Lewin, Fagen & Lown, Md Pc

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a proficiency testing (PT) desk review of Center for Medicaid and Medicare Service (CMS) PT data reports, the laboratory failed to enroll in an approved PT program for the specialties Chemistry, Endocrinology and Hematology in the calendar year 2023. Refer to D6015 D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. 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 a proficiency testing (PT) desk review of Center for Medicaid and Medicare Service (CMS) PT data reports, the laboratory failed to enroll in an approved PT program for the specialties Chemistry, Endocrinology and Hematology in the calendar year 2023. Refer to D2000 -- 2 of 2 --

Summary Statement of Deficiencies D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on the lack of humidity log, the laboratory failed to monitor humidity and room temperature since implementation February 2021 through survey date as required by Horiba Pentra 400 and Horiba Micros 60. Finding: 1. Horiba Pentra 400: Humidity 20- 85%, Room Temperature 59F-90F (15?-32?) 2. Horiba Micros 60: Humidity 20-80%, Room Temperature 65F-90F (18?-32?) 3. Confirmed on an interview with practice manager on 10/14/2022 about 11:30am. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (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 review of the laboratory's Quality Control (QC) records, the laboratory failed to perform a verification of current lot number to new lot number of the hematology analyzer Horiba Micros 60 and Horiba Pentra 400. FINDINGS: 1. The new QC lot to lot validation documentations of hematology analyzer were not available upon request during the survey since the hematology analyzer implementation date to survey date. 2. The laboratory director confirmed during interview on 10/14/2022 at 11am, the new lot to lot validation of QC material for Horiba Micros 60 and Horiba Pentra 400. -- 2 of 2 --