Barry M Schwartz Md Pc

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 inserts for the Siemens Multistix and interview with the laboratory director/testing person, the laboratory failed to follow the manufacturer's requirements for performing external positive and negative controls with each new vial opened for the Siemens urine Multistix 10SG FINDINGS: 1. The laboratory director confirmed on Nov. 17, 2021, at approximately 11:00 AM, that the surveyors findings that the laboratory failed to follow the manufactures Quality Control (QC) requirements for external controls. 2. The packet insert for the Siemens Multistix requires that external controls be performed with each new Vial of Multistix opened. a. QC was not performed on 2 vials of reagent strips, lot #103603, expiration date 9/30/22 3. The laboratory did not perform QC from January 1, 2021 through survey date. 4. Approximately 250 patient's specimens were tested and reported for urinalysis during the above time frame. D5637 CYTOLOGY CFR(s): 493.1274(d)(1)(ii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1)(ii) Each individual's workload limit is reassessed at least every 6 months and adjusted when necessary. This STANDARD is not met as evidenced by: 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 -- Based on surveyor's review of the laboratory's cytology procedure manual, daily cytology workload list and an interview with the laboratory director/pathologist, the laboratory director acting as the technical supervisor failed to follow established workload limit assessment procedures. Refer to D5645 FINDINGS: The pathologists confirmed on November 17, 2021 at 10 AM, the surveyor's findings that the workload list for calendar years 2019, 2020 and 2021 through survey date the laboratory pathologist, acting as the technical supervisor, failed to perform and document the six- month reassessment for the workload list for above calendar years. D5645 CYTOLOGY CFR(s): 493.1274(d)(3) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(3) The laboratory must maintain records of the total number of slides examined by each individual during each 24-hour period and the number of hours spent examining slides in the 24-hour period irrespective of the site or laboratory. This STANDARD is not met as evidenced by: Based on surveyor's review of the Cytology procedure manual and current workload records and an interview the pathologist/laboratory director, the pathologist failed to follow the established workload procedure. FINDINGS: 1. The pathologist/laboratory director confirmed on November 17, 2021 at approximately 10:00 AM, the surveyor's findings that the pathologist, the primary reader, failed to follow the established workload procedure for the calendar years 2019, 2020 and 2021 through survey date a. Surveyor reviewed the form titled, "Daily Cytology Workload" for the calendar years 2019, 2020 and 2021 through survey date and found that the pathologist name, and the location of the laboratory were not incorporated in the form. 2. Surveyor could not determine if the Daily Cytology Workload forms for the above calendar years were for this location. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the proficiency test verification records and an interview with the laboratory director, one of two clinical consultants in the laboratory failed to verify the accuracy of the urine microscopy slides. Findings Include: On March 26, 2018, at approximately 11:00 AM and confirmed by the laboratory director, one of two clinical consultants who performs urine microscopy in the laboratory failed to perform twice annual verification from March 31, 2016, through the date of this survey. Approximately 150 patient specimens were tested and reported for urine microscopy during that time. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a review of twice annual verification records and an interview with the laboratory director on March 26, 2018, at approximately 11:00 AM, the laboratory director failed to ensure that urine microscopic analysis was included in the laboratory QA program for the last two years. Refer to: D5417 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 --