Central California Pain Management

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 Surveyor review of laboratory's quality control (QC) and

Summary Statement of Deficiencies 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 and toured the laboratory facility, and instruments operations of BioLis 24i including built-in laboratory information system, review of the laboratory's patient test result reports, and computer and interview with the laboratory testing personnel (TP), it was determined that the laboratory failed to select a system which provides test results within the laboratory's stated performance specifications and to assure accurate and reliable test results. The findings included: a. The laboratory used BioLis 24i analyzer, and its laboratory information computer system, to perform and to report a semi-qualitative analysis for urine drug screen. b. The drug test names in the patient test result reports indicated as: COCM, OP300, OXYC, 6AM, UCRE, and METHA without its full names based on its built-in computer system. c. Review of "Current QC" records run on 10/28/20 for all six analyte identified in (b), exactly identical QC material information for Control Name: A1 or A2, as Lot No: H1903; "Exp.Date: 09/20" were noted e. The laboratory testing personnel affirmed (11/20/20 @10:55 AM) that the laboratory cannot correct the "Lot No" or Exp Date" information, since a newly installed computer system by the vendor on 8/3/2020 after the old one crushed on 7/31/2020. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 observation of the laboratory facility including a digital thermometer, review of the laboratory temperature records, and interview with the laboratory testing personnel (TP), it was determined that the laboratory failed to monitor the temperature of the refrigerator properly to assure the stability of the laboratory supplies, and failed to follow the manufacturer's instructions of the DT in a manner that provide the proper temperature monitoring within the acceptable temperature range to further assure the quality of the laboratory operations. The findings included: a. The laboratory uses a digital thermometer (DT) sold under VWR to monitor the temperature of a refrigerator for the storage of calibrators, controls, reagents (laboratory supplies), and the patient urine samples. d. The laboratory failed to understand the DT features fully and failed to assure the quality and the stability of the laboratory supplies including the patient urine samples in storage. c. The DT features include "Alarm on/off", Lo/HI" mode, "Min/Max" mode, and Reset. d. At the time of survey 11/20/20 @ 11:05 am, the DT with "Alarm" set on "Off", and when turned to "On", the alarm sounded off, which indicated that at one time in the past, the temperature inside the refrigerator was out of the laboratory established acceptable temperature range for the storage condition. e. Noticed the Lo/Hi mode was set between 10 to 30 oC. for the refrigerator, which is not the laboratory intended acceptable refrigeration temperature, i.e. 2 to 8 oC. f. Noticed "Min/Max" mode, the DT indicated Min was -4 and Max -26 oC, which indicated at some time passed the refrigerator inside condition was in -4 oC or -26 Max cooling conditions, which exceeded the acceptable range. 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 review of the laboratory patient test result reports (Report), and interview with the laboratory testing personnel (TP), and the laboratory director (LD), it was determined that the laboratory failed to indicate the test performed with the full name for a semi-qualitative urine drug screen analysis. The findings included: a. The laboratory used BioLis24i instrument and Carolina reagents to perform urine drug screen (UDS) including 5 drugs and one urine creatinine for adulteration purpose. b. The Report indicates the following test names: "COCM", "OP300", "OXYC", "6AM", -- 2 of 4 -- "UCRE" and "METHA" and indicate the results quantitatively. c. The laboratory affirmed on 11/20/20 @ 10 AM, that the laboratory intended to perform a semi- qualitative analysis, including qualitative and quantitative results. d. The laboratory failed to include and indicate the qualitative results in terms of "Negative/Positive" or "Non-detected/Detected" in the Report, in addition to drug concentrations. e. The Report failed to indicate what are the full test name for "COCM", "OP300", "OXYC", "6AM", "UCRE" and "METHA" stand for. f. There are also a "Provider's Assessment Immunology Results" statement, not pertaining to the laboratory report" included in the Report format, and Ashok Parmar MD (Medical Director): ________ CLIA # 05D1106349 Date Reviewed: ________, g. The LD affirmed that is for the provider to document what the actions taken based on the test results, when the provider consults with the patients. h. Reviewed a Report with patient ID 12269 and UDS run date of 03/29/20 indicated an unknow signature for Medical Director, and Date Reviewed Apr 10, 2020. h. TP affirmed 11/20/20 @ 10:55 AM that the signature on the patient Report of 12269 run on 03/29/20 was unknown to her, not the laboratory director's signature. D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) 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)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on observation of the laboratory facility and the instrumentation with built-in laboratory information system, review of the laboratory patient result reports, and the quality control records, and interview with the testing personnel, it was determined that the laboratory director failed to ensure the establishment and maintenance of acceptable levels of analytical performance for urine drug test system. The findings included: a. The laboratory used BioLis 24i and its laboratory information computer system, to perform and to report semi-qualitative analysis for urine drug screen including the following tests: COCM, OP300, OXYC, 6AM, UCRE, AND METHA, b. Review of "Current QC" records run on 10/28/20 for Control Name: A1 and A2 QC materials., identical QC material information; Lot No: H1903 and Exp Date: 09/20 were noticed for all drugs testing QC records, see D-5411 c. The laboratory uses a digital thermometer (DT) under VWR to monitor the temperature of the refrigerator for the storage of calibrators, controls, reagents and the patient urine samples. d. The laboratory failed to understand the DT features fully and failed to ensure the quality and the stability of the laboratory supplies and the patient urine samples in storage, see D-5413. D6026 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(8) 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 -- 3 of 4 -- director must-- (e)(8) Ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based on review of the laboratory patient test result report (Report), and interview with the laboratory testing personnel (TP), and the laboratory director (LD), it was determined that the laboratory director failed to ensure that the reports of test results include pertinent information required for interpretation. The findings included: a. The laboratory used BioLis24i instrument and Carolina reagents to perform urine drug screen (UDS) including 5 drugs and one urine creatinine for adulteration purpose. b. The Report includes the following test names as "COCM", "OP300", "OXYC", "6AM", "UCRE" and "METHA" without full name to be understand and a concentration result, which was not the laboratory's intention for a semi-qualitative analysis. c. The laboratory director failed to ensure that the test names clearly identified, and the results reported semi-qualitatively, see D-5805 -- 4 of 4 --

Summary Statement of Deficiencies 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 review of laboratory policies and procedures, random review of ten (10) patient records from 01/14/2017 to 07/23/2018, and an interview, it was determined that the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the preanalytic Toxicology quality assessment systems for 2017 and 2018 to the date of the survey. The Findings include: a. The surveyor requested on 08/02/108 (survey date) documentation of ongoing assessing practices/issues related to test requests, specimen submission, handing and referral, and the frequency of monitoring; the laboratory failed to provide written documentation (records) of any preanalytic quality assessment activities or problems. b. The testing personnel affirmed 08/02/108 12:25 AM that the laboratory did not follow the written policy and procedure to assess, monitor and correct problem in the preanalytical systems (refer to laboratory General QA Policy, Effective Date 01.01.2012, pgs.1-8). D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, random review of ten (10) patient records from 01/14/2017 to 07/23/2018, and an interview, it was determined that the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the postanalytic Toxicology quality assessment systems for 2017 and 2018 to the date of the survey. The Findings include: a. The surveyor requested on 08/02/108 (survey date) documentation of ongoing quality assessment (QA) for the postanalytic system includes assessing practices/issues related to test report monitoring and evaluating the accuracy and completeness of the laboratory's test reports and the laboratory's turn- around times and procedures for notification of test results. b. The testing personnel affirmed 08/02/108 12:25 AM that the laboratory did not follow the written policy and procedure to assess, monitor and correct problem in the postanalytical systems (refer to laboratory General QA Policy, Effective Date 01.01.2012, pgs.1-8). D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on lack of documentation for competency assessments, review of quality control records, and interview with the laboratory director and a testing person, it was determined that the technical consultant (laboratory director) failed to perform and document the performance of all testing personnel and assuring that the staff maintained their competency to perform test procedures promptly, accurately, and proficiently. The findings included: a. There was no documentation to show that the testing personnel were evaluated during the years 2017 and /2018, which is considered the following minimum requirements. 1. The procedures for evaluation of the competency of the staff must include, but are not limited to: 2. Direct observation of the testing performed (including sample handling, processing and testing). 3. Monitoring the recording and reporting of results. 4. Direct observation of instrument maintenance. 5. Review of intermediate worksheets, quality controls. 6. Assessment of testing previously analyzed specimens (external QC and proficiency testing). 7. Assessment of problem solving skills. c. On 068/02/2018 12:45 AM (Survey date) the laboratory testing person affirmed that no competency assessments were performed and documented during the above period. -- 2 of 2 --