Big Sky Laboratory

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 record review and interview with the Laboratory Director (LD) #1, the laboratory failed to enroll in an HHS-approved proficiency testing program for the isolation and differentiation of Group B Streptococcus (GBS) from May 7, 2023, to May 7, 2025. Findings: 1. A review of the Test Volume Report revealed 52 Strep B Cultures were performed from May 1, 2024, to May 1, 2025. (12 months). 2. A review of 2023 and 2024 American Proficiency Institute (API) testing program records lacked documentation of proficiency testing for the isolation and differentiation of Group B Streptococcus. 3. An interview on May 7, 2023, at 10:30 AM with the LD#1 confirmed the laboratory failed to enroll in an HHS-approved proficiency testing program for the isolation and differentiation of Group B Streptococcus from May 7, 2023, to May 7, 2025. D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) (c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this 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 -- section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on record review and interview with the Testing Personnel (TP) #1, the laboratory failed to follow the manufacturer's instructions for use (IFU) to inoculating vaginal-rectal specimens in a suitable Group B Streptococcus (GBS) enrichment broth before plating and did not perform a Group B Streptococci antigen test on isolated colonies from May 7, 2023, to May 7, 2025. Findings: 1. A review of Hardy Diagnostics GBS Detect instructions for use revealed the laboratory failed to perform 2 of the 5 procedure steps: "1. Using a vaginal-rectal specimen, inoculate a suitable GBS enrichment broth ..." and "5. Using isolated colonies from the GBS Detect plate described in step 4, perform the latex particle agglutination test ... or other tests recommended for the detection of group B streptococci antigen...." 2. A review of "Microbiology Media Check Off Sheet" lacked records of GBS enrichment broths from May 7, 2023, to May 7, 2025. 3. A review of microbiology records lacked documentation of latex particle agglutination testing or other recommended GBS antigen testing from May 7, 2023, to May 7, 2025. 4. An interview on May 7, 2023, at 10:45 AM with TP #1 confirmed the laboratory failed to follow the manufacturer's IFU regarding the inoculation of vaginal-rectal specimens in a suitable GBS enrichment broth before plating and performing a GBS antigen test on isolated colonies from May 7, 2023, to May 7, 2025. 5. A review of the Test Volume Report revealed 52 Strep B Cultures were performed from May 1, 2024, to May 1, 2025. (12 months). D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on record review, manufacturer's instruction, procedures, and interview with the Testing Personnel (TP) #1, the laboratory failed to establish the reactivity of each organism used for microbiology quality control (QC) and define its acceptable criteria from May 7, 2023, to May 7, 2025. Findings: 1. A review of the manufacturer's instructions for use for HardyDisk Bacitracin Differentiation Disks, Hardy Diagnostics Group B Streptococcus (GBS) Detect, Hardy Diagnostics MacConkey Agar (MAC) and Hardy Diagnostics Blood Agar (BAP) revealed the following American Type Culture Collection (ATCC) control organisms that where recommended for QC: Streptococcus pyogenes ATCC 19615 Streptococcus agalactiae group B ATCC 13813 Streptococcus agalactiae clinical Strain Enterococcus faecalis ATCC 29212 Escherichia coli ATCC 8739 Pseudomonas paraeruginosa ATCC 9027 Salmonella enterica ATCC 14028 Staphylococcus aureus ATCC 6538 Proteus -- 2 of 3 -- mirabilis ATCC 12453 Escherichia coli ATCC 25922 Streptococcus pneumoniae ATCC 6305 Streptococcus pyogenes ATCC 19615 Staphylococcus aureus ATCC 25923 2. A review of microbiology records lacked documentation of studies to establish the reactivity of each quality control organism it used from May 7, 2023, to May 7, 2025. 3. A review of the laboratory's "General Culturing Guidelines", "Throat Culture" and "Urine Cultures" procedures failed to define the quality control criteria of acceptability of each organism used as QC. 4. A review of the "Microbiology Media Check Off Sheet" and the patient workup log failed to document the identity of quality control organism used, lot numbers, date in use, expiration dates, and the actual reactions observed for the Bacitracin Differentiation Disks, GBS, MAC and BAP media being tested. 5. An interview on May 7, 2023, at 10:55 AM with TP #1 confirmed that the laboratory failed to establish the reactivity of each organism used for microbiology quality control (QC) and define its acceptable criteria from May 7, 2023, to May 7, 2025. -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of American Proficiency Institute records and an interview with the testing personnel (TP), the laboratory failed to achieve satisfactory performance for Sodium (Na) for two out of three testing events, resulting in unsuccessful proficiency testing performance. (See D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) scores and interview with testing personnel (TP) # 1, the laboratory failed to achieve a score of at least 80% for two out of three PT events (routine chemistry 2023 Event 3 and 2024 Event 2) for sodium (Na). Findings: 1. A review of API's Routine Chemistry PT scores for Na revealed that in 2023, Event 3 scored 60% and 2024 Event 2 scored 0%. 2. An interview with (TP) #1 on July 15, 2024, at 5:58 PM confirmed these findings and the manufacturer is scheduled to perform preventative maintenance. -- 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 from the American Proficiency Institute (API), biannual verification records, the test volume report and interview with laboratory director (LD) #1, the laboratory failed to perform one out of two biannual verifications for Mycology (KOH Preps) for year 2022. (Repeat Deficiency) Findings: 1. A review of Test Volume Report revealed one KOH Preps was performed from June 14, 2022 to June 14, 2023 (12 months). 2. A review of API records revealed no records of KOH and review of biannual verification records revealed the laboratory failed to perform one of two verifications of KOH in 2022. 3. Interview on June 14, 2023, at 9:00 AM with the LD #1 confirmed the laboratory failed perform one of two biannual verification of Mycology (KOH Preps) or participate in a proficiency testing program for the year 2022. 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 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. 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 record review of patient results reports, procedure, and interview with the laboratory director (LD) #1, the laboratory failed to establish and verify the reference ranges (normal values) for the laboratory's patient population for the Dimension Xpand Plus chemistry analyzer from June 14, 2021, to June 14, 2023. Findings: 1. A review patient results reports (#23050290, #23020153, #23010145, #23030169 and #22070094) for chemistry, special chemistry and lipid studies listed reference ranges in the report. 2. Expected values listed in the Flex reagent cartridge insert sheets did not match the patient results report's normal reference ranges and no other chemistry procedure with normal reference ranges were available for review. 3. No patient population verification studies for the Dimension Xpand Plus chemistry analyzer were available for review to support the references ranges (normal ranges) listed in the laboratory's patient results reports. 4. An interview with the LD #1 on June 14, 2023, at 11:30 AM, stated the reference ranges (normal values) were established by a different laboratory from June 14, 2021, to June 14, 2023. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation, review of maintenance documentation, procedure manual and interview with laboratory director (LD) #1, the laboratory failed to establish and follow procedures to certify one of one microscope and one of two centrifuges for accuracy from January 1, 2021 to June 14, 2023. Findings: 1. Observed two centrifuges and one microscope in the laboratory. No certification stickers or records were available for review for one of one microscope and one of two centrifuges (Hettich EBA 200 S). 2. A review of Test Volume Report revealed one KOH prep, and 251 microscopic uranalysis were performed using the microscope from June 14, 2022 to June 14, 2023 (12 months). 3. A review of laboratory procedures revealed the laboratory failed to establish a procedure that defines the function checks on each piece of equipment or instrument it uses, including those that are peripherally involved in patient testing. 4. An interview with LD #1 on June 14, 2023, at 9:40 AM confirmed the laboratory failed to certify the accuracy of one of two centrifuges and for one of one microscope from January 1, 2021 to June 14, 2023. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for -- 2 of 3 -- example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of chemistry quality control (QC) records, procedures, and interview with the laboratory director (LD) #1, the laboratory failed to establish acceptable criteria (mean and standard deviation) for new lots of Thermo Scientific MAS chemTRAK H liquid assayed general chemistryl controls performed on the Dimension Xpand Plus chemistry analyzer from June 14, 2021, to June 14, 2023. Findings: 1. No correlations studies for new lots of MAS chemTRAK H quality control materials to establish statistical limits for the Dimension Xpand Plus chemistry analyzer were available for review. 2. No chemistry procedure for the evaluation of new lots of quality control and acceptable control limits were available for review. 3. A review of the test volume sheet revealed 36,400 chemistry results were reported from June 14, 2022, to June 14, 2023 (12 months). 4. An interview with LD #1 on June 14, 2023, at 11:15 AM, confirmed the laboratory failed to establish acceptable QC statistical parameters for each analyte tested on the Dimension Xpand Plus chemistry analyzer from June 14, 2021, to June 14, 2023. D5893 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(b)(c) (b) The postanalytic systems quality assessment must include a review of the effectiveness of

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 record review and interview with Laboratory Director (LD) #1, the laboratory failed to ensure the laboratory was enrolled in an HHS-approved proficiency testing program for Mycology (KOH Preps), Chemistry (C-Reactive Protein (CRP)) and Chemistry (Hemoglobin A1c) for years 2019 and 2020. See D6015 D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This CONDITION is not met as evidenced by: Based on review of chemistry, hematology, virology and uranalysis procedures, the laboratory failed to include a step-by-step procedure for microscopic urinalysis and blood smear preparation for manual differential send-out (refer to D5403); failed to verify the performance specifications of COVID-19 IgG/IgM rapid test prior to reporting patient test results, (refer to D5421); failed to perform at least a three-point calibration for sodium, potassium, and chloride on the chemistry analyzer every six months (refer to D5439); and failed to include a negative and positive control material for COVID-19 IgG/IgM test for each day of patient testing (refer to D5449). 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 D0000 Based on an on-site recertification survey conducted on 4/23/19, deficiencies were cited for Big Sky Laboratory in Great Falls, MT. 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 record review and interview, the laboratory failed to verify the accuracy of the potassium hydroxide (KOH) test from 5/4/17 through 4/23/19. The findings include: 1. A review on 4/23/19 at 10:45 a.m. of the American Proficiency Institute (API) binders lacked documentation of proficiency testing enrollment for KOH. 2. A review on 4/23/19 at 10:45 a.m. of the API 2019 Order Confirmation form lacked enrollment for KOH. 3. On 4/23/19 at 10:45 a.m., staff member A stated the lab did not have enrollment for KOH and did not perform accuracy verification. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration 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 -- verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to perform calibration procedures with the frequency required by the manufacturer for four of five analytes (vitamin B12, vitamin D, free thyroxine (FT4), and free triiodothyronine (FT3)) performed on the TOSOH analyzer. The findings include: a. Vitamin B12 1. On 4/23/19 at 8:00 a.m. a TOSOH AIA-900 analyzer was observed in the laboratory. 2. A review on 4/23/19 at 1:00 p.m. of a patient (#18050059) report included results for B12 performed on 5/11/18. 3. A review on 4/23/19 at 1:50 p.m. of the TOSOH Calibration Data log sheet documented a B12 calibration performed on 3/23/18 with an expiration date of 30 days later on 4/23/18. No calibrations were recorded after the 3/23/18 calibration. 4. On 4/23/19 at 1:50 p.m., staff member A stated the B12 test was discontinued around that date and sent out to a reference lab. 5. A review on 4/23 /19 at 2:25 p.m. of the Big Sky Laboratory Data Log for B12 included 21 patients with B12 results reported from Big Sky Lab between the expired calibration on 4/23 /18 and 6/14/18 when the B12 began to be sent out to a reference laboratory. 6. On 4 /23/19 at 4:30 p.m., staff member A stated the TOSOH analyzer prints an error code on the printout when the calibration expires but will not prohibit testing until the date is twice the acceptable calibration date. b. Vitamin D 1. On 4/23/19 at 8:00 a.m. a TOSOH AIA-900 analyzer was observed in the laboratory. 2. A review on 4/23/19 at 1:50 p.m. of the TOSOH Calibration Data log sheet included: a. Calibration performed on 10/13/17 with a 90 day stability and a recalibration due on 1/13/18. b. Calibration performed on 3/6/18 with a 90 day stability and a recalibration due on 6/6 /18. c. Calibration performed on 8/10/18 with a 90 day stability and a recalibration due on 11/10/18. d. Calibration performed on 1/18/19 with a 90 day stability and a recalibration due on 4/18/19. 3. A review on 4/23/19 at 2:05 p.m. of the vitamin D package insert included the calibration curve for vitamin D is "stable for up to 90 days." 4. A review on 4/23/19 at 2:25 p.m. of the Big Sky Laboratory Test Tally report documented the number of patients with vitamin D resulted during expired calibrations. a. 96 patients were resulted during the expired calibration between 1/13 /18 through 3/6/18. b. 93 patients were resulted during the expired calibration between 6/6/18 through 8/10/18. c. 40 patients were resulted during the expired calibration between 11/10/18 through 1/8/19. 5. On 4/23/19 at 4:30 p.m., staff member A stated the TOSOH analyzer prints an error code on the printout when the calibration expires but will not prohibit testing until the date is twice the acceptable calibration date. c. FT4 1. On 4/23/19 at 8:00 a.m. a TOSOH AIA-900 analyzer was observed in the laboratory. 2. A review on 4/23/19 at 1:50 p.m. of the TOSOH Calibration Data log sheet included: a. Calibration performed on 8/24/18 with a 90 day stability and a recalibration due on 11/24/18. b. Calibration performed on 2/1/19 with a 90 day stability and a recalibration due on 5/1/19. 3. A review on 4/23/19 at 2:05 p.m. of the FT4 package insert included the calibration curve for FT4 is "stable for up to 90 days." 4. A review on 4/23/19 at 2:45 p.m. of the Big Sky Laboratory Test Tally report documented 40 patients with resulted FT4 between the expired calibration on 11 /24/18 and recalibration on 2/1/19. 5. On 4/23/19 at 4:30 p.m., staff member A stated the TOSOH analyzer prints a error code on the printout when the calibration expires but will not prohibit testing until the date is twice the acceptable calibration date. d. FT3 1. On 4/23/19 at 8:00 a.m. a TOSOH AIA-900 analyzer was observed in the laboratory. 2. A review on 4/23/19 at 1:50 p.m. of the TOSOH Calibration Data log sheet included: a. Calibration performed on 5/16/18 with a 90 day stability and a recalibration due on 8/16/18. b. Calibration performed on 10/12/18 with a 90 day stability and a recalibration due on 1/12/19. c. Calibration performed on 3/6/19 with a -- 2 of 3 -- 90 day stability and a recalibration due on 6/6/19. 3. A review on 4/23/19 at 2:05 p.m. of the FT3 package insert included the calibration curve for FT3 is "stable for up to 90 days." 4. A review on 4/23/19 at 2:55 p.m. of the Big Sky Laboratory Test Tally report documented the number of patients with FT3 resulted during expired calibrations. a. 15 patients were resulted during the expired calibration between 8/16 /18 through 10/12/18. b. 21 patients were resulted during the expired calibration between 1/12/19 through 3/6/19. 5. On 4/23/19 at 4:30 p.m., staff member A stated the TOSOH analyzer prints an error code on the printout when the calibration expires but will not prohibit testing until the date is twice the acceptable calibration date. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director failed to maintain a quality assessment program from 5/4/17 through 4/23/19. The findings include: 1. A review on 4/23/19 at 11:00 a.m. of the Big Sky Laboratory binders lacked documentation of QA projects. 2. On 4/23/19 at 4:15 p.m., staff member A stated QA projects were not done but the Laboratory Director had discussed starting them. -- 3 of 3 --