Abc Pediatrics Pc

Summary Statement of Deficiencies D0000 Based on an Initial CLIA Survey performed on January 31, 2018 this facility was found to be non- compliant with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. 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 review of proficiency test (PT) records and interview with the laboratory director (LD) , the LD failed to attest that PT samples were tested in the same manner as patient specimens. Findings include: 1. Review of the 2017 PT attestation statements revealed the LD did not sign the events of A & C. 2. Interview with the LD on 1/31/18 at approximately 330 PM in the back office, confirmed she did not sign the attestation forms mentioned. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the procedure manual (SOP), lab documents, and an interview 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 -- with the lab director (LD), the lab failed to establish and follow a written quality assurance (QA) plan to encompass and asses pre-analytical, analytical, and post analytical systems. Findings include: 1. Review of the SOP revealed no written QA plan to ensure quality patient results. 1. Review of the laboratory's records revealed no documentation of how the lab monitors, assesses, or when indicated, correct problems identified. 2. Interview with the LD on January 31, 2018 at 3:30 PM in the back office confirmed the laboratory did not have or follow a written QA plan. 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 calibration document review and staff interview, the lab failed to calibrate the Cell-Dyn Emerald analyzer every six (6) months as required by the manufacturer. Findings include: 1. Review of calibration data revealed the Emerald was calibrated March 2016, October 2016 (a seven (7) month span); March 2017 (a 5 month span); and November 2017 (a 8 month span). 2. Interview with testing personnel #3 (CMS 209 form) on 1/31/18 at approximately 3 PM in the back office, confirmed the time spans. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on January 2, 2018. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecutive events (2nd and 3rd events of 2017), resulting in 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 -- first unsuccessful occurrence for # 775, red blood cell count (RBC). Findings include: Refer to D 2130 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. This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports from the American Academy of Family Physicians (AAFP), the laboratory failed to maintain satisfactory performance in two consecutive events (2nd and 3rd events of 2017), resulting in the first unsuccessful occurrence for # 775 red blood cell count (RBC). Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #775 RBC on event 2 of 2017 with a score of 60% and & event 3 of 2017 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports from AAFP confirmed the laboratory failed RBC on events 2 and 3 of 2017 resulting in the first unsuccessful performance.. -- 2 of 2 --