Riverdale Park Pediatrics Pc

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the technical consultant (TC), the laboratory failed to ensure that a copy of all PT documents was maintained by the laboratory for a minimum of two years from the date of the PT testing event. Findings: 1. A review of hematology PT records from five PT events from 2023 through 2025 showed that the evaluation reports which show the laboratory ' s PT scores were not available at the time of the survey for the third PT event of 2023 ("Nonchemistry M3 2023") and the third PT event of 2024 ("Nonchemistry M3 2024"). 2. The TC was not able to locate the missing documents at the time of the survey, therefore there was no documentation that PT scores had been reviewed and evaluated for errors by the laboratory director or their designee. 3. During an interview on 05/08/2025 at 11:15 AM, the TC confirmed that the laboratory did not maintain all PT documents for a minimum of two years from the date of the PT testing event. D5785

Summary Statement of Deficiencies D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Based on review of the competency check records for Testing Person #3, #4 and #5 along with interview, the technical consultant did not have records for 2022 showing that each was observed during routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing to check annual competency. This was confirmed during interview with the technical consultant the afternoon of the survey. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of the competency check records for Testing Person #3, #4 and #5 along with interview, the technical consultant did not have records for 2022 showing that each had reviews of quality control records, and preventive maintenance records to check annual competency. This was confirmed during interview with the technical consultant the afternoon of the survey. 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 -- D6050 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iv) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observation of performance of instrument maintenance and function checks. This STANDARD is not met as evidenced by: Based on review of the competency check records for Testing Person #3, #4 and #5 along with interview, the technical consultant did not have records for 2022 showing that each had direct observation of performance of instrument maintenance and function checks. to check annual competency. This was confirmed during interview with the technical consultant the afternoon of the survey. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on quality control (QC) record review, observation, and interview with the technical consultant (TC), the laboratory failed to ensure that hematology QC was not used after it exceeded its expiration date. Findings: 1. The laboratory uses the "Minotrol-16 Hematology Reference Control" to run QC on their Horiba ABX Micros 60 hematology analyzer. During a tour of the laboratory at 9:15 AM, it was observed that the in-use hematology QC, lot # MX416, expiration date 5/5/19 was not labeled with the date the control was opened. 2. During an interview, the TC and testing person #1 stated that the opened QC was "good until the expiration date on the box"; and 3. A review of the package insert that came with the QC showed that under "stability and storage," "opened tubes are stable for 16 days provided they are handled properly." 4. During an interview on 4/24/19 at 12:00 PM, the TC confirmed that hematology QC was run using controls which had expired. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for 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 -- the laboratory's patient population. This STANDARD is not met as evidenced by: Based on hematology analyzer validation record review and interview with the technical consultant (TC), the laboratory did not ensure that the comparison study between the old and new hematology analyzer was evaluated for acceptability before using the new instrument. Findings: 1. The laboratory began using a Horiba ABX Micros 60 hematology analyzer in May, 2018. A comparison study was performed on 5/1/18 by running 30 specimens on the old and new hematology analyzer. 2. A review of the comparison study showed that the results were not evaluated for acceptability by the laboratory director before the analyzer was put in to use. 3. During an interview on 4/24/19 at 12:00 PM, the TC confirmed that the comparison study between the old and new hematology analyzer was incomplete at the time of the survey. -- 2 of 2 --