Oncology Specialties, Pc

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: Based on a review of the CMS CASPER Reports (#153/#155) and a review of MLE (Medical Laboratory Evaluation) proficiency testing records, the surveyor determined the laboratory scored sixty percent (60 %) for Chloride for Chemistry Events #2 and #3 of 2019, two consecutive testing events. These two consecutive failures resulted in the laboratory's unsuccessful participation in proficiency testing. The finding include: 1. A review of the CMS CASPER Reports revealed the laboratory was not successful in proficiency testing participation for Chloride testing for Events #2 and #3 of 2019, two consecutive testing events. The laboratory scored 60 % for Chloride for the two consecutive events, resulting in an initial unsuccessful participation for the laboratory. 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 -- 2. The surveyor's review of the MLE proficiency testing records confirmed the sixty percent scores for Chloride as mentioned in paragraph 1. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CMS CASPER Reports (#153/#155) and a review of MLE (Medical Laboratory Evaluation) proficiency testing records, the surveyor determined the laboratory failed to perform satisfactorily in proficiency testing of Chloride for Chemistry Events #2 and #3 of 2019, two consecutive testing events. These two consecutive failures resulted in the laboratory's unsuccessful participation in proficiency testing. The findings include: Refer to D2016. -- 2 of 2 --

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on reviews of the Horiba ABx 60C+ calibration procedure, calibration and quality control (QC) records, patient results in the Electronic Medical Record (EMR), and an interview with the Technical Consultant (also the Laboratory Manager), the surveyor determined the laboratory failed to follow the laboratory procedure to verify calibrations by running quality controls (QC) before patient CBC (Complete Blood Count) testing resumed, for one out of four calibrations of the Hematology analyzer performed in 2017 - 2018. The findings include: 1. A review of calibration records for the Horiba ABx 60C+ revealed the instrument was calibrated on 11/2/2017 at 12:12 PM. A review of Hematology records for this date revealed QC was performed only in the early morning. 2. During an interview on 5/30/2019 at 9:00 AM, the surveyor and the Technical Consultant reviewed the Horiba ABx 60C+ calibration procedure which required performance of three levels of QC to verify the calibration. The Technical Consultant confirmed the testing personnel had failed to run QC after the calibration, as per procedure. 3. As the interview continued, the surveyor then asked if patient CBC's were performed after the calibration on 11/2/2017. The Consultant 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 -- reviewed patients in the Onco EMR, and stated eleven CBC's were performed after completion of the calibration. Thus the above noted findings were confirmed. SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 2 of 2 --