Douglas County Memorial Hospital

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 8/28/24. Douglas County Memorial Hospital laboratory was found not in compliance with the following requirements: D6120 and D6125. 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) 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 record review and interview, technical supervisor A failed to ensure that one of five laboratory personnel (laboratory supervisor B) had received a competency evaluation in 2023 for the test methods they had performed under the laboratory's certificate. Competency assessment verifies testing personnel were competent to correctly process patient specimens and to ensure the accuracy of the patient specimen results reported. Findings include: 1. Review on 8/28/24 at 8:40 am. of the employee competency records revealed: *Laboratory supervisor B had not had an annual competency evaluation documented in 2023. *A request was made to laboratory supervisor B for any additional documentation of an annual competency assessment completed for 2023. *No additional documentation was provided during the survey. Review of the CMS 209 Laboratory Personnel Form revealed laboratory supervisor B had been listed as the general supervisor. Review of the laboratory's delegation of duties revealed: * Technical Supervisor for High Complexity Testing *Responsibilities (High Complexity)... "h) Evaluating the competency of all 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 2 -- personnel and perform test procedures, and report results promptly, accurately, and proficiently." Interview on 8/28/24 at 8:40 a.m. with laboratory supervisor B revealed: *She confirmed she had not had a competency assessment in 2023. *She confirmed that she had worked in all areas of the laboratory processing and reporting patient specimens. *She was aware a yearly competency had been required. 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 record review and interview, the technical supervisor failed to assess competency through the testing of blind samples or external proficiency samples on all testing platforms for four of four testing personnel (testing personnel C, D, E and F) in 2023. Assessment of blind testing of specimens and/or external proficiency testing (PT) helps ensure competency of staff reporting patient test reports. Findings include: 1. Review on 8/28/24 at 8:40 a.m. of the laboratory staff's annual competency assessment records revealed: *Testing personnel C's 2023 annual competency evaluation had been completed on 11/4/23. -"No PT events 2023" had been documented for blind testing in the areas of hematology, urinalysis, microbiology, serology, and arterial blood gas testing. *Testing personnel D's 2023 annual competency evaluation had been completed on 11/4/23. -"No PT events 2023" had been documented for hematology, coagulation, urinalysis, and arterial blood gas testing. *Testing personnel E's 2023 annual competency evaluation had been completed on 11/3/23. -"No PT events 2023" had been documented for serology, blood banking, arterial blood gas, and nucleic acid BioFire Torch RP2.1 and GI panel testing. -There had been no documentation of blind specimen testing in the area of urinalysis. *Testing personnel F's 2023 annual competency evaluation had been completed on 11/3/23. -"No PT events 2023" had been documented for nucleic acid BioFire Torch RP2.1 and GI panel blind specimen processing. -There had been no documentation of blind testing in the areas of hematology, urinalysis, microbiology, serology, and arterial blood gas testing. Review 8/28/24 of the laboratory's undated Delegation of Duties revealed: *Technical Supervisor for High Complexity Testing *Responsibilities (High Complexity)... "h) Evaluating the competency of all testing personnel and perform test procedures, and report results promptly, accurately, and proficiently. The procedures for the evaluation of competency of the staff must include, but not limited too... (v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples." Interview on 8/28/24 at 08:40 a.m. with laboratory supervisor B revealed: *She confirmed she had completed the 2023 annual competency assessments for testing personnel C, D, E, and F. *She confirmed testing personnel C, D, E, and F processed patient specimens on all testing platforms within the laboratory. *She confirmed she had not documented blind sample testing or external proficiency sample testing for all testing platforms in the laboratory for all testing personnel. *PT events were rotated between staff. There were only 2-3 PT events each year for each testing platform. *She had not been aware that specimen types other than PT samples had been acceptable to be used for blind specimen testing to ensure staff competency processing and reporting patient specimens. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 7/20/21. The Douglas County Memorial Hospital laboratory was found not in compliance with the following requirement: D2015. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to maintain a copy of the submitted results for thirty-four of thirty-four proficiency testing (PT) events reviewed (2019, 2020 and to date in 2021). These reports documented the results submitted by the laboratory for evaluation by the PT company. Findings include: 1. Review of the laboratory's PT event records on 7/20/2021 revealed: *The laboratory subscribed to PT events through the American Proficiency Testing Institute. *PT specimens were processed and the results submitted via the company's website upon completion of testing. *The result forms had been printed before the results had been submitted electronically. Those forms stated the test results had not been submitted, and therefore could have been changed prior to submission. *The laboratory had completed and received evaluation reports for the following testing events: a. 2021 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 -- API PT events -Immunology/Immunohematology- testing event 1. -Hematology /Coagulation- testing event 1. -Microbiology- testing event 1. -Chemistry Core- testing event 1 and 2. -Chemistry Miscellaneous- testing event 1. b. 2020 API PT events -Immunology/Immunohematology- testing events 1, 2, and 3. -Hematology /Coagulation- testing events 1, 2, and 3. -Microbiology- testing events 1, 2, and 3. - Chemistry Core- testing events 1, 2, and 3. -Chemistry Miscellaneous- testing events 1 and 2. -SARS CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2)- testing event 3. c. 2019 API PT events -Immunology/Immunohematology- testing events 1, 2, and 3. -Hematology/Coagulation- testing events 1, 2, and 3. -Microbiology- testing events 1, 2, and 3. -Chemistry Core- testing events 1, 2, and 3. -Chemistry Miscellaneous- testing events 1 and 2. Review of the Proficiency Testing procedure (last reviewed by the laboratory director on 10/9/20) revealed, "The worksheets, instrument printouts, and copies of the original paperwork with results submitted to API are all kept at DCMH [Douglas County Memorial Hospital]." Interview on 7/20 /21 at 10:05 a.m. with laboratory personnel A revealed she confirmed the laboratory had not kept the submitted result forms for the PT events the laboratory had completed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 9/12/18. The Douglas County Memorial Hospital laboratory was found not in compliance with the following requirements: D5217, D5421, and D6091. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) documentation, immunohematology patient testing log, and laboratory supervisor interview, the laboratory failed to verify and document the accuracy of the test method used for patient direct antiglobulin testing (DAT) twice a year for 20 of 20 months reviewed (January 2017 through August 2018). Findings include: 1. Review of the laboratory's PT documentation revealed there had been no documentation the accuracy of the DAT test had been verified twice a year for the above time frame. Review of the immunohematology patient testing log revealed one patient DAT test had been reported during the twenty months reviewed. Interview on 9/12/18 at 11:15 a.m. with the laboratory's supervisor revealed PT had not been ordered for the DAT test. It was an oversight on her part. DAT testing was rarely ordered as they no longer provided obstetrical services. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the 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 -- manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the performance specification verification records for the Beckman AU480 chemistry analyzer, patient record review and interview with laboratory supervisor, the laboratory failed to verify and approve the accuracy for 1 of 31 analytes (lipase) before patient specimens had been tested and their results reported. Findings include: 1. Review of the performance specification verification records for the lipase test method on the Beckman AU 480 chemistry analyzer revealed accuracy had not been verified and approved prior to testing of patient specimens. There was documentation of precision, reportable ranges, and normal range verifications. The laboratory director had signed off the performance specification verification records as acceptable on 4/11/18. Review of patient records revealed the accuracy of the lipase test method had not been verified before twelve patient lipase specimens had been reported between 4/1/18 (when the analyzer went live) and 9/12/18. Interview on 9/12/18 at 1:30 p.m. with the laboratory supervisor revealed: *The accuracy/comparison studies had not been included in the performance specification verification as the previous analyzer did not report lipase. *She had been told by the technical specialist who installed the analyzer the studies were complete. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require