Adlera Laboratory, Llc

Summary Statement of Deficiencies D0000 Based on an unannounced complaint survey conducted on February 28, 2023, deficiencies were cited for Adlera Laboratory, LLC, in Great Falls, MT. 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 a record review of patient results reports, order forms from the authorized person, and interview with student intern #1, the laboratory failed to ensure the information from the requisition or order forms were entered accurately into the laboratory information system (LIS) for four out of four patients from February 21, 2023 to February 27, 2023. Findings: 1. A review of the revised patient result's report (213702) revealed the laboratory failed to perform the Hemoglobin A1c test in a timely matter due to the order being omitted from being entered into the LIS on February 20, 2023. 2. Review of three out of three patient results reports (213697, 213738 and 213702), and corresponding order forms revealed the collection dates were entered incorrectly into the LIS from February 20, 2023, and February 21, 2023. 3. Interview with the student intern #1 on February 27, 2023, at 2:13PM confirmed the laboratory failed to accession information correctly into the LIS system from February 20, 2023, to February 22, 2023. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) 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 -- Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on observation, record review of patient results reports, procedures, and interview with student intern #1, the laboratory failed to establish and follow written procedures to maintain specimen integrity for three out three patient specimens and maintain positive identification for one of one patient's specimen throughout the testing process when performing testing on the Siemens Atellica chemistry and immunoassay analyzer from February 17, 2023 to February 24, 2023. Findings: 1. Observed February 28, 2023, at 11:30 AM several racks of chemistry and hematology blood specimen tubes in laboratory refrigerator of samples tested from February 21, 2023, through February 24, 2023. 2. Review specimen tube labels revealed the laboratory staff failed to follow its' Specimen Collection, Processing and Rejection procedure to have two identifiers on one of the specimen tube labels found in the racks. 3. A review of patient result reports (213619, 213644, and 213629) with specimen collection dates of February 17, 2023, and tests performed dates of February 21, 2023, for analytes calcium (Ca), glucose, total protein, Thyroid-Stimulating Hormone (TSH), and Vitamin B-12 revealed the laboratory did not adhere to the manufacturer's guidelines to ensure samples were not tested past their sample stability criteria. 4. Review of Quality Assurance (QA) Plan revealed the laboratory failed to follow their procedure for unacceptable samples as stated, "3. Specimen handling, collection, and labeling ...that the specimens are collected, handled, stored, and preserved as appropriate, that each written testing procedure will identify unacceptable samples ..." 5. An interview with student intern #1 on February 27, 2023, at 12:15 PM confirmed the laboratory failed to label one specimen tube with two identifiers and follow the manufacturer's instructions for specimen stability from February 17, 2023, to February 21, 2023. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on a record review of patient results reports, order forms from the authorized person, procedures, and interview with student intern #1, the laboratory failed to monitor, assess, and correct problems identified in their pre-analytical process from February 17, 2023, to February 27, 2023. Findings: 1. A review order form for (Accession 213702) revealed the laboratory staff failed to follow their Quality Assurance (QA) Plan to document

Summary Statement of Deficiencies 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 a review of maintenance documentation, procedure manual, observation of pipettes, automated pipette system, and microscope, and interview with Technical Supervisor (TS) #1, the laboratory failed to establish and follow procedures for performing function checks to verify the accuracy of six pipettes, one automated pipette system, and one microscope. Findings include: 1. No documentation of certification of performance was available to show the laboratory verified the performance of six of six pipettes and one automated pipette system from 3/31/2021 to 8/3/2022 and one microscope since 2016. 2. Observation of Evolve pipettes: 1-20 microliter, 1-20 microliter, 20-200 microliter, 100-1000 microliter, and two VIAFLO electronic pipettes: The 8-channel 125 microliter, 12-channel 1250 microliter, and one VIAFLO automated pipette system located in the laboratory lacked labels for function check. 3. Observation of one microscope located in the laboratory revealed a certification label expired in 8-18-2016. 4. Review of Quality Assessment and Control Policies and Statement revealed, "Preventative Maintenance & Service-Schedules, charts, and other documents pertaining to the maintenance of laboratory equipment 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 -- are to be kept for any instrument in the lab." The policy failed to define function checks for the microscope and pipettes. 5. Interview with TS #1 on August 3, 2022, at 2:30 PM, confirmed these findings. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of procedure manual, laboratory records and interview with the Technical Supervisor (TS)#1, the laboratory failed to document the intended staining characteristics for each day manual differentials slides were stained. Findings include: 1. Review of hematology records revealed the laboratory failed to document the staining quality of manual differential slides each day of Wright Stain use from January 1, 2020, to August 3, 2022. 2. Review of Peripheral Smear Preparation and Criteria for Smear Review procedure lacked how the laboratory would document staining quality control checks on manual differentials slides. 3. Interview on August 3, 2022, at 12:30 PM with TS #1, confirmed the laboratory failed to document staining quality of manual differential slides from January 1, 2020, to August 3, 2022. -- 2 of 2 --

Summary Statement of Deficiencies 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. This CONDITION is not met as evidenced by: Based on review of chemistry, hematology, molecular and urinalysis procedures, the laboratory failed to include normal values for chemistry, microscopic urinalysis and failed to have a step-by-step procedure for microscopic urinalysis (refer to D5403); failed to follow defined criteria to document temperature for molecular testing (refer to D5413); failed to document

Summary Statement of Deficiencies D0000 Based on an off-site proficiency testing desk review conducted on 3/21/19, deficiencies were cited for Adlera Laboratory, LLC in Great Falls, MT. 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 routine desk audit of CMS-153 and 155 reports of proficiency testing performance and interview, the laboratory failed to achieve satisfactory performance for blood urea nitrogen (BUN) for two consecutive (2018 event 3 and 2019 event 1), resulting in unsuccessful proficiency testing performance. See D2096. D2096 ROUTINE CHEMISTRY 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 -- CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 proficiency testing scores and interview, the laboratory failed to achieve a score of 80 percent for blood urea nitrogen (BUN) in two consecutive events in 2018 and 2019, resulting in unsuccessful performance. The findings include: 1. During a review on 3/18/19 at 11:30 a.m. of the CMS-153 Unsuccessful Proficiency Testing Report included Adlera Laboratory, LLC with unsuccessful proficiency testing scores for BUN. 2. During a review on 3/20/19 at 8:00 a.m. of the CMS-155 report, the American Proficiency Institute (API) BUN score for event 3 of 2018 was 0%. 3. During a review on 3/20/18 at 8:00 a.m. of the CMS-155 report, the API BUN score for event 1 of 2019 was 60%. 4. On 3/21/19 at 9:30 a.m., the laboratory manager stated the failures occurred and

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on 4/11/18, deficiencies were cited for Central Montana Laboratory in Great Falls, MT. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to state the number of controls used in one of two Individual Quality Control Plans (IQCPs) reviewed. The findings include: 1. A review on 4/11/18 at 4:03 p.m. of the Central Montana Laboratory Stratus Quality Control Plan Worksheet lacked the number of controls to be performed for b-type natriuretic peptide (BNP). 2. On 4/11/18 at 4:03 p.m., staff member A stated two controls are 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 1 --