Summary:
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 review of laboratory records and interview with the general supervisor (GS); the laboratory failed to establish policies and procedures to assess competency of all personnel listed on the CMS-209 (Laboratory Personnel Report). Findings Include: 1. Review of the laboratory's policy and procedure manual identified the policy, "Training and Competence Evaluation of Laboratory Personnel", which failed to address competency for the following laboratory personnel: technical consultant, clinical consultant, technical supervisor, and general supervisor. 2. On survey date 04- 26-2018 at 03:45 pm, the GS confirmed the above findings. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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 review of laboratory records and interview with the general supervisor (GS); 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 -- the technical supervisor (TS) failed to ensure 5 of 5 testing personnel reviewed maintained their competency to perform and report patient test results for the specialties of chemistry and hematology in 2017. Findings Include: 1. Review of the laboratory policy, "Training and Competence Evaluation of Laboratory Personnel", stated the following: "All previously trained and approved MT's and MLT's will be re- evaluated on an annually basis using the criteria based competency procedure. This will include direct observation, participation in proficiency testing, review of quality control results, review of patient samples, troubleshooting, problem solving, and general maintenance." 2. Review of competency assessment documents for 5 of 5 testing personnel (TP) in 2017 found they failed to assess all six elements of competency for each of the laboratory test systems: microscopic urinalysis, serum human chorionic gonadotropin, prothrombin time, routine chemistry analytes on the Abbott Architect, and complete blood counts with manual differentials on the Sysmex KX-21 and XN-1000. The 2017 competency assessment documents reviewed were titled, "Cancer Center Competency Evaluation", and a complete list of laboratory tests were documented on the form, "Test System Listing." 3. On survey date 04-26-2018, at 3:45pm, the GS confirmed that the competency assessments for 5 of 5 TP failed to cover all six elements of competency for all testing performed by laboratory testing personnel. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the general supervisor (GS); the technical supervisor (TS) failed to ensure annual competency assessments were completed for testing personnel (TP) #1 in 2016 and 2017. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the policy, "Authorization to Certify", which stated the following: "The following have been trained to work at the Quincy Medical Group Oncology lab, pass competency yearly, and are authorized to test and certify lab results 'TP#2, TP#1, TP#4, TP#3, TP#5, TP#6.'" 2. Review of competency assessment documentation found the TS failed to ensure annual competency assessments were completed for TP#1 in 2016 and 2017. 3. On survey date 04-26-2018, at 3:45 pm, the GS confirmed no competency assessments had been completed for TP#1. -- 2 of 2 --