Med Science Center Inc

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on September 2 2026, 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 American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) records (2025-3 and 2026-2), the laboratory failed to 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 -- successfully participate in a proficiency testing 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 Ferritin analyte 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 American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) report, the laboratory failed to achieve satisfactory performance for two out of three consecutive events (2025-3 and 2026-2) for the analyte Ferritin (specialty Chemistry): The findings include: 1. Ferritin 60% - 2025 third testing event; Ferritin 0% - 2026 second testing event. A review of the 2025 & 2026 scores from American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) 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 American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) records for 2025-3 and 2026-2 events, the laboratory director failed to provide overall management and direction of the laboratory services to ensure successful participation of the proficiency testing. 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 American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) records for 2025-3 and 2026-2 events, the laboratory director failed to ensure successful proficiency testing participation as required in this subpart. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on the surveyor's review of the American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records, CASPER Report 0155D, and interviews with the laboratory director (LD), testing personnel (TP) and technical consultant (TC) on August 11, 2026, the laboratory failed to attain an overall testing event score of at least 80 percent in Bacteriology for the third event of 2024 (Q3-2024) and third event of 2025 (Q3-2025). The findings include: 1. The laboratory was enrolled under AAB-MLE PT program and obtained an unsatisfactory scores of 77% during the Q3-2024 and 79% for Q3-2025 events for the Bacteriology subspecialty. This was further verified using the CASPER 0155D Individual Laboratory Profile report. 2. During an interview on August 11, 2026, at approximately 9:00 a.m., the LD, TP and TC confirmed that the laboratory obtained unsatisfactory scores for the Q3-2024 and Q3-2025 events due to the scores received under Antibiotic susceptibility testing. 3. According to the laboratory's testing declaration submitted at the time of the survey, the laboratory tested and reported approximately 10,000 patient tests annually for Bacteriology subspecialty during the time the unsatisfactory scores were obtained. . D2066 SYPHILIS SEROLOGY CFR(s): 493.835(a) (a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of the American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records, CASPER 0155 report and an interview with the laboratory director (LD), technical consultant (TC) and testing personnel (TP) on August 11, 2026, the laboratory failed to attain at least 80 percent of the acceptable score in the subspecialty of Syphilis Serology for the second event of 2025 (Q2-2025). The findings include: 1. The surveyor reviewed the laboratory's PT records wherein AAB-MLE reported an unsatisfactory score of 20% for the Syphilis Serology subspecialty for the Q2-2025 event. This was further verified from the CASPER 0155 report. 2. During an interview on August 11, 2026, at approximately 9:00 a.m., the LD, TC, and TP confirmed that the laboratory obtained the 20% unsatisfactory score for Syphilis Serology during the Q2-2025 event. 3. According to the laboratory's testing declaration submitted on the day of the survey, the laboratory performed approximately 1,000 patient test samples for Syphilis Serology subspecialty annually including the time the laboratory received unsatisfactory proficiency testing scores. . D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records and interviews with the laboratory director (LD), technical consultant (TC) and testing personnel (TP) on August 11, 2026, the laboratory failed to attain a score of at least 80 percent of acceptable responses for the Infectious Mononucleosis test during the second event of 2025 (Q2-2025). The findings include: 1. The laboratory participated in the AAB-MLE PT program and obtained an unsatisfactory score of 0% for the Infectious Mononucleosis test during the Q2-2025 event. 2. The LD, TC and TP confirmed by an interview on August 11, 2026, at approximately 9:00 a.m. that the laboratory received the unsatisfactory PT scores for the Infectious Mononucleosis test during the Q2-2025 event. 3. According to the testing declaration form submitted at the time of survey, the laboratory tested and reported approximately 22,000 General Immunology patient test samples annually including Infectious Mononucleosis test during the time when unsatisfactory scores were obtained. . D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) -- 2 of 5 -- documentation, CASPER 0155D Individual Laboratory Profile report, and interviews with the laboratory director (LD), testing personnel (TP) and technical consultant (TC) on August 11, 2026, the laboratory failed to attain at least 80 percent acceptable responses for the Alkaline Phosphatase (ALP) and Carbon Dioxide (CO2) analytes during the third event of 2025 (Q3-2025) and Iron during the first event of 2026 (Q1- 2026). The findings include: 1. The surveyor reviewed the AAB-MLE PT documentation and found that the laboratory obtained unsatisfactory scores of the following: a. 0% ALP analyte during the Q3-2025 event; b. 0% CO2 analyte during the Q3-2025 event; c. 60% Iron analyte during the Q1-2026 event. The scores were verified using the CASPER 0155D Individual Laboratory profile report. 2. During an interview on August 11, 2026, at approximately 9:00 a.m., the LD, TP and TC confirmed that the laboratory obtained unsatisfactory scores for ALP and CO2 analytes in the Q3-2025 event and Iron analytes in the Q1-2026 event. 3. According to the laboratory's testing declaration form (Lab-144) submitted at the time of survey, the laboratory performed and reported approximately 300,000 patient samples annually for Routine Chemistry that included the ALP, CO2 and Iron analytes including the time when the laboratory obtained unsatisfactory scores. . D2098 ENDOCRINOLOGY CFR(s): 493.843(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records and interviews with the laboratory director (LD), technical consultant (TC) and Testing Personnel on August 11, 2026, the laboratory failed to attain at least 80 percent of the acceptable score in Endocrinology for the CA125 analyte during the first event of 2025 (Q1- 2025) and Thyroid-Stimulating Hormone (TSH) analyte for the first event of 2026 (Q1-2026). The findings include: 1. The surveyor reviewed the AAB-MLE PT performance evaluation documentation and found that the laboratory obtained an unsatisfactory score of 40% for the CA125 analyte in Q1-2025 event and 40% TSH analyte during the Q1-2026. The report is as follows: 2. The LD, TC and TP confirmed by an interview on August 11, 2026, at approximately 9:00 a.m. that the laboratory obtained unsatisfactory PT scores for the CA125 analyte during the Q1- 2025 event and TSH analyte during the Q1-2026 event. 3. According to the laboratory's testing declaration, the facility performed and reported approximately 26,000 Endocrinology patient test samples-including CA125 and TSH analytes annually, during the period when the laboratory received unsatisfactory proficiency testing scores. . 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. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's competency assessment policy and procedure, eight patient records from August 1, 2024 to May 15, 2026, lack of personnel competency documentation, and an interview with the laboratory director on August 11, 2026, as specified in the personnel requirements in subpart M, the laboratory failed to follow the written personnel competency assessment policy and procedure. The findings include: 1. The laboratory's policy and procedure for testing personnel competency assessment aligned with CLIA requirements but was not followed. 2. Record review showed that the testing personnel lacked competency assessment documentation prior to testing the eight patient samples from August 1, 2024 to May 15, 2026. Specimen ID Date Tested 937564 08/01/2024 01004333 02/18 /2025 1019954 05/06/2025 1020774 06/01/2025 01014041 11/12/2025 01012867 10 /10/2025 10168869 02/06/2026 01020272 05/15/2026 3. During an interview on August 11, 2026, at approximately 11:06 a.m., the laboratory director confirmed that the laboratory failed to conduct and document the annual competencies of all testing personnel for the years 2024, 2025, and 2026. 4. No

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 --