Addiction Angels Of America, Llc

Summary Statement of Deficiencies D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on record review and an interview with the Technical Supervisor (TS) and Testing Personnel (TP#1), the laboratory failed to establish and follow written policies and procedures and document all assessment activities of the ongoing mechanism to monitor, assess, and correct problems identified in the analytic systems. Findings Include: 1. Review of the laboratory's "Quality Assessment Review" policy and procedure electronically mailed 10/25/2021 at 10:22 AM, found the following statement: "The purpose of the Quality Assessment Review Policy is to assure that all pertinent aspects of the laboratory department are monitored and reviewed to assure that patient testing is completed in a safe and compliant manner to meet regulatory requirements. The review process must be sufficiently comprehensive to identify physical items and laboratory processes that are deficient/non-compliant or require improvement. 2. Review of temperature monitoring sheets provided on the date of inspection for the laboratory freezer found no temperatures had been recorded for April 2020 through September 13th 2021. 3. Review of temperature monitoring sheets provided on the date of inspection for the laboratory refrigerator found no temperatures had been recorded for June 2020 through September 13th 2021. 4. Review of the "Laboratory Director Quality Assessment Summary" sheets electronically mailed 10/22/2021 at 1:49 PM, from April 2020 through September 2021, found no mention of missed temperature monitoring for the laboratory's refrigerator or freezer. 5. The Surveyor requested the laboratory's analytic systems quality assessment documentation for April 2020 through September 2021 showing 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 refrigerator and freezer temperature monitoring assessments from TP#1. TP#1 confirmed the laboratory did not monitor temperatures during the above mentioned timeframe and did not have analytical quality assessments which included refrigerator and freezer temperature monitoring assessments. TP#1 was unable to provide the requested documentation on 10/22/2021 at 1:46 PM. -- 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 record review and an interview with the Technical Supervisor (TS), the laboratory failed to establish and follow written policies and procedures for the competency assessment of the Clinical Consultant (CC). This deficient practice had the potential to affect all patients tested at this laboratory in the subspecialty of Toxicology. Findings include: 1. Review of the laboratory's CMS-209 form, signed and approved by the Laboratory Director (LD) on 11/5/19, found one person serving as a CC. 2. Review of the laboratory's delegation documentation found the same person delegated to perform the regulatory roles and responsibilities of a CC by the LD, approved on 6/25/19. 3. Review of the laboratory's 'Performance/Competency Testing' policy failed to find mention of competency assessment of the CC, based on the regulatory responsibilities of that role, at a frequency determined by the lab. 4. Review of the laboratory's competency assessment documentation failed to find evidence that the CC was assessed for competency, based on the regulatory responsibilities of that role, at a frequency determined by the lab. 5. An interview with TS, on 1/5/19 at 12:21 pm, confirmed that the lab failed to assess the CC for competency, based on the regulatory responsibilities of that role, at a frequency determined by the lab. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, 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 -- 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 record review, and an interview with the Technical Supervisor (TS), the laboratory failed to indicate the specimen source on the final report for 7 out of 7 final reports reviewed. This deficient practice has the potential to affect all patients tested at this lab in the subspecialty of Toxicology. Findings include: 1. Review of 7 patient final test reports, found that all 7 failed to indicate a specimen source: Date Source Patient #1: 9/3/19 none Patient #2: 10/8/19 none Patient #3: 10/21/19 none Patient #4: 10/25/19 none Patient #5: 10/30/19 none Patient #6: 11/1/19 none Patient #7: 11/4/19 none 2. An interview with the TS, on 11/5/19 at 12:02 pm, confirmed that the lab failed to indicate a specimen source on the patient final test report. -- 2 of 2 --