2nd Chance Treatment Center

Summary Statement of Deficiencies 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 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-specialty of Toxicology, with an approximate annual test volume of 300,000. The laboratory utilizes the Diatron Pictus 700 to perform a urine drug screen. 2. The test requisitions (CM495117, DD77000, FM608987 and BL380499) reviewed during the survey conducted on September 15, 2022 indicated the test to be performed as "Toxicology Screen". 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 Diatron Pictus 700 analyzer for a 'Toxicology Screen'. 4. The urine drug screen performed by the laboratory on the Diatron Pictus 700 analyzer tests for the following analytes: AMPH-FI, BENZ-FI, BUPR-FI, COCA-FI, FENT-FI, 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 -- METH-FI, OPIA-FI, OXY-FI, SPG, THC-FI, U CREAT, and pH DRI. 5. The facility personnel interviewed on 9/15/22 at 10:55am confirmed that the test requisitions reviewed during the survey failed to include the specific analytes tested in a Toxicology Screen. 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. This STANDARD is not met as evidenced by: Based on lack of post-analytic comparison documentation and interview with the facility personnel, the laboratory failed to follow established policies to ensure the accuracy of test results that are electronically interfaced into the laboratory's information system (LIS). Findings include: 1. The laboratory performs toxicology testing on urine specimens on the Diatron Pictus 700 with an approximate annual test volume of 300,000. 2. The test results from the Diatron analyzer are electronically interfaced into the Laboratory Information System (LIS). 3. The laboratory's established post-analytic Quality Assessment (QA) policy (SOP# SCTCL-QAU102) states, "Periodic evaluation of results is compared throughout the entire process LIS to instrument, instrument to LIS, and LIS to portal to confirm results match across all parameters." 4. No documentation from 2020 through the date of the survey on September 15, 2022 was presented for review to indicate the laboratory periodically verified the accuracy of test results which are electronically interfaced from the analyzer to LIS. 5. The facility personnel interviewed on 9/15/22 at approximately 11: 50am confirmed that the laboratory did not follow the established policy referenced above to periodically verify the accuracy of the patient test results that are electronically sent from the Diatron analyzer to the LIS. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on review of corrected test reports and interview with the facility personnel, the laboratory failed to maintain duplicates of the original report, as well as the corrected report. Findings include: 1. Review of corrected test reports generated from the Laboratory Information System (LIS) for sample ID# 71138 collected on 6/16/21 -- 2 of 4 -- included two separate corrected test reports: - All results included in the Toxicology Screen show "result corrected on 6/21/2021 at 02:21 PM from the previous result reported on 6/21/2021 at 02:11 PM." - All results included in the Toxicology Screen show "result corrected on 6/21/2021 at 05:21 PM from the previous result reported on 6/21/2021 at 05:11 PM." 2. The corrected test reports indicated above failed to include the original test result (previous result) and the corrected test result. 3. The technical consultant interviewed on 9/15/22 at 12:20 PM confirmed that the corrected test reports indicated above failed to include the original test results, as well as the corrected test results. 4. The facility personnel confirmed that 5 patient test reports were corrected during 2021. 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: Due to the number and severity of deficient practices identified during the survey conducted on September 15, 2022, the Condition of Laboratory Testing Personnel was found to be not met as evidenced by: D6070 - Failure of each individual performing moderate complexity testing to adhere to the laboratory's procedures for test reporting; and D6074 - Failure of each individual performing moderate complexity testing to identify problems that may adversely affect the reporting of test results and failure to immediately notify the technical consultant or director of issues related to discrepant test results. D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on review of the laboratory's established Standard Operating Procedure (SOP) for specimen testing on the Diatron 700 analyzer, review of patient test results and interview with the facility personnel, the testing personnel failed to follow the laboratory's procedures for test reporting. Findings include: 1. The laboratory performs toxicology testing on urine specimens on the Diatron Pictus 700 with an approximate annual test volume of 300,000. The testing is considered semi- quantitative, meaning the instrument produces a quantitative test result that is interpreted and resulted as a qualitative final result. 2. The laboratory's SOP (SCTCL- LABOP112, version 2) states, "Positives will be reported out as "Positive" and send out for confirmation per ordering provider/organizations direction....A patient sample may be repeated on the Diatron for the following reasons: (f.) The data reviewer may use their discretion to repeat a test if there are unexpected results from a patient's medication listed by the provider. The FIRST acceptable sample result will be reported." 3. Review of test results for sample ID# 71138 collected on 6/16/21 at 4:20 PM included the following test runs: - Originally run on 6/18/2021 at 12:29:04 PM - -- 3 of 4 -- the BUPR-FI (Buprenorphine) result showed 61 ng/mL, with a final qualitative result of 'Positive'. - Re-ran on 6/21/2021 at 11:23:56 AM - the BUPR-FI (Buprenorphine) result showed 0 ng/mL, with a final qualitative result of 'Negative'. The test results of this sample run were listed on the final test report. 4. The testing personnel failed to follow the laboratory's established procedures for test reporting by failing to send out the sample for confirmatory testing and failing to report the first sample result obtained. 5. The testing personnel interviewed on 9/15/22 at 12:04 PM stated that samples with questionable results are re-run the next business day and the test report is corrected if necessary. The testing personnel confirmed that the SOP was not followed as indicated above. D6074 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(5) Each individual performing moderate complexity testing must be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the technical consultant, clinical consultant or director. This STANDARD is not met as evidenced by: Based on review of patient test results, review of the laboratory's test procedure and interview with the facility personnel, the testing personnel failed to identify problems that may adversely affect the reporting of test results and failed to immediately notify the technical consultant or director. Findings include: 1. The laboratory performs toxicology testing on urine specimens on the Diatron Pictus 700 with an approximate annual test volume of 300,000. The testing is considered semi-quantitative, meaning the instrument produces a quantitative test result that is interpreted and resulted as a qualitative final result. 2. The laboratory's SOP (SCTCL-LABOP112, version 2) states, "Positives will be reported out as "Positive" and send out for confirmation per ordering provider/organizations direction....A patient sample may be repeated on the Diatron for the following reasons: (f.) The data reviewer may use their discretion to repeat a test if there are unexpected results from a patient's medication listed by the provider. The FIRST acceptable sample result will be reported." 3. Review of test results from the analyzer for sample ID# 71138 collected on 6/16/21 at 4:20 PM included the following test runs: - Originally run on 6/18/2021 at 12:29:04 PM - the BUPR-FI (Buprenorphine) result showed 61 ng/mL, with a final qualitative result of 'Positive'. - Re-ran on 6/21/2021 at 11:23:56 AM - the BUPR-FI (Buprenorphine) result showed 0 ng/mL, with a final qualitative result of 'Negative'. The test results of this sample run were listed on the final test report. 4. Review of corrected test reports in the Laboratory Information System (LIS) for sample ID# 71138 collected on 6/16 /21 at 4:20 PM indicated the sample was additionally analyzed on 6/21/21 at 2:21 PM and 6/21/21 at 5:21 PM by the same testing personnel who ran the samples on 6/18/21 at 12:29:04 PM and 6/21/21 at 11:23:56 AM. 5. The testing personnel failed to identify test result discrepancies that may adversely affect the reporting of test results and failed to immediately notify the technical consultant or director. 6. The testing personnel interviewed on 9/15/22 at 12:04 PM confirmed that the sample was continually re-analyzed until a test result for BUPR-FL was obtained that would be consistent with the patient's medical history, and the testing personnel confirmed that the technical consultant and/or laboratory director were not immediately notified of issues with the test results for the sample indicated above. -- 4 of 4 --

Summary Statement of Deficiencies 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 review of Quality Assessment (QA) documentation, analytic test records, laboratory policies and procedures and interview with the technical supervisor, (A) the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified with lot to lot verification and (B) the laboratory failed to identify problems associated with the matrix type assigned to Quality Control and calibration materials. Findings include: 1. The laboratory performs toxicology testing on urine specimens on the Diatron Pictus 400, with an approximate annual test volume of 100,000. A1. No documentation was presented for review to indicate the laboratory had established a written policy for the acceptable criteria when establishing a new mean of control reagents. A2. The laboratory's Quality Control policy #3005 states, "When at least 20 points of the new control material have been accumulated and values entered on the New Lot QC/Cal verification worksheet, determine the new mean and SD for each parameter and enter the verified mean and SD into the Pictus system", but the policy lacked the laboratory's criteria for acceptability for the new mean and SD. A3. The technical supervisor confirmed that the laboratory failed to have the laboratory's criteria for acceptability as stated above in written policy. B1. Review of the laboratory's Quality Control and Calibration data indicated serum as the specimen type. B2. The laboratory personnel confirmed that "serum" was entered into the Diatron analyzer as the specimen type instead of "urine". 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 -- 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. 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 have a system in place to ensure the accuracy of test results that are electronically interfaced into the laboratory's information system (LIS). Findings include: 1. The laboratory performs toxicology testing on urine specimens on the Diatron Pictus 400, with an approximate annual test volume of 100,000. 2. The laboratory performs testing on the Diatron Pictus 400 analyzer, and the test results do not automatically interface into the Laboratory Information System (LIS), Stratus DX. The patient test results are maintained in the LIS. The laboratory developed an interface to transfer the test results to an Excel spreadsheet which then automatically interface into the LIS. 3. No documentation was presented for review during the survey to indicate the laboratory has a system in place to ensure the accuracy of patient test results that are interfaced from the analyzer, to the Excel spreadsheet, and then to the LIS. 4. The facility personnel confirmed that the laboratory did not have a system in place to verify the accuracy of the patient test results that are electronically sent from the analyzer to the LIS. 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: The Condition of Laboratory Director was found to be not met based on the failure to have a director who meets the qualification requirements of 493.1443 of this subpart. See D6078 for findings. D6078 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1443 The laboratory director must be qualified to manage and direct the laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director 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) -- 2 of 4 -- (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) Be a doctor of medicine, a 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)(i) Have at least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(2)(ii) Have at least 2 years of experience directing or supervising high complexity testing; or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and-- (b)(3)(i) Be certified and continue to be certified by a board approved by HHS; or (b)(3)(ii) Before February 24, 2003, must have served or be serving as director of a laboratory performing high complexity testing and must have at least-- (b)(3)(ii)(A) Two years of laboratory training or experience, or both; and (b)(3)(ii)(B) Two years of laboratory experience directing or supervising high complexity testing. (b)(4) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; or (b)(5) On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located; or (b)(6) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, the American Osteopathic Board of Pathology, or possess qualifications that are equivalent to those required for certification. This STANDARD is not met as evidenced by: Based on review of the CMS-209, Laboratory Personnel Report presented for review during the survey and interview with the Technical Supervisor, the laboratory failed to have a qualified Laboratory Director at the time of the survey. Findings include: 1. The laboratory performs high complexity testing on the Diatron Pictus 400 analyzer, with an approximate annual test volume of 100,000. 2. During the survey conducted on October 25, 2019 it was discovered that the Laboratory Director listed in the CMS database at the time of the survey for CLIA# 03D2083937 was no longer affiliated with the facility as of May 2019. The State Agency received no notification of a Laboratory Director change for this CLIA certification. 3. The CMS-209, Laboratory Personnel Report presented for review during the survey listed a physician as the Laboratory Director, but there was no evidence presented for review at the time of the survey of the individual's experience directing or supervising high complexity testing for at least 2 years. 4. The Technical Supervisor acknowledged that the laboratory failed to provide evidence of a qualified Laboratory Director. 5. The individual assumed the responsibilities of the Laboratory Director of a high complexity testing lab in May 2019. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: -- 3 of 4 -- Based on review of personnel records and interview with the technical supervisor, the laboratory failed to indicate the correct dates on the competency evaluation documentation for one out of one testing personnel. Findings include: 1. The 6 month competency evaluation presented for review for one testing personnel hired on 1/16 /2018 indicated the competency evaluation was completed on 06/10/2018, however the form was signed and dated by the technical supervisor and employee on 06/10/19. 2. The technical supervisor confirmed that the signature dates were incorrect on the competency evaluation form referenced above. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the 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 technical supervisor, the laboratory failed to indicate the correct dates on the competency evaluation documentation for one out of one testing personnel. Findings include: 1. The annual competency evaluation presented for review for one testing personnel hired on 1/16 /2018 indicated the annual competency evaluation was completed on 01/25/2019, however the form was signed and dated by the laboratory director, technical supervisor and employee on 1/25/18. 2. The annual competency form referenced above listed the 'Period of Evaluation' as a "6 month evaluation" instead of an annual evaluation. 3. The technical supervisor confirmed that the signature dates and the Period of Evaluation were incorrect on the competency evaluation form referenced above. -- 4 of 4 --