Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at MD Express Urgent Care on April 28, 2026 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. MD Express Urgent Care was not in compliance with the applicable Conditions and Standards under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and includes the following Conditions under 42 CFR part 493 CLIA Regulation: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing], D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This CONDITION is not met as evidenced by: Based on a review of the Center for Medicaid and Medicare Services CASPER 0155 report, the laboratory's proficiency testing records and interviews, the laboratory failed to successfully participate within the Chemistry specialty for the Creatine kinase (CK) analyte. The laboratory had unsatisfactory CK scores for the third event of 2025 and first event of calendar year 2026. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) 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 review of the Center for Medicaid and Medicare Services CASPER 0155 report (CMS 0155), Proficiency Testing (PT) records, and interview, the laboratory failed to attain a score of at least 80% for the analyte Creatine kinase (CK) for two (2) consecutive chemistry module testing events resulting in an initial unsuccessful PT performance as reviewed on the date of the inspection on April 28, 2026 (review timeframe January 2024 through March 2026). The findings include: 1. A pre-survey review of the CMS 0155 report revealed the laboratory received an unsatisfactory score of 60% for the regulated analyte #0395, CK, in the 2025 Chemistry-1st Event and an unsatisfactory score of 40% in the 2026 Chemistry-1st Event. 2. Review of the laboratory's Medical Laboratory Evaluation (MLE) PT evaluations on April 28, 2026 revealed CK scores of less than 80% for the following 2 consecutive hematology PT events: MLE 2025 Chemistry Event 3: CK scored 60% ; MLE 2026 Chemistry Event 1: CK scored 40%; resulting in an initial unsuccessful PT performance. 3. In an interview with the Laboratory Coordinator on April 28, 2026 at 1:25 PM, the above findings were confirmed. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, proficiency testing records, and interview, the laboratory director failed to provide overall direction and management of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of the CASPER 0155 report, proficiency testing (PT) records, and interview, the laboratory director (LD) failed to ensure the overall quality of the laboratory services provided. The LD failed to ensure successful participation in the laboratory's Health and Human Services (HHS) approved PT program. Refer to D2096. -- 3 of 3 --