Summary:
Summary Statement of Deficiencies D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory records and interview with laboratory testing personnel (TP) #1; the laboratory failed to meet the toxicology subspecialty requirements specified in 493.1230 through 493.1256. Findings Include: 1. The laboratory failed to ensure 6 month calibration verifications were performed for urine toxicology analytes on the Mindray BS-200 in 2018. See D5439. 2. The laboratory failed to ensure Cannabinoid quality controls were within the manufacturer's acceptable range prior to reporting patient test results for 6 of 13 dates reviewed in 2018 on the Mindray BS- 200 analyzer. See D5481. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 review of laboratory records and interview with laboratory testing personnel (TP) #1; the laboratory failed to conduct six month calibration verifications as required for the Mindray BS-200 for drugs of abuse testing in 2018. Findings include: 1. Review of the laboratory's policy and procedure manual identified the procedure, "Calibration Verification", which stated the following on page 3 through 4: "For analyzers and analytes that are not calibrated with a minimum of three calibrators verifying the low, midpoint and high end of the reportable range, a calibration verification must be performed to substantiate the continued accuracy of the monitors throughout the reportable range, after initial validation studies are performed with the setup of the analyzer. Calibration verification is performed every six months, as stated in current CLIA regulations." 2. Review of the calibration records for the Mindray BS- 200 found two point calibrations are performed for the following analytes: Amphetamine, Barbiturate, Benzodiazepine, Cannabinoid (THC), Cocaine Metabolite, Methadone, Opiates, Phencyclidine, and Propoxyphene. 3. Interview on 12-18-2018, at 10:12 am, with laboratory TP#1 confirmed that all calibrations performed on the Mindray BS-200 are two point calibrations and no six month calibration verifications had been performed since the instrument was put into use for patient testing on March 1st, 2018. 4. Review of patient test records found 3,564 toxicology tests had been performed on the Mindray BS-200 in September of 2018 through November of 2018 when no six month calibration verification had been performed. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's 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 review of laboratory records and interview with testing personnel (TP) #1; the laboratory failed to ensure two levels of quality control (QC) materials were acceptable prior to reporting patient test results for cannabinoid (THC) testing on the Mindray BS-200 analyzer for 6 of 13 dates reviewed. Findings Include: 1. Review of the laboratory policy and procedure manual identified the policy, "Quality Control Acceptancy Policy", which states, "No control value will be accepted at APG Medical Center unless it is within the established limits set forth by the manufacturer of that control for the particular control lot number in use. This applies for each of the controls used to monitor Drug testing normal and abnormal. Controls which do not fall within the acceptable limits will be tested a maximum of two times before -- 2 of 4 -- performing some type of