Etowah Pain Associates

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) proficiency testing (PT) records and an interview with the current Laboratory Director, the previous Laboratory Director failed to sign the attestation statements for four of seven survey events reviewed from 2019 to 2022. The findings include: 1. A review of the API records revealed the previous Laboratory Director failed to sign the attestation statements for the following surveys: a. 2019 Miscellaneous Chemistry Event #1. b. 2019 Miscellaneous Chemistry Event #2. c. 2020 Miscellaneous Chemistry Event #2. d. 2021 Miscellaneous Chemistry Event #1. 2. A review of the API Attestation Statement page revealed the following instructions: "SIGNATURES REQUIRED- Testing personnel and the laboratory director must physically sign an attestation statement for all PT results. ...". The surveyor noted the words "physically sign" were underlined. 3. During the exit interview on August 11, 2022, at 2:50 PM, the Laboratory Director confirmed the above findings. . D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on a review of the American Proficiency Institute (API) proficiency testing records and an interview with the current Laboratory Director, the previous Laboratory Director failed to document review of results for four of seven 2019 - 2022 survey events. The findings include: 1. A review of the API records revealed the previous Laboratory Director failed to document review of the results (scores) for the following surveys: a. 2019 Miscellaneous Chemistry Event #1. b. 2019 Miscellaneous Chemistry Event #2. c. 2020 Miscellaneous Chemistry Event #2. d. 2021 Miscellaneous Chemistry Event #1. 2. During the exit interview on August 11, 2022, at 2:50 PM, the Laboratory Director confirmed the above findings. . D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) proficiency testing records and an interview with the current Laboratory Director, the Laboratory failed to verify the accuracy of an analyte not graded by API. This was noted for Buprenorphine (BUP), not graded on three of seven 2019 to 2022 survey events. The findings include: 1. A review of the API records revealed BUP was not graded due to less than ten participants. Surveyor noted no evidence the laboratory reviewed the participant summary, and performed an internal evaluation of their results for the following survey events: a. 2019 Miscellaneous Chemistry Event #2 b. 2020 Miscellaneous Chemistry Event #2 c. 2021 Miscellaneous Chemistry Event #1 2. During the exit interview on August 11, 2022, at 2:50 PM, the current Laboratory Director confirmed the above findings. . D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) proficiency testing (PT) records and an interview with the current Laboratory Director, the Laboratory failed to submit results by the cutoff dates established by the PT provider. The laboratory scored zero percent due to failure to participate on two of four 2020 - 2021 survey events. The laboratory further failed to perform an internal evaluation to verify the accuracy of their results on one of four 2020 - 2021 survey events. The findings include: 1. A review of the API records revealed the laboratory scored zero percent due to failure to participate on the following PT surveys: a. 2020 Miscellaneous Chemistry Event #1. b. 2021 Miscellaneous Chemistry Event #2. 2. A further review of 2020 Miscellaneous Chemistry Event #1 records revealed the results were due on May 13, 2020, and the laboratory performed the testing on December 9, 2020. A -- 2 of 3 -- review of the

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the laboratory policy and procedure manuals and an interview with the current Laboratory Director, the surveyor determined the laboratory failed to ensure the current Laboratory Director documented her review and approval (as indicated by her signature and date) of procedures in use, after assuming her responsibilities as the Laboratory Director in April 2018. The findings include: 1. A review of the Form CMS-116 submitted to the CLIA State Agency on 4/4/2018 revealed a change in Laboratory Director request; an update in the records was made on 4/10/2018. 2. An on-site review of the laboratory policy and procedure manual revealed the signature of the previous Laboratory Director dated March 2017 (reviewed during the previous survey). However, there was no evidence the procedures had been reviewed and approved by the current Laboratory Director after she had assumed her responsibilities in April 2018 (one year previous to the date of this survey on 4/11/2019). 3. During an interview and review of the manuals on 4/11 /2019 at 11:05 AM, the current Laboratory Director (LD) stated she had actually become the LD in March 2018; the LD stated she had reviewed the procedures in use by the Testing Personnel, but had not actually signed and dated her approval. Thus the above noted findings were confirmed. SURVEYOR ID#32558 Licensure and Certification Surveyor D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for 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 -- monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on a review of the annual competency evaluations for the Testing Personnel, and interviews with the Testing Personnel and the Laboratory Director, the Laboratory Director failed to implement policies, procedures and checklists to assess and ensure the annual competency of the Testing Personnel in the performance of high- complexity Toxicology testing on the Diatron Pictus 400 analyzer. This affected one of one testing personnel. The findings include: 1. A review of the annual competency evaluations for the one Testing Personnel (dated 4/26/2018 and 2/27/2019) revealed a very general assessment (including "Emergencies, General Laboratory Safety, Chemical Safety, Biological Safety and Radiation Safety"). 2. During an interview on 4/11/2019 at 10:20 AM, the surveyor asked the Testing Personnel if anyone had evaluated her preanalytical, analytical, and postanalytical competency in the performance of the Urine Drug Screen testing on the Diatron Pictus 400 analyzer. The Testing Personnel reviewed the evaluations, and stated the form on file was used annually by the technician who had trained her on the Pictus 400, however there was no documentation of the Testing Personnel's competency in the actual test performance. 3. As the interview continued at approximately 10:25 AM, the surveyor then asked the Laboratory Director (also the Technical Supervisor) if she had assessed the Testing Personnel's competency in the performance of the Urine Drug Screen testing on the Diatron Pictus 400 analyzer. The Director stated she had reviewed operations and procedures in the laboratory with the testing personnel, however she had not documented an assessment of competency in 2018 or 2019. Thus the above noted findings were confirmed. [NOTE: The surveyor provided the CMS pamphlet "What Do I Need to Do to Assess Personnel Competency?" which provided details on CLIA requirements for competency.] SURVEYOR ID#32558 Licensure and Certification Surveyor -- 2 of 2 --