Valley Pediatric Associates

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor review of the Temperature Logs (TL) and interview with Testing Personnel (TP), the laboratory failed to have ad defined range for the Incubator on the TL from 10/26/23 to 3/18/25. The finding includes: 1. There was no defined range for the incubator on the TL logs. 2. The TL did not state if the temperature was recorded in degrees Fahrenheit or degrees Celsius. 3. The TP #1 as stated on the CMS 209 form confirmed on 3/18/25 at 11:00 am, the TL did not have a defined range or state if recorded in degrees Fahrenheit or Celsius. Note: This deficiency was previously cited on the survey performed on 10/25/23. D5801 TEST REPORT CFR(s): 493.1291(a) (a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to 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 -- network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on surveyor review of the Electronic Medical Records (EMR), Manual Accession Log (MAL) and interview with the Testing Personnel (TP), the laboratory failed to ensure that laboratory results are accurately and reliably transcribed into the EMR for Urine Colony Count (UCC) tests from 9/20/24 to 3/18/25. The findings include: 1. Specimen identification number 2347 had a final read time for UCC stated as 9/20/24 at 2:00pm on the MAL, but The EMR report stated the final result date and time was 9/20/24 at 10:24 am. 2. Specimen identification number 41163 had a final read time for UCC stated as 9/27/24 at 5:00pm on the MAL, but The EMR report stated the final result date and time was 9/27/24 at 10:07 am. 3. TP # 1 as listed on CMS form 209, confirmed on 3/18/25 at 11:40 am, the laboratory failed to ensure that laboratory results were accurately and reliably transcribed into the EMR. -- 2 of 2 --

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on Surveyor observation of COVID test results and interview with the Office Manager (OM) the laboratory failed to report COVID test results to the state of New Jersey (NJ) under the NJ requirements for a NJ State Clinical Laboratory License (NJCLL) under New Jersey Statutes Annotated: N.J.A.C. 8:44-2.11(a) Reporting by laboratory supervisors in the calendar year 2023.. The finding includes: 1. There was no documented evidence that the laboratory reported positive and negative COVID test results run on the Cepheid genexpert to the State of NJ. 2. The OM confirmed on 10/25/23 the laboratory was not following the state statute. . D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor review of the Temperature Logs (TL) and interview with 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 -- Office Manger (OM), the laboratory failed to define a range for the Incubator on the TL from 8/03/21 to the date of the survey. The OM confirmed on 10/25/23 at 11:30 am that a temperature range wasn't defined. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files (PF) and interview with the Office Manager (OM), the Laboratory Director (LD) failed to have appropriate education and training documentation on all TP performing laboratory testing on the date of survey. The findings include: 1. The laboratory did not have education records for five out of ten TP listed on the CMS form 209. 2. The OM confirmed on 10/25/23 at 10:40 pm the laboratory did not have education records on all TP. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to ensure that all Testing Personnel (TP) who perform Bacteriology Tests participated in the College of American Pathologist (CAP) PT events in the calendar years 2017 and 2018. The finding includes: 1. A review of the PT attestation forms revealed 2017 PT was performed by a TP no longer employed there and 2018 PT was performed by TP #3 listed on the CMS form 209. 2. The TP #1 listed on CMS 209 confirmed on 1/24/19 at 10:30 am that PT events were not rotated amongst TP. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the Competency Assessment (CA) records and interview with the Testing Personnel (TP), the laboratory failed to perform CA correctly on five of five TP from 12/3/17 to the date of survey. The finding includes: 1. A review of CA revealed all CA procedures were used to assess each task listed on the CA. a. 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 -- Example: Assessment of test performance (PT/Blind samples) and Direct Observation of Instrument Maintenance were used to assess: i. Swabbing and plating of patients throat culture ii. Perform and repeat of rapid strep iii. Patient instruction on obtaining midstream iv. Performance of routine urine culture and reporting results v. Performance of routine throat culture and reporting results vi. Proper instruction in blood collection and testing procedure to perform hemoglobin and lead level vii. Performance and documentation of taxo disc testing 2. The TP #1 listed on CMS 209 confirmed on 1/24/19 at 10:25 am that CA was not done correctly. 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 Manufacturer's Package Insert (MPI), Test Reports (TR), and interview with the Testing Personnel(TP), the laboratory failed to follow the Uricult manufacturer's instruction for reading Urine Cultures from 2/3/17 to the date of survey. The finding includes: 1. The laboratory reported the results as Positive and Negative but the MPI interpretation was: a. Normal - Less than 10,000 CFU/ml urine. b. Doubtful - 10,000 - 100,000 CFU/ml urine. c. Positive - Greater than 100,000 CFU /ml urine. 2. The TP #1 listed on CMS 209 confirmed on 1/24/19 at 1:00 pm that the laboratory did not follow the MPI. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on the surveyor review of the Final Reports (FR) and interview with the Testing Personnel (TP), the laboratory failed to have a Reference Range (RR) for Throat Culture tests and Urine Colony counts on the FR from 2/3/17 to the date of the survey. The TP #1 listed on CMS 209 confirmed on 1/24/19 at 12:20 pm that the above tests did not have a RR on the FR. 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 Procedure Manual and interview with the Testing -- 2 of 3 -- Personnel (TP), the laboratory failed to have a procedure to verify manually entered Throat Culture and Urine Colony Count (UCC) results entered into the Patient's Medical Record for accuracy from 2/3/17 to the date of the survey. The TP #1 listed on CMS 209 confirmed on 1/24/19 at 12:15 pm that the laboratory did not have the procedure mentioned above. -- 3 of 3 --