Doctors Med Care Of Gadsden

Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with the Technical Consultant (TC) and Testing Personnel (TP), the TC failed to ensure TP had annual competency assessments for the moderate complexity testing which included the six minimal regulatory requirements. The surveyor noted one of the six requirements was missing on the annual competency assessment. The findings include: 1. A review of the 2022 through 2024 personnel records revealed four of the eight TP (listed on the CMS-209) who performed moderate complexity testing had no documentation on one of the six minimal regulatory requirements for the annual competency assessment. 2. The TC confirmed the above findings during the exit conference on 12-17-2024 at 1: 35 PM. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on a review of the personnel records and an interview with the Technical Consultant (TC), the TC failed to utilize previously analyzed, proficiency testing, or 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 -- blind samples in the assessment of the Testing Personnel (TP) performance evaluation. The surveyor noted the missing competency assessment was from the date of the last survey on 10-20-2022 to the date of the current survey on 12-17-2024. The findings include: 1. A review of the personnel records revealed four of the eight TP performing moderate complexity testing were not evaluated by the TC utilizing previously analyzed, proficiency testing or blind samples in the annual competency assessments. 2. During the exit conference on 12/17/2024 at 1:35 PM, the TC confirmed the above findings. -- 2 of 2 --

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 Cell Dyn Quick Reference Guide and an interview with Testing Personnel #2, the laboratory failed to ensure the Laboratory Director signed and dated his review and approval of the new procedure before use by the testing personnel for patient testing. The findings are: 1. A review of the Cell Dyn Quick Reference Guide had no signature to indicate the Director's review and approval for use by the testing personnel. CLIA regulations require the Laboratory Director's review and approval of all new procedures as indicated by his actual signature and the date. Patient testing on the new Cell Dyn Emerald began on 7/16/2016. 2. During an interview on 5/30/2018 at 12:20 PM, Testing Personnel (TP) #2 was asked if the Laboratory Director had reviewed, dated and signed his approval for the new analyzer procedures. TP #2 explained she had printed the new Reference Guide from the internet when they received the instrument, and had not realized the Laboratory Director needed to review and sign the procedures. Thus the above noted findings were confirmed. 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of the Abbott Cell Dyn Emerald Hematology analyzer quality control (QC) records, patient logs, and an interview with Testing Personnel #2, the laboratory failed to ensure at least two levels of Hematology QC were run and were within acceptable limits before patient testing began. This was noted on one day of patient CBC (Complete Blood Count) testing in 2017. The findings include: 1. A review of the 2017 Hematology cumulative QC reports revealed only the Low level QC was performed and within acceptable ranges on 4/11/2017. There were no results available for the Normal and High level QC on this date. 2. A review of the patient log revealed thirteen patient CBCs were performed on 4/11/2017. 3. During an interview on 5/30/2018 at 4:00 PM, the above noted findings were reviewed and confirmed with Testing Personnel #2. . D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a review of installation and validation documentation for the Abbott Cell Dyn Emerald Hematology analyzer and an interview with Testing Personnel #2, the Laboratory Director failed to document review and approval of the initial validation procedures as verifying the manufacturer's performance specifications for the analyzer, before patient testing began. The findings include: 1. A review of the Abbott Cell Dyn Emerald's installation documentation revealed no review and approval by the Laboratory Director (as indicated by a signature and date) on the initial verification procedures performed on 4/13/2016. Patient CBC (Complete Blood Count) testing on this analyzer began on 7/16/2016. 2. During an interview and review of these records on 5/30/2018 at 12:20 PM, Testing Personnel #2 stated she was unable to find any documentation of review and approval of the validation data by the Laboratory Director (as indicated by his signature and date). Thus the above noted findings were confirmed. SURVEYOR: Laura T. Williams, BS, MT (ASCP) Licensure and Certification Surveyor -- 2 of 2 --