Boundary Community Hospital

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 a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, laboratory procedures, training and competency assessment records and an interview with the laboratory manager on 2/25/2025, the laboratory failed to follow written policies and procedures to assess testing personnel competency in 2024. The findings include: 1. The CMS 209 identified six (6) testing personnel (TP) performing testing of which two (2) were new since the last inspection on 2/7/2023. 2. A review of laboratory procedures identified that the laboratory established policies and procedures to assess TP initial training, semiannual and annual competency. 3. A review of training and competency assessment records identified that the laboratory failed to have six month competency assessments for one (1) of two (2) TP in 2024. 4. An interview with the laboratory manager on 2/25/2025 at 9:35 am confirmed the above findings. 5. The laboratory reports performing 110,000 tests annually. 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 D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of maintenance records for the Sysmex CS-2500 and an interview with the laboratory manager on 2/7/2023, the laboratory failed to perform instrument maintenance as required by the manufacturer. The findings include: 1. A review of maintenance records for the Sysmex CS-2500 identified that the laboratory failed to complete daily maintenance which included rinsing the probe, discarding used cuvettes and waste and checking and discarding trap chamber fluid for four (4) of 24 days in October 2022, eight (8) of 30 days in November 2022, 12 of 31 days in December and eight (8) of 31 days in January 2023. 2. A review of maintenance records for the Sysmex CS-2500 identified that the laboratory failed to complete weekly maintenance which included cleaning the instrument and rinsing the rinse tank for one (1) of four (4) weeks in December 2022 and one (1) of four (4) weeks in January 2023. 3. A review of maintenance records for the Sysmex CS-2500 identified that the laboratory failed to complete the monthly maintenance of cleaning the filter for December 2022. 4. An interview with the laboratory manager on 2/7/2023 at 10:40 am confirmed the above findings. 5. The laboratory reports performing 930 prothrombin time and partial thromboplastin time tests on the Sysmex CS-2500 annually. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations 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 -- Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of BioFire quality control (QC) documents and an interview with the laboratory manger on 2/6/2023, the laboratory failed to have positive and negative controls for all analytes tested. The findings include: 1. A review of QC documents for the BioFire Pneumonia Panel identified that the laboratory failed to have a negative control for the 33 targets tested since the last inspection (3/11/21). 2. An interview with the laboratory manager on 2/6/2023 at 3:30 pm confirmed that the laboratory failed to test negative controls for the BioFire Pneumonia Panel. 3. The laboratory reports performing 16 BioFire Pneumonia Panels annually. -- 2 of 2 --

Summary Statement of Deficiencies 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 a record review of Proficiency Testing (PT) from the American Proficiency Institute (API) and an interview with the Laboratory Manager on 03/10/2021, the Laboratory Director, or designee, failed to sign PT attestation forms for all events and all specialties and subspecialties in 2020. The findings include: 1. A review of PT attestation forms from API on 03/10/2021 at 12:30 PM, for Events 1,2, and 3 in 2020 revealed that the Laboratory Director, or designee, failed to sign all PT attestation forms for all events and all specialties and subspecialties. 2. An interview with the Laboratory Manager on 03/10/2021 at 12:30 confirmed the above finding. 3. The laboratory reports performing 34,720 moderate and high complexity tests annually. 4. This is a repeat deficiency from the previous survey on 11/14/2018. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- 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 record review of the laboratory's procedure manual, the procedures "Daily Quality Assurance Check" and "Quality Assurance in Laboratory Services," and an interview with the Laboratory Manager on 03/11/2021, the laboratory failed to follow their written policies and document problems identified in the general laboratory system. The findings include: 1. A procedure record review of "Daily Quality Assurance Check" on 03/11/2021 at 10:30 AM, revealed that the laboratory failed to follow their written procedure and document that daily worksheets were crosschecked for errors on a daily interval. 2. A procedure record review of "Quality Assurance in Laboratory Services" on 03/11/2021 at 10:30 AM, revealed that the laboratory failed to follow their written procedure and document their ongoing mechanism to monitor, assess, review and correct problems identified in the analytic system on a monthly, semiannually, and yearly basis. 3. An interview with the Laboratory Manager on 03/11 /2021 at 11:00 AM confirmed that the laboratory failed to document these quality assurance reviews. 4. The laboratory reports performing 34,720 moderate and high complexity tests annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a proficiency testing (PT) record review and an interview with the laboratory manager, the laboratory failed to enroll in a PT program that covers all testing performed in the specialty of bacteriology since the last survey on March 2, 2017. Findings: 1. A record review of the American Association of Bioanalysts (AAB) PT documents revealed the laboratory failed to properly enroll for all testing performed in the bacteriology laboratory to include: interpretation of gram stains, isolation and identification of aerobic organisms from any source and antimicrobial susceptibility tests. 2. An interview on November 14, 2018 at 9:15 A.M., with the laboratory manager, confirmed the microbiology laboratory failed to enroll for all microbiology testing activities for the isolation and identification aerobic microorganism. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using 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 6 -- laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) record reviews and an interview with the laboratory manager, the laboratory director failed to sign the attestation statements from the American Association of Bioanalysts (AAB) for the specialty of Hematology, Chemistry, Immunohematology, Immunology, Endocrinology, Toxicology, and Bacteriology since last survey on March 2, 2017 Findings: 1. An AAB PT record review from 2017 and 2018, revealed the laboratory director failed to sign the attestation statements for the specialty of Hematology, Chemistry, Immunohematology, Immunology, Endocrinology, Toxicology, and Bacteriology. 2. An interview on November 14, 2018 at 9:45 A.M., with the laboratory manager, confirmed the laboratory director failed to sign the attestation statements from AAB and failed to delegate the responsibility of signing the attestation forms to the laboratory manager who is also the technical supervisor. 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 a proficiency testing (PT) record review, document reviews, and an interview with the laboratory manager, the laboratory failed to verify the accuracy of Cryptosporidium parvum and Giardia lamblia antigens, blood cultures, respiratory and gastrointestinal pathogens tests performed on the BioFire FilmArray, manual body fluid counts, and Helicobacter pylori stool antigen at least twice annually since the last survey on March 2, 2017. Findings: 1. A record review of proficiency testing from American Association of Bioanalysts and laboratory documents revealed the laboratory failed to document the accuracy of Cryptosporidium parvum and Giardia lamblia antigens, blood cultures, respiratory and gastrointestinal pathogens tests performed on the BioFire FilmArray, manual body fluid counts, and Helicobacter pylori stool antigen at least twice annually since the last survey. 2. An interview on November 14, 2018 at 9:35 A.M., with the laboratory manager, confirmed the laboratory failed to document accuracy at least twice annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)