Fairway Pediatrics Llc

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Fairway Pediatrics, CLIA ID 19D0928015, on May 15, 2025. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 observation, review of manufacturer's instructions and laboratory temperature records, as well as interview with personnel, the laboratory failed to define acceptable room temperature limits within the manufacturer's required range for supplies stored in the laboratory. Findings: 1. Observation by surveyor during the laboratory tour on May 15, 2025 at 9:05 a.m. revealed the following swabs stored in the laboratory at room temperature: a) Cultureswab Plus Collection and Transport System for aerobes and anaerobes - Manufacturer's required storage requirements 5 - 25 degrees Celsius 2. Review of the laboratory's room temperature records from January 2025 through April 2025 revealed the laboratory defined the acceptable room temperature limits as 65 - 95 degrees Fahrenheit (18.3 - 35 degrees Celsius) which exceeded the manufacturer's upper temperature limits. 3. In interview on May 15, 2025 at 10:50 a.m., Testing Personnel 1 confirmed the laboratory's acceptable room temperature limits exceeded the manufacturer's limits as identified above. 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 -- D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results; This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5413. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) (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 review of the laboratory's policies and personnel records as well as interview with personnel, the Laboratory Director failed to ensure one (1) of three (3) testing personnel reviewed had appropriate training documentation prior to patient testing. Findings: 1. Review of the laboratory's policy "Laboratory Personnel Competency Assesment {sic}" revealed "An initial competency assessment will be done after training is complete, and again at 6 months, and annually thereafter, for all laboratory personnel." 2. Review of the laboratory's personnel records revealed the laboratory did not have documentation of an initial training for Personnel 5. 3. In interview on May 15, 2025 at 10:25 a.m., Testing Personnel 1 stated training was performed and documented for Personnel 5, but she could not find the documentation. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) (b)(8)(v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and This STANDARD is not met as evidenced by: Based on review of the laboratory's CMS-209 (Laboratory Personnel Report), policies, and personnel records; as well as interview with personnel, the Technical Consultant failed to ensure the assessment of test performance through previously analyzed, internal blind samples, or external proficiency testing samples for two (2) of five (5) testing personnel reviewed. Findings: 1. Review of the laboratory's CMS-209 revealed the Laboratory Director also served as the Technical Consultant. 2. Review of the laboratory's form "Competency Assessment" revealed six (6) criteria for competency assessment which included "Assessment of test performance through previously analyzed specimens, internal blind samples, or external proficiency testing samples." 3. Review of the laboratory's personnel records revealed the laboratory documented competency assessments for the following personnel but failed to provide documentation to support the performance of blind sample testing: a) Testing -- 2 of 3 -- Personnel 3 - 2024 annual competency b) Testing Personnel 6 - 2023 semiannual competency and 2024 annual competency 4. In interview on May 15, 2025 at 10:40 a. m., Testing Personnel 1 confirmed the personnel identified above did not have an assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples performed. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's CMS-209 (Laboratory Personnel Report), policies, and personnel records; as well as interview with personnel, the Technical Consultant failed to perform a competency assessment semiannually for one (1) of two (2) testing personnel reviewed. Findings: 1. Review of the laboratory's CMS-209 revealed the Laboratory Director also served as the Technical Consultant. 2. Review of the laboratory's policy "Laboratory Personnel Competency Assesment {sic}" revealed "An initial competency assessment will be done after training is complete, and again at 6 months, and annually thereafter, for all laboratory personnel." 3. Review of the laboratory's personnel records revealed Personnel 5 began patient testing in December 2023 but a semiannual assessment was not performed in 2024. 4. In interview on May 15, 2025 at 10:25 a.m., Testing Personnel 1 stated a semiannual competency was performed and documented for Personnel 5, but she could not find the documentation. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Recertification Survey was performed at Fairway Pediatrics, CLIA ID # 19D0928015 on July 12, 2023. Fairway Pediatrics was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records and interview with laboratory personnel, the laboratory failed to ensure that proficiency testing attestation statements were signed by the laboratory director for four (4) of five (5) events reviewed. Findings: 1. Review of the laboratory's American Proficiency Institute (API) hematology proficiency testing records revealed the laboratory director did not sign the attestation statements for the following events: a) 2021 Hematology /Coagulation 3rd Event b) 2022 Hematology/Coagulation 2nd Event c) 2022 Hematology/Coagulation 3rd Event d) 2023 Hematology/Coagulation 1st Event 2. In interview on July 12, 2023 at 2:10 p.m., Testing Personnel 1 confirmed the laboratory director did not sign the attestation statements listed above. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to ensure the Laboratory Director reviewed the proficiency testing performance evaluation results for five (5) of five (5) events reviewed. Findings: 1. Review of the laboratory's American Proficiency Institute (API) hematology proficiency testing records revealed the laboratory did not have documentation of the review of the performance evaluation by the laboratory director for the following events: a) 2021 Hematology /Coagulation 3rd Event b) 2022 Hematology/Coagulation 1st Event b) 2022 Hematology/Coagulation 2nd Event c) 2022 Hematology/Coagulation 3rd Event d) 2023 Hematology/Coagulation 1st Event 2. In interview on July 12, 2023 at 2:10 p.m., Testing Personnel 1 confirmed the laboratory director did not sign the proficiency test evaluation reports for the events identified above. 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 review of the laboratory's policy and procedure manual and interview with laboratory personnel, the laboratory failed to maintain a complete policy for proficiency testing. Findings: 1. Review of the laboratory's policy "Proficiency Testing Procedures" revealed the laboratory did not include instructions for documentation of the following: a) Attestation to include appropriate personnel b) Performance evaluation review by the laboratory director 2. In interview on July 12, 2023 at 3:52 p.m., Testing Personnel 1 confirmed the laboratory's policy for proficiency testing did not include the information identified above. 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 D0000 A Recertification survey was performed on October 25, 2021 at Fairway Pediatrics, LLC, CLIA ID # 19D0928015. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of manufacturer's instructions, test menu, and interview with personnel, the laboratory failed to include "Fact Sheets" to providers or patients for Emergency Use Authorization (EUA) SARS COV-2 testing. Findings: 1. Observation by surveyor during laboratory tour on October 25, 2021 at 9: 00 am revealed the laboratory utilizes the following test systems for SARS CoV-2 testing: a) BD Veritor System for Rapid Detection of SARS-CoV-2 b) Quidel Sofia SARS-CoV-2 2. Review of the manufacturer's instructions for use under the "Conditions of Authorization for the Laboratory" section revealed "Authorized laboratories using your product must include with test result reports, all authorized Fact Sheets. Under extingent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media." 3. In interview on October 25, 2021 at 11:50 am, Personnel 4 stated that they were unaware that a fact sheet must be provided to patients with waived testing. Personnel 4 confirmed the laboratory does not include fact sheets upon patient testing. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 -- 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 review of the laboratory's policies and procedures and interview with personnel, the laboratory failed to have a complete policy and procedure manual. Findings: 1. Review of the laboratory's policies and procedures revealed the laboratory did not include the following: a) Reporting of SARS COV-2 test results to state public health agency, to include but not limited to frequency and who is responsible. 2. In interview on October 25, 2021 at 11:50 am, Personnel 4 stated she was unaware the laboratory needed a policy for SARS CoV-2 reporting of test results. Personnel 4 confirmed the laboratory did not have the identified policy. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure an approved policy and procedure manual was available to all personnel. Refer to D5401. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification Survey was performed at Fairway Pediatrics, LLC-CLIA ID # 19D092815 on May 29, 2019. Fairway Pediatrics was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 42 CFR 493.1421 CONDITION: Laboratories performing moderate complexity testing; Testing Personnel 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 record review and interview with personnel, the laboratory failed to retain instrument printouts that included flags for Complete Blood Count (CBC) testing. Findings: 1. Review of the laboratory's "Complete Blood Count Flag Policy" revealed "Any flagged CBC's that contain an $ ! or * will be held for a total of 15 minutes & again repeated; If a specimen results in another flag, a fresh specimen will be collected and processed. All platelet flags should be re-run after 15 minutes or redrawn then sent to a reference lab to verify a manual count." 2. In interview on May 29, 2019 at 11:50 am, Personnel 3 stated for CBC results with flags the laboratory waits fifteen (15) minutes then retests the sample. Personnel 3 stated often times the flags go away after the sample is retested. Personnel 3 stated the laboratory does not keep the initial flagged instrument printout. Personnel 3 stated she was unable to determine flagged samples that had been repeated. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- 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: I. Based on record review and interview with personnel, the laboratory failed to ensure written policies and procedures to assess competency for one (1) of two (2) Technical Consultants were complete. Findings: 1. Review of the laboratory's CMS- 209 form (Laboratory Personnel Report) revealed the Laboratory Director and Personnel 2 were listed as Technical Consultants. 2. Review of the laboratory's policies and procedures revealed the laboratory did not have a policy for competency assessment of Technical Consultant including frequency of performance. 3. Review of personnel records for Personnel 2 revealed a competency assessment for duties as Technical Consultant was not performed. 4. In interview on May 29, 2019 at 9:30 am, Personnel 2 stated he was added as a Technical Consultant. Personnel 2 confirmed he did not have a competency assessment performed for Technical Consultant duties. Personnel 2 further stated he was unaware it was required since he is a physician. II. Based on record review and interview with personnel, the laboratory failed to establish written policies and procedures to assess competency for testing personnel. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel performing laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 2. In interview on May 29, 2019 at 10:30 am, Personnel 3 stated the laboratory did not have a personnel competency policy. 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 record review and interview with personnel, the laboratory failed to perform an assessment for Hematology proficiency test (PT) results that scored less than one hundred (100) percent. Findings: 1. Review of the laboratory's 2017 and 2018 American Proficiency Institute (API) PT results revealed the laboratory received the following "unacceptable" results: 2017 3rd Event: Sample HEM-15 for Red Cell Count, API grade: "unacceptable"-80% 2018 3rd Event: Sample HEM-14 for Granulocytes, API grade: "unacceptable"- 80% 2018 3rd Event: Sample HEM-12 for Monocytes, API grade: "unacceptable"-80% 2. Review of the laboratory's PT records revealed the laboratory did not perform assessments for the "unacceptable" by API PT results. 3. In interview on May 29, 2019, Personnel 3 stated for the identified PT -- 2 of 10 -- results she thought nothing further needed to be done since the scores were 80%. Personnel 4 further stated she was unaware any score below 100 % needed to be investigated. 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 record review and interview with personnel, the laboratory failed to establish complete policies and procedures. Findings: 1. Review of the laboratory's documents and records revealed the laboratory did not have written polices and procedures that included: a) Complete Blood Counts (CBC) flagging issues that may occur on the Horiba ABX, to include what alternate methods/actions are required b) Record Retention requirements c) Performance specification: detailed procedures for performing accuracy and precision (day-to-day, run-to-run, and within-run variation, as well as operator variance), reportable and reference range studies, acceptability criteria for studies, and actions to take when data from the studies fail to meet acceptability criteria 2. In interview on March 9, 2017 at 11:22 am, Personnel 2 stated the laboratory did not have a policy and procedure manual. Personnel 2 stated the laboratory follows the user's guide provided to them when instrument was installed. 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)