Med Science Center Inc

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 11/20/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful [proficiency testing] participation; and 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. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and AAB-Medical Laboratory Evaluation records (2025-2 and 2025-3), the laboratory failed to successfully participate in a proficiency testing 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 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the analyte Cholesterol, Low Density resulting in unsuccessful performances. See 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB-Medical Laboratory Evaluation Report, the laboratory failed to achieve satisfactory performances for two of three consecutive events (2025-2 and 2025-3) for the analyte Cholesterol, Low Density Lipoprotein: The finding include: Cholesterol, Low Density Lipoprotein, 60% - 2025 second testing event; Cholesterol, Low Density Lipoprotein, 0% - 2025 third testing event; A review of the 2025 scores from AAB-Medical Laboratory Evaluation 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 a proficiency testing desk review of the CASPER 0155D report and AAB- Medical Laboratory Evaluation records for 2025-2 and 2025-3 events, the laboratory director 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 a proficiency testing desk review of the CASPER 0155D report and AAB- Medical Laboratory Evaluation records for 2025-2 and 2025-3 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, random patient sample, quality control (QC) and proficiency testing (PT) records for the years of 2019 and 2020, and interview with the laboratory director on January 13, 2021 at 2:05 pm, the laboratory failed to test the proficiency testing samples the same number of times that it routinely tests patient samples at 1 testing event out of 1 event, reviewed. The findings include: 1. The laboratory tested 5 CAP Q1-2020 BMP/CMP samples first at 18:48 on 2/14/2020 and then again at 19:29 on the same day using the automated device number 4053200. However, it routinely tests the patient sample only one time unless the results fall within the repeat criteria. 2. The laboratory director on January 13, 2021 at 2:05 pm, affirmed that the laboratory tested the PT samples 2 times. 3. The laboratory's testing declaration form, signed by the laboratory Director on 1/7 /2021, stated that the laboratory performs 276,000 tests in routine chemistry, annually. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's random patient samples test order records for the years of 2019 and 2020, and interview with the laboratory director on January 13, 2021 at 2:35 pm, the laboratory failed to document the date and time it received 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 -- specimens for 1 patient out of 1 sample, reviewed. The findings include: 1. The laboratory received a patient sample that was collected on 12/30/2020, accession number 00931856 with a test order form. However, the laboratory did not document the date and time it received the specimen. 2. The laboratory director on January 13, 2021 at 2:35 pm, affirmed that the laboratory did not document the date and time it received the specimen. 3. The laboratory's testing declaration form, signed by the laboratory Director on 1/7/2021, stated that the laboratory performs approximately 426,000 tests, annually. 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; This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy and procedure, PT records for the years of 2019 and 2020, and interview with the laboratory director on January 13, 2021 at 2:05 pm, the laboratory director failed to ensure that the proficiency testing samples are tested as required under subpart H of this part for 1 PT event out of 1 event, reviewed. The findings include: See D2010. -- 2 of 2 --