Kaloko Pain Center

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of laboratory records and confirmation by the Technical Supervisor on 12/17/2021 at 2:30 PM, it was determined that the laboratory failed to enroll in a HHS approved proficiency testing (PT) program for the Toxicology testing it performed in 2021. The findings include: 1. The Technical Supervisor stated that the laboratory failed to renew its CAP Urine Drug Screen Testing Confirmation proficiency testing survey for 2021. 2. The laboratory performed 686,400 Thermo Fisher Scientific Indiko Plus drug tests and 5,720,000 Shimadzu 845 LCMS drug tests in 2021. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. 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 CONDITION is not met as evidenced by: Based on a review of laboratory records and confirmation by the Technical Supervisor on 12/17/2021 at 2:30 PM, it was determined that the Laboratory Director failed to provide overall management and direction to ensure the laboratory was enrolled in an HHS approved proficiency testing (PT) program for the Toxicology testing it performed in 2021. See CFR 493.801, D tag D2000. -- 2 of 2 --

Summary Statement of Deficiencies D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on an on-site inspenction and an interview with the laboratory testing personnel on 06/07/2019, the lab failed to establish for the Easy RA system the performance specifications for verification of positive results. Findings included: 1. The laboratory used the Medica Easy RA Chemistry Analyzer and LZI Enzyme Immunoassay to perform and report clinical laboratory test results on amphetamine, barbiturates, buprenorphine, cocaine metabolite, opiates, oxycodone, phencyclidine (PCP), and Ecstasy in patient specimens. FDA had not approved the use of both systems to be used together. 2. The package insert for the LZI Cocaine Metabolite Enzyme Immunoassay reagent by Lin-Zhi International Inc. May 2017 Rev.8 stated under Limitations that "positive results should be confirmed by other affirmative, analytical chemistry methods." 3. The package insert for the LZI Phencyclidine Enzyme Immunoassay reagent by Lin-Zhi International Inc. May 2017 Rev.9 stated under Limitations that "positive results should be confirmed by other affirmative, analytical chemistry methods." 4. The testing personnel verified that speciments with positive Easy RA results were not confirmed by other affirmatory analytical chemistry 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 -- methods. 5. There were approximately 19,000 tests performed on the Medica Easy RA during 2018. -- 2 of 2 --