Advanced Orthopedics And Sports Medicine

Summary Statement of Deficiencies D0000 A Recertification survey was performed on February 22, 2024 at Advanced Orthopedics and Sports Medicine, CLIA ID # 19D2142238. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and twice per year verification records as well as interview with laboratory personnel, the laboratory failed to ensure proficiency testing samples were tested in the same manner as patients for two (2) of three (3) testing events. Findings: 1. Review of the laboratory's "Proficiency Testing Procedure" policy revealed "All proficiency testing samples will be tested in the same manner as patient samples." 2. Review of the laboratory's American Proficiency Institute (API) testing records revealed the laboratory tested the following samples twice: a) 2022 Chemistry - Miscellaneous - 2nd Event - UDS-04, UDS-05, UDS-06 b) 2023 Chemistry - Miscellaneous - 2nd Event - UDS-04, UDS-05, UDS-06 3. In interview on February 22, 2024 at 10:13 a.m., Testing Personnel stated the laboratory did not routinely test patient samples twice and the proficiency samples identified above were tested twice to ensure correct results. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 observation; review of the laboratory's test menu, manufacturer's package inserts and the laboratory's policies; as well as interview with laboratory personnel, the laboratory failed to establish a policy for storage of Toxicology specimens that followed the manufacturer's storage limits. Findings: 1. Observation by surveyor during the laboratory tour on February 22, 2024 at 9:05 a.m. revealed the laboratory utilized the Siemens Viva-ProE and Viva-E analyzers for Toxicology testing. 2. Review of the laboratory's test menu revealed the laboratory performed the following Toxicology testing: Amphetamines, Barbiturates, Benzodiazepines, Cocaine, THC, Opiates, Phencyclidine, and Methadone. 3. Review of the manufacturer's package inserts revealed "...if not analyzed immediately, specimens may be stored unrefrigerated for up to 7 days. Specimens may be stored refrigerated for 30 days before analysis. After 7 days unrefrigerated or 30 days refrigerated, samples should be stored frozen." 4. Review of the laboratory's policy "Urine Collection with Patient Instructions" revealed "After proper collection, the concentration of the following drugs in urine will not change significantly for at least ten (10) days at room temperature..." which exceeded the room temperature storage limits of the manufacturer. 5. In interview on February 22, 2024 at 12:23 p.m., Testing Personnel confirmed the laboratory's room temperature storage limits exceeded the room temperature storage limits of the manufacturer. 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 observation, review of validation records, and interview with personnel, the laboratory failed to have complete performance specification studies for the Viva- ProE analyzer. Findings: 1. Observation by surveyor during the laboratory tour on February 22, 2024 at 9:05 a.m. revealed the laboratory utilized the Viva-ProE analyzer serial number 22-1354. 2. Review of the laboratory's validation records revealed the laboratory did not include a validation plan and/or review for the -- 2 of 6 -- following studies: a) Accuracy b) Precision - to include day to day and run to run 3. In interview on February 22, 2024 at 11:40 a.m., Testing Personnel confirmed the above studies were not included in the validation records. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory 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 by surveyor, review of the operator's manuals and the laboratory's maintenance logs, as well as interview with laboratory personnel, the laboratory failed to perform quarterly maintenance procedures for the Toxicology analyzers were performed as required by the manufacturer for two (2) of four (4) quarters reviewed in 2023. Findings: 1. Observation by surveyor during the laboratory tour on February 22, 2024 at 9:05 a.m. revealed the laboratory utilized the Siemens Viva-ProE and Viva-E analyzers for Toxicology testing. 2. Review of the operator's manual for the Siemens Viva-ProE revealed the following required quarterly maintenance: - Replace the drying block 3. Review of the operator's manual for the Siemens Viva-E revealed the following required quarterly maintenance: a) Replace mixer belts. b) If not done by the service technician during preventative maintenance: - Replace water filter. - Replace drying block on wash arm. 4. Review of the laboratory's 2023 maintenance records for the Siemens Viva-ProE and Viva-E analyzers revealed the laboratory did not perform quarterly maintenance as follows: a) First quarter - not performed January through March 2023 b) Third quarter - not performed when due July 2023 5. In interview on February 22, 2024 at 11:40 a.m., Testing Personnel stated maintenance was being performed every four (4) months. She confirmed the maintenance identified above was not performed quarterly. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, observation, and interview with laboratory personnel, the laboratory failed to perform function checks as required by the laboratory for the centrifuge timer. Findings: 1. Review of the laboratory's "Centrifuge Operation" policy revealed "The timer will be checked every three months...The findings will be documented and the timer findings tagged on the centrifuge." 2. Observation by laboratory personnel during the laboratory tour on February 22, 2024 at 9:05 a.m. revealed the laboratory utilized a centrifuge for -- 3 of 6 -- spinning turbid specimens, but the centrifuge did not have documentation of a timer check. 3. In interview on February 22, 2024 at 11:50 a.m., Testing Personnel confirmed timer checks were not being performed on the centrifuge. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A Recertification survey was performed on June 17, 2022 at Advanced Orthopedics and Sports Medicine, CLIA ID # 19D2142238. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 review of laboratory policy and quality control records as well as interview with personnel, the laboratory failed to retain records of quality control troubleshooting for at least two (2) years for urine drug screen testing. Findings: 1. Review of the laboratory's quality control (QC) records and instrument records for urine drug screen testing revealed Benzodiazepine QC with the expected result of "positive" resulted negative on November 23, 2021. Further review of QC records resulted in no additional troubleshooting. 2. Interview with testing personnel on June 17, 2022 at 10:05am confirmed there was no record of quality control rerun with the expected Benzodiazepine result of positive. Testing Personnel also stated any out of range QC would be repeated prior to patient testing, but that record could not be produced at the time of the survey. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier 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 2 -- identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of random selection of patient test reports and interview with personnel, the laboratory failed to include the address of the laboratory where testing was performed. Findings: 1. Review of the following laboratory's patient test reports which is generate by the urine drug screen analyzer revealed the address of the laboratory that performed the testing was not the correct physical address of the laboratory. 2. In interview on June 17, 2022 at 9:45 am, the testing personnel stated the laboratory had relocated in March of 2022 to a new office. The laboratory was unable to change the physical address generated by the instrument upon relocation. The testing personnel confirmed the street address on the report was not correct. D6026 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(8) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(8) Ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure patient final reports included the address of the laboratory. Refer to D5805. -- 2 of 2 --

Summary Statement of Deficiencies D0000 AN INITIAL CERTIFICATION SURVEY was performed at Advanced Orthopedics and Sports Medicine - CLIA # 19D2142238 on May 21, 2018. Advanced Orthopedic and Sports Medicine was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1403 CONDITION: Laboratory Director performing moderate complexity testing. 42 CFR 493.1409 CONDITION: Technical Consultant. 42 CFR 493.1421 CONDITION: Testing Personnel. 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 policy and procedure manual, and interview with personnel, the laboratory failed to establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to establish written policies and procedures that include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel involved in any phase of laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative 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 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 -- samples or external proficiency testing samples. f) Assessment of problem solving skills. 2. Interview with personnel 2 on May 21, 2018 confirmed the laboratory failed to have a complete policy and procedure manual. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory failed to include the gender of the patient, and the specimen collection time on the patient test requisition for nine (9) of nine (9) patients received. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory did not include a policy for test requisitions that included: a) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. b) The patient's name or unique patient identifier. c) The sex and age or date of birth of the patient. d) The test(s) to be performed. e) The source of the specimen, when appropriate. f) The date and, if appropriate, time of specimen collection. g) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. 2. Review of a random selection of patient test requisitions from February 12, 2018 through May 15, 2018 revealed the laboratory failed to include the gender of the patient, and the specimen collection time on the patient test requisition for the following nine (9) patients for Urine Drug Screen (UDS) testing. NOTE: UDS testing includes: Amphetamine (Amph), Barbiturate (Barb), Benzodiazepine (BZO), Cocaine (COC) Ecstasy, Methadone (Meth), Opiate (OPI), and Cannabinoids (THC): On February 12, 2018 Patient 1. On February 26, 2018 Patient 2. On March 5, 2018 Patient 4. On March 23, 2018 Patient 3. ON April 6, 2018 Patient 6. On April 26, 2018 Patient 5. On May 3, 2018 Patients 7 and 8. On May 15, 2018 Patient 9. 3. Interview with personnel 2 on May 21, 2018 revealed the laboratory began UDS testing on February 11, 2018. Personnel 2 also revealed that samples for UDS are collected inhouse and at another location. Personnel 2 did confirm the laboratory failed to document the gender of the patient and the collection time of the specimen. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) -- 2 of 9 -- If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to establish detailed written instructions for the facilities the laboratory provides services for to maintain the integrity of samples and ensure accurate and reliable testing. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed instructions for specimen types, and the collection containers for the sample. However the laboratory failed to address: a) Collection techniques/methods to ensure that the appropriate specimen is collected and that the integrity of the sample meets the manufacturer's instructions b) Test Systems and methodologies. storage requirements and transportation needs for the Siemens Viva E Analyzer for Urine Drug Screen (UDS) testing which includes: Amphetamine (Amph), Barbiturate (Barb), Benzodiazepine (BZO), Cocaine (COC) Ecstasy, Methadone (Meth), Opiate (OPI), and Cannabinoids (THC): c) If the samples needed to be centrifuged to meet the manufacturer's instructions to maintain the integrity of the samples. d) Transportation of the samples to the laboratory at appropriate temperatures: if the samples needed to be maintained at room temperature, refrigerated or frozen. 2. Interview with personnel 2 on May 21, 2018 revealed he was unaware the laboratory was receiving samples from and outside source. Personnel 2 confirmed the laboratory manual does not include all the information required to maintain the integrity of patient samples. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with personnel, the laboratory failed to ensure the laboratory policy and procedure manual contained complete policies and procedures. Findings: 1. Review of the laboratory policy and procedure manual revealed the laboratory failed to have policies and procedures for: Test Requisitions: what mandated information needs to be on the test requisition: a) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. b) The patient's name or unique patient identifier. c) The sex and age or date of birth of the patient. d) The test(s) to be performed. e) The source of the specimen, when appropriate. f) The date and, if appropriate, time of specimen collection. g) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. Performance specifications to include: a) Detailed policies and procedures for testing personnel that instructed testing personnel what to do for studies for accuracy, precision (day-to-day, run-to-run, and -- 3 of 9 -- within-run variation, as well as operator variance), reportable and reference ranges and analytical sensitivity and specificity. a) Acceptability criteria for each of the studies for accuracy, precision, reportable and reference ranges and analytical sensitivity and specificity. a) Policies and procedures for when data from the studies for precision, accuracy, reportable range, reference range, analytical sensitivity and analytical specificity fail to meet acceptability criteria. Description of the course of action to take if the Siemens Viva E Analyzer becomes inoperable. Personnel Competency to include written policies and procedures that include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel performing laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative 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 that assessments are to be performed semi annually the first year and annually thereafter. 2. Interview with personnel 2 on May 21, 2018 confirmed the policy and procedure manual was incomplete D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on observation and record review, the laboratory failed to include on the report for Urine Drug Screen tests a statement that states the results are preliminary results and the disclaimer contained in the Siemens Viva E package inserts on the report for Urine Drug Screen testing. Findings 1. Observation by surveyors during the tour of the laboratory on May 21, 2018 revealed the laboratory maintained a Siemens Viva E Analyzer for testing Amphetamine (Amph), Barbiturate (Barb), Benzodiazepine (BZO), Cocaine (COC) Ecstasy, Methadone (Meth), Opiate (OPI), and Cannabinoids (THC). 2. Review of the Siemens Syva Emit Assay sheets for Amph, Barb, BZO, COC, Ecstasy, Meth, OPI, and THC revealed that these "assays provides only preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgement should be applied to any drug-of-abuse test results, particularly when preliminary positive results are used." 3. Review of a random selection of patient test records from February 12, 2018 through May 15, 2018 for Urine Drug Screen testing performed on the Siemens Viva E revealed the laboratory failed to state the results are preliminary and failed to add the disclaimer stated above for the following nine (9) -- 4 of 9 -- patients. On February 12, 2018 Patient 1. On February 26, 2018 Patient 2. On March 5, 2018 Patient 4. On March 23, 2018 Patient 3. ON April 6, 2018 Patient 6. On April 26, 2018 Patient 5. On May 3, 2018 Patients 7 and 8. On May 15, 2018 Patient 9. 4. Interview with personnel 2 on May 21, 2018 revealed laboratory personnel were unaware the laboratory had to assure that the reports stated the results were just preliminary results and that a disclaimer had to to be on each report. Personnel 2 confirmed patient reports failed to state results were preliminary and failed to include the disclaimer. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on observation, record review and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. Findings: 1. The Laboratory Director failed to ensure that all personnel have the appropriate education and experience to accurately report patient test results. Refer to D6029. 2 The Laboratory Director failed to ensure that an approved procedure manual was available to all personnel responsible for any aspect of the testing process. Refer to D6031. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records and interview with laboratory personnel, the Laboratory Director failed to ensure that all personnel have the appropriate education and experience to accurately report patient test results. Findings: 1. The Technical Consultant failed to possess a current license issued by the State of Louisiana. Refer to D6035. 2. The laboratory failed to provide documentation that testing personnel met the educational qualifications for performing moderate complexity testing for one (1) of one (1) testing personnel. Refer to D6065. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform -- 5 of 9 -- test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the Laboratory Director failed to ensure that an approved procedure manual was available to all personnel responsible for any aspect of the testing process. Findings: 1. Review of the laboratory policy and procedure manual revealed the laboratory failed to have policies and procedures for: Test Requisitions: what mandated information needs to be on the test requisition: a) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. b) The patient's name or unique patient identifier. c) The sex and age or date of birth of the patient. d) The test(s) to be performed. e) The source of the specimen, when appropriate. f) The date and, if appropriate, time of specimen collection. g) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. Performance specifications to include: a) Detailed policies and procedures for testing personnel that instructed testing personnel what to do for studies for accuracy, precision (day-to-day, run-to-run, and within-run variation, as well as operator variance), reportable and reference ranges and analytical sensitivity and specificity. a) Acceptability criteria for each of the studies for accuracy, precision, reportable and reference ranges and analytical sensitivity and specificity. a) Policies and procedures for when data from the studies for precision, accuracy, reportable range, reference range, analytical sensitivity and analytical specificity fail to meet acceptability criteria. Description of the course of action to take if the Siemens Viva E Analyzer becomes inoperable. Personnel Competency to include written policies and procedures that include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel performing laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative 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 that assessments are to be performed semi annually the first year and annually thereafter. 2. Interview with personnel 2 on May 21, 2018 confirmed the policy and procedure manual was incomplete D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. -- 6 of 9 -- This CONDITION is not met as evidenced by: Based on observation, record review, and interview with personnel, the Technical Consultant (Personnel 2) failed to meet the qualifications and provide technical oversight of the laboratory. Findings: 1. The Technical Consultant (Laboratory Director) failed to meet the qualifications for a Technical Consultant of moderate complexity testing. Refer to D6035. 2. The Technical Consultant failed to provide technical and scientific oversight for the laboratory. Refer to D6036. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(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 (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, 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 (b)(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 (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant 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, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with personnel, the Technical Consultant (Personnel 2) failed to meet the qualifications for a Technical Consultant of moderate complexity testing. Findings: 1. Review of Personnel Records for the Technical Consultant revealed the Technical Consultant failed to possess a current State License. 2. Interview with Personnel 2 on May 21, 2018 revealed he was unaware that he needed to possess a Louisiana State License to fulfill the position of Technical Consultant. Personnel 2 confirmed he did not have a Louisiana State License. -- 7 of 9 -- D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on observation, record review and interview with personnel, the Technical Consultant failed to provide technical and scientific oversight for the laboratory. Findings: 1. Review of the FORM CMS 209 submitted to the surveyor on May 21, 2018 revealed that Personnel 2 fulfilled the duties for Technical Consultant. 2. Observation, record review and interview with personnel revealed the Technical Consultant failed to address the following problems identified in the laboratory: a) The laboratory failed to establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. Refer to D5209. b) The laboratory failed to include the gender of the patient, and the specimen collection time for nine (9) of nine (9) patients received. Refer to D5305. c) The laboratory failed to establish detailed written instructions for the facilities the laboratory provides services for to maintain the integrity of samples and ensure accurate and reliable testing. Refer to D5317. d) The laboratory failed to ensure the laboratory policy and procedure manual contained complete policies and procedures. Refer to D5401. e) The laboratory failed to include on the report for Urine Drug Screen tests a statement that states the results are preliminary results and the disclaimer contained in the Siemens Viva E package inserts on the report for Urine Drug Screen testing. Refer to D5805. 3. Interview with Personnel 2 on May 21, 2018 confirmed it was his responsibility to assure that all the items cited above were in place prior to patient testing. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory failed to ensure testing personnel met the qualifications of education and licensure to perform moderate complexity testing. Findings: 1) The laboratory failed to have evidence that testing personnel performing non-waived testing met the educational qualifications for performing moderate complexity testing, for one (1) of one (1) testing persons. Refer to tag D6065. 2) Interview with personnel 2 on May 21, 2018 confirmed the above findings D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a -- 8 of 9 -- chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to provide documentation that testing personnel met the educational qualifications for performing moderate complexity testing for one (1) of one (1) testing personnel. Findings: 1. Review of personnel records on May 21, 2018 revealed the laboratory failed to maintain documentation of at least a High School Diploma or equivalent for moderate complexity laboratory testing for Personnel 3. 2. Interview with Personnel 2 on May 21, 2018 confirmed the laboratory did not maintain documentation of education for Personnel 3. -- 9 of 9 --