Beckwith Medical Group, Pllc

Summary Statement of Deficiencies D0000 An unannounced off-site proficiency testing desk review of Beckwith Medical Group, PLLC was conducted on May 1, 2023 by a Medical Facilities Inspector of the Virginia Department of Health's Office of Licensure and Certification. The laboratory was inspected under 42 CFR Part 493 CLIA regulations. The laboratory was not in compliance with the following Conditions under 42 CFR part 493 CLIA Regulations: D2016 - 42 C.F.R. 493.803 (a)(b)(c) Condition- Successful Participation. 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 an off-site desk review of the laboratory's American Proficiency Institutes proficiency testing (PT) records (2022 Third Event and 2023 First Event) and 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 -- interview, the laboratory failed to attain a score of at least eighty percent of acceptable responses for White Blood Cell count (WBC), Red Blood Cell count (RBC), Hemoglobin (HGB) Hematocrit (HCT), Platelet count (PLT) and WBC Differential (WBC diff) in two consecutive Hematology testing events resulting in unsuccessful PT performance. See 2130. 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 an off-site desk review of the laboratory's proficiency testing (PT) records and interview, the laboratory failed to attain a score of at least eighty percent (80%) of acceptable responses for White Blood Cell count (WBC), Red Blood Cell count (RBC), Hemoglobin (HGB) Hematocrit (HCT), Platelet count (PLT) and WBC Differential (WBC Diff) for two (2) consecutive hematology testing events resulting in unsuccessful PT performance. Findings include: 1. Desk review of the laboratory's American Proficiency Institute (API) PT records revealed WBC, RBC, HCT, HGB, PLT and WBC Diff scores of less than 80% for the following 2 consecutive hematology events: 2022 Event 3 - WBC=60%; RBC=60%; HGB=60%; HCT=60%; PLT=60%; and WBC diff=73%; 2023 Event 1 - WBC, RBC, HGB, HCT, PLT and WBC diff=0%, Unsuccessful, Failure to Participate; resulting in unsuccessful PT performance. 2. In a telephone interview with the Technical Consultant on May 1, 2023, at approximately 12:45 PM, the findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Beckwith Medical Group, PLLC on October 7, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Beckwith Medical Group, PLLC is performing COVID-19 testing and is in compliance with the applicable COVID-19 reporting requirements. The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D5400 - 42 C.F.R. 493.1250 Condition: Analytic Systems; D6000 - 42 C. F.R. 493.1403 Condition: Moderate complexity laboratory director. The specific deficiencies are as follows: 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 laboratory's proficiency testing (PT) records, lack of documentation, and an interview, the Laboratory Director (LD) and testing personnel (TP) failed to sign two (2) of seven (7) PT attestation statements from July 2019 to October 2021. Findings include: 1. Review of the American Proficiency Institute (API) PT records from July 2019 until October 2021 revealed the following PT event attestation statements were not signed by the Laboratory Director (LD) and Testing Personnel (TP): API 2019 Event 2 and API 2019 Event 3. Two (2) of 7 attestation statements were not signed by Laboratory Director and TP. The surveyor requested to review the signed attestation statements for the PT events listed above. The laboratory provided no documentation for review. 2. In an exit interview with the director of operations on October 7, 2021 at approximately 11:45 AM, the findings were confirmed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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 a review of Centers for Medicare and Medicaid Services CASPER 0096D report form (CMS CASPER 96), proficiency testing (PT) records, and an interview, the laboratory failed to attain an overall score of at least eighty (80) percent (%) of acceptable responses for Hematology in two (2) of seven (7) PT testing events from July 2019 until October 2021. Findings include: 1. Review of the CMS CASPER 96 report included an overall unsatisfactory PT score for the speciality of Hematology for 2020 Event 1 with a score 75% and an unsatisfactory analyte score for Cell Identification for 2021 Event 1 of 67%. 2. Review of the laboratory's American Proficiency Institute (API) PT records from July 2019 until October 2021 revealed the following unsatisfactory scores: 2020 Event 1 Hematology/Coagulation scored as 75% with individual scores of Red Blood Cell count 60% and Hematocrit 60%; 2021 Event 2 Hematology/Coagulation scored as Cell Identification 67%. 3. In an exit interview with the director of operations on October 7, 2021 at approximately 11:45 AM, the findings were confirmed. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policy and procedure manual, proficiency testing (PT) records, and interviews, the laboratory failed to follow their established policy and investigate three (3) unsatisfactory results in two (2 ) of seven (7) Hematology PT events from July 2019 until October 2021. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) PT records from July 2019 to October 2021, a total of 7 events, revealed a lack of evidence of the investigation for the following 3 unsatisfactory Hematology PT results: API 2020 - Event 1 Red Blood Cell Count (RBC) scored as 60% and Hematocrit (HCT) scored as 60%; API 2021 - Event 1 Cell Identification scored as 67%. The surveyor requested documentation of the investigation of API 2020 Event 1 RBC, HCT and API 2021 Event 1 Cell ID. The laboratory provided no documentation for review. 2. Review of the laboratory's policy and procedure manual revealed a "Monthly QA Checklist" with a statement, "PT failures were investigated and remedial action was documented." The surveyor requested to review the "Monthly QA Checklists" and

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Beckwith Medical Group on July 18, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies are as follows: 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 a review of the proficiency testing (PT) records, policy and procedure manual, and an interview with Testing Personnel A (TP A), the laboratory lacked a written policy to assess and address unacceptable analyte scores of less than one- hundred (100) percent (%) for four (4) of seven (7) American Proficiency Institute (API) events reviewed from November 2017 to July 2019. Findings include: 1. Review of the laboratory's API PT events revealed the following: 2018 Chemistry Core Event 1-Free Thyroxine=80%; 2018 Hematology/Coagulation Event 2- Erythrocyte Count=80%; 2018 Hematology/Coagulation Event 3-Erythrocyte Count, Hematocrit, MCH, MCHC, Platelet Count=80%; 2019 Hematology/Coagulation Event 1-Erythrocyte Count, Hematocrit, Hemoglobin, Leukocyte Count, MCH, MCHC=80%. A total of 4 events. The surveyor requested documentation of the assessment and remedial action taken for the PT events listed above. 2. Review of the laboratory's policy and procedure manual revealed a lack of a written policy for assessing and documenting remedial action taken for unacceptable analyte scores of less than 100 %. 3. In an exit interview with TP A at approximately 1:45 PM, TP A confirmed the findings. 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 -- D5781

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --