Medstar Laboratory Inc

Summary Statement of Deficiencies D0000 Based on a desk review of proficiency testing records from the Certification and Survey Provider Enhanced Reporting (CASPER) database and verified with the proficiency testing provider the laboratory was found to be out of compliance with the following CONDITION level deficiencies: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high 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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and College of American 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 -- Pathologists (CAP) Proficiency Testing (PT) records, the laboratory failed to achieve satisfactory performance for the routine chemistry analyte Cholesterol, Low Density Lipoprotein (Direct Measurement) for two consecutive PT events in 2025 (events 2 and 3) resulting in the initial unsuccessful PT performance. Refer to 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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and College of American Pathologists (CAP) Proficiency Testing (PT) records, the laboratory failed to achieve satisfactory performance for the routine chemistry analyte Cholesterol, Low Density Lipoprotein (Direct Measurement) for two consecutive PT events in 2025 (events 2 and 3) resulting in the initial unsuccessful PT performance. Findings include: 1. Review of the CASPER Report 0155D, generated on 12-04-2025, the laboratory received the following unsatisfactory scores for the routine chemistry analyte Cholesterol, Low Density Lipoprotein (Direct Measurement) . Cholesterol, Low Density Lipoprotein (Direct Measurement) Initial Unsuccessful PT Performance EVENT 2, 2025 - 0% Unsatisfactory EVENT 3, 2025 - 0% Unsatisfactory 2. Review of CAP PT evaluation reports (General Chemistry/Therapeutic Drugs (CZ)) confirmed the above unsatisfactory scores that resulted in the initial unsuccessful PT performance for the routine chemistry analyte Cholesterol, Low Density Lipoprotein (Direct Measurement). D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D Report and College of American Pathologists (CAP) Proficiency Testing (PT) records, the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for the routine chemistry analyte Cholesterol, Low Density Lipoprotein (Direct Measurement) resulting in the laboratory's initial unsuccessful PT performance. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D Report and College of American Pathologists (CAP) Proficiency Testing (PT) records, the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for the routine chemistry analyte Cholesterol, Low Density Lipoprotein (Direct Measurement) resulting in the laboratory's initial unsuccessful PT performance. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a desk review of proficiency testing records from the Certification and Survey Provider Enhanced Reporting (CASPER) database and verified with the proficiency testing provider the laboratory was found to be out of compliance with the following CONDITION level deficiencies: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high 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 a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D Report and College of American Pathologists 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 -- (CAP) Proficiency Testing (PT) records confirmed the initial unsuccessful PT performance for the analyte Free Thyroxine for two consecutive PT events in 2025 (events 1 and 2). Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D Report and College of American Pathologists (CAP) Proficiency Testing (PT) records, the laboratory failed to achieve satisfactory performance for the endocrinology analyte Free Thyroxine for two consecutive PT events in 2025 (event 1 and event 2) resulting in the initial unsuccessful PT performance. Findings include: 1. Review of the CASPER Report 0155D, generated on 10-01-2025, the laboratory received the following unsatisfactory scores for the endocrinology analyte Free Thyroxine. Free Thyroxine EVENT 1, 2025 - 20% Unsatisfactory EVENT 2, 2025 - 20% Unsatisfactory 2. Review of CAP PT evaluation reports (C-A & C-B 2025 General Chemistry/Therapeutic Drugs (CZ)) confirmed the above unsatisfactory scores that resulted in the initial unsuccessful PT performance for the endocrinology analyte Free Thyroxine. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D Report and College of American Pathologists (CAP) Proficiency Testing (PT) records, the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for the endocrinology analyte Free Thyroxine resulting in the laboratory's initial unsuccessful PT performance. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 Certification and Survey Provider Enhanced Reporting (CASPER) 0155D Report and College of American Pathologists (CAP) Proficiency Testing (PT) records, the laboratory director failed to ensure -- 2 of 3 -- successful participation in a Health and Human Services (HHS) approved PT program for the endocrinology analyte Free Thyroxine resulting in the laboratory's initial unsuccessful PT performance. Refer to D2107. -- 3 of 3 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on direct observation, laboratory standard operating procedures (SOP), and interview with testing personnel (TP); the laboratory failed to meet the requirements of this condition. The laboratory failed to maintain a unidirectional workflow for molecular amplification procedures to minimize contamination of patient specimens, equipment, instruments, reagents, materials, and supplies. (See D3005). D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on direct observation, laboratory standard operating procedures (SOP), and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- interview with testing personnel (TP); the laboratory failed to maintain a unidirectional workflow for molecular amplification procedures to prevent cross- contamination in specimen processing, preparation, amplification, and detection for one of one specimen tests plates processed on 12/14/2022 for SARS-CoV-2. Findings Include: 1. Review of the Medstar Laboratory Policy and Standard Operative Procedure (SOP) for Molecular Designs' Assurance FDA-EUA SARS-CoV-2 Extraction-less Assay revealed the following: a. Section 1.0 Intended Use - Item 1.5: "The Molecular Design's Assurance Scientific Laboratories SARS-CoV-2 assay is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures." b. Section 3.0 Warning and Precautions- Item 3.9: "Amplification technologies such as PCR are sensitive to accidental introduction of PCR product from previous amplifications reactions. Incorrect results could occur if either the clinical specimen or the real-time reagents used in the amplification step become contaminated by accidental introduction of amplification product (amplicon). Workflow in the laboratory should proceed in a unidirectional manner." c. Section 12.0 Data Analysis and Reporting - Item 12.18: "Save negative patient samples in refrigerator at 2 - 8 degrees Celsius for one week and positive patient samples in the freezer at -20 degrees Celsius for a month. 2. Direct observation on 12/14/2022 from 8:22 a.m. to 10: 15 a.m. of Molecular Designs' Assurance SARS-CoV-2 assay performed by TP 2 and TP 4 and review of the SOP revealed the following: a. Review of SOP Section 1.0 Intended Use - Item 1.5 and direct observation revealed the laboratory failed to prevent contact with patient sample tubes with the body of the one pipette utilized for the transfer patient samples to one of one specimen tests plates processed. b. Review of SOP Section 3.0 Warning and Precautions- Item 3.9 and direct observation revealed the laboratory failed to provide a separate biological safety cabinet for each process, the preparation of lysis buffer reagent and specimen preparation for one of one specimen tests plates processed affecting 69 patient specimens. c. Review of SOP Section 1.0 Intended Use - Item 1.5 and direct observation revealed the laboratory failed to ensure specimen amplification procedures were conducted in a dedicated biological safety cabinet with adequate space to perform clean molecular technique for one of one specimen tests plates processed affecting 69 patient specimens. d. Review of SOP Section 3.0 Warning and Precautions- Item 3.9 and direct observation revealed the laboratory failed to remove and change personal protective equipment (PPE) when rotating between the laboratory designated areas for specimen preparation and specimen amplification and detection for a minimum of five of five room rotations for one of one specimen tests plates processed affecting 69 patient specimens. e. Review of SOP Section 12.0 Data Analysis and Reporting - Item 12.18 and direct observation revealed the laboratory failed to provide storage of negative patient samples for one week at 2 - 8 degrees Celsius and positive amplified patient samples for one month at -20 degrees Celsius for 27 of 27 specimen tests plates processed from 12/01/2022 to 12/13/2022. 3. On 12/14/2022 at 10:15 a.m., the above findings were confirmed by TP 2. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: -- 2 of 4 -- Based on review of laboratory personnel records, employee training records, and employee competency records; the laboratory failed to meet the condition for high complexity testing personnel. The laboratory failed to ensure all testing personnel (TP) met the qualification requirements of 493.1489 for high complexity SARS-CoV- 2 testing for one of four testing personnel listed on the CMS-209 (Laboratory Personnel Report). See D6171. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry 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; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, -- 3 of 4 -- 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on review of laboratory employee training records, employee competency records, and testing personnel (TP) records, CMS-209 (Laboratory Personnel Report), the laboratory failed to ensure the Clinical Laboratory Improvement Amendments (CLIA) education requirements for high complexity SARS-CoV-2 testing for one of four testing personnel. Findings Include: 1. Review of laboratory employee training records revealed TP 4 was trained on 9/15/2022 by TP 3 to perform the following task: a. PCR Laboratory Procedures b. Patient Sample Testing: Correct specimen handling c. Patient Sample Testing: Extraction d. Patient Sample Testing: Amplification e. Patient Sample Testing: Reporting of Results f. Instruments Use and Maintenance 2. Review of laboratory employee competency records revealed TP 4 was evaluated on 9/15/2022 by TP 3 to perform the following task: a. Molecular Laboratory Procedures b. Patient Sample Testing: Correct specimen handling c. Patient Sample Testing: Extraction d. Patient Sample Testing: Amplification e. Patient Sample Testing: Reporting of Results f. Instruments Use and Maintenance 3. Review of CLIA education requirements for laboratory TP 4 revealed the laboratory failed to ensure TP 4 earned a doctoral, master's or bachelor's degree in a chemical, physical, biological, clinical laboratory science, or medical technology from an accredited institution. a. TP 4 - highest degree on record - High School Diploma 4. On 12/14 /2022 at 11:56 a.m., surveyor requested education records to qualify TP 4 for high complexity testing; no additional education records were provided. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A complaint survey was completed on March 9, 2022. It was determined that Immediate Jeopardy (IJ) existed for the following condition level deficiencies: 42 C.F. R. 493.1240 Condition: Preanalytic systems 42 C.F.R. 493.1250 Condition: Analytic systems 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director 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 record review and interview, the laboratory failed to test proficiency samples the same number of times that it routinely tests patient samples, during the year of 2021. Findings: 1. The College of American Pathologists (CAP) Proficiency Testing (PT) program records for the year of 2021, test data from 05/28/2021 and 07 /22/2021, the laboratory's SARS-CoV-2 Reverse Transcriptase (RT) Polymerase Chain Reaction (PCR) procedures, and PT policies and procedures were reviewed. 2. The laboratory enrolled in the SARS-CoV-2 Molecular Survey PT program to verify the accuracy of it's laboratory developed test (LDT) for SARS-CoV-2 RT-PCR testing. 3. The CAP-PT program documents and laboratory PT policy revealed the following: *Both stated that PT samples are to be analyzed in the same manner as patients. *Event ID3-B-2021 PT samples were tested in two different PCR runs. 4. The SARS-CoV-2 RT-PCR procedure and test data showed patients' samples were tested once and then the results were reported on the dates reviewed 5. On a Complaint survey conducted on March 9, 2022 at 1:30 PM, the owner and Staff-SP confirmed the above findings. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- 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. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview, the laboratory failed to establish and follow written policies and procedures to assess employees performing the SARS-CoV-2 Reverse Transcriptase (RT) Polymerase Chain Reaction (PCR) test, affecting six out of six testing personnel (TP). Findings include: 1. The Laboratory Personnel Report (CMS 209), employee files, and personnel policies and procedures were reviewed. 2. The laboratory used the SARS-CoV-2 Reverse Transcriptase (RT) Polymerase Chain Reaction (PCR) procedures to detect and identify SARS-CoV-2 in patients' samples. 3. CMS 209 listed six TP (TP1, TP2, TP3, TP4, TP5, and TP6) performing the SARS-CoV-2 RT-PCR test procedure. 4. The laboratory failed to establish a step-by-step procedure that includes the following criteria to access TP competency: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing, as applicable; b). Monitoring the recording and reporting of test results (for example, recording patients and their results in the labs' test log and EMR system); c). Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; d). Direct observation of performance of instrument maintenance and function checks; e). Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; f). Assessment of problem solving skills; and g). Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually. 5. On a Complaint survey conducted March 9, 2022 at 2:00 PM, the Owner and Staff-SP confirmed the above findings. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to evaluate the results received from the College of American Pathologists (CAP) proficiency test (PT) program, during the year of 2021. Findings: 1. The CAP-PT program records for the year of 2021 and PT policies and procedures were reviewed. 2. Review of the 2021 CAP-PT results revealed the following: LABORATORY RESULT INTENDED RESULT Event COV-2-01 COV-2-01 Not Detected (Negative) N.D. (NEG) COV-2- 02 Indeterminate Detected (Positive)=(POS) COV-2-03 Indeterminate Detected (POS) Event ID3-B 2021 ID3-06 - N.D.(NEG) N.D.(NEG) ID3-07 - N.D.(NEG) N.D. (NEG) ID3-08 - N.D.(NEG) N.D.(NEG) ID3-09 - N.D.(NEG) N.D.(NEG) ID3-10 - Indeterminate Detected (POS) Event ID3-C 2021 ID3-11 - Detected (POS) Detected (POS) ID3-12 - Invalid ID3-13 - Invalid ID3-14 - N.D.(NEG) N.D.(NEG) ID3-15 - Invalid 3. The laboratory failed to follow its PT policy and implement procedures to -- 2 of 13 -- review and evaluate all PT results received. 4. On a Complaint survey conducted March 9, 2022 at 1:30 PM, the owner and Staff-SP confirmed the above findings. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on direct observation, record review, and interview, the laboratory failed to follow established specimen collection, handling, and storage policies and procedures (D5311) and failed to monitor and evaluate the overall quality of the prenalytic systems and correct problems identified (5391) as specified in 42 CFR 493.1249. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory records, direct observation, and interview with testing personnel (Staff ID#1) the laboratory failed to follow the laboratory's policy for COVID-19 specimen collection, handling, and storage guidance as outlined in the laboratory's procedures affecting 1,777,655 patient test results. Findings Include: Item 1 - Specimen Handling and Storage 1. Review of the laboratory's policy and procedure manual identified the procedure, "Assurance SARS-CoV-2 Panel SOP for Partner Laboratories", which stated on page four under the heading of "6.0 Specimen collection, handling, and storage": "6.1 Specimens are collected according to the guidance by the CDC https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines- clinical-specimens.html\ 6.2 Upon receipt, samples are stored at approximately 4 degrees Celsius 6.3 Extracted nucleic acid will be stored at -70 degrees or below" 2. Review of the laboratory's policy and procedure manual identified the procedure, "Upper-Respiratory Specimen Collection for COVID-19 Test", which stated under the heading of "Specimen Handling": "Refrigerate all specimen types at 2-8 degrees Celsius after collection and up to 72 hours after collection. If a delay in testing or shipping is expected, store specimens at -70 degrees Celsius or below." This same information is also indicated in the CDC guidance for the for storing and shipping respiratory specimens. 3. Interview with Staff ID#1 at 10:35 am, on 3-8-2022 confirmed the laboratory performs COVID-19 testing on respiratory specimens. 4. During tour of the laboratory facility on 3-8-22 at 10:58 am no refrigerators or freezers were observed for the storage of respiratory specimens received for COVID- -- 3 of 13 -- 19 testing by the laboratory. 5. Interview with Staff ID#1 at 12:33 pm, on 3-8-22 confirmed the laboratory does not have any refrigerators or freezers to store respiratory specimens received by the laboratory for COVID-19 testing as outlined in the laboratory's procedure or per the CDC guidance for respiratory specimens. 6. During tour of the receiving area at 12:15 pm on 3-8-22 the surveyor observed a trash bag which contained COVID-19 specimens that had been collected on 3-4-22 but were received and were not refrigerated/frozen and had no way to be stored at -70 degrees Celsius or below as indicted in the CDC/laboratory guidance. 7. Review of requisitions from the specimens received on 3-8-22 observed during the tour of the laboratory facility on 3-8-22 at 12:15pm identified 84 patient samples that were received by the laboratory that should have been shipped and stored frozen due to the delay from the date of collection of 3-4-2022, as identified on the test requisitions. 8. Review of the patient test volume records found the laboratory has performed 1,777,655 tests when the laboratory failed to have the proper equipment in order to store COVID-19 respiratory specimens as indicated in the laboratory's procedure and in accordance with CDC guidance. Item 2 - Specimen Collection 1. Interview with Staff ID#1 on 3-8-22 at 10:32 am confirmed the laboratory uses the extraction-less method for SARS-CoV-2 testing. 2. Review of the laboratory's policy and procedure manual identified the procedure, "Assurance SARS-CoV-2 Panel SOP for Partner Laboratories", indicated on page five that for the extraction-less method respiratory samples are to be collected in saline. "9.2 Extraction-less Method (Saline samples ONLY):" 3. During a tour of the laboratory facility on 3-8-22 at 10:58 am, the surveyor observed ~11 racks (72 specimens per rack, ~792 patient samples) of patient specimens collected between 3-5-22 to 3-7-22 being prepared for COVID-19 testing had been collected in Virus Transport Medium (VTM) tubes from the supplier SNT Biotech. 4. Review of invoices for COVID-19 collection kits purchased by Medstar Laboratories from SNT Biotech found for invoices reviewed from December 2021 through February 9, 2022 were for collection kits containing VTM collection tubes. 5. Review of the laboratory protocol, "PCR Specimen Accessioning and Rejecting Protocol" failed to identify proper collection vessel as a criteria for specimen rejection. 6. Review of the patient test volume records found the laboratory has performed 1,777,655 tests for COVID-19 when the laboratory failed to ensure respiratory specimens were collected in the proper medium (Saline) for the test system in use. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of laboratory records, direct observation, and interview with testing personnel (Staff ID#1) the laboratory failed to establish policies and procedures to assess, monitor and correct problems with COVID-19 specimen collection, handling, and storage affecting 1,777,655 patient test results. Findings Include: 1. Surveyor requested all quality assurance documentation from Staff ID#1 on 3-8-22 at 2:00 pm. The laboratory failed to provide the laboratory's quality assessment policy and documentation during the survey that was completed on 3-9-2022. 2. The laboratory failed to identify multiple issues with specimen collection, handling, and storage. See D5311. 3. Surveyor requested on 3-9-22 at 12:53 pm patient test reports for 22 of the -- 4 of 13 -- 84 specimens that were received during the tour of the specimen receiving area on 3-8- 22 and found 22 of 22 patient sample reports reviewed were reported out by the laboratory and all were reported as negative for SARS-CoV-2. 4. Review of patient testing for SARS-CoV-2 found the laboratory has reported 1,777,655 patients in the past two years when no preanalytical quality assessment policy had been established and performed. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review, test data and proficiency testing records, lack of documentation, and interview, the laboratory failed to have complete written procedures (D5403); failed to ensure the storage requirements and proper use of reagents, solutions, test plates,, and other pertinent information were identified (D5415); failed to establish the performance specifications for laboratory developed SARS-CoV-2 Reverse Transcriptase (RT) Polymerase Chain Reaction (PCR) test (D5423); failed to establish control procedures (D5445); failed to document the lot number of each commercially prepared reagent, plate, and solutions used in the SARS- CoV-2 identification system (D5471); and failed to identify each person who performed SARS-CoV-2 PCR test (D5787), affecting 1,777,655 patients' tests. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the laboratory's testing menu; Laboratory Personnel Report - CLIA (FORM 209) patients test reports; and interview with 1 of 3 technical supervisors, the laboratory failed to report SARS-COV-2 IgG / IgM test results to the Illinois Department of Public Health during the Public Health Emergency. Findings: 1. On survey date 02/10/21 at 10:30 review of the laboratory's testing menu revealed that the laboratory added RT- PCR COVID -19 Antigen testing and COVID-19 serology testing for SARS-COV-2 IgG/IgM antibodies. 2. Review of patients' test reports revealed that the laboratory reported both RT-PCR COVID-19 Antigen and SARS-COV-2 IgG/IgM test results. 3. On survey date 02/10/21 at 4:30 PM the surveyor asked the lab to show her how COVID testing gets reported to the Illinois Department of Public Health. The surveyor was told that none of the serology test results for SARS-COV-2 IgG/IgM test results are reported to the Illinois Department of Public Health. 4. On survey date 02/10/21 at 5:00 PM the survey reviewed a total of 29 SARS-COV-2 IgG/IgM test results. There was no evidence that SARS-COV-2 IgG/IgM test results were reported to the Illinois Department of Public Health for 29 or 29 test results reviewed. 5. On survey date 02/10/21 at 5:30 PM, technical Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- supervisor # 3 (personnel #4 as listed on FORM 209 confirmed the surveyor's findings. 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. This STANDARD is not met as evidenced by: Based on review of Laboratory Personnel Report - CLIA (FORM 209); personnel records; and interview with the technical supervisor, the laboratory failed to establish and follow written policies and procedures to assess consultant competency. Findings: 1. Review of FORM 209 revealed that there are 15 persons listed as laboratory personnel for the following positions: a. Person # 1 as listed on Form 209 is listed as Laboratory Director and Clinical Consultant. b. Person #2 as listed on Form 209 is listed as Technical Supervisor. c. Person #3 as listed on Form 209 is listed as Technical Supervisor. d. Person #4 as listed on Form 209 is listed as Technical Supervisor and General Supervisor. e. Person # 5 as listed on Form 209 is listed as High Complexity Testing Person. f. Person # 6 as listed on Form 209 is listed as High Complexity Testing Person. g. Person # 7 as listed on Form 209 is listed as High Complexity Testing Person. h. Person # 8 as listed on Form 209 is listed as High Complexity Testing Person. i. Person # 9 as listed on Form 209 is listed as High Complexity Testing Person. j. Person # 10 as listed on Form 209 is listed as High Complexity Testing Person. k. Person # 11 as listed on Form 209 is listed as Moderate Complexity Testing Person. l. Person # 12 as listed on Form 209 is listed as Moderate Complexity Testing Person. m. Person # 13 as listed on Form 209 is listed as Moderate Complexity Testing Person. n. Person # 14 as listed on Form 209 is listed as Moderate Complexity Testing Person. o. Person # 15 as listed on Form 209 is listed as Moderate Complexity Testing Person. 2. On survey date 02/10/21 at 11:00 AM, review of personnel records revealed that there was no documentation to show a competency assessment for 1 of 3 Technical Supervisors (personnel #3 as listed on form 209) for 2019, 2020, and 2021. 3. On survey date 02/10/21 at 11:30 AM, Technical Supervisor #3 (personnel #4 as listed on Form 209) confirmed the surveyor's findings. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of manufacturer's assay information and instructions; laboratory records; patients' test reports; and interview with 1 of 3 technical supervisors, the -- 2 of 10 -- laboratory failed to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for Accuracy, Precision, Reportable Range; and reference intervals for its RT-PCVR for its COVID-19 assay. Findings: 1. The manufacturer assay information instructs the laboratory to determine the Limit of Detection (LOD) for the assay by performing a serial dilution of an Extraction Stock (ES) and then confirm the LOD by assaying a total of 20 specimens at the LOD (3 of which come from the initial dilution series. A set of 30 positive and 30 negative clinical samples is provided for a clinical validation. 2. The manufacturer instructions reads: "All experiments for the limit of detection (LoD) determination and confirmation must be performed in one day. 3. Review of laboratory records for validation of RT-PCR for its Covid-19 assay revealed that there was no documentation to show that the LOD is determined. 4. Review of the laboratory's "Preview Results Report" revealed that on January 21, 2021 the laboratory reported 101 RT-PCR results for COVID-19 Antigen and on February 02, 2021, the laboratory reported 97 RT-PCR COVID-19 Antigen test results prior to validation of the test. 5. During survey date February 10, 2021, Technical Supervisor #4 (as listed on ORM 209) confirmed the surveyor's findings. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions; variation records; patients test records; and interview with 1 of 3 technical supervisors, the laboratory director failed to ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristic of its RT- PCR for COVID- 19 Antigen testing. Findings: (See tag D5421) 1. The manufacture of the lab's RT- PCR Test for the COVID-19 Antigen, instructs the laboratory to determine the Limit of Detection (LOD) for the test and confirm and then confirm the LOD by assaying a total of 20 specimens at the LOD (3 of which come from the initial dilution series using a set of 30 positive and 30 negative clinical samples is provided for a clinical validation. 2. There was no documentation to show that the laboratory determined the LOD and confirmed it. 3. At total of 185 patients' specimens were tested for the COVID Antigen on January 21, 2021 and February 2, 2021 prior to the validation of the lab's RT-PCR COVID -19 test method. 4. On February 10, 2021, technical supervisor #3 (personnel #4 as listed of FORM 209) confirmed the surveyor's findings. D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on Laboratory Personnel Report- CLIA (FORM 209); personnel records; and -- 3 of 10 -- interview with 1 of 3 technical supervisors, 1 of 3 Technical Supervisors failed to have credentials that meet the qualification requirements of 493.1449 of this part. Findings: 1. Personnel # 3 as listed on FORM 209 did not have education credentials showing they qualify as Technical Supervisor of High Complexity testing. See tag D6111 D6111 TECHNICAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1449 (a) The technical supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory may perform anatomic and clinical laboratory procedures and tests in all specialties and subspecialties of services except histocompatibility and clinical cytogenetics services provided the individual functioning as the technical supervisor-- (b)(1) Is a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or Possesses qualifications that are equivalent to those required for such certification. (c) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of bacteriology, the individual functioning as the technical supervisor must-- (c)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (c)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (c)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (c)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (c)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (c)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; and (c)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology. (d) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycobacteriology, the individual functioning as the technical supervisor must-- (d)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (d)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (d) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor or podiatric medicine -- 4 of 10 -- licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (d)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (d)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (d)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (d)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology. (e) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycology, the individual functioning as the technical supervisor must-- (e)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (e)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (e) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (e)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (e)(3)(ii) Have at least 1 year of laboratory training or experience, or both in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(4) (i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (e)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (e)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology. (f) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of parasitology, the individual functioning as the technical supervisor must-- (f)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (f)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (f)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor -- 5 of 10 -- of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (f)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; (f)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (f)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (f)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (f)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology. (g) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of virology, the individual functioning as the technical supervisor must-- (g)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (g)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (g) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (g)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (g)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (g)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (g)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology. (h) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of diagnostic immunology, the individual functioning as the technical supervisor must- (h)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (h)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (h)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor -- 6 of 10 -- of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (h)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (h)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of diagnostic immunology; or (h)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (h)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (h)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology. (i) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of chemistry, the individual functioning as the technical supervisor must-- (i)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (i)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (i)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (i)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (i)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of chemistry; or (i) (4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (i)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (i)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry. (j) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of hematology, the individual functioning as the technical supervisor must-- (j)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (j)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (j)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (j)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of hematology (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (j) (3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (j)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of hematology; or (j)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (j)(4)(ii) Have at least 2 years of laboratory training or -- 7 of 10 -- experience, or both, in high complexity testing for the specialty of hematology; or (j) (5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (j)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology. (k)(1) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of cytology, the individual functioning as the technical supervisor must-- (k)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (k)(1)(ii) Meet one of the following requirements-- (k)(1)(ii)(A) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (k)(1)(ii) (B) Be certified by the American Society of Cytology to practice cytopathology or possess qualifications that are equivalent to those required for such certification; (l) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of histopathology, the individual functioning as the technical supervisor must-- (l)(1) Meet one of the following requirements: (l)(1)(i)(A) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (l)(1)(i)(B) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; (l)(1)(ii) An individual qualified under 493.1449(b) or paragraph (l)(1) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (l)(1)(i)(B) of this section, the responsibility for examination and interpretation of histopathology specimens. (l)(2) For tests in dermatopathology, meet one of the following requirements: (l)(2)(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (l) (2)(i)(B) Meet one of the following requirements: (l)(2)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B)(2) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B) (3) Be certified in dermatology by the American Board of Dermatology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(ii) An individual qualified under 493.1449(b) or paragraph (l)(2)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for examination and interpretation of dermatopathology specimens. (l) (3) For tests in ophthalmic pathology, meet one of the following requirements: (l)(3)(i) (A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (l)(3)(i)(B) Must meet one of the following requirements: (l)(3)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(3)(i)(B)(2) Be certified by the American Board of Ophthalmology or possess qualifications that are equivalent to those required for such certification and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or (l)(3)(ii) An individual qualified under 493.1449(b) or paragraph (1)(3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (1)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic -- 8 of 10 -- specimens; or (m) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of oral pathology, the individual functioning as the technical supervisor must meet one of the following requirements: (m)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (m)(1)(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (m)(2) Be certified in oral pathology by the American Board of Oral Pathology or possess qualifications for such certification; or (m)(3) An individual qualified under 493.1449(b) or paragraph (m)(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (m)(1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens. (n) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of radiobioassay, the individual functioning as the technical supervisor must-- (n)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (n)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (n)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (n)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (n)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of radiobioassay; or (n)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (n)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (n)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay. (o) If the laboratory performs tests in the specialty of histocompatibility, the individual functioning as the technical supervisor must either-- (o)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (o)(1)(ii) Have training or experience that meets one of the following requirements: (o)(1)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(1)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(1)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility; or (o)(2)(i) Have an earned doctoral degree in a biological or clinical laboratory science from an accredited institution; and (o)(2)(ii) Have training or experience that meets one of the following requirements: (o) (2)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(2)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(2)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility. (p) If the laboratory performs tests in the specialty of clinical cytogenetics, the individual functioning as the technical supervisor must-- (p)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to -- 9 of 10 -- practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (p)(1)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics; or (p)(2)(i) Hold an earned doctoral degree in a biological science, including biochemistry, or clinical laboratory science from an accredited institution; and (p)(2)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics. (q) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of immunohematology, the individual functioning as the technical supervisor must-- (q)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (q)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (q)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (q)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of immunohematology. Note: The technical supervisor requirements for "laboratory training or experience, or both'' in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service. For example, an individual, who has a doctoral degree in chemistry and additionally has documentation of 1 year of laboratory experience working concurrently in high complexity testing in the specialties of microbiology and chemistry and 6 months of that work experience included high complexity testing in bacteriology, mycology, and mycobacteriology, would qualify as the technical supervisor for the specialty of chemistry and the subspecialties of bacteriology, mycology, and mycobacteriology. This STANDARD is not met as evidenced by: Based on review of Laboratory Personnel Report - CLIA (FORM 209); personnel records; and interview with 1 of 3 technical supervisors, the laboratory failed to have qualifying credentials for 1 of 3 technical supervisors. Findings: 1. Review of FORM 209 revealed that there are 3 persons listed as technical supervisor of the laboratory. 2. Review of personnel records revealed that there was no documentation to show the credentialing records for 1 of 3 technical supervisors (personnel number 3 as listed on FORM 209). 3. On survey date 03/10/21 at 11:30 AM, Technical Supervisor #3 (personnel # 4 as listed on FORM 209) confirmed the surveyor's findings. -- 10 of 10 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the laboratory's testing menu; Laboratory Personnel Report - CLIA (FORM 209) patients test reports; and interview with 1 of 3 technical supervisors, the laboratory failed to report SARS-COV-2 IgG / IgM test results to the Illinois Department of Public Health during the Public Health Emergency. Findings: 1. On survey date 02/10/21 at 10:30 review of the laboratory's testing menu revealed that the laboratory added RT- PCR COVID -19 Antigen testing and COVID-19 serology testing for SARS-COV-2 IgG/IgM antibodies. 2. Review of patients' test reports revealed that the laboratory reported both RT-PCR COVID-19 Antigen and SARS-COV-2 IgG/IgM test results. 3. On survey date 02/10/21 at 4:30 PM the surveyor asked the lab to show her how COVID testing gets reported to the Illinois Department of Public Health. The surveyor was told that none of the serology test results for SARS-COV-2 IgG/IgM test results are reported to the Illinois Department of Public Health. 4. On survey date 02/10/21 at 5:00 PM the survey reviewed a total of 29 SARS-COV-2 IgG/IgM test results. There was no evidence that SARS-COV-2 IgG/IgM test results were reported to the Illinois Department of Public Health for 29 or 29 test results reviewed. 5. On survey date 02/10/21 at 5:30 PM, technical Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- supervisor # 3 (personnel #4 as listed on FORM 209 confirmed the surveyor's findings. 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. This STANDARD is not met as evidenced by: Based on review of Laboratory Personnel Report - CLIA (FORM 209); personnel records; and interview with the technical supervisor, the laboratory failed to establish and follow written policies and procedures to assess consultant competency. Findings: 1. Review of FORM 209 revealed that there are 15 persons listed as laboratory personnel for the following positions: a. Person # 1 as listed on Form 209 is listed as Laboratory Director and Clinical Consultant. b. Person #2 as listed on Form 209 is listed as Technical Supervisor. c. Person #3 as listed on Form 209 is listed as Technical Supervisor. d. Person #4 as listed on Form 209 is listed as Technical Supervisor and General Supervisor. e. Person # 5 as listed on Form 209 is listed as High Complexity Testing Person. f. Person # 6 as listed on Form 209 is listed as High Complexity Testing Person. g. Person # 7 as listed on Form 209 is listed as High Complexity Testing Person. h. Person # 8 as listed on Form 209 is listed as High Complexity Testing Person. i. Person # 9 as listed on Form 209 is listed as High Complexity Testing Person. j. Person # 10 as listed on Form 209 is listed as High Complexity Testing Person. k. Person # 11 as listed on Form 209 is listed as Moderate Complexity Testing Person. l. Person # 12 as listed on Form 209 is listed as Moderate Complexity Testing Person. m. Person # 13 as listed on Form 209 is listed as Moderate Complexity Testing Person. n. Person # 14 as listed on Form 209 is listed as Moderate Complexity Testing Person. o. Person # 15 as listed on Form 209 is listed as Moderate Complexity Testing Person. 2. On survey date 02/10/21 at 11:00 AM, review of personnel records revealed that there was no documentation to show a competency assessment for 1 of 3 Technical Supervisors (personnel #3 as listed on form 209) for 2019, 2020, and 2021. 3. On survey date 02/10/21 at 11:30 AM, Technical Supervisor #3 (personnel #4 as listed on Form 209) confirmed the surveyor's findings. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of manufacturer's assay information and instructions; laboratory records; patients' test reports; and interview with 1 of 3 technical supervisors, the -- 2 of 10 -- laboratory failed to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for Accuracy, Precision, Reportable Range; and reference intervals for its RT-PCVR for its COVID-19 assay. Findings: 1. The manufacturer assay information instructs the laboratory to determine the Limit of Detection (LOD) for the assay by performing a serial dilution of an Extraction Stock (ES) and then confirm the LOD by assaying a total of 20 specimens at the LOD (3 of which come from the initial dilution series. A set of 30 positive and 30 negative clinical samples is provided for a clinical validation. 2. The manufacturer instructions reads: "All experiments for the limit of detection (LoD) determination and confirmation must be performed in one day. 3. Review of laboratory records for validation of RT-PCR for its Covid-19 assay revealed that there was no documentation to show that the LOD is determined. 4. Review of the laboratory's "Preview Results Report" revealed that on January 21, 2021 the laboratory reported 101 RT-PCR results for COVID-19 Antigen and on February 02, 2021, the laboratory reported 97 RT-PCR COVID-19 Antigen test results prior to validation of the test. 5. During survey date February 10, 2021, Technical Supervisor #4 (as listed on ORM 209) confirmed the surveyor's findings. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions; variation records; patients test records; and interview with 1 of 3 technical supervisors, the laboratory director failed to ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristic of its RT- PCR for COVID- 19 Antigen testing. Findings: (See tag D5421) 1. The manufacture of the lab's RT- PCR Test for the COVID-19 Antigen, instructs the laboratory to determine the Limit of Detection (LOD) for the test and confirm and then confirm the LOD by assaying a total of 20 specimens at the LOD (3 of which come from the initial dilution series using a set of 30 positive and 30 negative clinical samples is provided for a clinical validation. 2. There was no documentation to show that the laboratory determined the LOD and confirmed it. 3. At total of 185 patients' specimens were tested for the COVID Antigen on January 21, 2021 and February 2, 2021 prior to the validation of the lab's RT-PCR COVID -19 test method. 4. On February 10, 2021, technical supervisor #3 (personnel #4 as listed of FORM 209) confirmed the surveyor's findings. D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on Laboratory Personnel Report- CLIA (FORM 209); personnel records; and -- 3 of 10 -- interview with 1 of 3 technical supervisors, 1 of 3 Technical Supervisors failed to have credentials that meet the qualification requirements of 493.1449 of this part. Findings: 1. Personnel # 3 as listed on FORM 209 did not have education credentials showing they qualify as Technical Supervisor of High Complexity testing. See tag D6111 D6111 TECHNICAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1449 (a) The technical supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory may perform anatomic and clinical laboratory procedures and tests in all specialties and subspecialties of services except histocompatibility and clinical cytogenetics services provided the individual functioning as the technical supervisor-- (b)(1) Is a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or Possesses qualifications that are equivalent to those required for such certification. (c) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of bacteriology, the individual functioning as the technical supervisor must-- (c)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (c)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (c)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (c)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (c)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (c)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; and (c)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology. (d) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycobacteriology, the individual functioning as the technical supervisor must-- (d)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (d)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (d) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor or podiatric medicine -- 4 of 10 -- licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (d)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (d)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (d)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (d)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology. (e) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycology, the individual functioning as the technical supervisor must-- (e)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (e)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (e) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (e)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (e)(3)(ii) Have at least 1 year of laboratory training or experience, or both in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(4) (i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (e)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (e)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology. (f) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of parasitology, the individual functioning as the technical supervisor must-- (f)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (f)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (f)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor -- 5 of 10 -- of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (f)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; (f)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (f)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (f)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (f)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology. (g) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of virology, the individual functioning as the technical supervisor must-- (g)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (g)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (g) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (g)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (g)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (g)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (g)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology. (h) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of diagnostic immunology, the individual functioning as the technical supervisor must- (h)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (h)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (h)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor -- 6 of 10 -- of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (h)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (h)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of diagnostic immunology; or (h)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (h)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (h)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology. (i) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of chemistry, the individual functioning as the technical supervisor must-- (i)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (i)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (i)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (i)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (i)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of chemistry; or (i) (4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (i)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (i)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry. (j) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of hematology, the individual functioning as the technical supervisor must-- (j)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (j)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (j)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (j)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of hematology (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (j) (3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (j)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of hematology; or (j)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (j)(4)(ii) Have at least 2 years of laboratory training or -- 7 of 10 -- experience, or both, in high complexity testing for the specialty of hematology; or (j) (5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (j)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology. (k)(1) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of cytology, the individual functioning as the technical supervisor must-- (k)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (k)(1)(ii) Meet one of the following requirements-- (k)(1)(ii)(A) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (k)(1)(ii) (B) Be certified by the American Society of Cytology to practice cytopathology or possess qualifications that are equivalent to those required for such certification; (l) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of histopathology, the individual functioning as the technical supervisor must-- (l)(1) Meet one of the following requirements: (l)(1)(i)(A) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (l)(1)(i)(B) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; (l)(1)(ii) An individual qualified under 493.1449(b) or paragraph (l)(1) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (l)(1)(i)(B) of this section, the responsibility for examination and interpretation of histopathology specimens. (l)(2) For tests in dermatopathology, meet one of the following requirements: (l)(2)(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (l) (2)(i)(B) Meet one of the following requirements: (l)(2)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B)(2) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B) (3) Be certified in dermatology by the American Board of Dermatology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(ii) An individual qualified under 493.1449(b) or paragraph (l)(2)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for examination and interpretation of dermatopathology specimens. (l) (3) For tests in ophthalmic pathology, meet one of the following requirements: (l)(3)(i) (A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (l)(3)(i)(B) Must meet one of the following requirements: (l)(3)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(3)(i)(B)(2) Be certified by the American Board of Ophthalmology or possess qualifications that are equivalent to those required for such certification and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or (l)(3)(ii) An individual qualified under 493.1449(b) or paragraph (1)(3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (1)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic -- 8 of 10 -- specimens; or (m) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of oral pathology, the individual functioning as the technical supervisor must meet one of the following requirements: (m)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (m)(1)(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (m)(2) Be certified in oral pathology by the American Board of Oral Pathology or possess qualifications for such certification; or (m)(3) An individual qualified under 493.1449(b) or paragraph (m)(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (m)(1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens. (n) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of radiobioassay, the individual functioning as the technical supervisor must-- (n)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (n)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (n)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (n)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (n)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of radiobioassay; or (n)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (n)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (n)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay. (o) If the laboratory performs tests in the specialty of histocompatibility, the individual functioning as the technical supervisor must either-- (o)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (o)(1)(ii) Have training or experience that meets one of the following requirements: (o)(1)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(1)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(1)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility; or (o)(2)(i) Have an earned doctoral degree in a biological or clinical laboratory science from an accredited institution; and (o)(2)(ii) Have training or experience that meets one of the following requirements: (o) (2)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(2)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(2)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility. (p) If the laboratory performs tests in the specialty of clinical cytogenetics, the individual functioning as the technical supervisor must-- (p)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to -- 9 of 10 -- practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (p)(1)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics; or (p)(2)(i) Hold an earned doctoral degree in a biological science, including biochemistry, or clinical laboratory science from an accredited institution; and (p)(2)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics. (q) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of immunohematology, the individual functioning as the technical supervisor must-- (q)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (q)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (q)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (q)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of immunohematology. Note: The technical supervisor requirements for "laboratory training or experience, or both'' in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service. For example, an individual, who has a doctoral degree in chemistry and additionally has documentation of 1 year of laboratory experience working concurrently in high complexity testing in the specialties of microbiology and chemistry and 6 months of that work experience included high complexity testing in bacteriology, mycology, and mycobacteriology, would qualify as the technical supervisor for the specialty of chemistry and the subspecialties of bacteriology, mycology, and mycobacteriology. This STANDARD is not met as evidenced by: Based on review of Laboratory Personnel Report - CLIA (FORM 209); personnel records; and interview with 1 of 3 technical supervisors, the laboratory failed to have qualifying credentials for 1 of 3 technical supervisors. Findings: 1. Review of FORM 209 revealed that there are 3 persons listed as technical supervisor of the laboratory. 2. Review of personnel records revealed that there was no documentation to show the credentialing records for 1 of 3 technical supervisors (personnel number 3 as listed on FORM 209). 3. On survey date 03/10/21 at 11:30 AM, Technical Supervisor #3 (personnel # 4 as listed on FORM 209) confirmed the surveyor's findings. -- 10 of 10 --