Kansas Spine & Specialty Hospital, Llc

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 an absence of thermometer function check records or certificates of accuracy, protocols for thermometer function checks and interview with the general supervisor (GS), the laboratory failed to define and perform a function check protocol for six of seven thermometers. Findings: 1. No documentation was available for function checks on six of seven thermometers at the time of survey. 2. No documentation was available for the certification of accuracy (NIST traceable) on six of seven thermometers at the time of survey. 3. Protocols for the function checks of thermometers were not made available at the time of survey. 4. Interview with the GS on 7/19/22 at 11:45 a.m. confirmed, the laboratory failed to define and perform a function check protocol for six of seven thermometers. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) 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 -- Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of competency assessment records, and interview, the technical supervisor failed to ensure that all six required elements for competency assessment were performed for four of four testing personnel (TP). Findings: 1. Competency assessments in 2021 and to date of survey 2022 for TP #1, 2,3, and 4 did not contain the following required elements: a. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; b. Monitoring the recording and reporting of test results; c. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records; d. Direct observation of performance of instrument maintenance and function checks; e. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or externalproficiency testing samples; and f. Assessment of problem solving skills. 2. All four TP have performed immunohematology testing. TP #4 retired in December 2020. No signature of the technical supervisor of immunohematology was present on the competency documents reviewed at survey. 3. Interview with the GS 7 /19/22 at 8:35 a.m. confirmed, the technical supervisor failed to ensure that all six required elements for competency assessment were performed for four of four testing personnel (TP). -- 2 of 2 --

Summary Statement of Deficiencies D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of blood bank procedure, patient antibody history and interview with technical supervisor #4 the laboratory failed to have an up to date policy on checking patient history. Findings: 1. Review of blood bank procedure states "If review of records reveals that the patient has had a positive antibody screen in the past, units used for cross matching must be negative for that antibody, even if the current screen is negative". Interview with technical supervisor #4 revealed testing personnel are supposed to check the computer and the files for patient history. 2. Review of computer for patient history showed patient history is placed in different files in the computer with no procedure to show how to retrieve it. 3. Review of antibody patient history revealed a folder with patient histories, not in alphabetical order. 4. Interview with technical supervisor #4 on November 9, 2018 at 1:00 PM confirmed blood bank procedure for checking patient antibody history was not well defined. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) 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 -- (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of chemistry Horiba Pentra 400, i-Stat and Sysmex XP300 procedures shows that twice a year the laboratory did not evaluate and define the relationship between test results using different methodologies and instruments in 2016 and 2017 and to date November 9, 2018. Findings: 1. Review of chemistry analytes sodium, potassium, chloride, CO2, BUN, creatinine and glucose showed they are performed on the Horiba Pentra 400 and the iStat. The laboratory failed to evaluate and define the relationship between test results. 2. Review of hematology analyte hematocrit showed it is performed on the iStat and the Sysmex XP300. The laboratory failed to define the relationship between test results. 3. Interview with the technical supervisor #4 on November 9, 2018 at 1:00 PM confirmed the laboratory failed to evaluate and define the relationship between test results for sodium, potassium, chloride, CO2, BUN, creatinine, glucose and hematocrit. -- 2 of 2 --