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 observation, record review, and interview with the Testing Personnel, the laboratory failed to establish safety procedures for its toxicology testing laboratory for 5 (October 2023 to February 2024) of 5 months since the laboratory started testing. Findings include: 1. The surveyor observed the laboratory on 2/6/24 at 9:09 am and noticed lack a of eyewash station present. 2. An interview on 2/6/24 at 9:31 am with the Testing Personnel revealed the laboratory started patient testing in October 2023. 3. A review of the laboratory's policies and procedures revealed a lack of safety procedures. 4. An interview on 2/6/24 at 9:50 am with the Testing Personnel revealed the laboratory had not established safety procedures. 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 observation, record review, and interviews, the laboratory failed to establish competency assessment policies and procedures to assess Clinical Consultant, Technical Consultant, and Testing Personnel competency (refer to 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 -- D5209), failed to establish written policies and procedures to include specimen collection, labeling, storage and preservation, acceptability and rejection, and specimen referral (refer to D5311), failed to establish written test procedures (refer to D5401), failed to ensure quality control materials and wash solution were not used when expiration dates were exceeded (refer to D5417), failed to verify the acceptability criteria for urine toxicology control materials (refer to D5469), failed to perform