Medical Specialists Inc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on October 17, 2025. 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: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: A tour of the facility confirmed that the laboratory failed to monitor and document the temperature of locations in which reagents were stored and/ or in use. THE FINDINGS INCLUDE: 1. A tour of the facility revealed that three locations, in which the room temperature was not monitored, with reagents that required specific storage temperature requirements. 2. The facility tour confirmed that at Nurse Testing Station #1 the following agents were stored and/ or in use: a. APTIMA URINE SPECIMEN COLLECTION KIT: STORAGE TEMP REQUIREMENT = 15C - 30C b. BECTON DICKINSON SERUM COLLECTION TUBES - EDTA: STORAGE TEMP REQUIREMENT = 4C - 25C c. BECTON DICKINSON SERUM COLLECTION TUBES - LITHIUM HEP: STORAGE TEMP REQUIREMENT = 4C - 25C d. BECTON DICKINSON SERUM COLLECTION TUBES - PINK: STORAGE TEMP REQUIREMENT = 4C - 25C e. BECTON DICKINSON SERUM COLLECTION 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 -- TUBES - RED: STORAGE TEMP REQUIREMENT = 4C - 25C f. BECTON DICKINSON SERUM COLLECTION TUBES - SST: STORAGE TEMP REQUIREMENT = 4C - 25C g. BECTON DICKINSON URINE CULTURE COLLECTION TUBES - SST: STORAGE TEMP REQUIREMENT = 4C - 25C h. COPAN FLU/ RSV NASAL COLLECTION SWABS: STORAGE TEMP REQUIREMENT = 2C - 30C i. MCKESSON CONSULT hCG COMBO TEST CASSETTES: STORAGE TEMP REQUIREMENT = 15C - 30C j. SIEMANS MULTISTIX 10SG URINALYSIS TEST TRIPS: STORAGE TEMP REQUIREMENT = 15C - 30C k. COPAN FLU/ RSV NASAL COLLECTION SWABS: STORAGE TEMP REQUIREMENT = 2C - 30C 3. A tour of the facility revealed that the Quest Drawing Station had the following reagents stored and/ or in use: a. BECTON DICKINSON SERUM COLLECTION TUBES - EDTA: STORAGE TEMP REQUIREMENT = 4C - 25C b. BECTON DICKINSON SERUM COLLECTION TUBES - GREEN: STORAGE TEMP REQUIREMENT = 4C - 25C c. BECTON DICKINSON SERUM COLLECTION TUBES - PINK: STORAGE TEMP REQUIREMENT = 4C - 25C d. BECTON DICKINSON SERUM COLLECTION TUBES - RED: STORAGE TEMP REQUIREMENT = 4C - 25C e. BECTON DICKINSON SERUM COLLECTION TUBES - SST: STORAGE TEMP REQUIREMENT = 4C - 25C 4. A tour of the facility revealed that the following reagents, in the Reagent Storage Closet, contained the following reagents stored: a. ALFA WASSERMANN SYSTEM DILUENT: STORAGE TEMP REQUIREMENT = 15C - 30C b. ALFA WASSERMAN CAL A REAGENT: STORAGE TEMP REQUIREMENT = 15C - 30C c. APTIMA URINE SPECIMEN COLLECTION KIT: STORAGE TEMP REQUIREMENT = 15C - 30C d. BECKMAN COULTER ACCESS WASH BUFFER II: STORAGE TEMP REQUIREMENT = 15C - 30C e. BECTON DICKINSON SERUM COLLECTION TUBES - EDTA: STORAGE TEMP REQUIREMENT = 4C - 25C f. BECTON DICKINSON SERUM COLLECTION TUBES - RED: STORAGE TEMP REQUIREMENT = 4C - 25C g. COPAN STERILE PLAIN DUAL SWABS: STORAGE TEMP REQUIREMENT = 5C - 25C h. EPENDIA 10% NEUTRAL BUFFERED FORMALIN: STORAGE TEMPERATURE REQUIREMENTS = 15C - 30C 5. An exit interview with the Laboratory Director and the Technical Consultant, on October 17, 2025 at 2:45pm, confirmed the laboratory failed to monitor and document the temperature of areas in which reagents required temperatue monitoring were stored and/or in use. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on May 12, 2025. 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 condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex 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. This CONDITION is not met as evidenced by: Based on review of the CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory proficiency 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 -- testing (PT) participation for Cell Identification (cell ID) in 2024 event 3 and for White Blood Cell Diff (WBC Diff) in 2025 event 1, resulting in an initial unsuccessful participation. Refer to D 2130 D2130 HEMATOLOGY CFR(s): 493.851(f) (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 review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory participation in two consecutive testing events ( 3rd event of 2024 and 1st event of 2025), resulting in an initial unsuccessful participation for Cell ID/WBC Diff. Findings: 1. A review of Casper Report 155 revealed the laboratory failed Cell ID/WBC Diff on the following: 2024 Event 3 Cell ID Score 47% 2025 Event 1 WBC Diff Score 60% 2. A review of the laboratory's API Reports confirmed the laboratory failed Cell ID/WBC Diff with the aforementioned scores. 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 the CMS CASPER 155 report and review of American Proficiency Institute (API) reports, the laboratory director failed to provide overall management and direction for proficiency testing performance. The laboratory director failed to ensure proficiency testing samples were tested as required. 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 the CMS CASPER Report 155 and the American Proficiency Institute (API) 2024 event 3 and 2025 event 1 PT evaluation reports, the laboratory director failed to ensure successful proficiency testing performance in 2 consecutive testing events (2024 event 3 and 2025 event 1), resulting in the initial unsuccessful participation for Cell ID/WBC Diff.. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on April 10, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the Laboratory Freezer Temperature charts for the years 2017, 2018, 2019, and Package Inserts for the Bio-Rad controls, the laboratory was not storing the Bio-Rad controls within the manufacturers required range equal to or less than -20 degrees centigrade. Findings: 1. Review of the Package Inserts for the Bio- Rad controls state that the storage temperature should be equal to or less than -20 degree centigrade. Review of the Laboratory Freezer Temperature charts for 2017, 2018, and 2019 showed that from June to December, 2017, the freezer temperature was documented as being greater than -20 degree centigrade 139 days. In 12 months of 2018, the freezer temperature was documented as being greater than -20 degree centigrade 252 times. The first three months of 2019, the freezer was documented as being greater than -20 degrees centigrade 5 times. 2. Staff interview with the office 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 -- manager and the laboratory supervisor, on Wednesday, April 10, 2019 at approximately 4:45 pm in the conference room, confirmed that the temperature was out of range the aforementioned days for 2017, 2018, and 2019. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of testing personnel(TP) documents and an interview with the office manager and the lab supervisor , the technical consultant (TC) failed to perform semiannual competency on all testing personnel. Findings: 1. Based of review of TP competency documents the TC failed to perform semiannual competency on three of the 19 testing personnel. 2. Interview with the office manager, and the lab supervisor on April 10, 2019 at approximately 4:20pm in the conference room confirmed that the TC failed to perform semiannual competency on three of the 19 testing personnel. -- 2 of 2 --