New Jersey Pediatric And Adolescent Care Llc

Summary Statement of Deficiencies D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) (b)(3) Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed; This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control Verification Records (QCVR), Procedure Manual (PM) and interview with Laboratory Director (LD), the TP failed to adhere to the Quality Control (QC) policies for the Horiba analyzer used for Hematology testing from 10/25/25 to 10/29/25. The findings include: 1. The "Quality Control New Lot Verification" stated "Perform this verification before you run out of the current control lot number." 2. The laboratory verified the new QC lot #5265 on 10 /26/25 after the previous lot #5209 of QC material expired on 10/25/25. 3. The LD confirmed on 10/29/25 at 11:00 am, TP failed to adhere to the QC policies. 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 --

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Laboratory Director (LD), the laboratory failed to document the evaluation of all incorrect scores and

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. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to retain all QC records for tests performed on the Horiba ABX Micros 60 from January 11/12/19 to the date of survey. The finding includes: 1. All hematology QC that was repeated due to a failed QC run were not retained. 2. The TP # 1 listed on the CMS form 209 confirmed on 2/1/22 at 11:00 am that the all QC records were not retained. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to follow their procedure for "Monthly Quality Control Review" (MQCR)log from 11/12/19 to the date of survey. 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 3 -- finding include: 1. There was no documented evidence that the MQCR log was completed. 2. The The TP#1 listed on CMS from 209 confirmed on 2/1/22 at 10:21 am the MQCR log was not being completed. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of the Operators Manual (OM), and interview with the Testing Personnel (TP), the laboratory failed to follow the OM for "2. Calibration", "2.1.1. Preliminaries" procedures from 11/12/19 to the date of survey. The findings include: 1. The OM stated as follows: 1- Carry out a Concentrated cleaning procedure (See Section 6, 1.3.6. Concentrated Cleaning, page 6-11). 2- Perform two blank cycles to check the cleanliness of the instrument. 3- Check the repeatability of the instrument by running a fresh normal whole blood sample 11 times with no alarms. Discard the first result and calculate the CV on the remaining 10 runs. 4- Check that the CV calculated using the remaining 10 runs meets or exceeds the specifications in "3.2. Precision Claims*, page 9" 2. There was no documented evidence that the above mentioned procedures were performed. 3. The TP#1 listed on CMS from 209 confirmed on 2/1/2021 at 10:32 am that the laboratory did not follow the OM. D5783