FEBRUARY 1992, VOL 55, NO 2
4ORN JOURNAL
ONOLF Meeting
N
ursing organizations discuss health care reform, Safe Medical Device Act, AIDS
Nov 15 and 16,1991
T
he eighth annual meeting of the National Organizational Liaison Forum (NOLF) was held in Kansas City. Mo, Nov 15 a n d 16. 1991. T h e NOLF consists of 49 national nursing organizations and the 1 I councils of the American Nurses Association ( A N A ) . Mark Phippen. RN: M S , CNOR. AORN immediate past President. presided over the meeting as vice chairperson of NOLF. He. along with ANA President Lucille Joel. RN. EdD, FAAN, and Wanda Roberts Johanson. RN, MN, CCRN. member-at-large. comprised the 1991 NOLF executive committee. The purpose of NOLF. which is a part of the ANA formal structure. is to promote concerted action by national nursing organizations on professional policy and national health policy issues by bringing recommendations to the ANA board for possible action. A report of the major items brought to this meeting follows.
Heultlz Cure Reform
D
r Joel reported on ANA’s w o r k on t h e N u r s i r i g ’s A g e i i d a F o r H r u l t h Care Rejbrm. She asked participants 592
to identify their wishes conc e r n i n g participation in the implementation of this reform measure as well as what the agenda means in their specific practice arenas. D r Joel r e v i e w e d a c t i o n s taken thus far. The ANA and the National L e a g u e f o r Nursing ( N L N ) are working together to make sure that this agenda is advanced in the legislative arena. She reminded the national nursjng organizations that have signed on to this document that anything ANA says c o n c e r n i n g this d o c u m e n t reflects on all 53 cosponsoring nursing o r g a n i z a t i o n s , a n d therefore, she brings everything to NLN for consultation. Dr Joel described the many visits to C o n g r e s s by A N A staff and board members to bring the agenda to the attention of influential groups and legislators. The ANA also has put together a teleconferencing system with its constituent state m e m b e r s to m o n i t o r t h e progress of this agenda on the state level. For example, she reported that the National Leadership Coalition, which is composed of influential business groups, has developed a similar plan. This is a great step in moving nursing’s plan, she
said, and therefore, ANA has endorsed it. T h e A N A has f o l l o w e d a consumer-friendly approach to marketing this plan, according to D r J o e l . It h a s tried to empower the consumer in health care reform. “We feel we have to reach out boldly to our consumers for their support for the agenda,” Dr Joel said. T h e A N A has been asked to cosponsor forums at which the presidential candidates will speak on health care reform, and it is planning to d o so at least three times. Managed care is a cornerstone of the agenda, according to Dr Joel. She has visited managed care settings and found n u r s i n g ’ s p r e s e n c e lacking. Nursing care, for the most part, is seen as that which is delivered by physician extenders and unlicensed assistive personnel who d o some nursing tasks. ANA is moving forward with the Group Health Insurance Company of America to identify what nursing, in the role of staff nurses, contributes to these settings. Other nursing issues will emerge as hospitals shrink and other sites become full-fledged health centers. Dr Joel asked the specialty nursing groups to dis-
FEBRUARY 1992, VOL 5.5, NO 2
cuss among themselves and with ANA how they see themselves participating in accruing the resources necessary to continue this work. “Our agenda is bold, but purposefully vague,” she said. To move forward, we need “white papers” (ie, resource documents, briefing papers) to cost out the budgetary implications of some of these initiatives. At least 11 white papers are to be completed by February 1992. As white papers become available, they will be distributed to all endorsing nursing organizations. A discussion period ensued. Matilda Babbitz, RN, MA, COHN, executive director, American Association of Occupational Health Nurses, said she is working on a white paper on health care in the workplace. She believes the only way primary care is going to be in the workplace is to have pilot projects. The biggest problem is the small business, she said. Small businesses need part-time nurses, she said, and she is working with small business administrations throughout the country to achieve that goal. Representatives from the Society of Pediatric Nurses supported the managed-care concept and urged ANA to continue to bring forward the need for advanced practice positions in these areas. The National Association of Neonatal Nurses is planning to bring the agenda to its leadership forum to “train the trainer” so that its members can conceive what they can do on the local level. AORN President Jean
AORN JOURNAL
Reeder, RN, PhD, CNOR, said AORN is stressing membership education concerning the agenda. She described AORN’s Project 2000 and reported that the Project Team to Identify New Practice Models for Perioperative Nursing is looking at case management in perioperative nursing. She urged participants not to forget the acute-care settings and to take the opportunity to provide testimony to the Lucille Joel provides update of the appropriate legislative and progress of Nursing’s Agendafor regulatory bodies. Health Care Rgform. Representatives from the Association of Rehabilitation Nurses said that rehabilita- can be saved with managed tion should be part of the man- care by cutting out unnecessary aged-care model. They are con- medicine and doing away with cerned that many people who much of the bureaucracy. She are making health care reform said that ANA is in the process decisions are not rehabilitation of getting an economic analysis nurses. of Nursing’s Agenda f o r Health The American Holistic Nur- Care Reform, and she believes ses Association emphasized the that no additional dollars will need to focus on prevention for be necessary except those to nurses as well as for their start the change process. She clients. also said that it would be very When asked about reform of helpful to look for existing propayment plans, Dr Joel said grams that resemble those that payment will depend on described in the agenda and positions on tort reform and have those programs collect the insurance reform. These posi- data necessary to prove that tions are in the process of being this plan will work. developed, but they are not The agenda does not support ready to be circulated to the a single-payer system. Most of cosponsors of the agenda. She the bills that have been introsaid she believes that much of duced have been a partnership the cost of health care is for plan, not a single-payer system. defensive and unnecessary If, however, that is the way tests, and the work of the effec- things go, ANA would have to tiveness initiative will lend discuss it with other nursing itself to learning what is effec- organizations to choose a new tive care. position. Dr Joel also believes money Judy Huntington, RN, MN, 593
FEBRUARY 1992, VOL 55, NO 2
AORN JOURNAI.
d i r e c t o r , A N A d i v i s i o n of governmental affairs, reminded the participants that major public policy shifts are not d o n e by d i s m a n t l i n g major s y s t e m s . T h a t i.s why. s h e said, she believes fundamental reform will not mean the complete dismantling of the insura n c e industry; but i t might mean f e w e r i n s u r a n c e programs in this country. We d o not h a v e t i m e t o wait. s h e said. I t is time to make the reform through the "play-orpay" a p p r o a c h b e c a u s e i t would be better accepted. The p I a y - or - pay approach g i v e s employers a choice. They could either "play" by obtaining i n s u r a n c e f o r t h e i r e m p 1o y e e s t hro ugh pr i vat e insurers o r "pay" into a public system. which would ensure a defined set of core benefits for all U S c i t i z e n $ . T h e r e a r e 1,600 insurance plans in this country. according to Dr Joel, a n d that n u m b e r m i g h t decrease. Dr Joel also asked the organizations to have their members write essays about the atrocities they have seen in the practice arena and how health care reform could have helped prevent those atrocities. Those types of anecdotes will make an impression on legislators. according to Dr Joel. The A N A is planning a week of nursing activity concerning health care reform in May i n Washington. DC. during national nurses week. In cl u d ed i n those act i v i t i e s will be a legislative a c t i o n day. federal agency briefings
on health c a r e r e f o r m , a n d meetings with key administration leaders on Capitol Hill.
the under reporting of problems with medical devices, CDR Withiam-Wilson said. The user reporting provision mandates The Safe Medical that hospitals, nursing homes, Device Act of I990 and ambulatory surgical facilities report problems with their arcia Withiam-Wilson. medical devices. The act specifiRN. MSN. commander. cally requires users to report all US Public Health Service. and deaths associated with medical nurse consultant. US Food and devices to the FDA. They also Drug Administration (FDA). must report all serious illnesses spoke about the Safe Medical and serious injuries associated Device Act. which went into with medical devices to the effect Nov 25, 1991. Although manufacturer. the act w a s e f f e c t i v e last B i a n n u a l s u m m a r i e s of November. the proposed regu- deaths, serious injuries, and illlations were not due to be pub- nesses must be submitted to the lished in the Federal Register FDA, CDR Withiam-Wilson until January 1997. All inter- said. The first summary was ested parties will have 60 days due last month to cover probor more to c o m m e n t on the lems that occurred between proposed rules before the final Nov 28 and Dec 31, 1991. The rules are established. FDA is planning to publish a Commander With i am - W i 1- n e w s l e t t e r to c o m m u n i c a t e son began her presentation by which d e v i c e s a r e c a u s i n g reviewing the role of the FDA problems. i n e n s u r i n g the safety a n d The FDA has struggled to effectiveness of medical de- define serious illness and serivices. The FDA reviews manu- ous injury, according to CDR facturers' submissions of new Withiam-Wilson. At the time devices and monitors device of the N O L F meeting, FDA problems. In addition to moni- had defined serious illness or toring mandatory manufacturer serious injury as life threatenreporting. it monitors lgoluntary ing or that which results in persystems by which health pro- manent impairment of a body fessionals report problems. The function or permanent damage FDA employs field investiga- to a body structure or necessitors. and it produces literature tates immediate medical or surand press releases about niedi- gical intervention to preclude cal device problems. p e r m a n e n t i m p a i r m e n t of a The FDA. according to CDR body function or permanent Withiam-Wilson. has regulatory damage to a body structure. A tools such as seizure. injunction, more definitive statement may recall. and patient notification. be published in the proposed The last two are new and were rules. in the Safe Medical Device Act The act requires a facility to of 1990. The act aims to address report a p r o b l e m within 10
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AORN JOURNAL
d a y s of becoming a w a r e of information that reasonably suggests there is a probability that a device has caused or contributed to a death. serious illness. or serious injury. That report must include the name of the device, serial number. model number. the name and address of the manufacturer. and a description of the event. Reports are not admissible in a court of law, according to CDR Withiam-Wilson. unless involved parties knew the information was false. Then civil action can take place, and the patient can sue the institution. T h e a c t a l s o requires the establishment of a d e v i c e tracking system so that the FDA can ascertain if a defective device is in use in the distribution c h a i n . Permanent implants, life-sustaining and life-supporting devices. and other designated devices must be tracked. A specific list will be established and regulations concerning this provision will be devised in May 1992. Another section of the law requires patient notification. The manufacturer would notify patients who are at risk because of a d e v i c e . T h e FDA may enlist the help of health care profession a1s i n identifying such patients. a c c o r d i n g to CDR Withiam-Wilson. The first step is for manufacturers to notify p h y s i c i a n s of the problem. so that they can notify the appropriate patient. If the physician d o e s not notify patients. then the manufacturer must. she said.
FEBRUARY 1992, VOL. 55, NO 2
As of February 1992, failure to comply with the act will bring sanctions against health care institutions. There will be civil penalties such as fines. The FDA will be allowed to inspect user facilities. T h e FDA has the responsibility to 0 implement regulations by Nov 28. 1991. 0 educate health care facility administrators about the new law by May 28. 1993. and 0 e v a l u a t e the FDA user reporting requirements. Commander Withiam-Wilson suggested that facilities establish procedures to comply with the act. They must implement the new procedures and train the appropriate staff so they understand their responsibilities. For more information, call or write to the US Pharmacopoeia, 12601 Twinbrook Parkway, Rockville. MD 20852, (800)638-6725. A discussion period ensued in which participants expressed their concerns about the act. Dr Reeder spoke about the inappropriateness of having physician offices exempt from this regulation. She also said that the 10-day reporting period is unrealistic because of the forms that must be filled out as well as the complexity of the information needed. Commander Withiam-Wilson advised the participants that the proposed regulation is still in the Office of Management and Budget, after which it will be published i n the Federal R e g i s t e r . She urged nursing organizations to comment on
those proposed rules. Commander Withiam-Wilson suggested that specialty organizations become involved so that the act and its regulations can be realistic and achieve the goal of providing better patient care.
AIDS
B
arbara Russell, RN, MPH, CIC, reported on the work of the ANA human immunodeficiency virus (HIV) resource task force concerning the July 12, 1991, Centers for Disease Control (CDC), Atlanta, guidelines and the development of a list of exposure-prone irivasive procedures. She said the list probably will not list procedures but instead list patient conditions in which the patient might be at risk to contract the HIV from a health care worker. Many feared that individual facilities would make their own lists that would reflect on various health care providers differently. Exposure-prone procedures are those in which a h e a l t h c a r e w o r k e r ’ s blood might mingle with a patient’s blood. Since this meeing, in December 1991, the CDC has decided not to develop such a list. Russell emphasized the need for consumer education about universal precautions. The ANA has produced a set of consumer advisories, including a walletsized card and bright colorful posters in two large sizes. The products are being offered to nurses, physicians, dentists, hospitals. and other health care providers nationwide.
AORN JOURNAL
Barbara Russell emphasizes the need for consumer education about universal precautions.
During the discussion period. Dr Reeder thanked Russell for representing nursing at the CDC meetings i n a positive way. Dr Reeder reemphasized the need for education. including nursing education. She said that many nurses do not understand modes of transmission and universal precautions and that this ignorance has been transformed into fear by some nurses. I n response to a question concerning re c e 11t 1egis1a t i o n mandating states to implement the CDC guidelines. Russell said the mandate is nebulous as to what .'reasonable equivalent" really means. She said that the C D C is opposed to mandatory testing even f o r those people w h o perform expos ti re -prone proc ed u re s . The states have one year to implement the guidelines. so e\'eryone must be on the alert
FEBRUARY 1992. VOL 5 5 , NO 2
about what their state legislators are doing. The Occupational S a f e t y a n d Health Ad m i n i strati o n stand a rd s on bloodborne diseases are about to come out, but it is unclear as to what they will say. according to Russell. R e p resent at i v e s fro in the spec i a I t y o 1.gan i at i o n s d i s cussed various aspects of care of patients with a c q u i r e d immune defrciency syndrome (AIDS) and prevention of HIV disease. Most agreed that nurses need to call for accessibility of testing. "Just because we are against manciatory testing does not mean we are against testing." Russell said.
Assistive Pei-soiiriel
E
Hen M. Sanders. RN, MS. chairperson. ANA congress o n nursing economics. addressed u,ork of the ANA task force on unlicensed assistive personnel to the registered nurse. The task force is developing education standards for unlicensed assistive personnel as well a s p o l i c i e s a n d a n advocacy p l m for the appropriate use o f these personnel when they perform patient care functions in a clinical setting. One reconunendation is that the nursing profession define the scope of nursing practice and the role of assistive personnel. The task force further recommends that the nursing profession agree that the purpose of assistive personnel is to support nurses so that nurses can concentrate on nursing care and that all assistive nurs-
ing personnel should report to nursing. The work of the task force will c o n t i n u e . a n d a report will be sent to the ANA h o u s e of d e l e g a t e s i n J u n e 1992. Various representatives spoke of their concerns about assistive personnel in home care and school settings. Scott Gray, R N , CRNA, president of the American Association of Nurse Anesthetists reported that a new society of anesthesiology technologists has been formed and has asked the nurse anesthetists and anesthesiologists for help. These technologists will not deliver direct patient care, but they will have a role in helping anesthesiologists and nurse anesthetists. T h e y will be u n d e r d i r e c t s u p e r v i s i o n at all t i m e s , according to Gray.
Nursing: A Social Policv Stutement
As
plan to revise Nursing: A (I c in 1 P o 1i c y Sta tern en t was presented by L i n d a R. Cronenwett, RN, PhD, FAAN, chairperson of the ANA congress of nursing practice. She said that the statement was 10 years old and it needcd to be revised, especially in sections addressing specialty practice. She invited specialty nursing organizations to participate. This process will begin at thc 1992 ANA house of delegates, and the goal is to have the publication revised by the fall of 1992. A special survey of specialty nursing organizations will gather input. A special
FEBRUARY 1992, VOI. 55, NO 2
AORN JOURNAL
forum on advanced practice uled to be d i s c u s s e d at t h e ment and foreign governmental will be conducted on June 24, National Federation of Spe- agencies have requested nurse 1992, 6 to 7 PM, at the ANA cialty Organizations meeting in speakers on such issues as AIDS, house of delegates in Las Vegas. January 1992. women’s health, and maternal/ child health. Nurses who wish to A m o n g the c o n t r o v e r s i a l receive an application for the issues, a c c o r d i n g to D r htemationtd International Nursing Talent Cronenwett, is a definition of Nursing Center Bank should call (800) 444-5720 advanced practice that inarbara Redman, R N , EdD, x 256. A small f e e will be cludes a graduate degree. One FAAN, executive director of charged for nurses who are not participant pointed out the difmembers of state nurses ference between a genassociations. eralist in a specialty area a n d a specialist Organizational within that a r e a a n d Afiliates that all nurses practicing within a specialty riteria for organizaarea do not need a mastional affiliation in ter’s degree. ANA is similar to criteT h e new statement ria to belong to NOLF. also needs to include Dr Joel invited all parcomponents of specialticipants to consider ization such as a n becoming part of ANA. emphasis on health proT h e r e will be public motion and the role of recognition of charter nursing in consultation, members at the next case management, and A N A house of deleprimary health care sergates in June 1992. vices, according to Dr Cronenwett. The new Newly elected NOLF officers Vickey Bradlev Elections social policy statement (right), member-at-large, and Marianne Chulay, vice-chairperson. also needs arianne Chulay, 0 an expanded list RN, DNSc, presof human responses to actual or potential ANA, reported on the establish- ident-elect, American Assocment of the International Nursing iation of Critical-Care Nurses, health problems, Center, headquartered at ANA in was elected vice-chairperson of 0 the inclusion of the theme of c a r i n g a s c e n t r a l to Washington, DC. The center, the 1992 NOLF executive comheaded by Margretta Styles, RN, mittee. Vicky Bradley, RN, nursing practice, and EdD, FAAN, has an International MS, C E N , p r e s i d e n t - e l e c t , 0 the theme of progression from novice to expert in Nursing Talent Bank that will Emergency Nurses Association our management of the link nurses with specific talents w a s e l e c t e d a s m e m b e r - a t with those in need in the interna- large. They will hold office for work force. tional community. The talent 1992 and preside over the next Dr Cronenwett suggested bank was established as a result meeting of NOLF. that a discussion of this issue PATNIESSNERPALMER,RN, MS of an increased number of take place at the next NOLF AORN DEPUTY EXECUTIVE requests from nurses and foreign meeting, which is scheduled DIRECTOR agencies, according to Dr for November 1992 in WashEDITOR, AORN JOURNAL Redman. Both the US governington, DC. It also was sched-
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600
4ORN JOURNAL
ONOLF Meeting
N
ursing organizations discuss health care reform, Safe Medical Device Act, AIDS
Nov 15 and 16,1991
T
he eighth annual meeting of the National Organizational Liaison Forum (NOLF) was held in Kansas City. Mo, Nov 15 a n d 16. 1991. T h e NOLF consists of 49 national nursing organizations and the 1 I councils of the American Nurses Association ( A N A ) . Mark Phippen. RN: M S , CNOR. AORN immediate past President. presided over the meeting as vice chairperson of NOLF. He. along with ANA President Lucille Joel. RN. EdD, FAAN, and Wanda Roberts Johanson. RN, MN, CCRN. member-at-large. comprised the 1991 NOLF executive committee. The purpose of NOLF. which is a part of the ANA formal structure. is to promote concerted action by national nursing organizations on professional policy and national health policy issues by bringing recommendations to the ANA board for possible action. A report of the major items brought to this meeting follows.
Heultlz Cure Reform
D
r Joel reported on ANA’s w o r k on t h e N u r s i r i g ’s A g e i i d a F o r H r u l t h Care Rejbrm. She asked participants 592
to identify their wishes conc e r n i n g participation in the implementation of this reform measure as well as what the agenda means in their specific practice arenas. D r Joel r e v i e w e d a c t i o n s taken thus far. The ANA and the National L e a g u e f o r Nursing ( N L N ) are working together to make sure that this agenda is advanced in the legislative arena. She reminded the national nursjng organizations that have signed on to this document that anything ANA says c o n c e r n i n g this d o c u m e n t reflects on all 53 cosponsoring nursing o r g a n i z a t i o n s , a n d therefore, she brings everything to NLN for consultation. Dr Joel described the many visits to C o n g r e s s by A N A staff and board members to bring the agenda to the attention of influential groups and legislators. The ANA also has put together a teleconferencing system with its constituent state m e m b e r s to m o n i t o r t h e progress of this agenda on the state level. For example, she reported that the National Leadership Coalition, which is composed of influential business groups, has developed a similar plan. This is a great step in moving nursing’s plan, she
said, and therefore, ANA has endorsed it. T h e A N A has f o l l o w e d a consumer-friendly approach to marketing this plan, according to D r J o e l . It h a s tried to empower the consumer in health care reform. “We feel we have to reach out boldly to our consumers for their support for the agenda,” Dr Joel said. T h e A N A has been asked to cosponsor forums at which the presidential candidates will speak on health care reform, and it is planning to d o so at least three times. Managed care is a cornerstone of the agenda, according to Dr Joel. She has visited managed care settings and found n u r s i n g ’ s p r e s e n c e lacking. Nursing care, for the most part, is seen as that which is delivered by physician extenders and unlicensed assistive personnel who d o some nursing tasks. ANA is moving forward with the Group Health Insurance Company of America to identify what nursing, in the role of staff nurses, contributes to these settings. Other nursing issues will emerge as hospitals shrink and other sites become full-fledged health centers. Dr Joel asked the specialty nursing groups to dis-
FEBRUARY 1992, VOL 5.5, NO 2
cuss among themselves and with ANA how they see themselves participating in accruing the resources necessary to continue this work. “Our agenda is bold, but purposefully vague,” she said. To move forward, we need “white papers” (ie, resource documents, briefing papers) to cost out the budgetary implications of some of these initiatives. At least 11 white papers are to be completed by February 1992. As white papers become available, they will be distributed to all endorsing nursing organizations. A discussion period ensued. Matilda Babbitz, RN, MA, COHN, executive director, American Association of Occupational Health Nurses, said she is working on a white paper on health care in the workplace. She believes the only way primary care is going to be in the workplace is to have pilot projects. The biggest problem is the small business, she said. Small businesses need part-time nurses, she said, and she is working with small business administrations throughout the country to achieve that goal. Representatives from the Society of Pediatric Nurses supported the managed-care concept and urged ANA to continue to bring forward the need for advanced practice positions in these areas. The National Association of Neonatal Nurses is planning to bring the agenda to its leadership forum to “train the trainer” so that its members can conceive what they can do on the local level. AORN President Jean
AORN JOURNAL
Reeder, RN, PhD, CNOR, said AORN is stressing membership education concerning the agenda. She described AORN’s Project 2000 and reported that the Project Team to Identify New Practice Models for Perioperative Nursing is looking at case management in perioperative nursing. She urged participants not to forget the acute-care settings and to take the opportunity to provide testimony to the Lucille Joel provides update of the appropriate legislative and progress of Nursing’s Agendafor regulatory bodies. Health Care Rgform. Representatives from the Association of Rehabilitation Nurses said that rehabilita- can be saved with managed tion should be part of the man- care by cutting out unnecessary aged-care model. They are con- medicine and doing away with cerned that many people who much of the bureaucracy. She are making health care reform said that ANA is in the process decisions are not rehabilitation of getting an economic analysis nurses. of Nursing’s Agenda f o r Health The American Holistic Nur- Care Reform, and she believes ses Association emphasized the that no additional dollars will need to focus on prevention for be necessary except those to nurses as well as for their start the change process. She clients. also said that it would be very When asked about reform of helpful to look for existing propayment plans, Dr Joel said grams that resemble those that payment will depend on described in the agenda and positions on tort reform and have those programs collect the insurance reform. These posi- data necessary to prove that tions are in the process of being this plan will work. developed, but they are not The agenda does not support ready to be circulated to the a single-payer system. Most of cosponsors of the agenda. She the bills that have been introsaid she believes that much of duced have been a partnership the cost of health care is for plan, not a single-payer system. defensive and unnecessary If, however, that is the way tests, and the work of the effec- things go, ANA would have to tiveness initiative will lend discuss it with other nursing itself to learning what is effec- organizations to choose a new tive care. position. Dr Joel also believes money Judy Huntington, RN, MN, 593
FEBRUARY 1992, VOL 55, NO 2
AORN JOURNAI.
d i r e c t o r , A N A d i v i s i o n of governmental affairs, reminded the participants that major public policy shifts are not d o n e by d i s m a n t l i n g major s y s t e m s . T h a t i.s why. s h e said, she believes fundamental reform will not mean the complete dismantling of the insura n c e industry; but i t might mean f e w e r i n s u r a n c e programs in this country. We d o not h a v e t i m e t o wait. s h e said. I t is time to make the reform through the "play-orpay" a p p r o a c h b e c a u s e i t would be better accepted. The p I a y - or - pay approach g i v e s employers a choice. They could either "play" by obtaining i n s u r a n c e f o r t h e i r e m p 1o y e e s t hro ugh pr i vat e insurers o r "pay" into a public system. which would ensure a defined set of core benefits for all U S c i t i z e n $ . T h e r e a r e 1,600 insurance plans in this country. according to Dr Joel, a n d that n u m b e r m i g h t decrease. Dr Joel also asked the organizations to have their members write essays about the atrocities they have seen in the practice arena and how health care reform could have helped prevent those atrocities. Those types of anecdotes will make an impression on legislators. according to Dr Joel. The A N A is planning a week of nursing activity concerning health care reform in May i n Washington. DC. during national nurses week. In cl u d ed i n those act i v i t i e s will be a legislative a c t i o n day. federal agency briefings
on health c a r e r e f o r m , a n d meetings with key administration leaders on Capitol Hill.
the under reporting of problems with medical devices, CDR Withiam-Wilson said. The user reporting provision mandates The Safe Medical that hospitals, nursing homes, Device Act of I990 and ambulatory surgical facilities report problems with their arcia Withiam-Wilson. medical devices. The act specifiRN. MSN. commander. cally requires users to report all US Public Health Service. and deaths associated with medical nurse consultant. US Food and devices to the FDA. They also Drug Administration (FDA). must report all serious illnesses spoke about the Safe Medical and serious injuries associated Device Act. which went into with medical devices to the effect Nov 25, 1991. Although manufacturer. the act w a s e f f e c t i v e last B i a n n u a l s u m m a r i e s of November. the proposed regu- deaths, serious injuries, and illlations were not due to be pub- nesses must be submitted to the lished in the Federal Register FDA, CDR Withiam-Wilson until January 1997. All inter- said. The first summary was ested parties will have 60 days due last month to cover probor more to c o m m e n t on the lems that occurred between proposed rules before the final Nov 28 and Dec 31, 1991. The rules are established. FDA is planning to publish a Commander With i am - W i 1- n e w s l e t t e r to c o m m u n i c a t e son began her presentation by which d e v i c e s a r e c a u s i n g reviewing the role of the FDA problems. i n e n s u r i n g the safety a n d The FDA has struggled to effectiveness of medical de- define serious illness and serivices. The FDA reviews manu- ous injury, according to CDR facturers' submissions of new Withiam-Wilson. At the time devices and monitors device of the N O L F meeting, FDA problems. In addition to moni- had defined serious illness or toring mandatory manufacturer serious injury as life threatenreporting. it monitors lgoluntary ing or that which results in persystems by which health pro- manent impairment of a body fessionals report problems. The function or permanent damage FDA employs field investiga- to a body structure or necessitors. and it produces literature tates immediate medical or surand press releases about niedi- gical intervention to preclude cal device problems. p e r m a n e n t i m p a i r m e n t of a The FDA. according to CDR body function or permanent Withiam-Wilson. has regulatory damage to a body structure. A tools such as seizure. injunction, more definitive statement may recall. and patient notification. be published in the proposed The last two are new and were rules. in the Safe Medical Device Act The act requires a facility to of 1990. The act aims to address report a p r o b l e m within 10
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d a y s of becoming a w a r e of information that reasonably suggests there is a probability that a device has caused or contributed to a death. serious illness. or serious injury. That report must include the name of the device, serial number. model number. the name and address of the manufacturer. and a description of the event. Reports are not admissible in a court of law, according to CDR Withiam-Wilson. unless involved parties knew the information was false. Then civil action can take place, and the patient can sue the institution. T h e a c t a l s o requires the establishment of a d e v i c e tracking system so that the FDA can ascertain if a defective device is in use in the distribution c h a i n . Permanent implants, life-sustaining and life-supporting devices. and other designated devices must be tracked. A specific list will be established and regulations concerning this provision will be devised in May 1992. Another section of the law requires patient notification. The manufacturer would notify patients who are at risk because of a d e v i c e . T h e FDA may enlist the help of health care profession a1s i n identifying such patients. a c c o r d i n g to CDR Withiam-Wilson. The first step is for manufacturers to notify p h y s i c i a n s of the problem. so that they can notify the appropriate patient. If the physician d o e s not notify patients. then the manufacturer must. she said.
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As of February 1992, failure to comply with the act will bring sanctions against health care institutions. There will be civil penalties such as fines. The FDA will be allowed to inspect user facilities. T h e FDA has the responsibility to 0 implement regulations by Nov 28. 1991. 0 educate health care facility administrators about the new law by May 28. 1993. and 0 e v a l u a t e the FDA user reporting requirements. Commander Withiam-Wilson suggested that facilities establish procedures to comply with the act. They must implement the new procedures and train the appropriate staff so they understand their responsibilities. For more information, call or write to the US Pharmacopoeia, 12601 Twinbrook Parkway, Rockville. MD 20852, (800)638-6725. A discussion period ensued in which participants expressed their concerns about the act. Dr Reeder spoke about the inappropriateness of having physician offices exempt from this regulation. She also said that the 10-day reporting period is unrealistic because of the forms that must be filled out as well as the complexity of the information needed. Commander Withiam-Wilson advised the participants that the proposed regulation is still in the Office of Management and Budget, after which it will be published i n the Federal R e g i s t e r . She urged nursing organizations to comment on
those proposed rules. Commander Withiam-Wilson suggested that specialty organizations become involved so that the act and its regulations can be realistic and achieve the goal of providing better patient care.
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arbara Russell, RN, MPH, CIC, reported on the work of the ANA human immunodeficiency virus (HIV) resource task force concerning the July 12, 1991, Centers for Disease Control (CDC), Atlanta, guidelines and the development of a list of exposure-prone irivasive procedures. She said the list probably will not list procedures but instead list patient conditions in which the patient might be at risk to contract the HIV from a health care worker. Many feared that individual facilities would make their own lists that would reflect on various health care providers differently. Exposure-prone procedures are those in which a h e a l t h c a r e w o r k e r ’ s blood might mingle with a patient’s blood. Since this meeing, in December 1991, the CDC has decided not to develop such a list. Russell emphasized the need for consumer education about universal precautions. The ANA has produced a set of consumer advisories, including a walletsized card and bright colorful posters in two large sizes. The products are being offered to nurses, physicians, dentists, hospitals. and other health care providers nationwide.
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Barbara Russell emphasizes the need for consumer education about universal precautions.
During the discussion period. Dr Reeder thanked Russell for representing nursing at the CDC meetings i n a positive way. Dr Reeder reemphasized the need for education. including nursing education. She said that many nurses do not understand modes of transmission and universal precautions and that this ignorance has been transformed into fear by some nurses. I n response to a question concerning re c e 11t 1egis1a t i o n mandating states to implement the CDC guidelines. Russell said the mandate is nebulous as to what .'reasonable equivalent" really means. She said that the C D C is opposed to mandatory testing even f o r those people w h o perform expos ti re -prone proc ed u re s . The states have one year to implement the guidelines. so e\'eryone must be on the alert
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about what their state legislators are doing. The Occupational S a f e t y a n d Health Ad m i n i strati o n stand a rd s on bloodborne diseases are about to come out, but it is unclear as to what they will say. according to Russell. R e p resent at i v e s fro in the spec i a I t y o 1.gan i at i o n s d i s cussed various aspects of care of patients with a c q u i r e d immune defrciency syndrome (AIDS) and prevention of HIV disease. Most agreed that nurses need to call for accessibility of testing. "Just because we are against manciatory testing does not mean we are against testing." Russell said.
Assistive Pei-soiiriel
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Hen M. Sanders. RN, MS. chairperson. ANA congress o n nursing economics. addressed u,ork of the ANA task force on unlicensed assistive personnel to the registered nurse. The task force is developing education standards for unlicensed assistive personnel as well a s p o l i c i e s a n d a n advocacy p l m for the appropriate use o f these personnel when they perform patient care functions in a clinical setting. One reconunendation is that the nursing profession define the scope of nursing practice and the role of assistive personnel. The task force further recommends that the nursing profession agree that the purpose of assistive personnel is to support nurses so that nurses can concentrate on nursing care and that all assistive nurs-
ing personnel should report to nursing. The work of the task force will c o n t i n u e . a n d a report will be sent to the ANA h o u s e of d e l e g a t e s i n J u n e 1992. Various representatives spoke of their concerns about assistive personnel in home care and school settings. Scott Gray, R N , CRNA, president of the American Association of Nurse Anesthetists reported that a new society of anesthesiology technologists has been formed and has asked the nurse anesthetists and anesthesiologists for help. These technologists will not deliver direct patient care, but they will have a role in helping anesthesiologists and nurse anesthetists. T h e y will be u n d e r d i r e c t s u p e r v i s i o n at all t i m e s , according to Gray.
Nursing: A Social Policv Stutement
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plan to revise Nursing: A (I c in 1 P o 1i c y Sta tern en t was presented by L i n d a R. Cronenwett, RN, PhD, FAAN, chairperson of the ANA congress of nursing practice. She said that the statement was 10 years old and it needcd to be revised, especially in sections addressing specialty practice. She invited specialty nursing organizations to participate. This process will begin at thc 1992 ANA house of delegates, and the goal is to have the publication revised by the fall of 1992. A special survey of specialty nursing organizations will gather input. A special
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forum on advanced practice uled to be d i s c u s s e d at t h e ment and foreign governmental will be conducted on June 24, National Federation of Spe- agencies have requested nurse 1992, 6 to 7 PM, at the ANA cialty Organizations meeting in speakers on such issues as AIDS, house of delegates in Las Vegas. January 1992. women’s health, and maternal/ child health. Nurses who wish to A m o n g the c o n t r o v e r s i a l receive an application for the issues, a c c o r d i n g to D r htemationtd International Nursing Talent Cronenwett, is a definition of Nursing Center Bank should call (800) 444-5720 advanced practice that inarbara Redman, R N , EdD, x 256. A small f e e will be cludes a graduate degree. One FAAN, executive director of charged for nurses who are not participant pointed out the difmembers of state nurses ference between a genassociations. eralist in a specialty area a n d a specialist Organizational within that a r e a a n d Afiliates that all nurses practicing within a specialty riteria for organizaarea do not need a mastional affiliation in ter’s degree. ANA is similar to criteT h e new statement ria to belong to NOLF. also needs to include Dr Joel invited all parcomponents of specialticipants to consider ization such as a n becoming part of ANA. emphasis on health proT h e r e will be public motion and the role of recognition of charter nursing in consultation, members at the next case management, and A N A house of deleprimary health care sergates in June 1992. vices, according to Dr Cronenwett. The new Newly elected NOLF officers Vickey Bradlev Elections social policy statement (right), member-at-large, and Marianne Chulay, vice-chairperson. also needs arianne Chulay, 0 an expanded list RN, DNSc, presof human responses to actual or potential ANA, reported on the establish- ident-elect, American Assocment of the International Nursing iation of Critical-Care Nurses, health problems, Center, headquartered at ANA in was elected vice-chairperson of 0 the inclusion of the theme of c a r i n g a s c e n t r a l to Washington, DC. The center, the 1992 NOLF executive comheaded by Margretta Styles, RN, mittee. Vicky Bradley, RN, nursing practice, and EdD, FAAN, has an International MS, C E N , p r e s i d e n t - e l e c t , 0 the theme of progression from novice to expert in Nursing Talent Bank that will Emergency Nurses Association our management of the link nurses with specific talents w a s e l e c t e d a s m e m b e r - a t with those in need in the interna- large. They will hold office for work force. tional community. The talent 1992 and preside over the next Dr Cronenwett suggested bank was established as a result meeting of NOLF. that a discussion of this issue PATNIESSNERPALMER,RN, MS of an increased number of take place at the next NOLF AORN DEPUTY EXECUTIVE requests from nurses and foreign meeting, which is scheduled DIRECTOR agencies, according to Dr for November 1992 in WashEDITOR, AORN JOURNAL Redman. Both the US governington, DC. It also was sched-
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