Dawson Pediatrics Pc

Summary Statement of Deficiencies D0000 A recertification survey was performed on February 04, 2025. The facility was found to be NOT in compliance with the CLIA conditions and standards for specialties /subspecialties for 42 CFR. D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director NOTE: The CMS-2567 (Statement of Deficiencies) is an official , legal document,. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 3, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on September ,05 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on surveyor review of laboratory records and an interview with the clinic's laboratory coordinator (TP #1 CMS 209) and laboratory director , the laboratory failed to enroll in a CMS approved Proficiency Testing (PT) program for the speciality of Microbiology (Throat cultures). Findings include: 1.) A review of laboratory documents revealed that there was no enrollment in a CMS approved proficiency testing program for the years of 2017 and 2018 for the speciality of Microbiology (Throat cultures). 2.) An interview with the Clinic's laboratory coordinator (TP # 1, CMS 209) and the laboratory director at approximately 11:30 am, on September 05, 2018 in the review room confirmed that the laboratory was not enrolled in a CMS approved PT program 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 -- D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on maintenance document review, observation, and interview with the laboratory coordinator (TP # 1 CMS 209), the laboratory failed to perform and document maintenance as defined by the manufacturer. Findings include: 1. Upon initial tour of the laboratory, it was observed the Horizon centrifuge was last calibrated 11/10/2016. Next due date was suppose to be 11/10/2017. 2. An interview with TP #1 (CMS 209) at approximately 11:40 a.m. on September 05, 2018 in the breakroom confirmed that Horizon centrifuge calibrations was not performed nor documented on 11/10/2017. -- 2 of 2 --