Medical Pain Consultant

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on lack of Medical Pain Consultants, Osteopathy of Tompkins County, PC Standard Operating Procedures (SOPs), thermometer calibration records, as well as interview with the Testing Person (TP), the laboratory failed to define a function check protocol that ensures instrument performance that is necessary for accurate and reliable test results and result reporting. FINDINGS: 1. There was no documentation of calibration for the Acurite and Ithaca Guitar Works promotion branded digital thermometer hygrometers utilized for monitoring ambient room temperature and humidity in the laboratory. No serial or model number was available for both the respective Acurite and Ithaca Guitar Works thermometer hygrometers. 2. The Traceable Thomas Scientific digital thermometer, serial number (SN) 221352774, model 1222W14, utilized for monitoring the temperature of the Frigidaire refrigerator where reagents, calibrators, controls, proficiency testing samples were stored, featured a tag indicating recalibration due March 15, 2024. No certificate of calibration or documentation was available. 3. The Traceable Thomas Scientific digital thermometer, SN: 221352768, model 1222W14, utilized for monitoring the temperature of the Frigidaire freezer where patient urine specimens were stored, featured a tag indicating recalibration due March 15, 2024. It was noted that the respective calibration thermometer certificate was retained. 4. Medical Pain Consultants, Osteopathy of Tompkins County, PC laboratory failed to draft and 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 -- approve procedures for thermometer calibration and certificate retention. 5. The TP confirmed the findings on May 19, 2026, at approximately 1:15 P.M. -- 2 of 2 --

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's validation records for the Carolina CLC800 analyzer, calibration records and an interview with the two laboratory testing personnel, the laboratory failed to perform calibration verification at least once every six months for toxicology Carolina CLC800 analyzer from 09/05/2017 through survey date. FINDINGS: The two testing personnel confirmed on 07/17/2018 at approximately 11:00 AM that the laboratory had not performed calibration 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 -- verification on the Carolina CLC800 for all analytes with less than three calibrators. Approximately 4,000 patients were tested during this time period. -- 2 of 2 --