Hematology Oncology Assoc Of Ne Pa Pc Lab

Summary Statement of Deficiencies D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 This facility is in compliance with 42 CFR Part 493. 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 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, the review Testing Personnel (TP) competency assessment (CA) records and interview General supervisor (GS), the Technical Supervisor (Laboratory Director) failed to evaluate the competency of all TP who performed Chemistry and Hematology testing from 2016 and 2017. Findings Include: 1. On the date of survey, 03/22/2018, review of TP's annual CA revealed that testing personnel who performed Chemistry and Hematology testing were not evaluated in 2016 and 2017. A. The 2016 CA records reviewed cover proficiency testing only, they did not cover the other 5 of 6 points in CLIA's Brochure #10 "What Do I Need to Do to Assess Personnel Competency", for each Hematology and Chemistry test performed by 5 of 5 TP. B. The 2017 CA records did not separate and review the 6 points of CLIA's Brochure #10 for each Hematology and Chemistry test performed by 5 of 5 TP. 2. Roughly 500,000 Hematology and Chemistry specimen were tested in 2016 3. About 522,004 Hematology and Chemistry specimen were tested in were tested in 2017. 4. The GS confirmed findings above on 03/22/2018 around 10:30 am. 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 --