Comprehensive Pain Management Institute

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Director (LD), the laboratory failed to perform test accuracy verification (TAV) twice annually for moderate complexity MedTox 9-Panel Drug (MedTox) testing procedures performed in the subspecialty of Toxicology. Analytes include Cannabinoids, Phencyclidine, Cocaine, Opiates, Amphetamine, Benzodiazepine, Tricyclic Antidepressants, Methadone and Barbiturates. This deficient practice had the potential to affect 72 out of 72 patient tests performed in this laboratory from 07/18/2024 through 08/16/2024. Findings Include: 1. Review of laboratory's "Proficiency Testing Policy" approved by LD by signature and date on 02/17/2025 found the following statement: "...The laboratory maintains annual enrollment in PT for the following types of tests (check all those that apply) [unchecked] regulated analytes performed by non-waived methods [unchecked] unregulated analytes performed by non-waived methods [unchecked] waived tests..." 2. Review of the laboratory's testing records failed to find PT enrollment for the year 2024 or TAV records for unregulated analytes. 3. An interview with the LD confirmed that the laboratory ceased moderately complexity testing prior to August 2024 and could not provide TAV or PT documents from 2024. The interview occurred on 08/28/2025 at 2:46 PM. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on record review and an interview with the Laboratory Director (LD), the LD failed to provide overall management and direction in accordance with 493.1407 of this subpart for moderate complexity MedTox 9-Panel Drug (MedTox) testing procedures performed in the subspecialty of Toxicology. Analytes include Cannabinoids, Phencyclidine, Cocaine, Opiates, Amphetamine, Benzodiazepine, Tricyclic Antidepressants, Methadone and Barbituates.This deficient practice had the potential to affect 72 out of 72 patient tests performed on 07/18/2024 through 08/16 /2024. Findings Include: 1. The Laboratory Director failed to ensure that the quality control (QC) and quality assessment (QA) program was established and maintained to assure the quality of the moderate complexity MedTox 9-Panel Drug testing and to identify failures in quality as they occur. (Refer to D6020) 2. The Laboratory Director failed to employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities. (Refer to 6028) 3. The Laboratory Director failed to ensure that testing personnel (TP) was trained and had demonstrated that they could perform the moderate complexity MedTox 9-Panel Drug (MedTox) testing procedures in subspecialty of Toxicology reliably to provide and report accurate results prior to performing patient testing. (Refer to D6029) 4. The Laboratory Director failed to ensure that an approved procedure manual was available to all laboratory personnel responsible for any aspect of the moderate complexity MedTox 9-Panel Drug (MedTox) testing procedures in the subspecialty of Toxicology. (Refer to D6031) D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Director (LD), the LD failed to ensure that the quality control (QC) and quality assessment (QA) programs were established and maintained to assure the quality of the moderate complexity MedTox 9-Panel Drug (MedTox) testing and to identify failures in quality as they occur. Analytes include Cannabinoids, Phencyclidine, Cocaine, Opiates, Amphetamine, Benzodiazepine, Tricyclic Antidepressants, Methadone and Barbituates. This deficient practice had the potential to affect 72 out of 72 patient MedTox tests on 07/18/2024 through 08/16/2024. Findings Include: 1. Review of the laboratory's "Quality Control" policy, unapproved by the LD found the following statements: "...In performing any testing, all procedural instructions must be followed exactly. ...Perform quality control per the procedure and record the results... ...confirm quality control testing results are acceptable prior to testing patients..." 2. Review of laboratory documents did not find any QC records for the patients tested on 07/18 /2024 thorugh 08/16/2024. 3. Review of the laboratory's policies failed to find a procedure for QA or indication that QA was performed in the year 2024. 4. An -- 2 of 8 -- interview with the LD confirmed that the laboratory ceased testing prior to August of 2024 and could not provide the documents. The interview occurred 08/28/2025 at 2: 46 PM. D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) (e)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Director (LD), the LD failed to employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities. This deficient practice had the potential to affect 72 out of 72 patient MedTox tests on 07/18/2024 through 08/16/2024. Findings: 1. The Surveyors requested copies of education documentation for the Laboratory Director, Clinical Consultant (CC), Technical Consultant (TC), and Testing Personnel (TP), quality control records, quality assessment records, training records, competency assessment records, proficiency test records, patient logs, and instrument maintenance records from the LD. 2. The LD confirmed he could not provide the above mentioned documents as requested. The interview occurred on 08/28/2025 at 2: 45 PM. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) (e)(11) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Director (LD), the LD failed to ensure that one out of one testing personnel (TP) was trained and had demonstrated that they could perform the moderate complexity MedTox 9-Panel Drug (MedTox) testing procedures in subspecialty of Toxicology reliably to provide and report accurate results prior to performing patient testing. Analytes include Cannabinoids, Phencyclidine, Cocaine, Opiates, Amphetamine, Benzodiazepine, Tricyclic Antidepressants, Methadone and Barbituates. This deficient practice had the potential to affect 72 out of 72 patient tests performed on 07/18/2024 through 08/16 /2024. Findings Include: 1. Review of the laboratory's policies failed to find a procedure for the training of moderate complexity Testing Personnel (TP). 2. Review of the patient MedTox testing logs from 07/18/2024 through 08/16/2024 found the initials of one TP performing moderately complex testing. 3. Review of the laboratory's policies, procedures and documentation from 07/18/2024 through 08/16 /2024 failed to find evidence that the TP was was trained and had demonstrated that they could perform the moderate complexity MedTox 9-Panel Drug (MedTox) testing -- 3 of 8 -- procedures in subspecialty of Toxicology reliably to provide and report accurate results prior to performing patient testing in the year of 2024. 4. An interview with the LD confirmed that the laboratory ceased testing prior to August of 2024 and could not provide the documents. The interview occurred 08/28/2025 at 2:46 PM. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Director (LD), the LD failed to ensure that an approved policy and procedure manual was available to all laboratory personnel responsible for any aspect of the moderate complexity MedTox 9-Panel Drug (MedTox) testing procedures in the subspecialty of Toxicology. Analytes include Cannabinoids, Phencyclidine, Cocaine, Opiates, Amphetamine, Benzodiazepine, Tricyclic Antidepressants, Methadone and Barbituates. This deficient practice had the potential to affect 72 out of 72 patient tests performed on 07/18/2024 through 08/16/2024. Findings Include: 1. Review of the laboratory's policies and procedures provided on 08/28/2025 at 10:52 AM by the LD, found the following policies and procedures approved by the LD by signature and date: Name of Policy: Approved Date: "Proficiency Testing Policy..." 02/17/2025 "Pre-Analytic Procedures..." [unapproved] "Analytic Processes..." [unapproved] "Incident Management Plan..." [unapproved] "Job Description..." [unapproved] "Post-Analytic Procedures..." [unapproved] 2. An interview with the LD confirmed that the LD failed to provide an approved policy and procedure manual to all laboratory personnel for the moderately complex MedTox testing in the subspecialty of Toxicology. The interview occurred on 08/28/2025 at 11:05 AM. D6033 TECHNICAL CONSULTANT-MODERATE COMPLEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on record review and an interview with the Laboratory Director (LD), the Technical Consultant (TC) failed to provide technical oversight in accordance with 493.1413 of this subpart for moderate complexity MedTox 9-Panel Drug (MedTox) testing procedures performed in the subspecialty of Toxicology. Analytes include Cannabinoids, Phencyclidine, Cocaine, Opiates, Amphetamine, Benzodiazepine, Tricyclic Antidepressants, Methadone and Barbituates. This deficient practice had the potential to affect 72 out of 72 patient tests performed on 07/18/2024 through 08/16 /2024. Findings Include: 1. The Technical Consultant failed to assure competency was maintained in order to perform moderate complexity MedTox 9-Panel Drug (MedTox) testing procedures performed in the subspecialty of Toxicology. (Refer to D6046) 2. The Technical Consultant (TC) failed to monitor the recording and reporting of patient results for moderate complexity MedTox 9-Panel Drug (MedTox) testing procedures performed in the subspecialty of Toxicology. (Refer to D6048) -- 4 of 8 -- D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (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. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Director (LD), the Technical Consultant (TC) failed to evaluate and document the competency of one out of one Testing Personnel (TP) in 2024, assuring their competency was maintained in order to perform moderate complexity MedTox 9-Panel Drug (MedTox) testing procedures performed in the subspecialty of Toxicology. Analytes include Cannabinoids, Phencyclidine, Cocaine, Opiates, Amphetamine, Benzodiazepine, Tricyclic Antidepressants, Methadone and Barbituates. This deficient practice had the potential to affect 72 out of 72 patient tests performed on 07/18/2024 through 08/16 /2024. Findings Include: 1. Review of the laboratory's policies provided on 08/28 /2025 at 10:52 AM by the LD failed to find a policy and procedure for the competency assessment of TP. 2. Review of the patient MedTox testing logs from 07 /18/2024 through 08/16/2024 found the initials of one TP that performed moderately complex testing for 72 patients. 3. Review of the laboratory's documents failed to find any competency assessment for one TP in the year 2024. 4. An interview with the LD confirmed that the laboratory ceased testing prior to August of 2024 and could not provide the documents. The interview occurred 08/28/2025 at 2:46 PM. D6048 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(ii) (b)(8)(ii) Monitoring the recording and reporting of test results; This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Director (LD), the Technical Consultant (TC) failed to monitor the recording and reporting of patient results for moderate complexity MedTox 9-Panel Drug (MedTox) testing procedures performed in the subspecialty of Toxicology on 07/18/2024 through 08/16/2024. This deficient practice had the potential to affect 72 out of 72 patient tests performed on 07 /18/2024 through 08/16/2024. Analytes include Cannabinoids, Phencyclidine, Cocaine, Opiates, Amphetamine, Benzodiazepine, Tricyclic Antidepressants, Methadone and Barbituates. Findings Include: 1. Review of the laboratory's policies provided on 08/28/2025 at 10:52 AM by the LD failed to have a policy and procedure for the monitoring and recording of patients results. 2. Review of the patient MedTox testing logs from 07/18/2024 through 08/16/2024 failed to find evidence that recording and reporting of patients results was being monitored by the TC by signature and date. 3. An interview with the LD confirmed that the laboratory ceased testing prior to August of 2024 and could not provide the documents. The interview occurred 08/28/2025 at 2:46 PM. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 -- 5 of 8 -- The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on record review and an interview with the Laboratory Director (LD), the LD failed to have have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493.1425 for the volume and complexity of tests performed. This deficeint practice had the potential to affect 72 out of 72 patient tests performed on 07/18/2024 through 08/16/2024. Findings Include: 1. The LD failed to ensure the Testing Personnel, (TP), had the appropriate education documentation to perform all test operations reliably to provide and report accurate results. (Refer to D6065) D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on document review and an interview with the Laboratory Director (LD), the LD failed to ensure the Testing Personnel (TP) had the appropriate education documentation to perform all test operations reliably to provide and report accurate results. This deficient practice affected one out of one TP. This deficient practice had the potential to affect 72 out of 72 patient tests performed on 07/18/2024 through 08 /16/2024. Findings Include: 1. Review of the patient MedTox testing logs from 07/18 /2024 through 08/16/2024 found the initials of one TP performing moderately complex testing for 72 patients. 2. Review of the laboratory's documents failed to find any qualifying education documents for one TP in the year 2024. 3. An interview with the LD confirmed that the laboratory ceased testing prior to August of 2024 and could not provide the documents. The interview occurred 08/28/2025 at 2:46 PM. D8100 INSPECTION REQUIREMENTS CFR(s): 493.1771 (a) Each laboratory issued a CLIA certificate must meet the requirements in 493.1773 and the specific requirements for its certificate type, as specified in 493.1775 through 493.1780. (b) All CLIA-exempt laboratories must comply with the inspection requirements in 493.1773 and 493.1780, when applicable. -- 6 of 8 -- This CONDITION is not met as evidenced by: Based on record review and interview with the Laboratory Director (LD), the laboratory failed to comply with the inspection requirements in 493.1773. This deficient practice had the potential to affect 72 out of 72 patient tests performed on 07 /18/2024 through 08/16/2024. Findings Include: 1. The laboratory failed to provide, upon request, the required copies of education documentation for the Laboratory Director, Clinical Consultant (CC), Technical Consultant (TC), and Testing Personnel (TP) to make a determination of the laboratory's compliance with testing personnel requirements for Moderate and Waived testing. (Refer to D8103) 2. The laboratory failed to provide, upon request, the required copies of quality control records, quality assessment records, training records, competency assessment records, proficiency test records, patient logs, and instrument maintenance records, to make a determination of the laboratory's compliance with Moderate and Waived testing. (Refer to D8103) D8103 BASIC INSPECTION REQUIREMENTS CFR(s): 493.1773(b)(c)(d) (b) General Requirements. As part of the inspection process, CMS or a CMS agent may require the laboratory to do the following: (b)(1) Test samples, including proficiency testing samples, or perform procedures. (b)(2) Permit interviews of all personnel concerning the laboratory's compliance with the applicable requirements of this part. (b)(3) Permit laboratory personnel to be observed performing all phases of the total testing process preanalytic, analytic, and postanalytic). (b)(4) Permit CMS or a CMS agent access to all areas encompassed under the certificate including, but not limited to, the following: (b)(4)(i) Specimen procurement and processing areas. (b)(4) (ii) Storage facilities for specimens, reagents, supplies, records, and reports. (b)(4)(iii) Testing and reporting areas. (b)(5) Provide CMS or a CMS agent with copies or exact duplicates of all records and data it requires. (c) Accessible records and data. A laboratory must have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection. (d) Requirement to provide information and data. A laboratory must provide, upon request, all information and data needed by CMS or a CMS agent to make a determination of the laboratory's compliance with the applicable requirements of this part. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Director (LD), the laboratory failed to provide copies of education documentation for the Laboratory Director, Clinical Consultant (CC), Technical Consultant (TC), and Testing Personnel (TP), quality control records, quality assessment records, training records, competency assessment records, proficiency test records, patient logs, and instrument maintenance records to make a determination of the laboratory's compliance with Moderate CLIA testing requirements and Waived testing according to manufacture's requirements. This deficient practice had the potential to affect 72 out of 72 patient tests performed on 07/18/2024 through 08/16/2024. Findings Include: 1. On 08/28 /2025 at 10:50 AM the LD confirmed the laboratory was conducting Waived testing but had ceased Moderate complexity testing. The LD also stated he could not remember the exact date the laboratory ceased Moderate complexity testing. 2. The Surveyors requested copies of education documentation for the Laboratory Director, Clinical Consultant (CC), Technical Consultant (TC), and Testing Personnel (TP), quality control records, quality assessment records, training records, competency -- 7 of 8 -- assessment records, proficiency test records, patient logs, and instrument maintenance records. 3. The Surveyors requested manufacture's requirements for the waived testing being conducted. 4. The LD confirmed he could not provide the above mentioned documents as requested. The interview occurred on 08/28/2025 throughout the course of the inspection. -- 8 of 8 --