Wren Laboratories, Llc

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on surveyor observation, record review and staff interview the laboratory failed to document routine maintenance and function checks for laboratory equipment in the subspecialties of routine Chemistry and Virology. Findings include: 1. Surveyor observation on 02/10/2022 at approximately 9:30 AM of the laboratory's amplification room revealed four QuantStudio 7 (QS7) Flex Real-Time Polymerase Chain Reaction (PCR) systems by Applied Biosystems. 2. Record review on 02/10 /2022 of the above instrumentation user guide Revision A, November 2013 revealed "The QuantStudio 6 and 7 Flex system require regular calibration and maintenance for proper operation. To ensure proper operation of your instrument, perform weekly, monthly, and semiannual maintenance..." 3. Record review on 02/10/2022 of the laboratory's Care & Maintenance: PCR Machines - WRL-FM-010c procedure revealed the laboratory did not have maintenance protocols/schedules for the weekly and monthly required maintenance tasks. 4. Record review on 02/10/2022 of the QS7 maintenance/calibration binder revealed the laboratory did not have the required weekly and monthly maintenance records. 5. Staff interview with technical supervisor (TS) on 02/10/2022 at 2:20 PM confirmed the laboratory did not conduct weekly and monthly required maintenance tasks. TS revealed he/she was unaware of the weekly and monthly required maintenance. D5781

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to follow manufacturer instructions for proper storage of reagents in the specialty of clinical cytogenetics. Findings include: 1. Surveyor observation of the FF4 laboratory refrigerator contents on 7/16/18 at 1:30 PM revealed: a. 1 bottle from Applied Biosystems (ABI) labeled DNA wipe test, lot# 1611035, expiration date 9/2/18. b. 6 bottles of ABI TaqMan Universal MMII with UNG used for QPCR for the NETest, lot# 1706037, expiration date 5/23/19. c. Manufacturer instructions on these bottles revealed proper storage is 2 to 8 degrees Celsius. 2. Record review on 7/16/18 of the FF4 laboratory refrigerator temperature logs from 10/12/16 through 5/31/18 revealed: a. The temperature logs from October and November 2016 do not have an acceptable range written on them. b. The acceptable range from December 2016 through May 2018 is listed as 1 to 9 degrees Celsius. c. The temperatures were out of range for the storage of the above reagents on 103 of 406 working days. d.