Bozeman Clinic

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 record review, and interview with the Technical Supervisor (TS)#1, the laboratory failed to retain patient test records for isolation and identification of bacteria and quality control (QC) records of microbiology reagents: catalase, indole, and PYR from January 2020 to November 2021. Findings: 1. No patient test records for isolation and identification of bacteria were available to review from January 2020 to November 2021. 2. Review of Bacteriology Log procedure revealed "On Day 1 this log will include: time and date a specimen was received in the lab, time a specimen was set up, media used for culture, and tech's initials. One Day 2 read and record the culture results and initial. When necessary record colony description, grams stain results, catalase, indole, oxidase, PYR reactions, media used for sub-culturing including ID tubes or sensitivities." 3. No QC documentation for microbiology reagent: catalase, indole, and PYR were available for review from January 2020 to November 2021. 4. Review of Bacteriology Log procedure revealed, "Quality Control must be performed and recorded on the Bacteriology log (Culture order) with each patient for gram stains, indole, oxidase, catalase, or PYR." 5. Interview on December 14, 2021 1:40 PM with (TS)#1 confirmed the patient test records for isolation and identification of bacteria and QC of microbiology reagents: catalase, indole and PYR were not retained from January 2020 to November 2021. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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 -- 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 5/16/19, deficiencies were cited for Bozeman Clinic in Bozeman, MT. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to include the identity of the assay used on the prostate specific antigen (PSA) test report as required by the manufacturer directions from January 31, 2019 through May 16, 2019. The findings include: 1. On 5/16/19 at 8:45 a.m., a Tosoh AIA-360 analyzer was observed in the laboratory. 2. On 5/16/19 at 8:45 a.m., staff member A stated PSA was performed on the Tosoh AIA-360 analyzer. 3. A review on 5/16/19 at 10:30 a.m. of a patient (#32366) PSA test report lacked the identity of the assay used for PSA. 4. A review on 5/16/19 at 10:30 a.m. of the Tosoh AIA manufacturer instructions for PSA included it "is mandatory that results reported by the laboratory to the physician include the identity of the assay used." 5. On 5/16/19 at 10:30 a.m., staff member A stated the electronic medical record system was implemented in January of 2019 and the methodology was not programmed for the PSA test report. 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 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 -- 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 and interview, the laboratory failed to check rotor speed for two of two centrifuges in the laboratory from 3/24/17 through 5/16/19. The findings include: 1.Two centrifuges were observed in the laboratory on 5/16/19 at 8:45 a.m. a. Horizon mini-E centrifuge. b. Hamilton Bell centrifuge. 2. An observation on 5/16/19 at 2:00 p.m. of the stickers on the centrifuges showed the last rotor speed check occurred on both centrifuges in 8/16. 3. On 5/16/19 at 2:00 p.m., staff member A stated the centrifuge speed had not been verified since 2016. -- 2 of 2 --