Valley Pain Clinic

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the Thermoscientific Indiko Plus Toxicology analyzer quality control (QC) records, the patient results log, policies and procedures, and an interview with the Technical Consultant, the laboratory failed to ensure at least two levels of QC were run and acceptable prior to analyzing patient specimens and reporting the results. This was noted for 5 days out of 2 months reviewed in 2024. The findings include: 1. A review of the QC records for the Thermoscientific Indiko Plus Toxicology analyzer revealed the following dates QC was out prior to patient testing: a) 2/20/2024: Buprenorphine (BUP) Hi and Lo out; 14 patients affected. b) 2/21/2024: BUP Hi and Lo out; 16 patients affected. c) 2/22/2024: BUP Hi and Lo out; 19 patients affected. d) 6/24/2024: 6-Acetylmorphine (6AM) Hi and Lo out; 12 patients affected. e) 6/25 /2024: No documentation of QC; 22 patients affected. 2. A review of the policies and procedures revealed, " Indiko Plus Daily Quality Control Procedure Actions to Take: 2. If any test has both QCs out, recalibrate and rerun." There was no evidence of

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 American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with the Testing Personnel, the Laboratory Director and Testing Personnel failed to sign the attestation statements for four out of four 2019 - 2020 PT events reviewed. The findings include: 1. A review of API Urine Drug Screen PT records revealed the following: A) 2019-Events #1 and #2: Attestation statements not signed by the Laboratory Director or the Testing Personnel B) 2020- Event #1: The attestation statement was not retained or available C) 2020-Event #2: Attestation statement not signed by the Laboratory Director 2. A review of "Proficiency Testing" in the Policy and Procedure Manual revealed, "...14. The Medical Director designates that the Technical Director and the testing personnel must sign the attestation page prior to submitting the results to API ...". [Note: The Laboratory Director and the Technical Supervisor are the same individual on the Form CMS-209--Laboratory Personnel Report.] 3. During an interview with the Testing Personnel on 8/11/2021 at 10:50 AM, the surveyor reviewed the instructions on the attestation statement requiring the Laboratory Director (or designee) and testing personnel to sign the document. Testing Personnel #1 explained when the laboratory entered the results electronically, she had not known signing the statement was still a requirement. . D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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 -- 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 a review of Quality Control (QC) records,

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the laboratory policy and procedure manual, the Indiko Plus procedures and an interview with the current Testing Personnel (TP), the surveyor determined the laboratory failed to ensure the current Laboratory Director documented her review and approval (as indicated by her signature and date) of procedures in use, after assuming her responsibilities as the Laboratory Director in June 2018. The findings include: 1. An on-site review of a copy of the Form CMS- 116 submitted to the CLIA State Agency revealed a change in Laboratory Director in June 2018. 2. A review of the laboratory policy and procedure manual revealed the signature of the previous Laboratory Director dated 3/16/2018; the Indiko Plus procedures were also signed by the previous Director on 2/23/2018. The new Testing Personnel had also signed and "approved" the procedures on 2/12/2019. However, there was no evidence the procedures had been reviewed and approved by the current Laboratory Director after she had assumed her responsibilities in June 2018 (nine months previous to the date of this survey on 3/13/2019). 3. During a review of the manuals on 3/13/2019 at approximately 11:00 AM, the current Testing Personnel stated she had contacted the previous testing personnel, who had recently retired. The previous testing personnel stated he did not think the new Director had reviewed and approved the laboratory procedures because he had forgotten to bring her the manuals. Thus the above noted findings were confirmed. 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 --