John R Zaso Do Pc

Summary Statement of Deficiencies D0000 Based on a proficiency testing (PT) desk review survey performed on December 24, 2025, 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), 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 out of three consecutive testing events in the Hematology specialty for the White Blood Cell (WBC) Differential test analyte in 2025 resulting in unsuccessful performance. Refer to D2130. 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 CMS PT CASPER 0155D and API summary reports from 2025, the laboratory failed to achieve satisfactory performance (80% or greater) for two out of three consecutive testing events in the Hematology specialty for the analyte WBC Differential. FINDINGS: a. A review of the CASPER 155 report revealed the following unsatisfactory scores: 1. WBC Differential Test Analyte: 2025 Second Event = 68% 2025 Third Event = 52% b. A review of the PT scores from API (2025) confirmed the above test event 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 summary reports from 2025, the Laboratory Director (LD) failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) 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 2025-2, and 2025-3 summary reports, the LD failed to ensure successful participation in a CMS-approved PT program. Refer to D2130. -- 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 packet insert for OSOM Genzyme Influenza A&B and Binax NOW RSV and interview with the laboratory supervisor /testing person, the laboratory failed to follow the manufacturer's requirements for performing external positive and negative controls with each new kit of Influenza A&B and Binax NOW RSV opened. FINDINGS: 1. The laboratory is using the OSOM Genzyme Influenza A&B and Binax NOW RSV kits. The manufacturer of the OSOM Genzyme and The Binax require that external positive and negative controls (provided in the kits) be performed with each new lot number/shipment. 2. On January 28, 2019 at approximately 11:00 AM the laboratory supervisor confirmed surveyor's findings that documentation for the required external control testing was not available at survey for calendar year 2017. 3. Approximately 50 patient specimens were tested and reported for Influenza A&B and RSV testing during the above time frames. 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. 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 -- This STANDARD is not met as evidenced by: Based on surveyor's review of the hematology quality Control (QC) records and an interview with the laboratory supervisor/testing person, the laboratory failed to discontinue the use of expired hematology quality control materials. FINDINGS: 1. On January 28, 2019 at approximately 11:00 AM the laboratory supervisor confirmed surveyor's findings that the laboratory used 3 levels of expired QC for hematology testing lot numbers:068300, 078300 and 088300 expired 2/15/18 for Quality controls low, normal and high respectively from 2/16/18 through 2/28/18. 2. The laboratory used 3 levels of expired QC for hematology testing lot numbers: 068800, 078800 and 088800 expired 5/8/17 for Quality controls low, normal and high respectively from 5/9 /17 through 5/27/17. 3. Approximately 60 patients were tested for hematology using the expired quality control materials during the above time frames. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor's review of the bacteriology Quality Control (QC) documentation and an interview with the laboratory supervisor/testing person, the laboratory failed to check each new batch, lot number and shipment of 0.04 bacitracin disc for positive and negative reactivity in calendar year 2017. FINDINGS: 1. On January 28, 2019 at approximately 10:30 AM the laboratory supervisor/testing person confirmed surveyor's findings that the laboratory failed to check each new batch, lot number and shipment of the bacitracin disc for positive and negative reactivity in calendar year 2017. 2. The laboratory failed to record the lot number/expiration date for the shipment of bacitracin disc received in the lab in calendar year 2017. 3. Approximately 1500 patients specimens were tested and reported for throat culture during this time period. 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 the surveyor's review of Quality Control (QC) records and confirmed, during this onsite survey with the laboratory supervisor/testing person, the laboratory director failed to ensure that the QC program for hematology and bacteriology testing -- 2 of 3 -- was maintained to assure quality of laboratory services. Refer to: D1001, D5417, D5471 -- 3 of 3 --