Denville Pediatrics

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with the Office Manager (OM), the laboratory failed to document and retain all QC information used for Bacteriology tests from 8/2/23 to 3/12/25. The finding includes: 1. There were no lot numbers or expiration dates documented or retained for the QC organisms used for performing QC on Uricult lots 1914389 and 1923617. 2. The OM confirmed on 3/12/25 at 10:45 am, all QC information was not retained. 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 surveyor review of the Procedure Manual (PM) and interview with the Office Manager (OM), the laboratory failed to establish

Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) and interview with the Laboratory Director (LD), the laboratory failed to correct problems in the postanalytic system from 6/9/16 to the date of the survey. The finding includes: 1. A review of the FR revealed that the laboratory reported patient results in the Reference Range column. 2. The FR revealed that the laboratory reported two results for urine culture tests. 3. The LD confirmed on 6/26/18 at 12:45 pm that the laboratory did not correct problems in the FR. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --