All Womens Health Center Of Gainesville Inc

Summary Statement of Deficiencies D0000 At the time of the announced, on-site recertification survey, All Womens Health Center of Gainesville, Inc., was found to NOT be in compliance with the CLIA laboratory requirements of 42 CFR 493. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the facility failed to ensure quality control testing was documented and in range before reporting patient results for 5 of 77 days reviewed in 2019 and 2020. The findings include: The 12/9/20 quality control record review showed: On 12/5/2019, no quality control (QC) was documented, and 9 patients were tested for Rhesus factor (Rh). On 3/31/20, no QC was documented, and 10 patients were tested for Rh. On 4/7/20, no QC was documented and 7 patients were tested for Rh. On 7/28/20, no QC was documented and 11 patients were tested for Rh. On 12/3/20, no QC was documented and 9 patients were tested for Rh. The interview with the office administrator on 12/9/20 at 11:30am confirmed the quality control had not been documented properly. 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 record review and interview with the Office Manager the laboratory failed to perform competency evaluations on testing personnel for 2 out of 2 years (2016- 2018) reviewed. Findings Included: Review of the CMS 209 revealed 4 Testing Personnel. Review of the 4 Testing Personnel files revealed no competency evaluations in 2016-2018. During the interview on 10/23/18 at 11:45 AM the Office Manager confirmed that no documentation of competency evaluation were performed. 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 --