Daniel M Libby Md Pllc

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 direct observation, review of the Standard Operating Procedures (SOPs), as well as interview with Technical Consultant (TC), the laboratory failed to remove from inventory expired patient testing supplies. FINDINGS: 1. The surveyor confirmed on July 11, 2025, at approximately 1:00 P.M. the following expired patient specimen collection tubes were not removed from inventory: a. One green-top lithium heparin tube, lot: 3136189, expiration: October 31, 2024, was stored in the laboratory. 2. This is contrary to instructions indicated in the current, approved routine chemistry testing SOPs. 3. TC assured the surveyor that the respective expired green-top lithium heparin, lot: 31436189 was not utilized for patient specimen collection, processing. 4. TC confirmed the findings on July 11, 2025, at approximately 1:00 P.M. 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 Based on a proficiency testing (PT) desk review survey performed on July 11, 2024, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation. D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity. 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 review of Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D) and American Proficiency Institute (API) PT summary reports, 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 -- laboratory failed to successfully participate in the CMS approved PT program for two of three consecutive testing events in the Routine Chemistry subspecialty for the Glucose (Non-Waived) test analyte in 2024, resulting in unsuccessful performance. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 CMS PT CASPER 0155D and API PT summary reports from 2024, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events in the Routine Chemistry subspecialty for the Glucose (Non-Waived) test analyte. FINDINGS: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: Glucose (Non-Waived) Test Analyte: 2024 First Event = 60% 2024 Second Event = 60% 2. A review of the proficiency testing scores from API (2024) confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 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 review of CMS PT CASPER 0155D and API PT summary reports from 2024, the laboratory director (LD) failed to failed to provide overall management and direction of the laboratory services. Refer to D2016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of CMS PT CASPER 0155D and API PT 2024-1 and 2024-2 summary reports, the LD failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies 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 surveyor's review of the manufacturer's package insert for Coaguchek XS PT /INR analyzer and interview with the technical consultant, the laboratory failed to follow the manufacturer's requirements for performing external controls with each new vial of test strips for PT/INR in the calendar years 2019 through survey date. FINDINGS: 1. The technical consultant confirmed on April 27, 2021 at approximately 2:00 PM confirmed the surveyor's findings that the laboratory did not follow the manufacturer's quality control requirements for performing external controls for each new lot of test strips. 2. The external Quality Control (QC) was not performed from January 1, 2019 through survey date. a. Surveyor could not determine the number of PT/INR test strips were used for patient testing. The laboratory did not record the lot numbers or expiration date for the previous lots of test strips. b. The current vial of test strips lot #47158918 expiration date 12/31/21 was not tested for quality control. 3. Approximately 50 patients' samples tested for PT/INR from January 1, 2019 through survey date. 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 D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a lack of Individualized Quality Control Plan (IQCP) procedure and an interview with the technical consultant, the laboratory failed to have in place the Risk Assessment (RA) part of the IQCP procedure for Hitachi CLA Allergy testing. Findings Include: It was confirmed with the technical consultant on October 30, 2018 at approximately 3:30 pm that the laboratory failed to perform the evaluation of the five risk assessment components (Test system, Reagent, Environment and Testing personnel) for all phases of testing on the Hitachi CLA Allergen-Specific IgE Assay test. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on a lack of documentation and an interview with the technical consultant, the laboratory has not performed the external and internal quality control (QC) each day of patient testing. Findings Include: It was confirmed with the technical consultant approximately 3:30 pm that the laboratory failed to performed the external and internal QC for Allergy testing performed for the Hitachi CLA Allergen-Specific IgE Assay each day of patient testing. Approximately 400 patients specimens were tested and results reported from July 2018 through October 2018. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a lack of QC records, and confirmed in an interview at the time of this survey with the technical consultant, the laboratory director failed to ensure that the QC program for the Hitachi Allergy testing panel was maintained to assure quality of laboratory services. Refer to: D5449 D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policy/procedure manual and an interview with the technical consultant, the laboratory director failed to ensure that the laboratory's quality assessment (QA) policy/procedure was followed. Refer to D5445 -- 2 of 2 --