Fayetteville Children's Clinic, Pa

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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 API (American Proficiency Institute) proficiency testing results 2/12/20, the laboratory failed to successfully participate in proficiency testing for RBC (red blood cell count) in two consecutive testing events. See the deficiency cited at 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 2 -- 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 API (American Proficiency Institute) proficiency testing results 2/12/20, the laboratory failed to successfully participate in proficiency testing for RBC (red blood cell count) in two consecutive testing events. Findings: 1. Desk review of CMS Casper report 155D and 2019 API proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for RBC on the 2019 Hematology 2nd event. 2. Desk review of CMS Casper report 155D and 2019 API proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for RBC on the 2019 Hematology 3rd event. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 API (American Proficiency Institute) proficiency testing results 2/12/20, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. See the deficiency cited at D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 API (American Proficiency Institute) proficiency testing results 2/12/20, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. Desk review of CMS Casper report 155D and 2019 API proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for RBC on the 2019 Hematology 2nd event. 2. Desk review of CMS Casper report 155D and 2019 API proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for RBC on the 2019 Hematology 3rd event. -- 2 of 2 --

Summary Statement of Deficiencies 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 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 review of manufacturer's instructions, review of laboratory calibration records and technical consultant (TC) (laboratory director) interview 10/30/2018, the laboratory failed to accurately perform 6 month calibrations on the Coulter Act Diff 2 hematology analyzer since 01/28/17, a period of approximately 2 years. Review of manufacturer's instructions for calibration of the Coulter Act Diff 2 hematology analyzer revealed on page 5-17 the following: "IF NEEDED appears for any of the 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 -- parameters, calibration adjustments are required. Touch the Save and Exit icon to automatically replace the NEEDED calibration factor with the new calibration factor. This automatically updates the instrument's calibration parameters." Review of laboratory calibration records for the Coulter Act Diff 2 hematology analyzer revealed the laboratory failed to replace "NEEDED" calibration factors with the new calibration factors for following calibrations: 1. Calibration performed on 01/28/17 revealed the Hemoglobin (HGB) parameter needed a calibration adjustment. The calibration adjustment of the HGB parameter was not performed. 2. Calibration performed on 07/12/17 revealed the HGB and Platelet (PLT) parameters needed calibration adjustments. The calibration adjustments of the HGB and PLT parameters were not performed. 3. Calibration performed on 01/17/18 revealed the HGB and PLT parameters needed calibration adjustments. The calibrations adjustments of the HGB and PLT parameters were not performed. 4. Calibration performed on 07/09/18 revealed the White Blood Count (WBC), Red Blood Count (RBC), HGB, Mean Cell Volume (MCV) and PLT parameters needed calibration adjustments. The calibration adjustments of the WBC, RBC, HGB, MCV, and PLT parameters were not performed. Interview with TC (laboratory director) at approximately 2:00 p.m. confirmed the calibration adjustments were not performed. She stated she was unaware that the calibration adjustments had not been updated after performing the calibrations on the Coulter Act Diff 2 analyzer. D6098 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(8) The laboratory director must ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Review of random patient test reports and technical consultant (TC) (laboratory director) interview 10/30/18 revealed patient test reports generated from the laboratory's computer system, Eclinical, failed to include reference ranges needed for test result interpretation. The laboratory scans test reports for Complete Blood Count (CBC) directly into the patient's chart. The test report for CBC includes reference ranges for test result interpretation. The laboratory enters waived testing results and urine culture results manually into the laboratory's computer system, Eclinical. Review of random patient test report for urine culture; Patient DOB 10/25/12, dated 10 /30/18, revealed the report contained no reference range for urine culture testing. In addition, random patient test report for waived testing "Rapid Strep; Patient DOB 02 /20/09, dated 10/30/18, revealed the report contained no reference range for "Rapid Strep" testing. Interview with TC (laboratory director) at approximately 2:00 p.m. confirmed the patient test reports generated from the laboratory's computer system, Eclinical, failed to include reference ranges for the testing performed. She stated it was a very difficult to get the customer support they needed to address problems the laboratory has with the Eclinical computer system. . -- 2 of 2 --