Advanced Pain Diagnostic & Solutions

Summary Statement of Deficiencies D5467 CONTROL PROCEDURES CFR(s): 493.1256(d)(9)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- When using calibration material as a control material, use calibration material from a different lot number than that used to establish a cut-off value or to calibrate the test system. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's quality control material, calibrator, and interview with the laboratory testing person on October 23, 2023, at 12:00 pm, the laboratory failed to use different lot's control material from the calibrator. The findings include: 1. The laboratory used an LC-MS/MS method to detect various drugs in the patient urine sample. It generates a standard curve each time of testing. The laboratory used a calibrator to generate the standard curve, however, it used the calibrator material from the same lot as quality control material. Therefore, the validity of the test method cannot be assured and might have had harmed patient. 2. The laboratory testing person on October 23, 2023, at 12:00 pm, affirmed that the laboratory used the calibrator material from the same lot as quality control material. 3. The laboratory's testing declaration form, signed by the laboratory owner on 10/9 /2023, stated that the laboratory performed approximately 352,000 tests, annually. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. 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 -- This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's patient test records, quality control material, calibrator, and interview with the laboratory testing person on October 23, 2023, at 12: 00 pm, the laboratory director failed to ensure that the laboratory is providing quality results for patient care. The findings include: See D5467. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation of the digital thermometers used in the laboratory, review of the temperature records, and interview with the testing personnel (TP), it was determined that the laboratory failed to familiarize the features of the digital thermometers used to monitor and documented properly for proper storage of the laboratory reagents, supplies including control and calibrator materials. The findings included: a. At the time of survey (08/29/18 @ 11 AM), observed a digital thermometer for a freezer which is used to hold the urine samples before they are ready for urine drug screen testing. b. The laboratory stated that the optimal acceptable temperature to store the urine samples properly is below -20 oC. c. The digital temperature at the time (@ 11 AM) indicated that it was -19 oC, which was outside of the acceptable range. d. Interview of TP about the features and functions of this digital thermometer, the TP who was assigned to read and document the temperature conditions showed lack of knowledge of the digital thermometer's functions. e. Further discussion and observations of the digital thermometers, the laboratory failed to set up the acceptable temperature ranges correctly for both refrigerator and freezer digital thermometers. f. The laboratory intentionally switched the built-in "Alarm" to "Off" position to avoid its noise, when the temperature reach outside of the acceptable ranges. 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 -- D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory supplies including the calibrator and control materials in the refrigerator, and interview with the laboratory testing personnel (TP), it was determined that the laboratory failed to label the supplies after opened to indicate the storage requirements and preparation and expiration date to ensure the strength, concentration as appropriate. The findings included: a. The laboratory performed urine drug screen and reported "Positive" or "Negative" results for a total of 10 drugs analyze including but are not limited to the following analyte: Buprenorphine, Oxycodone, Cannabinoids. Opiates. b. Observed the calibrator and control materials in a refrigerator, calibrators for Buprenophine and Oxycodone were not labeled with open date and expiration date. Neither the controls materials were not labeled with opened date and expiration date. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on observation of the laboratory operations, and interview with the laboratory testing person (TP), it was determined that the laboratory director failed to ensure that quality assessment programs were established and maintained to assure the quality of laboratory services provided. The findings included See D- 5413 and D-5415 -- 2 of 2 --