Comprehensive Pain Solutions, Pllc

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Laboratory Director (LD), the laboratory failed to ensure control materials did not exceed their expiration date for the negative control in use. Findings include: 1. The surveyor observed a clear plastic bottle in the refrigerator labeled "Surine" with the expiration date of "1/21" on 1 /25/22 at 11:06 am. 2. A review of the laboratory's "Reagent Handling" policy revealed a section stating, "All reagents, calibrators, controls and solutions are used within their indicated expiration date, whether this date is manufacturer-provided for purchased materials or assigned for laboratory prepared materials." 3. An interview on 1/25/22 at 11:06 am with the Laboratory Director revealed the laboratory was currently using the expired solution as a negative control in toxicology testing and confirmed it was expired. 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 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 record review and interview with the Laboratory Director (LD), the individual testing proficiency testing samples failed to attest to the routine integration of samples into the patient workload for 1 (UT-B 2018) of 6 testing events reviewed. Findings include: 1. A review of the laboratory's College of American Pathologists' (CAP) proficiency testing records revealed a lack of attestation from a previously employed testing personnel performing proficiency testing for the 2018 UT-B event. 2. An interview on 2/5/2020 at 10:40 am with the LD confirmed the previously employed testing personnel did not attest to the integration of samples into the patient workload. 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 record review and interview with the Laboratory Director (LD), the laboratory failed to verify the accuracy of toxicology testing at least twice annually for 1 (2018) of 2 years reviewed. Findings include: 1. A review of the laboratory's "Peer Comparison Data and Target Comparison Data" revealed a lack of 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 -- documentation of twice annual verification of accuracy for the second testing event for the following analytes: a. 2-OH-ethylflurazepam b. Secobarbital c. MDEA d. Tapentadol 2. An interview on 2/5/2020 at 10:47 am with the LD confirmed twice annual verification of accuracy testing was not performed for the second event in 2018 for the analytes listed above. -- 2 of 2 --