Bear Lake Memorial 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 policies, competency assessment records and an interview with the laboratory manager on 12/5/2024, the laboratory failed to follow written policies to assess new testing personnel and failed to have a policy to address supervisor competency assessments. The findings include: 1. A review of the CMS 209 form identified one new testing personnel, two technical supervisors and three general supervisors. 2. The laboratory did not have a policy or procedure in place to assess technical supervisor and general supervisor competency. 3. A review of competency assessments identified the laboratory failed to have a six month competency assessment for one of one new testing personnel in 2023. The laboratory failed to provide documentation of competencies for two of two technical supervisors and three of three general supervisors. 4. An interview with the laboratory manager on 12/5/2024 at 8:58 am confirmed the above findings. 5. The laboratory reports performing 144,667 tests annually. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and interview with the laboratory manager on 12/6/2024, the laboratory failed to establish and follow a policy for urine sediment examinations. The findings include: 1. A review of the laboratory policies and procedures identified that the laboratory failed to have a procedure for urine sediment examinations for testing personnel to follow. 2. An interview with the laboratory manager on 12/6/2024 at 8:09 am confirmed that they did not have a policy for urine sediment examinations. 3. The laboratory reports performing 829 urine sediment examinations annually. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observations and an interview with the laboratory manager on 1/12 /2023, the laboratory failed to discontinue the use of expired Trypticase soy agar with 5% sheep blood (TSA II) plates. The findings include: 1. A direct observation of the microbiology refrigerator during the laboratory tour on 1/12/2023 identified that the laboratory failed to discontinue the use of 33 expired BD BBL TSA II plates lot 225779 expiration 2023-01-06. 2. A direct observation of the microbiology incubator during the laboratory tour on 1/12/2023 identified two (2) patient urine cultures with the expired BD BBL TSA II plates. 3. An interview with the laboratory manager on 1 /12/2023 at 10:06 am confirmed the above findings. 4. The laboratory reports performing 1203 microbiology cultures 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 D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on a direct observation and an interview with the laboratory manager on 4/15 /2021, the laboratory failed to label containers with the identity, preparation and expiration dates and other pertinent information required for proper use. The findings include: 1. A direct observation in the laboratory on 4/15/2021 identified three unlabeled containers in the hematology department. 2. An interview with the laboratory manager on 4/15/2021 at 10:24 am identified that the contents were wright- giemsa stain and confirmed that they were not properly labeled. D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations 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-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: 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 -- Based on a random review of immunohematology quality control (QC), patient records and an interview with the laboratory manager on 4/14/2021, the laboratory failed to document control material results with graded or titered reactivity and include negative control material. The findings include: 1. A random record review of immunohematology QC and immunohematology patient logs for 2019 and 2020 identified that the laboratory failed to document QC with a graded or titered reactivity and a negative control on 6/7/2019, 1/31/20 and 4/13/2020. 2. One patient blood and Rh type, antibody screen and crossmatch was performed on 6/7/2019 and the laboratory failed to document positive QC (1-4+) and negative QC as required by regulation for immediate spin crossmatch testing. 3. One patient blood and Rh type was performed on 1/31/2020 and the laboratory failed to document positive QC (1- 4+) and negative QC as required by regulation for all immunohematology testing. 4. Two patient blood and Rh types, and one antibody screen and crossmatch were performed on 4/13/2020 and the laboratory failed to document positive QC (1-4+) and negative QC as required by regulation for antibody screen testing. 5. An interview with the laboratory manager on 4/14/2021 at 1:00 pm confirmed the above findings. 4. The laboratory reports performing 418 immunohematology tests annually. -- 2 of 2 --

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 from the American Association of Bioanalysts (AAB) and an interview with the laboratory manager, the laboratory failed to enroll in a PT program that covers the type of testing performed in the specialty of bacteriology since the last survey on July 26, 2017. Findings: 1. A record review of the AAB PT documents revealed the laboratory failed to enroll in PT for the interpretation of gram stains. 2. An interview on December 13, 2018 at 9:15 A.M. with the laboratory manager, confirmed the microbiology laboratory failed to enroll for testing in gram stain interpretation. 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. 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 -- This STANDARD is not met as evidenced by: Based on records reviewed and an interview with the laboratory manager, the laboratory failed to retain instrument quality control and patient print-outs, as well as quality control assay sheets from the Osmometer, the Excyte Mini sedimentation, and ABL 80 blood gas instruments since the last survey on July 26, 2017. Findings: 1. A review of records for the Excyte Mini sedimentation rate instrument revealed the laboratory failed to retain quality control and patient test print-outs. 2. An interview on December 13, 2018 at 1:25 P.M., with the laboratory manager, confirmed the testing personnel failed to retain instrument printouts for quality controls and patient tests for the instruments. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on proficiency testing (PT) records from the American Association of Bioanalysts (AAB) and an interview with the laboratory manager, the laboratory failed to verify the accuracy of total thyroxine scored an artificial 100% for events 1 and 2 in 2018. Findings: 1. A review of AAB PT documents revealed the laboratory failed to evaluate all artificial scores received from AAB for total thyroxine for events 1 and 2 in 2018. 2. An interview on December 13, 2018 at 9:15 A.M., with the laboratory manager, confirmed artificial scores of 100% received from AAB for the analyte were not evaluated and verified for accuracy. 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 from the American Association of Bioanalysts (AAB) and an interview with the laboratory manager, the laboratory failed to verify the accuracy of microscopic urine sediment examinations, manual cell counts, and direct, conjugated and unconjugated bilirubin at least twice during 2018. This is a repeat deficiency from the last survey on July 26, 2017. Findings: 1. A review of AAB PT documents revealed the laboratory failed to verify the accuracy of microscopic urine sediment examinations, manual cell counts, and direct, conjugated and unconjugated bilirubin at least twice a year in 2018. 2. An interview on December 13, 2018 at 9:15 A.M., with the laboratory manager, confirmed the analytes were not verified for accuracy at least twice a year. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) -- 2 of 3 -- All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from the American Association of Bioanalysts (AAB) and an interview with the laboratory manager, the laboratory failed to document the evaluation and