Ridgefield Pediatric Associates

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 record review and staff interview the laboratory failed to follow their established Quality Control (QC) procedure to verify the new lot of controls upon receipt in the specialty of Hematology. Findings include: 1. Record review on 10/22 /2025 of the laboratory's "Hematology Quality Control for Beckman Coulter DxH520" procedure revealed "When receiving new set of controls, run each level of controls 5x to confirm they are running properly. Do not discard the old set (keep in use) for at least 24 hours, in case of any issues with the new set." 2. Record review on 10/22/2025 of the "Beckman Coulter cell check" QC package insert revealed the following: a. Three levels of quality controls, 'Abnormal Low, Normal and Abnormal High' are in use. b. Current lot in use are: 352517711/362517712/372517713 with an expiration date of 2025-12-05. 3. Record review on 10/22/2025 of the laboratory's "IQAP Cell Control Daily Data" revealed lack of documentation of controls are run 5x to confirm the new QC lot verification as follows: a. Control/Level: DxH 5Diff/ Abnormal Low/ Normal/ Abnormal High with lot numbers: 352517711/362517712 /372517713 respectively. b. Start date for the current QC lot documented as 10/10 /2025. c. Only One data point for all three levels of controls on 10/10/2025. 4. Staff interview on 10/22/2025 at 12:30 PM with Testing Personnel #1 confirmed the laboratory failed to perform the new QC lot verification 5x run as established in their policy. 5. The laboratory performs 93 complete blood count tests annually in the specialty of hematology. 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 -- D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D0000 A proficiency testing desk review of the Ridgefield Pediatrics Associates Laboratory was conducted pursuant to 42CFR Part 493 of the Clinical Laboratory Improvement Amendments (CLIA) of 1998. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on record review of the proficiency testing (PT) data report (Casper 155) and graded results from College of American Pathologist (CAP), the laboratory failed to perform PT successfully for the regulated analytes: hematology, red blood cells and hematocrit for 2025. The laboratory had unsatisfactory scores for both Event 1 and Event 2. Refer to D2130 and D2131. 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to achieve satisfactory performance for the hematology, red blood cells (RBC), and hematocrit (HCT) analytes for two consecutive Events 1 and 2 for 2025 in the specialty of Hematology. Findings include: 1. Record review on 7/11/2025 of the Proficiency Testing (PT) data report (Casper 155) revealed the laboratory failed to achieve successful scores for 2025 as follows: Analyte Event #1(score) Event # 2(score) 0760 Hematology 76 73 0775 RBC 60 20 0785 HCT 60 40 2. Record review on 7/11/2025 of the College of American Pathologist (CAP) "FH16-A 2025 Hematology Auto Differentials, FH16" Event #1, PT evaluation report revealed unsuccessful score for the following analytes: a. Hematology analyte: 76%. b. RBC analyte: 60%. c. HCT analyte: 60%. 3. Record review on 7/11/2025 of the CAP "FH16-B 2025 Hematology Auto Differentials, FH16" Event #2, PT evaluation report revealed unsuccessful score for the following analytes: a. Hematology analyte: 73%. b. RBC analyte: 20%. c. HCT analyte: 40%. 4. A telephone interview with the office manager on 7/14/2025 at 08:49 AM revealed the laboratory has still not received the PT "Original Evaluation Report" for Event 2 from CAP. He/she further commented that they are unaware of the unsuccessful scores for the Event 2 PT Survey. D2131 HEMATOLOGY CFR(s): 493.851(g) (g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to achieve an overall satisfactory performance in hematology (0760) for two consecutive Events 1 and 2 for 2025 in the specialty of Hematology. Findings include: 1.Record review on 7/11/2025 of the Proficiency Testing (PT) data report (Casper 155) revealed the laboratory failed to achieve satisfactory PT scores for 2025 as follows: Analyte Event #1(score) Event # 2(score) 0760 Hematology 76 73 2. Record review on 7/14/2025 of the CAP "FH16- A 2025 Hematology Auto Differentials, FH16" Event #1 evaluation reports revealed unsuccessful score of 76% for "Hematology (0760)" analyte. 3. Record review on 7/14 /2025 of the CAP "FH16-B 2025 Hematology Auto Differentials, FH16" Event #2 evaluation reports revealed unsuccessful score of 73% for "Hematology (0760)" analyte. 4. A telephone interview with the office manager on 7/14/2025 at 08:49 AM revealed the laboratory has still not received the PT "Original Evaluation Report" for Event 2 from CAP. He/she further commented that they are unaware of the unsuccessful scores for the Event 2 PT. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 2 of 3 -- The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on record review of the 2025, Event 1 and Event 2 proficiency testing (PT) data report (Casper 155) and graded results from College of American Pathologist (CAP), the laboratory director failed to ensure effective remedial action was instituted in response to unsatisfactory PT score resulting in the second unsuccessful performance for the hematology, red blood cells and hematocrit analytes in 2025. Refer to D2130 and D2131. -- 3 of 3 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to ensure proficiency testing (PT) samples were handled in the same manner and rotated amongst all testing personnel (TP) in the specialty of hematology. Findings include: 1. Record review of the 2020 College of American Pathologists PT records on 2/23/22 revealed 4 of 5 TP had not tested any PT samples for events two (FH3-B) and three (FH3-C) in the specialty of hematology. 2. Staff interview with the laboratory manager on 2/23/22 at 1:00 PM confirmed PT samples were not being examined in the same manner as patient samples for the events listed above and were tested by one TP. 3. The laboratory performs 124 complete blood count tests annually. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by 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 -- laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to establish control procedures that monitor the accuracy and precision of the complete analytic process in the speciality of hematology. Findings include: 1. Record review of the laboratory's peer group "Interlaboratory Quality Assessment Program (IQAP)" on 2/23/22 revealed the following: a) Quality control (QC) results for platelets (PLT) and basophil (%) were out of 3 standard deviation (SD) for the high level QC with lot# 372010813 from 1/8/20 through 2/17/20. b) QC results for PLT were out of 3 SD for the high level QC with lot# 372011213 from 4/17/20 through 5/20/20. c) QC results for MCV were out of 3 SD for all three (high lot# 372112813, normal lot# 362112812 and low lot# 352112811) levels QC from 9/10/21 through 10/27/21. d) QC results for MCV were out of 3 SD for all three (high lot# 372113013, normal lot# 362113012 and low lot# 352113011) levels QC from 10/28/21 through 1/3/22. e) QC results for WBC, HGB and Lymphocytes(%) were out of 3 SD for the high level QC with lot# 372113213 from 1/5/22 through 2/10/22. f) IQAP records were not available for review for the month of March 2020 and June 2020 through August 2021. Handwritten documentation for the above QC outliers stated "Monthly review of QC OK, a few parameters where QC is greater than 2 CVI. Manufacturer is contacted to tweak. OK to run patient sample. At least two levels of QC within recommended parameters." 2. Staff interview with the laboratory manager (LM) on 2/23/22 at 11:00 AM confirmed the above findings. The LM further stated there were some staffing changes occurred and they are still learning about laboratory QC policies. 3. The laboratory performs 744 tests in the specialty of hematology annually. 4. This is a repeat deficiency. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to check each lot number and shipment of media for its ability to support growth and, as appropriate, select or inhibit specific organisms in the specialty of microbiology. Findings include: 1. Review of the laboratory's quality control records for Strep Select Agar (SSA) on 2 /23/22 revealed the laboratory failed to document the ability of the media to support growth, select or inhibit specific organisms for each lot number and shipments received in 2020 and 2021. 2. Staff interview with the laboratory manager (LM) on 2 -- 2 of 3 -- /23/22 at 1:15 PM confirmed the laboratory did not check each new lot number or shipment of SSA media for their ability to support growth and, as appropriate, select or inhibit specific organisms. The LM stated the laboratory gets 18 shipments of SSA media annually. 3. The laboratory performs 2,571 throat cultures annually in the specialty of microbiology. 4. This is a repeat deficiency. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on an offsite desk review of the laboratory's 2019 and 2020 College of American Pathologists (CAP) proficiency testing (PT) records and an email communication with the practice manager on 5/22/20, the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the regulated analyte of hemoglobin (HGB) in two (2) out of three (3) events resulting in unsuccessful PT performance. See tags D2121 and D2130. D2121 HEMATOLOGY CFR(s): 493.851(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 2 -- Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review of the College of American Pathologists (CAP) proficiency testing (PT) results on 5/22/20, the laboratory failed to obtain a score of at least 80% for the specialty of hematology leading to an unsatisfactory performance as evidenced below. Findings include: 1. Review of PT records from CAP on 5/22/20 revealed test scores below 80% was obtained by the laboratory for the following analytes in the specialty of hematology: 2019-Event 2: Hemoglobin 0% 2020-Event 1: Hemoglobin 0% 2020-Event 1: White Blood Cell (WBC) 20% 2020-Event 1: WBC Differential 0% 2. Review of the laboratory's PT documentation received via email communication with the practice manager from 5/22/20 through 5/28/20 confirmed the above scores. 3. The laboratory performs 358 complete blood count tests annually. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an offsite desk review of the laboratory's 2019 and 2020 College of American Pathologists (CAP) proficiency testing (PT) records and an email communication with the practice manager on 5/22/20, the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the regulated analyte of hemoglobin (HGB) in two (2) out of three (3) consecutive events resulting in unsuccessful performance. Findings includes: 1. Review of the CAP proficiency testing records on 5/22/20 revealed the laboratory failed to obtain a score of at least 80% leading to unsatisfactory performance in 2 out of 3 consecutive PT events as follows. Year/Event # Score 2019 Event-2: Hemoglobin 0% 2020 Event-1: Hemoglobin 0% 2. Review of the laboratory's PT documentation received via email communication with the practice manager from 5/22/20 through 5/28/20 confirmed the above scores. 3. This is the first unsuccessful performance for the regulated analyte of hemoglobin. 4. The laboratory performs 358 complete blood count tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document when quality controls (QC) were out of range and establish QC procedures to monitor QC shifts and trends in the speciality of hematology. Findings include: 1. Record review of the laboratory's quality control (QC) records on 7/8/19 revealed the following: a) The laboratory failed to monitor QC results over time to monitor shifts and trends. b) The laboratory failed to document