Sterling Urgent Care

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on an off-site Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded results from the American Proficiency Institute (API), and an interview with the Laboratory Manager on 03/20 /2024 the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events for the subspecialty Endocrinology. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a Proficiency Testing (PT) desk review of the CASPER 0155D report, graded results from the American Proficiency Institute (API), and an interview with the Laboratory Manager on 03/20/2024 the laboratory failed to achieve an overall satisfactory score for two consecutive testing events for the analyte: Thyroid Stimulating Hormone (TSH) The Findings Include: 1. A PT desk review of the laboratories graded 2023 and 2024 results from API revealed that the laboratory failed to achieve satisfactory scores for two consecutive testing events in the subspecialty of Endocrinology for the analyte Thyroid Stimulating Hormone (TSH). Analyte Year Event Score TSH 2023 3 60 TSH 2024 1 60 2. A review of the API PT results from 2023 event 3 and 2024 event 1 revealed the laboratory received scores of 60 for each event respectively for the analyte: TSH 3. A phone interview with the Laboratory Manager at 9:20 AM on 03/20/2024 confirmed the results. -- 2 of 2 --

Summary Statement of Deficiencies D5785

Summary Statement of Deficiencies 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 a record review and an interview with the laboratory lead, the laboratory failed to retain the manufacturer's assay information sheets for quality control testing on the Sysmex pocH 100 hematology analyzer and the Nano Entek Frend analyzer since the last survey on September 6, 2016. Findings: 1. A review of quality control records for the Sysmex and Frend analyzer used to test patient complete blood counts (CBC), thyroid stimulating hormone (TSH), and prostate specific antigen (PSA), revealed the laboratory failed to retain the manufacturer's quality control assay sheets for determination of the acceptable range of results. 2. An interview on June 11, 2018 at 1:45 PM, with the laboratory lead, confirmed the laboratory failed to retain the assay sheets for both the test systems. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- Based on proficiency testing (PT) record review and an interview with the laboratory lead, the laboratory failed to evaluate the thyroid stimulating hormone (TSH) and prostate specific antigen (PSA) scores for the American Association of Bioanalysts (AAB) PT program for 2018 event 1 and 2. Findings: 1. An AAB record review revealed the laboratory failed to evaluate the scores for TSH samples (1, 3, 5) that were assigned an artificial score of 100%. The TSH results were outside the range resulting in an unsatisfactory score for TSH during 2018 event 2. 2. An interview on June 11, 2018 at 9:50 AM, with the laboratory lead, confirmed the laboratory failed to evaluate the PT scores. 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 proficiency testing (PT) record review and an interview with the laboratory lead, the laboratory failed to document the evaluation and