Wellbeing Institute

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 Indiko Plus analyzer and interview with the Laboratory Director (LD), 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 August 25, 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 Indiko Plus toxicology analyzer. 2. The LD interviewed on August 25, 2023 at 10:50 AM 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 18,000 urine drug screen tests annually, which are performed on the Indiko Plus analyzer. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- Based on lack of accuracy verification documentation for review for urine drug screen testing and interview with the Laboratory Director (LD), the laboratory failed to verify the accuracy of urine drug screen testing at least twice annually during 2021 and 2022. Findings include: 1. No documentation was presented for review during the survey conducted on August 25, 2023 to indicate the laboratory verified the accuracy of urine drug screen testing at least twice annually during 2021 and 2022. 2. The LD interviewed on August 25, 2023 at 11:45 AM confirmed the laboratory failed to verify the accuracy of urine drug screen testing at least twice annually during 2021 and 2022. 3. The laboratory performs urine drug screen testing on the Indiko Plus analyzer, with an annual test volume of 18,000. The urine drug screen test includes the following analytes: Amphetamine, Benzodiazepine, Cocaine, Opiate, Oxycodone, Buprenorphine II and Creatinine. 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 Laboratory Director (LD), the laboratory failed to have a written or electronic request for patient testing for two out of two patient records reviewed during the survey. Findings include: 1. No written or electronic request for urine drug screen testing was presented for review for two out of two patient records reviewed during the survey, accession# 0100020566 tested on 8/03/23 and accession# 0100016182 tested on 8/03 /22. 2. The LD interviewed on August 25, 2023 at 10:30 AM confirmed the laboratory failed to have an electronic or written test requisition for testing that was performed on the patients indicated above. 3. The laboratory reports approximately 18,000 urine drug screen tests annually. 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 Laboratory Director (LD), the laboratory failed to verify the criteria for acceptability of quality control materials. -- 2 of 7 -- Findings include: 1. The laboratory performs a semi-quantitative urine drug screen test on the Indiko Plus analyzer, with a reported annual test volume of 18,000. 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 January 2021 through the date of the survey on August 25, 2023. 3. The laboratory's established QA policy states, "New lot check in of reagents is done in order to validate the lot to lot variability. When the use new control lot is started, record the new lot # on the run control sheet. Make sure the control lot runs according to the Package Insert. QC should be acceptable for new lots in which there has been no loss of integrity to the sample or analyte." 4. The LD interviewed on August 25, 2023 at 11:35 AM confirmed the laboratory failed to follow the established policy indicated above to verify and document the criteria for acceptability of control lots used on the Indiko Plus analyzer. 5. The number of QC lots used on the analyzer from January 2021 through the date of the survey could not be determined at the time of the survey. D5781

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 laboratory director, the laboratory's test requisition failed to include the required information. Findings include: 1. The laboratory began patient testing in December 2017 under the sub- specialties of Routine Chemistry and Toxicology, with an approximate annual test volume of 17,400. 2. It is the practice of the laboratory to perform a urine drug screen test on each patient's specimen. The testing is performed on the Indiko Plus Analyzer and includes the following analytes/assays: Creatinine, Amphetamine, Cocaine, Opiate, Oxycodone, and Buprenorphine. 3. The laboratory's test requisition presented for review during the survey failed to include the patient's sex and age or date of the birth of the patient. 4. The laboratory's test requisition presented for review during the survey failed to include the time of specimen collection. 5. The laboratory's test requisition presented for review during the survey failed to include the test(s) to be 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 -- performed, specific to the analytes tested. 6. The laboratory director confirmed that the test requisitions reviewed during the survey failed to include the information listed above. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 lack of documentation for review and interview with the facility personnel, the laboratory failed to monitor and document the room temperature, refrigerator temperature, freezer temperature and humidity of the laboratory where reagents and specimens are stored and patient testing is performed. Findings include: 1. The laboratory began patient testing in December 2017 under the sub-specialties of Routine Chemistry and Toxicology, with an approximate annual test volume of 17,400. 2. The laboratory performs patient testing on the Indiko Plus Chemistry analyzer which has a humidity requirement of 40% - 80%, as stated in the manufacturer's operating manual. 3. The laboratory utilizes a refrigerator and freezer to store test reagents and patient specimens, if needed. 4. No documentation was presented for review during the survey to indicate the laboratory monitored and documented the room temperature and humidity of the laboratory where patient testing was performed, as well as the refrigerator and freezer temperatures. 5. The facility personnel confirmed that the laboratory was not monitoring the temperatures and humidity levels as stated above. 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 manually transcribed into the patients' Electronic Medical Record (EMR). Findings include: 1. The laboratory performs approximately 17,400 patient tests annually under the sub-specialty of Routine Chemistry and Toxicology. 2. The laboratory performs testing on the Indiko Plus analyzer, and the test results are -- 2 of 3 -- transmitted from the analyzer to a secure email connection. The test results are then manually transcribed into the patients' EMR. 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 manually transcribed from the Indiko Plus analyzer to the patients' EMR.. 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 generated from the analyzer and transcribed into the EMR. -- 3 of 3 --