Quality Of Life Medical Center, Llc

Summary Statement of Deficiencies 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 lack of accuracy verification documentation for review and interview with the Technical Consultant (TC-1), the laboratory failed to verify the accuracy of urine drug screen testing performed under the subspecialty of Toxicology at least twice annually during 2024. Findings include: 1. The laboratory performs urine drug screens on patient samples utilizing the Siemens Aviva-ProE analyzer with an annual test volume of 13,000. 2. The laboratory failed to provide documentation to indicate the laboratory verified the accuracy of urine drug screen testing testing at least twice annually during 2024. 3. The TC-1 interviewed on 1/21/25 at 10:45 AM confirmed the laboratory failed to verify the accuracy of urine drug screen testing testing at least twice annually during 2024. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of established quality assessment (QA) policies and procedures and interview with the Technical Consultant (TC-1), the laboratory failed to establish Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- policies and procedures to monitor, assess and correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. Findings include: 1. No QA documentation was provided for review during the survey conducted on 1/21/25 to indicate the laboratory established policies and procedures to monitor, assess and, when indicated, correct problems identified in the general laboratory system requirements specified at 493.1231 through 493.1236, including but not limited to Proficiency Testing. 2. The TC-1 interviewed on 1/21/25 at 11:00 AM confirmed the laboratory failed to provide documentation of an established QA policy and procedure to monitor, assess and correct problems identified in the general laboratory systems requirements. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on lack of written policies and procedures for review and interview with the Technical Consutlant (TC-1), the laboratory failed to establish policies and procedures for patient preparation, specimen collection, specimen labeling, specimen storage and preservation, conditions for specimen transportation, specimen processing, specimen acceptability and rejection, and specimen referral. Findings include: 1. The laboratory performs urine drug screens on patient samples utilizing the Siemens Aviva-ProE analyzer with an annual test volume of 13,000. 2. No documentation was presented for review during the survey conducted on 1/21/25 to indicate the laboratory established policies and procedures for patient preparation, specimen collection, specimen labeling, specimen storage and preservation, conditions for specimen transportation, specimen processing, specimen acceptability and rejection, and specimen referral. 3. The TC-1 interviewed on 1/21/25 at 10:15 AM confirmed the laboratory failed to provide evidence of the above referenced policies and procedures at the time of the survey D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of temperature records from 2024 and interview with the Technical -- 2 of 4 -- Consultant (TC-1), the laboratory failed to monitor and document the humidity, room, refrigerator and freezer temperatures for one of three days of patient testing. Findings include: 1. The laboratory performs urine drug screens on patient samples utilizing the Siemens Aviva-ProE analyzer with an annual test volume of 13,000. 2. The laboratory records the humidity, room, freezer and refrigerator temperatures on each day of patient testing. 3. The laboratory failed to provide documention demonstrating the humidity, room, freezer and refrigerator temperatures were monitored and recorded on one of three testing dates reviewed during the survey: 11/27/24. 4. The number of patients tested on the dates indicated above could not be determined at the time of the survey. 5. The TC-1 interviewed on 1/21/25 at 10:00 AM confirmed the laboratory failed to monitor and document the humidity and temperatures as indicated above. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records from 2023 through 2024, lack of QC lot correlation documentation and interview with the Technical Consultant (TC-1), the laboratory failed to verify the criteria for acceptability of quality control materials. Findings include: 1. The laboratory performs urine drug screens on patient samples utilizing the Siemens Aviva-ProE analyzer with an annual test volume of 13,000. 2. No documentation was presented for review to indicate the laboratory verified the criteria for acceptability of each lot of control material used on the analyzer indicated above from 2023 through 2024. 3. The number of QC lots used on the analyzer from 2023 through 2024 could not be determined at the time of the survey. 4. The TC-1 interviewed on 1/21/2025 at 9:30 AM confirmed the laboratory failed to verify the criteria for acceptability of quality control materials for each lot of QC used on the Siemens Aviva-ProE analyzer from 2023 through 2024. 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. This STANDARD is not met as evidenced by: Based on lack of quality assessment (QA) policies and procedures and interview with the technical consultant (TC-1), the laboratory failed to establish QA policies and procedures to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1256 and 493.1281 through -- 3 of 4 -- 493.1289. Findings include: 1. No QA documentation was provided for review during the survey conducted on 1/21/25 to indicate the laboratory established policies and procedures to monitor, assess and, when indicated, correct problems identified in the analytic systems specified at 493.1251 through 493.1256 and 493.1281 through 493.1289. 2. The facility personnel interviewed on 1/21/25 at 11:00 AM confirmed the laboratory failed to provide documentation of an established QA policy and procedure to monitor, assess and correct problems identified in the analytic systems. D5807 TEST REPORT CFR(s): 493.1291(d) (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of patient test reports for urine drug screens and interview with the Technical Consultant (TC-1), three out of three patient test reports failed to include the reference intervals for urine drug screen results on the test reports issued to the individual responsible for using the test results. Findings include: 1. The laboratory performs urine drug screens on patient samples utilizing the Siemens Aviva-ProE analyzer with an annual test volume of 13,000. 2. Three out of three urine drug screen test reports reviewed during the survey failed to include reference intervals or normal values for urine drug screen testing that is performed using the Siemens Aviva-ProE analyzer. Records include: Accession # 112308 from 1/10/24, Accession # 24095 from 6/27/24, and Accession # 26139 from 11/27/24. 3. The TC-1 interviewed on 1/21 /25 at 9:45 AM confirmed the laboratory's test report failed to include the reference intervals or normal values for urine drug screens. -- 4 of 4 --

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 lack of manufacturer's package inserts presented for review for testing performed on the Siemens Viva-Pro analyzer and interview with the General Supervisor (GS), the laboratory failed to retain the manufacturer's package insert for at least 2 years for each lot of Quality Control (QC) and test reagent material used on the analyzer. Findings include: 1. During the survey conducted on June 21, 2023, no evidence was presented for review to indicate the laboratory retained the manufacturer's assay information sheets for at least 2 years for each lot of QC and test reagent material used on the Siemens Viva-Pro toxicology analyzer. The laboratory began patient testing on the analyzer in August 2022. 2. The GS interviewed on June 21, 2023 at 1:10 PM confirmed the laboratory failed to retain the manufacturer's assay information sheets for at least 2 years for each lot of QC and test reagent material used on the analyzer indicated above. 3. The laboratory reports approximately 75,120 patient tests annually. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's CMS-209 personnel form, review of the Technical Consultant/Supervisor competency evaluation form and interview with the laboratory general supervisor listed on the CMS-209 (GS-TP1), the laboratory failed to establish written policies and procedures to assess employee and supervisor competency. Findings include: 1. The laboratory's CMS-209 personnel form lists two (2) Technical Consultants and Technical Supervisors (TC-1/TS-1 and TC-2/TS-2), and one (1) general supervisor (GS-TP1). 2. The laboratory lacked documentation of a competency assessment for TC-2/TS-2 listed on the CMS-209 form. 3. The "Technical Consultant/Supervisor Competency Evaluation" form presented for review for TC-1/TS-1 from January 20, 2020 failed to include the laboratory director signature and date, as required on the form. 4. The laboratory lacked a policy or procedure for competency evaluation and documentation of the technical consultant, technical supervisor and general supervisor, including but not limited to, frequency of the competency assessment. 5. The laboratory lacked a policy or procedure for documenting training and competency assessments for persons performing preanalytic (specimen collection) activities in the laboratory. 6. The GS-TP1 interviewed on June 21, 2023 at 11:09 AM confirmed the lack of established policy or procedures for performing and documenting competency assessments for the Technical Consultants, Technical Supervisors, General Supervisor and persons performing preanalytic activities. 7. The laboratory's reported annual test volume is 75,120, in the subspecialty of Toxicology. 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 review of patient test requisitions and interview with the General Supervisor (GS), two out of two test requisitions reviewed during the survey failed to include the time of specimen collection. Findings include: 1. The laboratory utilizes the Siemens Viva-Pro analyzer for urine drug screen testing and the Sciex API4000 LC/MS analyzer for drug confirmation testing. 2. Two out of two test requisitions presented for review during the survey for MR# 23329 from 11/11/21 and MR# 12195 from 4/13 /23 failed to include the time of specimen collection. 3. The GS interviewed on June 21, 2023 at 12:42 PM confirmed the time of specimen collection was not documented on the test requisitions referenced above. D5407 PROCEDURE MANUAL -- 2 of 6 -- CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's test procedures and interview with the General Supervisor (GS), the laboratory failed to have the current laboratory director approve, sign and date test procedures before use. Findings include: 1. The current laboratory director assigned on the CMS-209, Laboratory Personnel Form presented for review during the survey has been listed as laboratory director in the CLIA Federal Database since March 16, 2023. 2. The Laboratory Director failed to approve, sign and date the following test procedures reviewed during the survey: Siemens Viva-ProE Pain Panel, General Operation Pain Panel and Sciex LC/MS Pain Panel. 3. The GS interviewed on June 21, 2023 at 11:01 AM confirmed the test procedures indicated above were not approved, signed and dated by the current laboratory director. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control (QC) records and policies, lack of QC lot correlation documentation and interview with the General Supervisor (GS), the laboratory failed to verify the criteria for acceptability of quality control materials used on the Siemens Viva-Pro toxicology analyzer. Findings include: 1. The laboratory performs a semi-quantitative urine drug screen test on the Siemens Viva- Pro analyzer. The laboratory's reported annual test volume is 75,120. 2. No documentation was presented for review to indicate the laboratory verified the criteria for acceptability of each lot of control material used on the analyzer indicated above from August 2022 through the date of the survey on June 21, 2023. 3. The GS interviewed on June 21, 2023 at 1:12 PM confirmed the laboratory failed to verify and document the criteria for acceptability of control materials used on the Siemens Viv- Pro analyzer from August 2022 through June 21, 2023. 4. The number of QC lots used on the analyzer from August 2022 through the date of the survey could not be determined at the time of the survey. D5781

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) evaluations for 2019 and interview with the facility personnel, the laboratory failed to evaluate and review the PT results for Urine Drug testing. Findings include: 1. The laboratory participated in PT provided by CAP, performing 2 separate testing events for each program during 2019. The PT programs included Urine Drug Adulterant (DAI-2019, A & B) and Drug Monitoring for Pain Management (DMPM-2019, A & B). 2. No documentation of a review, including a written comment and signature, was presented during the survey that indicated the laboratory director or designee reviewed the PT results for each testing event of 2019. 3. The facility personnel acknowledged that the PT results indicated above were not evaluated and reviewed. 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 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 -- 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 review of patient test requisitions and interview with the facility personnel, the laboratory's test requisition failed to include the test(s) to be performed. Findings include: 1. The laboratory performs patient testing under the sub-specialties of Routine Chemistry and Toxicology, with an approximate annual test volume of 102,720. The laboratory performs a drug screen on the Carolina Industries CLC720 analyzer and a confirmation drug screen on the AB Sciex API4000 LC/MS analyzer. 2. The test requisition (MR# 25181) reviewed during the survey conducted on January 20, 2021 indicated the lab tests as "Drug Screen" and "Drug Confirmation". 3. The laboratory failed to produce documentation, whether on the test requisition or in laboratory policy, to indicate the specific analytes that are tested by the laboratory on the Carolina Industries CLC720 analyzer for a 'Drug Screen'. 4. The laboratory failed to produce documentation, whether on the test requisition or in laboratory policy, to indicate the specific analytes that are tested by the laboratory for a 'Drug Confirmation' performed on the AB Sciex API4000 LC/MS analyzer. 5. The urine drug screen performed by the laboratory on the CLC720 analyzer tests for the following analytes: 6-Acetyl Morphine, DRI Amphetamine, Benzodiazepine, Buprenorphine, Cocaine, Methadone, Ethanol, Opiate, Oxycodone, Cannabinoid, Urine Creatinine, and pH. 6. The urine drug confirmation performed by the laboratory on the API4000 LC/MS analyzer tests for the following drug classes: Methadone, Amphetamines, Muscle Relaxant, Benzodiazepines, Opiate, Tapentadol, Fentanyl, Methylenedioxyamphetamine, Heroin, Hypnotic, Oxycodone, Tramadol, PCP, Synthetic Opioid, Buprenorphine, Cannabinoid and Cocaine. 6. The facility personnel confirmed that the test requisitions reviewed during the survey failed to include the specific analytes tested in a Urine Drug Screen and a Urine Drug Confirmation. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory policy and procedure manual presented for review during the survey and interview with the facility personnel, the laboratory failed to have a procedure manual that was approved, signed, and dated by the current laboratory director. Findings include: 1. The laboratory's procedure manual presented for review during the survey conducted on January 20, 2021 failed to include the approval, signature and date of the laboratory director. 2. The facility personnel acknowledged that the procedure manual was not signed and dated by the laboratory director at the time of the survey. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the -- 2 of 3 -- performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with the facility personnel, the laboratory failed to document the competency evaluation of one testing personnel for 2019. Findings include: 1. No 2019 competency evaluation was presented for review for one out of one testing personnel. 2. The facility personnel confirmed the testing personnel indicated above was missing a competency evaluation for 2019. -- 3 of 3 --

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 lack of test requisition documentation for review and interview with the facility personnel, the laboratory failed to have a written or electronic request for patient testing for one patient record reviewed during the survey. Findings include: 1. The laboratory began patient testing in April 2017 under the sub-specialties of Routine Chemistry and Toxicology, with an approximate annual test volume of 134,744. The laboratory performs a urine drug screen on the Carolina Industries CLC720 analyzer and performs a drug confirmation test using a Sciex API 4000 LC /MS analyzer. 2. Review of test report for patient R.B. indicated a drug screen was performed on 01/23/18 and a drug confirmation test was performed on 01/26/18. 3. No documentation was presented for review during the survey to indicate the laboratory had a written or electronic test requisition for either test performed on the patient indicated above. 4. The facility personnel confirmed that the laboratory did not have an electronic or written copy of the test requisition for testing that was performed on the patient specimen indicated above, and confirmed that the laboratory did not have a system in place at the time of the survey to document and retain patient test requisitions. 5. The number of patients tested without a test requisition could not be determined at the time of the survey. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed 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 -- in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on review of established and verified performance specification documentation for the Carolina Industries CLC720 analyzer used for urine drug screens and for the Sciex API 4000 LC/MS analyzer used for urine drug confirmation testing and interview with the facility personnel, the laboratory (A) failed to establish the reportable range and reference range for pH and Creatinine testing performed on the CLC720 analyzer and (B) failed to document information regarding interfering substances that may effect the analytical specificity of the LC/MS test system. Findings include. A1. The performance specification documentation presented for review for the Carolina Industries CLC720 analyzer failed to include documentation to indicate the laboratory established the reportable range and reference range for pH and Creatinine testing that is performed on the analyzer. A2. The facility personnel confirmed that the laboratory did not establish or verify the reportable range or reference range for pH and Creatinine testing performed on the analyzer indicated above prior to testing patient specimens. B1. The performance specification documentation presented for review during the survey failed to include documentation regarding interfering substances that may effect and/or inhibit the analytical specificity of the test system, including but not limited to, information regarding the patients' clinical conditions, disease states, and any common medications. B2. The facility personnel acknowledged that there was no specific analysis performed that included the effects of the patients' clinical conditions, disease states and common medications as possible interfering substances that may effect analytical specificity of the test system. 3. The laboratory started patient testing using the Carolina Industries CLC720 analyzer and the Sciex API 4000 LC/MS analyzer in April 2017 with an approximate annual test volume of 134, 744. 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 review of patient test reports and interview with the facility personnel, the laboratory failed to include on the test report the laboratory address where the testing was performed. Findings include: 1. The laboratory performs patient testing in the -- 2 of 3 -- specialty of Chemistry, with an approximate annual test volume of 134,744. The laboratory address listed in the CLIA database for CLIA# 03D1012182 is 5390 E. Erickson Rd., Tucson, AZ 85712. 2. One patient test report reviewed during the survey listed the laboratory address as 5350 E. Erickson Rd., Tucson, 85712. 3. The facility personnel confirmed that the laboratory address where the testing was performed was not listed correctly on the test reports issued by the laboratory since testing began in April 2017. D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) The technical supervisor is responsible for verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on lack of verification documentation for testing performed by the laboratory and interview with the facility personnel, the technical supervisor failed to ensure the establishment of the laboratory's test performance characteristics, including the assessment of interfering substances, reference range and reportable range. See D5423 for findings. -- 3 of 3 --