Mercy

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of blood bank procedures and interview with testing personnel (TP) #7 and the technical supervisor, the laboratory failed to provide an updated written procedure for confirming patient history prior to patient testing. Findings: 1. Review of "Retyping of the Use of Historical Blood Type"procedure states "Check patient record for a historical Blood Type using Blood Bank History cards." 2. Interview with TP # 7 on April 13, 2021 at 11:30 AM , TP #7 stated when "confirming patient history, they must check the blood bank history cards and the computer prior to patient testing." 3. Interview with the technical supervisor on April 13, 2021 at 12:00 PM confirmed the laboratory failed to provide an updated written procedure for confirming patient history prior to patient testing. 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 D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: 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 blood bank procedures, blood bank alarm checks and interview with technical supervisor #2 the laboratory failed to follow procedure and perform blood bank alarm checks quarterly in 2017. Findings: 1. Review of blood bank 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 -- procedure states "The proper function of the alarm system should be validated quarterly", 2 Review of "quarterly blood bank refrigerator/freezer alarm" worksheet shows an alarm check was not completed in two of four quarters in 2017. 3. Interview with the technical supervisor on July 3, 2018 at 11:30 confirmed the laboratory failed to follow procedure and perform blood bank alarm checks quarterly in 2017. -- 2 of 2 --