[MCOH-EH] USP 800 and HD surveillance

Thomas Kibby thomas.kibby at bjc.org
Tue May 14 11:11:22 PDT 2019
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I have the highest respect for NIOSH and their conservative approach to science. But IMO they missed the mark on this. Medical surveillance is useful when there is an identified marker of exposure or disease that may lead to effective early intervention, (e.g. CXR for silica). But there is no demonstrated objective study to demonstrate effective surveillance exam or lab for HD workers, including the provided citations.

Surveillance is nothing more than tertiary prevention. The more effective interventions are primary preventions, which include the standard hierarchy of controls. I would also point out that after effective engineering controls and work practices are implemented, environmental monitoring (surface wipe sampling) can verify effective controls and provide feedback to the workers. Studies (Yoshida 2013) have shown that surface wipe sampling results improve safety behavior and lower the absorbed dose as measured by urine HD levels. 

Medical directors will have to decide for themselves whether to challenge the heft of a USP standard. NIOSH owes it to the Occupational Health community to  admit that their recommendation of medical surveillance for HD-exposed workers has been adopted as a "do something, anything" approach without scientific basis.


Tom Kibby, MD MPH


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Today's Topics:

   1. Re:  [EXTERNAL] ACOEM Medical Center Occupational Health
      Section (Hodgson, Michael - OSHA)
   2. Re:  [EXTERNAL] ACOEM Medical Center Occupational Health
      Section (Dr Joe Fanucchi)


----------------------------------------------------------------------

Message: 1
Date: Mon, 13 May 2019 15:08:50 +0000
From: "Hodgson, Michael - OSHA" <Hodgson.Michael at dol.gov>
To: MCOH/EH <mcoh-eh at mylist.net>
Subject: Re: [MCOH-EH] [EXTERNAL] ACOEM Medical Center Occupational
	Health Section
Message-ID:
	<DM6PR09MB2825EECAD88E8082FCE11998F20F0 at DM6PR09MB2825.namprd09.prod.outlook.com>
	
Content-Type: text/plain; charset="utf-8"

Two years ago, OSHA redid its hazardous drugs webpage about two years ago, as the USP 800 document was in review and release preparation.
https://urldefense.proofpoint.com/v2/url?u=https-3A__www.osha.gov_SLTC_hazardousdrugs_solutions.html&d=DwICAg&c=RYn7j5vsAd-LktzDTBPGzQ&r=0gSEgQBA98H5rp4eXv9v8Q&m=Vmo1zT7Nsn90WkHroO-Y06BKH6ZPcYpyBRZqnDmVX-E&s=1hotOc8kHPDs_E9m0qI_c5ax_pkdcisEYCZ9QB38Gt4&e=

We did attach a white paper that went through internal concurrence and so had some changes from the version initially submitted by an outside consultant.  OSHA?s view was that ?
https://urldefense.proofpoint.com/v2/url?u=https-3A__www.osha.gov_SLTC_hazardousdrugs_controlling-5Foccex-5Fhazardousdrugs.html-23pre-2Dplacement&d=DwICAg&c=RYn7j5vsAd-LktzDTBPGzQ&r=0gSEgQBA98H5rp4eXv9v8Q&m=Vmo1zT7Nsn90WkHroO-Y06BKH6ZPcYpyBRZqnDmVX-E&s=7t_S5E2jINbD4Tn0rwXaDWM86kcaw4b2_nHqdBd0E7c&e=
That contains the following language:
1.    The most valuable test in a laboratory assessment is a complete blood count with differential. This allows for a determination of any pre-existing blood condition that may place the worker at increased risk when handling HDs. Other laboratory testing (liver function tests, blood urea nitrogen, creatinine, and a urine dipstick for blood) may sometimes be appropriate (Polovich, 2011). However, these tests should be conducted only at the discretion of the physician, as a function of the medical history obtained, or as part of a formal surveillance program with well-defined goals.
2.    Due to poor reproducibility, inter-individual variability, and difficulty in interpreting individual results, measures of genetic effects (i.e., chromosomal aberrations, micronuclei, or other markers of genotoxic exposure) are not recommended in routine surveillance.
3.    Biological monitoring, i.e., the measure of a specific agent or its metabolite in a body fluid (such as a urine 5-FU level), is also not recommended for a screening protocol on a routine basis due to the large number of agents an employee handles on a given work shift.
There are additional sections on periodic and post-exposure examinations.  This was discussed extensively at one of the MCOH meetings.


Michael Hodgson, MD, MPH
Chief Medical Officer
Occupational Safety and Health Administration
200 Constitution Ave NW Rm3653
Washington DC 20210
202-693-1768




From: MCOH-EH <mcoh-eh-bounces at mylist.net> On Behalf Of Mickelson, John G. via MCOH-EH
Sent: Monday, May 13, 2019 9:44 AM
To: MCOH/EH <mcoh-eh at mylist.net>
Cc: Mickelson, John G. <John.Mickelson2 at va.gov>
Subject: Re: [MCOH-EH] [EXTERNAL] ACOEM Medical Center Occupational Health Section

Will ACOEM publish USP 800 medical surveillance guidelines?

From: MCOH-EH <mcoh-eh-bounces+john.mickelson2=va.gov at mylist.net<mailto:mcoh-eh-bounces+john.mickelson2=va.gov at mylist.net>> On Behalf Of Dr Joe Fanucchi
Sent: Friday, May 10, 2019 1:41 AM
To: MCOH/EH <mcoh-eh at mylist.net<mailto:mcoh-eh at mylist.net>>
Subject: [EXTERNAL] [MCOH-EH] ACOEM Medical Center Occupational Health Section


Colleagues,

Attendance at the recent American Occupational Health Conference in Anaheim was the highest it's been in more than a decade, and the MCOH Section<https://urldefense.proofpoint.com/v2/url?u=https-3A__gcc01.safelinks.protection.outlook.com_-3Furl-3Dhttps-253A-252F-252Facoem.org-252FMembership-252FSpecial-2DInterest-2DSections-252FMedical-2DCenter-2DOccupational-2DHealth-26data-3D02-257C01-257CHodgson.Michael-2540dol.gov-257C6563f0cb0c074b2ec22f08d6d7a91808-257C75a6305472044e0c9126adab971d4aca-257C0-257C0-257C636933518586766041-26sdata-3DkqKVuPuQu0bE6qkF0qN3VABM3d-252FLxNINalOxbS2C9Pw-253D-26reserved-3D0&d=DwICAg&c=RYn7j5vsAd-LktzDTBPGzQ&r=0gSEgQBA98H5rp4eXv9v8Q&m=Vmo1zT7Nsn90WkHroO-Y06BKH6ZPcYpyBRZqnDmVX-E&s=3gdOFfDA4t36qH3UnYH2E_6OVsIic-8rlWSx_Rn4Yfc&e=> sponsored eight individual (and very well attended) CME sessions on subjects related to employee health in health care facilities. Additionally, the annual dinner meeting of the Section was very well attended and featured extended discussions on TB screening in health care workers as well as the potential impact of USP800 recommendations.

What does the MCOH Section do?

  *   Conducts the yearly presentation of medical center-based topical material at AOHC seminars.
  *   Conducts a bi-annual ACOEM Medical Center Occupational Health and Safety Course.
  *   Participates in planning of ACOEM conferences.
  *   Participates in formulating ACOEM responses to federal requests for commentary regarding medical center-based guidance.
  *   Participates as liaison on federal advisory committees.
  *   Produces and updates ACOEM Guidance Documents:
   HIV and AIDS in the Workplace
   Seasonal Influenza Prevention in Health Care Workers
   Guidance For Occupational Health Services In Medical Centers

Not a Section member yet?

Membership in the Section is now over 300, and we'd like to expand that number to take advantage of the wealth of expertise shown by our 1500+ maillist members. If you're already an ACOEM member, you can become a Section member for just $25 per year.

Not an ACOEM member yet?

Non-physicians who have attained the doctorate level degree of PhD, ScD, DrPH, or EdD in an occupational and environmental health discipline, a master's level degree or other advanced training in a related field, or are a certified Physician Assistant, licensed Nurse Practitioner, or a certified Occupational Health Nurse (COHN) may join ACOEM as Associate Members. Annual dues are $225 plus regional component dues.

Full-time residents who have an MD or DO degree and an interest in occupational and environmental medicine may join as Resident Members. Membership includes two free special interest sections of your choice plus the Residents and Recent Graduates Section and complimentary access to the MD Guidelines<https://urldefense.proofpoint.com/v2/url?u=https-3A__gcc01.safelinks.protection.outlook.com_-3Furl-3Dhttp-253A-252F-252Fwww.mdguidelines.com-252F-26data-3D02-257C01-257CHodgson.Michael-2540dol.gov-257C6563f0cb0c074b2ec22f08d6d7a91808-257C75a6305472044e0c9126adab971d4aca-257C0-257C0-257C636933518586776041-26sdata-3D-252F3-252BVVI-252B02-252Bn3AfRqiVqA-252BzulyEDT01a5eGo30oLE93M-253D-26reserved-3D0&d=DwICAg&c=RYn7j5vsAd-LktzDTBPGzQ&r=0gSEgQBA98H5rp4eXv9v8Q&m=Vmo1zT7Nsn90WkHroO-Y06BKH6ZPcYpyBRZqnDmVX-E&s=f_oXG8MYnKYASj1P3vfPmbfLV91sy9T0rJJc7mn_C1k&e=>. Residents must provide documentation of their residency at the time of application. Resident member annual dues are $45.

Full-time medical students earning an MD or DO degree, with an interest in occupational and environmental medicine, are eligible to join ACOEM as Medical Student Members. Membership includes the Residents and Recent Graduates Special Interest Section. Medical students must provide documentation of their full-time enrollment at the time of application. Student membership is complimentary.

Please feel free to contact any of us with any questions.

Regards,

Amy J Behrman MD FACOEM FACP<mailto:behrman at pennmedicine.upenn.edu>

Chair, Medical Center Occupational Health Section, ACOEM



Melanie Swift MD MPH FACOEM<mailto:swift.melanie at mayo.edu>

Immediate Past Chair, Medical Center Occupational Health Section, ACOEM



Joe Fanucchi MD FACOEM<mailto:drjoe at meditrax.com>

MCOH-EH Maillist Moderator
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Message: 2
Date: Mon, 13 May 2019 09:18:38 -0700
From: Dr Joe Fanucchi <drjoe at meditrax.com>
To: mcoh-eh at mylist.net
Subject: Re: [MCOH-EH] [EXTERNAL] ACOEM Medical Center Occupational
	Health Section
Message-ID: <27fe3fd9-cfed-1599-b384-f985511b7c81 at meditrax.com>
Content-Type: text/plain; charset="utf-8"; Format="flowed"

Colleagues,


As Dr Hodgson indicates, there was extended discussion of this subject at the dinner meeting of the ACOEM Medical Center Occupational Health Section in Anaheim. Employee Health directors from several institutions which routinely administer cancer chemotherapy agreed that, as Dr Andrew Vaughn <mailto:vaughn.andrew at mayo.edu> of the Rochester Mayo Clinic has stated,

    /"given the lack of truly relevant lab tests, and the difficulty of
    identifying and cleaning up contaminated surfaces, the greatest
    effort and importance should be directed at preventing
    dermal/inhalation/parenteral exposures through the use of
    engineering controls. Administering questionnaires and providing
    training on effective work practices will hopefully meet USP 800
    requirements."/

Regards,


Joe Fanucchi


*Joe Fanucchi MD FACOEM*
President and Medical Director
MediTrax / OHS, Inc. <https://urldefense.proofpoint.com/v2/url?u=http-3A__www.meditrax.com_&d=DwICAg&c=RYn7j5vsAd-LktzDTBPGzQ&r=0gSEgQBA98H5rp4eXv9v8Q&m=Vmo1zT7Nsn90WkHroO-Y06BKH6ZPcYpyBRZqnDmVX-E&s=Ybre5h5RBEnhsAwTnBD81njr1WhsjzH2QjbUj-ORtJM&e=>
o:925-820-7758
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/MediTrax software: Everything you need, at a fraction of the cost!/

------------------------------------------------------------------------

On 5/13/2019 8:08 AM, Hodgson, Michael - OSHA via MCOH-EH wrote:
>
> Two years ago, OSHA redid its hazardous drugs webpage about two years 
> ago, as the USP 800 document was in review and release preparation.
>
> https://urldefense.proofpoint.com/v2/url?u=https-3A__www.osha.gov_SLTC
> _hazardousdrugs_solutions.html&d=DwICAg&c=RYn7j5vsAd-LktzDTBPGzQ&r=0gS
> EgQBA98H5rp4eXv9v8Q&m=Vmo1zT7Nsn90WkHroO-Y06BKH6ZPcYpyBRZqnDmVX-E&s=1h
> otOc8kHPDs_E9m0qI_c5ax_pkdcisEYCZ9QB38Gt4&e=
>
> We did attach a white paper that went through internal concurrence and 
> so had some changes from the version initially submitted by an outside 
> consultant.? OSHA?s view was that ?
>
> https://urldefense.proofpoint.com/v2/url?u=https-3A__www.osha.gov_SLTC
> _hazardousdrugs_controlling-5Foccex-5Fhazardousdrugs.html-23pre-2Dplac
> ement&d=DwICAg&c=RYn7j5vsAd-LktzDTBPGzQ&r=0gSEgQBA98H5rp4eXv9v8Q&m=Vmo
> 1zT7Nsn90WkHroO-Y06BKH6ZPcYpyBRZqnDmVX-E&s=7t_S5E2jINbD4Tn0rwXaDWM86kc
> aw4b2_nHqdBd0E7c&e=
>
>
> That contains the following language:
>
> 1.The most valuable test in a laboratory assessment is a complete 
> blood count with differential. This allows for a determination of any 
> pre-existing blood condition that may place the worker at increased 
> risk when handling HDs. Other laboratory testing (liver function 
> tests, blood urea nitrogen, creatinine, and a urine dipstick for
> blood) may sometimes be appropriate (Polovich, 2011). However, these 
> tests should be conducted only at the discretion of the physician, as 
> a function of the medical history obtained, or as part of a formal 
> surveillance program with well-defined goals.
>
> 2.Due to poor reproducibility, inter-individual variability, and 
> difficulty in interpreting individual results, measures of genetic 
> effects (i.e., chromosomal aberrations, micronuclei, or other markers 
> of genotoxic exposure) are not recommended in routine surveillance.
>
> 3.Biological monitoring, i.e., the measure of a specific agent or its 
> metabolite in a body fluid (such as a urine 5-FU level), is also not 
> recommended for a screening protocol on a routine basis due to the 
> large number of agents an employee handles on a given work shift.
>
> There are additional sections on periodic and post-exposure 
> examinations.? This was discussed extensively at one of the MCOH meetings.
>
> Michael Hodgson, MD, MPH
>
> Chief Medical Officer
>
> Occupational Safety and Health Administration
>
> 200 Constitution Ave NW Rm3653
>
> Washington DC 20210
>
> 202-693-1768
>
> *From:*MCOH-EH <mcoh-eh-bounces at mylist.net> *On Behalf Of *Mickelson, 
> John G. via MCOH-EH
> *Sent:* Monday, May 13, 2019 9:44 AM
> *To:* MCOH/EH <mcoh-eh at mylist.net>
> *Cc:* Mickelson, John G. <John.Mickelson2 at va.gov>
> *Subject:* Re: [MCOH-EH] [EXTERNAL] ACOEM Medical Center Occupational 
> Health Section
>
> Will ACOEM publish USP 800 medical surveillance guidelines?
>

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