Summary:
Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on surveyor observation and staff interview the laboratory failed to ensure adequate safety measures are maintained for the safety of its personnel. Findings include: 1. Surveyor observation of the laboratory's testing area on 5/3/18 at 10:30 AM revealed the following: a. Three bulging water damaged ceiling tiles which were located above laboratory equipment and reagents. b. Five cloth chairs that cannot be properly decontaminated. 2. Staff interview with the laboratory director on 5/3/18 at 11:00 AM confirmed the above findings. 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 record review and staff interview it was revealed that testing personnel were not following laboratory policies and procedures for toxicology tests Findings include: 1. Record review of patient final test reports on 5/3/18 revealed patients were being reported as quantitative for Amphetamines(AMP), Cocaine Metabolite (COC), Heroin Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Metabolite (6-MAM), Methadone Metabolite (MTD) and Opiates (OP) tested on the Indiko initial screening instrument. 2. Record review of the Laboratory Procedure Manual on 5/3/18 revealed initial screening results tested on the Indiko instrument are reported as "positive" or "Negative". 3. Staff interview with the laboratory director on 5/3/18 at 11:00 AM confirmed the above. 4. The laboratory performs 12,5000 initial toxicology screening tests annually. D5781