Summary:
Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. 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 review of the laboratory policy, personnel records for 2016 through 2018, and verified by interview, the Technical Consultant, who is also the lab director, failed to perform the competency evaluations for 2 of 7 testing personnel (TP) for the Horiba ABX hematology analyzer. (TP #2, TP#6) Findings were: 1. Review of the laboratory policy Laboratory Quality Assurance TCP Policy approved by the lab director on 7/10 /17 revealed under Personnel "each new employee who will be performing laboratory tests will be trained and observed prior to performing patient testing. Competency will be documented upon hire, at 6 months and then annually." 2. A review of the facility's personnel files revealed 1 of 7 testing personnel (TP #2, hire date 7/5/2000) had documentation of an annual 2017 competency assessment performed by TP# 7 on 07 /17/17, who did not meet the requirements as a technical consultant. Testing person #7 has a high school diploma. 3. A review of the facility's personnel files revealed 1 of 7 testing personnel (TP #6, hire date 09/18/17) had documentation of an initial competency assessment performed by TP# 1 on 11/13/17, who did not meet the requirements as a technical consultant. Testing person #1 has a high school diploma. 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 -- 4. An interview with the Quality assurance representative on 05/24/18 at 1025 hours in the break room confirmed the above findings. She acknowledged that both TP#2 and TP#6 both performed patient testing. She also stated that TP#7 and TP#1 should have only been doing the competency for waived testing. She was unaware they were doing the non-waived competencies also. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of the laboratory policy, personnel records for 2016 through 2018, and verified by interview, the Technical Consultant, who is also the lab director, failed to perform the 2017 annual competency evaluations for 3 of 7 testing personnel (TP) for the Horiba ABX hematology analyzer. (TP#1, TP# 3, TP#4) Findings were: 1. Review of the laboratory policy Laboratory Quality Assurance TCP Policy approved by the lab director on 7/10/17 revealed under Personnel "each new employee who will be performing laboratory tests will be trained and observed prior to performing patient testing. Competency will be documented upon hire, at 6 months and then annually." 2. A review of the facility's personnel files revealed 3 of 7 testing personnel (TP#1, TP# 3, TP#4) had no documentation of an annual 2017 competency assessment. TP#1 hire date 7/5/2000 TP#3 hire date 10/2015 TP#4 hire date 09/2016 2. An interview with the Quality assurance coordinator on 05/24/18 at 1025 hours in the break room confirmed the above findings. She acknowledged that TP#1, TP# 3, TP#4 all performed patient testing and that the technical consultant should have performed the competencies. -- 2 of 2 --