Pediatricare Associates

Summary Statement of Deficiencies 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: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Office Manager (OM), the laboratory failed to review and evaluate PT results obtained from the American Association of Bioanalysts (AAB) for the Throat Culture event Q1 2020. The OM confirmed on 11/9/21 at 10:00 am that the laboratory did not review PT results stated above. D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: Based on the surveyor review of the Final Reports (FR), Overnight Throat Culture Logs and interview with the Office Manager (OM) the laboratory failed to have a Test Result (TR) on one out of ten FR reviewed from 9/12/18 to the date of the survey. The OM confirmed on 11/9/21 at 10:30 am am that the TR was not on all the FR. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 surveyor review of the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to perform and document CA on one out of two TP in the calendar year 2017. The TP #1 listed on CMS form 209 confirmed on 9/12/18 at 1:00 pm that CA was not done in 2017. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --