Johnson Memorial Health Services

Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory director failed to ensure initial training on two new chemistry analyzers was documented for one of four testing personnel in 2021. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor during a tour of the laboratory on 06/02/22 at 8:05 a.m. 2. Testing personnel 5 (TP5) began working in the laboratory in October 2021 as indicated in laboratory records. TP5 met the qualifications to perform moderate complexity testing at 493.1423(b)(2) based on a review of education documents. 3. The laboratory implemented testing on two new Chemistry analyzers, the Beckman Coulter AU480 and the Beckman Coulter Access 2, in December 2021 as indicated in laboratory records. 4. Training documents for the two new chemistry analyzers were not found during review of TP5's personnel records. The laboratory was unable to provide the missing documents upon request. 5. In an interview at 11:35 a.m. on 06/02/22, the Technical Consultant confirmed the above finding. 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 D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the technical supervisor (TS) failed to ensure competency assessments for all testing personnel included assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples for all testing performed by the laboratory. Findings are as follows: 1. The laboratory performed Microbiology, General Immunology, Chemistry, Hematology and Immunohematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory 06/07/18 at 10:15 a.m. 2. The laboratory established blind sample testing evaluation requirements in the Technical Competency policy located in the Policy General Lab manual. The Laboratory Employee Competency Review form included assessment of proficiency testing results for each of the following testing specialties/subspecialties. Microbiology (Micro) Hematology (Heme) Coagulation (Coag) Chemistry (Chem) Urinalysis (UA) Immunohematology (BB) 3. Documentation of blind sample evaluations was not found for 4 of 6 testing personnel for each testing specialty in 2016 and 2017. See below where "0" indicates the blind sample testing evaluation was not found. 2016 Specialty Testing Personnel 1 2 5 GS Micro 0 0 Heme 0 0 0 Coag 0 0 0 Chem 0 0 UA 0 0 0 BB 0 0 0 0 2017 Specialty Testing Personnel 1 2 5 Micro Heme 0 0 Coag 0 0 Chem 0 0 UA 0 0 BB 0 0 4. A 2017 competency assessment document for the GS was not found during review of laboratory records. The laboratory was unable to provide this document upon request. See D6128. 5. In an interview on 06/07/18 at 12:05 p.m., the GS confirmed the testing personnel had not been evaluated using blind sample testing as indicated above. 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 -- D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Technical Supervisor failed to evaluate 1 of 6 testing personnel for testing competency in 2017. Findings are as follows: 1. The laboratory performed Microbiology, General Immunology, Chemistry, Hematology and Immunohematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory 06/07/18 at 10:15 a.m. 2. The General Supervisor (GS) stated during the entrance meeting that she performed patient sample testing. 3. A 2017 competency assessment for the GS was not found during review of laboratory records. The laboratory was unable to provide this document upon request. 4. In an interview on 06/07/18 at 12:05 p.m., the GS confirmed she had not been evaluated for testing competency in 2017. *This is a repeat finding. D6128 was previously cited on 09/09/16* -- 2 of 2 --