Summary:
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: Through observation, lack of documentation and interview it was determined the laboratory failed to monitor room temperature in one of three rooms in which supplies with storage temperature requirement were stored. Findings follow: A) During a tour of the laboratory on 1/8/20 at approximately 12:30 PM, eight BD 5 ml. Sodium Citrate blood collection tubes lot# 9095659 with an expiration date of 2020-01-31, eight BD 5 ml. EDTA blood collection tubes lot# 9220465 with an expiration date 2020-12-31, fifteen BD SST blood collection tubes lot# 181204 with an expiration date of 2020-02-29 and five BD 15 ml. Red Top blood collection tubes lot# 913788 with an expiration date 2021-04-30 all with a storage temperature requirement of 4 degrees C. to 25 degrees C. were observed stored in a phlebotomy room area separated from the laboratory by a closable door . B) Upon request, the laboratory was unable to provide records of room temperature in the phlebotomy room for the years of 2018 and 2019. C) In an interview on 1/9/20 at approximately 12:45 PM, the laboratory staff member, identified as number three on the CMS 209 form, stated that the laboratory did not monitor the room temperature in the phlebotomy room identified above. 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 --