Highland Community Hospital

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 the laboratory's Policy and Procedure Manual for Blood Bank, the Blood Bank Transfusion Service Testing record from 6/3/2022 through 2/28/2024, and interview with General Supervisor #6, listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory personnel failed to follow the laboratory's "ABO/Rh and Weak D Testing" procedure for two cord blood tests performed during twenty-one months of testing. Findings include: 1. Review of the laboratory's Policy and Procedure Manual for Blood Bank revealed the "ABO/Rh and Weak D Testing" procedure states, "Testing for a weak D is not required for all negative anti-D immediate spin reactions except for cord bloods, which always require a weak D test for negative reactions with Anti-D." 2. Review of the Blood Bank Transfusion Service Testing record from 6/3/2022 through 2/28/2024 revealed the laboratory personnel failed to perform weak D testing on the following two cord blood samples when a negative reaction was obtained with Anti-D testing: 12/6/2023- Patient Medical Record #20680582. 12/13/2023-Patient Medical Record #20616090. 3. In an interview on 2/28/2024 at 5:00 p.m., General Supervisor #6 confirmed that weak D testing was not performed on these two patient cord blood samples. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all 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 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 review of personnel records, new analyzer verification records and the CMS 209 personnel form, the laboratory director failed to ensure two of seventeen testing personnel, responsible for moderate complexity testing, received the appropriate training and demonstrated that they could perform all testing operations reliably, to provide and report accurate results, on new analyzers put in use in 2023. Findings include: 1. Review of personnel records and new analyzer verification records since 6 /2/2022 revealed Testing Personnel #18, date of hire November 2022, listed on the CMS 209 personnel form, had no documentation of training or documentation of performance of testing operations for the following four Beckman Coulter analyzers, in use for eight months from 6/27/23 through the day of the survey, 2/29/24: DxC 700AU and AU 480 for routine chemistry testing; DxI 600 and Access II for immunoassay testing. 2. Review of personnel records and new analyzer verification records since 6/2/2022 revealed Testing Personnel #20 had no documentation of training or documentation of performance of testing operations, since this individual's date of hire in September 2023, for the Instrumentation Laboratories (IL) ACL TOP 350 coagulation system, put in use 4/12/23, and ACL Elite coagulation system, put in use 4/20/23, or for the following Beckman Coulter analyzers put in use on 6/27/23: DxC 700AU and AU 480 for routine chemistry testing; DxI 600 and Access II for immunoassay testing. -- 2 of 2 --

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 the laboratory's Policy and Procedure Manual for Blood Bank, the Blood Bank Transfusion Service Testing record from 6/3/2022 through 2/28/2024, and interview with General Supervisor #6, listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory personnel failed to follow the laboratory's "ABO/Rh and Weak D Testing" procedure for two cord blood tests performed during twenty-one months of testing. Findings include: 1. Review of the laboratory's Policy and Procedure Manual for Blood Bank revealed the "ABO/Rh and Weak D Testing" procedure states, "Testing for a weak D is not required for all negative anti-D immediate spin reactions except for cord bloods, which always require a weak D test for negative reactions with Anti-D." 2. Review of the Blood Bank Transfusion Service Testing record from 6/3/2022 through 2/28/2024 revealed the laboratory personnel failed to perform weak D testing on the following two cord blood samples when a negative reaction was obtained with Anti-D testing: 12/6/2023- Patient Medical Record #20680582. 12/13/2023-Patient Medical Record #20616090. 3. In an interview on 2/28/2024 at 5:00 p.m., General Supervisor #6 confirmed that weak D testing was not performed on these two patient cord blood samples. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all 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 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 review of personnel records, new analyzer verification records and the CMS 209 personnel form, the laboratory director failed to ensure two of seventeen testing personnel, responsible for moderate complexity testing, received the appropriate training and demonstrated that they could perform all testing operations reliably, to provide and report accurate results, on new analyzers put in use in 2023. Findings include: 1. Review of personnel records and new analyzer verification records since 6 /2/2022 revealed Testing Personnel #18, date of hire November 2022, listed on the CMS 209 personnel form, had no documentation of training or documentation of performance of testing operations for the following four Beckman Coulter analyzers, in use for eight months from 6/27/23 through the day of the survey, 2/29/24: DxC 700AU and AU 480 for routine chemistry testing; DxI 600 and Access II for immunoassay testing. 2. Review of personnel records and new analyzer verification records since 6/2/2022 revealed Testing Personnel #20 had no documentation of training or documentation of performance of testing operations, since this individual's date of hire in September 2023, for the Instrumentation Laboratories (IL) ACL TOP 350 coagulation system, put in use 4/12/23, and ACL Elite coagulation system, put in use 4/20/23, or for the following Beckman Coulter analyzers put in use on 6/27/23: DxC 700AU and AU 480 for routine chemistry testing; DxI 600 and Access II for immunoassay testing. -- 2 of 2 --

Summary Statement of Deficiencies 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 records, interview with the technical consultant on 5-10-18 at 5:00 p.m., and lack of verification of accuracy of erythrocyte sedimentation rate (ESR) performed on the ESR STAT Plus reader, the laboratory failed to verify the accuracy of ESR since the ESR STAT Plus moderate complexity reader was put in use for patient testing in March 2017. Findings include: Interview with the technical consultant on 5-10-18 at 5:00 p.m. revealed the ESR STAT Plus moderate complexity reader was put in use for patient testing in March 2017. Review of proficiency testing records since March 2017 revealed the laboratory was not enrolled in proficiency testing to verify accuracy of ESR performed on the ESR STAT Plus moderate complexity reader. The technical consultant confirmed verification of accuracy of ESR had not been performed since the reader was put in use. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records since the last survey on 6-8-16 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 -- and the laboratory's Proficiency Testing policy, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems with patient test results when PT results are unsatisfactory. Findings include: Review of the laboratory's Proficiency Testing policy revealed no procedure for reviewing patient test results and assessing accuracy of results during the time frame when PT scores are unsatisfactory. Review of PT records since 6-8-16 revealed the following unsatisfactory scores, with no documentation of review of patient test results during these time frames: Pro-BNP (B- type Natriuretic Peptide) - 40% for Event 2 of 2016; 20% for Event 1 of 2017. Troponin T - 60% for Event 1 of 2017. Digoxin - 60% for Event 3 of 2017. -- 2 of 2 --