II

106TH CONGRESS

2D SESSION S. 2038

To amend the Public Health Service Act to reduce accidental injury and

death resulting from medical mistakes and to reduce medication-related

errors, and for other purposes.

IN THE SENATE OF THE UNITED STATES

FEBRUARY 8, 2000

Mr. SPECTER (for himself, Mr. HARKIN, and Mr. INOUYE) introduced the following bill; which was read twice and referred to the Committee on

Health, Education, Labor, and Pensions

A BILL

To amend the Public Health Service Act to reduce accidental

injury and death resulting from medical mistakes and

to reduce medication-related errors, and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Medical Error Reduc5 tion Act of 2000’’.

6 SEC. 2. FINDINGS AND PURPOSE.

7 (a) FINDINGS.—Congress makes the following find8 ings:
2

•S 2038 IS

1 (1) The United States has the finest health

2 care system in the world. However, there is con3 tinuing concern and fear among the public about the

4 safety of the nation’s health care system as a result

5 of a high occurrence of medical mistakes—the fifth

6 leading cause of death.

7 (2) One national study estimates that more

8 than 100,000,000 Americans have experience with

9 medical errors and 1 out 3 cases caused permanent

10 harm, with half of the errors occurring in hospitals.

11 (3) Three of the top patient-safety issues were

12 exposure to infection, level of care received, and the

13 credentials of health care professionals.

14 (4) A recent large-scale study indicates that at

15 least 44,000 Americans may die each year as a re16 sult of medical error. Another study suggests that

17 this number may be as high as 98,000 Americans.

18 (5) When using the lower estimate in paragraph

19 (4), deaths due to medical errors still exceed the

20 number of deaths attributable to motor vehicle acci21 dents (43,458), breast cancer (42,297), or AIDS

22 (16,516).

23 (6) Deaths from adverse drug events total more

24 than 7,000 annually—exceeding the number of year25 ly workplace injuries (6,000).
3

•S 2038 IS

1 (7) The total national cost of preventable med2 ical errors resulting in injury is estimated to be be3 tween $17,000,000,000 and $29,000,000,000, from

4 direct medical costs, lost productivity, and disability.

5 (8) One recent study found that about 2 out of

6 every 100 admissions involves a preventable adverse

7 drug event. If these findings are generalized, these

8 adverse drug events affecting inpatients cost

9 $2,000,000,000 nationally.

10 (9) Medical errors are costly in terms of repeat

11 tests and medical countermeasures, which also are

12 subject to compounding errors. Purchasers and pa13 tients pay for errors when insurance costs and co14 payments are inflated by services that would not

15 have been necessary had proper care been provided.

16 (10) Errors also erode trust in the health care

17 system by patients who experience longer hospital

18 stays or disabilities and physical and psychological

19 discomfort. Health care professionals pay for errors

20 with loss of morale and frustration at not being able

21 to provide the best care possible.

22 (b) PURPOSE.—It is the purpose of this Act to ensure

23 that individuals enjoy the right to be free from accidental

24 injury, accidental death, and medication-related errors, in25 cluding medication-related errors.
4

•S 2038 IS

1 SEC. 3. AMENDMENT TO PUBLIC HEALTH SERVICE ACT.

2 Title IX of the Public Health Service Act (42 U.S.C.

3 299 et seq.) is amended—

4 (1) by redesignating part C as part D;

5 (2) by redesignating sections 921 through 928,

6 as sections 931 through 938, respectively;

7 (3) in section 938(1) (as so redesignated), by

8 striking ‘‘921’’ and inserting ‘‘931’’; and

9 (4) by inserting after part B the following:

10 ‘‘PART C—REDUCING ERRORS IN HEALTH CARE

11 ‘‘SEC. 921. DEFINITIONS.

12 ‘‘In this part:

13 ‘‘(1) ADVERSE EVENT.—The term ‘adverse

14 event’ means an injury resulting from medical man15 agement rather than the underlying condition of the

16 patient.

17 ‘‘(2) ERROR.—The term ‘error’ means the fail18 ure of a planned action to be completed as intended

19 or the use of a wrong plan to achieve the desired

20 outcome.

21 ‘‘(3) HEALTH CARE PROVIDER.—The term

22 ‘health care provider’ means an individual or entity

23 that provides medical services and is a participant in

24 a demonstration program under this part.

25 ‘‘(4) HEALTH CARE-RELATED ERROR.—The

26 term ‘‘health care-related error’’ means a prevent-
5

•S 2038 IS

1 able adverse event related to a health care interven2 tion or a failure to intervene appropriately.

3 ‘‘(5) MEDICATION-RELATED ERROR.—The term

4 ‘medication-related error’ means a preventable ad5 verse event related to the administration of a medi6 cation.

7 ‘‘(6) SAFETY.—The term ‘safety’ with respect

8 to an individual means that such individual has a

9 right to be free from preventable serious injury.

10 ‘‘(7) SENTINEL EVENT.—The term ‘sentinel

11 event’ means an unexpected occurrence involving an

12 individual that results in death or serious physical

13 injury that is unrelated to the natural course of the

14 individual’s illness or underlying condition.

15 ‘‘SEC. 922. ESTABLISHMENT OF STATE-BASED MEDICAL

16 ERROR REPORTING SYSTEMS.

17 ‘‘(a) IN GENERAL.—The Secretary shall make grants

18 available to States to enable such States to establish re19 porting systems designed to reduce medical errors and im20 prove health care quality.

21 ‘‘(b) REQUIREMENT.—

22 ‘‘(1) IN GENERAL.—To be eligible to receive a

23 grant under subsection (a), the State involved shall

24 provide assurances to the Secretary that amounts re25 ceived under the grant will be used to establish and
6

•S 2038 IS

1 implement a medical error reporting system using

2 guidelines (including guidelines relating to the con3 fidentiality of the reporting system) developed by the

4 Agency for Healthcare Research and Quality with

5 input from interested, non-governmental parties in6 cluding patient, consumer and health care provider

7 groups.

8 ‘‘(2) GUIDELINES.—Not later than 90 days

9 after the date of enactment of this part, the Agency

10 for Healthcare Research and Quality shall develop

11 and publish the guidelines described in paragraph

12 (1).

13 ‘‘(c) DATA.—

14 ‘‘(1) AVAILABILITY.—A State that receives a

15 grant under subsection (a) shall make the data pro16 vided to the medical error reporting system involved

17 available only to the Agency for Healthcare Research

18 and Quality and may not otherwise disclose such in19 formation.

20 ‘‘(2) CONFIDENTIALITY.—Nothing in this part

21 shall be construed to supersede any State law that

22 is inconsistent with this part.

23 ‘‘(d) APPLICATION.—To be eligible for a grant under

24 this section, a State shall prepare and submit to the Sec25 retary an application at such time, in such manner and
7

•S 2038 IS

1 containing, such information as the Secretary shall re2 quire.

3 ‘‘SEC. 923. DEMONSTRATION PROJECTS TO REDUCE MED4 ICAL ERRORS, IMPROVE PATIENT SAFETY,

5 AND EVALUATE REPORTING.

6 ‘‘(a) ESTABLISHMENT.—The Secretary, acting

7 through the Director of the Agency for Healthcare Re8 search and Quality and in conjunction with the Adminis9 trator of the Health Care Financing Administration, may

10 establish a program under which funding will be provided

11 for not less than 15 demonstration projects, to be competi12 tively awarded, in health care facilities and organizations

13 in geographically diverse locations, including rural and

14 urban areas (as determined by the Secretary), to deter15 mine the causes of medical errors and to—

16 ‘‘(1) use technology, staff training, and other

17 methods to reduce such errors;

18 ‘‘(2) develop replicable models that minimize

19 the frequency and severity of medical errors;

20 ‘‘(3) develop mechanisms that encourage report21 ing, prompt review, and corrective action with re22 spect to medical errors; and

23 ‘‘(4) develop methods to minimize any addi24 tional paperwork burden on health care profes25 sionals.
8

•S 2038 IS

1 ‘‘(b) ACTIVITIES.—

2 ‘‘(1) IN GENERAL.—A health care provider par3 ticipating in a demonstration project under sub4 section (a) shall—

5 ‘‘(A) utilize all available and appropriate

6 technologies to reduce the probability of future

7 medical errors; and

8 ‘‘(B) carry out other activities consistent

9 with subsection (a).

10 ‘‘(2) REPORTING TO PATIENTS.—In carrying

11 out this section, the Secretary shall ensure that—

12 ‘‘(A) 5 of the demonstration projects per13 mit the voluntary reporting by participating

14 health care providers of any adverse events,

15 sentinel events, health care-related errors, or

16 medication-related errors to the Secretary;

17 ‘‘(B) 5 of the demonstration projects re18 quire participating health care providers to re19 port any adverse events, sentinel events, health

20 care-related errors, or medication-related errors

21 to the Secretary; and

22 ‘‘(C) 5 of the demonstration projects re23 quire participating health care providers to re24 port any adverse events, sentinel events, health

25 care-related errors, or medication-related errors
9

•S 2038 IS

1 to the Secretary and to the patient involved and

2 a family member or guardian of the patient.

3 ‘‘(3) CONFIDENTIALITY.—

4 ‘‘(A) IN GENERAL.—The Secretary and the

5 participating grantee organization shall ensure

6 that information reported under this section re7 mains confidential.

8 ‘‘(B) USE.—The Secretary may use the in9 formation reported under this section only for

10 the purpose of evaluating the ability to reduce

11 errors in the delivery of care. Such information

12 shall not be used for enforcement purposes.

13 ‘‘(C) DISCLOSURE.—The Secretary may

14 not disclose the information reported under this

15 section.

16 ‘‘(D) NONADMISSIBILITY.—Information re17 ported under this section shall be privileged,

18 confidential, shall not be admissible as evidence

19 or discoverable in any civil or criminal action or

20 proceeding or subject to disclosure, and shall

21 not be subject to the Freedom of Information

22 Act (5 U.S.C. App). This paragraph shall apply

23 to all information maintained by the reporting

24 entity and the entities who receive such reports.
10

•S 2038 IS

1 ‘‘(c) USE OF TECHNOLOGIES.—The Secretary shall

2 encourage, as part of the demonstration projects con3 ducted under subsection (a), the use of appropriate tech4 nologies to reduce medical errors, such as hand-held elec5 tronic prescription pads, training simulators for medical

6 education, and bar-coding of prescription drugs and pa7 tient bracelets.

8 ‘‘(d) DATABASE.—The Secretary shall provide for the

9 establishment and operation of a national database of

10 medical errors to be used as provided for by the Secretary.

11 The information provided to the Secretary under sub12 section (b)(2) shall be contained in the database.

13 ‘‘(e) EVALUATION.—The Secretary shall evaluate the

14 progress of each demonstration project established under

15 this section in reducing the incidence of medical errors and

16 submit the results of such evaluations as part of the re17 ports under section 926(b).

18 ‘‘(f) REPORTING.—Prior to October 1, of the third

19 fiscal year for which funds are made available under this

20 section, the Secretary shall prepare and submit to the ap21 propriate committees of Congress an interim report con22 cerning the results of such demonstration projects.

23 ‘‘SEC. 924. PATIENT SAFETY IMPROVEMENT.

24 ‘‘(a) IN GENERAL.—The Secretary shall provide in25 formation to educate patients and family members about
11

•S 2038 IS

1 their role in reducing medical errors. Such information

2 shall be provided to all individuals who participate in Fed3 erally-funded health care programs.

4 ‘‘(b) DEVELOPMENT OF PROGRAMS.—The Secretary

5 shall develop programs that encourage patients to take a

6 more active role in their medical treatment, including en7 couraging patients to provide information to health care

8 providers concerning pre-existing conditions and medica9 tions.

10 ‘‘SEC. 925. PRIVATE, NONPROFIT EFFORTS TO REDUCE

11 MEDICAL ERRORS.

12 ‘‘(a) IN GENERAL.—The Secretary shall make grants

13 to health professional associations and other organizations

14 to provide training in ways to reduce medical errors, in15 cluding curriculum development, technology training, and

16 continuing medical education.

17 ‘‘(b) APPLICATION.—To be eligible for a grant under

18 this section, an entity shall prepare and submit to the Sec19 retary an application at such time, in such manner and

20 containing, such information as the Secretary shall re21 quire.

22 ‘‘SEC. 926. REPORT TO CONGRESS.

23 ‘‘(a) INITIAL REPORT.—Not later than 180 days

24 after the date of enactment of this part, the Secretary

25 shall prepare and submit to the appropriate committees
12

•S 2038 IS

1 of Congress a report concerning the costs associated with

2 implementing a program that identifies factors that con3 tribute to errors and which includes upgrading the health

4 care computer systems and other technologies in the

5 United States in order to reduce medical errors, including

6 computerizing hospital systems for the coordination of

7 prescription drugs and handling of laboratory specimens,

8 and contains recommendation on ways in which to reduce

9 those factors.

10 ‘‘(b) OTHER REPORTS.—Not later than 180 days

11 after the completion of all demonstration projects under

12 section 923, the Secretary shall prepare and submit to the

13 appropriate committees of Congress a report concerning—

14 ‘‘(1) how successful each demonstration project

15 was in reducing medical errors;

16 ‘‘(2) the data submitted by States under section

17 922(c);

18 ‘‘(3) the best methods for reducing medical er19 rors;

20 ‘‘(4) the costs associated with applying such

21 best methods on a nationwide basis; and

22 ‘‘(5) the manner in which other Federal agen23 cies can share information on best practices in order

24 to reduce medical errors in all Federal health care

25 programs.
13

•S 2038 IS

1 ‘‘SEC. 927. AUTHORIZATION OF APPROPRIATIONS.

2 ‘‘There is authorized to be appropriated such sums

3 as may be necessary to carry out this part.’’.

Æ