Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and an interview with Testing Personnel (TP) #1, the laboratory failed to have a qualified Technical Consultant (TC) attest to the routine integration of the proficiency testing samples into the patient workload using the laboratory's routine methods in 2018 and 2019. All patients tested in the specialties of hematology and chemistry, and the subspecialty of urinalysis had the potential to be affected by this deficient practice. Findings Include: 1. Review of the CMS-209 'Personnel Report Form' found the Laboratory Director (LD) listed as performing the duties of the TC. 2. Review of the 'Lab Policy and Procedure Manual' found a 'Proficiency Testing Authorization' which stated the following: "I [Laboratory Director] give [TP #1] authorization to be the Designee signature, on all proficiency testing result forms. She is to attest to the routine integration of the proficiency samples into the patient work load using the lab's routine methods and equipment." 3. Review of proficiency testing documentation found that TP #1 attested for all proficiency testing events in 2018 and 2019 via signature and date. "API Attestation Statement Lab Director (or designee): [TP #1] 2-8-18 Lab Director (or designee): [TP #1] 3-30-18 Lab Director (or designee): [TP #1] 9-13-19 Lab Director (or designee): [TP #1] 10-20-19 Lab Director (or designee): [TP #1] 11-7-19 Lab Director (or designee): [TP #1] 12-1-19" 4. An interview with TP #1, on 12/30/19 at 1:36 pm, confirmed that TP #1 failed to meet the education requirements of the TC with an Associate's degree, but attested, by signature and date, to the routine integration of the samples into the patient workload using the laboratory's routine methods. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on record review and an interview with Testing Personnel (TP) #1, the laboratory failed to have a Technical Consultant (TC) who met the qualification requirements of 493.1411 of this subpart and who provided technical oversight of moderately complex testing in the specialities of hematology and chemistry and the subspecialty of urinalysis performed in accordance with 493.1413 of this subpart. All patients tested at this lab had the potential to be affected by this deficient practice. Findings Include: 1. The laboratory failed to have a qualified TC evaluate and document the annual competency assessment of TP #2, TP #3, and TP #4 who were responsible for moderately complex hematology, chemistry and urinalysis testing procedures. (Refer to D6046) 2. The laboratory failed to have a qualified TC review quality control records, and maintenance records. (Refer to D6049) 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 record review and an interview with Testing Personnel (TP) #1, the laboratory failed to have a qualified Technical Consultant (TC) evaluate and document the annual competency assessment of TP #2, TP #3 and TP #4, who were responsible for moderately complex hematology, chemistry and urinalysis testing procedures. All patients tested in the specialties of hematology and chemistry, and the subspecialty of urinalysis had the potential to be affected by this deficient practice. Findings Include: 1. Review of the CMS-209 'Personnel Report Form' found the Laboratory Director (LD) listed as performing the duties of the TC. 2. Review of the 'Technical Consultant' job description found the following statements: "...Evaluates the competency of all testing personnel on an ongoing basis..." "Personnel Requirements: ...Bachelor's degree in laboratory science and 2 years lab training or experience in the non-waived speciality/subspecialty of service..." 3. Review of competency assessment documentation from 2018 and 2019 found that TP #1 assessed TP #2, TP #3, and TP #4 for competency. TP #3 assessed by TP #1 on 6-2- 18 TP #3 assessed by TP #1 on 9-13-18 TP #2 assessed by TP #1 on 12-9-18 TP #4 assessed by TP #1 on 10-9-19 4. An interview with TP #1, on 12/30/19 at 1:36 pm, confirmed that they failed to meet the education requirements of the TC with an Associate's degree, but assessed TP #2, TP #3 and TP #4 for competency; thus, TP #1 was not qualified to perform duties of the TC. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) -- 2 of 3 -- The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on record review and an interview with Testing Personnel (TP) #1, the laboratory failed to have a qualified Technical Consultant (TC) review quality control and preventative maintenance records in 2018 and 2019. All patients tested in the specialties of hematology and chemistry, and the subspecialty of urinalysis had the potential to be affected by this deficient practice. Findings Include: 1. Review of the CMS-209 'Personnel Report Form' found the Laboratory Director (LD) listed as performing the duties of the TC. 2. Review of laboratory records found that TP #1 reviewed quality control documentation and preventative maintenance records in 2018 and 2019 via signature and date. "Jan 2018 Horiba ...Maintenance" reviewed by TP #1 on 2-1-18 "Jan 2018 Sysmex CA560...Maintenance" reviewed by TP #1 on 2-1-18 "Jan 2018 Sysmex XS-1000 Maintenance Log" reviewed by TP #1 on 2-1-18 "Jan 2018 Urinalysis...Log" reviewed by TP #1 on 2-1-18 "Nov 2019 Horiba ... Maintenance" reviewed by TP #1 on 12-9-19 "Nov 2019 Sysmex CA560... Maintenance" reviewed by TP #1 on 12-9-19 "Nov 2019 Sysmex XS-1000 Maintenance Log" reviewed by TP #1 on 12-9-19 "Nov 2019 Urinalysis...Log" reviewed by TP #1 on 12-9-19 3. An interview with TP #1, on 12/30/19 at 1:36 pm, confirmed that TP #1 failed to meet the education requirements of the TC with an Associate's degree, but reviewed quality control records and preventative maintenance records; thus, TP #1 was not qualified to perform duties of the TC. -- 3 of 3 --