ML23179A172
| ML23179A172 | |
| Person / Time | |
|---|---|
| Site: | 03001250 |
| Issue date: | 07/19/2023 |
| From: | Paul Krohn Decommissioning, ISFSI, and Reactor Health Physics Branch |
| To: | Edwards J Hosp of Central Connecticut |
| References | |
| EA-23-059 IR 2023001 | |
| Download: ML23179A172 (1) | |
See also: IR 05000202/2030001
Text
UNITED STATES
NUCLEAR REGULATORY COMMISSION
REGION I
475 ALLENDALE ROAD, SUITE 102
KING OF PRUSSIA, PA 19406-1415
July 19, 2023
Janette Edwards, MPH, MBA,
Vice President of Operations
The Hospital of Central Connecticut
100 Grand Street
Administrative Offices
New Britain, CT 06050
SUBJECT: NRC INSPECTION REPORT 030-01250/2023-001
Dear Janette Edwards:
This letter refers to the announced inspection conducted on March 7-9, 2023, at your facilities
in New Britain, Southington, and Plainville, Connecticut, with an in-office review through
June 13, 2023. The inspection was an examination of activities conducted under your license as
they relate to public health and safety, to confirm compliance with the U.S. Nuclear Regulatory
Commissions (NRC) rules, regulations, and with the conditions of your license. Within these
areas, the inspection consisted of a selected examination of procedures and representative
records, observations of activities, independent radiation measurements, and interviews with
personnel. The preliminary inspection findings were discussed with you and your staff following
the conclusion of the onsite portions of the inspection on March 7 and 8, 2023. A final exit
briefing was conducted telephonically with you and representatives of your staff, including
Gregory Hisel, Radiation Safety Officer, and George Pavlonnis, Associate Radiation Safety
Officer, on June 28, 2023. The enclosed report presents the results of the inspection.
Based on the results of the inspection, the NRC identified six apparent violations (AV), the
first of which is being considered for escalated enforcement action, including a civil penalty, in
accordance with the NRC Enforcement Policy. The current Enforcement Policy is available on
the NRCs website at http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html.
These AVs involved the apparent failures to: (1) monitor occupational exposure of an
interventional radiologist; (2) assess occupational dose to twelve staff who had occupational
duties outside of the Hospital of Central Connecticut that involved exposure to radiation;
(3) ensure that byproduct material being decayed-in-storage had a physical half-life of less
than 120 days and perform adequate monitoring of the byproduct material prior to disposal;
(4) create and retain a record of each disposal of byproduct material via decay-in-storage;
(5) confine the possession and use of byproduct material to the locations authorized in the
license; and (6) provide commensurate training to staff involved in the disposal of byproduct
material via decay-in-storage.
The enclosure provides a description of the AVs. Please be advised that the number and
characterization of AVs described in the enclosure may change as a result of further NRC
review. You will be advised by separate correspondence of the results of our deliberations on
this matter.
J. Edwards 2
Before the NRC makes its enforcement decision, we are providing you an opportunity to
(1) respond to the apparent violations addressed in this inspection report in writing within 30
days of the date of this letter, (2) request a Pre-decisional Enforcement Conference (PEC); or
(3) request alternative dispute resolution (ADR). If a PEC is held, it will be open for public
observation and the NRC will issue a press release to announce the time and date of the
conference.
If you decide to participate in a PEC or pursue ADR, please contact Anne DeFrancisco at
(610) 337-5078 or via email at Anne.DeFrancisco@nrc.gov within 10 days of the date of
this letter. A PEC should be held within 30 days of the date of this letter and an ADR session
within 45 days of the date of this letter.
If you choose to provide a written response, it should be clearly marked as a Response to
Apparent Violations in NRC Inspection Report (030-01250/2023-001); EA-23-059 and should
include for each apparent violation: (1) the reason for the apparent violation or, if contested, the
basis for disputing the apparent violation; (2) the corrective steps that have been taken and
the results achieved; (3) the corrective steps that will be taken; and (4) the date when full
compliance will be achieved. Your response may reference or include previously docketed
correspondence if the correspondence adequately addresses your response. Additionally, your
response should be sent to U.S. Nuclear Regulatory Commission, ATTN: Document Control
Desk, Washington, DC 20555-0001, with a copy mailed to Paul Krohn, Director, Division of
Radiological Safety & Security, U.S. Nuclear Regulatory Commission Region I, 475 Allendale
Road, Suite 102, King of Prussia, PA, 19406, and emailed to R1Enforcement@nrc.gov within 30
days of the date of this letter. If an adequate response is not received within the time specified
or an extension of time has not been granted by the NRC, the NRC will proceed with its
enforcement decision.
In lieu of providing this written response, you may choose to provide your perspective on
this matter, including the significance, cause, and corrective actions, as well as any other
information that you believe the NRC should take into consideration by requesting a PEC to
meet with the NRC. If you choose to request a PEC, the conference will afford you the
opportunity to provide your perspective on these matters and any other information that you
believe the NRC should take into consideration before making an enforcement decision. The
decision to hold a PEC does not mean that the NRC has determined that a violation has
occurred or that enforcement action will be taken. This conference would be conducted to obtain
information to assist the NRC in making an enforcement decision. The topics discussed during
the conference may include information to determine whether a violation occurred, information
to determine the significance of a violation, information related to the identification of a violation,
and information related to any corrective actions taken or planned. In presenting your corrective
actions, you should be aware that the promptness and comprehensiveness of your actions will
be considered in assessing any civil penalty for the apparent violations. The guidance in NRC
Information Notice 96-28, Suggested Guidance Relating to Development and Implementation
of Corrective Action, may be helpful in preparing your response (Agencywide Documents
Access and Management System (ADAMS) Accession No. ML061240509 1).
1 NRC Agencywide Documents Access and Management System (ADAMS) Accession Numbers listed in
this report may be accessible using the hyperlink below with the associated ADAMS Accession Number
inserted in place of the ML at the end. https://www.nrc.gov/docs/ML
J. Edwards 3
Finally, you may request ADR with the NRC in an attempt to resolve this issue. ADR is a
general term encompassing various techniques for resolving conflicts using a neutral third-party
mediator. The technique that the NRC has decided to employ is mediation. Mediation is a
voluntary, informal process in which a trained neutral mediator works with parties to help them
reach resolution. If the parties agree to use ADR, they select a mutually agreeable neutral
mediator who has no stake in the outcome and no power to make decisions. Mediation gives
parties an opportunity to discuss issues, clear up misunderstandings, be creative, find areas of
agreement, and reach a final resolution of the issues.
Additional information concerning the NRCs ADR program can be obtained at:
http://www.nrc.gov/about-nrc/regulatory/enforcement/adr.html. The Institute on Conflict
Resolution (ICR) at Cornell University has agreed to facilitate the NRCs program as a neutral
third party. Please contact ICR at 877-733-9415 within 10 days of the date of this letter if you
are interested in pursuing resolution of this issue through ADR.
In accordance with 10 CFR 2.390 of the NRCs Agency Rules of Practice and Procedure, a
copy of this letter, its enclosure, and your response, if you choose to provide one, will be made
available electronically for public inspection in the NRC Public Document Room and from the
NRCs ADAMS, accessible from the NRC website at http://www.nrc.gov/reading-rm/adams.html.
To the extent possible, your response should not include any personal privacy or proprietary
information so that it can be made available to the public without redaction.
If you have any questions related to this matter, please contact Anne DeFrancisco of my staff at
610-337-5078 or Anne.DeFrancisco@nrc.gov.
Sincerely,
Digitally signed by Paul G.
Krohn
Paul G. Krohn Date: 2023.07.19
08:45:43 -04'00'
Paul G. Krohn, Director
Division of Radiological Safety and Security
Docket No. 030-01250
License No. 06-02388-01
Enclosure:
NRC Inspection Report 030-01250/2023-001
cc w/ enclosure:
J. Semancik, Director, Radiation Division
Connecticut Dept. of Energy and Environmental Protection
G. Hisel, Radiation Safety Officer
G. Pavlonnis, Associate Radiation Safety Officer
J. Edwards 4
SUBJECT: NRC INSPECTION REPORT 030-01250/2023-001 - DATED JULY 19, 2023.
Distribution:
OEMAIL
D Pelton, OE RIDSOEMAILCENTER
J Peralta, OE
N Hasan, OE
L Sreenivas, OE
D Bradley, OE
R Augustus, OGC
K Williams, NMSS RIDSNMSSOD RESOURCE
M Burgess, NMSS
Enforcement Coordinators
RII, RIII, RIV (M Kowal; D Betancourt-Roldan ; R Kumana)
H Harrington, OPA RIDSOPAMAILCENTER
R Feitel, OIG RIDSOIGMAILCENTER
D DAbate, OCFO RIDSOCFOMAILCENTER
P Krohn, DRSS, RI R1DRSSMAILRESOURCE
J Quichocho, DRSS, RI
C Cahill, DRSS, RI
A DeFrancisco, DRSS, RI
J vonEhr, DRSS, RI
M Wutkowski, DRSS, RI
N Patel, DRSS, RI
D Screnci, PAO-RI
N Sheehan, PAO-RI
F Gaskins, SAO-RI
M Ford, SAO-RI
B Klukan, ORA, RI
J Nick, ORA, RI
R1Enforcement.Resource
ADAMS ACCESSION NUMBER: ML23179A172
SUNSI Review: ADAMS: Non-Publicly Available Non-Sensitive Keyword:
By: JEV Yes No Publicly Available Sensitive N/A
OFFICE RI:DRSS RI:DRSS RI:DRSS RI:ORA OGC OE
NAME MWutkowski NPatel JvonEhr MMcLaughlin RAugustus DBradley
SIGNATURE MJW NSP JEV MMM RAA DSB
DATE 06/29/23 06/29/23 06/28/23 07/05/23 07/11/2023 07/11/2023
OFFICE RI:DRSS RI:DRSS
NAME ADeFrancisco PKrohn
SIGNATURE CCahill /for/ PGK
DATE 07/13/23 07/19/23
OFFICAL RECORD COPY
U.S. NUCLEAR REGULATORY COMMISSION
REGION I
Docket: 030-01250
License: 06-02388-01
Report: 2023-001
Licensee: The Hospital of Central Connecticut
Locations Inspected: 100 Grand Street, New Britain, CT
183 North Mountain Road, New Britain, CT
201 North Mountain Road, Plainville, CT
Inspection Dates: March 7-9, 2023, with in-office review
through June 13, 2023
Inspectors: __Jason vonEhr__________________ _06/28/2023_
Jason vonEhr, Senior Health Physicist Date
Medical & Licensing Assistance Branch
Division of Radiological Safety & Security
__Netra Patel____________________ _06/29/2023_
Netra Patel, Health Physicist Date
Medical & Licensing Assistance Branch
Division of Radiological Safety & Security
__Michael Wutkowski______________ _06/29/2023_
Michael Wutkowski, Health Physicist Date
Commercial, Industrial, Research and Development,
and Academic Branch
Division of Radiological Safety & Security
Approved By: __Christopher Cahill_/for/___________ _07/13/2023_
Anne DeFrancisco, Chief Date
Medical & Licensing Assistance Branch
Division of Radiological Safety & Security
Attachment: Supplemental Inspection Information
Enclosure
EXECUTIVE SUMMARY
The Hospital of Central Connecticut
NRC Inspection Report 030-01250/2023-001
A routine announced inspection was performed at the Hospital of Central Connecticut
on March 7-9, 2023, with in-office review through June 13, 2023. The inspection was an
examination of activities conducted under the NRC license as they relate to public health and
safety, to confirm compliance with the U.S. Nuclear Regulatory Commission's rules, regulations,
and with the conditions of the NRC license. Within these areas, the inspection consisted of a
selected examination of procedures and representative records, observations of activities,
independent radiation measurements, and interviews with personnel.
Program Overview
The Hospital of Central Connecticut was authorized by the U.S. Nuclear Regulatory
Commission Materials License No. 06-02388-01 to use a variety of sealed and unsealed
byproduct material for medical use, including diagnostic and therapeutic uses authorized by
Title 10 of the Code of Federal Regulations (10 CFR) 35.100-300, 35.600, as well as emerging
medical technologies under 10 CFR 35.1000. Storage and use of NRC-licensed byproduct
materials was authorized at the licensees facilities in and around New Britain, Connecticut.
(Section 1)
Inspection Findings
Six apparent violations of NRC requirements were identified. These apparent violations included
the apparent failures to: (1) monitor occupational exposure of an interventional radiologist;
(2) assess occupational dose to twelve staff who had occupational duties outside of the Hospital
of Central Connecticut that involved exposure to radiation; (3) ensure that byproduct material
being decayed-in-storage had a physical half-life of less than 120 days and perform adequate
monitoring of the byproduct material prior to disposal; (4) create and retain a record of each
disposal of byproduct material via decay-in-storage; (5) confine the possession and use of
byproduct material to the locations authorized in the license; and (6) provide commensurate
training to staff involved in the disposal of byproduct material via decay-in-storage.
Corrective Actions
The licensee performed a reconstruction to address the apparent gap in the occupational
exposure records for the affected interventional radiologist. The licensee has not yet
communicated its actions, planned or completed, to address the consistent and accurate
monitoring of occupational exposure in the future to ensure durable and lasting compliance with
the associated regulatory requirement. Further actions concerning apparent violation No. 2
identified above are described in Section 3.8.2 and No. 3-6 in Section 3.8.3 of this report.
2
REPORT DETAILS
1. Program Overview (Inspection Procedure 87130 and 87132)
1.1. Program Scope
The Hospital of Central Connecticut (HOCC) was authorized by the U.S. Nuclear
Regulatory Commission (NRC) Materials License No. 06-02388-01 to use a variety of
sealed and unsealed byproduct material for medical use, including diagnostic and
therapeutic uses authorized by Title 10 of the Code of Federal Regulations (10 CFR)
35.100-300, a High Dose Rate Afterloader (HDR) under 10 CFR 35.600, as well as
emerging medical technologies in the form of yttrium-90 microspheres under 10 CFR
35.1000. Storage and use of NRC-licensed byproduct materials was authorized at the
licensees facilities in New Britain, Southington, and Plainville, Connecticut.
The license was amended three times since the NRCs last routine inspection (started
on March 5, 2021). These amendments included:
- Amendment No. 121, issued on November 22, 2021, which removed two
Authorized Users (AU) and a medical physicist from the NRC license, removed
the authorization to use radioactive materials for manual brachytherapy under
10 CFR 35.400, and added a new location of use within HOCCs facilities;
- Amendment No. 122, issued on December 3, 2021, which authorized a
change in the NRC-approved Radiation Safety Officer (RSO) and removed
the self-shielded irradiator from the NRC license; and
- Amendment No. 123, issued on February 7, 2023, renewed the NRC license,
changed the RSO, and added an Associate Radiation Safety Officer (ARSO).
1.2. Inspection Scope
The inspection was an examination of activities conducted under the NRC license as
they relate to public health and safety, to confirm compliance with the NRCs rules,
regulations, and with the conditions of the HOCC license. Within these areas, the
inspection consisted of a selected examination of procedures and representative
records, observations of activities, independent radiation measurements, and interviews
with personnel.
The inspection included a review of the findings, root cause(s), and corrective actions
from the NRCs last routine inspection, as documented in Inspection Report
No. 030-01250/2021-001, which resulted in escalated enforcement.
2. Review of Inspection Report No. 2021-001 Escalated Enforcement Findings
The NRC issued its report for Inspection Report No. (IR) 2021-001 on
September 15, 2022 (redacted public version found at ADAMS Accession
No. ML22258A099 2, nonpublic version at Accession No. ML22258A097), and revised
the report on January 23, 2023 (public version: Accession No. ML23023A111, nonpublic
version: Accession No. ML23023A106), in response to HOCCs written response dated
2 NRC Agencywide Documents Access and Management System (ADAMS) Accession Numbers listed in
this report may be accessible using the hyperlink below with the associated ADAMS Accession Number
inserted in place of the ML at the end. https://www.nrc.gov/docs/ML
3
October 21, 2022 (nonpublic document: Accession No. ML22336A183). The NRC
issued its final enforcement action on January 24, 2023 (public version: Accession
No. ML23024A024, nonpublic version: Accession No. ML22314A103).
The enforcement action described above involved one or more violations of NRC
security requirements that were categorized at Severity Level III. The NRC action
stemmed from the licensees failure to comply with requirements involving a category 2
quantity of radioactive material, as defined in 10 CFR Part 37 Physical Protection of
Category 1 and Category 2 Quantities of Radioactive Material. The NRC performed a
non-routine, limited scope inspection on September 22, 2021 (IR2021-002, ADAMS
Accession No. ML21326A047), which provided oversight of HOCCs transfer of the
category 2 quantity of radioactive material to the Department of Energy. This material
triggered HOCCs need to comply with the 10 CFR Part 37 requirements, and therefore,
with its removal, HOCC was no longer responsible for the requirements in 10 CFR Part
37. The HOCC NRC license was amended on December 3, 2021, to remove the
authorization to possess this material.
As a result of all the above, the NRC is closing all violations issued under IR2021-001,
as the requirements therein are no longer applicable to HOCCs operations. These
closures are further noted in this enclosures attached Supplemental Inspection
Information.
3. Observations and Findings
3.1. Locations Inspected and Licensee Oversight
This inspection included observations, interviews with staff, and select review of records
and procedures at the 100 Grand Street, New Britain, Connecticut facilities (New Britain
General Campus) and the satellite facility located at both 183 North Mountain Road,
New Britain, and 201 North Mountain Road, Plainville, Connecticut (Radiation Oncology
Treatment Center). The inspection did not address the licensed location located at
81 Meriden Ave, Southington, CT (Bradley Memorial Campus), as a result of the lack of
licensed activities.
The inspectors toured all areas where licensed material was used or stored at the New
Britain General Campus and the Radiation Oncology Treatment Center. This included
but was not limited to observations of initial package receipt, dose calibrator quality
control, dose preparation, administration, patient interaction, performance of radiation
surveys, and radioactive waste management. Additionally, independent radiation
surveys were performed and found to be consistent with licensee postings and within
regulatory limits.
The radiation safety program operated under the direction of a Radiation Safety
Committee (RSC) which met quarterly and included the representation required by
10 CFR 35.24. During the inspection period, the RSO changed from an onsite AU, who
received the support of an ARSO, and a physics consultant who performed quarterly
audits. The audits included, but were not limited to: equipment calibration, review of
written directives, training, general records review, exposure evaluations, and the
performance of sealed source leak tests and physical inventory.
4
3.2. Nuclear Medicine Operations - Imaging and Diagnostic
The inspector performed a sample review of records, polices, and procedures as they
related to the licensees nuclear imaging and diagnostic operations authorized under
10 CFR 35.100 and 10 CFR 35.200. The Nuclear Medicine Department had two full-time
and two per diem Nuclear Medicine Technologists (NMT). One of the full-time NMT and
one per diem NMT rotate at the cancer center. The licensee used technicium-99m to
perform cardiac stress testing. The licensee imaged approximately nine to fifteen
patients per day. PET/CT (Positron Emission Tomography/Computed Tomography)
scans were only performed at the cancer center. The licensee used fluorine-18 and
gallium-68 to perform PET scans. All the dosages were received from Cardinal Health as
unit doses, except technicium-99m which was received as bulk doses. All doses were
assayed prior to administration. The licensee also performed iodine-123 uptake studies
with approximately four patients per quarter. During the course of the review of the
licensees imaging and diagnostic operations, four apparent violations were identified
concerning the handling of unanticipated radioactive waste, which is discussed in
Section 3.8 below.
3.3. Nuclear Medicine Operations - Therapeutic
The inspectors reviewed the licensees nuclear unsealed therapeutic operations. The
inspectors found that the licensee had not performed any recent radium-223 Xofigo
administrations. The licensee provided the most recent administration, which occurred
prior to the last routine inspection. No other cases occurred in that time period, and
none were performed during the inspection. The licensee also performed therapeutic
iodine-131 administrations. These ranged from treatments for hypothyroidism through
thyroid ablations. The licensee performed four administrations in calendar year 2023
through the date of the inspection, including two ablations utilizing approximately
150 mCi of iodine-131.
No administrations were scheduled while the inspectors were onsite. All iodine-131
administrations were performed on an outpatient basis. The licensee provided sufficient
patient release instructions and performed adequate patient release exposure
calculations pursuant to 10 CFR 35.75. A sample of written directives representing
recent iodine administrations was reviewed, with no issues or concerns identified.
3.4. Manual Brachytherapy
The inspectors did not review the licensees now-terminated manual brachytherapy.
The NRC license was amended on November 22, 2021, to remove the AUs and
authorization for the 10 CFR 35.400 manual brachytherapy program. As a result, no
inspection effort was expended on the activities performed between the last NRC
inspection, which started remotely on March 6, 2021, and continued with an onsite
inspection on March 21, 2021, and the termination of authorization for the program on
November 22, 2021.
3.5. Remote Afterloader Brachytherapy
The inspectors performed interviews and reviewed select records, policies, and
procedures as they related to the licensees remote afterloader brachytherapy program
authorized under 10 CFR 35.600. The licensee possessed a single Elekta Model
5
microSelectron 106.990 HDR remote afterloader. The licensee demonstrated its
activities associated with this unit, including pre-treatment spot checks, periodic full
calibration, use during patient treatment, security of the device and its associated keys,
and availability of emergency response equipment. The licensee averaged between 130
and 140 treatments per year with this system. No patients were scheduled for treatment
the week the inspection was performed, and as a result no observations were able to
be made. The licensee was able to provide a walkthrough demonstration in order to
facilitate a general overview of a procedure. No issues or items of concern were
identified with respect to the licensees remote afterloader brachytherapy program.
3.6. Yttrium-90 Microsphere Program
The inspectors performed a review of records, policies, and procedures as they related
to the licensees yttrium-90 microsphere program authorized under 10 CFR 35.1000.
The licensee utilized the BWXT Medical Ltd. Model Therasphere for the performance of
its administrations. The licensees single AU for this type of activity was not onsite during
the inspection and was interviewed telephonically after the onsite inspection. The
licensees yttrium-90 program performed eight administrations in calendar year 2021,
ten in 2022, and a single administration in year-to-date 2023 (through the date of the
onsite inspection). The licensee was committed to the NRCs Yttrium-90 Microsphere
Brachytherapy Sources and Devices TheraSphere and SIR-Spheres Licensing
Guidance (Revision 10.2, dated April 20, 2021), which is accessible at Accession
No. ML21089A364. During the course of the review of the licensees yttrium-90 program,
one apparent violation was identified concerning the occupational monitoring of the AU,
which is discussed in Section 3.8 below.
3.7. Independent Radiation Surveys
The inspectors performed independent radiation surveys throughout the inspection in
areas of use or storage of radioactive materials, and included, but were not limited to:
the administration rooms in the nuclear medicine suite, radioactive waste areas,
radiopharmacy packages post-delivery, and the HDR unit. The survey results were
generally consistent with the licensees postings and applicable regulatory limits. One
item was discussed with the licensee concerning a posting for the HDR, specifically the
storage location storage for the HDR (an annex within the treatment room). HOCC
had posted this area with Caution: Radiation Area, despite the room not plausibly
exceeding the 5 millirem in any one hour at 30 centimeters from the surface of the HDR
as described in 10 CFR 20.1902(a) and as defined in 10 CFR 20.1003. The licensee
explained that this was in case of emergency, rather than the expectation of meeting or
exceeding the 10 CFR Part 20 requirement for posting this level of hazard during the
course of routine operations. The licensee was encouraged to ensure that their postings
were comparable and commensurate with the associated radiation hazard, and to not
over-post a room or area.
The inspectors surveys were performed with a: Ludlum Model 2401-P, serial number
145164, calibration date November 3, 2022; Ludlum 2401-P, serial number 285217,
calibration date January 05, 2023; and Ludlum 2401-P serial number 281353, calibration
date September 19, 2022.
6
3.8. NRC Findings
Over the course of the NRCs observations, three areas of concerns were identified,
resulting in six apparent violations. The first area of concern involved the licensees
occupational exposure monitoring program as it applied to a single interventional
radiologist and AU. The second area of concern involved the licensees monitoring for
individuals with exposure external of the license. The third area of concern involved
the licensees handling of unanticipated radioactive waste that was identified in its
non-radioactive waste streams.
Within the areas of concern identified above, six apparent violations of NRC
requirements were identified. These apparent violations included the apparent failures
to: (1) monitor occupational exposure of an interventional radiologist; (2) assess
occupational dose to twelve staff who had occupational duties outside of the HOCC that
involved exposure to radiation; (3) ensure that byproduct material being decayed-in-
storage had a physical half-life of less than 120 days and perform adequate monitoring
of the byproduct material prior to disposal; (4) create and retain a record of each
disposal of byproduct material via decay-in-storage; (5) confine the possession and
use of byproduct material to the locations authorized in the license; and (6) provide
commensurate training to staff involved in the disposal of byproduct material via
decay-in-storage.
These areas of concern and associated apparent violations are described in detail in
Sections 3.8.1-3.8.3 below.
3.8.1. Occupational Exposure Monitoring (AV1)
During a review of HOCC dosimetry, an AU (an interventional radiologist) for yttrium-90
microspheres was identified as having abnormal dosimetry results. This included 16
months in Calendar Years (CY) 2021 and 2022 with no radiation exposure results at all,
and three further months with exceptionally low radiation exposure results in contrast to
the type and frequency of work with both radioactive material and machine-produced
radiation. The machine-produced radiation was from the practice of interventional
radiology and, primarily, the use of a fluoroscope.
The licensee reviewed the subject dosimetry results and agreed that they did not
accurately reflect this AUs true occupational exposure and, as a result, took steps to
perform a dose reconstruction. This dose reconstruction was based on the amount of
time with the fluoroscopic beam on and combining this with academic literature in order
to estimate the occupational exposure to the individual. The literature the licensee used
suggested an exposure rate, as a result of scatter radiation from the fluoroscope, of
between 3 millirem/minute of beam time for the fluoroscope (with a lead shield skirt
on the patients table) and 6 millirem/minute (without this lead shield). As a result,
the licensee concluded that the AU experienced a radiation exposure of between
1,082 - 2,164 millirem for CY2021, and between 1,400 - 2,800 millirem for CY2022.
This estimate was compared to the five months in CY2021 and CY2022 where the
individuals dosimetry results appeared to be reasonable and potentially representative
7
of the interventional radiologists actual exposure. This comparison suggested the
licensees academic literature-based estimate was reasonable: these five months
dosimetry results suggested a per-minute radiation exposure from a low of 2.35
millirem/minute of beam time to 6.17 millirem/minute of beam time, with an overall
weighted average of 3.64 millirem/minute of beam time.
While this AU performed work at two other facilities, these facilities were within the
overall Hartford HealthCare system, and the Hartford HealthCare system demonstrated
during the inspection that it appeared to adequately aggregate occupational radiation
exposure from facilities within its purview. Furthermore, these other two facilities
contributed only very minor exposures to the AUs overall occupational exposure (the AU
works 1 day every 2 months at the first facility, and 1 day every 6 months at the second).
The AU and licensee confirmed that there was separately-issued dosimetry from each
facility and the corporate Hartford HealthCare primary dosimetrist demonstrated how
these were aggregated across the different Hartford HealthCare facilities.
In addition to the efforts described above, the licensee planned to provide extra
dosimetry for an 8-week trial period after the inspection (starting in June 2023). This
dosimetry would be provided to the AU with additional measures by the licensee to
provide high confidence in the consistent and accurate wearing of this dosimetry. The
purpose of this trial period was to supplement the academic literature and existing
occupational exposure results in order to provide confidence in and narrow the
estimated range of the final reconstructed occupational exposure result. As of the date of
this report, the trial had not yet concluded. HOCC provided communications to the NRC
regarding this reconstruction on April 13, 2023 (ADAMS Accession No. ML23166A148),
which was revised following NRC input on April 18, 2023 (ADAMS Accession
No. ML23166A149).
As a result of the gap identified between the AUs likely occupational exposure and what
was recorded and reported by the individuals dosimeter, and the dosimetry programs
apparent failure to identify the abnormal results in order to take compensatory
measures, an apparent violation of 10 CFR 20.1502 was identified and is described
below (030-01250/2023-001-01):
Apparent Violation No. 1: Occupational Monitoring
10 CFR 20.1502(a)(1) requires that each licensee shall monitor exposures to
radiation and radioactive material at levels sufficient to demonstrate compliance with
the occupational dose limits in 10 CFR Part 20. At a minimum, each licensee shall
monitor occupational exposure to radiation from licensed and unlicensed radiation
sources under the control of the licensee and shall supply and require the use of
individual monitoring devices by adults likely to receive, in 1 year form sources
external to the body, a dose in excess of 10 percent of the limits in 10 CFR
20.1201(a).
Contrary to the above, from at least March 24, 2021, through March 6, 2023, the
licensee failed to monitor exposures to radiation and radioactive material at levels
sufficient to demonstrate compliance with the occupational dose limits in 10 CFR
Part 20. Specifically, the licensee failed to monitor an interventional radiologists
exposure to radiation from radioactive materials and unlicensed radiation sources
under the
8
control of the licensee, and the subject interventional radiologists reconstructed
radiation exposures were in excess of the 10 CFR 20.1201(a)(1) 10% threshold to
require monitoring.
As a result of the estimated dose provided by HOCC at the time of this reports writing
and potential for the AU to exceed NRC regulatory requirements for annual occupational
dose, this AV is being considered for escalated enforcement action in accordance with
the NRCs Enforcement Policy.
3.8.2. External Occupational Exposure Monitoring (AV2)
HOCC had staff, contractors, and physicians who were exposed to radiation from
NRC-licensed radioactive materials under the HOCC NRC license who were also
exposed to radiation as part of their occupational duties from both unlicensed sources of
radiation at HOCC as well as licensed and unlicensed sources of radiation at other
Hartford HealthCare system facilities. In the examples reviewed and discussions with
knowledgeable staff, HOCC appeared to have systems in place to collect and aggregate
monitored occupational radiation exposure from other facilities within the Hartford
HealthCare network. However, the licensee did not appear to have considered the need
to collect and aggregate occupational radiation exposure that occurs outside this
network.
Several staff were identified by the inspectors who worked under the scope of the HOCC
NRC license in addition to facilities external to the Hartford HealthCare network. The
occupational exposures experienced by these staff at these outside facilities was not
aggregated into the radiation monitoring records or accounted for in the licensees
implementation of its radiation safety program.
Following identification by the NRC, HOCC worked to identify which staff, contractors,
and physicians may be impacted by this gap in the monitoring program. Twelve
individuals were identified by HOCC as having occupational exposure to radiation
occurring outside of the HOCC and Hartford HealthCare network. At HOCC, this
impacted eight staff in radiation oncology and four staff from nuclear medicine (which
included PET).
Once identified, HOCC contacted each of the external facilities to share occupational
exposure information, with the consent of the impacted individuals (as these records are
generally protected from public disclosure under 10 CFR 20.2106(d) because of their
personal privacy nature). In no instance was staff, following aggregation of other
third-party entities, exposed to more than the NRC regulatory limits in 10 CFR 20.1201.
The magnitude of the external exposure that was unaccounted for by HOCC ranged
from no recorded (or minimal) exposure, which is common and reasonable in routine
radiation oncology operations, to 233 millirem whole body and 595 millirem extremity
for the nuclear medicine staff. The licensees initial outreach and final conclusions
were documented in letters to the NRC dated April 13, 2023 (ADAMS Accession No.
ML23166A147) and May 12, 2023 (redacted to protect privacy information, ADAMS
Accession No. ML23166A151).
9
As a result of all the above, an apparent violation of 10 CFR 20.1201(f) was identified
and is described below (030-01250/2023-001-02):
Apparent Violation No. 2: External Occupational Monitoring
10 CFR 20.1201(f) requires that the licensee shall reduce the dose that an individual
may be allowed to receive in the current year by the amount of occupational dose
received while employed by any other person.
Contrary to the above, in twelve instances from at least March 24, 2021, and
March 6, 2023, the licensee failed to reduce the dose that an individual may be
allowed to receive in the current year by the amount of occupational dose received
while employed by any other person. Specifically, for twelve individuals who
performed licensed activities under the NRC license, the licensee failed to assess
occupational dose received while the individuals continued their employment by
other organizations outside of the Hartford HealthCare , and from which the
individuals had duties that involved exposure to radiation.
3.8.3. Handling of Unanticipated Radioactive Waste (AV3-6)
The licensees RSC meeting minutes described Area Radiation Detectors and
low level alarms with some regularity. The inspectors noted a total of 27 alarms
documented in the RSCs meeting minutes in calendar year 2022. The HOCC staff and
representatives described these alarms as related to radiation portal monitors installed
at two points in the main facilitys exits for general trash services. While some of the
minutes described this as the result of in-patient waste (meeting minutes for 2022
Quarter 1) and in-house Tc-99m waste (meeting minutes for 2022 Quarter 2), it did not
appear that HOCC had exerted any material effort to investigate and identify the source
of this apparently radioactive waste, and therefore conclude with any certainty or
speculation on its origins.
The inspectors interviewed the manager of the Environmental Services group, who
described the procedures and training for handling these alarms and provided a
walk-down of a storage area and the two radiation portal monitors. The manager
explained that waste which triggered the radiation portal monitors would be partitioned
to identify the bag or container causing the alarm and that this bag or container would
be segregated into a separate room for radioactive decay for three days before being
passed through the radiation portal monitor again. If the portal monitor did not alarm, the
waste would be deemed non-radioactive and continue to be handled through the normal
non-radioactive waste processes. If the portal monitor alarmed for this post-decay check,
Environmental Services would contact the Nuclear Medicine Department for assistance.
As the source of the waste was not identified and no further material efforts were exerted
to identify the isotope of concern, HOCC could not conclude what the potential hazard
was posed by the waste. Furthermore, HOCC could not state whether their existing
controls for handling and processing known radioactive waste were experiencing failures
or if this unanticipated waste resulted from other uncontrolled areas (for example, from
patients in the Emergency Department who had radioactive administrations prior to their
emergency, whether this administration had occurred at HOCC or another licensed
facility). This, in part, contributed to deficiencies in addressing NRC regulatory
10
requirements, license limitations and commitments, and applicable HOCC policies
and procedures.
While it is likely that the subject radioactive material was from or related to nuclear
medicine operations, and thus represents short-lived, low-activity radionuclides, and
therefore relatively limited hazards, HOCC had not demonstrated this to be the case.
These deficiencies can be further subdivided into four areas of concern: (1) decay-in-
storage and monitoring; (2) decay-in-storage records; (3) confinement of possession and
use of byproduct material to locations authorized by the NRC license; and (4) training for
staff (10 CFR 35.92(a), 10 CFR 35.92(b) & 35.2092, 10 CFR 30.34(c), and License
Condition 15(A), respectively). These items are described, in brief, below, along with the
associated apparent violation.
First, the licensees apparent failure to identify the isotopes of concern resulted in its
inability to demonstrate that it was authorized to use the decay-in-storage provision
provided in 10 CFR 35.92, as this authorization is contingent upon the byproduct
material having a physical half-life of less than or equal to 120 days. In addition, the
licensees use of the radiation portal monitors failed to meet the regulatory requirement
for monitoring the byproduct material that is being released via decay-in-storage, as it
failed to monitor the byproduct material at its surface with an appropriate instrument at
its most sensitive scale with no interposed shielding.
As a result of the above, an apparent violation of 10 CFR 35.92(a) was identified and is
described below (030-01250/2023-001-03):
Apparent Violation No. 3: Decay-in-Storage Half-Life Limitation and Monitoring
10 CFR 35.92(a) states, in part, that a licensee may hold byproduct material with
a physical half-life of less than or equal to 120 days for decay-in-storage before
disposal without regard to its radioactivity if the licensee monitors the byproduct
material at the surface before disposal and determines that its radioactivity cannot be
distinguished from the background radiation level with an appropriate radiation
detection survey meter set on its most sensitive scale and with no interposed
shielding.
Contrary to the above, in numerous instances from at least March 24, 2021, through
March 6, 2023, the licensee: (1) failed to ensure that byproduct material had a
physical half-life of less than or equal to 120 days, prior to that byproduct material
being decayed-in-storage; and (2) failed to monitor the byproduct material at the
surface before disposal and determine that its radioactivity could not be distinguished
from the background radiation level with an appropriate radiation detection survey
meter set on its most sensitive scale and with no interposed shielding. Specifically,
the licensee disposed of unknown radioactive isotopes via decay-in-storage before
releasing them as non-radioactive waste, and that disposal occurred without
monitoring using an adequate instrument at the surface of the material.
Second, the licensee generated only auxiliary notes associated with the disposal of this
unanticipated radioactive material, such as the notes in the RSC meeting minutes. The
licensee attempted to identify and produce more detailed information such as the times
11
and occasions, or personnel involved, with individual disposals, and was not able to
produce such records.
As a result of the above, an apparent violation of 10 CFR 35.92(b) and its associated
requirement in 10 CFR 35.2092 was identified and is described below (030-01250/2023-
001-04):
Apparent Violation No. 4: Decay-in-Storage Record Creation and Retention
10 CFR 35.92(b) requires that the licensee retain a record of each disposal permitted
under 10 CFR 35.92(a) in accordance with 10 CFR 35.2092.
10 CFR 35.2092 requires that the licensee shall maintain records of the disposal
of licensed materials, as required by 10 CFR 35.92, for 3 years. The record must
include the date of the disposal, the survey instrument used, the background
radiation level, the radiation level measured at the surface of each waste container,
and the name of the individual who performed the survey.
Contrary to the above, in numerous instances from at least March 24, 2021, through
March 6, 2023, the licensee failed to create and retain a record of each disposal
permitted under 10 CFR 35.92(a). Specifically, the licensee disposed of unknown
radioactive isotopes and failed to create or retain a record regarding that disposal,
including the specific items described in 10 CFR 35.2092.
Third, the licensees retention of the unanticipated radioactive material involved
temporary storage for the three-day period following initial identification in a secure
room near the Environmental Services operations. This room was not identified by
the licensee to the NRC in its most recent license application or subsequent
communications amending the NRC license. The licensees applications and
subsequent communications include descriptions, consistent with NUREG-1556,
Volume 9, Section 8.9 Facilities and Equipment, of areas where byproduct material is
prepared, used, administered, and stored.
As a result of the above, an apparent violation of 10 CFR 30.34(c) was identified and is
described below (030-01250/2023-001-05):
Apparent Violation No. 5: Confinement of Byproduct Material to Authorized Locations
10 CFR 30.34(c) requires, in part, that each licensee shall confine its possession and
use of byproduct material to the locations authorized in the license.
License Condition 15 of NRC License No. 06-02388-01, Amendment No. 123, dated
February 7, 2023, requires, in part, that the licensee shall conduct its program in
accordance with the statements, representations, and procedures contained in the
application dated August 18, 2022, and subsequent letters dated November 22,
2022, and January 19, 2023, including any enclosures.
The application dated August 18, 2022, and subsequent letters dated
November 22, 2022, and January 19, 2023, identify and describe the locations
where radioactive materials will be stored.
12
Contrary to the above, in numerous instances from at least February 7, 2023 3,
through March 6, 2023, the licensee failed to confine its possession and use of
byproduct material to the locations authorized in the license. Specifically, the
licensee stored radioactive materials in a room not identified in the license
application or subsequent letters by the licensee as a location of storage.
Fourth, and finally, the personnel of the Environmental Services Department were
provided cursory hazard awareness training, consistent with all auxiliary staff at HOCC.
While this would be sufficient to address the limited potential these staff normally have to
encounter or be in proximity to radioactive materials, this training did not address
subjects consistent with the handling of radioactive waste, such as the performance of
adequate radiation surveys, contamination control, emergency procedures, record
creation and retention, or other HOCC policies, procedures, and NRC regulations as
they concern the handling and disposal of radioactive waste.
As a result of the above, an apparent violation of License Condition 15.A was identified
and is described below (030-01250/2023-001-06):
Apparent Violation No. 6: Adequacy of Training
License Condition 15 of NRC License No. 06-02388-01, Amendment No. 123, dated
February 7, 2023, requires, in part, that the licensee shall conduct its program in
accordance with the statements, representations, and procedures contained in the
documents, including any enclosures, in the letter dated November 22, 2022.
The application dated November 22, 2022, requires, in part, that the Hospital of
Central Connecticut shall develop and will implement and maintain written
procedures for a program for training required under 10 CFR 19.12 for each group of
workers, including (i) topics covered, (ii) qualifications of the instructors, (iii) method
of training, (iv) method for assessing the success of the training, (v) initial training,
and (vi) annual refresher training.
Contrary to the above, from February 7, 20233, through March 6, 2023, the licensee
failed to develop and implement and maintain written procedures for a program for
training. Specifically, auxiliary staff in the Environmental Services Department were
assessing and disposing of unknown radioactive isotopes and the licensee failed to
provide commensurate training to handle, assess, survey, and dispose of this
radioactive waste properly.
3 NRC License No. 06-02388-01 was renewed with Amendment No. 123, which was finalized and issued
on February 7, 2023, and as a result included a new application to the NRC from HOCC consistent with
NUREG-1556, Volume 9, Revision 3. The license prior to Amendment No. 123, and thus prior to
February 7, 2023, included equivalent and commensurate commitments and descriptions. Therefore,
while the apparent violation is quoted as beginning on February 7, 2023, this is for simplicity of
communication, rather than an actual description of the licensees apparent deficiency, which preceded
the quoted date.
13
3.8.4. Additional Observation Regarding Unanticipated Radioactive Waste
The licensee committed in its November 22, 2022, application to the NRC to develop,
implement, and maintain written waste disposal procedures for radioactive material in
accordance with 10 CFR 20.1101, which also meets the requirements of the applicable
section in 10 CFR Part 20, Subpart K, and 10 CFR 35.92. An equivalent and consistent
commitment was made with the license prior to the renewal of the license3. While the
inspectors noted several apparent gaps between the licensees practices as described
throughout Section 3.8.3 of this report with regards to the disposal of this unanticipated
radioactive material and HOCCs written policy, the specific items were determined to be
sufficiently addressed by AV3-6 above and therefore would be duplicative to include as a
separate AV. As a matter of completeness and communication, a brief description is of
this additional observation is provided below.
The licensees responsive waste disposal procedure (titled Radioactive Waste
Management Plan Revision August 2018, Manual Code 03.0005), required, in part, that:
- Section II General Information: All persons required to handle radioactive
wastes will be provided with appropriate orientation, equipment, and on-the-job
training; and Only the Nuclear Medicine Department and the Radiation
Oncology Department are authorized by the Nuclear Regulatory Commission
to possess radioactive material;
- Section IV Storage of Waste Material: All radioactive waste material will be
stored in the designed shielded enclosures and Environmental Services
employees will follow departmental policies for responding to the radiation
alarm; and
- Section IV [sic] Records for Disposal: Records of disposal will include the
following information: (1) the date placed in storage for decay and the container
identification if applicable; (2) approximate total activity and volume (or number
of sources for capsules, seeds, columns, etc.) at the time placed in storage; and
(3) date disposed as regular trash and the survey meter reading.
As AV4 and 6 already address apparent deficiencies in record generation and retention
as well as the training provided to staff in the Environmental Services Department, these
apparent gaps are already captured and described in the subject AVs. Regarding the
second bullet noted above (Storage of Waste Material), the inspectors found that the
segregated waste was not provided any designed shielded enclosure, and would instead
be stored, absent any additional shielding, in the secured room near the Environmental
Services Department. As the licensee did not know the isotope or quantity of material, it
is unclear what hazard this posed to staff working in or around this room.
HOCC provided the NRC copies of its draft revisions to relevant policies and
procedures, specifically the documents titled NRC Regulated Radioactive Waste
Disposal, Radioactive Waste Management Plan, and Radiation Portal Monitor Alarm.
HOCC emphasized, however, that these were yet under draft and final decisions on
long-term corrective actions were still being discussed and under review.
14
3.9. Conclusions
As a result of the NRCs inspection efforts, six apparent violations of NRC requirements
were identified. These apparent violations included the failures to: (1) monitor
occupational exposure of an interventional radiologist; (2) assess occupational dose to
twelve staff who had occupational duties outside of the HOCC that involved exposure to
radiation; (3) ensure that byproduct material being decayed-in-storage had a physical
half-life of less than 120 days and perform adequate monitoring of the byproduct
material prior to disposal; (4) create and retain a record of each disposal of byproduct
material via decay-in-storage; (5) confine the possession and use of byproduct material
to the locations authorized in the license; and (6) provide commensurate training to staff
involved in the disposal of byproduct material via decay-in-storage.
4. Corrective Actions
With regards to AV1 concerning the apparent failure to monitor the occupational
exposure of an interventional radiologist, the licensees efforts to reconstruct the
apparent gap in the occupational exposure records are documented in Section 3.8.1
above. The licensee had not yet communicated its actions, planned or completed, to
address the consistent and accurate monitoring of occupational exposure in the future to
ensure durable and lasting compliance with the associated regulatory requirement.
Similarly, for AV2 concerning the apparent failure to assess occupational dose to staff
who had occupational duties outside of the HOCC that involved exposure to radiation,
the licensees actions to address prior occupational exposure at outside facilities is
described in Section 3.8.2. The licensee has not yet communicated its actions, planned
or completed, for how it intends to address this in the future to ensure durable and
lasting compliance with the associated regulatory requirement.
Finally, for AV3-6, the licensee has taken steps to review and begin revision for relevant
policies and procedures related to the handling of radioactive waste. Draft versions of
these documents were shared with the NRC. However, HOCC has not yet
communicated its final decision in how it intends to handle further radioactive waste
identified outside its normal processes, which includes whether the current practice of
handling this material principally by the Environmental Services Department will continue
or not.
5. Exit Meeting Summary
The NRC inspectors presented preliminary inspection findings following the onsite
inspection on March 7 and 8, 2023. The licensee acknowledged the findings presented
and committed to formulating a corrective action plan. The NRC conducted a final exit
briefing via teleconference on June 28, 2023. HOCC was represented by: Janette
Edwards, MPH, MBA, Vice President of Operations; Gregory Hisel, Consultant and
Radiation Safety Officer; George Pavlonnis, Associated Radiation Safety Officer; and
other health physics and corporate support staff. The licensee again acknowledged the
findings presented and did not dispute any of the facts presented.
15
SUPPLEMENTAL INSPECTION INFORMATION
LIST OF PERSONS CONTACTED
Janette Edwards, MPH, MBA, Vice President of Operations
Greggory Hisel, Consultant and Radiation Safety Officer
George Pavlonnis, Associate Radiation Safety Officer
Daniel Chiappetta, Radiation Safety Physicist
INSPECTION PROCEDURES USED
87130, Revision 1 - Nuclear Medicine Programs
87132 - Brachytherapy Programs
ITEMS OPENED, CLOSED, AND DISCUSSED - PUBLIC
Opened
030-01250/2023-001-01 AV Apparent failure to monitor occupational exposure of an
interventional radiologist.
030-01250/2023-001-02 AV Apparent failure to assess occupational dose to staff who
had occupational duties outside of HOCC that involved
exposure to radiation.
030-01250/2023-001-03 AV Apparent failure to ensure that byproduct material being
decayed-in-storage had a physical half-life of less than 120
days and the apparent failure to perform adequate
monitoring of the byproduct material prior to disposal.
030-01250/2023-001-04 AV Apparent failure to create and retain a record of each
disposal of byproduct material via decay-in-storage.
030-01250/2023-001-05 AV Apparent failure to confine the possession and use of
byproduct material to the locations authorized in the
license.
030-01250/2023-001-06 AV Apparent failure to provide commensurate training to staff
involved in the disposal of byproduct material via decay-in-
storage.
(Continued on next page)
Attachment
Closed
All violations associated with IR2021-001 are considered closed. The licensee no longer
possesses, plans to possess, or is authorized to possess quantities of radioactive materials
within the scope of 10 CFR Part 37.
Discussed
None
LIST OF ACRONYMS AND ABBREVIATIONS USED
ADAMS Agencywide Documents Access and Management System
ADR Alternative Dispute Resolution
ARSO Associate Radiation Safety Officer
AU Authorized User
AV Apparent Violation
CFR Code of Federal Regulations
CY Calendar Year
HDR High Dose Rate Afterloader
HOCC The Hospital of Central Connecticut
ICR Institute on Conflict Resolution
IR Inspection Report
NMT Nuclear Medicine Technologist
NRC Nuclear Regulatory Commission
PEC Pre-Decisional Enforcement Conference
PET/CT Positron Emission Tomography / Computed Tomography
RSC Radiation Safety Committee
RSO Radiation Safety Officer
2