Statmed Quick Quality Clinic At North Pinellas

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Statmed Quick Quality Clinic at North Pinellas on 10/02/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D2000 493.801 Condition: Enrollment and Testing of Proficiency Samples D6000 493.1403 Condition: Moderate Complexity Laboratory Director D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and interview, the Hematology proficiency samples failed to be examined or tested by personnel who routinely perform the testing in the laboratory from 2nd 2024 Hematology event to 2nd 2025 Hematology event. (See D2007) D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview, the Hematology proficiency samples failed to be examined or tested by personnel who routinely perform the testing in the laboratory from 2nd 2024 Hematology event to 2nd 2025 Hematology event. This is a repeat citation from the 11/27/2023 recertification survey. Findings included: 1. The CMS-209 Laboratory Personnel Report signed by the Laboratory Director on 10/2 /2025 listed four Testing Personnel (TP-A, TP-B, TP-C, and TP-D). 2. The accepted

Summary Statement of Deficiencies D0000 An announced onsite CLIA recertification survey was conducted at Statmed Quick Quality at North Pinellas on 11/27/23. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the Laboratory Personnel Report, the laboratory procedure manual, proficiency testing (PT) records and staff interview, the laboratory failed to have three (#D, #E, #F) of four testing personnel (#C - #F) rotate through performance of PT in the specialty of Chemistry Core for six out of six events (2022 1st, 2nd, 3rd and 2023 1st, 2nd, and 3rd) and Hematology/Coagulation for 4 out of 4 events (2022 1st, 2nd and 2023 1st and 2nd) for 2 out of 2 years reviewed (2022-2023). Findings included: Record review of the CMS 209 form, Laboratory Personnel Report, signed by the Laboratory Director on 11/25/2023 showed the laboratory had 4 testing personnel (#C, #D, #E, and #F). Record review of the Laboratory Proficiency Testing procedure (signed by the Laboratory Director on 10/06/21) revealed "The Proficiency Testing event should be assigned to the testing personnel, rotating personnel to assess competency." Review of the PT records from American Proficiency Institute (API) showed all PT attestation forms were signed by Testing Person #C as the "Person Performing Test" for Chemistry Core for 2022 1st, 2nd, 3rd and 2023 1st, 2nd, and 3rd events and Hematology/Coagulation for 2022 1st, 2nd and 2023 1st and 2nd events. No attestation forms for Testing Person #D, #E, and #F were present. On 11/27 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 -- /23 at 11:00 AM, the Technical Consultant confirmed that the laboratory had not been rotating testing personnel to perform Chemistry Core and Hematology/Coagulation proficiency testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 09/08/21 to 09/14/21 at Statmed Quick Quality Clinic at North Pinellas. The laboratory was not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. Based on the survey findings, an Immediate Jeopardy situation was identified and the laboratory was notified at 12:30 PM on 09/11/21. The laboratory failed to ensure the correct specimen type was used in accordance with manufacturer's instructions for the iSTAT chemistry analyzer (See D5411) and failed to perform 2 levels of quality control prior to patients being reported on three of three moderately complex analyzers (D5441). The following Conditions were not met: D2016-Successful Participation 493.803(a)(b) (c) D5400-Analytic Systems 493.1250 D6000-Moderate Complexity Laboratory Director 493.1403 D6033-Technical Consultant Moderately Complexity 493.1409 D6063-Laboratory Testing Personnel 493.1421 D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory staff, the laboratory failed to sign and retain American Proficiency Institute (API) Proficiency Testing (PT) Attestation forms for 6 out of 6 testing events in 2020 and 4 out of 4 testing events in 2021. Findings included: Record review of API PT documents revealed that no signed Attestation forms were retained for: Hematology/ Coagulation Testing Event 1 - 2020 Chemistry Testing Event 1 - 2020 Hematology/ Coagulation Testing Event 2 - 2020 Chemistry Testing Event 2 - 2020 Hematology/ Coagulation Testing Event 3 - 2020 Chemistry Testing Event 3 - 2020 Hematology/ Coagulation Testing Event 1 - 2021 Chemistry Testing Event 1 - 2021 Hematology/ Coagulation Testing Event 2 - 2021 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 19 -- Chemistry Testing Event 2 - 2021 Interview on 09/08/21 at 4:30 PM with Testing Personnel #B confirmed there were no signed Attestation forms retained for the proficiency testing events in 2020 and 2021. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain all raw data of analyzer print outs for American Proficiency Institute (API) proficiency testing (PT) results for two of two years reviewed (2020 and 2021). Findings included: Record review of PT documents revealed no direct analyzer print outs were retained for the specialty of Hematology for two of the three testing events in 2020 and two of the two testing events in 2021. For the specialty of Chemistry, no direct analyzer print outs were retained for any of the testing events in 2020 or 2021. Interview 09/08/21 at 4:30 PM with Testing Personnel #B confirmed raw data was not retained for Hematology and Chemistry PT testing events in 2020 and 2021. 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 American Proficiency Institute (API) proficiency testing (PT) -- 2 of 19 -- results and staff interview, the lab had two out of three consecutive unsuccessful testing events for Erythrocyte count, Hematocrit, Hemoglobin, Leukocyte Count, Platelet Count, White Blood Cell Differential, Lymphocytes, Monocytes/Mixed, Neutrophil/Granulocyte, in the specialty of Hematology of 2 (2020 and 2021) out of 2 years reviewed (See D2130). D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 record review of American Proficiency Institute (API) proficiency testing results and interview with laboratory staff, the laboratory failed to attain a score of at least 80 percent of acceptable responses for Creatinine Kinase in the specialty of Chemistry. Findings included: Review of American Proficiency Institute (API) proficiency testing results revealed unsuccessful scores for the first testing event in 2020 Creatinine Kinase, Isoenzyme at 20%. Interview on 09/08/21 at 5:15 PM with Testing Personnel #B confirmed the proficiency testing failures. D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on record review of American Proficiency Institute (API) proficiency testing (PT) results and interview with laboratory staff, the lab failed to submit PT results within the time frame specified for the 3rd testing event of 2020 for the specialty Hematology, resulting in a score of 0% for all Hematology analytes. Findings included: Record review of API Hematology 3rd testing event of 2020, revealed a 0% score for Erythrocyte Count, Hematocrit, Hemoglobin, Leukocyte Count, Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin Concentration (MCHC), Mean Corpuscular Volume (MCV), Mean Platelet Volume (MPV), Platelet Count, Red Cell Distribution Width, White Blood Cell Count, Lymphocytes, Monocytes/Mixed, and Neutrophil/Granulocytes. There was no documentation of the review of results compared with the peer results from API or any

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on May 12, 2021 for Statmed Quick Quality Clinic. The Statmed Quick Quality Clinic laboratory is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. 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 laboratory's proficiency testing records for 2020 and 2021, the laboratory did not have successful performance in proficiency testing in the specialty of hematoloty. Refer to D2130. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers 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 -- for Medicare & Medicaid Services (CMS) 153 and 155 reports, on May 12, 2021 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analytes, white blood cell count (WBC), red blood cell count )RBC), hemoglobin (HGB), hematocrit (HCT), platelet count (PLT), and the white blood cell differential (WBC Diff) for two out of three testing events in 2020 and 2021. D2130 HEMATOLOGY CFR(s): 493.851(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 the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the specialty of hematology. Findings include: On May 12, 2021 on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analytes, white blood cell count (WBC), red blood cell count (RBC), hemoglobin (HGB), hematocrit (HCT), platelet count (PLT), and the white blood cell differential (WBC Diff), as shown below. Event #3, 2020 WBC-0% RBC- 0% HGB-0% HCT-0% PLT-0% WBC diff-0% Event #1, 2021 WBC-60% RBC-60% HGB-60% HCT-60% PLT-60% WBC diff-60% 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 the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the specialty of hematology. Findings include: On May 12, 2021 on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for the analytes, white blood cell count (WBC), red blood cell count (RBC), hemoglobin (HGB), hematocrit (HCT), platelet count (PLT), and the white blood cell differential (WBC Diff), in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2130. 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 -- 2 of 3 -- 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 the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing in the specialty of hematology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on May 12, 2021 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores for two out of three testing events as shown below. Event #3, 2020 WBC-0% RBC-0% HGB-0% HCT-0% PLT-0% WBC diff-0% Event #1, 2021 WBC-60% RBC-60% HGB-60% HCT-60% PLT-60% WBC diff-60% -- 3 of 3 --

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on January 25, 2021 for Statmed Quick Quality Clinic At North Pinellas. The Statmed Quick Quality Clinic At North Pinellas laboratory is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. 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 laboratory's proficiency testing records for 2019 and 2020, the laboratory did not have successful performance in proficiency testing for the specialty of hematology. Refer to D2130. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers 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 -- for Medicare & Medicaid Services (CMS) 153 and 155 reports, on January 25, 2021 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, hemoglobin for two out of three testing events in 2020. D2130 HEMATOLOGY CFR(s): 493.851(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 the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the specialty of hematology. Findings include: On January 25, 2021 on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, hemoglobin, as shown below. Event #1, 2020 hemoglobin-40% Event #3, 2020 hemoglobin-0% 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 the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the specialty of hematology. Findings include: On January 25, 2021 on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for the analyte, hemoglobin, in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2130. 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 the review of the laboratory's proficiency testing scores, the laboratory -- 2 of 3 -- director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for the analyte, hemoglobin in the specialty of hematology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on January 25, 2021 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #1, 2020 hemoglobin-40% Event #3, 2020 hemoglobin-0%. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Statmed Quick Quality Clinic at North Pinellas on 05/13/19. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D6063- Laboratory Testing Personnel 493.1421 D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with Testing Person #B the laboratory failed to establish their own QC (quality control) target values for each new lot number for 2 out of 2 years (2017-2019) reviewed for the CBC (Complete Blood Count) analyzer. Findings Included: Review of the CBC controls manufacturer's instructions (Revision 13) revealed that "Assay means are not intended for use as analyzer QC file target values. For effective QC, each laboratory should set its own target values. Sysmex recommends that laboratories establish their own QC target values for each new lot number by collecting at least 10 data points per control level over 5 days." Review 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 2 -- QC records for the CBC analyzer revealed no lot to lot comparisons performed. Interview on 05/13/19 at 3:50 PM with Testing Person #B, confirmed that the laboratory had not performed lot to lot comparison when a new lot was opened. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on record review and interview with Testing Person #B the laboratory failed to verify the education of 3 (#C, #E, and #G) out of 8 (#A, #B, #C, #D, #E, #G, #H, and #I) Testing Personnel reviewed (See D6065). D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on record review and interview with Testing Person #B the laboratory failed to verify the education of 3 (#C, #E, and #G) out of 8 (#A, #B, #C, #D, #E, #G, #H, and #I) Testing Personnel reviewed. Findings Included: Review of the CMS 209, Laboratory Personnel Report, signed by the Laboratory Director on 05/03/19 revealed Employee #C, #E, and #G held the position of Testing Personnel (TP) for moderate complexity. Review of personnel files revealed no documentation of education for Testing Person #C, #E, and #G. Interview on 05/13/19 at 4:30 PM with Testing Person #B, confirmed that the laboratory only had licenses, but not proof of education. -- 2 of 2 --