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 Xpand manufacturer's instructions, Cuvette temperature records (years 2020 and 2021) review, testing personnel interview on December 15, 2021 at 10:30 AM, it was determined that the laboratory failed to follow the Dimension Xpand manufacturer's instruction for system daily maintenance when 200 out of 200 patients specimens were processed and reported for comprehensive metabolic panel (CMP) tests by the Dimension Xpand system from June 29, 2020 to August 18, 2020. The findings include: 1. The Dimension Xpand system manufacturer's requires the Cuvette temperature range from 36.8 C to 37.2 C. 2. The Dimension Xpand Cuvette temperature records showed that the laboratory processed and reported 200 patients specimens for CMP tests out of the required manufacturer temperature range during the following days from June 29, 2020 to August 18, 2020: Date cuvette CMP's patients temperature specimens 06/29/2020 35.6 C 11 07/01/2020 35.9 C 8 07/03 /2020 37.4 C 5 07/06/2020 37.5 C 14 07/08/2020 37.3 C 13 07/10/2020 37.3 C 9 07/11 /2020 37.4 C 10 07/15/2020 37.3 C 11 07/17/2020 37.3 C 16 07/20/2020 37.4 C 15 07 /22/2020 37.3 C 5 07/24/2020 37.3 C 7 07/29/2020 37.4 C 7 07/31/2020 37.4 C 9 08 /01/2020 37.3 C 10 08/07/2020 37.4 C 4 08/13/2020 37.4 C 15 08/14/2020 37.4 C 10 08/15/2020 37.4 C 5 08/18/2020 37.4 C 16 3. The testing personnel confirmed on December 15, 2021 at 10:30 AM, that the laboratory processed those patients specimens for CMP tests out of the manufacturer cuvette temperature range from June 29, 2020 to August 18, 2020. 4. The laboratory processed 200 patients specimens for CMP tests from June 29, 2020 to August 18, 2020. 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 -- 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 lack of preventive maintenance instructions and preventive maintenance records for the Clinitek 100 system and interview with the testing personnel on December 15, 2021 at 11:03 AM, it was determined that the laboratory failed to perform the preventive maintenance of the Clinitek 100 system from December 15, 2020 to December 15, 2021. The findings include: 1. The laboratory performed the urinalysis tests by the Clinitek 100 system. 2. The laboratory did not have the Clinitek 100 system manufacturer's instruction nor the daily preventive maintenance records available in the laboratory. 3. The laboratory did not perform the daily preventive maintenance of the Clinitek 100 system from December 15, 2020 to December 15, 2021. 4. The testing personnel confirmed that the laboratory did not have available the manufacturer's preventive instruction nor the Clinitek 100 daily preventive maintenance records. She stated that the preventive maintenance the Clinitek 100 system were performed daily during this period but the laboratory not recorded. 5. The laboratory processed 4,752 urine specimens by the Clinitek 100 system for urinalysis tests from December 15, 2020 to December 15, 2021. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on lack of preventive maintenance instructions and preventive maintenance records for the Clinitek 100 system, on Dimension Xpand manufacturer's instructions and Cuvette temperature records (years 2020 and 2021) review and testing personnel interview on December 15, 2021 at 11:03 AM, it was determined that the laboratory director failed to compliance with the requirements for urinalysis and routine chemistry analytic systems. Refer to D 5429 (The laboratory did not perform the preventive maintenance of the Clinitek 100 system). Refer to D 5405 (The laboratory failed to follow the Dimension Xpand manufacturer's instruction for system daily maintenance). -- 2 of 2 --