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: Based on review of the temperature records, and interview with the laboratory staff, it was determined that the laboratory failed to monitor and document the temperature conditions. The findings included: a. The laboratory established an acceptable room temperature range between 21 to 28 centigrade (oC). b. Reviewed the laboratory temperature records, there were 9 out of a total of 22 temperature recorded in April 2018 at 20 oC which was out of the acceptable range. c. Reviewed the laboratory temperature records, there were 5 out of a total of 19 temperature recorded in May 2018 at 20 oC which was out of the acceptable range. d. The laboratory performed complete semen analysis, the temperature monitoring is essential for proper storage of the specimen, and to ensure accurate and reliable test system operation, and test results reporting. e. The laboratory staff affirmed (7/5/18 @ 11:05 AM) that no remedial actions were taken to correct the temperatures out side the acceptable room temperature. f. The laboratory performed complete semen analyses in approximately 30 patient specimens monthly D5781