Katherine W Jones Md Plc

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: The laboratory failed to maintain satisfactory proficiency testing (PT) performance in two out of three testing events for the Red Blood Cell (RBC) analyte resulting in the 1st unsuccessful PT occurrence for the RBC analyte in 2020. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. 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 Centers for Medicare and Medicaid Services Casper report 155 (CMS 155) and American Proficiency Institute (API) evaluation reports, the laboratory failed to achieve satisfactory performance for Red Blood Cell (RBC) analyte in two out of three testing event resulting in the 1st unsuccessful PT performance in 2020. The findings include: 1. 1) Review of the CMS 155 revealed the following scores for the RBC analyte: 2019 Event three = 60% 2020 Event two = 60% 2. Review of the laboratory's API evaluation report revealed the RBC analyte with a score of 60% for the 3rd event 2019, and a score of 60% for the 2nd event in 2020. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of Proficiency Test attestation records for Hematology Complete Blood Count testing (CBC) and an interview with the lead testing person the Technical Consultant failed to ensure proficiency testing samples are performed by personnel who routinely perform CBC testing in 2018. The Findings include: 1. Review of the proficiency testing attestation records revealed the Technical Consultant failed to ensure proficiency testing samples are performed by personnel who routinely perform CBC testing in 2018. 2. Interview with the lead testing person on February 7, 2019 at 12:30 confirmed the Technical Consultant failed to ensure proficiency testing samples are performed by personnel who routinely perform CBC testing in 2018. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test 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 -- system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of Proficiency Test records for Hematology Complete Blood Count testing (CBC) and an interview with the lead testing person the Technical Consultant (TC) failed to ensure the laboratory retain a copy of proficiency testing records for the 3rd event 2017; signed attestation statements for the 2nd event 2017 and 1st event 2018 and signed Performance Evaluations for 2nd event 2017 and the 2nd and 3rd event 2018. The findings include: 1. Review of the proficiency testing records revealed the Technical Consultant failed to maintain copies of proficiency testing records for the 3rd event in 2017; have signed attestation statements for the 2nd event 2017 and 1st event 2018 and failed to sign the performance evaluations for the 2nd event 2017 and 2nd and 3 event 2018. 2. Interview with the lead testing person on February 7, 2019 at 12:30 confirmed the Technical Consultant failed to maintain copies of proficiency testing records for the 3rd event in 2017; signed attestation statements for the 2nd event 2017 and 1st event 2018 and signed performance evaluations for the 2nd event 2017 and 2nd and 3 event 2018. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on lack of record review of analyzer verification performance specifications for the Horiba Complete Blood Count (CBC) Analyzer and interview with the lead testing person the laboratory failed to verify the performance specifications after relocation of the CBC analyzer in August 2017. The Findings include: 1. Lack of record review of analyzer verification performance specifications for the Horiba CBC Analyzer revealed the laboratory failed to verify the performance specifications after relocation of the CBC analyzer in August 2017. 2. Interview with the lead testing person on February 7, 2019 at 12:45 confirmed the laboratory failed to verify the performance specifications after relocation of the CBC analyzer in August 2017. 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 testing personnel Semi-Annual and Annual competency -- 2 of 3 -- evaluations forms and interview with the lead testing person the Technical Consultant (TC) failed to evaluate 3 or 4 testing personnel annual competencies for Hematology Complete Blood Count (CBC) test in 2018. The Findings include: 1. A review of the testing personnel Semi-annual and Annual competency evaluation forms for Hematology CBC testing revealed the Technical Consultant failed to perform 3 of 4 testing personnel annual competency evaluations in 2018. 2. Interview with the lead testing person on February 7, 2019 at 12:40 confirmed the Technical Consultant failed to perform 3 of 4 testing personnel's annual competency evaluations for Hematology CBC testing in 2018. D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of testing personnel Semi-Annual and Annual Competency evaluations forms and interview with the lead testing person the Technical Consultant (TC) failed to evaluate 4 or 4 testing personnel semi-annual competencies for Hematology Complete Blood Count (CBC) test in 2018. The Findings include: 1. A review of the testing personnel Semi-Annual and Annual Competency evaluations forms for Hematology CBC testing revealed the Technical Consultant failed to perform 4 of 4 testing personnel semi-annual competency evaluations in 2018. 2. Interview with the lead testing person on February 7, 2019 at 12:45 confirmed the Technical Consultant failed to perform 4 of 4 testing personnel's semi-annual competency evaluations for Hematology CBC testing in 2018. -- 3 of 3 --