Idaho Bureau Of Laboratories

Summary Statement of Deficiencies D0000 Federal surveyors from the Division of Clinical Laboratory Improvement and Quality (DCLIQ) Survey Branch conducted an announced CLIA recertification survey at the Idaho Bureau of Laboratories from December 2, 2025 to December 3, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA regulations and was found to be in compliance with condition-level CLIA requirements, the following standard- level deficiencies were found. 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 review of standard operating procedures (SOP), lack of a supervisory personnel competency assessment procedure, and interview with the laboratory director (LD), the laboratory failed to establish a competency assessment procedure to assess the competency of laboratory personnel with supervisory responsibilities for two of two years (December 2023 - December 2025). Findings Included: 1. Review of the IBL CLIA QA PLan, version 5.0 authorized on October 29, 2025, revealed, the laboratory SOP lacked a procedure to assess supervisory personnel responsibilities two of two years (December 2023 - December 2025). 2. Interview with the LD on December 2, 2025 at 9:45 am confirmed the laboratory did not establish a written policy for accessing the supervisory responsibilities for technical and general supervisors. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 review of standard operating procedures (SOP), the lack of proficiency testing (PT) / biannual verification records, and an interview with Technical Supervisor (TS) #1, the laboratory failed to perform PT or biannual verification for six of six Centers for Disease Control and Prevention's Laboratory Response Network for Biological Threats (LRN-B) test methods in 2025. Findings Included: 1. Review of the IBL CLIA QA Plan, version 5.0, authorized (Page four) on October 29, 2025, stated, 7. Proficiency Testing and biannual verification, "IBL performs testing on regulated and non-regulated analytes. IBL will enroll in formal Proficiency Testing whenever possible and conduct in-house biannual verification for analyses without a commercial vendor". 2. The laboratory failed to provide Proficiency Testing or biannual verifications records for the below LRN-B test methods: a. Orthopox virus rule out b. Bacillus anthracis rule out c. Brucella sp. rule out d. Burkholderia mallei /pseudomallei rule out e. Francisella tularensis rule out f. Yersinia pestis rule out 3. Interview with TS#1 on December 3, 2025, at 2:45 p.m. confirmed the LRN-B PT or biannual verifications were not performed biannually. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 observation of the Centers for Disease Control and Prevention's Laboratory Response Network for Chemical Threats (LRN-C) laboratory (Room 116), an interview with Technical Supervisor (TS) #4, the laboratory failed to ensure expired testing supplies were not available for use (a sampling of 17 out of 17 boxes of blood collection tubes and six of six containers of calibrators). Findings Included: 1. Observation of the laboratory on December 3, 2025 at 12:15 pm revealed expired reagents, calibration materials and other supplies were available for use. 2. A sampling of the following expired calibration materials and blood collection tubes were observed: a. Four boxes of Becton Dickinson (BD) Blood Collection Tubes - Lavender Top. Lot#4045192 - Expired: 06/30/2025. b. Eight boxes of BD Blood Collection Tubes - Lavender Top. Lot#4198188 - Expired: 11/30/2025. c. Five Boxes of 8 BD Blood Collection Tubes - Gray Top. Lot#4073042 - Expired: 07/31/2025. d. Two Racks of ABRC7 int. Cals/QCBL Rack 2 - CT043507 - Expired: 08/30/2019 e. Two Racks of ABRC7 int. Cals/QCBL Rack 6 - CT043506 - Expired: 08/30/2019 f. Two Racks of ABRC7 int. Cals/QCBL Rack 7 - CT043506 - Expired: 08/30/2019 3. Interview with TS#4 on December 2, 2025, at 12:15 p.m. confirmed room 116 had expired testing materials available for use. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems -- 2 of 4 -- identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on review of laboratory standard operating procedures (SOP), lack of documented quality assessment (QA) activities, and interview with the technical supervisor (TS) #2 and the laboratory director (LD), the laboratory failed to establish and follow the IBL CLIA QA plan to ensure ongoing mechanisms to monitor, assess, and document

Summary Statement of Deficiencies D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on a review of patient records, the laboratory's Standard Operating Procedures (SOP), and interviews by the Laboratory Director (LD) and Technical Supervisors (TS), the laboratory failed to document (ND) the temperatures and media when SARS- CoV2 patient specimens are received. Findings include: 1. A review of six (6) of Six (6) SARS CoV2 patient specimens in 2022 and 2023, revealed the laboratory failed to document the temperature and media type upon receipt of SARS CoV2. Spec ID Collected Received Tempt/Media C220301725 03/07/2022 03/08/2022 ND C220702307 07/13/2023 07/14/2022 ND C221001205 10/14/2022 10/17/2022 ND C230100764 01/10/2023 01/12/2023 ND C230400005 03/31/2023 04/03/202 ND C230800582 08/13/2023 08/14/2023 ND 2. The laboratory's Virology department SOP requires specimens not received within 72 hours of collection to be frozen at negative 70 degrees if submitted on VTM media or at room temperature if submitted 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 -- on ITM media. 3. One (1) of six (6) SARS-CoV2 patient specimens received were outside of the 72-hour receipt for the testing time frame. The laboratory did not have documentation of the temperature or the type of media at the time the specimen was received. C230400005-001 Collected 03/31/2023@00:00 received 04/03/2023@10: 32, test performed 04/05/2023@15:34. 4. The Virology TS confirmed during an interview on 11/14/2023 at 142:30 PM, the lack of documentation of temperatures and media type of the SARS-CoV2 patient specimens received. 5. The laboratory reports performing approximately 8113 SARS CoV2 SARS CoV2 patient specimens annually. D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on the review of the laboratory's test requisitions, patient test reports, and interview with the laboratory Virology Technical Supervisor (VTS) the laboratory failed to ensure the accuracy of patient information manually entered in the laboratory's information system (LIMS). Findings include: 1. A review of 17 patient records revealed that one (1) of 17 patient records had the date of birth (DOB) from the requisition submitted and the DOB entered in the laboratory LIMS, as different dates. Accession ID DOB Requisition DOB Patent Report C230800567-001 06/17 /2008 06/18/2008 2. The laboratory VTS confirmed by an interview on 11/15/2023 at 10:20 AM the inaccurate entry of the patient's DOB into the LIMS system. 3. The laboratory reports performing 9,194 patient tests annually. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a review of patient records, a lack of a laboratory's Quality Assessment (QA) policies or procedures, and an interview with the Laboratory Director (LD) and Technical Supervisors (TS), the LD failed to establish a QA plan to monitor, assess, and correct problems for all facets of the laboratory processes to ensure quality laboratory patient testing. Findings include: 1. A review of the laboratory's patient records revealed a lack of documentation on patient requisitions and a discrepancy of a patient testing report for seven (7) of 17 patient records from March 08, 2022, through August 14, 2023. See D5305, D5304 Specimen ID C220301725-001- Lack of documentation C220702307-001- Lack of documentation C230800567-001- Lack of documentation C221001205-001- Lack of documentation C230100764-001- Lack of documentation C230400005-001- Lack of documentation C230800582-001- Data entry error 2. A request for the laboratory's QA policies and procedures revealed the lack of QA policies or procedures having been established by the LD for an ongoing review process to monitor pre-analytic, analytic, and post-analytic patient testing. 3. -- 2 of 3 -- The LD and TS confirmed during the interview on 11/13/2023 at 12:30 PM, the lack of QA policies or procedures being established. 4. The laboratory reports performing 9,194 patient tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the Quality Assurance procedure, Thermo Fisher TaqPath COVID- 19 manufacturer's instructions, documentation of freezer temperatures, observation of quality control (QC) material stored in the freezer, and interview with the technical supervisor's (TS) #1, #2, the laboratory failed to follow the manufacturer's instructions for storage of Thermo Fisher TaqPath COVID-19 positive control material since July 2021. Findings: 1. Review of the Quality Assessment procedure showed "Laboratory room temperature and humidity are recorded as well as the temperature in refrigerators, freezers, ovens and incubators." 2. Review of the Thermo Fisher TaqPath COVID-19 manufacturer's instructions revealed, " controls must be stored at less than or equal to minus 70 degrees Celsius (C)." 3. Review of the laboratory's temperature charts revealed the laboratory failed to document the temperature for the REVCO minus 70 degrees freezer named "Sweetums". 4. Observation of the REVCO laboratory freezer showed 1 box of Thermo Fisher TaqPath COVID-19 positive control currently in use in the laboratory. 5. Interview with the TS #1 and TS #2 on February 15, 2022 at 11:00 am confirmed the laboratory failed to properly monitor the freezer temperature and store QC materials and supplies per manufacturer's instructions. 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 -- 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: Based on review of 2020 and 2021 quality control (QC) logs, three of three patient results, and interview with the technical supervisor (TS) #2, the laboratory failed to perform a titered positive control for BD VDRL Syphilis testing. Findings: 1 No titered QC was performed at least once a day for BD VDRL Syphilis testing. 2. Review of three of three patient results showed the laboratory reports titered results but failed to report the titer of the positive control for 2020 and 2021. 3. Approximately 235 of VDRL tests are reported annually for 2020 and 2021. 4. Interview with TS #2 on February 16, 2022 at 11:00 am confirmed the laboratory failed to report the titer of the known positive control material each day of testing. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on review of personnel competency documentation and interview with the laboratory director (LD) and technical supervisor (TS) #1, the LD failed to ensure competency for three of three TS positions and three of three general supervisor (GS) positions for 2020 and 2021. Findings: 1. Review of 2020 and 2021 personnel competency documentation revealed the laboratory failed to perform competency assessments for three of three TS and three of three GS positions. 2. Interview with the LD and TS #1 February 16, 2020 at 1:30 pm confirmed the laboratory failed to ensure competency of three of three TS and three of three GS for 2020 and 2021. -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on a quality control record review and an interview with the mycobacteriology testing personnel, the laboratory failed to retain the QCI AFB quality control slide lot and expiration dates since the last survey on January 23, 2018. Findings: 1. A review of the quality control documents for AFB smear testing revealed the laboratory failed to retain the manufacturer's quality control reference sheets, lot number and expiration dates for each box of control slides used since January 23, 2018. 2. An interview with the mycobacteriology testing personnel on January 30, 2020 at approximately 3:00 PM, confirmed the laboratory failed to retain the quality control lot and expiration dates for commercially prepared quality control slides. 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 record review of personnel competency documents and the procedure manual, and an interview with the Chemistry General Supervisor(C-GS), the laboratory failed to follow written policies and procedures to evaluate the competency Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- of testing personnel performing testing on the GC/MS and on the Perkin Elmer ICP- MS in 2018. Findings: 1. A review of competency assessment documents for all testing personnel and of the laboratory policies and procedures revealed the laboratory failed to follow the policy to perform competency assessment for 2 testing personnel for whole blood cyanide and volatile organic compounds (VOCs) on the GC/MS and for blood metal testing on the ICP-MS in 2018. 2. An interview on January 29, 2020 at approximately 10:25 AM, with the C-GS, confirmed the laboratory failed to follow written policies and procedures to assess and document the competency of testing personnel on the GC/MS and the ICP-MS in 2018. 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 and an interview with the Microbiology General Supervisor (M-GS), the laboratory failed to verify the accuracy of conventional serotyping for 3 organisms in 2018 and 2019. Findings: 1. A review of the Wisconsin State Laboratory of Hygiene (WSLH) PT documents revealed the laboratory failed to verify the accuracy of Neisseria and Haemophilus serotyping at least twice a year in 2018, additionally Salmonella serotyping was not verified for accuracy in 2018 or 2019. 2. The laboratory performed serotyping on approximately 26 patient samples for these organisms in 2019. 3. An interview on January 30, 2020 at approximately 9:20 AM, with the M-GS, confirmed the 3 conventional serotypes were not verified for accuracy at least twice per year. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observations, record reviews of temperature logs and interviews with laboratory staff, the laboratory failed to establish acceptable temperature ranges for the refrigerators and freezers where reagents, media and samples are stored throughout the laboratory. Findings: 1. (a) An observation in the chemistry section, room 116, revealed two freezers where Wisconsin State Laboratory of Hygiene blood metal quality control (QC) material and SPEX HNPAA calibrators, internal standards and QC was being stored. Both manufacturers require a storage of less than or equal to-20C. (b) A review of temperature logs for freezers CT-F3 and CT-F4 revealed the laboratory failed to establish an acceptable temperature for storage of reagents. (c) An interview on January 29, 2020 at approximately 11:00 AM, with the C-GS and technical supervisor confirmed that the laboratory failed to establish temperature -- 2 of 11 -- ranges that met the manufacturer's storage requirements. 2. (a) An observation in the microbiology section revealed a deli style refrigerator where commercially prepared media was being stored. The manufacturer's requirement was defined as 2-8 C. (b) ) A review of temperature logs for the media refrigerator revealed the laboratory failed to establish an acceptable temperature for the storage of media. (c) An interview on January 30, 2020 at approximately 10:00 AM, with the M-GS confirmed that the laboratory had not established an appropriate storage range for commercial media used in clinical testing. 3. (a) An observation in the virology section, room 5, revealed that Influenza A/B and RNase primer and probe sets and instrument verification plates were being stored in the freezers. The manufacturers' require a storage of less than or equal -20C. (b) A review of the freezer temperature logs for freezers VR 172053 and HQ-VWR 17D874-1704 revealed the laboratory failed to establish an acceptable storage temperature for the products being stored. (c) An interview on January 30, 2020 at approximately 1:00 PM, with the V-GS confirmed that the laboratory had not established an acceptable storage range for virology reagent storage. D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a record review and an interview with the Microbiology General Supervisor (M-GS), the laboratory failed to run the control organisms for susceptibility testing each day of patient testing on the MicroScan microbiology analyzer since the last survey on January 23, 2018. Findings: 1. A review of the bacteriology quality control logs and worksheets from December 2019 revealed that the laboratory failed to perform and document quality control for the appropriate organisms for susceptibility on the MicroScan test system each day of patient testing. 2. The laboratory ran approximately 61 susceptibility panels on patient samples in 2019. 3. An interview with the M-GS on January 29, 2020 at approximately 3:00 PM, confirmed that the laboratory failed to perform quality control for antimicrobial susceptibility testing using appropriate control organisms to check the procedure, each day of patient testing since the last survey. D5781