Ksb Hospital Cath Lab

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory records and interviews with testing personnel (TP) #1; the laboratory failed to retain all quality control (QC), patient run result, and manufacturer's electronic simulator printouts for Activated Clotting Time (ACT) testing on the i-Stat analyzer for six of six testing dates in 2022 through the survey date of 03/12/2024. Findings include: 1. Review of the laboratory's "I-Stat Celite Activated Clotting Time's Individualized Quality Control Plan" (IQCP), under "Final QCP - iSTAT", it's stated, "Testing of appropriate external QC every thirty (30) days, or new lot number or shipment of reagent kits." 2. Upon a tour of the facility on 03/12 /2024, at 08:10 am, TP #1 stated external electronic simulator checks were performed upon instruments updates mailed to the facility by the manufacturer. 3. Review of QC, patient run results, and electronic stimulator performance records for ACT testing on the i-Stat analyzer found no instrument QC, patient result, or electric stimulator printout records were retained for six of six testing dates (06/22/2022, 11/10/2022, 02 /22/2023, 05/30/2023, 09/05/2023, 01/24/2024) reviewed from 2022 through the survey date of 03/12/2024. 4. An interview on 03/12/2024, at 08:17 am, with TP #1 confirmed that the laboratory did not print QC, patient run result, or electronic simulator printouts performed on the i-Stat analyzer for ACT testing. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency 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 3 -- performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual, College of American Pathologists (CAP) proficiency testing (PT) records, and interview with laboratory technical consultant (TC); the laboratory a) failed to ensure Activated Clotting Time (ACT) PT results were evaluated and b) failed to ensure

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and personnel records and interview with the technical consultant; the laboratory failed to follow written policies and procedures to assess consultant competency. Findings: 1. There were no procedures for how the laboratory accesses the technical consultant's competency to perform her duties. 2. Review of personnel records revealed that the laboratory director delegated 1 person to the position of technical consultant. 3. There was no documentation to show that competency assessment was performed on the technical consultant in 2018, 2019, and 2020. 4. On March 4, 2020, the technical consultant confirmed the surveyor's findings. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) 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; This STANDARD is not met as evidenced by: Based on review of Laboratory Personnel Report (FORM CMS 209) and personnel records and interview with the technical consultant; the technical consultant failed to 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 -- be responsible for identifying training needs of everyone performing tests received regular in-service training and education appropriate for the type of testing performed. Findings: 1. There are a total of 8 persons listed on FORM CMS 209, that are responsible for performing Active Clotting Time (ACT) testing in the laboratory. 2. Review of 8 personnel records revealed that there was no documentation to show the training for 1 of 8 testing personnel performing ACT testing. 3. On March 4, 2020 at 10:30 AM, the technical consultant confirmed the surveyor's finings. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) 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 review of Laboratory Personnel Report (FORM CMS 209) and personnel records and interview with the technical consultant; the technical consultant failed to be responsible for evaluating the competency of all testing personnel to ensure that staff maintained their competency to perform test procedures and report test results. Findings: 1. There are a total of 8 testing personnel and 1 technical consultant listed on FORM CMS 209. 2. Review of the delegation form for the technical consultant revealed that the technical consultant was responsible for evaluating the following: a. Qualtiy Control b. Patient Results c. Proficiency Testing d. Competency 3. Review of personnel records revealed that there was no documentation to show a competency assessment for 1 of 8 testing personnel performing ACT testing. 4. On March 4, 2020 at 10:30 AM, the technical consultant confirmed the surveyor's findings. -- 2 of 2 --