Pain & Rehabilitation Consultants

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with Testing Personnel #1, the laboratory failed to ensure the Laboratory Director signed the attestation statement for one of one event reviewed in 2024. The findings include: 1. A review of the API PT records revealed no signature by the Laboratory Director (or designee) on the attestation statement for 2024 Chemistry Miscellaneous 1st Event. 2. During an interview on 8/6/24, at 11:31 PM, Testing Personnel #1 confirmed the above findings. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a review of the validation records for the Thermo Scientific Indiko Plus 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 -- Toxicology analyzer and an interview with the Laboratory Director, the Laboratory Director failed to document review and approval of the validation procedures prior to instrument use for patient testing on 9/14/2022. The findings include: 1. A review of Thermo Scientific Indiko Plus validation records revealed no evidence of the Laboratory Director's review and approval (as evidenced by signature and date) before the instrument was utilized for patient testing on 4/9/2024. 2. During an interview on 8 /6/2024 at 11:07 AM, the Laboratory Director confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on reviews of the API (American Proficiency Institute) proficiency testing (PT) records, and an interview with the Testing Personnel, the surveyor determined the laboratory failed to submit results for the API 2022-Event #2 Chemistry survey before the cutoff date. This was noted on one of four 2021-2022 PT survey events reviewed. This is a repeat deficiency. The findings include: 1. A review of the scores for the API 2022-Event #2 Chemistry survey (for qualitative Urine Drug Screens) revealed the laboratory received a score of 0% due to failure to participate. 2. A review of the instrument printouts for the API 2022-Event #2 Chemistry survey revealed testing was performed on 10/12/2022. The API instruction sheet specified results were due on 11/2/2022 at 11:59 PM ET (Eastern Time). The API records included the "Preview Result Form" with the electronically-entered results, and a printed comment on page one, "THESE TEST RESULTS HAVE NOT BEEN SUBMITTED." 3. During an interview on 12/6/2022 at 12:35 PM, the Testing Personnel confirmed the above findings, and explained there was a miscommunication concerning a text the Technical Consultant sent on 11/1/2022, as follows, "Send in the api b4 11 we'd. My computer is down". The Testing Personnel stated she thought the Technical Consultant meant 11 November, not 11:00 PM on Wednesday. SURVEYOR ID #32558 Licensure and Certification Surveyor Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on reviews of the proficiency testing (PT) records, quality assurance documentation, patient records, and an interview with the Technical Supervisor, the surveyor determined the laboratory failed to submit results for the API (American Proficiency Institute) 2019-Event 2 Chemistry survey before the cutoff date. This was noted on one out of seven 2018-2021 PT survey events reviewed. The findings include: 1. A review of the instructions for the API 2019-Event 2 Chemistry survey (for qualitative Urine Drug Screens) revealed the PT results should have been submitted on-line on or before 11/1/2019. However a review of the Indiko instrument printouts revealed specimens were run on 11/13/2019; the survey received a score of 0% due to failure to participate. 2. During an interview on 5/13/2021 at 12:15 to 12:25 PM, the Technical Supervisor stated the laboratory may have been out of reagents in October thru early November 2019. The surveyor then asked if there was documentation of the problem, and if patient testing was performed during that period; a review of the quality assurance records revealed no documentation of any problems. The Technical Supervisor confirmed the laboratory performed patient testing on 10/21/2019 and 10/28/2019. SURVEYOR ID #32558 Licensure and Certification Surveyor Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --