Summary:
Summary Statement of Deficiencies D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory environmental records and interview with lab staff the laboratory failed to retain records for room temp and humidity for at least two years. Findings include: A) Review of environmental records in the laboratory revealed logs were not kept for at least two years for the following: a. No room temperature documentation for 7 of 12 months in 2016. b. No humidity documentation 7 of 12 months in 2016 B) Interview with the lab staff conducted on 02/13/2018 @ 10:00 AM confirmed temperature and humidity logs were not retained on the dates specified above. 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 review of temperature logs, and interview with the laboratory staff, the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- laboratory failed to monitor the temperature for the Cypress Hematology Laboratory Refrigerator (sensor ID: C9970724/2, Description PO23308) for 2 of 12 months in 2017. Findings include: 1. Review of temperature logs in the TempTrack system revealed temperatures were not monitored due to the TempTrack system being off line from 07/24/2017 through 09/28/2017. 2. In an interview conducted on 02/13/2018 at approximately 10:00 AM, laboratory staff confirmed the TempTrack system was offline from 07/24/2017 through 09/28/2017 and the temperature for the Cypress Hematology Laboratory Refrigerator was not monitored during that timeframe. D5781