Seventy Second Street Medical Associates Pc

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD 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 as well as interviews with the General Supervisor (GS) and Testing Personnel (TP), the laboratory failed to attain a score in the CMS approved PT program of at least 80 percent of acceptable responses in each testing event for Hematocrit (HCT) (Non- Waived) and Red Blood Cell (RBC) test analytes resulting in unsatisfactory analyte performance. FINDINGS: a. A review of the CASPER 155 report revealed the following unsatisfactory scores: 1. HCT Test Analyte: 2025 First Event = 60% 2. RBC Test Analyte: 2025 First Event = 60% b. There was no documentation of

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the personnel files for the nine testing personnel, lack of training, six-month and annual competency evaluation, SOP for competency evaluation, and an interview with general supervisor, the laboratory director failed to follow the established competency evaluation policy regarding the training, six-month and annual evaluations for the first year of employment. FINDINGS: 1. The competency evaluation policy states, "Each individual performs require a degree of skill commensurate with the individual's education, training or experience, and technical abilities. o Follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. o Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient samples. o Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. o Follow the laboratory's established

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 Endocrinology, Chemistry and Hematology for the calendar year 2021. 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 PT desk review of the CMS PT data reports, the laboratory director failed to enroll the laboratory in an approved Health and Human Services (HHS) PT program for the specialties Endocrinology, Chemistry and Hematology for the calendar year 2021. Refer to D2000. -- 2 of 2 --

Summary Statement of Deficiencies 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)