ML21158A231

Phase a Report Associated with the Covid-19 Public Health Emergency Oversight Activities Assessment

ML21158A231
Person / Time
Issue date:	06/17/2021
From:	Leira Cuadrado NRC/NMSS/DMSST/MSLB
To:
Cuadrado L/NMSS/MSST
Shared Package
ML21158A229	List: ML21158A230 ML21158A231
References
Download: ML21158A231 (12)

Text

Office of Nuclear Material Safety and Safeguards COVID-19 Public Health Emergency Oversight Activities Assessment COVID-19 Public Health Emergency Oversight Activities Assessment

- Phase A Report -

Contact:

Leira Cuadrado, Sr. Project Manager Material Safety and Tribal Liaison Branch Division of Materials Safety, Security, State and Tribal Programs Office of Nuclear Material Safety and Safeguards

Page l2 COVID-19 Public Health Emergency Oversight Activities Assessment - Phase A I. Approach The Office of Nuclear Material Safety and Safeguards (NMSS) is undertaking a phased approach for its COVID-19 Public Health Emergency Oversight Activities Assessment effort.

Phase A of this effort consisted of a short-term evaluation of feedback received through a survey to all the U.S. Nuclear Regulatory Commission (NRC) staff with responsibility for implementing the oversight programs in the Nuclear Materials and Waste Safety Programs, and through numerous engagements discussing implementation of the oversight programs among the leadership team and staff. The Phase A objective was to assess this feedback and make recommendations to the leadership team to enhance practices or processes in place during the current COVID-19 Public Health Emergency (PHE) and share challenges and good practices in implementing the oversight programs during the PHE among staff in the various programs.

Phase B is envisioned to be a more comprehensive evaluation by a working group with specialized inspection and programmatic experience and representation from each of the NMSS business lines and regional offices. The ultimate objective is to provide recommendations on potential enhancements to the inspection programs based on what has been experienced during the COVID-19 PHE so that we can continue to effectively implement the oversight programs and position them for success in the future. Finally, Phase C is envisioned to be the implementation phase of this effort, consisting of implementing recommendations endorsed by NRC leadership.

II.Purpose This report documents the results of Phase A of NMSS COVID-19 Public Health Emergency Oversight Activities Assessment. Phase A of this effort consisted of evaluating feedback from a survey and ongoing practices at that time related to inspection, to share best practices and challenges, document how the oversight programs operated under the PHE, and make recommendations to the leadership team on how to provide for near-term enhancements to practices or processes implemented during the COVID-19 PHE.

III. Nuclear Materials and Waste Safety Programs Oversight Activities The oversight activities in the Nuclear Materials and Waste Safety Programs include programmatic oversight and inspection activities of decommissioning facilities, uranium recovery activities, low-level waste facilities, fuel cycle facilities, spent fuel storage and transportation activities, and academic, industrial, and medical uses of nuclear materials. The vast majority of inspection activities are conducted out of the four NRC regional offices, except for the spent fuel storage and transportation cask vendor inspections that are conducted by a group of inspectors in Headquarters.

The Division of Fuel Management (DFM) is responsible for the programmatic oversight for activities under the Fuel Facilities Business Line and the Spent Fuel and Transportation Business Line, the Division of Materials Safety, Security, State, and Tribal Programs (MSST) is

Page l3 responsible for the programmatic oversight for activities in the Nuclear Materials Users Business Line, including the Agreement States, and the Division of Decommissioning, Uranium Recovery, and Waste Programs is responsible for the programmatic oversight for activities under the Decommissioning and Low-Level Waste Business Line.

IV. Summary of the implementation of the oversight programs during the COVID-19 Public Health Emergency On January 31, 2020, the U.S. Department of Health and Human Services declared a PHE for the United States to aid the nations healthcare community in responding to COVID-19. On March 11, 2020, the COVID-19 outbreak was characterized as a pandemic by the World Health Organization. On March 20, 2020, the NRC required mandatory telework for all non-mission-critical functions. In the subsequent months, each oversight program implemented by NMSS and the four regions, adjusted their inspection programs as necessary to continue to exercise its oversight responsibilities given the new challenges presented by the PHE. Many adjustments to inspection schedules had to be made based upon the health and safety of the staff with a focus on maintaining reasonable assurance of adequate protection. Although many inspections were initially postponed at the time mandatory telework was in effect, the NRC was always prepared to undertake mission critical inspections, such as reactive inspections, to ensure public health and safety. In the subsequent weeks, the inspections were being evaluated on a case-by-case basis by taking into consideration such factors as the necessary mode(s) of travel, travel restrictions or limitations in place at the time, personal health concerns of available inspection personnel, and the local site conditions and government mandates associated with the COVID-19 PHE.

On April 17, 2020, NMSS issued Implementation of Resident Inspector Coverage at Category I Fuel Facilities during Covid-19 to provide guidance on resident inspector office coverage at Category I fuel facilities during maximum teleworking for COVID-19 (Agencywide Documents Access and Management System [ADAMS] Accession No. ML20106F226). Subsequently, on June 1, 2020, NMSS issued "Inspection Guidance During Transition from COVID-19 Mandatory Telework for the Nuclear Materials and Waste Safety Program (ADAMS Accession No. ML20143A281) and provided decision-making considerations for the conduct of inspections as the agency transitioned from mandatory telework to maximum flexibilities telework. Staff continues to evaluate future inspections on a case-by-case basis to determine if inspections should be deferred, conducted on-site, remotely, or a combination thereof during the maximum flexibility telework phase. To date, staff has conducted fully remote inspections, full on-site inspections, and hybrid inspections with remote and focused on-site portions to fulfill its important oversight mission.

Various measures were in place to assist inspection planning and execution in the Nuclear Materials and Waste Safety Program during the COVID-19 PHE including a Transition Readiness Group in Region II for Fuel Facilities inspections that evaluated inspections, including resident inspections, on a case-by-case basis in light of site conditions, instituting additional inspection planning tools that focused on near-term inspections to make necessary adjustments by prioritizing inspection activities and implementing mitigation strategies where necessary, and documentation of decision-making considerations in support of on-site travel.

In some instances, inspection schedules were adjusted to shift required on-site inspection activities to either the earliest open window or to defer to later in the inspection cycle window.

When necessary to conduct portions of an inspection remotely, staff reviewed inspection procedures to determine which portions could be done remotely versus on-site for that specific

Page l4 facility and the selected focus areas of the specific inspections. Where the flexibility existed, the focus areas of the inspections were often selected in order to maximize the amount that could be performed remotely. Staff engaged licensees personnel earlier in the planning of inspections to facilitate decision-making and ensure appropriate measures were taken in support of inspection activities.

Many licensed facilities continued operations and implemented preventive measures to minimize exposure and spread of the virus by reducing staffing on-site, mandating mask wearing, performing COVID testing, and implementing flexible staffing measures to reduce person-to-person contact. Resident Inspectors at Category I fuel facilities continued on-site activities at a reduced schedule and performed oversight functions remotely in a manner similar to the resident inspectors at power reactor sites. NMSS identified an enterprise risk associated with inspection programs due to the extended conditions of the COVID-19 PHE which threatened the ability to complete inspections within its Inspection Manual Chapter frequency or timelines. This enterprise risk will serve as another management tool to monitor the implementation of the inspection programs until such time the challenges associated with the COVID-19 PHE are overcome.

NMSS and the regions coordinated closely with the Agreement States to oversee the implementation of the National Materials Program. Most Agreement States are conducting a combination of on-site and remote inspections as local conditions and restrictions permit. Some Agreement States continue to temporarily postpone routine inspections at facilities (e.g.,

medical facilities) and will only perform reactive inspections, allegation follow-ups, or respond to events, on a case-by-case basis at these facilities. Many Agreement States developed plans to resume onsite inspections and are phasing in the implementation of their respective plans.

Communications were key in ensuring openness, transparency, and consistency while adjusting the oversight activities to the COVID-19 PHE. NMSS and the regional offices held periodic town hall meetings with staff among all regions and Headquarters. These meetings served as an avenue to disseminate best practices and challenges in implementing inspection programs during the COVID-19 PHE. In addition, MSST hosted a series of National Materials Program Champions Chats and leveraged the monthly teleconference with the Organization of Agreement States and the Conference of Radiation Control Program Directors to communicate adjustments to the programs and challenges and best practices.

Most recently, on February 19, 2021, NMSS provided additional guidance and clarification (ADAMS Accession No. ML21048A030) to the business line (BL) and regional management with regard to the COVID-19 PHE, to ensure consistency in decision-making and documentation with regard to adjustments to inspections schedules, determining the manner for conducting inspections (e.g., remote vs. on-site), and reporting adjustments in inspections to appropriate Headquarters BL managers.

V. Phase A Assessment Phase A consisted of obtaining feedback through a survey and from inspectors townhall meetings. In August 2020, NMSS issued a survey titled: PHE Feedback for Oversight Activities in the Nuclear Materials & Waste Safety Programs to obtain feedback related to the oversight activities associated with the Nuclear Materials and Waste Safety Programs during the COVID-19 PHE and its associated mandatory/maximum telework period. The survey results were evaluated to gather and share challenges and best practices of inspection activities during the

Page l5 PHE and to develop recommendations to enhance inspection-related and programmatic guidance for the current COVID-19 or future public health emergencies.

The survey was available to all inspectors in all four regional offices and Headquarters that conduct inspections associated with the BLs in NMSS. It collected feedback on the following areas:

• best practices and challenges in conducting oversight activities during the COVID-19 PHE;

• guidance issued by NMSS during the PHE;

• feedback on remote inspection activities;

• licensee feedback obtained by the inspectors during inspections conducted during the PHE;

• appropriateness of Information Technology (IT) capabilities and infrastructure;

• telework for resident inspectors;

• program enhancements needed to prepare for future pandemics; and

• appropriateness of protective personal equipment (PPE) for inspectors.

A. SURVEY HIGHLIGHTS: Best Practices Best Practice 1: Early planning and communications with licensees are needed to support inspection activities during the PHE.

While prior coordination has been standard practice in preparation for inspections, the staff needed to continuously assess the evolving situation of COVID-19 cases at the site and in the surrounding areas to make informed decisions to support on-site travel. Of note, inspections in the nuclear materials users BL are usually unannounced, so this represented a change in current practice that was appropriate to ensure the wellness and safety of the inspectors and licensee personnel. The coordination aspect is even more critical when planning to conduct inspections partially, or completely remotely, as licensee and staff need to ensure document sharing platforms are established and accessible and the licensee has enough time to upload requested information.

Best Practice 2: Staff need to be flexible on inspection duration in the conduct of remote inspections It was noted the conduct of remote inspections may take longer, in general. Therefore, it is important to afford flexibility and make sure the inspector or inspection team do not feel rushed to complete an inspection in the usual timeframe. Some shared examples of delays encountered during remote inspections included, additional time needed by licensees to scan documents when additional information was requested, setting up meetings with licensee personnel in different time zones, reviewing information electronically, and difficulties in setting up meetings with licensee personnel or teams as this required additional coordination as compared to a typical on-site inspection.

Best Practice 3: For inspections that were partially conducted remotely, it is very important that during or immediately after the remote inspection portion is completed, inspectors document detailed notes on exactly what needs to be inspected during the on-site portion so there is clear understanding and no duplication of effort.

This is particularly important for team inspections and/or when different inspectors are assigned to an inspection that remains open for a longer period, as may be the case for an inspection that has a portion done remotely and a later portion on-site. For a partial remote inspection, keeping a shared log with the applicable inspection procedures and

Page l6 inspection requirements with notes and details of on what was inspected and what remains to be inspected ensures no duplication of effort and effective transition and resource utilization.

Best Practice 4: Maximize remote review of licensee documentation In order to minimize close contact with other persons, staff maximized the remote review of documentation in support of inspections. In some instances, file sharing platforms such as BOX-EFSS was utilized to have files available to review remotely prior to completion of the on-site portion of the inspection, while in other instances a team inspection member will conduct a document review remotely while another inspector conducted all the on-site observations needed.

B. SURVEY HIGHLIGHTS: Challenges Challenge 1: No access to printers and electronic review of documents Reading extensive documents or site plans from a laptop screen and perform documentation reviews solely electronically was a challenge shared by some respondents. Specifically, if you are solely using a laptop without any additional monitor(s), documentation review to support inspections can be very challenging and time consuming. Access to printers was also highlighted as a challenge since employees cannot print from home and initially, during the mandatory telework phase, staff could not to go to the office to print documents.

Challenge 2: Document sharing Staff also highlighted some initial challenges for sharing documentation electronically as licensee capabilities varied greatly. Of note, the ability to share sensitive information (e.g.

proprietary, personal identifiable information) to support inspection activities in secured way was challenging.

Challenge 3: Gaining access to licensee IT systems Staff shared varied challenges to either access licensee systems or for licensee personnel to access NRC information sharing platforms (e.g. BOX). There were some examples shared that the ability to observe virtually to support an inspection relied upon accessing the camera feed at licensed facilities or in some instances, video call.

However, the extent to which those could be accessed or used depending on the facility or site being inspected varied greatly (e.g. feed of a plant or site, versus a medical facility).

Challenge 4: Getting tested for COVID-19 in support of inspection activities States mandates in response to the pandemic were varied and included getting tested either prior to entering the State, upon return, or both. Some inspectors shared that to perform on-site inspections for which they did interstate travel they needed to be tested for COVID per States guidelines. This was particularly challenging during the early stages of the PHE as COVID testing was not widely available and evolving concurrently with the planning of inspections.

Page l7 Challenge 5: Social distance and facial coverings Staff shared that the adherence to proper social distancing and use of facial coverings at licensee facilities varied. While inspectors were provided with personal protective equipment, such as masks, and tried to maintain social distancing and adhere to any site guidelines, there were instances in which it was difficult to adhere to proper measures on-site to minimize close contact.

Challenge 6: Travel-related limitations and challenges Staff shared challenges to access facilities and restaurants while traveling for inspections during the early stages of the PHE. For example, driving long distances to perform onsite inspections was challenging at first due to limited access to restrooms and restaurants as many businesses were closed near or at facilities.

Challenge 7: Conducting remote inspections Staff shared some challenges in the conduct of remote inspections. Challenges reported included the inability to conduct impromptu interviews with licensee personnel, difficulty in scheduling meetings and interviews at facilities located in different time zones, an inability to walk down a process at the site and conduct a thorough assessment of process safety, and problems obtaining sensitive information from the licensee.

C. Feedback on remote inspections Survey Question 1: In light of the conduct of more remote inspections in the last 4 months, please provide your views on the following statements.

a. Remote inspections were as effective as on-site inspections.

b. Remote inspections served as a good tool to replace on-site inspections ONLY during periods of travel restrictions.

c. I can see myself conducting more inspections fully or partially remotely if I am given that option during the normal implementation of my inspection program.

Most of respondents disagree that remote inspections were as effective as on-site inspections and agreed that remote inspections served as a good tool to replace on-site inspections only during periods of travel restrictions. Neutral feedback was received on future use of remote inspections (fully or partially) outside of the PHE or during the normal implementation of the inspection programs. This feedback was consistent with that shared during the inspectors townhalls.

Page l8 Survey Question 2: Given a potential need to conduct more remote inspections during the current or future pandemics, should inspection procedures be revised to provide more flexibility?

There was neutral feedback with the need revise inspection procedures to provide more flexibility to conduct remote inspections. From the expanded feedback in this survey, some staff shared the Inspection Manual Chapters (IMC) and associated Inspection Procedures (IP), as written, did not specifically limit the opportunity to conduct inspection activities remotely.

However, the degree to which the inspection guidance provided specificity as to whether inspection activities could or should be performed in-person or remotely varied and was subject to interpretation. It is worth noting that during the COVID-19 PHE, staff in the fuel facilities and the spent fuel and transportation BLs were revising the entire suite of IMCs and IPs associated with those programs related to a separate inspection enhancement efforts (i.e. smarter fuel cycle inspection and the Independent Spent Fuel Storage Installation Facilities inspection enhancement efforts) and leveraged that opportunity to include remote inspections as a tool to conduct inspection activities at the IMC level and included a new Appendix to IMC 2600 and 2690 titled: Inspection Program Modifications During Pandemics, Epidemics, or Other Widespread Illnesses or Diseases.

Since the NMSS June 1, 2020, memorandum, already provides guidance that specifically allows the conduct of remote inspections where it is deemed appropriate, there is no immediate need to provide additional guidance for the conduct of remote inspections during the COVID-19 PHE.

However, each business line should assess their inspection practices during the PHE and incorporate additional guidance into the IMC and/or IPs, as appropriate, to facilitate decision-making in the future. This will be an area that will be further evaluated in Phase B of this assessment.

Survey Question 3: How useful was the guidance issued by NMSS (ML20143A281) as a tool for resuming inspections during the PHE?

Page l9 Generally positive feedback was obtained with regard to the June 1st NMSS memorandum providing decision-making considerations for the conduct of inspections during maximum flexibility telework. We should note that the survey took place four months into the pandemic and only a couple of months since the issuance of this memo. Therefore, Phase B assessment will provide additional insights into the effectiveness of this guidance since it would have been more widely used by the time that assessment is completed.

D. Looking forward Survey Question 4: To prepare for future public health emergencies, which inspection activities should the NRC have the capability and flexibility to perform remotely?

Full Text of Choices: Certain routine inspections; Inspections of higher-risk activities; Inspection of lower risk activities; Reactive inspections; Other Most of the respondents indicated the NRC should have the capability and flexibility to perform certain routine inspections and inspection of lower risk activities remotely in future public health emergencies. During the COVID-19 PHE, while inspection travel was initially halted, the staff always maintained the capability and capacity to support any on-site or remote high priority inspection, such as reactive inspections. Many routine inspections that could be delayed were delayed in consideration of the pandemic. The responses demonstrate that some routine inspection should continue as eventually staff did as we adjusted our inspection practices in light of the pandemic.

Survey Question 5: Which program aspect(s) should be prioritized for enhancement to prepare for future pandemics?

Full Text of Choices: Guidance for remote inspections; Guidance for on-site inspections during a pandemic; NRC IT capabilities; Protocols for information sharing; Memoranda of understanding expectations; Program office communications; Your respective office/region/division communications; No basis

P a g e l 10 Guidance for remote inspections and on-site inspections during a pandemic, agency IT capabilities, and protocols for information sharing were the focus areas identified for enhancement to prepare for future pandemics. This is consistent with feedback received in the commentary sections of the survey as well as townhall meetings with inspection staff. Some staff shared challenges with IT protocols and capability to access licensee video feeds or document sharing platforms. As staff continue to share their experiences conducting inspections during the PHE, including more reliance on remote inspection techniques, this assessment recommends creating a inspection resource-sheet that summarizes document sharing resources available to staff as well as available technology to support remote inspection activities.

Survey Question 6: Should the NRC undertake a reassessment of what and how we inspect given the paradigm shift that have been experiencing the COVID-19 PHE?

Full Text of Choices: Yes, absolutely; Yes, but only for targeted aspects of the existing program; No, we need to get back to the way things were pre COVID-19 Survey Question 7: Should the infrastructure (e.g., IT capabilities, scheduling, inspection guidance) be modified to better enable effective remote inspection activities?

Staff shared the following specifics regarding Survey Question 6 and 7 with regard to program enhancements needed in the future based on the experience implementing the inspection programs during the COVID-19 PHE:

• A more portable device will be very useful in the field

• Two monitors to support more effective remote documentation review during inspections

• Tools to share a large number of documents with licensee and to safely share sensitive information

• Overcome IT challenges to access licensees' software tools so we can access those remotely without security compromises

• Maximize the use of the NRC BOX for file sharing - some even suggested having editing capability so the team can flag and share notes

P a g e l 11

• Tools, additional guidance, or expectations for file sharing platforms that could be used with all licensees and vendors vice the ad-hoc approach with each individual licensee/CoC holder inspected E. Feedback obtained by licensees The following highlights the feedback inspectors received from the licensees:

• Making information available electronically (e.g. uploading, files) was burdensome and time consuming for some of the licensees

• Generally appreciative with the flexibilities provided by NRC staff during the scheduling, planning, and execution of inspections

• Some fuel facilities shared they want on-site inspections where at all possible while others would like to see more remote inspections in the future F. Feedback on telework for resident inspectors o The survey indicated that eight hours a week of routine telework could continue and be as effective in implementing the fuel facility resident inspector inspection program at a Category I fuel facility.

G. Feedback on PPE for inspectors o Most of the respondents received PPE to conduct inspections and indicated to be satisfied with what was provided. Comments were received that the agency should continue to provide PPE for NRC inspectors for the foreseeable future.

H. Feedback on practices during the PHE that should continue o More telework flexibility for inspection staff o More remote inspections for inspection activities that are mostly document review (follow-up to enforcement, exempt distribution, etc.)

o More flexibility for how we conduct inspections (e.g. provide additional flexibility as to when you exit the inspection) o Continue the use of BOX or document sharing o Adopt a more paperless way of working o Continue providing PPE to support inspections VI. Assessment Summary:

As part of Phase A of this assessment, staff evaluated feedback from a survey and ongoing practices related to inspection activities, to:

• share best practices and challenges,

• document how the oversight programs operated under the PHE, and

• make recommendations to the leadership team to enhance practices or processes in place during the current COVID-19 PHE.

As highlighted in this report, staff has conducted periodic townhall meetings across the Nuclear Materials and Waste Safety Programs business lines to share inspection experiences during the COVID-19 PHE. In addition, staff continuously engaged the Agreement States via monthly teleconferences and the National Materials Champion Chat to share best practices and challenges in the implementation of the materials inspection program nationally. This assessment recommends this practice to continue during the PHE and during follow-up

P a g e l 12 assessments of the inspection programs with the purpose of further enhancing these programs and better preparing them for the future. It is worth noting, that Phase B of this assessment, will include significant outreach and engagement with those responsible of implementing inspection programs in the agency and externally. The charter for the Phase B assessment is available via ADAMS Accession No. ML21085A576.

This report highlights how the inspection programs in the Nuclear Materials and Waste Safety Programs have adjusted to the COVID-19 PHE up to this date. Practices, processes, and guidance have been adapted in order to continue to fulfill the very important oversight mission of the agency. NMSS has been monitoring the implementation of these programs and providing additional guidance when needed, as recently demonstrated by the issuance of the February 19, 2021, memorandum on reporting program adjustments. Business line managers continue to monitor the implementation of the respective inspection programs and facilitate engagements, alignment, and resources to ensure the continuous implementation of the oversight programs. For this reason, Phase A assessment did not find the need to revise or supplement the interim guidance in place to assist inspection activities during the COVID-19 PHE. Instead, it recommends relying on the Phase B more holistic assessment and any recommendations stemming from it to determine what additional inspection program enhancements are needed to better prepare the oversight programs for future public health emergencies.

As noted in this report, additional clarification and guidance on the tools and technology to support remote inspections activities could be of benefit to the inspection staff. For this reason, this assessment recommends the development of an inspection resource-sheet that summarizes document sharing resources available to staff as well as available technology to support remote inspection activities.

In summary, Phase A assessment recommends:

Recommendation 1: Continue periodic engagements among inspection staff across the Nuclear Materials and Waste Safety Programs and with the Agreement States to share inspection best practices and challenges during the COVID-19 PHE and build upon those experiences to adapt the inspection programs and practices to achieve the most effective implementation of the inspection programs.

Recommendation 2: Develop an inspection resource-sheet that summarizes document sharing resources available to staff as well as available technology to support remote inspection activities.