Advanced Spine & Pain Center

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on March 25, 2022. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on a random patient audit of eight patient records tested between the dates of February 13, 2020 and December 16, 2021, and an interview with the laboratory general supervisor, the laboratory failed to ensure that positive patient identification identification was maintained from collection of the specimen through the reporting of the test results. Findings include: 1. A random patient audit of eight patients tested between the dates of February 13, 2020 and December 16, 2021 revealed that the laboratory failed to maintain positive identification of two unique identifiers for the patient that was tested on June 1, 2021 who was identified by the medical record number 3359, and the date of birth of October 15, 1979 on the requisition and on the final report for a urine drug screen . 2. The patient date of birth entered on the requisition, and on the final test report did not match the patient date of birth recorded on the patient result record printed from the BioLis 24i chemistry analyzer. 3. The 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 -- findings were confirmed during an interview with the General Supervisor conducted on March 25, 2022 at approximately 12:00 PM. The laboratory performs approximately 32000 routine chemistry and toxicology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on October 23, 2019. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on a random audit of ten patient test reports from 1/10/18 through 9/10/19 and an interview with the laboratory manager, the laboratory failed to ensure the positive identification of the patient's specimen from the time of collection through the completion of testing and the reporting of the laboratory results. Findings include: 1. Based on a random audit of patient chemistry and toxicology testing from 1/10/18 through 9/10/19, the laboratory failed to ensure the positive identification of one of ten patient samples from the time of the provider's request for chemistry and toxicology testing through collection and final result of the laboratory tests. 2. One of ten patients that had chemistry and toxicology testing performed on 7/16/19 was found to have a requisition with the patient's date of birth as 6/02/43. The final patient test report revealed the patient's date of birth as 6/02/48. This was confirmed by the laboratory manager on October 23, 2019 at approximately 11:00 AM. The laboratory performs approximately 50,000 chemistry and toxicology tests annually. 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 -- 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 a review of the American Proficiency Institute (API) proficiency test results for chemistry and toxicology for testing years 2018 and 2019, a review of all