Siouxland District Health Department

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of proficiency testing (PT) records, the Laboratory Test List & Annual Volume form, and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 10:00 am on 01/23/2020, the laboratory failed to enroll in an approved proficiency testing program for the subspecialty of bacteriology (endocervical and urethral gram stains) for three out of three years from 2018-2020. The findings include: 1. The Laboratory Test List & Annual volume form indicated that the laboratory performed limited bacteriology testing, including endocervical and urethral gram stains. 2. At the time of the survey, personnel identifier #2 confirmed that the laboratory did not enroll in an approved proficiency testing program for the subspecialty of bacteriology (endocervical and urethral gram stains) from 2018-2020. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of procedure manuals, lack of centrifuge speed and timer checks, and confirmed by laboratory personnel identifier #2 (refer to Laboratory Personnel Report) at approximately 10:00 am on 01/26/2018, the laboratory failed to define a function check protocol for performing centrifuge speed and timer checks. In addition, the laboratory failed to perform speed and timer checks on two out of two centrifuges (International Cent centrifuge and the IEC Central 4-B centrifuge) in 2016 and 2017. The findings include: 1. At the time of the survey, the laboratory did not have a function check protocol defining the frequency for performing centrifuge speed and timer checks on the centrifuges. 2. The laboratory did not perform speed and timer checks on either of their centrifuges (International Cent centrifuge and the IEC Central 4-B centrifuge) in 2016 or 2017. 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 --