Summary:
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 review of laboratory records, interview with the office manager, and the testing person, the laboratory did not enrolled in CMS approved proficiency testing program for performing urine drug screens. Findings: On the day of the initial survey March 30, 2018 the laboratory was not enrolled in an approved proficiency testing program (PT) and the laboratory did not have written procedures for performing PT. The office manager stated that she was unsure if PT enrollment was performed. The laboratory did not have documentation of enrollment until April 13, 2018 that showed the laboratory submitted paperwork on April 4, 2018 for PT enrollment. The laboratory began patient testing in October 2017. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory records, interview with the laboratory manager, and the testing person, the laboratory did not have policies and procedures for performing urine drug screens collection and processing. Findings: 1. The laboratory did not have written step by step instructions for the collection of urine specimens when performing drug screens. 2. The laboratory did not have written instructions for specimen labeling containers once urine specimens were collected. 3. The laboratory did not have written instructions for urine specimen processing after the collection of the patient specimen and stating how much specimen is needed to perform the test. 4. The testing person stated that she labels the urine specimen cuvettes with the patient name and line the cuvettes up on the analyzer before adding 2 ml's of specimen. 5. The laboratory did not have written instructions for urine specimen storage when testing can not be performed. 6. The laboratory did not have written instructions when urine specimens did not meet the laboratory's criteria of acceptability and needed recollection. 7. The "Quality Assurance/ Quality Management Plan" states that specimen preparation, storage, and stability are described in individual procedures for each test. This plan was made available at survey closing on April 13, 2018. 8. The "Quality Control Policy" states that the laboratory will provide instructions for collection, labeling, preservation, transportation of specimens. This plan was made available at survey closing on April 13, 2018. 9. The testing person and the laboratory manager confirmed that written step by step instruction for the collection and processing of urine dug screens was not available. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of laboratory records, interview with the laboratory manager, and the testing person, the laboratory did not have a written procedure manual for performing urine drug screen testing reviewed and signed by the laboratory director. Findings: 1. On the day of the survey the laboratory did not have a written procedure manual that was approved by the laboratory director with step by step instructions for the daily operations of running the laboratory including performing urine drug screens, patient normal values, and patient critical values. 2. The testing person had a packet of procedures for daily start up of the analyzer, loading patient specimens on the analyzer, quality control, calibration of the analyzer, and maintenance procedures. 3. The testing person stated that she was not aware of a laboratory standard operation procedure manual. She was given a packet of procedures she follows for performing patient testing. 4. The testing person packets of procedures were not reviewed and signed by the laboratory director as being a part of the standard operation procedures. 5. The "Quality Assurance/Quality Management Plan" states that all polices and -- 2 of 10 -- procedures have been authorized by the laboratory director prior to implementation and personnel has reviewed and read the policies. This plan was made available at survey closing on April 13, 2018. 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)