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 20070H0912B1062 - 2 -
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 20070H0912B1062 - 3 -
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. 20070H0912B1062 - 4 -
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 20070H0912B1062 - 5 -
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' 20070H0912B1062 - 6 -
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, 20070H0912B1062 - 7 -
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: 20070H0912B1062 - 8 -
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 20070H0912B1062 - 9 -
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.] 20070H0912B1062 - 10 -
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 20070H0912B1062 - 11 -
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 20070H0912B1062 - 12 -
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 20070H0912B1062 - 13 -
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 20070H0912B1062 - 14 -
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 20070H0912B1062 - 15 -
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 20070H0912B1062 - 16 -
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 20070H0912B1062 - 17 -
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 20070H0912B1062 - 18 -
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. 20070H0912B1062 - 19 -
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. 20070H0912B1062 - 20 -
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 20070H0912B1062 - 21 -
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. A16L35JAM/20070H0912B1062 - 22 -