Doctors Med Care Of Fort Payne

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 a review of laboratory personnel records, and interviews with the Technical Consultant and Testing Personnel (TP) #1, the surveyor determined the facility failed to implement clear consistent procedures to assess and document the training and competency of the testing personnel in 2018-2019. The findings include: 1. A review of laboratory personnel records revealed the following noted problems: A) TP #1 had competency assessments for October 2018 and "Laboratory Training Checklist #295" dated 2/10/20 which were signed by personnel not qualified to perform the assessments. [Competency should reviewed/approved by the Laboratory Director, the Technical Consultant or a qualified designee of the Laboratory Director with a minimum of a Bachelor of Science degree and laboratory training.] There appeared to be no 2019 competency assessment for TP #1. B) TP #2 was hired 2/6/2019 with training dates on one form documented 3/6-5/6/19, and the manufacturer's training checklist from the Emerald analyzer dated as 5/2/19. However the "Competency" was dated 4/24/19, and the "Laboratory Training Checklist #295" was dated 2/10/20. C) TP #3 was hired 4/1/19 with training dated 7/1/19, and the "Laboratory Training Checklist #295" was dated 2/10/20. There was no documentation of a semi-annual competency evaluation. D) TP #5 was hired 9/16/19 with training dated 9/16/19 thru January 2020; the training checklist from the Emerald analyzer was undated. E) TP #6 was hired 2/23/19 with training dated 2/23 thru 5/21/19; the training checklist from the Emerald analyzer was dated 5/21/19. However the "Competencies" were dated 3/2 /19 and 5/21/19, and the "Laboratory Training Checklist #295" was dated 2/10/20. There was no documentation of a semi-annual competency evaluation. The surveyor 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 -- also noted some of the personnel records included a quality assessment (QA) form usually used for general laboratory QA. 2. During an interview and review of the personnel records on 2/27/2020 at 10:15 AM with the Technical Consultant and TP #1 (who functions as the Laboratory Supervisor), the surveyor observed the personnel records were very confusing; the surveyor explained generally the date of an employee's training was clearly specified, with any remedial or as needed training for new test platforms also documented. Thereafter, a semiannual within the first year and annual assessment were performed and documented. Procedures should be available specifying the process. 3. As the interview continued at approximately 10:30 AM, TP #1 explained the personnel records consisted of older forms and newer forms which the new Technical Consultant had provided after July 2018. TP #1 explained training consisted of three parts, and she had documented a competency assessment after one- and three-month portions of the training, but she had overlooked the requirement for a "semiannual" assessment. 4. As the interview continued at approximately 10:40 AM, the Technical Consultant (TC) pointed out the new forms, and explained the "Laboratory Training Checklist #295" form was intended only for new employees, however the facility had completed the form for all of the testing personnel on 2/20 /2020. The TC also provided the surveyor with the signed 2019 competency assessment for TP #1, however it had not been dated or fully completed. The surveyor reviewed the records with the TC and TP #1 and explained the laboratory needed to ensure procedures were in place for training and assessment of the testing personnel, forms were clearly labeled (training, semi-annual and annual assessments) and fully completed before review and approval by the Technical Consultant and / or Laboratory Director. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of CMS Casper reports (#153/#155), and a review of American Proficiency Institute (API) proficiency testing performance evaluations, the surveyor determined the laboratory failed to successfully participate in proficiency testing for the WBC (White Blood Cell) Differential for two of three consecutive testing events, Events #1 and #2 of 2018. These failures resulted in initial unsuccessful proficiency testing participation for the laboratory. The findings include: 1. A review of the Casper reports (#153/#155) revealed the laboratory failed to successfully participate in WBC Differential testing (Hematology) for two of three consecutive testing events, Events #1 and #2 of 2018. 2. A review of the Casper report #155 and API proficiency 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 -- testing performance evaluations revealed the laboratory scored 33 % (percent) for the WBC Differential (0 % for Granulocytes and Lymphocytes) for Event #1, 2018; and 67 % for Event #2, 2018 (0 % for Monocytes). D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of CMS Casper reports (#153/#155), and a review of American Proficiency Institute (API) proficiency testing performance evaluations, the surveyor determined the laboratory failed to satisfactorily perform in proficiency testing for the WBC (White Blood Cell) Differential for two of three consecutive testing events, Events #1 and #2 of 2018. These failures resulted in initial unsuccessful proficiency testing participation for the laboratory. The findings include: 1. Refer to D2016. Patricia Watson, BS, MT (ASCP) Licensure and Certification Supervisor -- 2 of 2 --