Preparing for an NRC or Agreement-State Inspection: An RSO's Guide

An NRC or Agreement-State inspection of a medical materials licensee reviews the entire 10 CFR Part 35 program — not isolated procedures — so the only reliable preparation strategy is maintaining a program that is inspection-ready at all times. RSOs who treat inspection preparation as an ongoing practice rather than an event-driven scramble consistently experience fewer findings and faster corrective-action cycles when a violation is cited.

This guide covers everything from how inspections are initiated and scheduled, through each technical program area the inspector will examine, to building the document binder, running a mock inspection, navigating the exit interview, and drafting a corrective-action response. DRPS provides RSO consulting and radioactive material license support to medical facilities across Florida, Maryland, Virginia, Washington DC, California, and Nevada, and the patterns described here are drawn from real inspection cycles in those jurisdictions.

Introduction

Medical materials licensees operate under two overlapping obligations: they must run a clinically effective program and a radiologically compliant one. When an NRC or Agreement-State inspector arrives, the two worlds converge. The inspector is not evaluating clinical outcomes — they are verifying that the regulatory program is documented, implemented, and effective.

The good news is that inspection procedures are published. The NRC's Inspection Manual governs the materials inspection program through Inspection Manual Chapter (IMC) 2800, Materials Inspection Program, and a set of medical-use Inspection Procedures — IP 87130 (nuclear medicine, written directive not required), IP 87131 (nuclear medicine, written directive required), and IP 87132 (brachytherapy programs) — that describe exactly which program areas are reviewed and what records are requested. ¹ NUREG-1556, Volume 9 provides program-specific guidance for medical-use licenses and articulates the NRC's expectations for the entire 10 CFR Part 35 program; reading it as a self-audit checklist is one of the highest-value preparation steps an RSO can take. ² Agreement States generally mirror these procedures, though RSOs should confirm the specific inspection checklist their state uses.

The following sections walk through every element of a well-prepared inspection posture.

Topic Explanation

Types of NRC inspections

Medical licensees encounter several distinct inspection types:

Routine (periodic) inspections are the most common. The NRC and Agreement States assign each license a priority code under IMC 2800 based on the types of use authorized and the risk profile of the program. Periodic inspections occur on a cycle determined by that priority. ¹

Initial inspections are scheduled for newly licensed programs — typically within the first year of a new license, and again after a significant amendment such as adding a new modality (for example, Lu-177 therapy) or a new therapy room. These inspections verify that the facility, equipment, and personnel are actually consistent with what the license authorizes. ¹

Reactive (for-cause) inspections are triggered by a reported event, public complaint, media report, or allegation. They are frequently unannounced. A facility that reports a medical event under 10 CFR 35.3045 can expect a follow-up inspection to verify that the root cause has been identified and corrective actions implemented. ^{1, 3}

Special and team inspections may be conducted after a significant event, a pattern of violations, or a regulatory concern identified through means other than routine reporting. They typically involve the NRC regional office and may include additional NRC staff.

Inspection frequency by license priority

Under IMC 2800, the priority code is also the routine inspection interval: the priority number equals the number of years between routine inspections. ¹ In practice, for medical materials licensees:

• Priority 2 — every 2 years: broad-scope medical licenses, high-dose-rate (HDR) remote afterloading brachytherapy programs, and nuclear pharmacies.
• Priority 3 — every 3 years: typical medical institutions authorized for written-directive uses (most diagnostic nuclear medicine and standard therapy programs).
• Priority 5 — every 5 years: the lowest-risk private-practice, in-vitro, and limited-use programs.

Scheduling carries tolerance windows (Priority 1–2 may shift roughly ±50% around the due date; Priority 3 and lower allow about ±1 year), and an inspection is flagged overdue when it slips months past due. Agreement States follow equivalent risk-based cycles. A licensee with previous escalated violations or a for-cause trigger may be inspected more frequently than its base priority suggests.

Announced versus unannounced inspections

Routine inspections are typically announced. The NRC inspector (or Agreement-State inspector) contacts the RSO or facility representative to schedule the visit, which allows the licensee to prepare records, arrange for key personnel — RSO, authorized users, radiation safety staff — to be available, and confirm equipment is operational.

For-cause inspections are frequently unannounced. The inspector may arrive without prior contact when responding to a medical event report, allegation, or complaint. Facilities that maintain a perpetually organized program — binders current, QC records filed, personnel files complete — are far less vulnerable to adverse findings in an unannounced visit.

Key Technical Principles

Program areas the inspector reviews

The following table summarizes the principal inspection areas, the key records requested, and the most common documentation pitfalls observed in medical license inspections.

Program Area	Key Records Requested	Common Pitfalls
RSO and authorized user credentials	RSO appointment letter signed by management (10 CFR 35.24); RSO/AU training and experience or board-certification documentation (35.50, 35.190, 35.290, 35.390, 35.490, 35.690); named authorization on the license or permit for each use	RSO appointment letter predates current management authorization or is unsigned; AU training records missing modality-specific preceptor attestation; visiting/temporary AU acting under 35.27 not documented
Dose-calibrator (instrument) QC	Constancy (each day of use), accuracy/calibration (at installation and annually), linearity (at installation and quarterly), geometry (at installation), per 10 CFR 35.60	Constancy missing on a day the calibrator was used; linearity documented without correction factors or not spanning the clinical activity range; geometry not performed at installation; accuracy check not repeated after repair
Survey-meter calibration	Current calibration certificates for all survey/dose-rate instruments; calibration within the preceding 12 months and after repair (10 CFR 35.61)	Instruments used beyond the 12-month calibration interval; certificates not on file at the facility; serial numbers on the certificate do not match the in-use instruments; calibration range does not bracket the readings of interest
Sealed-source inventory and leak tests	Inventory record for each sealed/brachytherapy source; leak tests at intervals not to exceed 6 months (10 CFR 35.67(b)); semiannual physical inventory (35.67(g)); leak-test log with calculated removable activity	Leak tests overdue or gaps in the 6-month cycle; semiannual inventory not reconciled; wipe results not documented with date, source ID, net count, and calculated activity; no action when a result meets or exceeds the 185 Bq (0.005 µCi) limit
Ambient and removable-contamination surveys	Area survey records and removable-contamination wipes (10 CFR 35.70); survey-instrument and frequency per procedure	Survey records missing required fields (date, instrument, background, location, result, surveyor); no survey performed after a spill, source movement, or maintenance
Occupational dosimetry	Dosimetry enrollment and monitoring reports (10 CFR 20.1502); declared-pregnant-worker records and the 5 mSv gestational limit (10 CFR 20.1208); licensee-set ALARA investigation levels and investigation records	Workers monitored late (after the 10% TEDE/extremity threshold of 20.1502 was reached); ALARA investigation levels not established or not in writing; investigation not triggered or not documented when a level was exceeded; declaration of pregnancy not processed
Written directives and medical event reporting	Written directives for applicable administrations (10 CFR 35.40, 35.41); identity-verification and post-administration check records; medical event files if applicable (10 CFR 35.3045)	WD signed/dated after the administration; missing authorized-user signature; patient-identity verification (35.41) not documented; medical event not reported within the required timeframe
Posting, labeling, and security	"Caution, Radioactive Material" posting (10 CFR 20.1902–20.1904); labeling of containers, vials, and syringes; physical security of stored sources (35.41/Part 20.1801–20.1802); Part 37 access-authorization and security plan only if aggregated Category 1/2 quantities are present	Hot lab or storage area not posted; refrigerators/sources not labeled; waste containers without required labels; sources left unsecured/unattended; signs faded or the wrong type
Training and instructions to workers	Radiation safety training and instructions to workers (10 CFR 19.12); NRC Form 3 ("Notice to Employees") posted; supervised-individual training (10 CFR 35.27)	Required training not documented; no worker acknowledgment on file; NRC Form 3 not posted at each work location
Radioactive waste	Waste log (radionuclide, activity, disposal/decay date); decay-in-storage records (10 CFR 35.92); transfer and disposal manifests (10 CFR 20.2001–20.2008)	No decay-in-storage log; material released before decay through at least 10 half-lives and a survey confirming background; manifests not retained for the required period; logs missing required fields

Wipe-test calculation: converting counts to activity

The leak-test action level under 10 CFR 35.67(e) is 185 Bq (0.005 µCi) of removable contamination: a sealed or brachytherapy source is considered to be leaking if a test detects 185 Bq or more. ⁴ Evaluating a wipe-test result requires converting the detector count rate to activity:

$$A_{\text{removable}}=\frac{R_{\text{net}}}{\epsilon \times 60}$$

where $R_{\text{net}}$ is the net count rate in counts per minute (cpm) above background, $\epsilon$ is the detector counting efficiency for the radionuclide (counts per disintegration, a dimensionless fraction between 0 and 1), and dividing by 60 converts cpm to counts per second (Bq, since 1 dps = 1 Bq).

Worked example. A Tc-99m wipe sample reads 340 cpm gross; the background is 40 cpm; the NaI well-counter efficiency for Tc-99m is 0.65 (65%).

$$R_{\text{net}}=340-40=300\text{ cpm}$$

$$A_{\text{removable}}=\frac{300}{0.65\times 60}\approx 7.7\text{ Bq}$$

Since 7.7 Bq is well below the 185 Bq action level, this wipe is acceptable and no action is required. However, the result — date, source ID, wipe location, gross cpm, background cpm, net cpm, calculated activity in Bq, and pass/fail — must be recorded in the leak-test log. A practical inspector-proofing habit is to record the well-counter efficiency and background used for each calculation so the arithmetic is reproducible.

If a source is found leaking — 185 Bq or more removable — 10 CFR 35.67(e) requires the licensee to immediately withdraw the source from use and have it decontaminated and repaired, or disposed of, and to file a report within 5 days of the test (the leaking-source report under § 35.3067) with the appropriate NRC Regional Office (Agreement-State licensees report to their state agency) describing the equipment involved, the test results, and the corrective action taken.

Occupational dose fraction versus the annual limit

An inspector reviewing dosimetry records may calculate each worker's dose fraction against the applicable 10 CFR Part 20 occupational dose limit to verify ALARA compliance. The annual occupational total effective dose equivalent (TEDE) limit is 50 mSv (5 rem) under 10 CFR 20.1201(a)(1); the same section also caps the lens-of-eye dose at 150 mSv (15 rem) and the shallow dose to skin or any extremity at 500 mSv (50 rem) per year. ⁵ A quick check of whether a worker's year-to-date dose is consistent with the ALARA program is expressed as a fraction of the annual limit:

$$f_{\text{limit}}=\frac{H_{\text{received}}}{H_{\text{limit}}}=\frac{H_{\text{received}}}{50\text{ mSv/yr}}$$

For example, a nuclear-medicine technologist who has received 3.5 mSv in the first six months of the year has used:

$$f_{\text{limit}}=\frac{3.5}{50}=0.07\text{ (7\%)}$$

A dose fraction this low is typical and unremarkable for diagnostic nuclear medicine. A key point inspectors probe — and a common misconception — is that 10 CFR 20.1201 establishes only annual limits; there is no federal quarterly occupational dose limit. The "investigation levels" the program must apply are not federally mandated numbers but licensee-set administrative thresholds. NRC Regulatory Guide 8.18 illustrates the customary two-tier scheme — for example an annual Level I of 30% and Level II of 100% of the applicable limit (with monitoring-period equivalents) — but the specific values are a facility decision. ⁸ What the inspector will hold the licensee to is that the program defines its investigation levels in writing and documents an ALARA review whenever a worker exceeds one.

The public dose limit is set separately under 10 CFR 20.1301: 1 mSv (0.1 rem) TEDE per year to an individual member of the public, and no more than 0.02 mSv (0.002 rem) in any one hour in an unrestricted area. ⁹ Survey and dose-rate records for areas adjacent to unrestricted space must support compliance with both limits.

Clinical Impact

Why documentation gaps create the most citations

The most frequent inspection findings in medical licensee inspections are not catastrophic technical failures — they are documentation gaps: dose-calibrator constancy checks not performed every day of use, survey meters used after their annual calibration expired, leak-test records missing a source identifier, or an authorized user whose training documentation is not on file at the facility.

These findings occur not because the programs are unsafe, but because the documentation discipline that makes the program legible to an inspector received less attention than the clinical operations themselves. A well-functioning department can still receive a Severity Level III Notice of Violation for a missing signature on a written directive.

The clinical impact of a NOV extends beyond the regulatory response. Severity Level I or II NOVs involving medical events require public disclosure by the NRC ³. A pattern of violations can result in a Confirmatory Action Letter or escalated enforcement, and in serious cases, license suspension. Joint Commission accreditation surveyors also review radiation safety compliance, so an NRC citation can trigger parallel accreditation scrutiny.

Medical event reporting and inspection follow-up

Under 10 CFR 35.3045, a reportable medical event must be reported to the NRC Operations Center (or the Agreement-State agency) by telephone no later than the next calendar day after discovery (35.3045(c)), followed by a written report within 15 days to the appropriate NRC Regional Office (35.3045(d)). ³ The licensee must also notify the referring physician and the patient (or the patient's responsible relative or guardian) no later than 24 hours after discovery (35.3045(e)), unless the referring physician personally elects to inform the patient or judges, and documents, that disclosure would harm the patient. ³

Medical event reports are a primary trigger for reactive inspections. When the NRC or Agreement State receives a medical event notification, a follow-up inspection is nearly always scheduled to verify that the event was correctly characterized, root cause was identified, and corrective actions have been implemented. An inspector arriving in response to a reported event will review the full therapy program, not just the specific event — making it essential that all other program areas are current before the follow-up visit.

Practical Optimization Tips

Building the inspection-ready document binder

The most practical preparation step is maintaining a physical or electronic binder organized around the inspection checklist. Organize it with tabs that mirror the inspection procedure sections:

1. License and amendments — current license, all amendments, correspondence with the regulatory authority.
2. RSO appointment and authorization — signed appointment letter, RSO training and experience documentation, AU training records for each authorized use.
3. Dose-calibrator QC — constancy logs (all dates of use), accuracy certificates, linearity records with correction factors, geometry test records.
4. Survey-meter calibration — current calibration certificates for all instruments; instrument serial number log cross-referenced to calibration records.
5. Sealed-source inventory and leak tests — source inventory list (manufacturer, model, serial number, radionuclide, activity, location); leak-test log with all wipe-test results, calculated activity in Bq, and pass/fail; 6-month schedule tracker.
6. Radiation surveys — area survey records (date, instrument ID, background, locations measured, results); removable-contamination wipe survey records.
7. Dosimetry — enrollment records; TLD/OSL/film badge monitoring reports; investigation level documents and investigation records; declared-pregnant-worker records.
8. Written directives — blank WD template; completed WD examples (de-identified); post-administration verification records.
9. Training records — annual radiation safety training sign-in sheets; instructions-to-workers acknowledgment forms; NRC Form 3 posting photographs.
10. Radioactive waste — decay-in-storage log; waste disposal manifests; generator return records.
11. ALARA program — written ALARA procedures; investigation levels; ALARA review records.
12. Medical event files — if applicable: NRC notification confirmations, written event reports, root-cause analysis, corrective-action documentation.

Maintain a current-status log at the front of the binder that tracks the due dates for recurring requirements: next dose-calibrator accuracy check, next survey-meter calibration dates, next leak-test due dates for each sealed source, next annual training.

Running a mock inspection

A mock inspection is the single most effective preparation tool. Six to twelve weeks before an anticipated periodic inspection — or quarterly as a standing practice — the RSO or a consulting medical physicist walks through the inspection procedure as if they were the inspector:

1. Request the binder cold and try to find each record within two minutes.
2. Pick three sealed sources at random and verify the inventory record, last leak-test date, and wipe-test result.
3. Pull the calibration certificate for each survey meter and verify serial numbers match instruments in service.
4. Select five random days of use in the past quarter and verify dose-calibrator constancy checks exist for those dates.
5. Pull the personnel monitoring reports for three randomly selected staff members and verify they are enrolled and their quarterly doses are documented.
6. Review two written directives from the past six months and verify the authorized-user signature predates the administration.
7. Walk the hot lab and treatment areas to verify posting and labeling.

Document every gap found and close it before the actual inspection. Repeat the mock inspection within four weeks to confirm that corrections were sustained.

DRPS can conduct a formal mock inspection as an independent RSO consulting engagement, providing an objective review and a written findings report that documents program status against the inspection procedure. Contact us through our radiation safety officer consulting services.

Regulatory Considerations

10 CFR Parts 20, 35, and 37 framework

The inspection framework for a medical materials licensee rests on three primary federal regulations:

10 CFR Part 20 sets the Standards for Protection Against Radiation applicable to all NRC licensees. It establishes the occupational dose limits in 20.1201 (50 mSv/year TEDE; 150 mSv/year to the lens of the eye; 500 mSv/year to extremities or skin) ⁵, the embryo/fetus limit for a declared pregnant worker (5 mSv over the gestation, 20.1208), the public dose limit in 20.1301 (1 mSv/year, and 0.02 mSv in any one hour in an unrestricted area) ⁹, the ALARA requirement (20.1101), survey requirements (20.1501), dosimetry requirements (20.1502), posting and labeling (20.1902–20.1904), and records retention (20.2101 et seq.). ⁵

10 CFR Part 35 governs the Medical Use of Byproduct Material. It defines the categories of authorized use (Subparts C–F and H), establishes requirements for written directives, calibration and survey instrumentation, sealed-source inventory and leak testing, training and experience for RSOs and authorized users, medical event definitions and reporting, and records retention. ⁴ The RSO's duties and the requirement for management to appoint an RSO in writing are also in Part 35. ⁴

10 CFR Part 37 establishes physical security requirements for aggregated Category 1 and Category 2 quantities of radioactive material listed in Part 37 Appendix A. ⁶ Facilities at or above a threshold quantity must maintain an access-authorization program (trustworthiness and reliability determinations), a documented security plan, and additional records that are inspected separately. The key point for a medical program is that Part 37 applies to high-activity sealed sources, not to routine unsealed diagnostic or therapeutic nuclear medicine. Tc-99m, F-18, I-131, Lu-177, and similar unsealed clinical activities do not reach a Category 2 aggregate. The sources that realistically cross the threshold are Co-60 teletherapy and Gamma Knife units, legacy Cs-137 irradiators or sources, and HDR remote-afterloader Ir-192 sources — for reference, the Category 2 thresholds are about 8.1 Ci (0.3 TBq) for Co-60, 27 Ci (1 TBq) for Cs-137, and 22 Ci (0.8 TBq) for Ir-192. A licensee that possesses, or aggregates to, these quantities should confirm Part 37 applicability; most diagnostic and unsealed-therapy nuclear medicine programs are out of scope.

Agreement States administer their own equivalent programs under NRC oversight. Of the jurisdictions DRPS serves: Florida, Maryland, Virginia, California, and Nevada are NRC Agreement States that regulate medical materials use under their own radiation-control regulations. Washington, DC is regulated directly by the NRC. RSOs must know which authority issued their license, since inspection procedures, reporting deadlines, and corrective-action response formats can vary between the NRC and individual Agreement States.

NUREG-1556 Volume 9 and the NRC Inspection Manual

NUREG-1556, Volume 9, Revision 3, Consolidated Guidance About Materials Licenses — Program-Specific Guidance About Medical Use Licenses, is the primary NRC reference for what a compliant medical materials license program looks like. ² It contains checklists, example procedures, training and experience criteria, and documentation templates that directly parallel what an inspector expects to find. Reading it as a self-audit tool before an inspection is one of the highest-value preparation steps an RSO can take.

The NRC Inspection Manual publishes the procedures inspectors actually follow. The materials inspection program is framed by Inspection Manual Chapter 2800, and the medical-use Inspection Procedures — IP 87130 (nuclear medicine, written directive not required), IP 87131 (nuclear medicine, written directive required), and IP 87132 (brachytherapy programs) — list each program area to be reviewed, the specific records to be requested, and the inspection criteria. ¹ An inspector typically applies the combination that matches the license (for instance, IP 87131 plus IP 87132 at a hospital with both therapy nuclear medicine and HDR brachytherapy). Agreement States may use equivalent procedures that differ in detail; RSOs should request a copy from their regulatory authority and self-audit against it.

NRC Enforcement Policy: severity levels and corrective-action responses

The NRC Enforcement Policy defines how violations are categorized and what response is required. ⁷ Materials violations are assigned a severity level based on their actual or potential safety significance, willfulness, and regulatory significance:

• Severity Level I — the most significant: actual significant radiological harm, or a condition that could have produced serious consequences. Escalated enforcement and a civil penalty are likely, and a written corrective-action response is required.
• Severity Level II — a significant violation with a substantial reduction in the safety margin but without immediate harm. A civil penalty is typically considered.
• Severity Level III — a violation of more-than-minor regulatory significance; the most common escalated level for medical licensees. A civil penalty may apply for willful or repetitive conduct.
• Severity Level IV — a violation of more-than-minor but limited safety or regulatory significance. Cited in a Notice of Violation; ordinarily no civil penalty, but a corrective-action response is still required.
• Minor violations — below Severity Level IV; under current policy these are normally not cited in writing, although the inspector expects them corrected. (This is the materials-program counterpart to the non-cited treatment used elsewhere in the NRC enforcement framework.)

A medical event meeting the definition of 10 CFR 35.3045 is generally dispositioned at Severity Level III, escalating to Level I or II when the dose magnitude, willfulness, or a broader program breakdown warrants it. ^{3, 7} The severity level — not the existence of a single finding — drives whether a civil penalty, a predecisional enforcement conference, or only a routine written reply follows.

The Notice of Violation itself specifies the elements of an acceptable reply, and the corrective-action response must be submitted in writing within 30 days of receiving it. For each cited violation it must state, in the NRC's own framing:

1. The reason for the violation, or, if contested, the basis for disputing it.
2. The corrective steps that have been taken and the results achieved.
3. The corrective steps that will be taken to avoid further violations.
4. The date when full compliance will be achieved.

A strong response goes beyond restating these four points: it identifies a genuine root cause (not just the proximate symptom), distinguishes the corrective action for the specific finding from the broader corrective action to prevent recurrence, and gives realistic completion dates the program can actually meet. A response that promises a date and then misses it converts a one-time finding into a repeat violation at the next inspection — a far more serious posture. The licensee may also deny a violation in the response if it has a documented factual basis; the NRC will then evaluate the denial before finalizing enforcement. If a licensee believes the corrective actions are self-evident and already complete, it may request that the NRC exercise its discretion not to require a written response, but this should not be assumed.

For Severity Level I or II violations, or for cases involving a proposed civil penalty or apparent willfulness, a predecisional enforcement conference (PEC) with NRC regional staff may be offered or required before the final enforcement decision is issued. The PEC is the licensee's opportunity to present its understanding of the facts, root cause, and corrective actions before the agency sets the final severity level and any penalty. ⁷

Exit interview

At the conclusion of the inspection, the inspector conducts an exit interview with the RSO and, typically, facility management. The inspector summarizes each finding — distinguishing between apparent violations (which may be cited) and observations (which may be noted informally). The licensee should listen carefully, take notes, and use the exit interview to provide any clarifying information or documentation that may modify the inspector's preliminary characterization.

Exit interview statements should be factual and specific. RSOs should avoid characterizing violations as isolated or unlikely to recur unless they have documented evidence to support that characterization. Inspectors expect acknowledgment and a commitment to corrective action, not argument.

The exit interview findings are preliminary. The NRC issues a formal written inspection report, typically within 30–45 days, after internal review. That report is the official record and starts the response clock.

Frequently Asked Questions (FAQs)

How often does the NRC inspect a medical materials licensee?

Frequency is set by the license priority code under NRC Inspection Manual Chapter 2800, where the priority number equals the routine inspection interval in years. Most therapy and broad-scope medical programs are Priority 2 (inspected every 2 years); standard diagnostic nuclear medicine programs are typically Priority 3 (every 3 years); the lowest-risk uses fall to Priority 5 (every 5 years). Agreement States run equivalent risk-based cycles. For-cause inspections can occur at any time following a reported event, complaint, allegation, or media report, independent of the routine cycle.

Will the NRC announce an inspection in advance?

Routine announced inspections are common for medical licensees. The NRC typically contacts the licensee to schedule a date. However, for-cause inspections — triggered by a medical event report, alleged violation, or public complaint — may be unannounced. Treating your program as perpetually inspection-ready eliminates the distinction.

What records does an inspector most often request?

Inspectors typically request RSO appointment letter, authorized-user and RSO training and experience records, dose-calibrator QC logs (constancy, accuracy, linearity, geometry), survey-meter calibration certificates, sealed-source inventory and leak-test records, occupational dosimetry reports, ALARA program records, survey records (ambient and removable contamination), written directives, radioactive waste records, and personnel training documentation.

What is a Notice of Violation and how serious is it?

A Notice of Violation (NOV) is a formal document issued by the NRC or Agreement State identifying a regulatory violation. Under the NRC Enforcement Policy, materials violations are categorized by severity: Severity Level I (most serious — actual or high-potential significant radiological consequences), Level II (significant), Level III (more-than-minor regulatory significance), and Severity Level IV (more-than-minor but limited significance). Minor violations are not normally cited. Medical events are typically dispositioned at Severity Level III, and at Level I or II when dose magnitude, willfulness, or program breakdown is involved. Civil penalties are generally associated with Severity Levels I–III.

What are the medical-event reporting deadlines under 10 CFR 35.3045?

After discovering a reportable medical event, the licensee must notify the NRC Operations Center by telephone no later than the next calendar day (10 CFR 35.3045(c)), submit a written report to the appropriate NRC Regional Office within 15 days (35.3045(d)), and notify the referring physician and the patient (or the patient's responsible relative or guardian) no later than 24 hours after discovery (35.3045(e)). A medical event is also a near-certain trigger for a reactive inspection, so the entire program should be current, not just the event file.

What happens at the inspection exit interview?

After completing the inspection, the inspector meets with the RSO and facility management to summarize preliminary findings, describe any apparent violations observed, and explain next steps. The licensee can provide clarifying information at this time. Preliminary findings are not final; the NRC issues a formal inspection report after internal review. Licensees typically have 30 days to respond in writing to any cited violations.

How does a wipe-test result get evaluated against the leak-test action level?

The net count rate (gross cpm minus background cpm) is divided by the detector's counting efficiency for the radionuclide and converted to activity. That removable activity is compared to the 0.005 µCi (185 Bq) leak-test action level in 10 CFR 35.67(e). If a sealed or brachytherapy source is found to be leaking — 185 Bq or more of removable contamination — it must be withdrawn from use immediately, decontaminated/repaired or disposed of, and a report filed with the NRC within 5 days under 10 CFR 35.67(e) (the leaking-source report required by § 35.3067).

What is the corrective-action response deadline after receiving a Notice of Violation?

For most medical licensee NOVs, the NRC requires a written response within 30 days of receipt of the inspection report. For each cited violation the reply must state the reason for the violation (or the basis for contesting it), the corrective steps taken and the results achieved, the corrective steps that will be taken to avoid further violations, and the date when full compliance will be achieved. A strong response also identifies a true root cause and gives realistic completion dates, because a missed promised date turns a one-time finding into a repeat violation. For Severity Level I or II violations or proposed civil penalties, a predecisional enforcement conference may be offered or required.

Key Takeaways

• Inspection-ready is not a sprint — it is the default state of a well-managed program. RSOs who treat compliance as a standing practice rather than an inspection-triggered activity almost always fare better than those who scramble at notice.
• Documentation gaps drive most citations. Missing constancy logs, expired survey-meter calibrations, and unsigned written directives are the most common findings; they are fully preventable.
• Know your priority code and inspection cycle — under IMC 2800 the priority number is the interval in years (most medical programs are Priority 2 or 3) — so you can budget mock inspections and binder reviews appropriately.
• Medical event reporting triggers reactive inspections. A 10 CFR 35.3045 report will bring an inspector to your facility; having the full program current before that visit is not optional.
• The leak-test action level is 185 Bq (0.005 µCi) removable activity (10 CFR 35.67(e)). Convert wipe-test counts to Bq using detector efficiency; if a source leaks, withdraw it and file the 5-day leaking-source report (35.67(e), per § 35.3067).
• ALARA investigation levels are licensee-set, not federal. There is no federal quarterly dose limit; 10 CFR 20.1201 caps the annual limits. Define your investigation levels in writing and document the review whenever one is exceeded.
• Part 37 applies to high-activity sealed sources, not routine unsealed nuclear medicine. Co-60, Cs-137, and HDR Ir-192 can reach Category 1/2 quantities; Tc-99m, F-18, I-131, and Lu-177 do not.
• The exit interview is preliminary. Provide factual clarification at that time; the written response to the NOV is the place for the full corrective-action narrative.
• NUREG-1556 Volume 9 and the medical-use Inspection Procedures (IP 87130/87131/87132) are your checklists. Self-audit against them before the inspector does.

Conclusion

An NRC or Agreement-State inspection is a detailed, documented review of the entire 10 CFR Part 35 program. Facilities that build the document binder first, conduct periodic mock inspections, close gaps as they are found, and maintain current records for every recurring requirement consistently demonstrate stronger inspection outcomes than those that treat preparation as a last-minute exercise.

The regulatory framework is not ambiguous: 10 CFR Part 20 sets the dose limits and program infrastructure, Part 35 sets the medical use requirements, and NUREG-1556 Volume 9 translates both into operational expectations. The NRC's inspection procedure is public and available. The only reason for a citation should be a genuine gap in the program — not a gap in finding the documentation.

RSOs who want an independent review of their program before an anticipated inspection, or after receiving a Notice of Violation and need assistance preparing a corrective-action response, can engage DRPS for a formal mock inspection and gap analysis.

How DRPS Can Help

Diagnostic Radiation Physics Services provides radiation safety officer consulting and radioactive material license support to medical materials licensees across Florida, Maryland, Virginia, Washington DC, California, and Nevada. Services directly relevant to inspection preparation include:

• Mock NRC/Agreement-State inspection with written gap report
• RSO program documentation review and binder organization
• Dose-calibrator and survey-meter QC record audits
• Sealed-source inventory and leak-test program review
• Occupational dosimetry and ALARA program evaluation
• Written directive and medical event reporting procedure review
• Corrective-action response drafting after a Notice of Violation
• Medical physics consulting to support new license applications and amendments

DRPS is staffed by board-certified medical physicists and health physicists who have supported programs through initial, periodic, and reactive inspections. We treat preparation the same way we treat compliance — as an ongoing process, not a point-in-time event.

Related Resources

• Radiation Safety Officer role and responsibilities
• Medical event reporting under 10 CFR 35.3045
• Common radiation safety violations and how to avoid them
• Occupational exposure monitoring
• NRC radioactive material license guide
• Package receipt and wipe testing
• Radiation Safety Officer consulting
• Radioactive material license support
• Medical physicist consulting

References

1. U.S. Nuclear Regulatory Commission. NRC Inspection Manual Chapter 2800: Materials Inspection Program; and Inspection Procedures IP 87130 (Nuclear Medicine Programs, Written Directive Not Required), IP 87131 (Nuclear Medicine Programs, Written Directive Required), and IP 87132 (Brachytherapy Programs). nrc.gov
2. U.S. Nuclear Regulatory Commission. NUREG-1556, Volume 9, Revision 3: Consolidated Guidance About Materials Licenses — Program-Specific Guidance About Medical Use Licenses. nrc.gov
3. U.S. Nuclear Regulatory Commission. 10 CFR 35.3045: Report and Notification of a Medical Event. ecfr.gov
4. U.S. Nuclear Regulatory Commission. 10 CFR Part 35: Medical Use of Byproduct Material (including 35.40–35.41 written directives, 35.60–35.61 instrument and survey-meter checks, and 35.67 sealed-source leak tests and inventory). ecfr.gov
5. U.S. Nuclear Regulatory Commission. 10 CFR 20.1201: Occupational Dose Limits for Adults (and 20.1208, dose to an embryo/fetus). ecfr.gov
6. U.S. Nuclear Regulatory Commission. 10 CFR Part 37: Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material. ecfr.gov
7. U.S. Nuclear Regulatory Commission. NRC Enforcement Policy. nrc.gov
8. U.S. Nuclear Regulatory Commission. Regulatory Guide 8.18: Information Relevant to Ensuring that Occupational Radiation Exposures at Medical Institutions Will Be As Low As Is Reasonably Achievable. nrc.gov
9. U.S. Nuclear Regulatory Commission. 10 CFR 20.1301: Dose Limits for Individual Members of the Public. ecfr.gov