Wasatch Women's Center

Summary Statement of Deficiencies D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on competency records review, lack of documentation, and interview with staff, the laboratory technical consultant failed to evaluate the Rh type testing competency for 2 of 5 testing personnel for 1 of 2 years of testing performed (2019). Findings include: 1. Competency evaluation record review failed to include documentation Testing personnel C and D were evaluated in 2019 for Rh type competency through direct observation of Rh typing procedures, monitoring the recording and reporting of test results, review of intermediate worksheets and preventive maintenance records, assessment of test performance through proficiency testing samples, and assessment of problem solving skills. 2. In an interview with staff on 09/22/2020 at approximately 10:15 A.M. staff confirmed two staff members lacked 2019 competency evaluations. 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 D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on procedure manual review and interview with staff, the laboratory director failed to sign and date as approved the Rh slide tests procedure. Findings include: 1. Procedure manual review included a newly revised Rh factor slide type procedure that did not include the signature and date of the director's approval. 2. In an interview conducted on 04/23/2018 at approximately 4:00 P.M. staff conformed the director had not approved the newly written procedure. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on manufacturer's package insert instructions review, test record review, and interview with staff, the laboratory failed to follow Rh typing antisera manufacturer's instructions to incubate patient's cells with Rh anti-sera at 20 to 24 degrees Centigrade for 5 minutes. The laboratory performed approximately 5 tests per day. Findings include: 1. Quotient Anti D (Rh) typing sera reagent instructions stated the slide should be tested at 20 to 24 degrees Centigrade. 2. Temperature records review 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 -- included documentation the laboratory performed testing on a 45 Degree Centigrade slide warming tray. 3. In an interview conducted on 04/24/2018 at approximately 4:15 P.M., testing personnel confirmed they used the 45 degree slide warmer to incubate the Rh slides. -- 2 of 2 --