ML20127C212
| ML20127C212 | |
| Person / Time | |
|---|---|
| Issue date: | 01/24/1992 |
| From: | Thompson H NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Macrae J OFFICE OF MANAGEMENT & BUDGET |
| Shared Package | |
| ML19341F879 | List: |
| References | |
| FRN-57FR41376, RULE-PR-35 AC65-2-054, AC65-2-36, AC65-2-54, NUDOCS 9202050416 | |
| Download: ML20127C212 (1) | |
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January 24, 1992 Mr. James B. MacRae, Jr.
Acting Administrator and Deputy Administrator Office of Information and Regulatory Affairs Office of Management and Budget 1725 - 17th Street, NW Washington, DC 20503
Dear Mr. MacRae:
Despite considerable efforts by both of our staffs to settle the differences of opinion concerning the proposed information collection requirements associated with the final rule amending Part 35, a satisfactory resolution has not been reached.
Because the January 27, 1992 implementation date is imminent, the NRC must decide on the enforceability of the information collection requirements.
Based on your conversation with members of my staff on January 23, we expect to receive a letter from OMB elaborating OMB's remaining concerns. We note that NRC submitted a revised package dated September 11, 1991 for the revised information collection requirements in the final rule. The latter reduced the burden from 65,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> to 6,900 hours0.0104 days <br />0.25 hours <br />0.00149 weeks <br />3.4245e-4 months <br /> annually.
In view of the fact that we have not been advised of an OMB disapproval within 90 days of our submittal, NRC's legal counsel has concluded that we can proceed with full implementation of the amendment.
Indeed, given the reduced information collection requirements in the final rule, it seems to us that OMB review of the final rule was not needed, and that the final rule can become effective on the basis of OMB's March 30, 1990 appraisal of the proposed rule.
But we nevertheless can proceed with continued interaction with OMB to resolve your concerns on the collections of information associated with amended Part 35.
This experience emphasizes the importance of good timely communication between our agencies and I thank you for your personal efforts in this matter.
Sincerely, J
fM ug.. Thompso, J ty Executi >D ec r for uclear Materi s
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- VRon, JAN 2 41992 Mr. James Taylor Executive Director for Operations Nuclear Regulatory Commission Washington DC 20555 Daar Mr. Taylor:
On December 24, 1991, the Nuclear Regulatory Commission (NRC) resubmitted to the office of Management and Budget (OMB) an information collection request (ICR) antitled "The Medical Use of Byproduct Material" for review under the Paperwork Reduction Act (pRA).
This ICR would establish as a part of its quality management (QM) programs several additional recordkeeping and reporting requirements for practitioners of nucisar medicina and several types of therapy which use byproduct natarial.
I'am concerned with the NRC's failure to demonstrate clearly the practical utility of these requirements and to provide estimates of their burden as required by th3 PRA.
NRC reports that the purpose of this ICR is to require practitioners of nuclear medicine to maintain records and submit certain data to the NRC as part of its QM programs.
Thema programs are designed to assura-that radiopharmaceuticals are administered as prescribed by the authorized user physician, and that proceduras are carried out as prescribed by authorized physicians.
The NRC has not,.however, clearly demonstrated that there is currently a significant'problan requiring such a quality management program.
Given the already high cost of medical-care, it is important that the Fadaral government avoid further burdens for the health care sector, unless these additional requirements have practical utility and are likely to yield significat benafits. 'The NRC has not made this demonstration.
While OMB initially. approved the QM requirements at proposal, CMB staff have reexamined these requirements in response to public comments that were received when the final package was submitted to OMB for review.
OMB has received written-comments from the Society.of Nuclear Medicine /Amarican Collega of Nuclear Physicians, and copias of letters concerning-the' final rule,.and the pilot study from the small Business Administration and the University of california at Los Angeles.
Following these initial contacts,-CMB staff discussed these requirements extensively with other members of the regulated community.
These includa reprenantativas of three'agramment states (New York, California, and Louisiana), several' physicians who practica nuclear medicine, representatives of thraa other professional organizations (American Collage of Radiology,-Joint Commission on the
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Accreditation of Health Care Organizations, and the American Medical Association), members of the NRC's Advisory Committee on the Medical Use of Isotopes, and the staff of the Food and Drug Administration.
oMB has also received numerous written comments from physicians and health cara facilities in recent weeks.
While the concerns outlined below are based on our own-avaluation, we believe they also reflect the concerns of many of these individuals and organizations.
Practical Utility The current rate of misadministration of radiopharmaceuticals is alraady quite low.'
There appears to be videspread agreement on this point among almost avaryone familiar With the issue.
This is likely a result of several facto"k-Most practitioners already implement quality managemens c:ograms on a voluntary basis; many as part of an accreditation or certification process sponsored by a professional association.
There are important reasons for practitioners to do so.
First, practitioners need to taka avary care that their procedures are done correctly to avoid malpractice suits.
In addition, since records of their mistakes are available to the general public, such care is important to maintain their professional reputation.
Finally, practitioners in the field are acutely aware of the public's general concerns about radiation, and taxe special care to ensure that mistakes do not occur to maintain the credibility of their specialty.
The care with which these procedures are conducted is reflected in the low rate of error for these proceduras.
Misadministrations or abnormal occurrences occur about one in 6very 3,300 procedures.
The NRC's records indicate that there were 200 patients who received misadministrations between 1980 and 1990 in 89 recordable avants.
(When adjusted to account for misadministrations in agreement states, one can assume that there were perhaps 600 patients affseted during this time period nationwide.)
Assuming 600 arrors between 1980 and 1990, this-would indicate on overall error rate of approximately 0.03% for nuclear medicine, talatharapy and brachytherapy.
Extrapolating from error rates in 1989 and 1990, one could roughly estimate that errors occur in 0.04% of all taletherapy proceduras, in 0.02% of all brachytharapy proceduras and in 0.03% of all nuclear medicine proceduras.
1The NRC estimates that there were approximately 600 misadministrations between 1980 and 1990, during approximately 1,980,000 procedurss.
Most misadministrations have no significant health effects; there have baan only a relatively small numbar of incidents in which misadministrations or abnormal occurrences hava clearly contributed to death or serious, permanent, or debilitating injury.
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These are aspecially low misadministration rates when compared with rates of arrer in the administration of other drugs.
A recent journal article reported that overall,-medication errors occur in 13% to 18% of all hospital administered doses.8 Among the errors found vara the administration of the wrong dose, the j
wrong drug, or unordered drugs, administration to the wrong patient, at the wrong time, or by the wrong routs.- A published study of arrors in the intensive care unit of one hospital indicated a medication arror rate of 2.24.8 Finally, a third study of medication errors in two children's hospitals found medication arror rates of 0.49% and 0.45%.*
The error rate in l
nuclear medicina and therapies, then, are tan to one thountand times lower than the error rate for other drugs.
Given the already low rate of misadministrations and abnormal occurrences, the NRC has f ailed to demonstrate how thesa reporting requirements are likely to further decrease these ratas, and thus have any practical utility.
The NRC states that most medical facilities already hava quality management programs in place which are similar to, the equivalent of, or even more stringent than the program mandated by the NRC.
The occurrence of misadministrations at these facilities in the past demonstrates that despite good proceduras, human fallibility will always result in some errors.
Furthermore, there is significant concern within the medical community that any stsps which must be taken which are not directly related to the delivery of safe and-accurately administered procedures might be distracting and lead to other mistakes.
Burden of the ICR The NRC claims that thesa QM requiremants will impose only 6,490 hours0.00567 days <br />0.136 hours <br />8.101852e-4 weeks <br />1.86445e-4 months <br /> of burdon on the regulated community.
A review of the record suggests, hovaver, that physicians trying to comply with this rule will probably bear a significant recordknaping and reporting burden.s Physicians will naad to design and implamant 2"What Wa Know About Medication Errors: A Literature Review," Journal of Nursing Quality Assurance, November 1988, page 1).
8" Medication Administration Errors in an Adult Intensiva Care Unit,"
Heart & Lung, July 1987, page 450.
d"Hadication Error Prevention by Clinical Pharmacists in Two j
Children's Hospitals", Pediatrics, May 1987, page 718.
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'Part of the problem in calculating our own estimate of the burden is the disagreement between the NRC and the regulated l
community as to what is required by these regulations.
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a quality assuranca program and recordkeeping system to satisfy the NRC's requirements, even though most physicians already hava QM programs designed and monitored by professional associations.
In addition, it is likely that the development of a complete quality management program would take longer than the 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> indicated in the ICR's supporting statement.
This is based on discussions with several physicians who practice in these fields, and their estimates of how long it took them to develop their programs, and OMB's own review of the regulatory guide for the
- rule, rurthermore, this estimate does not appear to include the time necessary for those who already have quality management programs to review carefully their programs to determine whether or not they meat the NRC's criteria.
The NRC supporting statement does not include the hurden for the development of diagnostic clinical procedure manuals described in 10 CFR 35.2.
Although there is no clear requirement to develop such manuale, the NRC later defined " prescribed dosage" as "an activity as documented: 1) In a written directive; or 2) Either in the diagnostic clinical procedures manual or in any appropriate record in accordance with the directions of the authorized user for diagnostic procedures."
NRC's refarance to the manual has been interpreted by many physicians as meaning that the NRC requires such manuals.
The NRC supporting statement also claims that there is no burden associated with maintenanca of records conostning administered dosas or dosages because these records are already kept as requirad by 10 CFR 35.53.
But, the current requirementa are not the same as the new requirements.
The current regulations require that facilities Xsep records of doses that have been administered.
However, they do not appear to require the maintenance of records, in an auditable form, of the prescription that led to the dosa.
To maintain these records in a fashion that would be easily auditable physicians will probably have to g
keep a duplicate set of files The NRC also states that there is no burden associated with changes to a quality management program, since these changes are there is no agreement between the regulated community and the NRC on what is requirad, it is not possible for oMB to independently develop our own estimata of the burden contained in this ICR.
' Physicians generally keep these records in each patient's individual filest however, upon being inopseted, he/she would i
have to remove these documents from each patient file for the inspector and then replace th'am once the inspection was complete.
Therefore, the best way to meat this requirement is to kaap duplicate records.
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5 voluntary.
However, the implementing regulations for the-PRA clearly stata that voluntary reporting requirements are covered under the scope of tha PRA (see 5 CFR 1320.7(c)), and must therefore be included in tha burden calculations.
Furthermora, although these steps may be viewed as voluntary,_to the extent that physicians faal they need to modify their programs consistant with good practica, they will make these changas.
OMB believes that most facilities will implomant other recordkaaping procaduras as part of thair programs.
The NRC prgrau, as outlined in the rule and the regulatory guida is ambiguous in some instancas and very specific in others.', The NRC's failure to specify what records must be maintained as part of a QM program does not mean that practitioners will not have to kaap recordse In fact, given the uncertainty within the regulated community as to what constitutes compliance with these requirements, it is likely that people will kamp extensive records to ensure that they can produce any records that NRC inspectors request to sea.
Tinhlly, based on discussions which OMB has had with several physicians, the periodic reviews described in Section 6 of the Regulatory Guidance documents Ara likely to impose a significant burden on practitioners without having any real practical utility.
Since the overwhelming majority of licensees have no misadministration in any given year, the requirement to engage in a lengthy review of'their proceduras to ensure that they are doing avarything possible to reduce misadministration to zero, appears to have little if any value.
Although it might make sense for those facilitias that experienced misadministrations to review their proceduras, this requirement is imposed on a significantly larger population with no apparent banafit.
Conclusion I am conaarned that the new reporting and recordkaaping requiramants hava little, if any, practical utility.
I do not baliava, based on the supporting documents providad_by the NRC,
'For instance, the ambiguity as to whether or not clinical procedura manuals are required will probably result in physicians taking the time to develop them whether or not the NRC intended to require them.
On the other hand, the guidelines require that before any procedura tha licensaa should verify the patient's identity by_asking the patient their name and than confirmed by cross-referencing information in the patient' record including-at least one of the followings birth date, social security number, address, signatura, or identification card.
This is an extremely specific requirement which would better be left to the licensea's discretion.
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misadministrations;or abnormal events.: I an=also concerned that-the NRc.and~the regulated community haveividely different estimates for the burden of meeting these requirements.~
Nonetheless,-these_ requirements willLclearly impose a burden on the regulated _ community,_without any: clear-benefits.-
I' encourage:
the NRC to once'again review the-concerns we have outlined-above-d with members 1of : the regulated community: so that they may come-to -
some understanding of-exactly what; burdens are imposed-by this program on the regulated community, and what purpose they will serve.
Since there is a significant discrepancy between-what.the NRC believes is the burden imposed by this1 program,-and the burden which the regulated community feels _they will be required to: shoulder, wa-feel.that such a meeting would be useful.' once both sides can agree on the requiraments.of this program both the-g NRC and OMB would be in a much better. position to evaluate whether or not the burden imposed by these requirements would be-justified by its practical utility.
sincerely, E
r James-B. MacRae,-Jr.
Acting Administrator-and Deputy-Administrator office-of Information and RegulatoryJAffairs cc:
Hugh L._ Thompson, Jr.
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