Medical Center, Llp, The

Summary Statement of Deficiencies D0000 A recertification survey was performed on , February 25, 2025. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. 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: Based on review of the Temperature charts for 2023- 2024 and staff interview, the laboratory failed to monitor the temperature for one month out of 2023, and three months of 2024. The temperature range for the HiSense Refrigerator is 34 to 46 degrees Fahrenheit or 2 to 8 degrees Celsius. Findings 1. Review of the temperature charts for June 2023 for the HiSense Refrigerator confirmed that the temperature was recorded and was out of range 24 out of 27 days, with no

Summary Statement of Deficiencies D0000 A recertification survey was performed on January 31, 2023. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on observation during the lab tour, review of manufacturer insert, and staff interview, the laboratory was not following the manufacturer instructions for the placement of the tube rack, used to perform the Globe Scientific, INC., Sedi-Rate E.S. R. system (ESR), Erythrocyte Sedimentation Rate waived test. Findings: 1. During the tour of the laboratory, it was observed that the rack used to hold the Westergren E.S. R. tubes, in the performance of testing was sitting on the counter beside a centrifuge. There was a patient sample in the rack as the centrifuge was spinning, causing the patient sample to vibrate. 2. Review of the package insert for the ESR test, the manufacturer states: "PRECAUTION: The rack and test unit must remain vertical in an area free from vibrations, drafts, and direct sunlight. NOTE: To ensure a completely level testing surface, use out acrylic leveling platform in conjunction with the appropriate rack." 3. Interview with the Technical Consultant and the laboratory supervisor, on 01/31/2023, at approximately 10:30 am in the laboratory, confirmed the aforementioned statements. It was also confirmed that the 956 samples that were resulted over the last 12 months for the ESR testing, were not validated as accurate, there was no Quality Control performed each day of patient 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 1 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on April 6, 2022. 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 (2nd event of 2021 and 1st 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 -- 2022), resulting in the first unsuccessful occurrence for Endocrinology # 525 including: Free Thyroxine (Free TY) #545. Findings include: Refer to D 2099 D2099 ENDOCRINOLOGY CFR(s): 493.843(b) 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 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 events (2nd event of 2021 and 1st event of 2022), resulting in the first unsuccessful performance for Free thyroxine analyte # 545. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte # 545 Free Thyroxine on event 2 of 2021 with a score of 0% and event 1 of 2022 with a score of 40%. 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed Free thyroxine on Event 2 of 2021 and event 1 of 2022 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 (2nd event of 2021 and 1 event of 2022), resulting in the first unsuccessful occurrence for Free Thyroxine (Free TY, analyte # 545. 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; 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 -- 2 of 3 -- proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (2nd event of 2021and 1st event of 2022), resulting in the first unsuccessful occurrence for Free Thyroxine (Free TY), analyte # 545. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #545 , Free TY on event 2 of 2021 with a score of 0% and event 1 of 2022 with a score of 40%. 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed Free TY on Event 2 of 2021 and 1 of 2022, resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on February 23, 2021. 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: 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 American Proficiency Institute, (API) proficiency testing (PT) provider, the laboratory failed to participate and score successfully in several events in 2019 and 2020, and failed to provide evidence that steps have been taken to correct the problem identified by the unsuccessful PT performance. Reference: D6019 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 -- D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on October 25, 2018. 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: D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on October 3, 2018. 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 American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in five of nine consecutive events ( 3rd 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 -- event of 2015, 3rd event of 2016, 1st event of 2017 and 1st and 2nd events of 2018), resulting in subsequent unsuccessful occurrence for cholesterol, analyte # 375, failed to maintain satisfactory performance in four of six consecutive events ( 3rd event of 2016, 2nd event of 2017 and 1st and 2nd events of 2018), resulting in subsequent unsuccessful occurrence for glucose, analyte # 415 and failed to maintain satisfactory performance in three of nine consecutive events ( event 3 of 2015, event 2 of 2016 and event 2 of 2018) resulting in subsequent unsuccessful occurrence for calcium, analyte # 345. Findings include: Refer to D 2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in five of nine consecutive events (3rd event of 2015, 3rd event of 2016, 1st event of 2017 and 1st and 2nd events of 2018), resulting in subsequent unsuccessful occurrence for cholesterol, analyte # 375, failed to maintain satisfactory performance in four of six consecutive events ( 3rd event of 2016, 2nd event of 2017 and 1st and 2nd events of 2018), resulting in subsequent unsuccessful occurrence for glucose, analyte # 415 and failed to maintain satisfactory performance in three of nine consecutive events ( event 3 of 2015, event 2 of 2016 and event 2 of 2018) resulting in subsequent unsuccessful occurrence for calcium, analyte # 345. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed cholesterol analyte # 375 , on event 3 of 2015 with a score of 0%, event 3 of 2016 with a score of 0%, event 1 of 2017 with a score of 60%, event 1 of 2018 with a score of 20% and event 2 of 2018 with a score of 20%. 2. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed glucose, analyte #415 , on event 3 of 2016 with a score of 0%, event 2 of 2017 with a score of 40%, event 1 of 2018 with a score of 40% and event 2 of 2018 with a score of 0%. 3. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed calcium, analyte #345 , on event 3 of 2015 with a score of 40%, event 2 of 2016 with a score of 20%, and event 2 of 2018 with a score of 60%. 4. Desk review of the laboratory's proficiency testing reports from API confirmed the laboratory failed cholesterol , glucose and calcium on the events and with scores listed above resulting in subsequent unsuccessful performance for the three analytes. 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 an in-office desk review of proficiency testing records, the laboratory -- 2 of 3 -- director failed to ensure the laboratory successfully participated in five of nine consecutive PT testing events in the speciality of Routine Chemistry for analyte # 365, cholesterol, four of six consecutive testing events for analyte # 415, glucose and three of nine consecutive testing events for analyte #345, calcium. Findings include: 1. Review of PT records and reports revealed the laboratory failed cholesterol on five of nine consecutive testing events: event 3 of 2015, event 3 of 2016, event 1 of 2017 and events 1 and 2 of 2018, failed glucose on four of six consecutive events: event 3 of 2016, event 2 of 2017 and events 1 and 2 of 2018 and failed calcium on three of nine consecutive events: event 3 of 2015, event 2 of 2016 and event 2 of 2018. Also 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; This STANDARD is not met as evidenced by: Based on an in-office desk review of proficiency testing records, the laboratory director failed to ensure the laboratory successfully participated in five of nine consecutive PT testing events in the speciality of Routine Chemistry for analyte # 365, cholesterol, four of six consecutive testing events for analyte # 415, glucose and three of nine consecutive testing events for analyte #345, calcium. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed cholesterol analyte # 375 , on event 3 of 2015 with a score of 0%, event 3 of 2016 with a score of 0%, event 1 of 2017 with a score of 60%, event 1 of 2018 with a score of 20% and event 2 of 2018 with a score of 20%. 2. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed glucose, analyte #415 , on event 3 of 2016 with a score of 0%, event 2 of 2017 with a score of 40%, event 1 of 2018 with a score of 40% and event 2 of 2018 with a score of 0%. 3. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed calcium, analyte #345 , on event 3 of 2015 with a score of 40%, event 2 of 2016 with a score of 20%,and event 2 of 2018 with a score of 60%. 4. Desk review of the laboratory's proficiency testing reports from API confirmed the laboratory failed cholesterol , glucose and calcium on the events and with scores listed above resulting in subsequent unsuccessful performance for the three analytes. -- 3 of 3 --