PRINTER'S NO. 1062
No. 912 Session of 2007
INTRODUCED BY COHEN, CALTAGIRONE, MUNDY, FRANKEL, CURRY, DALEY,
DeLUCA, DENLINGER, FABRIZIO, FREEMAN, GEORGE, GIBBONS,
GRUCELA, HENNESSEY, JAMES, JOSEPHS, KULA, LEACH, MAHONEY,
MANN, MARKOSEK, MELIO, NICKOL, PALLONE, PETRONE, SIPTROTH,
McILVAINE SMITH, SOLOBAY, STABACK, STURLA, SURRA, SWANGER,
WATERS AND WHEATLEY, MARCH 22, 2007
REFERRED TO COMMITTEE ON HEALTH AND HUMAN SERVICES,
MARCH 22, 2007
AN ACT
1 Reenacting and amending the act of September 26, 1951 (P.L.1539,
2 No.389), entitled, as amended, "An act defining clinical
3 laboratory; regulating the operation of the same; requiring
4 such laboratories to obtain permits, and to be operated under
5 the direct supervision of qualified persons; imposing certain
6 duties upon the Department of Health; and providing
7 penalties," further providing for the title and for the short
8 title; providing for legislative findings; further providing
9 for definitions; providing for clinical laboratory permits;
10 further providing for permit applications, for regulations,
11 for hearings and appeals, for exemptions and for unlawful
12 conduct; providing for regulations, for forensic DNA
13 laboratories, for exemptions and for hearings and appeals;
14 and further providing for penalties.
15 The General Assembly of the Commonwealth of Pennsylvania
16 hereby enacts as follows:
17 Section 1. The title of the act of September 26, 1951
18 (P.L.1539, No.389), known as The Clinical Laboratory Act,
19 amended December 6, 1972 (P.L.1388, No.297), is reenacted and
20 amended to read:
21 AN ACT
1 Defining clinical laboratory and forensic deoxyribonucleic acid
2 (DNA) laboratory; regulating the operation of [the same]
3 clinical laboratories and forensic DNA laboratories;
4 requiring such laboratories to obtain permits or
5 accreditation, and to be operated under the direct
6 supervision of qualified persons; imposing certain duties
7 upon the Department of Health; and providing penalties.
8 Section 2. The preamble of the act, amended December 6, 1972
9 (P.L.1388, No.297), is reenacted to read:
10 Whereas, the health and lives of the citizens of this
11 Commonwealth are endangered by incompetent supervision of
12 clinical laboratory tests; and
13 Whereas, a due regard for public health and preservation of
14 human life demands that none but scientists competent and
15 properly qualified by sufficient training in the fundamental
16 sciences and experienced in their applications in the clinical
17 laboratory shall be permitted to supervise the work of such
18 laboratories.
19 Section 3. The act is amended by adding a chapter heading to
20 read:
21 CHAPTER 1
22 PRELIMINARY PROVISIONS
23 Section 4. Section 1 of the act, amended December 6, 1972
24 (P.L.1388, No.297), is reenacted and amended to read:
25 Section [1] 101. Short Title.--This act shall be known and
26 may be cited as "The Clinical and Forensic DNA Laboratory Act."
27 Section 5. The act is amended by adding a section to read:
28 Section 102. Legislative Findings.--The General Assembly
29 finds as follows:
30 (1) The health and lives of the citizens of this
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1 Commonwealth are endangered by incompetent supervision of
2 clinical laboratory tests.
3 (2) A due regard for public health and preservation of human
4 life demands that none but scientists competent and properly
5 qualified by sufficient training in the fundamental sciences and
6 experienced in their applications in the clinical laboratory
7 shall be permitted to supervise the work of such laboratories.
8 (3) In a short period of time deoxyribonucleic acid (DNA)
9 evidence has become a significant element in many court cases.
10 In this Commonwealth and across the nation, DNA evidence has
11 proven to be the deciding factor in determining innocence or
12 guilt. Because of the increasing demand for this information,
13 the gathering, processing, handling and tabulating of DNA
14 materials in court cases and other areas has become an area of
15 great activity. There is often considerable pressure placed on
16 the few laboratories that process DNA materials. Processing and
17 handling DNA materials requires considerable expertise and
18 unique equipment. As is the case in this Commonwealth, most DNA
19 casework is carried out by large police departments and State
20 facilities. There are, however, some private labs conducting
21 this work. As DNA evidence continues to play an integral part in
22 determining the innocence or guilt of a person, it is vitally
23 important that laboratories conducting this type of analysis are
24 well regulated and accredited.
25 Section 5.1. Section 2 of the act, amended December 6, 1972
26 (P.L.1388, No.297), is repealed:
27 [Section 2. Definitions.--The term "Clinical Laboratory"
28 means any place, establishment or institution organized and
29 operated primarily for the performance of all or any
30 bacteriological, biochemical, microscopical, serological, or
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1 parasitological tests by the practical application of one or
2 more of the fundamental sciences to material originating from
3 the human body, by the use of specialized apparatus, equipment
4 and methods, for the purpose of obtaining scientific data which
5 may be used as an aid to ascertain the state of health.
6 The term "Department" means the Department of Health.]
7 Section 5.2. The act is amended by adding a section to read:
8 Section 103. Definitions.--The following words and phrases
9 when used in this act shall have the meanings given to them in
10 this section unless the context clearly indicates otherwise:
11 "ASCLD-LAB" means the American Society of Crime Laboratory
12 Directors/Laboratory Accreditation Board.
13 "Blind external proficiency testing" means a test sample that
14 is presented to a forensic laboratory for forensic
15 deoxyribonucleic acid (DNA) testing through a second agency, and
16 which appears to the analysis to involve routine evidence
17 submitted for forensic DNA testing.
18 "Board" means the Forensic DNA Accreditation Board
19 established in section 502.
20 "Bureau" means the Bureau of Laboratories in the Department
21 of Health of the Commonwealth.
22 "Clinical laboratory" means any place, establishment or
23 institution organized and operated primarily for the performance
24 of all or any bacteriological, biochemical, microscopical,
25 serological or parasitological tests by the practical
26 application of one or more of the fundamental sciences to
27 material originating from the human body, by the use of
28 specialized apparatus, equipment and methods, for the purpose of
29 obtaining scientific data which may be used as an aid to
30 ascertain the state of health.
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1 "Department" means the Department of Health of the
2 Commonwealth.
3 "DNA" means the deoxyribonucleic acid which is located in the
4 cells and provides the personal genetic blueprint of each
5 individual through encoded genetic information that is the basis
6 of human heredity and forensic identification.
7 "DNA testing methodology" means the methods and procedures
8 used to extract and analyze deoxyribonucleic acid (DNA)
9 material, as well as the methods, procedures, assumptions and
10 studies used to draw statistical inferences from the test
11 results.
12 "FBI" means the Federal Bureau of Investigation.
13 "Forensic DNA laboratory" means any forensic laboratory
14 operated in this Commonwealth that performs forensic DNA testing
15 on crime scenes or for purposes of identification.
16 "Forensic DNA testing" means any test that employs techniques
17 to examine deoxyribonucleic acid (DNA) derived from the human
18 body for the purpose of providing information to resolve issues
19 of identification.
20 "Secretary" means the Secretary of Health of the
21 Commonwealth.
22 "State DNA identification record system" means the State DNA
23 Data Base reestablished under 42 Pa.C.S. § 4712 (relating to
24 State DNA Data Base) and the State DNA Data Bank reestablished
25 under 42 Pa.C.S. § 4713 (relating to State DNA Data Bank).
26 "Supreme Court" means the Supreme Court of the Commonwealth
27 of Pennsylvania.
28 Section 6. The act is amended by adding a chapter heading
29 and a section to read:
30 CHAPTER 3
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1 CLINICAL LABORATORIES
2 Section 301. Clinical Laboratory Permits.--The department
3 shall issue a permit for the operation of any clinical
4 laboratory which meets the requirements of this chapter and
5 complies with the regulations promulgated under this chapter.
6 Section 7. Sections 3 and 3.1 of the act, amended December
7 6, 1972 (P.L.1388, No.297), are reenacted, renumbered and
8 amended to read:
9 Section [3. Limitations] 302. Supervision.--A clinical
10 laboratory shall be under the direct and personal supervision
11 of:
12 [1.] (1) A holder of a doctor of science degree or its
13 equivalent in the basic sciences, including professional degrees
14 in public health, medicine, osteopathy, pharmacy, dentistry and
15 veterinary medicine, from a college or university recognized by
16 the National Committee of Regional Accrediting Agencies or the
17 Department of Education, in chemistry, biology or microbiology,
18 and who has had two years of experience in a laboratory
19 acceptable to the department.
20 [2.] (2) The holder of a master of science degree or its
21 equivalent in the basic sciences from a college or university
22 recognized by the National Committee of Regional Accrediting
23 Agencies or the Department of Education, in chemistry, biology
24 or microbiology, and who has had a minimum of four years'
25 experience in a laboratory acceptable to the department.
26 [3.] (3) The holder of a bachelor of science degree or its
27 equivalent in the basic sciences from a college or university
28 recognized by the National Committee of Regional Accrediting
29 Agencies or the Department of Education, in chemistry, biology
30 or microbiology, and who has had a minimum of five years'
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1 experience in laboratory work in a laboratory acceptable to the
2 department.
3 [4.] (4) From and after July 1, 1973, no clinical laboratory
4 shall be under the direction and personal supervision of any
5 person who does not meet the qualifications set forth in clause
6 [2] (2) of this section, and from and after July 1, 1974, no
7 clinical laboratory shall be under the direction and personal
8 supervision of any person who does not meet the requirements of
9 clause [1] (1) of this section[: Provided, however, That this].
10 This clause shall apply only to those laboratories for which an
11 application for a permit is made on or after the dates herein
12 specified[: And provided further, That this]. This provision
13 shall apply only to those clinical laboratories required to have
14 a permit pursuant to the provisions of this [act] chapter.
15 [5.] (5) The [foregoing] limitations in this section shall
16 not apply to those persons operating a clinical laboratory prior
17 to [the effective date of this act] January 1, 1952.
18 Section [3.1. Advisory Committee] 303. Advisory Committee
19 on Clinical Laboratories.--An advisory committee shall be
20 established for the purpose of advising the secretary in matters
21 relating to administration of [the act] this chapter. There
22 shall be seven members, each of whom is experienced in the
23 clinical laboratory field. At least one member shall be
24 qualified in the discipline of anatomic pathology and one in
25 clinical pathology and licensed to practice medicine in [the]
26 this Commonwealth or eligible for licensure, one shall be
27 qualified in the field of clinical chemistry, and one shall be
28 qualified in the field of clinical microbiology. Members of the
29 committee shall be appointed by the secretary.
30 Section 8. Sections 4 and 5 of the act are reenacted,
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1 renumbered and amended to read:
2 Section [4] 304. Application for Clinical Laboratory
3 Permit.--All persons now operating or hereafter desiring to
4 operate an analytical-biochemical-biological laboratory shall
5 make written application to the department for a permit to
6 operate, which application shall be accompanied by [a fee of
7 twenty-five dollars ($25)] an application fee, payable to the
8 department, and shall be retained by the department.
9 Section [5] 305. Contents of Application for Clinical
10 Laboratory Permit.--The application shall contain at least the
11 following:
12 [(a)] (1) The name and address of the persons owning the
13 place, establishment or institution in which the analytical-
14 biochemical-biological laboratory is to be or is operated.
15 [(b)] (2) The name and address of the persons operating or
16 to operate such laboratory.
17 [(c)] (3) The name and address of the qualified person under
18 whose direct and personal supervision such laboratory is to be
19 or is operated.
20 [(d)] (4) The kind and nature of the laboratory work to be
21 or is being done.
22 [(e)] (5) The description of the building, its location,
23 facilities, equipment, apparatus and appliances to be furnished
24 or used in the operation of such laboratory.
25 [(f)] (6) Such additional information as the department may
26 require by any rule or regulation.
27 The facts as set forth in the application shall be duly sworn to
28 or affirmed by one of the owners of such laboratory.
29 Section 9. Sections 6 and 7 of the act are reenacted and
30 renumbered to read:
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1 Section [6] 306. Revocation of Permit.--(a) Permits shall
2 become void upon change of director and also upon the removal of
3 the laboratory to other quarters. A new permit may be issued
4 without charge when the department has passed upon the
5 qualifications of the new director or upon the adequacy of the
6 new quarters and equipment.
7 (b) A permit may be revoked at any time for failure to
8 maintain proper standards of accuracy, for unethical practice or
9 for unethical advertising, or for any other cause deemed
10 adequate by the department.
11 Section [7] 307. Investigation by Department.--Upon the
12 filing of any application for a permit or for renewal, the
13 department shall investigate the facts set forth in the
14 application.
15 Section 10. Sections 8 and 9 of the act are reenacted,
16 renumbered and amended to read:
17 Section [8] 308. Issuance of Permit.--If the department
18 finds the statements contained in the application are true, the
19 [said] department shall issue a permit.
20 Section [9] 309. Contents and Signing of Permit.--(a) The
21 permits shall contain at least the following:
22 [(a)] (1) The name and address of the laboratory and of its
23 owner.
24 [(b)] (2) The name and address of the person charged with
25 the operation of the laboratory.
26 [(c)] (3) The name of the qualified person under whose
27 supervision the laboratory is operated.
28 [(d)] (b) All permits shall be signed or counter-signed by
29 the Secretary of Health.
30 Section 11. Section 10 of the act is reenacted and
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1 renumbered to read:
2 Section [10] 310. Statement of Grounds for Denial of
3 Permits.--If the department does not, within six months after
4 the filing of the application, issue a permit, it shall state
5 the grounds and reasons for its refusal, in writing, furnishing
6 a copy to the applicant.
7 Section 12. Section 11 of the act, amended August 4, 1961
8 (P.L.920, No.400), is reenacted and renumbered to read:
9 Section [11] 311. Inspection.--The department may at any
10 time visit, enter, examine and inspect the premises occupied,
11 maintained and conducted by any laboratory, and may examine all
12 matters in relation thereto. Periodically the department shall
13 verify the accuracy of the work of each laboratory using such
14 means and standards as the department shall specify by rule or
15 regulation.
16 Section 13. Section 11.1 of the act, added August 4, 1961
17 (P.L.920, No.400), is repealed:
18 [Section 11.1. Rules and Regulations.--The Department of
19 Health shall have the power, and its duty shall be, to adopt
20 rules and regulations for the proper enforcement of this act
21 with regard to the following:
22 (1) Contents of application;
23 (2) Adequacy of laboratory quarters and equipment;
24 (3) Means and standards of accuracy of laboratory
25 procedures;
26 (4) Definition of unethical practice and unethical
27 advertising;
28 (5) Any other matters it may deem advisable for the
29 protection of the public and for carrying out the provisions and
30 purposes of this act.]
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1 Section 14. Section 12 of the act, repealed in part April
2 28, 1978 (P.L.202, No. 53), is repealed:
3 [Section 12. Hearings and Appeals.--If an application for a
4 permit is denied, as provided in section ten hereof, the
5 applicant may request and be entitled to a hearing before the
6 Secretary of Health, if such request was made within thirty days
7 after the permit was denied. A permit issued under the
8 provisions of this act may be revoked or suspended by the
9 department for cause: Provided, That the permittee is permitted
10 to be heard by the department, either personally, by counsel, or
11 both: And provided further, That a written copy of the causes be
12 furnished him, by registered mail, ten days in advance of the
13 date set for hearing. Said notice shall fix the time and place
14 for said hearing, which shall not be more than thirty days from
15 the date of the mailing of said notice.
16 Any person who shall be aggrieved by any action of the
17 department under this act or by any rule or regulation
18 promulgated by the department shall have the right to file a
19 complaint with the Secretary of Health and to have a hearing
20 thereon before the Secretary of Health. Such hearing shall be
21 conducted and the decision of the Secretary of Health on the
22 issue involved shall be rendered in accordance with the
23 provisions of the Administrative Agency Law and its amendments,
24 approved June fourth, one thousand nine hundred forty-five
25 (Pamphlet Laws 1388), relating to adjudication procedure.]
26 Section 15. Section 13 of the act is repealed:
27 [Section 13. Exemptions.--This act shall not include nor
28 apply to any laboratory or laboratories maintained and operated
29 by the Federal government; nor to any laboratory or laboratories
30 maintained and operated purely for research or teaching
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1 purposes.]
2 Section 16. Section 13.1 of the act, added December 6, 1972
3 (P.L.1388, No.297), is reenacted and amended to read:
4 Section [13.1] 312. Unlawful Conduct.--It shall be unlawful
5 for any person to solicit, receive, accept, deliver or transmit,
6 by mail or otherwise, material originating from the human body
7 on behalf of any person operating a clinical laboratory not in
8 possession of a permit under this [act] chapter regardless of
9 whether such laboratory is located in this Commonwealth. The
10 provisions of this section shall not apply to transactions with
11 any person operating a clinical laboratory located in another
12 state, which laboratory has been issued a license or permit in
13 conformity with the "Clinical Laboratories Improvement Act of
14 1967," and related statutes. Neither shall this section apply to
15 transactions with laboratories operated in this State which are
16 exempt from the permit requirements of this [act.] chapter.
17 Section 17. Section 13.2 of the act, added November 9, 2006
18 (P.L.1354, No.144), is reenacted and renumbered to read:
19 Section [13.2] 313. Glomerular Filtration Rate Testing.--The
20 director of a clinical laboratory licensed in this Commonwealth
21 shall provide that when the laboratory tests a specimen to
22 determine the serum creatinine level for a patient age 18 or
23 older, the laboratory shall also calculate the patient's
24 estimated glomerular filtration rate at no additional charge.
25 The laboratory shall include the patient's estimated glomerular
26 filtration rate with its report to the health care professional.
27 Clinical laboratories in health care facilities shall report the
28 estimated glomerular filtration rate based on a protocol
29 developed by the laboratory in consultation with either or both
30 its medical staff or clinical departments. A laboratory shall
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1 only be required to calculate and report a patient's estimated
2 glomerular filtration rate if information necessary for the
3 calculation to be considered medically appropriate and valid for
4 the patient has been made available to the laboratory by the
5 health care professional. This section shall not apply to
6 clinical trials and research. Clinical laboratories that do not
7 have information systems capable of providing estimated
8 glomerular filtration rates on an automated basis shall have two
9 years to comply with this section.
10 Section 18. The act is amended by adding a section to read:
11 Section 314. Rules and Regulations.--The department shall
12 have the power, and its duty shall be, to adopt rules and
13 regulations for the proper enforcement of this chapter with
14 regard to the following:
15 (1) Contents of application;
16 (2) Adequacy of laboratory quarters and equipment;
17 (3) Means and standards of accuracy of laboratory
18 procedures;
19 (4) Definition of unethical practice and unethical
20 advertising;
21 (5) Any other matters it may deem advisable for the
22 protection of the public and for carrying out the provisions and
23 purposes of this chapter.
24 Section 19. The act is amended by adding chapters to read:
25 CHAPTER 5
26 FORENSIC DNA LABORATORIES
27 Section 501. Accreditation of Forensic DNA Laboratories.--
28 The department shall accredit, regulate and oversee the
29 operations of forensic DNA laboratories in this Commonwealth
30 using the standards and system of accreditation established by
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1 the board.
2 Section 502. Forensic DNA Accreditation Board.--(a) The
3 forensic science DNA accreditation board is established in the
4 department and shall consist of seven voting members and one ex-
5 officio member as follows:
6 (1) The Secretary of Health or a designee of the secretary,
7 who shall be chair of the board.
8 (2) The director of the Bureau of Laboratories or its
9 successor, who shall serve as an ex-officio member of the board.
10 (3) The Commissioner of the Pennsylvania State Police or a
11 designee.
12 (4) The Attorney General or a designee.
13 (5) One member to be appointed by the secretary for a term
14 of six years who shall be a scientist having experience in the
15 area of laboratory standards or quality assurance regulation and
16 monitoring.
17 (6) Two members to be appointed by the Governor for terms of
18 four years, one to be a prosecuting attorney, and one to be a
19 public defender.
20 (7) One member to be appointed by the Chief Justice of the
21 Supreme Court for a term of six years who shall be a judge or
22 attorney with a background in biomedical ethics and privacy
23 issues.
24 (b) The members of the Forensic DNA Accreditation Board
25 appointed by the Governor, the Chief Justice of the Supreme
26 Court and the secretary shall be confirmed by a majority vote of
27 the Senate.
28 (c) Any vacancy created other than by expiration of a term
29 shall be filled by the appointing authority for the unexpired
30 term of the member. Any vacancy shall be filled in the same
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1 manner as the original appointment. All members shall serve
2 until successors are appointed.
3 (d) The accreditation board shall meet at least four times
4 each year and may establish its own rules and procedures
5 concerning the conduct of its meetings and other affairs not
6 inconsistent with law.
7 (e) No member of the board shall be disqualified from
8 holding any public office or employment, nor shall the member
9 forfeit any such office or employment, by reason of appointment
10 to the board. Members of the board shall not be required to take
11 and file oaths of office before serving on the board.
12 (f) Members of the board shall receive no compensation for
13 their services but shall be allowed their actual and necessary
14 expenses incurred in the performance of their functions under
15 this chapter.
16 Section 503. Powers and Duties of Board.--The board shall
17 have the following powers and duties:
18 (1) To establish minimum standards for:
19 (i) Qualifications for forensic DNA laboratory directors and
20 such other personnel as the board may determine to be necessary
21 and appropriate.
22 (ii) The approval of forensic DNA laboratories for the
23 performance of specific forensic methodologies.
24 (2) To adopt accreditation standards for forensic DNA
25 laboratories which, at a minimum, include or require:
26 (i) Standards equivalent to or greater than standards
27 promulgated by ASCLD-LAB.
28 (ii) Standards that require the applicant to comply with the
29 standards issued by the FBI for forensic DNA laboratories.
30 (iii) Standards which meet the requirements of the
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1 Pennsylvania State Police used for the State DNA Identification
2 Record System.
3 (3) The adoption and implementation of internal and external
4 proficiency testing programs, which may include a blind external
5 proficiency testing program for forensic laboratories performing
6 forensic DNA testing.
7 (4) The designation of one or more entities for the
8 performance of proficiency tests required under this chapter.
9 (5) The qualifications for and employment of forensic DNA
10 laboratory inspectors.
11 (6) To establish, appoint and set terms of members to as
12 many advisory councils as it deems necessary to provide
13 specialized expertise to the board with respect to new forensic
14 DNA technologies including testing methodologies.
15 (7) To designate one or more approved methodologies for the
16 performance of forensic DNA testing.
17 (8) To review and act upon applications by forensic DNA
18 laboratories for approval to perform forensic DNA testing.
19 (9) To assess and evaluate all DNA methodologies proposed to
20 be used for forensic analysis.
21 (10) To require a demonstration by an independent laboratory
22 of any proposed forensic DNA testing methodology proposed to be
23 used by a forensic laboratory.
24 (11) To develop an application for forensic DNA laboratory
25 accreditation.
26 Section 504. Objectives of Standards and Accreditation.--The
27 minimum standards and program of accreditation shall be designed
28 to accomplish all of the following objectives:
29 (1) Set minimum requirements for the effectiveness,
30 efficiency, reliability and accuracy of forensic DNA
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1 laboratories.
2 (2) Recommend and assist the implementation of the highest
3 performance of DNA standards.
4 (3) Promote increased cooperation and coordination among
5 forensic DNA laboratories and other agencies in the criminal
6 justice system.
7 (4) Ensure compatibility, to the extent consistent with the
8 provisions of this chapter and any other applicable provision of
9 law pertaining to privacy or restricting disclosure or
10 redisclosure of information, with Federal and other state
11 forensic DNA laboratories to the extent necessary to share and
12 exchange information, data and results of forensic DNA analysis
13 and tests.
14 (5) Set forth minimum requirements for the quality and
15 maintenance of equipment.
16 Section 505. Requirements for Obtaining Accreditation.--The
17 program of forensic DNA laboratory accreditation shall include,
18 at a minimum, all of the following requirements:
19 (1) An initial laboratory inspection, and routine
20 inspections, as necessary, to ensure compliance with
21 accreditation requirements.
22 (2) Routine internal and external proficiency testing of all
23 laboratory personnel involved in forensic DNA analysis,
24 including blind external proficiency testing if the board
25 determines such a blind proficiency testing program is
26 practicable and appropriate, the board shall consider such
27 factors as accuracy and reliability of laboratory results, cost-
28 effectiveness, time, allocation of resources and availability.
29 (3) Quality control and quality assurance protocols, a
30 method validation procedure and a corrective action and remedial
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1 program.
2 (4) Annual certification to the department by the forensic
3 DNA laboratories of their continued compliance with the
4 requirements of the accreditation program.
5 Section 506. Revocation and Suspension of Accreditation.--
6 The accreditation of a forensic DNA laboratory may be revoked,
7 suspended or otherwise limited, upon a determination by the
8 department that the laboratory or one or more persons in its
9 employ:
10 (1) Is guilty of misrepresentation in obtaining a forensic
11 DNA laboratory accreditation.
12 (2) Rendered a report on laboratory work actually performed
13 in another forensic DNA laboratory without disclosing the fact
14 that the examination or procedure was performed by such other
15 forensic DNA laboratory.
16 (3) Showed a pattern of excessive errors in the performance
17 of forensic DNA laboratory examination procedures.
18 (4) Failed to file any report required to be submitted
19 pursuant to this act or the rules and regulations promulgated
20 pursuant thereto.
21 (5) Violated in a material respect any provision of this
22 chapter or the promulgated rules and regulations.
23 Section 507. Cooperation with Department.--The department
24 may require and receive from any agency of the Commonwealth or
25 any political subdivision such assistance and data as may be
26 necessary to enable the department to administer the provisions
27 of this chapter. The department may enter into such cooperative
28 arrangements with the State Crime Laboratory, and any other
29 Commonwealth agency, each of which is authorized to enter into
30 such cooperative arrangements as shall be necessary or
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1 appropriate. Upon request of the department any Commonwealth
2 agency may transfer to the department such officers and employes
3 as the department may deem necessary from time to time to assist
4 the department in carrying out its functions and duties.
5 Officers and employes so transferred shall not lose their civil
6 service status or rights, and shall remain in the negotiating
7 unit, if any, established prior to such transfer.
8 Section 508. Subcontracting of DNA Testing.--Any
9 Commonwealth accredited forensic DNA laboratory must require
10 certification of compliance with the standards issued by the
11 board when an out-of-state subcontractor performs forensic DNA
12 analysis for the laboratory. The forensic DNA laboratory will
13 establish and use appropriate review procedures to verify the
14 integrity of the data received from the subcontractor.
15 Section 509. Confidentiality.--All records, findings,
16 reports and results shall not be released to insurance
17 companies, employers or potential employers, health providers,
18 employment screening or personnel companies, agencies, or
19 services, or private investigation services, and may not be
20 disclosed upon request or order of any agency, authority,
21 division, office, corporation, partnership or any other private
22 or public entity or person. Nothing contained in this chapter
23 shall prohibit disclosure in response to a subpoena.
24 Section 510. Unlawful Conduct.--It shall be unlawful for any
25 person to intentionally disclose a DNA record, or the results of
26 a forensic DNA test or analysis, to an individual or agency
27 other than one authorized to have access to such records
28 pursuant to this chapter or to intentionally use or receive DNA
29 records, or the results of a forensic DNA test or analysis, for
30 purposes other than those authorized pursuant to this chapter.
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1 Section 511. Compliance Schedule.--Upon enactment of this
2 chapter, the board shall have one year to establish and
3 promulgate minimum standards and a program of accreditation for
4 all forensic DNA laboratories in this Commonwealth. All DNA
5 laboratories shall apply for accreditation within six months of
6 the promulgation of the standards. Four years after the
7 effective date of this chapter, all forensic DNA labs in this
8 Commonwealth shall be in full compliance with this chapter. Any
9 forensic DNA laboratory not in full compliance after this time
10 shall be subject to penalties adopted by the department.
11 Section 512. Additional Research.--(a) Nothing in this
12 chapter shall be deemed to preclude forensic DNA laboratories
13 from performing research and validation studies on new
14 methodologies and technologies which may not yet be approved by
15 the board at that time.
16 (b) Regulation pursuant to this chapter shall not include
17 DNA testing on materials derived from the human body for the
18 purpose of determining a person's genetic disease or medical
19 condition.
20 CHAPTER 7
21 PROVISIONS OF GENERAL APPLICABILITY
22 Section 701. Exemptions.--This act shall not include nor
23 apply to any clinical or forensic DNA laboratory or laboratories
24 maintained and operated by the Federal government; nor to any
25 clinical or forensic DNA laboratory or laboratories maintained
26 and operated purely for research or teaching purposes.
27 Section 702. Hearings and Appeals.--(a) All adjudications
28 and final actions of the department under this act or the rules
29 and regulations promulgated under this act shall be subject to
30 appeal.
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1 (b) All hearings on appeals and all procedures relating to
2 those hearing shall be conducted under the provisions of 2
3 Pa.C.S. Chs. 5 Subch. A (relating to practice and procedure of
4 Commonwealth agencies) and 7 Subch. A (relating to judicial
5 review of Commonwealth agency action).
6 Section 20. Section 14 of the act, amended December 6, 1972
7 (P.L.1388, No.297), is reenacted, renumbered and amended to
8 read:
9 Section [14. Penalty.--] 703. Penalties.--(a) Any person
10 operating a clinical laboratory without first having obtained a
11 permit from the [Department of Health] department or violating
12 the provisions of section [13.1 of the act] 312 shall, upon
13 conviction thereof, be sentenced to pay a fine not exceeding
14 [five hundred dollars ($500)] $500 or to imprisonment not
15 exceeding one [(1)] year, or both.
16 (b) (1) Any person operating a forensic DNA laboratory
17 without obtaining the accreditation required by this act, or
18 who, with the intent to mislead or deceive, misrepresents a
19 material fact to the department shall be subject to a civil
20 penalty not to exceed $7,500 and such other penalties as are
21 prescribed by the law.
22 (2) Any person who:
23 (i) intentionally discloses a DNA record, or the results of
24 a forensic DNA test or analysis, to an individual or agency
25 other than one authorized to have access to such records
26 pursuant to this act; or
27 (ii) intentionally uses or receives DNA records, or the
28 results of a forensic DNA test or analysis, for purposes other
29 than those authorized pursuant to this act shall be guilty of a
30 felony, and upon conviction thereof, shall be subject to a fine
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1 of not more than $10,000 and such other penalties as are
2 prescribed by the law.
3 Section 21. The act is amended by adding a chapter heading
4 to read:
5 CHAPTER 9
6 MISCELLANEOUS PROVISIONS
7 Section 22. Sections 15 and 16 of the act are reenacted and
8 renumbered to read:
9 Section [15] 901. Interpretation of Act.--The provisions of
10 this act are severable and if any of its provisions shall be
11 held unconstitutional, the decision of the court shall not
12 affect or impair any of the remaining provisions of this act. It
13 is hereby declared to be the legislative intent that this act
14 would have been adopted had such unconstitutional provisions not
15 been included herein.
16 Section [16] 2102. Effective Date.--This act shall become
17 effective on the first day of January, one thousand nine hundred
18 fifty-two.
19 Section 23. This act shall take effect in 120 days.
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