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When the Institute of Medicine issued "To Err Is Human, Building A Safer Health System," the political response was swift. Both at the national and state level, legislators began calling for reform and promising to make the reduction of medical mistake a top priority. Whereas Congress failed to adopt any meaningful legislative reform last year, a number of states succeeded in passing legislation intended to improve patient safety by reducing medical errors.¹ What follows is a sampling of the initiatives introduced throughout the country.

Some states have only just begun to address the issue of medical mistakes and are in the process of forming investigative commissions and task forces to study the problem: Kentucky, Missouri, Mississippi, New Jersey and Oregon are all examples.

Other states have taken an additional step by establishing, (or seeking to establish), a state office on patient safety: In New Jersey, a bill to create An Office of Medical Error Reduction recently failed, but The Council On Patient Safety was successfully established in Florida this year.

Many states have accepted the existence of the problem and are focused on developing reporting mechanisms and establishing or refining systems to collect medical error data from physicians, hospitals and other health care institutions: Connecticut, Maine, Maryland, Massachusetts and New York have all been actively pursuing legislation on this topic. New York and Florida are among the few states in the country to have sought to disclose this data, making the information available to the public.

In other states, the legislature has sought to make patient safety an element of certification requirements: Connecticut and Massachusetts offer examples of this approach.

Still others have focused on the safety concerns that arise when over-burdened health care workers make mistakes, including initiatives to address mandatory overtime: California has already passed such a law, Ohio is currently considering a similar proposal and North Carolina recently passed regulations to limit pharmacists' work days, although these regulations are now under dispute.

There have also been proposals to digitalize prescription methods, in an effort to reduce medication-related errors: California, Connecticut, Massachusetts and Washington have all pursued this approach.

Finally, at least one state, New York, sought, and failed, to pass an initiative to protect workers who reported institutional problems related to patient safety.

From these activities at the state level, we can conclude that a few basic themes in regulatory response have emerged:

(A) Increased costs to multistate providers who must comply with potentially conflicting and inconsistent regulatory schemes;

What these trends will mean, particularly in the context of potentially disparate approaches to regulation and enforcement, as well as the inevitable involvement of the federal government is increased costs to multistate providers who must comply with potentially conflicting and inconsistent regulatory schemes,

(C) a too-little-too-late federal response that allows more restrictive state programs to co-exist with federal standards, thereby exacerbating the effects described in clauses (A) and (B).

So we present for your information, and to permit you to draw your own conclusions, the state legislative responses since the IOM study was published.

Last year, the Florida legislature established a commission to research and recommend methods to reduce medical errors to the state legislature. The commission recently made its report, recommending the formation of a new office, the Council on Patient Safety, and charging it with gathering and disseminating information about medical mistakes to both health professionals and the public. Because the council will be created as part of the existing Department of Health, it doesn't need legislative approval. See http://www.doh.state.fl.us/mqa/FCHCE/FCHCEfinalrpt02-01-01.pdf.

In Kentucky, the legislature has put forward a joint resolution this year to establish a hospital medical errors task force to evaluate and investigate the cause and cost of medical errors in the state's hospitals, make recommendations and report findings to the Legislative Research Commission and Interim Joint Committee on Health and Welfare by Nov. 1, this year. See http://www.lrc.state.ky.us/2001rsrecord/hc24.htm.

"The Patient's Safety Act of 2001," introduced in Maryland on February 12, and signed by the Governor on April 20, 2001 requires the Maryland Health Care Commission to study the feasibility of developing a system for reducing preventable adverse medical events. The Commission is required to issue a final report before January 1, 2003 that recommends methods for preventing adverse medical events. See http://mlis.state.md.us/2001rs/billfile/hb1376.htm.²

The Missouri State House is currently considering a bill to require the State Department of Health to develop recommendations on methods for reducing medical errors and submitting those recommendations to the General Assembly before the end of the year. See http://www.house.state.mo.us/bills01/biltxt01/intro01/HB0620I.htm.

A bill to direct the Nevada Legislative Committee on Health Care to appoint a subcommittee to conduct an interim study concerning the development of a system for reporting medical errors in the state was referred to the Committee on Health and Human Services on February 27th of this year. See http://www.leg.state.nv.us/71st/bills/acr/acr7.html.

A bill to establish a commission on medical safety, to develop policies and procedures for reducing medical errors and to promote patient safety in the state Oregon was introduced this session. The commission would also be charged with developing recommendations to promote public access to medical error information. The bill was referred to committee on March 15. See http://www.leg.state.or.us/01reg/measures/hb3500.dir/hb3512.intro.html; see also http://www.leg.state.or.us/ahmadii-bin/searchMeas.pl.

Massachusetts was the first state to maintain a database containing comprehensive medical malpractice information on the state's physicians and make it publicly available to state residents. Malpractice settlements, disciplinary actions and criminal convictions are all public information in the state. Laws requiring the public disclosure of physicians' medical malpractice records have subsequently taken effect in Arizona California, Connecticut, Florida, Idaho, Maryland, New York, Rhode Island, Tennessee, Texas and Virginia. For example, Florida's law took effect at the beginning of this year and New York's law was enacted last October. As of the beginning of 2001, legislation was pending in Hawaii, New Jersey, New Mexico, Ohio, Oklahoma, Pennsylvania, West Virginia and Wisconsin.³

New York's "Patient Health Information and Quality Improvement Act of 2000" directs the state Department of Health to increase the information available to patients about health care providers and health care plans. The Department must establish a statewide health information system and a patient safety center, "to maximize patient safety, reduce medical errors and improve the quality of health care." This will be achieved by providing public access to health care information as well as providing for enhanced reporting and investigation of suspected medical errors. The law allows patients to access their physicians backgrounds including education, languages spoken, insurance accepted, hospital affiliation, all malpractice judgments paid in the last 10 years and the 3rd malpractice settlement paid in the last 10 years through a website as well as a toll-free telephone number. See Public Health, Article 29-D, at http://leginfo.state.ny.us:82/nysleg/menugetf.cgi.

The Florida legislature adopted a law in the 2000 Session that permits the State Department of Health to create practitioner profiles of physicians in the state. The profile includes information about any malpractice claims for more than $5,000, paid in the previous ten years. However, "such claims information shall be reported in the context of comparing an individual practitioner's claims to the experience of other practitioners within the same specialty or profession. . . ." The profile will also include information about disciplinary actions against the physician, as well as any criminal history. See http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&Search_String=&URL=Ch0456/SEC041.HTM&Title=-%3E2000-%3ECh0456-%3ESection%20041.

Beginning on Jan. 1, 2001, the Arizona Board of Medical Examiners will make physician profiles available to the public on the Internet. The profiles will include information about any criminal convictions, any medical malpractice court judgments and any arbitration awards within the last five years. See http://www.azleg.state.az.us/ars/32/01403-01.htm.

Reporting requirements emerged as a major reason for Congress' failure to pass legislation to reduce medical errors this year. In Congress, the dispute centered around mandatory versus voluntary reporting. Many entities and providers feared the potential consequences of mandatory reporting of medical errors. The tension between the need to establishing effective and complete reporting systems and providers' fear of backlash stymied efforts at the national level. Numerous states have, nevertheless taken up the challenge and introduced reporting–related initiatives of their own:

"The Medical Error Reduction Act" was introduced in the New Jersey legislature last May and would not only have created an office of medical error reduction, an executive branch of the state government to promote health care safety, but also would have implemented a voluntary reporting system for collecting data about provider errors. However, the bill was withdrawn last October. See http://www.njleg.state.nj.us/2000/Bills/a2500/2396_i1.htm.

The Maine legislature introduced an act to establish the Maine Health Care Quality Improvement Center to assist health care facilities and practitioners in improving quality of care, in part by adopting rules that establish a mandatory reporting system for medical errors and collecting and reporting the data to the legislature. The bill was referred to Committee this month. See http://janus.state.me.us/legis/bills/billtexts/ld136301-1.asp.

Massachusetts already has a confidential reporting system in effect, but a Senate bill introduced this year "To Improve Patient Safety and the Quality of Patient Care" would require an examination of the methods for reporting that are now in place. The bill would require a Patient Care Assessment Board to report to the governor and the legislature on the current methods used to report medical errors, possible medical errors and health care system deficiencies that could result in error, along with recommendations to improve the coordination and effectiveness of these programs. See http://www.state.ma.us/legis/bills/st00567.htm.

Another Massachusetts Senate bill, introduced January 3, 2001 would impose administrative fines of up to $1,000 for every failure to report the improper administration of a drug (or the theft or loss of a controlled substance), to the Massachusetts Department of Health, as are currently required by the department regulations. See http://www.state.ma.us/legis/bills/st00531.htm.

In New York, where a mandatory "adverse events" reporting system for hospitals has been in place since 1999, legislators have discovered significant underreporting. Whereas hospitals must now pay $2,000 every time they are caught not reporting an occurrence, the health commissioner is working with the governor to push for state legislation that will increase those fines for failure to report. He reportedly wants to raise the fine to $6,000 for the first failure; $25,000 for the second and $50,000 for the third.⁴

A bill is currently under consideration in Connecticut to enable the commissioner of public health to adopt regulations that require hospitals, outpatient surgical facilities and outpatient clinics to report medical errors to the commissioner and annually report to the legislature on compliance with such requirements. See http://prdbasis.cga.state.ct.us/2001/tob/h/2001HB-06941-R00-HB.htm.

A Connecticut bill currently under consideration would require hospitals and surgical clinics to submit a formal plan to eliminate medication-related errors to the Department of Public Health for approval, as a condition of licensure. See http://prdbasis.cga.state.ct.us/2001/tob/s/2001SB-00169-R00-SB.htm.

A Massachusetts Senate bill now pending would condition all license renewals on or after Dec. 31, 2004 upon evidence of participation in a patient safety and medical error reduction program. If passed, the law would also demand that any state agency or department that contracts with a public or private health care entity require that entity to develop and implement a patient safety and medical error reduction program as a condition of their contract. Furthermore, state departments that provide care, contract with providers or license entities would have to promulgate minimum standards for patient safety and medical error reduction programs to be effective on or after June 30, 2003. Finally, all commissions and departments that receive error reports would have to provide quarterly updates to the Secretary of the Office of Health and Human Services. See http://www.state.ma.us/legis/bills/st00559.htm.

California is the first state in the nation to adopt a law regulating nurse-to-patient ratios in hospitals in an effort to reduce the mistakes that result from excessive workload.⁵ Assembly Bill 394 was signed into law in October and will take effect January 1, 2002 according regulations now being devised. See http://info.sen.ca.gov/pub/99-00/bill/asm/ab_0351-0400/ab_394_bill_19991010_chaptered.html. A minimum ratio of one nurse to two patients in intensive care is already mandated by law. However, the battle is on to establish ratios in other settings. The California Nurses Association made recommendations on March 14 that are generally higher than those already proposed by the hospitals, at the same time sharply criticizing the hospitals' proposals as inadequate. The State Department of Health Services is expected to issue regulations this summer.

Last September, the New Jersey State Nurses Association managed to get a law banning mandatory overtime into the state legislature. However, the law was ultimately vetoed by then Governor Christy Todd-Whitman.⁶

In February, the "Safe Nursing Patient Care Bill" was introduced in the Ohio legislature to prohibit health care facilities from mandating that a nurse work overtime and require health care facilities to provide adequate nursing staff according to the level of health care needs of patients. Both provisions are intended to improve safety by removing the likelihood of error imposed by long hours and inadequate nurse-staff ratios. See http://www.legislature.state.oh.us/bills.cfm?ID=124_HB_78.

In North Carolina, the Pharmacy Board is seeking enforcement of a proposed rule that would prohibit employers from requiring that a pharmacist work more than twelve hours a day. The rule also has provisions for rest breaks after six and four hours, and would hold pharmacy owners and pharmacists equally responsible for errors when a pharmacy dispenses more than 150 Rxs per pharmacist per day. However, the Rules Review Commission in state government halted implementation of the rule and the Board is currently litigating the issue. See http://www.ncbop.org/newprop.htm.

The American Medical Student's Association is seeking reformation of the resident physician work hour system, based on the idea that sleep deprivation is a significant cause of medical error. Although the association is seeking to have federal legislation introduced, states may follow suit. The AMSA would like to see legislation to require hospitals to curtail resident work hours or face stiff penalties.⁷

Last year, California became a leader in the effort to reduce medication errors by requiring health care facilities to adopt computerized physician order entry systems.⁸ The "Minimization of Medication-Related Errors Act," signed by the governor on September 28, requires health care facilities to adopt technology that will reduce medication errors as a condition of licensure. All general acute-care hospitals, specialty hospitals and surgical clinics must adopt a plan to eliminate or substantially reduce medication-related errors and get it approved by the State Health Department by January 1, 2002. Entities must have their system actually in place by Jan. 1, 2005. If the plan does not include computerized physician order-entry, it must utilize other technology that has been shown effective in eliminating or substantially reducing error. See http://www.leginfo.ca.gov/pub/99-00/bill/sen/sb_1851-1900/sb_1875_bill_20000928_chaptered.pdf.

Last year, the California legislature also enacted a new law requiring all pharmacies in the state to implement pharmacy quality assurance programs.⁹ Specifically, pharmacies must evaluate medication errors and identify changes in prescribing and dispensing processes that could prevent drug errors. The law protects quality assurance data and reports from discovery proceedings. See http://www.leginfo.ca.gov/pub/99-00/bill/sen/sb_1301-1350/sb_1339_bill_20000926_chaptered.pdf.

The Pharmacy Board which sponsored the legislation, has until September 2001 to implement regulations. The proposed regulations are posted on the Board's web-site. See http://www.pharmacy.ca.gov/.

This year, the California legislature is following up last year's progress, with the submission of Assembly Bill 1589. Introduced February 23, 2001 the bill would require the Medical Board of California to study the electronic transmission of prescriptions and report its findings to the legislature before May 1, 2002. The report would include recommendations for methods to encourage physicians and surgeons to issue prescriptions electronically and identification of systems to protect patients in the process including the use of digital certification (an electronic signature) to verify the identity of the prescriber. See http://www.leginfo.ca.gov/pub/bill/asm/ab_1551-1600/ab_1589_bill_20010223_introduced.pdf.

A Connecticut bill would require the Department of Consumer Protection to review and evaluate the number of complaints by consumers involving mistakes or errors in the dispensing of prescriptions and to report those findings to the legislature, as well as make recommendations to improve dispensing, by January 1, 2001. See http://www.cga.state.ct.us/2001/TOB/h/pdf/2001HB-05803-R00-HB.pdf.

Massachusetts endorsed a specific set of recommendations to reduce medication mistakes in hospitals several years before the IOM Report was published.¹⁰ If Senate Bill 571 passes this year, the state would award a one-time bonus to health care institutions that can certify to the Commissioner of Health that they have implemented a comprehensive computerized medication order entry system or other computerized system designed to identify, track and prevent medical errors. See http://www.state.ma.us/legis/bills/st00571.htm.

The Washington state legislature enacted a bill in 2000 directing the state Department of Health to develop recommendations for reducing medication errors, including prescription legibility and labeling, and urging health care organizations to develop automated drug-ordering systems. See http://www.leg.wa.gov/sl/1999-00/2798-s_sl.pdf. The Department's report submitted in February of this year recommends eliminating handwritten prescriptions by 2005, and implementing electronic drug orders instead. The report also suggests adopting standard prescription preparation practices. See http://www.doh.wa.gov/Publicat/2000_phip/PHIP2V.pdf.

The Health Care Whistleblower Protection Act, to protect nurses from retaliation when they came forward with information about unsafe conditions in hospitals, passed unanimously in the New York state legislature last year but died in January of this year when Governor Pataki failed to sign it.¹¹

1 It is important to note, however, that not every state waited for the IOM to issue its report before adopting legislation to reduce medical errors. In New York, for example, hospitals have been required to report medical errors to the state since 1985. Massachusetts, another pioneer, initiated the Massachusetts Coalition for the Prevention of Medical Errors in 1997 and was the first state to maintain a publicly available database containing comprehensive medical malpractice information on the state's physicians.

2 See also http://mlis.state.md.us/2001rs/billfile/hb1376.htm."The Patient Safety Improvement Act of 2001," introduced to the Maryland legislature on February 22, would have required the Maryland Health Care Commission to establish a Patient Safety Information Collection Program, in part by adopting regulations to implement a system for "mandatory, collaborative, and confidential reporting of egregious and non-egregious medical errors involving health care practitioners in the state." However, this more prescriptive and punitive version of the bill died in committee.

3 See USA Today, Medicare Hides Physician Errors As States Open Up, January 5, 2001; see also http://www.mhalink.org/mcpme/mcpme_welcome.htm (for information on the Massachusetts Coalition for Prevention of Medical Errors).

4 See Lovern, Modern Health Care, Flouting the law; New York Taking Steps to Counter Hospitals' Underreporting of Errors, Feb. 19, 2001.

5 See BNA Health Care Daily Report, Vol.6, No. 50, California State Nurses Assoc. Proposes Nurse-to-Patient Ratios to Health Agency, March 14, 2001; American Health Line, Nursing Shortage: RN's "Go Public" To Highlight Concerns, Dec. 20, 2000.

6 See Julie Eisenband, Daily Pennsylvanian, Overtime Crunch Hits Nurses Hard, March 2, 2001.

7 See U.S. Newswire, Universal health Care Disparities, Resident Work Hour Reform Top Med Student Legislative Agenda for 2001, Jan. 16, 2001; U.S. Newswire, Medical Students to Warn Boston Citizens About the Dangers Of Overtired Doctors in Hospitals, Nov. 9, 2000.

8 See Todd McConnell, Health Management Technology, Safer, Cheaper, Smarter, March 2001.

9 See Drug Topics, New Calif. Law Requires QA to Cut Drug Errors, Nov. 6, 2000; Drug Topics, Calif. Pharmacy Board Regulates for Quality, Oct. 16, 2000; PR Newswire, Governor Signs Groundbreaking Bill on Medication Errors, Oct. 6, 2000.

10 See Larry Tye, The Boston Globe, Mass. Hospitals Cite Effort on Drug Errors, Feb. 27, 2001.

11 See Lorraine Seidel, The Times Union, Whistleblower Act is Matter of Public Safety, Feb. 22, 2001.