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 record review and interviews, the laboratory failed to ensure protection from chemically hazardous materials for 8 (June 2023 to January 2024) of 8 months since the laboratory started testing. Findings include: 1. An interview on 1/3/24 at 10: 36 am revealed the laboratory started urine toxicology testing in patients in June 2023. 2. A review of the laboratory's "Methanol" Safety Data Sheet (SDS) revealed a section stating "Provide eyewash stations, quick-drench showers and washing facilities accessible to areas of use and handling. Have supplies and equipment for neutralization and running water available." 3. The surveyor toured the laboratory on 1 /3/24 at 10:59 am and observed a lack of eyewash station, shower, or sink present. 4. An interview on 1/3/24 at 12:31 pm with the Laboratory Director confirmed the laboratory had not installed an eyewash, shower, or sink in the laboratory. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This CONDITION is not met as evidenced by: . Based on record review, observations, and interviews, the laboratory failed to establish a procedure for its urine toxicology testing using the Thermo Fisher Scientific Indiko Plus analyzer (refer to D5401), failed to ensure reagents and calibrators had not exceeded their expiration dates (refer to D5417), failed to verify performance specifications for its urine toxicology testing using the Thermo Fisher Scientific Indiko Plus analyzer (refer to D5421), failed to document its data used to establish performance specifications of its quantitative urine toxicology testing using the AB Sciex Triple Quad analyzer (refer to D5427), failed to establish criteria for acceptability for its urine toxicology screening controls (refer to D5469), and failed to perform