Summary:
Summary Statement of Deficiencies D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on Dimension EXL system manufacturer's instructions, Dimension Cuvette record temperature review (year 2019) and technical supervisor interview on May 24, 2019 at 11:40 AM, it was determined that the laboratory failed to follow the Dimension EXL manufacturer's instruction when 100 percent patients specimens were processed and reported for routine chemistry tests by the Dimension EXL system from January 2, 2019 to May 17, 2019. The findings include: 1. The laboratory processed the 100 percent of the routine chemistry tests by the Dimension EXL system. 2. The Dimension EXL system manufacturer establish the cuvette temperature range from 36.8 C to 37.2 C. 3. On May 24, 2019 at 11:40 AM, the Dimension EXL system temperatures records showed that the laboratory processed and reported the 100 percent of patients specimens out of the cuvette temperature range the following dates from January 2, 2019 to May 17, 2019: a. From January 2, 2019 to January 31, 2019: 20 out of 21 days at 36.7 C. b. From February 1, 2019 to February 28, 2019: 17 out of 19 days at 36.7 C. c. From March 1, 2019 to March 29, 2019: 18 out of 21 days at 36.7 C. d. From April 1, 2019 to April 30, 2019: 20 out of 20 days, 18 days at 36.7 C and 2 days at 36.6 C. e. From May 1, 2019 to May 17, 2019: 13 out of 13 days at 36.7 C. 4. The laboratory technical supervisor confirmed on May 24, 2019 at 11:40 AM, that the cuvette temperature records showed temperatures out of the manufacture's limits and no