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 manufacturer instructions, syphilis serology quality control records review (years 2020-2021) and laboratory general supervisor interview on October 13, 2021 at 10:00 AM, it was determined that the laboratory failed to follow the manufacturer's instruction when patient specimen were tested for syphilis serology by ASI Rapid plasma reagin (RPR) method. The findings include: 1. The laboratory uses ASI Rapid plasma reagin (RPR) method when patient specimen were tested for syphilis serology since January 2021. 2. The manufacturer's instruction establishes that three levels of control material ( non reactive, minimal to moderate and reactive) must be included each day of testing. The laboratory only include two levels (reactive and non reactive). 3. From January 4, 2021 to October 12, 2021 (213 days - two hundred thirteen days), the syphilis serology quality control records showed that the laboratory did not include the three levels of control material when it processed and reported 941 out of 941 patients specimens for syphilis serology by ASI RPR method. 4. The laboratory general supervisor stated that the laboratory performed only two levels of controls those days (non reactive and reactive). D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument 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 -- and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on manufacturer instructions, syphillis serology quality control records review (years 2020-2021)and laboratory general supervisor interview on October 13, 2021 at 10:00 AM, it was determined that testing personnel failed to follow quality control procedures. Refer to D5405. 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 manufacturer instructions, syphillis serology quality control records review (years 2020-2021) and laboratory general supervisor interview at 10:00 AM on October 13, 2021, it was found that the laboratory director did not ensure that syphillis serology quality controls procedures were established as per state by the manufacturer. Refer to D5405. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on manufacturer instructions, syphillis serology quality control records review (years 2020-2021) and laboratory general supervisor interview at 10:00 AM on October 13, 2021, it was determined that the general supervisor did not assure that quality control procedures were followed by the testing personnel. Refer to D5405. -- 2 of 2 --