Quest Diagnostics

Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document centrifuge function checks every 6 months to ensure platelet poor plasma (PPP) for accurate and reliable test results for the Prothrombin Time (PT) test in the specialty of hematology. Findings include: 1. Record review of the Siemens manufacturer package insert for Dade Innovin reagent on 9/30/19 revealed the following statement under the Specimen Collection and Preparation Section: "Please refer to CLSI document H21- A5 for detailed information on sample preparation and storage." 2. Record review on 9 /30/19 of the CLSI H21-A5 document, Section 6.2: Processing Suitable Specimens revealed: "The reliability of the centrifugation procedure, to ensure plasma platelet counts are within acceptable limits, should be validated every six months or after modification of the centrifuge." 3. Record review of the laboratory PPP log sheets on 9 /30/19 revealed the following: a. Two centrifuges are in use: Fisher Scientific Serial Number (S/N) 72401510308 and Horizon Premier S/N 17056UAB873. b. PPP studies were performed on 9/11/18 and 7/30/19 for S/N 7241510308. c. PPP studies were performed on 9/13/18 and 8/14/19 for S/N 17056UAB873. 4. Staff interview with the technical supervisor #1 (TS1) on 9/30/19 at 12:30 PM confirmed PPP performance for the 6 month check was missed for March 2019 and TS1 was unable to provide the laboratory policy for PPP function check. 5. The laboratory performs 9,830 PT tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D3003 FACILITIES CFR(s): 493.1101(a)(2) The laboratory must be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to ensure humidity and temperature of the laboratory testing area is maintained. Findings include: 1. Record review of the laboratory's "Humidity / Temperature Chart" on 2/9/18 revealed the following: a. Humidity readings were out of the acceptable range (30-85%) listed on the above chart as follows: 1 of 14 working days in August 2017 5 of 22 working days in October 2017 11 of 21 working days in November 2017 20 of 20 working days in December 2017 18 of 22 working days in January 2018 7 of 7 working days to-date in February 2018 b. Room temperature readings were out of the acceptable range (18-24C) listed on the above chart as follows: 10 of 14 working days in August 2017 6 of 20 working days in September 2017 5 of 22 working days in October 2017 7 of 21 working days in November 2017 10 of 20 working days in December 2017 14 of 22 working days in January 2018 2 of 7 working days to-date in February 2018 c.