Scarborough Family Medicine, Llc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 07, 2026. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on maintenance records review and staff interviews, the laboratory failed to perform and document ALL equipment maintenance checks for the Cell-Dyn Emmerald Hematology analyzer as required by the instrument manufacturer every six months in 2024 and 2025. Findings: 1. A review of the Cell-Dyn Emmerald 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 -- Hematology analyzer maintenance logs revealed that intrument calibration was performed once in 2024 (06/27/2024) and once in 2025 (11/07/2025) instead of twice annually. 2. An interview with the laboratory coordinator TP#2 (CMS 209) , at approximately 11:45 AM, in the break review room. confirmed that calibration was performed once annually in 2024 and 2025. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on maintenance document review and interview with staff, the laboratory director failed to ensure that all phases of quality testing (preanalytic, analytic and post analytic) guidelines were followed to identify and fix problems in the laboratory from June 2024 - November 2025 as required by the Clinical Laboratory Improvement Amendments (CLIA). Findings: 1. Quality Assurance (QA) documents review revealed the laboratory director, who is also the technical consultant (TC), failed to ensure ALL monthly maintenace checklists, to identify and fix problems in the laboratory from June 2024 - November 2025, were followed. 2. Bi-annual instrument calibrations for the Cell-Dyn Emmerald Hematology analyzer was done only once in 2024 and once in 2025. 3. An interview with the lab coordinator (TP#2 on form CMS 209) in the break review room on 07/07/2026 at approximately 11:20 AM, confirmed the lab director failed to ensure proper oversight of the laboratory from June 2024 - November 2025. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August 11, 2022.. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on laboratory policy and procedure manual (SOP) review and staff interview, the laboratory failed to establish and follow a policy and procedure to assess Testing Personnel(TP) competency as required for Hematology. The Findings include: 1. SOP document review revealed there was no policy and procedure to assess TP competency available at the time of the survey. 2. During an interview with TP#2 (CMS 209) on August 11, 2022 at approximately 1:15 PM in the breakroom, confirmed the lack of a written policy and procedure for all competencies as required for Hematology. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on August 8, 2019. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (3rd event of 2018 and 2nd event of 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 -- 2019), resulting in the first unsuccessful occurrence for Hematology # 760 and Hematocrit (HCT) # 785. Findings include: Refer to D 2130 D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (3rd event 2018 and 2nd event of 2019), resulting in the first unsuccessful occurrence for Hematology #760 and Hematocrit (HCT) # 785. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed Hematology #760 on Event 3 of 2018 with a score of 70% and Event 2 of 2019 with a score of 78%. Also, the labotatory failed analyte #785 HCT on Event 3 of 2018 with a score of 40% and & Event 2 of 2019 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from American Association of Bioanalyst (AAB)confirmed the laboratory failed Hematology and HCT on Event 3 of 2018 and Event 2 of 2019 resulting in the first unsuccessful performance.. 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (Event 3 of 2018 & Event 2 of 2019), resulting in the first unsuccessful occurrence for Hematology #760 and Hematocrit (HCT), analyte # 785. Findings include: Refer to D 6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (Event 3 of 2018 & Event 2 of 2019), resulting in the first unsuccessful occurrence for Hematology #760 and Hematocrit (HCT), analyte # 785. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed Hematology #760 on Event 3 of 2018 with a score of 70% and Event 2 of 2019 with a score of 78%. Also, the labotatory failed analyte #785 HCT on Event 3 of 2018 with a score of 40% and & Event 2 of 2019 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from American Association of Bioanalyst (AAB)confirmed the laboratory failed Hematology and HCTon Event 3 of 2018 and Event 2 of 2019 resulting in the first unsuccessful performance. -- 3 of 3 --