Cvfp-Walk In-Amherst

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Physicians Treatment Center of Amherst on 01/12/23 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: The laboratory is performing COVID-19 testing and is in compliance with the applicable COVID-19 reporting requirements. 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 the review of the CASPER 0096D CLIA Application and Survey Summary Report, proficiency testing (PT) records and an interview, the laboratory failed to participate in one of four Complete Blood Count (CBC) events reviewed. Record review included second and third PT events in 2021 and the first two events in 2022. Findings include: 1. Review of the CASPER 0096D CLIA Application and Survey Summary Report and the American Proficiency Institute (API) PT records for the second and third events in 2021 and the first two events in 2022 revealed the 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 -- laboratory received a score of 0% for the following event: 2022 Event 2- 0%- for the CBC module (Notation by API-failure to participate). 2. An exit interview with the testing personnel and lab consultants on 01/12/23 at 1310 confirmed the findings. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of quality control (QC) records, lack of documentation, and interview, the laboratory failed to retain the "Boule Con-Diff Hematology Control " manufacturer's assay information inserts documenting Complete Blood Cell (CBC) count QC acceptable ranges for ten of ten lot numbers utilized from 04/01/21 up to 12 /22/22. Findings include: 1. Review of the laboratory's end of the QC lot instrument printouts from 04/01/21 up to 12/22/22 revealed the laboratory received and utilized ten lot numbers of the "Boule Con-Diff Hematology Control". The following QC lot numbers lacked documentation of acceptable ranges or manufacturer's package inserts: 1013, 1043, 1053, 1073, 1103, 1093, 0101, 0401, 0701, and 0933. The inspector requested to review the aforementioned package inserts. The documentation was not available for review. 2. An exit interview with the testing personnel and lab consultants on 01/12/23 at 1310 confirmed the findings. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on observation of hematology procedures, review of policy and procedures (P&P), lack of documentation, and interviews, the lab failed to implement a mechanism to verify the accuracy of manually transcribed patient results from the Medonic hematology analyzer printout into the Athena electronic health record (EHR) at the date of survey on 01/12/23. Findings include: 1. An observation and interview with the testing personnel (TP) on 01/12/23 at approximately 1245 revealed the TP print the patient's complete blood count (CBC) results from the Medonic hematology analyzer. The results are manually transcribed into the Athena EHR. A barcode label is placed on the printed CBC result and then later scanned into the patient's chart. In addition, the TP stated that either the manually transcribed CBC results in Athena or the scanned copy of the CBC results would be provided to patients upon request. 2. Review of the P&P revealed a lack of documentation of a procedure to verify the accuracy of the manually transcribed CBC results into the Athena EHR. 3. An exit -- 2 of 3 -- interview with the lab consultants on 01/12/23 at 1310 confirmed the lab did not have a mechanism to ensure accuracy of manually transcribed patient CBC results into the Athena EHR. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification on-site survey was conducted at the Physicians Treatment Center of Amherst on March 9, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The initial contact and entrance interview with laboratory conducted on February 22, 2021 with off-site record review of documentation and a follow-up email on March 4, 2021. Specific deficiencies cited are as follows: The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D2000 - 42 C.F.R. 493-801 Condition: Enrollment and Testing of Samples. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of proficiency testing (PT) records and interviews, the laboratory failed to enroll in a hematology PT complete blood count (CBC) module for the first and second events in 2019. (Cross Reference D 2123.) D2123 HEMATOLOGY CFR(s): 493.851(c) 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 -- 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 the review of proficiency testing (PT) records, lack of documentation, and interviews, the lab failed to enroll in a hematology PT complete blood count (CBC) module for the first and second events in 2019. Record review include 2019 and 2020 PT event documents. Findings include: 1. Review of the CASPER Report 0096D CLIA Application and Survey Summary revealed lack of documentation of scores for the first and second events in 2019. 2. A phone call with an American Proficiency Institute (API) service representative on 03/04/21 at 11:18 AM confirmed that the site did not enroll with their hematology (CBC) module until 10/29/19. In addition, review of the available API hematology PT records on 03/04/21 for 2019 and 2020 revealed lack of documentation of enrollment with a PT program for the CBC module. 3. An interview with the lab consultant and primary testing personnel on 03/09/21 at 11:00 AM confirmed that the lab did not enroll for the first two events in 2019 for the CBC module. D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on the review of proficiency testing (PT) documents and interview, the laboratory failed to submit one (1) of 4 PT events within the PT program's established timeframe in the calendar year 2020. PT events reviewed include one event in 2019 and three events 2020. Findings include: 1. Review of the CASPER Report 0096D CLIA Application and Survey Summary revealed the lab received a score of 0% for the second event in 2020. 2. Review of the American Proficiency Institute (API) records revealed documentation by the lab director that the lab staff failed to submit the results of the 2nd Hematology Event within the timeframe established by API. The lab received a score of 0%. 3. An interview with the lab consultant and primary testing personnel on March 09, 2021 at approximately 11:30 AM confirmed the findings. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the review of the manufacturer operator's guide, lack of documentation, and interview, the lab failed to perform the monthly maintenance for the Medonic M- series hematology analyzer for twenty-five (25) of 25 months. Dates of record review include January 1, 2019 and up to the date of survey on March 9, 2021. Findings include: 1. Review of the manufacturer operator's guide revealed instructions for performing monthly cleaning procedures utilizing the Boule Cleaning Kit (cleaning procedure and clot prevention) listed under "Section 8: Cleaning, Maintenance & Transport", "8.2 Monthly Cleaning". 2. Review of the available maintenance records for the analyzer revealed lack of documentation of the performance of the monthly maintenance. Dates of record review include January 1, 2019 and up to the date of survey on March 9, 2021 (25 months). The inspector requested to review aforementioned documents on 03/09/21 at approximately 12:00 PM. The primary testing personnel stated that they were not aware that the procedures needed to be done on the instrument and did not perform the procedures. 3. An interview with the lab consultant and primary testing personnel on 03/09/21 at 12:45 PM confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Physicians Treatment Center of Amherst on December 4, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited 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 the review of proficiency testing (PT) records and interview, the testing personnel (TP) failed to sign three (3) of the three (3) attestation statements reviewed. Findings include: 1. Review of the American Proficiency Institute (API) hematology PT records for all two (2) events in 2017 and one (1) event in 2018 revealed a lack of the TP signature on the attestation statements for the following: 2017 Event B, 2017 Event C, 2018 Event A. 2. An interview with the primary TP and lab consultant at approximately 12:00 PM confirmed the findings. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing 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 -- samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on the review of proficiency testing (PT) records and interview, the laboratory failed to maintain the original Complete Blood Count (CBC) test records for three (3) of the three (3) events reviewed. Findings include: 1. Review of the American Proficiency Institute (API) hematology PT records for the two (2) events in 2017 and one (1) event in 2018 revealed no original CBC testing records for the following events: 2017 Event B, 2017 Event C, 2018 Event A. 2. An interview with the primary testing personnel and lab consultant at approximately 12:00 PM confirmed the findings. 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 the review of proficiency testing (PT) records and interview, the laboratory failed to participate in one (1) of the four (4) Complete Blood Count (CBC) module events reviewed. Record review included 2017 and 2018 testing events. Findings include: 1. Review of the CASPER 096 Laboratory Application and Survey Summary Report and the American Proficiency Institute (API) PT records revealed the laboratory received a score of 0% for the 2018 Event B CBC module due to a failure to participate. 2. An interview with the primary testing personnel and lab consultant at approximately 12:00 PM confirmed the above-listed findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the manufacturer operator's guide, policy/procedures, hematology -- 2 of 5 -- records, quality assurance (QA) records, testing personnel (TP) records and interviews, the laboratory failed to 1) follow manufacturer's instructions for performing instrument calibrations (Cross Reference D5437); and 2) follow the established QA policy (Cross Reference D5791). **Repeat 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 review of the manufacturer operator's guide, instrument calibration records, and interview, the laboratory failed to follow manufacturer's instructions for the performance of calibration procedures at least once every six (6) months in calendar year 2018. Findings include: 1. Review of the Beckman Coulter Operator's guide- 5.1 Calibration procedures reveals that the laboratory testing personnel are to perform calibration procedures at least once every six (6) months. 2. Review of the calibration records for the instrument revealed calibration performed on May 24, 2017 and September 20, 2017. Calibration documentation was not available for review for the calendar year 2018. 3. An interview with the lab consultant at approximately 12:00 PM confirmed the above-listed findings. *This is a repeat deficiency. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of policy/procedures, hematology records, quality assurance (QA) records, testing personnel (TP) records and interviews, the laboratory failed to follow the established QA policy from June 1, 2017 and up to the date of survey on December 4, 2018. Findings include: 1. Review of the QA policy (signed by the lab director 11/28/2016) revealed the following statements: " Three major phases of laboratory testing evaluated are as follows: 1. Pre-analytical a. Specimen collection b. Storage and processing c. Personnel training 2. Analytical a. Quality control b. Preventative maintenance c. Calibrations and calibration verifications 3. Post- analytical a. Result reporting b. Turn-around times Implementation of a Quality Assessment Program: the major processes to be evaluated are organized by month. The frequency of QA reviews will vary depending on the area of review. Areas that -- 3 of 5 -- are particularly problematic or have a greater potential to affect the quality of patient test results will be reviewed at a greater frequency. A problem log will be utilized to enable visual recognition of patterns and trends. Monthly checklists are provided for each of these reviews." 2. Review the hematology records from June 1, 2017 and up to the date of survey revealed no documentation of the monthly checklists. Documentation of the review of QC records was not available for review. 3. Review of the instrument calibration records revealed no documentation of the performance of the required 6-month calibration in 2018 (Cross Reference D5437). 4. Review of personnel records revealed no documentation of training or competency assessments performed for 2 new TP in 2017 and 2018 (Cross Reference D6029). 5. An interview with the primary TP and lab consultant at approximately 12:00 PM confirmed the above-listed findings. **Repeat deficiency. 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 manufacturer operator's guide, policy/procedures, hematology records, quality assurance (QA) records, testing personnel (TP) records and interviews, the laboratory director failed to 1) follow the established QA policy (Cross Reference D6021); and 2) ensure TP received training and perform competency assessments prior to patient testing in 2017 and 2018 (Cross Reference D6029). D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of policy/procedures, hematology records, quality assurance (QA) records, testing personnel (TP) records and interviews, the laboratory director failed to follow the established QA policy from June 1, 2017 and up to the date of survey on December 4, 2018. (Cross Reference D5791). D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel -- 4 of 5 -- have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records and interviews, the laboratory director failed to ensure that two (2) of two (2) new TP had documented training and competency assessments prior to performing patient testing procedures for hematology from November 15, 2017 and up to the date of survey on December 4, 2018. Findings include: 1. Review of CLIA CMS-209 form revealed that TP A and TP B were new TP (See attached TP Code Sheet). 2. Review of TP records and an interview with the lab consultant at approximately 10:30 AM revealed that just prior to on-site survey, the training and competency assessment documents for TP A and TP B were completed. There was no documentation of training or competency assessments prior to patient testing procedures by the laboratory director for the following TP: TP A- hired and performing testing November 15, 2017; TP B- hired and performing testing July 9, 2018. 3. An interview with the lab consultant and primary TP at approximately 12:00 PM confirmed the above-listed findings. -- 5 of 5 --