Summary:
Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on review of the Maryland State licensing database, the laboratory failed to have a current Maryland State Permit for Medical laboratory testing as required in the Code of Maryland Regulations Title 10, subtitle 10 for toxicology testing. Findings: 1. Review of the Maryland state licensing database showed that the laboratory's Maryland State license expired on 12/31/2017. The Office of Health Care Quality for the Maryland Department of Health and Mental Hygiene did not have a current application to renew the laboratory's medical laboratory permit. 2. The laboratory is not in compliance with the applicable Maryland State laboratory requirements. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) results and interview with the technical consultant, the laboratory did not ensure that all laboratory analytes that were not included in subpart I of this part were verified for accuracy at least twice annually. Findings: 1. The laboratory records show that the laboratory was not enrolled in a PT program for urine creatinine and urine heroin testing. 2. The technical consultant stated that the PT agency confirmed that the program that they were Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- enrolled in would include all the required analytes tested in the lab. The PT results submitted to the PT agency did not include urine creatinine and urine heroin. 3. The laboratory's policies and procedures did not include a written procedure for verifying the accuracy of urine creatinine and urine heroin at least twice a year as required. 4. During the survey on 03/29/18 at 12:30 PM the technical consultant confirmed that the first set of PT results did not include urine creatinine and urine heroin. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to have written policies and procedures for retention of laboratory records and entering and reporting patient test results (D5403); and failed to ensure that the verification of the toxicology analyzer was completed prior to testing and reporting patient test results (D5421). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)