Shenandoah Oncology, Pc

Summary Statement of Deficiencies D0000 An off-site CLIA proficiency testing desk review of Shenandoah Oncology, PC was completed on April 23, 2024 by a Medical Facilities Inspector of the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The laboratory was found 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. 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: 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 proficiency testing (PT) desk review of the laboratory's Certification and Survey Provider Enhanced Reporting (CASPER)-0155 report and American Association of Bioanalysts/Medical Laboratory Evaluation (AAB/MLE) records for 2023 (Events one, two and three), and 2024 (Event one), the laboratory failed to successfully participate in a proficiency testing program approved by Health and Human Services (HHS), for the analyte chloride. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 proficiency testing (PT) desk review of the laboratory's Certification and Survey Provider Enhanced Reporting (CASPER)-0155 report and American Association of Bioanalysts/Medical Laboratory Evaluation (AAB/MLE) evaluation reports for 2023 (Events one, two and three), and 2024 (Event one), the laboratory failed to achieve satisfactory performance (80%) for the analyte chloride for three of four events reviewed. The laboratory had unsatisfactory scores for chloride for 2023 Event one (1), 2023 Event two (2) and 2024 Event one (1) resulting in non-initial unsuccessful participation. The findings include: 1. Review of the CASPER-0155 report revealed the following unsatisfactory scores: 2023 Event 1: Chloride = 40%, 2023 Event 2: Chloride = 40%, 2024 Event 1: Chloride = 40%. 2. A review of the laboratory's 2023 and 2024 AAB/MLE PT scores for the analyte chloride confirmed the above findings resulting in non-initial unsuccessful participation for the analyte chloride. 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 a proficiency testing (PT) desk review of the laboratory's Certification and Survey Provider Enhanced Reporting (CASPER)-0155 report and the American Association of Bioanalysts/Medical Laboratory Evaluation (AAB/MLE) 2023 (Events one, two and three), and 2024 (Event 1) result reports, the laboratory director failed to provide overall management and direction of laboratory services. 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 -- 2 of 3 -- required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the laboratory's Certification and Survey Provider Enhanced Reporting (CASPER)-0155 report and American Association of Bioanalysts/Medical Laboratory Evaluation (AAB/MLE) for 2023 (Events one, two and three), and 2024 (Event 1) result reports, the laboratory director failed to ensure the laboratory successfully participated in a proficiency testing program for the analyte chloride for three of four events. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An unannounced, off-cite CLIA proficiency testing (PT) desk review was conducted for Shenandoah Oncology, PC on July 13, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and include the following condition under 42 CFR part 493 CLIA Regulation: D2016 - 42 CFR. 493.803 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 2023 proficiency testing (PT) records, a total of two (2) events, and interview, the laboratory failed to attain a score 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 -- of at least eighty (80) percent of acceptable responses for Chloride in two (2) consecutive Chemistry testing events resulting in unsuccessful PT performance. See 2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 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 (80) percent of acceptable responses for Chloride in two (2) consecutive Chemistry testing events (2023 Event 1 and 2) resulting in unsuccessful PT performance Findings include: 1. Desk review of the laboratory's 2023 American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) PT records, a total of 2 events, revealed Chloride scores of less than 80% for the following Chemistry events: AAB-MLE 2023 1st event - Chloride score of 20%, AAB-MLE 2023 2nd event - Chloride score of 40%, resulting in an unsuccessful PT performance. 2. In a telephone interview with the laboratory manager on July 13, 2023, at approximately 9:35 AM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced virtual CLIA recertification survey was conducted for Shenandoah Oncology, PC on January 26, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on December 21, 2020 and virtual record review conducted on January 22, 2021. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiency is as follows: D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures, manufacturer's instructions, equipment maintenance records, and interviews, the laboratory failed to establish maintenance and calibration protocols for pipettes used for dilution of patient specimens for analysis from March 2019 until January 2021. Findings include: 1. During the virtual survey, at approximately 12:40 PM on January 26, 2021, the inspector inquired if pipettes where used in the Chemistry testing area. Testing personnel A (TP A) stated they use pipettes for diluting patient specimens for testing on the TOSOH chemistry analyzer. TP A provided a copy of the manufacturer's instructions for a Eppendorf Reference 2 1-Channel pipette. 2. Review of the manufacturer's instructions for the Eppendorf Reference 2 1-channel pipette revealed the following statement, "Maintenance-Check the performance of your pipettor 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 -- regularly e.g. every 3 months and after every in-house service or maintenance. Calibration-Each pipette has been checked conforming to EN ISO 8655 standards. It is recommended to check the calibration at lease once per year for regularly used pipettes." 3. Review of the laboratory's policies and procedures revealed no policy or procedure for the maintenance and calibration of the Eppendorf Reference 2 1- Channel pipette. The surveyor requested to review written maintenance and calibration protocols for the pipettor. TP A stated they did not have a policy. TP A stated they purchase new pipettes every two years. 4. Review of the laboratory's equipment maintenance records from March 2019 until January 2021 revealed two pipettor "Calibration Reports" for the following pipettors: a. Serial number NF99650 with a report date of 6/6/2018 and received date of 2/6/19 (calibration due 2/2020); b. Serial number P1239755 with a report date of 9/9/2020 and received date of 1/13 /2021 (calibraton current). The inspector requested additional pipette calibration documentation. The laboratory provided no additional documentation to review. 5. In an interview with the Technical Consultant and TP A at 12:45 PM on January 26, 2021, the findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Shenandoah Oncology, PC on February 28, 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: D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of analyzer validation records, user guide, patient test logs, and an interview, the laboratory director (LD) failed to verify the normal values (reference ranges) for the Sodium, Potassium, Chloride, Carbon Dioxide, Creatinine, Calcium, Albumin, Alkaline Phosphotase, Alanine Transaminase (ALT), Aspartine Aminotranferase (AST), BUN, Glucose, Total Bilirubin, Direct Bilirubin and Total Protein testing prior to reporting fourteen thousand six hundred ninety-three (14,693) patient results from October 17, 2017 to the date of the survey, February 28, 2019. Findings include: 1. Review of the Horiba Pentra C 400 validation records revealed a new instrument installation occurred on 10/10/17. The inspector noted the validation documentation contained no verification of the Sodium, Potassium, Chloride, Carbon Dioxide, Creatinine, Calcium, Albumin, Alkaline Phosphotase, Alanine Transaminase (ALT), Aspartine Aminotranferase (AST), BUN, Glucose, Total Bilirubin, Direct Bilirubin and Total Protein patient normal values by the LD for the new Horiba Pentra 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 -- C 400 instrument (Serial Number 707CU-0531). The surveyor requested documentation of the normal range verification. No documentation was provided by the laboratory. 2. Review of the Horiba Pentra 400 User's Guide for new instrument installation revealed the instruction: "The patient reference ranges must be validated by the Lab Director". 3. Review of the patient test log from the laboratory's electronic medical record, Orchard Harvest, revealed the laboratory reported 14,693 patient results from 10/17/17 to the date of the survey on 2/28/19. 4. An interview with the Lab Director and testing personnel A, at approximately 3:00 PM, confirmed the findings listed above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced, off-cite CLIA proficiency testing (PT) desk review was conducted for Shenandoah Oncology, PC on December 3, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed 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 an off-site desk review of the laboratory's 2017 and 2018 proficiency testing (PT) records, a total of six (6) events, and interview, the laboratory failed to attain a 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 -- score of at least eighty (80) percent of acceptable responses for Chloride in two (2) of three (3) Chemistry testing events resulting in unsuccessful PT performance. See 2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 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 (80) percent of acceptable responses for Chloride in two (2) of three (3) Chemistry testing events resulting in unsuccessful PT performance Findings include: 1. Desk review of the laboratory's 2018 Medical Laboratory Evaluation (MLE) PT records, a total of 3 events, revealed Chloride scores of less than 80% for the following Chemistry events: 2018 2nd event - Chloride score of 20%, 2018 3rd event - Chloride score of 60%, resulting in an unsuccessful PT performance. 2. In a telephone interview with the laboratory manager on December 3, 2018, the findings were confirmed for the PT testing events as outlined above. -- 2 of 2 --