Summary:
Summary Statement of Deficiencies D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to properly ventilate one of three instruments observed. Findings include: 1. During the tour of the laboratory on March 29, 2018 from approximately 10:00 AM to 12:00 PM, the surveyor observed a missing piece of vent hose connecting the 4500 analyzer to the ventilation system. 2. During the tour of the laboratory on March 29, 2018 from approximately 10:00 AM to 12:00 PM, technical supervisor #1 confirmed that the 4500 analyzer was not connected to the ventilation system and was venting directly into the room. 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 record review and interview, the laboratory failed to meet the requirements for the specialty in Toxicology as specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. Findings include: 1. The laboratory failed to order one test (Phenobarbital) in the Comprehensive Panel. Refer to D5309. 2. The laboratory failed to monitor and document the room temperature and humidity readings. Refer to D5413. 3. The laboratory failed to label the toxicology reagents with the preparation Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- and/or expiration date. Refer to D5415. 4. The laboratory failed to document the