Panacea O'Neill Medical Group

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 laboratory's proficiency testing provider, WSLH (Wisconsin State Laboratory of Hygiene) Proficiency Testing. The laboratory was found to be out of compliance with CONDITION LEVEL DEFICIENCIES, as follows: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate 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 off-site proficiency testing (PT) desk reviews of the CASPER Reports 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 -- 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from WSLH (Wisconsin State Laboratory of Hygiene) Proficiency Testing, the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for White Blood Cells (WBC), WBC Differential, Hemoglobin, and the Specialty of Hematology. The laboratory failed two consecutive PT events in 2024-2025, resulting in initial unsuccessful proficiency testing performance. Refer to D2130 and D2131. . D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), an interview with the Laboratory Director, and an email with PT evaluation reports from WSLH (Wisconsin State Laboratory of Hygiene) Proficiency Testing, the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for White Blood Cells (WBC), WBC Differential, and Hemoglobin in two consecutive 2024-2025 events, resulting in initial unsuccessful performance. The findings included: 1. Based on review of the CASPER Report 0153D and 0155D Individual Laboratory Profile reports, the laboratory received failing scores in two consecutive events, resulting in initial unsuccessful PT performance, as follows: A. 2024-Event #3: 40% for White Blood Cells; 0% for the WBC Differential; and 0% for Hemoglobin B. 2025-Event #1: 20% for White Blood Cells; 0% for the WBC Differential; and 0% for Hemoglobin 2. In a telephone interview on 4/14/2025 at 10:35 AM, the Laboratory Director confirmed the failing scores, stating the laboratory had a new Hematology analyzer, a Beckman Coulter DxH520. The laboratory had failed to order compatible PT for the new instrument for Event #3, 2024, and failed to specify the correct PT module in the 2025 re-enrollment order with WSLH. 3. In a 4/14/2024 email, the WSLH representative provided the laboratory's PT results, confirming the above scores. In addition, the representative stated WLSH provided instructions on ordering the correct PT module, but the laboratory "never followed through with letting us know of the needed program change at re-enrollment time ...". . D2131 HEMATOLOGY CFR(s): 493.851(g) (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 off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), an interview with the Laboratory Director, and an email with PT evaluation reports from WSLH (Wisconsin State Laboratory of Hygiene) Proficiency Testing, the laboratory failed to successfully participate (achieve scores of -- 2 of 3 -- 80% or greater) in proficiency testing for the specialty of Hematology in two consecutive 2024-2025 events, resulting in initial unsuccessful performance. The findings included: 1. Based on review of the CASPER Report 0153D and 0155D Individual Laboratory Profile reports, the laboratory received failing scores in two consecutive events, resulting in initial unsuccessful PT performance, as follows: A. 2024-Event #3-Hematology: 50% B. 2025-Event #1-Hematology: 50% 2. In a telephone interview on 4/14/2025 at 10:35 AM, the Laboratory Director confirmed the failing scores, stating the laboratory had a new Hematology analyzer, a Beckman Coulter DxH520. The laboratory had failed to order compatible PT for the new instrument for Event #3, 2024, and failed to specify the correct PT module in the 2025 re-enrollment order. 3. In a 4/14/2024 email, the WSLH representative provided the laboratory's PT results, confirming the above scores. In addition, the representative stated WLSH provided instructions on ordering the correct PT module, but the laboratory "never followed through with letting us know of the needed program change at re-enrollment time...". . 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 off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), an interview with the Laboratory Director, and an email with proficiency testing evaluation reports from WSLH (Wisconsin State Laboratory of Hygiene) Proficiency Testing, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D6016. . D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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 off-site proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), an interview with the Laboratory Director, and an email with PT evaluation reports from WSLH (Wisconsin State Laboratory of Hygiene) Proficiency Testing, the laboratory director failed to ensure the laboratory had successful participation in an HHS approved proficiency testing program for White Blood Cells (WBC), WBC Differential, Hemoglobin, and the Specialty of Hematology for two consecutive 2024 - 2025 WSLH PT events, resulting in initial unsuccessful participation. Refer to D2130 and D2131. -- 3 of 3 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of the Laboratory Personnel Report (CMS-209), a review of API (American Proficiency Institute) and Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records and an interview with Testing Personnel #1, the laboratory failed to ensure proficiency testing samples were rotated between all personnel who performed patient testing. This was noted for two testing personnel on five out of six Hematology proficiency testing events reviewed for 2022 and 2023. This is a repeat deficiency. The findings include: 1. A review of the laboratory's current Laboratory Personnel Report revealed two Testing Personnel that should be participating in and rotating proficiency testing samples. 2. A review of API and WSLH attestation statements revealed: a. Testing Personnel #1 performed 2022 Events 1-3 and 2023 Events 1 and 2. b. Testing Personnel #2 performed 2023 3rd Event. 3. During an interview on 2/13/2024 at 11:44 AM, Testing Personnel #1 confirmed the above findings. 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) 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 -- (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 a review of the Hematology calibration records, Horiba ABX Micros 60 hematology analyzer user manual, and an interview with Testing Personnel #1, the Laboratory failed to perform calibration on the Horiba ABX Micros 60 analyzer every six months as per the manufacturers recommendation. This was noted for one of four calibrations reviewed from 2022 to 2024. The laboratory failed to perform one calibration due January 2024. The findings include: 1. A review of the Hematology calibration records revealed the Micros 60 was calibrated on 7/7/2022, 1/16/2023, and 7/18/2023. There was no documentation of a calibration performed January 2024. 2. A further review of the Micros 60 user manual revealed on the resource page, "The manufacturer recommends calibrating the device every 6 months." 3. During an interview on 2/13/2024, at 11:53 AM, Testing Personnel #1 confirmed the calibration due January 2024 was not performed. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of API (American Proficiency Institute) proficiency testing (PT) records and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to ensure proficiency testing samples were rotated between all personnel who performed patient testing. This was noted on six out of seven Hematology surveys reviewed for 2019 (3rd Event), 2020 (all three events), and 2021 (all three events). The findings include: 1. A review of API attestation statements revealed Testing Personnel #1 had performed all the testing on six out of seven Hematology surveys reviewed. 2. During an interview on 03/08/2022 at 11:45 AM, Testing Personnel #1 confirmed the proficiency testing was not rotated with Testing Personnel #2 because she was not comfortable with her running the PT samples. The surveyor asked if Testing Personnel #2 performed patient testing; Testing Personnel #1 confirmed has performed patient testing since August 2020. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION 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 3 -- Based on a review of the Laboratory Personnel Report (CLIA CMS - 209), personnel records, and an interview with the Laboratory Director, the laboratory failed to have a qualified individual to fulfull the position as Technical Consultant. This was noted from July 2021 to the survey date (03/08/2022). The findings include: 1. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on a review of the Laboratory Personnel Report (CLIA CMS - 209), personnel records, and an interview with the Laboratory Director, the laboratory failed to have a qualified individual to fulfill the position as the Technical Consultant. This was noted from July 2021 to the survey date (03/08/2022). The findings include: 1. A review of the Laboratory Personnel Report (CLIA CMS - 209) revealed the Laboratory Director intended to fulfill the position as the Technical Consultant. 2. A review of the personnel records revealed the Laboratory Director could not provide documentation of at least one year of laboratory training or experience in non-waived testing for -- 2 of 3 -- Hematology, and thus failed to meet the CLIA requirements to qualify as the Technical Consultant. 3. During an interview on 03/08/2022 at 10:35 AM, the Laboratory Director confirmed the above findings. -- 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 review of the CMS (Centers for Medicare and Medicaid) CASPER Reports for Proficiency Testing (PT), API (American Proficiency Institute) PT evaluations, and telephone interview with testing personnel, the surveyor determined the laboratory failed to successfully participate in Hematocrit (HCT) for three out of four consecutive events Event #3 2020, Event #1 2021, and Event #3 2021. The failures of HCT for these three out of four consecutive events resulted in a non-initial unsuccessful participation. The findings include: 1. Refer to D2123. 2. Refer to D2130. 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 -- 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 a review of the CMS (Centers for Medicare and Medicaid Services) Casper reports, a review of the API (American Proficiency Institute) proficiency testing records, and a telephone interview with testing personnel, the surveyor determined the laboratory failed to participate in Hematocrit (HCT) testing for Events #3 2021. This failure along with D2130 resulted in a non-initial unsuccessful participation for the laboratory. The finding include: 1. A review of the CASPER reports revealed the laboratory failed to participate in 2021 Event #3 resulting in a score of zero for HCT. 2. A review of the API proficiency testing confirmed the above noted findings. 3. During a telephone interview on 02/04/2022 at 10:00 AM, the testing personnel explained when the samples came in for Event #3 2021 she was the only testing personnel trained to perform Proficiency Testing (PT), and was out of the office, due to being sick. New Testing Personnel was performing patient testing for for Complete Blood Count (CBC which included the HCT) during this time. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CMS (Centers for Medicare and Medicaid Services) Casper reports, a review of the API (American Proficiency Institute) proficiency testing records, and a telephone interview with testing personnel, the surveyor determined the laboratory failed to satisfactorily perform in proficiency testing for Hematocrit (HCT) testing for three out of four consecutive testing events. These failures resulted in a non- initial unsuccessful participation for the laboratory The finding include: 1. A review of the CASPER reports revealed the laboratory scored forty percent (40 %) for HCT for Event #3 2020 and sixty percent (60 %) for Event #1 2021. For 2021 Event #3 the laboratory failed to participate resulting a score of zero for HCT. 2. A review of the API proficiency testing confirmed the above noted findings. 3. During a telephone interview on 02/04/2022 at 10:00 AM, the testing personnel explained when the samples came in for Event #3 2021 she was the only testing personnel trained to perform Proficiency Testing (PT), and was out of the office, due to being sick. New Testing Personnel was performing patient testing for for Complete Blood Count (CBC which included the HCT) during this time -- 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 the CMS (Centers for Medicare and Medicaid) CASPER reports and a review of the American Proficiency Institute (API) proficiency testing reports, the surveyor determined the Laboratory Director failed to fulfill the Laboratory Director's responsibilities. The failures of Hematocrit (HCT) for these three out of four consecutive events resulted in a non-initial unsuccessful participation. The findings include: 1. 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 the CMS (Centers for Medicare and Medicaid) CASPER reports and a review of the American Proficiency Institute (API) proficiency testing reports, the surveyor determined the Laboratory Director failed to ensure proficiency testing samples are tested as required. This affected Hematology [Complete Blood Count (CBC) which include Hematocrit] testing for Event #3 2021. The findings inlcude: 1. Refer to D2123. 2. Refer to D2130. -- 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 review of the CMS (Centers for Medicare and Medicaid) CASPER reports and a review of API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory failed to successfully participate in proficiency testing for Hematocrit (HCT) for two consecutive testing events. These failures resulted in an initial unsuccessful participation. This affected Event #3, 2020 and Event #1, 2021. The findings include: 1. A review of the CASPER reports revealed the laboratory scored forty percent (40 %) for HCT for Event #3, 2020, and 60 % 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 2 -- Event #1, 2021. These two consecutive failures of the same analyte resulted in an initial unsuccessful participation in proficiency testing. 2. A review of the API testing evaluations confirmed the above noted findings. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CMS CASPER reports and a review of API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory failed to satisfactorily perform in proficiency testing for Hematocrit (HCT) for two consecutive testing events. These failures resulted in an initial unsuccessful participation. This affected Event #3, 2020 and Event #1, 2021. The findings include: 1. A review of the CASPER reports revealed the laboratory scored forty percent (40 %) for HCT for Event #3, 2020, and 60 % for Event #1, 2021. These two consecutive failures of the same analyte resulted in an initial unsuccessful participation in proficiency testing. 2. A review of the API testing evaluations confirmed the above noted findings. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the 2017 - 2019 API (American Proficiency Institute) proficiency testing records and an interview with Testing Personnel (TP) #2, the laboratory failed to ensure attestation statements for four out of seven surveys were signed by the Laboratory Director and the testing personnel. The findings include: 1. A review of the API Proficiency Testing (PT) records revealed missing signatures of the Laboratory Director or the Testing Personnel on the attestation statements for the following Hematology surveys: A) 2017-Event #3, 2018-Event #1 and 2019-Event #2: No signature by the Laboratory Director B) 2018-Events #1 and #3: No signatures by the Testing Personnel (The names of the Laboratory Director, TP #1 and a previous TP had been written in the "Testing Analyst" section (not signed by the actual personnel). 2. In an interview on 9/3/2019 at 3:10 PM, the surveyor reviewed the API directions on the attestation statement which specified the Laboratory Director and Testing Analysts must physically sign the document. TP #2 confirmed TP #1 had written in the names on the attestation statements for the 2018-Events #1 and #3 surveys. TP #2 further confirmed the Laboratory Director had failed to sign three of the attestation statements. 3. In addition the above noted findings were reviewed with the Practice Manager on 9/3/2019 at 3:25 PM. . D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- patient samples. This STANDARD is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency testing records and an interview with Testing Personnel (TP) #2, the laboratory failed to ensure proficiency testing samples were tested the same number of times as patient samples. This was noted on one of seven surveys reviewed. The findings include: 1. A review of the 2018 Event #3 API proficiency testing records revealed three CBC (Complete Blood Count) printouts for each API PT Hematology sample (11-15), for a total of 15 printouts for the survey, all run on 11/13/2018. The surveyor noted at least two of the samples were relatively normal, and there were no error codes indicating sample problems. 2. In an interview on 9/3/2019 at 3:10 PM, the surveyor reviewed the 2018 Event #3 API proficiency testing records with TP #2 who confirmed patient CBC samples are not routinely run three times each unless there is a problem. TP #1 was unable to explain why testing personnel ran the PT sample from this survey multiple times. Thus the above noted findings were confirmed. 3. In addition the above noted findings were reviewed with the Practice Manager on 9/3/2019 at 3:25 PM. . D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency testing (PT) records and an interview with Testing Personnel #2, the surveyor determined the laboratory failed to investigate and perform