Bio Tox Laboratory Llc

Summary Statement of Deficiencies D0000 The Department of Licensing and Regulatory Affairs has evaluated this facility during an announced recertification survey and determined that it is not in compliance with CLIA regulations (42 CFR Part 93, effective April 24, 2003) and Immediate Jeopardy was identified. The following Conditions were not met: 493.1100 Condition: Facility administration 493.1250 Condition: Analytic systems 493.1441 Condition: Laboratories performing high complexity testing; laboratory director 493.1459 Condition: Laboratories performing high complexity testing; general supervisor 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 record review and interview with the Technical Supervisor (TS), the laboratory failed to report all positive SARS-CoV-2 test results every day of patient testing for 22 ( to February 2022) of 24 months reviewed. Findings include: 1. The surveyor observed the laboratory's Atila Biosicences analyzer and high complexity molecular iAMP COVID-19 Detection test system on 5/17/22 at 9:00 am. 2. A review of the laboratory's records on 5/17/22 revealed an email from the local health department requesting the laboratory not report negative results. 3. The surveyor requested documentation indicating all positive SARS-CoV-2 patient test results were Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- reported to the local health department on 5/17/22 at 1:35 pm and they were not made available. 4. An interview on 5/17/22 at 1:36 pm with the TS revealed the laboratory only had fax transmissions of positive SARS-CoV-2 dating to March 2022 and confirmed the laboratory did not have record that of all positive SARS-CoV-2 patient test results were sent to the local health department. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #1 (TP1), the laboratory failed to retain quality control and patient test records for 15 (May 2020 to August 2021) of 24 months reviewed. Findings include: 1. The surveyor requested documentation of quality control and patient test records from May 2020 on 5/17/22 at 10:51 am and it was not made available. 2. A review of the laboratory's test run documentation on 5/17/22 revealed a lack of documentation prior to 3/10/21. 3. An interview with TP1 on 5/17/22 at 10:51 am revealed the laboratory did not have documentation of quality control and patient test records prior to 3/10/22 and was intermittently unable to retain data from all testing dates until August 2021 due to power outages and flooding. The laboratory had not backed up its data to ensure retention. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Supervisor (TS), the laboratory failed to have a request for patient testing from an authorized person for 8 (Patients 63511, 23743, 27825, 34488, 13536, 13535, 13627, and 13007) of 77 patient test requests reviewed. Findings include: 1. A review of patient test requests revealed a lack of an authorized person for the following patients: a. Patient 13007, tested for SARS-CoV-2 on 3/10/22. b Patient 13627, tested for SARS-CoV-2 on 3/17/22. c. Patient 13535, tested for SARS-CoV-2 on 3/17/22. d. Patient 13536, tested for SARS- CoV-2 on 3/17/22. 2. An interview on 5/17/22 at 11:37 am with the TS confirmed the patients listed above did not have an authorized person on the test request and revealed the laboratory's process for patients seeking testing without a test request from an authorized person is to have the patient's health provider's name added to the form without receiving requests for patient testing from those health providers. 3. A review of patient test requests revealed the following patients with an authorized person's name written on the test request were not received from an authorized person: a. Patient 34488, tested for SARS-CoV-2 on 11/4/21. b. Patient 27825, tested for SARS-CoV-2 on 9/9/21. c. Patient 23743, tested for SARS-CoV-2 on 7/15/21. d. Patient 63511, tested for SARS-CoV-2 on 5/7/22. -- 2 of 9 -- 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 and interviews, the laboratory failed to meet applicable analytic system requirements and correct identified problems. Findings include: 1. The laboratory failed to perform quarterly and annual maintenance for its Air Science Purair-Flow biosafety cabinet used in SARS-CoV-2 sample preparation as required by the manufacturer. Refer to D5431. 2. The laboratory failed to ensure results of control materials were within acceptable limits before reporting patient SARS-CoV-2 test results. Refer to D5481. 3. The laboratory failed to follow established policies to monitor and correct problems in analytic systems for its SARS-CoV-2 testing. Refer to D5791. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Supervisor (TS), the laboratory failed to perform quarterly and annual maintenance for its Air Science Purair-Flow biosafety cabinet used in SARS-CoV-2 sample preparation as required by the manufacturer for 2 (May 2020 to May 2022) of 2 years reviewed. Findings include: 1. A review of the laboratory's "AIR SCIENCE PURAIR-FLOW Series Laminar Flow Cabinets" user and service manual revealed a section titled "5.1 Maintenance Schedule" stating, "Quarterly 1. Replace pre-filters" and "Annually 1. Have the cabinet recertified by a qualified certification technician." 2. A review of the laboratory's maintenance documentation on 5/17/22 for the biosafety cabinet revealed a lack of documentation of quarterly and annual maintenance or recertification performed. 3. An interview on 5/17/22 at 10:18 am with the TS confirmed the laboratory had not had the biosafety cabinet recertified. 4. An interview on 5/17/22 at 10:31 am with the TS confirmed the laboratory had not performed and documented quarterly maintenance for the biosafety cabinet. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. -- 3 of 9 -- This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Supervisor (TS), the laboratory failed to ensure results of control materials were within acceptable limits before reporting patient SARS-CoV-2 test results for 7 (3/10/21, 3/17/21, 6/3/21, 7/14 /21, 7/15/21, 7/17/21, and 8/2/21) of 14 testing dates reviewed. Findings include: 1. A review of the laboratory's "iAMP COVID-19 Detection Kit" manufacturer's instructions for use on 5/17/22 revealed a section titled "Interpretation of Test Controls" stating, "Negative Control Template - serves to verify that analyte contamination does not occur during reaction setup and is used once in each instrument run. There should be NO exponential amplification curve shown in any channel (FAM or HEX) for the negative control template, otherwise the test is invalid, and the results cannot be used for diagnosis." and "Positive Control Template - serves as a control for amplification and detection of SARS-CoV-2 RNA specific sequences of the N and ORF1ab genes. It should show exponential curves in both channels (FAM and HEX)." 2. A review of the results of control materials on 5/17/22 revealed controls had not passed for the following test dates: a. On 3/10/21, the negative control had a cycle threshold (Ct) value of 28.09 in the FAM channel and a Ct value of 27.62 in the HEX channel. The run had two patient samples. b. On 3/17/21, the negative control had a Ct value of 19.2 in the FAM channel. The run had 23 patient samples. c. On 6/3/21, the positive control showed no amplification in the FAM channel. The run had 10 patient samples. d. 7/14/21 had two patient runs: i. The first run with one patient sample, the negative control showed a Ct of 37.2 in the HEX channel. The positive control did not show amplification in either the FAM or HEX channels. ii. The second run with two patient samples, the negative control had a Ct of 28.99 in the HEX channel. e. On 7/15/21, the negative control showed a Ct of 28.76 in the HEX channel. The run had three patient samples. f. On 7/17/21, the negative control showed a Ct of 31.12 in the HEX channel. The run had 18 patients. g. 8/2/21 had three patient runs: i. The first run with six patient samples, the negative control had a Ct of 19.79 in the FAM channel. ii. The second run with six patient samples, the negative control had a Ct. of 19.07 in the FAM channel. iii. The third run with 66 patient samples, the negative control showed a Ct value of 47.83 in the HEX channel. 3. A review of 15 patient test reports from the dates listed above revealed the laboratory reported patient test results when the results of control materials did not meet the criteria for acceptability. 4. An interview on 5/17/22 at 1:41 pm with the TS confirmed the laboratory did not have documentation of reruns for the patient test runs listed above and patient test results were reported. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Supervisor (TS), the laboratory failed to follow established policies to monitor and correct problems in analytic systems for its SARS-CoV-2 testing for 7 (3/10/21, 3/17/21, 6/3/21, 7/14/21, 7 /15/21, 7/17/21, and 8/2/21) of 14 testing dates reviewed when quality control did not -- 4 of 9 -- meet acceptability criteria. Findings include: 1. 1. A review of the laboratory's "iAMP COVID-19 Detection Kit" manufacturer's instructions for use on 5/17/22 revealed a section titled "Interpretation of Test Controls" stating, "Negative Control Template - serves to verify that analyte contamination does not occur during reaction setup and is used once in each instrument run. There should be NO exponential amplification curve shown in any channel (FAM or HEX) for the negative control template, otherwise the test is invalid, and the results cannot be used for diagnosis." and "Positive Control Template - serves as a control for amplification and detection of SARS-CoV-2 RNA specific sequences of the N and ORF1ab genes. It should show exponential curves in both channels (FAM and HEX)." 2. A review of the results of control materials on 5/17/22 revealed controls had not passed for the following test dates: a. On 3/10/21, the negative control had a cycle threshold (Ct) value of 28.09 in the FAM channel and a Ct value of 27.62 in the HEX channel. The run had two patient samples. b. On 3/17/21, the negative control had a Ct value of 19.2 in the FAM channel. The run had 23 patient samples. c. On 6/3/21, the positive control showed no amplification in the FAM channel. The run had 10 patient samples. d. 7/14 /21 had two patient runs: i. The first run with one patient sample, the negative control showed a Ct of 37.2 in the HEX channel. The positive control did not show amplification in either the FAM or HEX channels. ii. The second run with two patient samples, the negative control had a Ct of 28.99 in the HEX channel. e. On 7/15/21, the negative control showed a Ct of 28.76 in the HEX channel. The run had three patient samples. f. On 7/17/21, the negative control showed a Ct of 31.12 in the HEX channel. The run had 18 patients. g. 8/2/21 had three patient runs: i. The first run with six patient samples, the negative control had a Ct of 19.79 in the FAM channel. ii. The second run with six patient samples, the negative control had a Ct. of 19.07 in the FAM channel. iii. The third run with 66 patient samples, the negative control showed a Ct value of 47.83 in the HEX channel. 3. A review of the laboratory's "BIOTOX" policy on 5/17/22 revealed a section titled "Responsibility for the Quality Assurance Program" stating, "The Laboratory Director has overall responsibility for the Quality Assurance Program. The Laboratory Director will act to implement the Quality Assurance policies as a part of the all-encompassing Risk Management Program. The Director will evaluate the laboratory's QA needs, write the QA policies, regularly monitor QA indicators, document actions, and communicate QA policies to all employees. The Director and Technologist will write procedures to implement QA policies, monitor and document indicators daily, monthly, or as needed, and maintain an on-going Quality Control program. The Director will review all laboratory proficiency testing results and all quarterly and annual QA indicator monitoring done. The laboratory staff has the ultimate responsibility for performing quality work, reporting accurate and timely results, and identifying, correcting, and reporting problems. 4. The surveyor requested

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview with the Testing Personnel, the laboratory failed to have a request for patient testing for 6 (patients 6191, 6469, 7992, 8650, 10657, and 3344) of 10 patient records reviewed. Findings include: 1. A review of patient testing records revealed the following patients had COVID-19 testing performed without test requests: a. Patient 6191, performed on 7/28/20 b. Patient 6469, performed on 8/3/20 c. Patient 7992, performed on 9/9/20 d. Patient 8650, performed on 9/28/20 e. Patient 10657, performed on 11/7/20 f. Patient 3344, performed on 12/20/20 2. An interview on 12/28/20 at 11:40 am with the Testing Personnel confirmed the test requests for the patients listed above were not available. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- This STANDARD is not met as evidenced by: . Based on record review and interview with the Testing Personnel, the laboratory failed to ensure test results were accurately transferred to the patient test report for 1 (Patient 7992) of 10 patient test records reviewed. Findings include: 1. A review of the laboratory's "Sentosa SA201 Reports" including quality controls and patient test runs revealed Patient 7992, tested on 9/9/20, had a result of "SARS-CoV-2 virus detected". 2. A review of the final test report for Patient 7992 dated 9/9/20 revealed the results for the test to be negative. 3. An interview on 12/28/20 at 11:57 am with the Testing Personnel confirmed the patient test report had the incorrect patient test result listed. 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 record review and interview, the laboratory director failed to provide the laboratory with overall management and direction. Findings include: 1. The Laboratory Director failed to ensure the laboratory notified the State Agency when there were any deletions or changes in test methodologies for which the laboratory has been issued a certificate of compliance per 493.51. Refer to D6079. 2. The Laboratory Director failed to ensure the laboratory verified performance specifications for the the Sentosa SA201 test system and the Atila BioSystems test system used in COVID-19 testing. Refer to D6086. 3. The Laboratory Director failed to ensure quality assessment programs were maintained. Refer to D6094. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: . A. Based on record review and interview with the Testing Personnel, the Laboratory Director failed to ensure the laboratory notified the State Agency when there were any deletions or changes in test methodologies for which the laboratory has been issued a certificate of compliance in accordance with 493.51 for 2 (December 2018 to December 2020) of 2 years. Findings include: 1. A phone interview on 12/28/20 at 10: 31 am with a laboratory employee revealed the laboratory stopped urine toxicology testing in 2018. 2. A review of the laboratory's records and the CMS database -- 2 of 12 -- revealed the laboratory did not notify the State Agency when the laboratory stopped testing urine toxicology specimens in 2018 according to 493.51, which states: Laboratories issued a certificate of compliance must meet the following conditions: (a) Notify HHS or its designee within 30 days of any change in-- (1) Ownership; (2) Name; (3) Location; (4) Director; or (5) Technical supervisor (laboratories performing high complexity only). (b) Notify HHS no later than 6 months after performing any test or examination within a specialty or subspecialty area that is not included on the laboratory ' s certificate of compliance, so that compliance with requirements can be determined. (c) Notify HHS no later than 6 months after any deletions or changes in test methodologies for any test or examination included in a specialty or subspecialty, or both, for which the laboratory has been issued a certificate of compliance.. 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 record review and interview with the Testing Personnel, the Laboratory Director failed to ensure the laboratory verified performance specifications for the Sentosa SA201 test system and the Atila BioSystems test system used in COVID-19 testing for 5 (July 2020 to December 2020) of 5 months the laboratory has been testing patients for COVID-19. Findings include: 1. A review of the laboratory's "Policy and Procedure" revealed a section titled "Validation" stating, "Sars-covid19-rt PCR test validation consistes of running the positive and negative controls plus 2 negative and two positive samples two times in two different days. EUA document and FDA document are showing approval of the usage of covid test reagents. The accuracy and the sensitivity is so important and must be 98% or above." 2. A review of the laboratory's "Accuracy Study" revealed it did not contain the verification of performance specifications for the Vela Diagnostics Sentosa SA201 for precision. 3. A review of the laboratory's data revealed it did not contain verification of performance specifications for the Atila BioSystems test system for accuracy or precision. 4. An interview on 12/28/20 at 10:09 am with the Testing Personnel confirms the above verification of performance specifications were not available. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: . Based on record review and interview with the Testing Personnel, the Laboratory Director failed to ensure quality assessment programs were maintained for 2 (December 2018 to December 2020) of 2 years reviewed. Findings include: 1. A review of the laboratory's "Patient Test Management (Test Tracking) System" policy revealed a sections stating, "to verify the integrity of the communication path from physician order to patient test record." and "Each element of the Patient Test -- 3 of 12 -- Management (PTM) system should be evaluated annually." 2. A review of the laboratory's records revealed a lack of annual reviews for the Patient Test Management System between December 2018 and December 2020. 3. An interview on 12/28/20 at 11:20 am with the Testing Personnel confirmed the annual Patient Test Management System reviews were not available. 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 record review and interview, the Technical Supervisor did not meet the qualification requirements of 493.1449. Findings include: 1. The Technical Supervisor failed to provide experience documentation needed for to qualify as a Technical Supervisor. See 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 -- 4 of 12 -- 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 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 -- 5 of 12 -- 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 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 -- 6 of 12 -- 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 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 -- 7 of 12 -- 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 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 -- 8 of 12 -- 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 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 -- 9 of 12 -- 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 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 record review and interview with the Testing Personnel, the Technical Supervisor failed to provide experience documentation to qualify as a Technical Supervisor for 1 (Technical Supervisor #1) of 1 Technical Supervisors listed on the CMS-209 form. Findings include: 1. The surveyor requested educational and experience documentation for Technical Supervisor #1 listed on the CMS-209 form on 12/28/20 at 9:25 am and the following was not made available: a. Documentation of 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. 2. An interview on 12 /28/20 at 12:41 pm with the Testing Personnel confirmed the laboratory did not have -- 10 of 12 -- the experience documentation available for Technical Supervisor #1. 3. The laboratory was given an additional 7 days to provide the necessary documentation and it was not made available. D6141 GENERAL SUPERVISOR CFR(s): 493.1459 The laboratory must have one or more general supervisors who are qualified under 493.1461 of this subpart to provide general supervision in accordance with 493.1463 of this subpart. This CONDITION is not met as evidenced by: . Based on record review and interview, the General Supervisor did not meet the qualification requirements of 493.1463. Findings include: 1. the General Supervisor failed to provide experience documentation to qualify as a General Supervisor. Refer to D6143. D6143 GENERAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1461 (a) The general supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The general supervisor must be qualified as a-- (b)(1) Laboratory director under 493.1443; or (b)(2) Technical supervisor under 493.1449. (c) If the requirements of paragraph (b)(1) or paragraph (b)(2) of this section are not met, the individual functioning as the general supervisor must-- (c)(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 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; and (c)(1)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing; or (c)(2)(i) Qualify as testing personnel under 493.1489(b)(2); and (c)(2)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing; or (c)(3)(i) Except as specified in paragraph (3)(ii) of this section, have previously qualified as a general supervisor under 493.1462 on or before February 28, 1992. (c)(3)(ii) Exception. An individual who achieved a satisfactory grade in a proficiency examination for technologist given by HHS between March 1, 1986 and December 31, 1987, qualifies as a general supervisor if he or she meets the requirements of 493. 1462 on or before January 1, 1994. (c)(4) On or before September 1, 1992, have served as a general supervisor of high complexity testing and as of April 24, 1995-- (c) (4)(i) Meet one of the following requirements: (c)(4)(i)(A) Have graduated from a medical laboratory or clinical laboratory training program approved or accredited by the Accrediting Bureau of Health Education Schools (ABHES), the Commission on Allied Health Education Accreditation (CAHEA), or other organization approved by HHS. (c)(4)(i)(B) Be a high school graduate or equivalent and have successfully completed an official U.S. military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician). (c)(4)(ii) Have at least 2 years of clinical laboratory training, or experience, or both, in high complexity testing; or (c) (5) On or before September 1, 1992, have served as a general supervisor of high complexity testing and-- (c)(5)(i) Be a high school graduate or equivalent; and (c)(5) (ii) Have had at least 10 years of laboratory training or experience, or both, in high -- 11 of 12 -- complexity testing, including at least 6 years of supervisory experience between September 1, 1982 and September 1, 1992. (d) For blood gas analysis, the individual providing general supervision must-- (d)(1) Be qualified under 493.1461(b)(1) or (2), or 493.1461(c); or (d)(2)(i) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (d)(2)(ii) Have at least one year of laboratory training or experience, or both, in blood gas analysis; or (d)(3) (i) Have earned an associate degree related to pulmonary function from an accredited institution; and (d)(3)(ii) Have at least two years of training or experience, or both in blood gas analysis. (e) The general supervisor requirement is met in histopathology, oral pathology, dermatopathology, and ophthalmic pathology because all tests and examinations, must be performed: (e)(1) In histopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l)(1); (e)(2) In dermatopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l) or (2); (e)(3) In ophthalmic pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(1)(3); and (e)(4) In oral pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(m). This STANDARD is not met as evidenced by: Based on record review and interview with the Testing Personnel, the General Supervisor failed to provide experience documentation to qualify as a General Supervisor for 1 (General Supervisor #1) of 1 General Supervisors listed on the CMS- 209 form. Findings include: 1. The surveyor requested educational and experience documentation for General Supervisor #1 listed on the CMS-209 form on 12/28/20 at 9:25 am and the following was not made available: a. Documentation of at least 1 year of laboratory training or experience, or both, in high complexity testing. 2. An interview on 12/28/20 at 12:41 pm with the Testing Personnel confirmed the laboratory did not have the experience documentation available for General Supervisor #1. 3. The laboratory was given an additional 7 days to provide the necessary documentation and it was not made available. -- 12 of 12 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to retain 1) patients report in the laboratory information system (LIS) and 2) the testing personnel performing the toxicology testing, and 3) the quality control records for three (#2-#4) of seven patient charts audited. Findings include: 1. On April 18, 2018 at 1:54 PM, record review for three of seven patient charts audited revealed 1) the patient's final report 2) the testing personnel performing the toxicology testing and 3) the quality control records for the toxicology testing was not available to the surveyor on the day of the survey. Results were on the old LIS system and irretrievable at the time of the survey. 2. During the interview on April 18, 2018 at 1:54 PM, general supervisor #1 as listed on the CMS-209 confirmed the patient test results, testing personnel, and the quality control records were not available to the surveyor at the time of the survey. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to verify the accuracy of testing for the urine toxicology testing for one (2017) of two years at least twice 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 -- annually. Findings include: 1. On April 18, 2018 at 1:02 PM, record review for the verification of accuracy of the urine toxicology testing revealed there was no documentation to show the testing was completed at least twice annually in 2017 for the following panels and corresponding individual drugs as follows: a. Anti-Epileptics 1. Carbamazepine 2. Gabapentin 3. Pregabalin b. Anti-Psychotics 1. 9- Hydroxyrisperidone 2. Dehydro aripiprazole 3. Desmethylolanzapine 4. Haloperidol 5. Ioperidone 6. Ziprasidone c. Barbiturates 1. Butalbital 2. Phenobarbital 3. Secobarbital d. Benzodiazepines 1. 7-Amino Clonazepam 2. Alpha Hydroxyalprazolam 3. Alpha Hydroxytriazolam 4. Alprazolam 5. Lorazepam 6. Nordiazepam 7. Oxazepam 8. Temazepam e. Illicits 1. Benzoylecgonine 2. MDMA 3. PCP 4. THC-COOH f. Muscle Relaxants/Sedatives 1. Cyclobenzaprine 2. Meprobamate g. Opioids 1. 6-Acetylmorphine 2. Burprenorphine 3. Codeine 4. Fentanyl 5. Hydrocodone 6. Hydromorphone 7. Meperidine 8. Methadone 9. Morphine 10. Norbuprenorphine 11. Norfentanyl 12. Norhydrocodone 13. Normeperidine 14. Oxycodone 15. Oxymorphone 16. Tapentadol 17. Tramadol h. Others 1. 7-Hydroxymitragynine 2. Cotinine 3. Ketamine 4. Mitragynine 5. Norketamine 6. Zolpidem 7. Zolpidem P4CA i. - SSRI/SNRI 1. Duloxetine 2. Fluoxetine 3. N-Desmethylcitalopram 4. Paroxetine 5. Venlafaxine j. - Stimulants 1. Amphetamine 2. Methamphetamine 3. Phentermine 4. Ritalinic acid k. - TCA: Trycyclic Antidepressants 1. Amitriptyline 2. Desipramine 3. Imipramine 4. Nortriptyline 2. During the interview on April 18, 2018 at 1:02 PM, general supervisor #1 as listed on the CMS-209 confirmed the testing was not completed. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Based on observation and interview, the laboratory failed to label the toxicology reagents with the preparation and/or expiration date for the reagents "AA, MeOH, 5mm no FA, AB ammonium acetate + LCMS H2O + formic acid, B Acetonitrile Rinse 75% methanol 25% LCMS H2O and the IPA {needle rinse}" on the day of the survey. Findings include: 1. On April 18, 2018 at 9:20 AM during a tour of the laboratory, the surveyor observed bottled reagents in use that did not have documentation of a preparation and/or expiration date as follows: a. prep room - 1. AA - no preparation or expiration date 2. MeOH - no prepartion or expiration date 3. 5mm no FA - no prepartion or expiration date b. processing room - 1. AB ammonium acetate + LCMS H2O + formic acid - no expiration date 2. B Acetonitrile - no prepartion or expiration date 3. Rinse 75% methanol 25% LCMS H2O - no expiration date 4. IPA - no prepartion or expiration date 2. During the tour on April 18, 2018 at 9: 20 AM, general supervisor #1 as listed on the CMS-209 confirmed the reagent bottles did not contain a prepartion and/or expiration date. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory -- 2 of 3 -- must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview, the laboratory failed to perform and document 1) thermometer calibrations for 24 (April 18, 2016 to April 18, 2018) of 24 months, 2) pipette calibration for one (2017) of two years, and 3) weekly eyewash flush maintenance for one (November 2016) of 19 months reviewed. Findings include: 1. During a tour of the laboratory on April 18, 2018 at 9:20 AM, the surveyor observed a MarketLab thermometer in refrigerator #1 and one for room temperature with a calibration due date of 10/31/09. 2. On April 18, 2018 at 11:31 AM and 11:33 AM, record review of the "Maintenance, Temperatures, Pipettes, and Eyewash" manual revealed the lab did not have any documentation for the following: a. annual pipette calibration for one (2017) of two years reviewed from April 18, 2016 to April 18, 2018. b. eyewash flush revealed the laboratory did not have any documentation to show the weekly flush was completed for one (November 2016) of 19 months reviewed. 3. On April 18, at 9:20 AM, 11:31 AM, and 11:33 AM, general supervisor #1 as listed on the CMS-209 confirmed the thermometers and pipettes were not calibrated annually and the eyewash flush was not performed weekly in November of 2016. ***Repeat Deficiency from the October 3, 2016 survey*** D5785