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PRIOR PRINTER'S NO. 2982
PRINTER'S NO. 4381
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
2103
Session of
2019
INTRODUCED BY JOZWIAK, FEE, PETRARCA, GILLEN, KNOWLES, MOUL,
KEEFER, SCHLOSSBERG, RADER, YOUNGBLOOD, COX, HARKINS AND
READSHAW, DECEMBER 2, 2019
AS REPORTED FROM COMMITTEE ON HEALTH, HOUSE OF REPRESENTATIVES,
AS AMENDED, SEPTEMBER 16, 2020
AN ACT
Amending the act of October 24, 2018 (P.L.719, No.112), entitled
"An act providing for notification of patient test results to
be sent directly to a patient or the patient's designee; and
providing for duties of the Department of Health," further
providing for definitions, for test results and for duties of
Department of Health. FURTHER PROVIDING FOR DEFINITIONS, FOR
TEST RESULTS AND FOR DUTIES OF DEPARTMENT OF HEALTH.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. The definitions of "diagnostic imaging service"
and "significant abnormality" in section 2 of the act of October
24, 2018 (P.L.719, No.112), known as the Patient Test Result
Information Act, are amended to read:
Section 2. Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Diagnostic imaging service." [A medical imaging test
performed on a patient that is intended to diagnose the presence
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or absence of a disease, including, but not limited to, a
malignancy.] D iagnostic magnetic imaging, computed tomography,
nuclear medicine or ultrasounds, performed to diagnose the
presence or absence of a disease, including, but not limited to,
a malignancy. The term includes positron emission tomography.
* * *
["Significant abnormality." A finding by a diagnostic
imaging service of an abnormality or anomaly which would cause a
reasonably prudent person to seek additional or follow-up
medical care within three months.]
Section 2. Section 3 and 4 of the act are amended to read:
Section 3. Test results.
(a) General rule.--[When, in the judgment of the entity
performing a diagnostic imaging service, a significant
abnormality may exist, the] The entity performing the diagnostic
imaging service shall [directly notify] provide written notice
directly to the patient or the patient's designee [by providing
notice] at the time of service that the entity [has completed]
will complete a review of the test performed on the patient and
[has sent] will send the results to the health care practitioner
who ordered the diagnostic imaging service. The notice shall, at
a minimum, include [all of the following] the following
statement:
[(1) The name of the ordering health care practitioner.
(2) The date the test was performed.
(3) The date the results were sent to the ordering
health care practitioner.
(4) The following statements:
You are receiving this notice as a result of a
determination by your diagnostic imaging service that
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further discussions of your test results are warranted
and would be beneficial to you.
The complete results of your test or tests have been or
will be sent to the health care practitioner that ordered
the test or tests. It is recommended that you contact
your health care practitioner to discuss your results as
soon as possible.
(5) The contact information necessary for the patient to
obtain a full report.]
The complete results of your test or tests will be sent
to the health care practitioner who ordered the test or
tests. If you are not contacted by the ordering health
care practitioner within 21 days of today's date, it is
recommended that you contact your health care
practitioner to discuss your results.
(b) Exceptions.--The following shall be exempted from the
requirements of subsection (a):
(1) Routine obstetrical ultrasounds used to monitor the
development of a fetus.
(2) Diagnostic imaging services performed on a patient
who is being treated on an inpatient basis [or], in an
emergency [room] department, in an emergency department
observation unit or in an urgent care center.
(3) Diagnostic radiographs.
(4) Diagnostic imaging services performed on a patient
with a chronic condition if the patient has previously
received a notice of the chronic condition, unless additional
diagnostic imaging reveals a clinically actionable change.
(5) All noninvasive evaluations for suspected or known
coronary artery disease, cardiac functional capacity,
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arrhythmias, valvular and other heart disease, including, but
not limited to, the following exercise and pharmacologic
cardiac stress tests:
(i) Adjunctive imaging.
(ii) Cardiopulmonary stress tests.
(iii) Electrocardiograms.
(iv) Ambulatory heart rhythm monitors.
(6) Resting echocardiography, including transthoracic
and transesophageal echocardiograms.
(7) Multiple-gated acquisition scans or other nuclear
cardiology studies.
(8) Cardiac portions of planar, computed tomography,
positron emission tomography and magnetic resonance imaging
studies.
(9) Vascular imaging studies.
(10) All cardiovascular angiography and fluoroscopy,
including, but not limited to, coronary angiography,
peripheral angiography and ventriculography.
[(c) Time.--Except as provided under subsection (d)(2)(v),
no later than 20 days after the date the results were sent to
the ordering health care practitioner as provided under
subsection (a)(3), the entity performing the diagnostic imaging
service shall provide the patient or patient's designee with the
notice under subsection (a).]
(d) Method of transmittal.--
[(1) The notice under subsection (a) shall be provided
in a manner deemed acceptable by the patient or the patient's
designee.
(2) A notice provided under subsection (a) shall be
presumed to comply with this act if:
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(i) mailed in a properly addressed and stamped
letter through the United States Postal Service;
(ii) sent electronically by e-mail;
(iii) sent by automatic alert from an electronic
medical record system that the notice under subsection
(a) has been posted to the patient's electronic medical
record that is presently viewable;
(iv) sent by facsimile; or
(v) provided directly to the patient at the time of
service, so long as the patient acknowledges the receipt
of the results and signs the patient's medical record
accordingly.] The notice under subsection (a) shall be
provided in writing directly to the patient or patient's
designee at the time of service and the entity performing
the diagnostic imaging service shall document providing
the notice to the patient or the patient's designee in
the patient's medical record.
(e) Construction.--
(1) Nothing in this act shall be construed to require an
entity to provide a patient or patient's designee the notice
under subsection (a) if the results of the diagnostic imaging
service are provided to the patient or patient's designee by
the health care practitioner at the time of the test.
(2) Nothing in this act shall be construed to prohibit
an entity from providing a patient with:
(i) the summary of a diagnostic imaging service
report, otherwise known as an impression or conclusion;
or
(ii) the complete results of the diagnostic imaging
service provided to the ordering health care
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practitioner.
Section 4. Duties of Department of Health.
(a) Duties.--The Department of Health shall:
(1) in accordance with law, conduct compliance reviews
as part of the inspection performed by the department or an
accrediting organization and investigate complaints filed
relating to the requirements of section 3; [and]
(2) establish a complaint procedure, which shall be made
available on the department's publicly accessible Internet
website[.]; and
(3) coordinate with the applicable State licensing
boards on complaints received by the department relating to
health care practitioners not under the department's
jurisdiction and how the complaints will be referred to the
appropriate State licensing boards for review.
(b) Regulations.--The department may, by regulation, exempt
other tests from the notice requirements under section 3.
Section 3. This act shall take effect in 60 days.
SECTION 1. THE DEFINITION OF "SIGNIFICANT ABNORMALITY" IN
SECTION 2 OF THE ACT OF OCTOBER 24, 2018 (P.L.719, NO.112),
KNOWN AS THE PATIENT TEST RESULT INFORMATION ACT, IS AMENDED AND
THE SECTION IS AMENDED BY ADDING A DEFINITION TO READ:
SECTION 2. DEFINITIONS.
THE FOLLOWING WORDS AND PHRASES WHEN USED IN THIS ACT SHALL
HAVE THE MEANINGS GIVEN TO THEM IN THIS SECTION UNLESS THE
CONTEXT CLEARLY INDICATES OTHERWISE:
"CHRONIC CONDITION." AN ILLNESS THAT FREQUENTLY RECURS OR
PERSISTS FOR A PERIOD IN EXCESS OF THREE MONTHS.
* * *
["SIGNIFICANT ABNORMALITY." A FINDING BY A DIAGNOSTIC
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IMAGING SERVICE OF AN ABNORMALITY OR ANOMALY WHICH WOULD CAUSE A
REASONABLY PRUDENT PERSON TO SEEK ADDITIONAL OR FOLLOW-UP
MEDICAL CARE WITHIN THREE MONTHS.]
SECTION 2. SECTIONS 3(A) AND (B) AND 4 OF THE ACT ARE
AMENDED TO READ:
SECTION 3. TEST RESULTS.
(A) GENERAL RULE.--[WHEN, IN THE JUDGMENT OF THE ENTITY
PERFORMING A DIAGNOSTIC IMAGING SERVICE, A SIGNIFICANT
ABNORMALITY MAY EXIST, THE] AN ENTITY PERFORMING [THE] A
DIAGNOSTIC IMAGING SERVICE SHALL [DIRECTLY NOTIFY] PROVIDE
WRITTEN NOTICE TO THE PATIENT OR THE PATIENT'S DESIGNEE [BY
PROVIDING NOTICE] THAT THE ENTITY HAS COMPLETED A REVIEW OF THE
TEST PERFORMED ON THE PATIENT AND HAS SENT RESULTS TO THE HEALTH
CARE PRACTITIONER WHO ORDERED THE DIAGNOSTIC IMAGING SERVICE.
THE NOTICE SHALL INCLUDE ALL OF THE FOLLOWING:
(1) THE NAME OF THE ORDERING HEALTH CARE PRACTITIONER.
(2) THE DATE THE TEST WAS PERFORMED.
(3) THE DATE THE RESULTS WERE SENT TO THE ORDERING
HEALTH CARE PRACTITIONER.
(4) THE FOLLOWING STATEMENTS:
[YOU ARE RECEIVING THIS NOTICE AS A RESULT OF A
DETERMINATION BY YOUR DIAGNOSTIC IMAGING SERVICE THAT
FURTHER DISCUSSIONS OF YOUR TEST RESULTS ARE WARRANTED
AND WOULD BE BENEFICIAL TO YOU.
THE COMPLETE RESULTS OF YOUR TEST OR TESTS HAVE BEEN OR
WILL BE SENT TO THE HEALTH CARE PRACTITIONER THAT ORDERED
THE TEST OR TESTS. IT IS RECOMMENDED THAT YOU CONTACT
YOUR HEALTH CARE PRACTITIONER TO DISCUSS YOUR RESULTS AS
SOON AS POSSIBLE.] THE COMPLETE RESULTS OF YOUR TEST OR
TESTS HAVE BEEN SENT TO THE HEALTH CARE PRACTITIONER WHO
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ORDERED THE TEST OR TESTS. IF YOU ARE NOT CONTACTED BY
THE ORDERING PRACTITIONER WITHIN 14 DAYS OR YOU ARE NOT
ABLE TO ACCESS YOUR TEST RESULTS ON YOUR ELECTRONIC
HEALTH RECORD, IT IS RECOMMENDED THAT YOU CONTACT YOUR
HEALTH CARE PRACTITIONER TO DISCUSS YOUR RESULTS.
(5) THE CONTACT INFORMATION NECESSARY FOR THE PATIENT TO
OBTAIN A FULL REPORT.
(B) EXCEPTIONS.--THE FOLLOWING SHALL BE EXEMPTED FROM THE
REQUIREMENTS OF SUBSECTION (A):
(1) ROUTINE OBSTETRICAL ULTRASOUNDS USED TO MONITOR THE
DEVELOPMENT OF A FETUS.
(2) DIAGNOSTIC IMAGING SERVICES PERFORMED ON A PATIENT
WHO IS BEING TREATED ON AN INPATIENT BASIS [OR], IN AN
EMERGENCY [ROOM] DEPARTMENT OR OBSERVATION UNIT OF A
HOSPITAL.
(3) DIAGNOSTIC RADIOGRAPHS.
(4) DIAGNOSTIC IMAGING SERVICES PERFORMED ON A PATIENT
WITH A CHRONIC CONDITION IF THE PATIENT HAS PREVIOUSLY
RECEIVED NOTICE OF THE CHRONIC CONDITION.
(5) DIAGNOSTIC IMAGING SERVICES TEST RESULTS PROVIDED TO
A PATIENT AT THE TIME OF THE TEST.
* * *
SECTION 4. DUTIES OF DEPARTMENT OF HEALTH.
(A) DUTIES.-- THE DEPARTMENT OF HEALTH SHALL:
(1) IN ACCORDANCE WITH LAW, CONDUCT COMPLIANCE REVIEWS
ON HEALTH CARE FACILITIES LICENSED BY THE DEPARTMENT AS PART
OF THE INSPECTION PERFORMED BY THE DEPARTMENT OR AN
ACCREDITING ORGANIZATION AND INVESTIGATE COMPLAINTS FILED
RELATING TO THE REQUIREMENTS OF SECTION 3; [AND]
(2) ESTABLISH A COMPLAINT PROCEDURE, WHICH SHALL BE MADE
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AVAILABLE ON THE DEPARTMENT'S PUBLICLY ACCESSIBLE INTERNET
WEBSITE[.]; AND
(3) COORDINATE WITH THE APPLICABLE STATE LICENSING
BOARDS ON COMPLAINTS RECEIVED BY THE DEPARTMENT RELATING TO
ENTITIES PERFORMING DIAGNOSTIC IMAGING SERVICES NOT UNDER THE
DEPARTMENT'S JURISDICTION AND HOW THE COMPLAINTS WILL BE
REFERRED TO THE APPROPRIATE STATE LICENSING BOARDS FOR
REVIEW.
(B) REGULATIONS.--THE DEPARTMENT MAY, BY REGULATION, EXEMPT
OTHER TESTS FROM THE NOTICE REQUIREMENTS UNDER SECTION 3.
SECTION 3. THIS ACT SHALL TAKE EFFECT IN 60 DAYS.
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