Hartford Healthcare Cancer Institute At

Summary Statement of Deficiencies D5781

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 review of the proficiency testing (PT) data report (Casper Report 155 D) and PT graded results from American Association of Bioanalysts (AAB), the laboratory failed to successfully participate for the regulated analyte hematocrit. The laboratory had unsatisfactory scores for the 3rd event of 2020 and the first event of 2021. Refer to D2130 D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review of the Casper Report 155 D, CMS Cumulative Scores- Regulated Analytes proficiency testing (PT) scores from American Association of Bioanalysts (AAB), laboratory's investigation/

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have a policy in place to assess the competency based on position responsibilities for laboratory personnel in the specialty of hematology. Findings include: 1. Review of the laboratory's competency records on 5/23/19 revealed the following: a. The laboratory did not have policy in place to assess the competency based on position responsibilities for the technical consultant and clinical consultant. b. Competency documentation for the above laboratory personnel was not available for 2017 and 2018. 2. Staff interview with the laboratory supervisor on 5/23/19 at 11:30 AM confirmed the above findings. 3. the laboratory performs 6,787 complete blood count tests annually. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for 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 2 -- system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to perform calibration on the hematology analyzer at the required frequency. Findings include: 1. Record review of the calibration records on 5/23/19 revealed the following: a. Abbott Diagnostics Emerald Analyzer was calibrated on: 5/2/17, 9/26/17, 12/7/17, 2/23/18, 4 /19/18 and 4/19/19. b. Records of semi-annual calibration was not available for the period of April 2018 to April 2019. 2. Staff interview with the laboratory supervisor on 5/23/19 at 11:00 AM confirmed the semi-annual calibrations were not performed in a timely manner for the above indicated period. 3. The laboratory performs 6,787 complete blood count tests annually. 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 staff interview, the laboratory failed to evaluate testing personnel to ensure competency to perform and report accurate test results in the specialty of hematology. Findings include: 1. Record review of testing personnel (TP) competency records on 5/23/19 revealed 1 of 5 TP performing complete blood count (CBC's) was not evaluated in 2017 to assess their competency for all six required competency assessment criteria. 2. Staff interview with the laboratory supervisor 5/23 /19 at 10:00 AM confirmed the findings above. 3. The laboratory performs 6,787 CBC tests annually. -- 2 of 2 --