory did not report proficiency test results to Health and Human Services (HHS) for testing performed with the Quidel QuickVue Strep A Plus, a moderately complex regulated test system, for four of the last four PT events since July 2023. Findings include: 1. Review of the CASPER report 0155D (Individual Laboratory Profile) for this laboratory created on October 29, 2024, showed no Bacteriology proficiency testing data after event three in 2021. 2. Review of the laboratory's PT records from 2023 and 2024 showed the laboratory reported the QuickVue Dipstick as the test method used for Streptococcus testing to API (American Proficiency Institute). The API report identified the QuickVue Dipstick as a waived test. The records showed the laboratory tested the samples for event 2 in 2023 in June 2023. 3. Interview with the Technical Consultant on November 12, 2024, at 9:05 AM revealed the laboratory used the Quidel Quick Vue Strep A Plus test system starting in July 2023 and confirmed the test method was moderately complex. Further interview confirmed the laboratory performed PT Streptococcus testing in event three in 2023 and the three events in 2024 with the Quick Strep A Plus test but did not correct their report to API to reflect the use of a moderately complex regulated test system and confirmed results were not reported to HHS. 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 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 surveyor review of laboratory quality control procedures and records and interview with the technical consultant, the laboratory did not follow their procedures to test two levels of external quality control material when they opened a new lot number of the OSOM Mono test on March 1, 2021 or prior to testing a patient sample on March 12, 2021. Findings include: 1. Review of the laboratory's Individualized Quality Control Plan showed the laboratory required testing two levels of external control material (one positive and one negative) with each new lot number of OSOM Mono test kits prior to testing patient samples. 2. Review of electronic quality records showed OSOM Mono lot E201070 expired February 28, 2021 and the system started lot E201268 on March 1, 2021. Electronic quality control records showed the laboratory first tested external quality control samples on lot E201268 on March 26, 2021. 3. Review of test records showed the laboratory tested one patient (patient 1) on March 12, 2021. 4. Interview with the technical consultant on April 19, 2021 at 11:37 AM confirmed the laboratory records showed the laboratory had not tested two levels of external quality control material with OSOM Mono test lot E201268 prior to performing an OSOM Mono test on patient 1 on March 12, 2021. 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 --