Advanced Spine & Pain Management

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the laboratory's CMS 209 form, proficiency testing (PT) records, and an interview with the Practice Administrator (PA), the laboratory failed to examine or test PT samples by all personnel who routinely perform testing in the laboratory. Patients tested with the 2018 PT UDS kit 31085722 3 08 39 event B have the potential to be affected by this deficient practice. Findings Include: 1. Review of one out of seven of the laboratory's 2017-2018 College of American Pathology (CAP), PT attestation pages revealed the PA participated in PT testing for the 2018 UDS kit 31085722 3 08 39 event B. 2. Review of the laboratory's CMS-209 form, approved, signed, and dated by the Laboratory Director on 01/22/2019, did not indicate the PA listed as Testing Personnel. 3. A competency assessment document was provided for the PA for the AO400 instrument, however it was dated 09/25/2018. The PT test date was 07/18/2018. The competency assessment document was not signed by the PA. 4. The PA stated they stepped-in to help out when short staffed for the 2018 UDS kit 31085722 3 08 39 event B. The interview occurred on 01/23/2019 at 12:22 PM. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of 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 7 -- proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and an interview with the Practice Administrator (PA), the laboratory failed to document the handling, preparation, processing, examination and each step in the testing and reporting of proficiency testing (PT) results. All patients tested with the PT events below have the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's College of American Pathologist (CAP), 2017 DMPM attestation page for kit 29968175 3 05 18 and 2017 UDS attestation page for kit 29968220 7 07 77 found no Lab Director signature. 2. Review of the attestation page for the 2017 UDS CAP kit 29968239 8 07 43 found a signature from a former Testing Personnel on the Director or designee attestation line. 3. Review of the original attestation page for the 2018 DMPM CAP kit 31662577 1 05 72 found no Testing Personnel signature on the (original) attestation page. Two other attestation pages for the 2018 DMPM CAP kit 31662577 1 05 72 kit were found with only typed names for the attestation of both the Laboratory Director and Testing Personnel. 4. Review of the attestation page(s) for the 2018 UDS CAP kit 31086008 7 07 71 found two separate pages. One attestation page contained the Testing Personnel signature only. Another page contained the Laboratory Director's signature only. 5. Review of the attestation page for the 2018 UDS CAP kit 31085436 2 07 28 found only typed names, no signature as required by CAP. 6. The PA confirmed all PT attestation pages are sent to the Lab Director for review and submission. The interviews occurred on 01/23/2019 at 12:15 PM. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record reviews and interviews with the Laboratory Director and Practice Administrator, the laboratory failed to meet the applicable general laboratory systems requirements to monitor and evaluate the overall quality of the general laboratory systems and correct identified problems. All patients have the potential to be affected by this deficient practice. Findings Include: 1. The laboratory failed to establish and follow written policies and procedures to assess and document the competency of TP and the General Supervisor. (Refer to D5209) 2. The laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general laboratory systems specified in 493.1239. (Refer to D5291) 3. The laboratory failed to review assessment -- 2 of 7 -- policies, procedures and notes to ensure continuous improvement as specified in 493.1239. (Refer to D5293) 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 record review and an interview with the Practice Administrator (PA), and the Laboratory Director (LD), the laboratory failed to establish and follow written policies and procedures to assess the competency of the General Supervisor (GS) based on the responsibilities of the position. All patients from 01/21/2019 until the competency assessment has been completed have the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's Form CMS-209, approved, signed, and dated by the LD on 01/22/2019, found one individual listed as GS. 2. Review of the laboratory's competency assessment policy and procedure titled "Personnel Competency Assessment Policy", lists six elements of evaluation. 3. Review of the "General Supervisor Competency Assessment" document signed and dated by the LD on 01/21/2019, lists eight responsibilities only. No signature and date from the GS was found. 3. The surveyor requested the General Supervisor's competency assessment document listing the six elements of evaluation as stated in the policy and procedure. The LD and PA were unable to provide the requested documentation. The interviews occurred on 01/23/2019 at 10:57 AM. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on policy and procedure review, record review, and an interview with the Laboratory Director (LD), the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems. All patients tested have the potential to be affected by this deficient practice. Findings include: 1. Review of the quality assessment policy and procedure titled, "Quality Assurance Protocol", found the following statement: "Staff Training and Documentation" "Each laboratory staff member is trained for their respective duties prior to testing patient samples." 2. Review of documentation found no General Supervisor training for 2017-2018. 3. One competency assessment document was provided for Testing Personnel #2 labeled as "initial competency" for the API3000, however no dates or Testing Personnel signature were recorded. 4. No initial competency assessments for Testing Personnel #2 for the AO400 instrument and respective lab duties were found. 5. Review of the quality assessment policy and procedure titled, "Quality Assurance Protocol", found the following statement: "Quality Assurance/Quality Improvement Meetings" "2. The -- 3 of 7 -- meetings will define issues; the plans of actions to address the issues, implementation of the plans of action, and summarize the outcomes for which the laboratory has tried to improve its function." 6. Meeting notes provided on the date of inspection found no implementation of a plan of action, or a summary of an outcome for which the laboratory has tried to improve its function. 7. An interview with the LD confirmed quality assessment was not performed as stated in the policy and procedures. The interview occurred on 01/23/2019 at 1:10 PM. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of