Southern Idaho Pain Institute Pc

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 a lack of laboratory temperature and humidity logs and an interview with the technical supervisor (TS) on 1/14/2026, the laboratory failed to monitor the testing temperature and humidity since the previous inspection on 12/4/2023. The findings include: 1. A lack of laboratory temperature and humidity logs identified the laboratory failed to monitor testing temperature and humidity per the Shimadzu LCMS /MS manufacturer requirements. 2. An interview with the TS on 1/14/2026 at 2:10 pm confirmed that the laboratory failed to monitor temperatures and humidity since the last inspection on 12/4/2023. 3. The laboratory reports performing 67,200 toxicology tests 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 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 review of proficiency testing (PT) records from College of American Pathologists (CAP) and an interview with the general supervisor (GS) on 12/4/2023, the laboratory failed to enroll in proficiency testing for 2022. The findings include: 1. A review of proficiency testing records from CAP identified that the laboratory failed to enroll and participate in PT for all analytes performed by the laboratory in 2022. The analytes include: codeine, hydrocodone, norhydrocodone, morphine, oxycodone, noroxycodone, oxymorphone, noroxymorphone, fentanyl, norfentanyl, methadone, EDDP, Tramadol, O-DSMT, tapentadol, buprenophine, norbuprenophine, meperidine, normeperidine, nalbuphine, alorazilam, a-OH-Alprazolam, Clonazepam, 7- aminoclonazepam, diazepam, nordiazepam, Oxazepam, temazepam. lorazepam, carisoprodol, cyclobenzaprine, meprobamate, amphetamine, methamphetamine, phentermine, methylphenidate, 6-MAM, benzoylecgonine, MDA, MDMA, PCP, gabapentin, pregabalin, zaleplon, zolpidem, zolpidem phyenyl-4-COOH, zopiclone, amitriptline, nortriptyline, Venlafaxine, duloxetine, fluoxetine, paroxetine, citalopram, sertraline, Ketamine, norketamine, nalaxone, propoxyphene, cotinine, Phenobarbital, 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 -- THC-COOH, ethyl sulfate. 2. An interview with the GS on 12/4/2023 at 1:31 pm confirmed that the laboratory failed to enroll and participate in PT for all analytes for 2022. 3. The laboratory reports performing 202,800 tests annually. -- 2 of 2 --

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 records and testing person interview the laboratory failed to document annual competency assessments for the testing person, the general supervisor, and the technical supervisor for 2018 and 2019. Findings: 1. A review of available records revealed no documentation for 2018 and 2019 of competency evaluations for the testing person, general supervisor, and technical supervisor. 2. An interview with the testing person on 03/12/2020 at 9:10 AM confirmed the above findings. 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 record review, procedure review, and interview of the testing person the 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 -- laboratory failed to document the temperature of the incubator. Findings: 1. A review of available temperature charts did not reveal any documentation of the incubator temperature. 2. A review of the LCMS Standard Operating Procedure, V1.1 3/5/2018, page 14 revealed the following statement, "Incubate plate for 120 minutes at 55 degrees Celsius". 3. An interview of the testing person on 03/12/2020 at 10:45 AM confirmed that the laboratory was not documenting the temperature of the incubator. 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 observations of available thermometers, record review, and interview of the testing person the laboratory failed to perform calibration checks on all thermometers in use at the time of the survey. Findings: 1. Observation of 4 of 4 digital thermometers on 03/12/2020 at 10:10 AM revealed documentation on the back of the thermometers that stated recalibration was due on November 6, 2019. 2. A review of available records revealed no documentation of periodic calibration checks of the 4 observed digital thermometers or the one glass thermometer used in the incubator. 3. An interview of the testing person on 03/12/2020 at 10:15 AM confirmed the above findings. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of test reports and interview of the testing person the laboratory failed to include the correct address of the location where the tests were performed. Findings: 1. A review of test reports revealed that the address of the location where the tests were performed was not on the report. 2. An interview of the testing person on 03/12/2020 at 9:35 AM confirmed the above finding. -- 2 of 2 --

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 an observation of laboratory refrigerator and freezer, a procedure manual review, and an interview with the laboratory testing personnel, the laboratory failed to define the storage requirements for the drug analysis standards and controls since the last survey on March 7, 2016. Findings: 1. An observation on February 7, 2018 at 12: 15 PM, of the laboratory Hot-Point freeze-thaw freezer where drug analysis standards and controls were stored, revealed the temperature of the freezer had not been monitored and the refrigerator failed to include acceptable temperature ranges. 2. An observation on February 7, 2018 at 12:15 PM, of the laboratory Hot-Point freeze-thaw freezer revealed the 72 Cerilliant reference drug standards stored in the freezer were not in a frozen state. 3. A review of the drug testing standard operating procedure revealed the operating procedure failed to include the temperature storage requirements for the standards stored in the freezer and the reagents and controls stored in the refrigerator. 4. An interview on February 7, 2018, at 12:14 PM, with the testing personnel, confirmed the laboratory failed to monitor the lab freezer temperature. D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) 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 laboratory director must ensure that the physical plant and environmental conditions provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: Based on an observation of chemical storage and handling in the laboratory and an interview with the laboratory testing personnel, the laboratory director failed to provide and establish a safe environment that ensures adequate chemical storage and handling for methanol, isopropanol, and acetone since January 2017. Findings: 1. An observation on February 7, 2018 at 11:50 AM, of the laboratory space, revealed there were nine 4-liter bottles of methanol, six 4-liter bottles of isopropanol, and twelve 4- liter bottles of acetone stored on the floor and on an open shelf in the open laboratory space. 2. An interview on February 7, 2018, at 11:50 AM, with the testing personnel, confirmed the laboratory failed to establish safety procedures for the storage of chemicals. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on record review and an interview with the testing personnel, the laboratory director failed to specify, in writing, the responsibilities and duties of each consultant, supervisor, and testing person engaged in the preanalytical, analytic, and postanalytical phases of testing since March 7, 2016. Findings: 1. A record review revealed the laboratory director failed to specify, in writing, the responsibilities for the technical supervisor who is also the general supervisor and the testing personnel. 2. An interview on February 7, 2018 at 11:00 AM, with the testing personnel, confirmed there was no delegation of responsibilities identified in writing for the personnel listed on the CMS-209 form. -- 2 of 2 --