All Family Medicine Pc

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on July 17, 2025, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation. D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity. 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 review of Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D) and American Proficiency Institute (API) PT summary reports, the 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 -- laboratory failed to successfully participate in the CMS approved PT program for two of three consecutive testing events in the Endocrinology subspecialty for the Free Thyroxine (TY) test analyte in 2024 and 2025 resulting in unsuccessful performance. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 CMS PT CASPER 0155D and API PT summary reports from 2024 and 2025, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events for the subspecialty Endocrinology in the analyte Free TY. FINDINGS: a. A review of the CASPER 155 report revealed the following unsatisfactory scores: 1. Free TY Test Analyte: 2024 Third Event = 60% 2025 Second Event = 0% b. A review of the PT scores from API (2024 and 2025) confirmed the above findings. 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 review of CMS PT CASPER 0155D and API PT summary reports from 2024 and 2025, the laboratory director (LD) failed to provide overall management and direction 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; This STANDARD is not met as evidenced by: Based on review of CMS PT CASPER 0155D and API PT 2024-3 and 2025-2 summary reports, the LD failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2107. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on the surveyor's review of American Proficiency Institute (API) Proficiency Testing (PT) reports and an interview with the technical consultant/testing person, the laboratory failed to evaluate, perform and document remedial action for the PT scores of less than 100% for the following analytes: 2018 second event: UIBC = 60% 2018 first event: Total Calcium = 80% 2017 first event: Vit D = 0% D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a lack of policies and procedures and confirmed in an interview with the technical consultant/testing person at the time of this survey, the laboratory failed to establish and follow a written Quality Assessment (QA) policy and procedure for an ongoing mechanism to monitor, assess, and when indicated correct problems that may occur in the laboratory testing. PLEASE NOTE: THIS IS A RECITED DEFICIENCY FROM THE SURVEY CONDUCTED ON JANUARY 31, 2017. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (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 a surveyor's review of the laboratory's calibration verification records and an interview with the technical consultant/testing person, the laboratory failed to perform calibration verification at least once every six months for all chemistry analytes on the AMS Liasys 450 analyzer. FINDINGS: 1. The calibrators for the analytes, tested on the AMS Liasys 450 analyzer have fewer than three points, therefore, the laboratory is required to perform calibration verification every six months. 2. At approximately 11: 00 AM on August 7, 2018, the technical consultant/testing person confirmed that the documentation of the calibration verification available for review was for calibration verification performed on 3/22/17 and 10/14/17. 3. The AMS Liasys 450 analyzer was out of calibration from 4/15/18 through the survey date. 4. Approximately 500 patient specimens were tested and reported for chemistry analytes when the AMS Liasys 450 analyzer was out of calibration verification. 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 surveyor's findings and confirmed in an interview with the office manager, the laboratory director failed to provide overall management of the laboratory. The laboratory director failed to ensure that the laboratory: 1. Maintained the