Doctor's Clinical Laboratory

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity. testing; laboratory director 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 desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER) 0155 report and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) 2024 and 2025 records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the subspecialty of Syphilis Serology and in the subspecialty of ABO Group and Rh typing. Refer to D2074, D2162, and D2163. D2074 SYPHILIS SEROLOGY CFR(s): 493.835(e) (e) 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 proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2025 proficiency testing records, the laboratory failed to achieve overall satisfactory performance (80% or greater) for the subspecialty of Syphilis Serology in two of three consecutive testing events (2024, Event 3 and 2025, Event 1) Finding included: 1. A review of the CASPER 0155 report revealed the following results: AAB-MLE 2024 - 3rd Event The laboratory received an unsatisfactory score of 0% for Syphilis Serology. AAB-MLE 2025 - 1st Event The laboratory received an unsatisfactory score of 0% for Syphilis Serology. 2. A review of AAB-MLE 2024 and 2025 proficiency testing records confirmed the laboratory received the above results D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) (f) Failure to achieve satisfactory performance for the same analyte 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 proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2025 proficiency testing records, the laboratory failed to achieve satisfactory performance (100%) in the specialty of Immunohematology for the RH typing subspecialty in two consecutive testing events (2025, Event 1 and 2) Finding included: 1. A review of the CASPER 0155 report revealed the following results: AAB-MLE 2025 - 1st Event The laboratory received an unsatisfactory score of 80% for RH typing. AAB-MLE 2025 - 2nd Event The laboratory received an unsatisfactory score of 0% for RH typing. 2. A review of AAB-MLE 2025 proficiency testing records confirmed the laboratory received the above results. D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) (g) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2025 proficiency testing records, the laboratory failed to achieve overall satisfactory performance (100%) in the specialty of Immunohematology for the subspecialty of ABO Group and RH typing in two consecutive testing events (2025, Event 1 and 2) Finding included: 1. A review of the CASPER 0155 report revealed the following results: AAB-MLE 2025 - 1st Event The laboratory received an unsatisfactory score of 90% for ABO Group and RH typing. AAB-MLE 2025 - 2nd Event The laboratory received an unsatisfactory score of 0% for ABO Group and RH typing.. 2. A review of AAB-MLE 2025 proficiency testing records confirmed the laboratory received the above results. 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 a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2025 proficiency testing records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2025 proficiency testing records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2074, D2162, and D2163. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced routine CLIA recertification survey was conducted at Doctor Clinical Laboratory on September 23, 2021 by the Centers for Medicare and Medicaid Services (CMS) New York branch federal surveyor. The laboratory was surveyed under 42 CFR part 493 CLIA requirements: Specific deficiencies cited are as follows: D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on lack of COVID reporting documentation and interview with the testing person (TP) the laboratory failed to ensure both negative and positive results we reported to the local department of health. Findings include: On 09/23/2021 at approximately 10:40 AM the surveyor requested documentation of COVID results to the local department. TP stated "We only phone in positive results to the health department by Hotline #340-776-1519 and do not have a have log " During the exit interview at 5:00 PM the laboratory director confirmed the laboratory did not report positive and negative results. D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. 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 -- This STANDARD is not met as evidenced by: Based on observation and interview with the laboratory director (LD) the laboratory failed to have appropriate space necessary for conducting all phases of testing. Findings include: On 09/23/2021 at approximately 11:05 AM during a tour of the laboratory the surveyor observed the chemistry analyzer not in use in the back section of the testing area with numerous binders, files, and papers on top of the instrument. The surveyor asked if the chemistry analyzer in use for testing. The LD confirmed is was not is use, she stated, "The chemistry analyzer has not been in use since the 2016 hurricane" During the exit interview at 5:00 PM the LD confirmed the above findings. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on observation, lack of documentation, and interview the laboratory failed to provide an established policy and procedure (P&P) that ensures proper identification from specimen collection through reporting of results. Findings include: On 09/23 /2021 at approximately 10:50 AM during a tour of the laboratory the surveyor noted a specimen logbook. The surveyor requested the policy of Specimen Processing of how the laboratory labels specimens and ensures the correct test is performed and resulted with the correct specimen. The testing person (TP) verbally explained the process however no written policy was provided. During the exit interview at 5:00PM the laboratory director confirmed the laboratory does not have written procedures for specimen identification and integrity. 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 lack of documentation of

Summary Statement of Deficiencies D0000 An unannounced CLIA off-site proficiency testing (PT) review of Doctors Clinical Laboratory was conducted on July 27, 2021 by a federal surveyor from the Centers for Medicare and Medicaid Service CLIA New York Operation Branch. The laboratory was inspected under 42 CFR Part 493 CLIA regulations. Specific deficiencies cited are as follows: 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, the laboratory failed to achieve 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 -- satisfactory performance of at least 80% for three consecutive events for the Hematology analyte for the first and second testing event in 2021. ( Cross Reference D2121) D2121 HEMATOLOGY CFR(s): 493.851(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 an off-site review of the federal proficiency testing Casper Reports 0096D CLIA Application and Survey Summary Report and 0153D Unsuccessful proficiency testing (PT) report, the laboratory failed to achieve satisfactory performance of at least 80% for two out of three consecutive events for the Hematology, Hematocrit (HCT) for the first and second testing events in 2021. Findings include: 1. Review of the CASPER 153D Unsuccessful PT report and 0096D CLIA Application and Survey Summary report Hematology PT scores for the first and second testing events in 2021 revealed the following scores: a. Analyte: 0760 Hematology i. American Association of Bioanalyst 2021 1st event 53% ii.American Association of Bioanalyst 2021 2nd event 73% b. Analyte: 0785 Hematocrit (HCT) (Non-Waived) i. American Association of Bioanalyst 2021 1st event 60% ii .American Association of Bioanalyst 2021 2nd event 40% D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on an off-site review of the federal proficiency testing Casper Reports 0096D CLIA Application and Survey Summary Report and 0153D Unsuccessful proficiency testing (PT) report, the laboratory failed to participate in both first and second testing events in 2020 and 2021 resulting in a score of 0 for the testing event . Findings include: 1) Review of the CASPER 153D Unsuccessful PT report and 0096D CLIA Application and Survey Summary report cores for the first and second testing events 2020 and 2021revealed the following scores: a)Analytes: 0765 Cell I.D. or WBC Diff i) American Association of Bioanalyst 2020 Event 1 Score 0% ii) American Association of Bioanalyst 2020 Event 2 Score 0% iii) American Association of Bioanalyst 2021 Event 1 Score 0% iv) American Association of Bioanalyst 2021 Event 2 Score 0% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR -- 2 of 3 -- 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 an off-site review of the federal proficiency testing Casper Reports 0096D CLIA Application and Survey Summary Report and 0153D Unsuccessful proficiency testing (PT) report, the laboratory director failed to ensure the laboratory successfully participated in the American Associate of Bioanalyst (AAB) PT program for Hematology, Hematocrit (HCT) Non- waived and Cell I.D. or WBC Diff testing in which the laboratory is certified under CLIA. ( Cross reference D2121, D2123) -- 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: 1. Based on review of PT records and interview with the laboratory director, the laboratory failed to successfully participate in RPR Serology for second and 3rd events of 2016. The findings include: a. For QTR 2, 2016 the laboratory obtained 60% and for QTR3, 2016, the laboratory obtained 20%. b. The laboratory director stated the Styrofoam underneath the cover for the rotator had been replaced. c. She stated the laboratory successfully participated in QTR 1 and 2 in 2017, obtaining 100% in each event. d. The CLIA lab consultant discussed with the laboratory director that CMS had given a blanket waiver in PT participation for QTR3, 2017 by labs in USVI and in Puerto Rico due to natural disaster. 2. Based on review of PT records and interview 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 -- with the laboratory director, the laboratory failed to participate in QTR1, 2017 for the specialty of Hematology. The findings include: a. The laboratory director stated that AAB PT program did not send the samples because the laboratory had enrolled in the wrong CBC module. b. The laboratory director stated the laboratory no longer performed manual cell differential, and should have enrolled in Module A for automated differential, rather than Module G, which include manual cell differential. c. The laboratory consultant discussed with the laboratory director that CMS had given a blanket waiver in PT participation for QTR3, 2017 by laboratories in USVI and Puerto Rico due to natural disasters. 3. Based on review of PT records and interview with the laboratory director, the laboratory failed to participate in QTR1 2018 event for the specialty of Hematology. The laboratory director stated that CBC Quality Control samples for Act Diff2 Coulter instrument did not come on time from the supplier for the PT samples to be tested. -- 2 of 2 --