Beacon Pain Clinic

Summary Statement of Deficiencies D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a record review of the Siemens Viva ProE instrument verification and an interview with testing personnel 1 on 9/14/2023, the laboratory director failed to ensure that the instrument verification was adequate before patient testing began. The findings include: 1. A record review of the new instrument verification for the Siemens Viva ProE, used for toxicology testing, identified that the laboratory director failed to review and approve performance specification verification results to ensure that they were adequate before patient testing began on 6/27/2023. 2. An interview with testing personnel 1 on 9/14/2023 at 2:18 pm confirmed that the laboratory director failed to review and approve instrument performance specification verifications before patient testing began. 3. The laboratory reports performing 15,000 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 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 a review of laboratory records, manufacturers package inserts and an interview with the laboratory supervisor on 12/6/21, the laboratory failed to store reagents and quality control (QC) material for toxicology testing within the manufacturers temperature requirements. The findings include: 1. A review of the package inserts for the Mindray toxicology reagents and package inserts for the Thermo Scientific MAS DOA Total controls identified storage requirements of 2-8 C. 2. A review of the laboratory "thermometer temperature record" for the refrigerator identified a temperature range of 5-9 C. The laboratory failed to store reagents and QC within the manufacturers requirements two (2) of 18 days in July 2020, seven (7) of 20 days in October 2020, three (3) of 14 days in November 2020, six (6) of 17 days in January 2021, eight (8) of 17 days in February 2021, seven (7) of 18 days in March 2021, three (3) of 21 days in April, two (2) of 21 days in May 2021 and three (3) of 23 days in June 2021. 3. An interview with the laboratory supervisor on 12/6/2021 at 2: 21 pm confirmed the above findings. 4. The laboratory reports performing 15,000 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 D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a record review and an interview with the technical supervisor, the laboratory failed to perform and document calibration verification procedures at least once every 6 months for urine ethyl alcohol analyte performed on the Mindray BS- 200 toxicology analyzer used to test drugs of abuse since the last survey on February 23, 2018. Findings: 1. A record review of calibration verification reports for urine ethyl alcohol revealed the laboratory failed to perform calibration verification 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 -- activities since the last survey. 2. The laboratory performed approximately 15,000 urine ethyl alcohol the past year. 3. An interview on September 24, 2019, at 12:30 PM, with the technical supervisor, confirmed the laboratory failed to perform calibration verification activities on urine ethyl alcohol. -- 2 of 2 --

Summary Statement of Deficiencies 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 record review of patient test reports and an interview with the testing person, the laboratory failed to include units of measurement for the drugs of abuse testing on patient test reports since the last survey on March 15, 2016. Findings: 1. A record review of three patient test reports revealed the laboratory failed to identify the units of measurement for benzodiazepine, cannabinoid, methadone, opiates, oxycodone, amphetamine, and ethanol testing performed on the Mindray BS-200 analyzer since the last survey. 2. An interview on February 23, 2018, at 2:30 PM, with the testing person, revealed the units of measurement for the seven drugs of abuse were not reported on the patient reports since the last survey. 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 --