Gregory Shifrin Md Pc Ob Gyn

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 review of the Centers of Medicare and Medicaid Services (CMS) CASPER 155D Report and the American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to obtain successful PT performance for four of four PT events reviewed for the analyte Alpha-fetoprotein (AFP). Findings: 1. The laboratory failed to attain a score of at least 80% for four of four events reviewed for the analyte AFP. The following scores were assigned: Alpha-Fetoprotein Test Analyte: 2023 First Event = 40% 2023 Second Event = 0% 2023 Third Event = 0% 2024 First Event = 40% This is considered repeatedly unsuccessful PT performance. Refer to D2084. 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 -- D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 review of the CMS CASPER 155D Report and the API PT reports, the laboratory failed to achieve satisfactory performance for the alpha-fetoprotein test analyte in two consecutive testing events. Findings: 1. The laboratory failed to attain a score of at least 80% for four of four events reviewed for the analyte AFP. The following scores were assigned: Alpha-Fetoprotein Test Analyte: 2023 First Event = 40% 2023 Second Event = 0% 2023 Third Event = 0% 2024 First Event = 40% This is considered repeatedly unsuccessful 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 review of the CMS CASPER 155D Report and the API PT reports, the laboratory director (LD) failed to fulfill LD responsibilities and ensure that the laboratory achieved a satisfactory performance for the alpha-fetoprotein test analyte as well as successfully participate in the CMS approved PT program. Findings: 1. The laboratory failed to attain a score of at least 80% for four of four events reviewed for the analyte AFP. The following scores were assigned: Alpha-Fetoprotein Test Analyte: 2023 First Event = 40% 2023 Second Event = 0% 2023 Third Event = 0% 2024 First Event = 40% This is considered repeatedly unsuccessful PT performance. 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 review of the CMS CASPER 155D Report and the API PT reports, the LD failed to test the alpha-fetoprotein analyte as required as well as achieve a satisfactory performance in the CMS approved PT program. Findings: 1. The laboratory failed to attain a score of at least 80% for four of four events reviewed for the analyte AFP. The following scores were assigned: Alpha-Fetoprotein Test Analyte: 2023 First -- 2 of 3 -- Event = 40% 2023 Second Event = 0% 2023 Third Event = 0% 2024 First Event = 40% This is considered repeatedly unsuccessful PT performance. -- 3 of 3 --

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 current, approved standard operating procedures, and training records as well as interview with the General Supervisor (GS), it was determined that the Laboratory Director (LD) failed to perform and document GS competency evaluation. FINDINGS: 1. The GS was hired on September 30, 2023, and basic lab training was completed on October 1, 2023. 2. There was no documentation of GS competency evaluation. 3. The GS confirmed the findings on January 24, 2024, at 2: 00 P.M. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the current, approved Quality Assurance (QA) policy and interview with the GS, the laboratory failed to identify and address multiple test requisitions in use, expired reagent inventory, as well as GS competency evaluation. FINDINGS: 1. It was noted that LD QA review was performed and documented for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 2021, 2022, and 2023. It was also noted that QA review frequency was updated from semi-annual to annual. 2. The QA review failed to identify and address retention and use of expired cytostain and Hematoxylin reagents for patient specimen processing. 3. The GS confirmed the findings on January 24, 2024, at 2:00 P.M. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of randomly selected patient test requisitions, month of December 2023 test requisitions and an interview with the general supervisor (GS), the laboratory failed to ensure that the address for the three locations was recorded on the test requisition four different test requisition in use. FINDINGS: Based on review of selected patient test requisitions and interview with the GS, the laboratory failed to document patient specimen collection site address on the test requisition. FINDINGS: 1. The four, current, approved laboratory test requisitions did not document which address the patient specimens were received from: 1502 East 14th Street, Brooklyn, New York; 100 Einstein Loop North Bronx, New York; and 3 East 69th Street, New York, New York. a. Seventy-three December 2023 test requisitions did not specify patient specimen collection and receipt locations: 1766 12th Street Brooklyn, New York; or East 69th Street New York, New York; or 100 Einstein Loop, Ground Floor, North Bronx, New York; or 1502 East 14th Street, Brooklyn, New York. 2. The GS confirmed the findings on January 25, 2024, at approximately 10:30 A.M. Refer to D5291 and D6094. THIS IS A RECITED DEFICIENCY FROM THE SURVEY CONDUCTED SEPTEMBER 30, 2021. 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 review of the laboratory procedure manual and interview with the GS, the laboratory failed to document the date and time patient specimens were received in the laboratory. FINDINGS: 1. Patients samples were collected from 1502 East 14th Street, Brooklyn, New York; 100 Einstein Loop, North Bronx, New York; and 3 East 69th Street, New York, New York; and subsequently transported to the main -- 2 of 5 -- laboratory location at 1776 12th Street, Brooklyn, New York. 2. The GS confirmed on January 25, 2024, at approximately 10:30 A.M., that the current, approved laboratory procedure manual did not include written instructions for receipt and accessioning of patient samples collected from the three respective site locations. a. No documentation was available to determine the number of patient samples received from January 2, 2022, through the survey date. Refer to D5305. 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 review of the PAP staining quality control log, direct observation, and interview with the LD, the laboratory failed to remove from inventory and dispose of expired reagents utilized for patient specimen processing. Findings: 1. According to the QC log, Hematoxylin stain Lot 104357 expired September 2022 and was utilized for patient specimen processing of: a. October 2022, 165 patient slides; November 2022, 116 patient slides; December 2022, 105 patient slides; January 2023, 123 patient slides; February 2023, 92 patient slides; March 2023, 138 patient slides; April 2023, 168 patient slides; May 2023, 102 patient slides. b. The LD confirmed the findings on January 23, 2024, at 1:00 P.M. 2. According to the QC log, Cytostain Lot 101581 expired November 2022 and was utilized for patient specimen processing of: a. December 2022, 105 patient slides; January 2023, 123 patient slides; February 2023, 92 patient slides; March 2023, 138 patient slides; April 2023, 168 patient slides; May 2023, 102 patient slides. b. The LD confirmed the findings on January 23, 2024, at 1:00 P.M. 3. According to the QC log as well as direct observation of the reagent container, Cytostain Lot 129845 expired August 2023 and was utilized for patient specimen processing of: a. September 2023, 148 patient slides; October 2023, 146 patient slides; November 2023, 110 patient slides; December 2023, 96 patient slides; January 2024, 39 patient slides. b. The LD confirmed the findings on January 23, 2024, at 1:00 P.M. 4. According to the QC log, Cytoseal Lot 105926 and Clarifier Lot 101692 both expired March 2023 and were utilized for patient specimen processing of: a. April 2023, 168 patient slides; May 2023, 102 patient slides. b. The LD confirmed the findings on January 23, 2024, at 1:00 P.M. 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: Based on review of the current, approved Cytology procedure manual, 2022 and 2023 cytology workload records, as well as interview with the pathologist/technical supervisor, the laboratory failed to comply with current, approved policies and procedures ensuring that workload limits would be reassessed at least every six months and adjusted when necessary for the pathologist(s) who performed the -- 3 of 5 -- cytology slide primary gynecologic screening. FINDINGS: 1.The pathologist /technical supervisor, confirmed on January 23, 2024, at approximately 1:00 P.M. that the laboratory failed to comply with current, approved policies and procedures for pathologist workload reassessment at least every 6 months and adjustment when necessary. Refer to D6130. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the current, approved standard operating procedures, training records, as well as interview with the GS, the LD failed to perform and document GS competency evaluation and assure compliance with applicable GS regulations. Refer to D5209 and D6107. 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 QA review performed, the LD failed to identify and address multiple test requisitions in use, expired reagent inventory, as well as GS competency evaluation. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the current, approved policies and procedures, training records, as -- 4 of 5 -- well as interview with the GS, the LD failed to draft and develop written GS responsibilities and duties. Refer to D5209. D6130 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(c)(2)(3) (c) In cytology, the technical supervisor or the individual qualified under 493.1449(k) (2)-- (c)(2) Must establish the workload limit for each individual examining slides and (c)(3) Must reassess the workload limit for each individual examining slides at least every 6 months and adjust as necessary. This STANDARD is not met as evidenced by: Based on review of the Cytology procedure manual, 2022 and 2023 cytology workload records, as well as interview with the pathologist/technical supervisor, the pathologist, acting as the technical supervisor, failed to reassess workload limit for personnel who performed cytology slide primary gynecologic screening. Refer to D5637. -- 5 of 5 --

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 Proficiency Test (PT) desk review of the Center for Medicaid & Medicare Services (CMS) PT data reports and PT summary reports from American Proficiency Institute (API) PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the speciality General Immunology and the test analyte Alpha Fetoprotein (AFP). The following scores were assigned: Speciality General Immunology and AFP 2023 first event = 40% 2023 second event = 0% This is considered unsuccessful PT performance. Refer to D2084 and D2085 D2084 GENERAL IMMUNOLOGY 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): 493.837(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 and PT summary reports from API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the test analyte Alpha Fetoprotein (AFP). The following scores were assigned: AFP 2023 first event = 40% 2023 second event = 0% This is considered unsuccessful PT performance. D2085 GENERAL IMMUNOLOGY CFR(s): 493.837(g) Failure to achieve an overall testing event score of satisfactory performance for 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 and PT summary reports from API PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the speciality General Immunology. The following scores were assigned: Speciality General Immunology 2023 first event = 40% 2023 second event = 0% This is considered unsuccessful 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 and API 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 speciality for the speciality for the speciality General Immunology and the test analyte AFP. 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on PT desk review of the CMS PT and API 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 speciality for the speciality for the speciality General Immunology and the test analyte AFP. The following scores were assigned: Speciality General Immunology and AFP 2023 first event = 40% 2023 second event = 0% This is considered unsuccessful PT performance. -- 3 of 3 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's Quality Assessment (QA) policy, QA review records for the calendar year 2020, 2021 and an interview with the general supervisor/testing person, the laboratory failed to follow their established QA policy for an ongoing mechanism to monitor, assess and correct problems identified in the general laboratory systems. FINDINGS: 1. The general supervisor/testing person confirmed on September 29, 2021 at approximately 3:15 PM, that the laboratory failed to follow their established QA policy for an ongoing mechanism to monitor, assess and correct problems identified in the general laboratory systems. 2. The laboratory's QA policy requires an annual review of all phases of laboratory's testing and take

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 proficiency testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT data reports and PT records from the American Proficiency Institute (API) PT program, the laboratory failed to participate successfully in proficiency testing for the specialty General Immunology and test analyte Alpha-fetoprotein (AFP). The following scores were assigned: General immunology and AFP 2020 second event = 60% 2020 third event = 60% This is considered unsuccessful PT performance. Refer to D2084 and 2085. D2084 GENERAL IMMUNOLOGY 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): 493.837(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 reports and PT records from the API PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Alpha-fetoprotein (AFP). The following scores were assigned: 2020 second event = 60% 2020 third event = 60% This is considered a unsuccessful PT performance. D2085 GENERAL IMMUNOLOGY CFR(s): 493.837(g) Failure to achieve an overall testing event score of satisfactory performance for 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 CMS PT and PT records from the API PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the specialty General Immunology. The following scores were assigned: 2020 second event = 60% 2020 third event = 60% This is considered a unsuccessful PT performance. 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 a PT desk review of the CMS PT reports and PT records from the API PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Total Bilirubin. The following scores were assigned 2020 third event = 20% 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 PT CMS data reports and API PT reports, the -- 2 of 3 -- 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 specialty General Immunology and the test analyte's AFP and Total Bilirubin. 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 and API PT 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 specialty General Immunology and the test analyte's AFP and Total Bilirubin. The following scores were assigned: Specialty General immunology and AFP 2020 second event = 60% 2020 third event = 60% This is considered unsuccessful PT performance. Total Bilirubin. 2020 third event = 20% -- 3 of 3 --

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 reports and PT records from the American Proficiency Institute (API) PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Thyroid Stimulating Hormone (TSH). The following scores were assigned: 2019 third event = 60% 2020 first event = 100% 2020 second event = 0% This is considered unsuccessful PT performance. Refer to D2107. D2107 ENDOCRINOLOGY 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 -- 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 a PT desk review of the CMS PT reports and PT records from the API PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Thyroid Stimulating Hormone (TSH). The following scores were assigned: 2019 third event = 60% 2020 first event = 100% 2020 second event = 0% This is considered unsuccessful 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 PT CMS data reports and API 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, for the test analyte TSH. 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 and API 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, for the test analyte TSH. The following scores were assigned: 2019 third event = 60% 2020 first event = 100% 2020 second event = 0% This is considered unsuccessful PT performance. -- 2 of 2 --

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on surveyor's review of hematology calibration records and an interview with the laboratory supervisor/testing person, the laboratory failed to calibrate the ABX Horiba Micros 60 hematology analyzer at the six month intervals as required by the manufacturer. FINDINGS: The laboratory supervisor/testing person confirmed on December 12, 2018 at approximately 1:30 PM, the surveyor's findings that the analyzer was calibrated on September 19, 2017 and again on July 12, 2018 therefore, the analyzer was out of calibration for 4 month period. Approximately 240 patient specimens were tested and reported for hematology during the above time frames when the analyzer was out of calibration. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification 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 -- procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's calibration verification records and an interview with the laboratory supervisor/testing person, the laboratory failed to perform calibration verification at least once every six months for all analytes on the Roche Cobas e 411 endocrinology analyzer and the Roche Cobas 400 plus chemistry analyzer. FINDINGS: The laboratory supervisor/testing person confirmed on December 12, 2018 at approximately 10:30 AM, the surveyor's findings that the laboratory did perform a calibration verification for both instruments on November 18, 2017 and again on October 18, 2018. Therefore, the analyzers were out of calibration for 5 months. Approximately 300 patient samples were tested and reported during this time-period for both analyzers. THIS IS A RECITED STANDARD DEFICIENCY FROM THE SURVEYS CONDUCTED ON JANUARY 12, 2017 and JANUARY 7, 2015. 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,workload form and an interview the pathologist/laboratory director, the pathologist failed to record the number of hours spent examining the cytology slides for the 2017 and 2018 calendar years. FINDINGS: 1. The pathologist/laboratory director confirmed on December 11, 2018 at approximately 11:30 AM, the surveyor's findings that the workload forms used to evaluate the workload limits in a 24 hour period did not contain the number of hours spent examining the cytology slides for the 2017 and 2018 calendar years. 2. The workload form did contain the number of QC and cytology slides that were examined but not the hours spent. Therefore, the surveyor could not verify the -- 2 of 3 -- maximum number slides examined in a specific timeframe for a workload limit of 100 slides per 24 hours. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on surveyor's review of laboratory records and findings and an interview with the pathologist/laboratory director, the laboratory director failed to fulfill his responsibilities and provide overall management of the laboratory including failure to maintain the