Meeting Minutes: Radioactive Materials Unit March 6, 2018

Transcription

1 Meeting Minutes: Radiactive Materials Unit March 6, 2018 Minutes prepared by: Tyler Kruse Lcatin: OLF B-145 Attendance MDH Staff: Sherrie Flaherty, Supervisr, Radiactive Materials Unit Lynn Frtier, Radiatin Prtectin Specialist Tyler Kruse, Radiatin Prtectin Specialist WebEx 28 lines pen Jaqueline Cavanagh, Plicies and Rules Analyst Mary Navara, Manager, IER Sectin Nrma Leland, Office Administrative Specialist Kelly Smeltzer, WebEx Crdinatr Decisins Made See Actin Items belw Actin Items Add a training and experience pathway t the definitin f an authrized physician. Dne Add a training and experience pathway t the definitin f a Qualified Medical Physicist - Dne cmpare the definitin f a Qualified Medical Physicist with the AAMP definitin t make sure they are cnsistent Dne Define weekly with regard t the medical event definitin. Nt necessary, weekly requirement replaced with a dse per fractin requirement Cnsider reverting the weekly dse medical event criteria, back t the single fractin definitin in past versins f the regulatins. Dne Cntact Stakehlder abut cncerns invlving medical event definitin. Dne Replace the term written rder with prescribed dse in the definitin fr medical events. - Dne In reference t letter D f the medical event definitin (treatment with the wrng treatment mdality r energy): Wuld the term particle be mre applicable than mdality? kept as mdality

2 Discuss the ptential fr HIPA issues when asking the registrants t ntify the manufacturer f medical events as required by The Stakehlders feel this is an FDA issue, nt MDH. Remved the requirement fr this t be in the prcedure. Review the peratr and physicist requirements t ensure we are nt inadvertently denying the physicists frm perating the machines fr QAQC purpses. N changes made Verify that Subpart 1. Item N. (daily, weekly, and mnthly equipment perfrmance tests) refers t the apprpriate rule part. All internal rule references will be reviewed at a later date Include a certified health physicist as a pathway fr training fr Radiatin Safety Officers. Dne Allw qualified RSOs t attest t the cmpetency f a prpsed RSO. Dne Include reviewing dsimetry recrds (item C.) and radiatin surveys (Item B.) frm the Qualified Medical Physicist s respnsibilities ( Subpart2). Add them t the RSO respnsibility t perfrm, r arrange t have perfrmed ( subpart 4. H.) Dne Subpart 4: Cnsider allwing a designee, wh the Qualified Medical Physicist has deemed qualified, t verify treatment plans. Dne Cnsider requiring verificatin f treatment plans prir t 1 st treatment n all plans ( subpart 4) N change made. Investigate ntificatins required under t determine if it is necessary. Changed t ntificatins required nly if a dse t the member f the public Cnsider including ABHP r ABMPs as qualified fr shielding plans. - Dne Agenda and ntes Presenter: Sherrie Flaherty 1:00-1:10 Intrductin 1:10 2:50 Discussin and Questins 2:50 3:00 Wrap up and Next Steps Rule Part and Discussin Pints Definitins Authrized Physician Qualified Medical Physicist Ntificatin and Registratin Requirements Medical Events General Equipment Operatr Requirements Recrds Radiatin Safety Officer Qualified Medical Physicist Written Orders Next Meeting Date: April 17, 2018 Time: 1:00 pm

3 Lcatin: OLF-B145 Agenda items: Meeting Ntes Definitins Authrized Physician MDH: Reviewed the definitin and explained that this is the persn wh signs the written rder. This is cnsistent with CRCPD suggested state regulatins. Stakehlder: There is n training and experience rute included. Will there be a training and experience rute? MDH: We left this ut intentinally. We wuld like stakehlder cmments as t if it is necessary. Stakehlder: there is a year perid where an AP wuld be wrking, nt under the supervisin f a bard certified AP, and wuld nt yet have bard certificatin. Therefre, a training and experience rute wuld be necessary. Stakehlder: A new graduate wuld be signing rders, while nt technically certified yet. Stakehlder: We als have APs wh sign prescriptins, and are new graduates wh have nt cmpleted their bards yet. We wuld like t see a training and experience pathway. MDH: We will cnsider adding a training and experience pathway. Stakehlder: Hw many peple are currently authrized under part B (Certificatin in Radiatin Onclgy by the American Ostepathic Bard f Radilgy)? Is it necessary t include? I have never seen ne. MDH: We dn t have that infrmatin Stakehlder: We have ne Authrized Physician that wuld fall under this categry Qualified Medical Physicist (pssibly adding grandfather clause) MDH reviewed the definitin f a QMP. Explained that we are requiring bard certificatin accrding t the CRCPD suggested state regulatins with n training and experience pathway. We remved a large prtin f the definitin that allwed very specific, nn-bard certified QMPs. Fr circumstances where this decisin wuld exclude a current QMP, MDH wuld issue a variance. Stakehlder: Wh wuld be reviewing the qualificatins fr a variance? MDH: Our unit staff wuld be reviewing the individual s credentials and granting the variances Stakehlder: Can we add a training and experience pathway fr this definitin as well? MDH: we will cnsider adding this pathway. Stakehlder: In my experience, variances are a temprary authrizatin intended t fill in the time gap fr an individual wh is in the prcess f becming cmpliant. Is this the case? MDH: MDH has the ability t grant a variance fr any amunt f time and fr reasns we deem necessary. It is nt MDH s intent fr this rule t exclude any current QMPs. Stakehlder: Previus versins f the rule had the AAPM definitin included.

4 Medical event MDH: We will cmpare ur definitin with the AAMP definitin t make sure they are cnsistent MDH prvide the definitin f a medical event and asked fr cmments Stakehlder: What is the definitin f weekly? Is it Mnday thrugh Sunday, r 7 days frm the time the treatment was delivered? MDH: We interpret weekly t mean 7 cnsecutive days. We can define this if needed. Stakehlder: 7 cnsecutive days makes mre sense as mst departments are checking charts every 5 fractins. MDH: We have a sectin abut chart checks. Stakehlder: We wuld be fine with a week defined as 7 cnsecutive days. Stakehlder: Why MDH eliminate medical events fr a single fractin deviatin and fcus mre n a weekly dse? MDH: We based this n decisins made by ther jurisdictins and a general assumptin that this apprach is preferred by the regulated cmmunity. Stakehlder: Prefer the single fractin medical event criteria t the weekly. In situatins where a large dse is delivered ver few fractins, a fairly large deviatin in dse fr a single fractin wuld nt meet the definitin f a medical event if we are nly cnsidering n a weekly basis as all fractins culd be delivered within ne week. WebEx Submittal: in favr f ging back t the single fractin dse definitin. MDH: We will cnsider reverting the weekly dse medical event criteria, back t the single fractin definitin in past versins f the regulatins. Stakehlder: is there a definitin fr treatment site MDH: N. Stakehlder: it is subjective. A Medical event shuld be defined as under dsing r verdsing. Hw t define it radibilgically is nt knwn and may flirt with medical decisins. Stakehlder: hw wuld we be able t determine the radibilgical effects in a shrt amunt f time in rder t reprt it? MDH: that is why we use mre general medical event definitin criteria. Stakehlder: Why d we have treating with the wrng energy fr a medical event Stakehlder: the effects f treating with the wrng energy are nt detrimental Stakehlder: As lng as the mnitr units are crrect. Stakehlder: dn t think this is necessary fr this t be a medical event Stakehlder: Wuld it be a medical event if: the written rder specifies an energy, the dsimetrist will uses a different energy during planning, and the written rder wasn t amended. MDH: it wuld depend n what yu cnsider the written rder. The Authrized Physician must sign ff n the change made by the dsimetrist prir t treatment, and generally wuld when they apprve the plan. This apprval is what we cnsider the written rder in mst cases. Nt the riginal prescriptin.

5 Stakehlder: physicians d nt necessarily dictate what energy is used t treat. It is dne during planning. In a situatin where everything is dne accrding t the plan, but written rder riginally signed by the physician is different frm what is planned, it is a dcumentatin errr. MDH: this will nt be an issue as lng as the Authrized Physician has signed ff n the final plan with the energy that will be used during treatment. Webex questin: when the plan is missing infrmatin, a plan wuld lead t a medical event. MDH: we are attempting t cver this withut getting int the realm f a medical decisin. Stakehlder: quality f dsimetry is a quality issue fr each institutin Stakehlder: (clarifying) there are instances where plans were signed ff, that were incrrect that were clearly medical events. Hwever, the definitin did nt capture them. MDH: will have a discussin with this stakehlder abut cncerns invlving specific facilities. We may need t add the term written rder t the definitin rather than prescribed dse. Stakehlder: agrees with taking ut prescribed dse and using written rder. Written rder definitin wuld clarify the definitin f medical event, and all items required in a written rder are cnsistent and understd in the regulated cmmunity. MDH: agree Stakehlder: in reference t letter D (treatment with the wrng treatment mdality r energy): Wuld the term particle be mre applicable than mdality? MDH: We will lk int this Registratin Requirements Different prcess. Registratin will nw include an applicatin prcess and submittal f prgram infrmatin. Including authrized physicians, qualified medical physicists, RSOs, and each s qualificatins. Shwed an example f what a registratin will lk like. Stakehlder: Des this include cne beam CT and OBI etc. MDH: Yes. We wuld like t list all f thse things t keep them ff the X-ray unit s plate. Stakehlder: wuld we need t track tube changes n OBI system? MDH: We will nt be tracking tube changes. Only tracking changes in equipment. Stakehlder: D we need t register the OBI with the X-ray department t? MDH: At this pint, yes. There is nt currently a way t separate this cmpletely. Stakehlder: the $500 fee includes everything fr the entire facility. Our facility wuld prefer t nly register the [radiatin therapy] equipment with therapy unit. Having the X-ray track these parts f the system in additin is redundant. Stakehlder: What is the lag time n setting this up? Hw lng d the registrants have t get this set up? MDH: that is defined in rule. Registrants will have 120 days t get yur applicatin t us frm the day the rule is implemented. Stakehlder: when intending t purchase and cnstruct new facility, it states the registrant must submit an applicatin 60 r 90 days prir. Are yu asking fr ur pinin n this? MDH: yes, what is reasnable?

6 Stakehlder: I wuld like it t allw as much time as pssible fr the registrant t submit dcumentatin. 60 days seems reasnable as lng as MDH this allws MDH enugh time t apprve the applicatin. Stakehlder: Will it be pssible t register nline? MDH: we are planning t tgether guidance dcuments and have registrants submit electrnically. WebEx Questin: will registratin include treatment-planning systems? MDH: we had nt cnsidered the treatment planning system. Stakehlder: Other states d nt have the treatment planning system included Medical Event Ntificatin This is similar t the current regulatins. We have include a sectin f patient interventin, but nly if the interventin results in permanent functinal damage. Stakehlder: [nte: there are tw subpart 4 s fr this sectin]. Refereeing t the secnd subpart 4, item H. Ntifying authrized physician, shuld this be the referring physician? MDH: Yes, referring physician. Stakehlder: an medical event require us t cntact the state, make a reprt and cntact the AU and the individual. Are we assuming a medical event has caused r may cause serius medical damage/issues? MDH: we d nt make that determinatin the AU des. Stakehlder: we culd figure ut ways t make things that meet the definitin f medical events, that we culd fix and have the same bilgical utcme as the riginal plan. MDH: A medical event des nt mean that there are detrimental effects n the patient. Hwever by reprting it there is an pprtunity t identify issues in the quality management prgram and ensure they dne happen again. Stakehlder: Thanks fr clarifying. Stakehlder: requires the registrant t include ntifying the manufacturer f medical events in their prcedures, is this necessary? MDH: this wuld nly be required if the event is machine related. We d nt intend t have yu ntify the manufacturer if there is an medical event that is nt equipment related. Stakehlder: Ntifying the manufacturer may cause issues with HIPA cmpliance if manufactures are getting HIPA prtected infrmatin. I believe this is an FDA issue that shuld nt be addressed in this rule. MDH: This is part f the emergency prcedures (which is nt n the agenda fr this meeting). We will lk int FDA cverage f this requirement. We will discuss this issue further in the next meeting General Equipment Operatr Requirements Our intent is t separate peratrs fr human use and veterinary use. We are prpsing that peratrs bust be ARRT certified fr human use, we will accept ther equivalent certificatins.

7 Stakehlder: Des this include perating fr QAQC testing? MDH: This sectin is in reference t the peratr during actual treatment. MDH will review the peratr requirements and physicist requirements t ensure we are nt inadvertently denying the physicists frm perating the machines fr QAQC purpses Recrds (all the required recrds and retentin) We put all recrd requirements int ne sectin. In additin, each sectin that requires recrds t be kept will refer back t the recrd sectin. Stakehlder: Subpart 1. Item N. (daily, weekly, and mnthly equipment perfrmance tests) des nt refer t the prper rule part. MDH: We will crrect this Radiatin Safety Officer Reviewed the Radiatin Safety Officer training and respnsibilities frm ; Stakehlder: Can we include a certified health physicist as a pathway fr training fr Radiatin Safety Officers? MDH: Yes. Stakehlder: The rule requires the radiatin safety fficer preceptr attestatin be signed Medical physicist. Can we include attestatins signed by qualified RSOs? MDH: Yes. Stakehlder: There are things under medical physicist that are typically dne by radiatin safety staff. Such as: reviewing dsimetry recrds and radiatin surveys. I believe these items shuld be listed under the RSO respnsibility t perfrm, r arrange t have perfrmed ( subpart 4. H.) Stakehlder: Agree, take B and C frm the physicist s respnsibilities ( Subp. 2) and give them t the RSO under Subp 4 H. MDH: we will make this change Qualified Medical Physicist Reviewed the Qualified Medical Physicist training and respnsibilities frm ; Stakehlder: Subpart 4 states that a Qualified Medical Physicist must verify treatment plans. This is nt necessary and shuld be changed t a qualified medical physicist r a designee that the qualified medical physicist has deemed qualified. Als thinks verificatin f treatment plans this shuld be dne prir t 1 st treatment f all plans. MDH we will cnsider that.

8 Written Orders Reviewed quality management prgram and written rders. Therapy and simulatin. Asked fr cmments abut wh is respnsible fr each rder. Stakehlder: in ur facility, the physician creates a separate simulatin written rder and therapy written rder. Stakehlder: This will be the same at all facilities because f billing. Stakehlder: page 46 subpart 4: What? MDH: This cmment was nt intended t be published in this draft. Open discussin: Stakehlder: Why are we requiring ntificatin f nn-medical events ( )? What is the purpse? MDH: this is likely fr prtecting a member f the public frm expsure due t a nn-medical event. We will lk at this rule, and where it riginated t determine if it is necessary. Stakehlder: I wuld like MDH t cnsider ABHP r ABMPs as qualified t d a shielding plan. MDH: we will cnsider this. Stakehlder: are yu lking t define what mnthly and annual mean? MDH: We can if we need t. We will take yur suggestins and cnsider a definitin Stakehlder: has seen in ther regulatins that years mean between 10 and 14 mnths MDH: A definitin will need t be cnsistent between X-ray, RAM and Therapy. Submit yur suggestins and we will cnsider. 625 Rbert Street Nrth Minnesta Department f Health PO Bx St. Paul, MN health.ram@state.mn.us 03/06/2018 T btain this infrmatin in a different frmat, call: