Fallingwater Medical Associates Pllc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 09/04/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with testing persons #1 and #3 at the conclusion of the survey. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #3, the laboratory failed to utilize the demonstrated reportable ranges for one of one new test methods for complete blood count (CBC) testing. Findings include: (1) On 09/04/2025 at 10:00 am, testing person #3 stated the laboratory began performing CBC (Complete Blood Count) testing using the Beckman Coulter DXH 520 analyzer on 08/22/2024; (2) A review of the performance specification records identified the laboratory had demonstrated the following reportable ranges: (a) Hemoglobin - 0.9 - 19.29 g/dL (3) Interview with testing person #3 and a review of the CBC- Complete Blood Count policy on 09/04/2025 at 10:24 am confirmed the laboratory was using the following manufacturer's reportable ranges: (a) Hemoglobin - 2.1 -20.25 g/dL 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 D0000 The recertification survey was performed on 12/19/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the office manager and testing person #1 at the conclusion of the survey. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1, the laboratory failed to ensure proficiency testing attestation records had been signed by the laboratory director for one of six events reviewed. Findings include: (1) On 12/19 /2023 at 11:30 am, a review of 2022 and 2023 proficiency testing records identified the following for one of six events: (a) 2023 Hematology - First Event (i) The attestation statement had not been signed by the laboratory director. (2) The findings were reviewed with the office manager and testing person #1. Both stated on 12/19 /2023 at 1:00 pm, the attestation statement had not been signed by the laboratory director. 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 D0000 The recertification survey was performed on 10/01/2021. The findings were reviewed with the laboratory consultant and the laboratory supervisor at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulation: 493.1409; D6033: Technical Consultant D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records and interview with the laboratory consultant, the technical consultant failed to provide technical oversight in accordance with 493.1413 of this subpart. Findings include: (1) The technical consultant failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of 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 -- podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory consultant, the laboratory failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications for 1 of 4 competency evaluations performed. Findings include: (1) On 10/01/2021 at 09:45 am, surveyor #2 reviewed records for 4 persons performing moderate complexity testing in 2019, 2020 and to date in 2021. The records showed the evaluations for 1 of 4 persons had been performed by an individual who did not meet the regulatory qualification requirements of the technical consultant: (a) Testing Person #4 - The 04 /01/2021 evaluation had been performed by the laboratory supervisor (this person had earned an Associates Degree in Science); (2) Surveyor #2 reviewed the records with the laboratory consultant on 10/01/2021 at 10:30 am, and explained that all components of the competency evaluations must be performed by a person who qualifies as a technical consultant (an individual with a minimum of a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution, and at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service). The laboratory consultant stated to surveyor #2 on 01/01/2021 at 10:45 am, the above evaluation had been performed by an individual who did not meet the educational qualifications of a technical consultant. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/11/19. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory supervisor and office manager at the conclusion of the survey. 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)