Women's Health Care Pc

Summary Statement of Deficiencies 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 a proficiency testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT data reports, and College of American Proficiencies (CAP) PT records, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Total Bilirubin (T. Bili). The following scores were assigned: 2020 second event = 20% 2020 third event = 100% 2021 first event = 60% This is considered an unsuccessful PT performance Refer to D2096 D2087 ROUTINE CHEMISTRY 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 -- CFR(s): 493.841(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 PT desk review of the CMS PT data reports and PT records from the CAP PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte's Alanine Aminotransferase (ALT/SGPT), Alkaline Phosphates, Albumin, Aspartate Aminotransferase (AST/SGOT), Chloride (CL), Total Calcium (T. Ca), Total Protein (T. Protein) Creatine, Glucose, Magnesium (Mg), Potassium (K), Sodium (Na), Blood Urea Nitrogen (BUN) and Uric Acid The following score was assigned: ALT/SGPT, Alkaline Phosphates, Albumin, AST/SGOT, CL, Creatine, Glucose, Mg, K, Na, T. Protein, and Uric Acid 2021 first event = 60% BUN 2021 first event= 20% SGOT and T CA 2021 first event = 40% This is considered unsatisfactory PT performance. D2088 ROUTINE CHEMISTRY CFR(s): 493.841(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a PT desk review of the CMS PT data reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the specialty Chemistry. The following scores were assigned: 2021 first event = 54% This is considered a unsatisfactory PT performance. 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 a PT desk review of the CMS PT data reports, and CAP PT program records, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Total Bilirubin (T. Bili). The following scores were assigned: 2020 second event = 20% 2020 third event = 100% 2021 first event = 60% This is considered an unsuccessful PT performance D2098 ENDOCRINOLOGY CFR(s): 493.843(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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on PT desk review of the CMS PT data reports and CAP PT program records, the laboratory failed to participate successfully in proficiency testing for the test analyte Triiodothyronne (T3) The following score was assigned: 2020 second event = 0% This is considered unsatisfactory PT performance. 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 PT desk review of the CMS PT data reports and CAP PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the specialty Routine Chemistry and the test analyte's ALT/SGPT, Alkaline Phosphates, Albumin, AST/SGOT, CL, T. Bili., Creatine, Glucose, Mg, K, Na, T. Protein, BUN, T. CA, Uric Acid and T3 Refer to D6016. 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 PT desk review of the CMS PT data reports and CAP PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the specialty Routine Chemistry and the test analyte's ALT/SGPT, Alkaline Phosphates, Albumin, AST/SGOT, CL, T. Bili., Creatine, Glucose, Mg, K, Na, T. Protein, BUN, T. CA, Uric Acid and T3. The following scores were assigned: Total Bilirubin (T. Bili). 2020 second event = 20% 2020 third event = 100% 2021 first event = 60% This is considered an unsuccessful PT performance specialty Chemistry. 2021 first event = 54% ALT/SGPT, Alkaline Phosphates, Albumin, AST/SGOT, CL, Creatine, Glucose, Mg, K, Na, T. Protein, and Uric Acid 2021 first event = 60% BUN 2021 first event= 20% AST/SGOT and T CA 2021 first event = 40% Triiodothyronne (T3) 2020 second event = 0% This is considered unsatisfactory PT performance. -- 3 of 3 --

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on a proficiency testing ( PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT records and the verified with the College of American Pathologists (CAP) PT program, the laboratory failed to have the PT test results released to the New York State Department of Health (NYSDOH), Physician Office Laboratory Evaluation Program (POLEP) in the calendar year 2020. 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 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 -- 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 PT desk review of the CMS PT data reports, the laboratory failed to participate successfully in proficiency testing for the test analyte Triiodothyronine (T3). The following scores were assigned: 2019 third event = 0% 2020 first event = 100% 2020 second event = 0% This is considered unsuccessful PT performance. Refer to D2107. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 PT desk review of the CMS PT data reports, the laboratory failed to participate successfully in proficiency testing for the test analytes Total Bilirubin and Creatine. The following scores were assigned: Creatine 2019 third event = 20% Total Bilirubin 2020 second event = 20% This is considered unsatisfactory PT performance. D2098 ENDOCRINOLOGY CFR(s): 493.843(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 a PT desk review of the CMS PT reports, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Thyroxine. The following test scores were assigned : Thyroxine 2020 first event = 40% This is considered a unsatisfactory PT performance. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 PT desk review of the CMS PT data reports, the laboratory failed to participate successfully in proficiency testing for the test analyte Triiodothyronine (T3). The following scores were assigned: 2019 third event = 0% 2020 first event = 100% 2020 second event = 0% This is considered unsuccessful PT performance -- 2 of 3 -- 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 PT desk review of the PT CMS data reports, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, for the test analytes T3, Total Bilirubin, Creatine and Thyroxine. Refer to D6016. 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 PT desk review of the PT CMS data reports, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, for the test analytes T3, Total Bilirubin, Creatine and Thyroxine. The following scores were assigned: Triiodothyronine 2019 third event = 0% 2020 first event = 100% 2020 second event = 0% This is considered unsuccessful PT performance. Creatine 2019 third event = 20% Total Bilirubin 2020 second event = 20% Thyroxine 2020 first event = 40% This is considered unsatisfactory PT performance. -- 3 of 3 --

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)

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on surveyor's observation of the reagents located in the laboratory refrigerator and confirmed in an interview with the technical consultant and the two testing personnel, the laboratory failed to discard expired reagents. FINDINGS: The technical consultant and two testing personnel confirmed on May 8, 2018 at approximately 1:30 PM, the following expired reagents were stored in the refrigerator: a. ABX Pentra 400 CO2 calibrator Lot #60112554 expiration date 10/31/2017 b. Bio-rad Wash Solution 30X expiration date 4/30/2018 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: 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 the surveyor's review of the laboratory's Indivdiual Quality Control Plan (IQCP), Quality Control Plan (QCP) and Quality Assessment (QA) procedures and confirmed in the interview with the technical consultant and the two testing personnel, the laboratory's QCP failed to include the type of external control material used for QC testing, frequency QC material is tested and the criteria for acceptability of the controls. FINDINGS: The technical consultant and the two testing personnel confirmed on May 8, 2018 at approximately 2:30 PM , the surveyor's findings that the laboratory failed to include the type of external control material used for QC, frequency QC material is tested and the criteria for acceptability for BD Affirm VPN QC . a. The BD Affirm VPN manufacturer requires a Trivalent swab to be tested with each new lot of PAC test cassettes. b. The laboratory director failed to establish the frequency and the criteria for acceptability for the QCP. -- 2 of 2 --