Interventional Pain Management Center

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: Through review of proficiency testing attestation forms and interview it was determined that testing personnel failed to sign attestation forms for two of five American Proficiency Institue (API) proficiency testing events reviewed. Findings follow, A. Through review of proficiency testing doumentation for 2023 it was determined that testing attestation forms were not signed by one of three testing personnel for the API Hematology/Coagulation 2nd event of 2023 (dated 5/23/23) and the API Chemistry Core 2nd Event of 2023 (dated 7/24/23). B. In an interview on 9/28 /23 at 10:12 am, the technical consultant verified that the attestation forms were not signed by the testing personnel listed as terting person #3 (TP#3) on the CMS 209 form.. C. The attestation statements missing a signature contained a note stating that "TP#3 is currently working PRN. She will sign the next time she works." 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 D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: . Through a review of package instruction for Roche Coagucheck, laboratory patient logs, patient medical records, lack of documentation, as well as interviews with staff, it was determined the laboratory failed to follow manufacturer's instructions when performing the Coaguchek test system for evaluating Prothrombin Test (PT) and International Normalized Ratio (INR). The laboratory performed seventy-four PT /INR tests. Survey Findings Follow: A. A review of Roche Coaguchek package insert revealed the purpose of the test system "The purpose of Coaguchek test system is intended for use by professional healthcare providers for quantitative Prothrombin Time (PT) Testing for monitoring Warfarin therapy." B. A review of laboratory patient logs from March 2020-September 2021 revealed patient #100651, patient #020153, patient #061563, patient #071130, patient #071967, patient #071641, patient #040545, patient #011661, patient #071164 and patient #101848 had PT/INR test performed on the Roche Coagucheck. C. A review of medical records for the patients listed above revealed these patients had the PT/INR test performed on the Roche Coagucheck but were not on Warfarin Therapy. D. In an interview with the Clinic Manager on 10/7/2021 at 11:30, she confirmed the patients were not on Warfarin therapy and the "PT/INR was performed on these patients as part of their Sedation Protocol and that each patient receives a CBC, BMP, PT/INR before their surgical procedure." 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 --