reglab/statecodes huggingface dataset:
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 1 - ADMINISTRATION OF VITAL RECORDS › CORRECTION OF RECORDS › Section 1.34 - Correction of spelling of names

Current through Register Vol. 54, No. 28, July 13, 2024
Changes in the spelling of names on birth certificates
					 shall be made in compliance with the following:
(1) If the subject is less than 1 year of
				  age, correction may be accomplished by a statement signed by both
				  parents.
(2) If the subject is over
				  1 year of age, correction may be accomplished by an affidavit of the parents or
				  of the subject, if of legal age.
(3) If the correction requested suggests a
				  change in surname rather than the correction of the spelling of a surname, then
				  the Department of Health may require additional recorded evidence or an order
				  from a court of competent jurisdiction if it is deemed necessary to preserve
				  the integrity of the records.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 1 - ADMINISTRATION OF VITAL RECORDS › CORRECTION OF RECORDS › Section 1.35 - Changing names of children under the age of 15

Current through Register Vol. 54, No. 28, July 13, 2024
(a) When a child of at least 7 but no more
				  than 14 years of age has established through usage a name different from the
				  name originally recorded on the birth certificate, the Division of Vital
				  Records may, upon application therefor by the subject's custodial parent,
				  guardian or legal representative, issue a regular certificate in the name the
				  subject is actually using. Before the certificate is issued, the applicant
				  shall submit to the Division of Vital Records adequate proof establishing usage
				  of the name.
(b) Adequate proof
				  shall consist of documents or official records demonstrating actual use of the
				  name by the child during at least half of the child's lifetime.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 1 - ADMINISTRATION OF VITAL RECORDS › CORRECTION OF RECORDS › Section 1.36 - Addition or correction of information on death certificates

Current through Register Vol. 54, No. 28, July 13, 2024
(a) To add to or
				  correct information pertaining to the deceased person except the medical
				  certification and the place and date of death on a death or fetal death
				  certificate, a signed statement covering the necessary corrections or additions
				  shall be submitted by the informant who signed the original certificate or by
				  the funeral director who filed such certificate.
(b) To add to or correct information
				  pertaining to date or place of burial on a death or fetal death certificate a
				  written statement covering the necessary corrections or additions shall be
				  submitted by the funeral director.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 1 - ADMINISTRATION OF VITAL RECORDS › CORRECTION OF RECORDS › Section 1.37 - Changes in the medical certification of cause of death

Current through Register Vol. 54, No. 28, July 13, 2024
(a) To add to or correct information
				  pertaining to the medical certification of cause of death or date or place of
				  death, a written statement covering the necessary corrections or additions
				  shall be submitted by the physician or coroner who signed the medical
				  certification on the original certificate.
(b) If the correction requested changes the
				  medical certification from a death due to natural causes to a death due to
				  other than natural causes, then the affidavit of the person who signed the
				  medical certification shall be requested.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 1 - ADMINISTRATION OF VITAL RECORDS › MISCELLANEOUS PROVISIONS › Section 1.41 - Qualifications for registrar

Current through Register Vol. 54, No. 28, July 13, 2024
The following qualifications shall be required of a person
					 who is appointed local registrar or deputy registrar:
(1) Legibility of hand writing or ability to
				  use a typewriter.
(2) Training or
				  experience in simple office procedures, such as filing, indexing and the
				  handling of valuable documents.
(3)
				  The ability to transcribe accurately from original documents.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 1 - ADMINISTRATION OF VITAL RECORDS › MISCELLANEOUS PROVISIONS › Section 1.42 - Responsibilities of local registrars

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Verifications.
Local registrars in cities of the third class
				  shall be authorized to verify the place and date of birth of a child for
				  representatives of the Department of Education when they receive a signed
				  request from an official of the school district.
(b)
Disclosures.
Local
				  registrars shall be authorized to disclose information contained in vital
				  statistics records to persons who have been supplied with an authorization card
				  signed by the Secretary of Health.
(c)
Motor vehicle deaths.
The local registrar shall report to the Bureau of Highway Safety in Harrisburg
				  the following facts copied from the death certificate received by the local
				  registrar, and concerning deaths resulting from motor vehicle accidents:
(1) Name and address of deceased.
(2) Date and place of accident.
(3) Date of death.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 1 - ADMINISTRATION OF VITAL RECORDS › MISCELLANEOUS PROVISIONS › Section 1.43 - Designation of registrars

Current through Register Vol. 54, No. 28, July 13, 2024
The Secretary of Health may designate a medical director of
					 a county department of health to act as local registrar within his registration
					 district, with the authority to certify records, as long as the director shall
					 have agreed, in writing, to be bound by the rules, regulations and directives
					 of the Department of Health concerning records.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 1 - ADMINISTRATION OF VITAL RECORDS › MISCELLANEOUS PROVISIONS › Section 1.44 - Penalties for unauthorized duplication

Current through Register Vol. 54, No. 28, July 13, 2024
Subject to the penalties provided in sections 901 and 902
					 of the Vital Statistics Law of 1953 (35 P. S. §§
											450.901 and
					 450.902), no person may
					 photograph, photostat, duplicate or issue what purports to be a certified copy,
					 certification or certificate of birth, death or fetal death except for
					 authorized employes of the Department of Health or its local registrars of
					 vital statistics acting in accordance with directives, regulations or law
					 governing their official duties.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 1 - ADMINISTRATION OF VITAL RECORDS › MISCELLANEOUS PROVISIONS › Section 1.45 - Supplemental reports

Current through Register Vol. 54, No. 28, July 13, 2024
Information omitted from original certificates of birth,
					 death or fetal death may be added to the original certificate within 6 months
					 after the date of filing of the certificate.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 1 - ADMINISTRATION OF VITAL RECORDS › MISCELLANEOUS PROVISIONS › Section 1.46 - Fees for copies

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A fee of $4.00
				  shall be paid by the applicant for each certified copy and for each No-Record
				  Certification (NC-8) of a birth record issued to the applicant by the Division
				  of Vital Records.
(b) A fee of
				  $3.00 shall be paid by the applicant for each certified copy and for each
				  No-Record Certification (NC-8) of a death record issued to the applicant by the
				  Division of Vital Records.
(c) A
				  No-Record Certification shall be issued in each instance in which a thorough
				  search of the records reveals that the certificate requested by the applicant
				  is not on file with the Division of Vital Records.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 1 - ADMINISTRATION OF VITAL RECORDS › MISCELLANEOUS PROVISIONS › Section 1.47 - Burial permits

Current through Register Vol. 54, No. 28, July 13, 2024
No burial permit may be issued until the local registrar
					 has been satisfied that the funeral director has complied with this
					 chapter.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 1 - ADMINISTRATION OF VITAL RECORDS › MISCELLANEOUS PROVISIONS › Section 1.48 - Maximum fees payable to local registrar

Current through Register Vol. 54, No. 28, July 13, 2024
A local registrar may not receive an aggregate amount of
					 fees in excess of $20,000 in any one calendar year.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 1 - ADMINISTRATION OF VITAL RECORDS › MISCELLANEOUS PROVISIONS › Section 1.49 - Access by adoptees to identification of biological parents

Current through Register Vol. 54, No. 28, July 13, 2024
(a) As used in this
				  section, the term "biological parent" means natural parent as used in
				  23 Pa.C.S. §§
											2101-2910 (relating to the Adoption
				  Act).
(b) A biological parent may
				  consent to the disclosure of his identity by filing a Biological Parent
				  Registration Identification Form with the Division of Vital Records. Each
				  biological parent shall complete a separate form and each form shall be
				  notarized. The Biological Parent Registration form is available from the
				  Division of Vital Records.
(c) A
				  biological parent may update his identifying information by filing an
				  additional Biological Parent Registration Form with the Division of Vital
				  Records.
(d) A biological parent
				  may withdraw his consent to the disclosure of identifying information by filing
				  a Withdrawal of Biological Parent Consent Form with the Division of Vital
				  Records. Each biological parent shall complete a separate form and each form
				  shall be notarized. The Withdrawal of Biological Parent Consent Form is
				  available from the Division of Vital Records.
(e) The Division of Vital Records will
				  release a biological parent's identifying information if the following
				  requirements are met:
(1) The information is
				  requested by an adoptee who is at least 18 years old or the information is
				  requested by the adoptive parent or legal guardian of an adoptee who is less
				  than 18 years old.
(2) A Biological
				  Parent Registration Form is on file with the Division of Vital
				  Records.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 4 - HEAD INJURY PROGRAM › Section 4.1 - Scope and purpose

Current through Register Vol. 54, No. 28, July 13, 2024
(a) This chapter
				establishes standards for the Department to administer the Fund.
(b) The Department will use the Fund to
				administer a head injury program, as set forth in this chapter, to pay for
				medical, rehabilitation and attendant care services for persons with traumatic
				brain injury.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 4 - HEAD INJURY PROGRAM › Section 4.3 - Services eligible for payment

Current through Register Vol. 54, No. 28, July 13, 2024
HIP will pay for the following:
(1) Assessments of applicants by
				providers.
(2) Development of
				rehabilitation service plans by providers.
(3) Rehabilitation services.
(4) Case management services.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 4 - HEAD INJURY PROGRAM › Section 4.4 - Requirements for provider participation

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Providers of residential, outpatient, day
				and home-based rehabilitation services shall be accredited by a National
				accrediting body as approved by the Department. From time to time, the
				Department will publish a list of approved National accrediting bodies in the
Pennsylvania Bulletin
.
(b) Providers shall provide rehabilitation
				services in accordance with their contractual agreements with the
				Department.
(c) Providers shall use
				forms and procedures as prescribed by the Division in the provision of
				rehabilitation services.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 4 - HEAD INJURY PROGRAM › Section 4.6 - Assessment

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Eligibility for assessment
. The Division will review an
				application for enrollment in HIP to determine whether the applicant is
				eligible for an assessment, as follows:
(1)
General criteria
. An applicant shall be eligible for an
				assessment only if all of the following requirements are met:
(i) The applicant sustained a TBI after July
				2, 1985.
(ii) The applicant is a
				citizen of the United States and was domiciled in this Commonwealth at the time
				of the injury and at the time of application for enrollment in HIP.
(iii) The applicant is 21 years of age or
				older.
(iv) The application is
				completed and is accompanied by the documentation that is requested to verify
				the applicant's satisfaction of the eligibility criteria in this
				subsection.
(v) The applicant's
				alternative financial resources are at or below 300% of the Federal Poverty
				Income Guidelines.
(A) The applicant's income
				will be assessed using the applicant's most recent Federal Income Tax form,
				which the applicant shall provide. If that form is unavailable, the Division
				may request other documentation of income. If the most recent Federal Income
				Tax form is not representative of the applicant's income at the time of
				application, the applicant may submit documents to that effect in support of
				the application.
(B) The applicant
				shall provide, on forms provided by the Division, information about any court
				award or financial settlement made or pending as a result of the TBI, and any
				other funds which are available to the applicant. If all or part of the award,
				settlement or other funds is unavailable to the applicant to use for HIP
				services, the applicant may submit documents to that effect in support of the
				application.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 4 - HEAD INJURY PROGRAM › Section 4.8 - Rehabilitation service plan

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Development of rehabilitation service plan
. The provider shall
				collaborate with the applicant or authorized representative, and may
				collaborate with other individuals identified by the applicant, to develop a
				rehabilitation service plan for the applicant.
(b)
Goal
. The primary goal
				of the rehabilitation service plan shall be to enable the client to progress to
				a higher level of functioning, which will, in turn, enable the client to
				transition to a less restrictive environment.
(c)
Requirements
. The
				initial rehabilitation service plan shall contain the following:
(1) A description of desirable goals and the
				anticipated outcomes in objective and measurable terms, including the expected
				time frames for the achievement of each goal and outcome, for the entire
				enrollment period.
(2) A
				specification of the HIP services necessary to attain the agreed-upon
				goals.
(3) A specification of any
				other services to which the applicant is entitled and a description of the
				impact of those services upon the attainment of the agreed-upon
				goals.
(4) Beginning and ending
				dates of each HIP service.
(5) The
				terms and conditions for HIP service delivery.
(6) The specific responsibilities of the
				applicant and service provider relative to implementation of each HIP
				service.
(7) The extent of
				financial responsibility of the applicant, HIP and any third party.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 4 - HEAD INJURY PROGRAM › Section 4.9 - Rehabilitation period

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Provision of rehabilitation services
. During the
				rehabilitation period a provider shall coordinate the provision of
				rehabilitation services to a client to ensure achievement of goals consistent
				with the rehabilitation service plan, and as appropriate to the needs of the
				client to improve the client's health, welfare and the realization of the
				client's maximum physical, social, cognitive, psychological and vocational
				potential for useful and productive activity.
(b)
Supervision
.
				Rehabilitation services shall be provided or their provision shall be
				supervised by a physician or other appropriate health professional qualified by
				training or experience to provide or supervise these services.
(c)
Purpose
. If authorized
				under the rehabilitation service plan, rehabilitation services may be provided
				for the following purposes:
(1) Helping a
				client develop behaviors that enable the client to take responsibility for the
				client's own actions.
(2)
				Facilitating a client's successful community integration.
(3) Assisting a client to accomplish
				functional outcomes at home and in the community.
(4) Teaching a client skills to live
				independently.
(5) Supervising a
				client living in a home setting through the following:
(i) Home facilitation.
(ii) Physical rehabilitation.
(iii) Cognitive remediation.
(iv) Life-skills coaching.
(v) Assisting the client in maintaining
				independence.
(6)
				Providing transitional living services to assist a client with community
				reentry skills.
(7) Maximizing a
				client's physical potential.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 4 - HEAD INJURY PROGRAM › Section 4.10 - Transition period

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Provision of case management services
. Following the
				rehabilitation period, HIP will provide case management services to assist the
				client in making the transition out of HIP.
(b)
Commencement of transition
				period
. The transition period will commence immediately following the
				end of the rehabilitation period.
(c)
Duration of transition
				period
. The transition period may not exceed 6 consecutive months, and
				shall end when the maximum funds available for allocation to the client are
				exhausted under §
									4.12 (relating to funding
				limits).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 4 - HEAD INJURY PROGRAM › Section 4.11 - Case management services

Current through Register Vol. 54, No. 28, July 13, 2024
Case management services shall be provided by a case manager
				  who has a minimum of 1 year of experience in TBI case management, and shall
				  include the following activities by the case manager:
(1) Monitoring the client's progress with
				respect to the rehabilitation service plan and collaborating with the client or
				authorized representative, the client's significant others and the rest of the
				treatment team in the development and modification of the rehabilitation
				service plan.
(2) Assisting the
				client in gaining access to services from which the client may benefit and for
				which the client may be eligible.
(3) Monitoring and evaluating the client's
				progress in transitioning to living in a home or community setting and ensuring
				that any necessary supports are in place, or facilitating placement of the
				client in a long-term care facility.
(4) Determining that the client has fully
				transitioned to the home or community or has been referred to the appropriate
				long-term care facility.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 4 - HEAD INJURY PROGRAM › Section 4.12 - Funding limits

Current through Register Vol. 54, No. 28, July 13, 2024
(a) HIP will
				provide no more than $100,000 for case management and rehabilitation services
				for a client during a rehabilitation period. This amount will be reduced by any
				client share of costs under §
									4.13(b) (relating
				to payment for HIP services).
(b)
				HIP will provide no more than $1,000 for case management services for a client
				during a transition period. This amount will be reduced by any client share of
				costs under § 4.13(b).
(c) The
				Division will notify an applicant of these maximum funding limits when it
				accepts the applicant as a client.
This section cited in 28 Pa. Code §
											4.7 (relating to enrollment); 28
					 Pa. Code §
											4.10 (relating to transition
					 period); and 28 Pa. Code §
											4.15 (relating to administrative
					 review).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 4 - HEAD INJURY PROGRAM › Section 4.13 - Payment for HIP services

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Written authorization
. The Division will provide written
				authorization, to the client and to the provider, as to HIP services for which
				the client is eligible and the maximum available funding and time limits for
				those services.
(b)
Client
				responsibility for payment
. If the Division determines that a client
				is responsible to pay for any part of HIP services, the client will be informed
				of that fact, and of the amount for which the client is responsible, as
				follows:
(1) The client shall be assessed a
				share of the cost of HIP based upon alternative financial resources between
				185% and 300% of the Federal Poverty Income Guidelines. The patient's share of
				the cost shall be determined using the Patient Share of Cost Table in Appendix
				A, as periodically updated and published in the
Pennsylvania
				Bulletin
.
(2) The client
				will be responsible to pay for HIP services up to the amount of alternative
				financial resources which exceed 300% of the Federal Poverty Income
				Guidelines.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 4 - HEAD INJURY PROGRAM › Section 4.14 - Peer review

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Purpose
. The Department will appoint a peer review committee
				to conduct a review of services and rehabilitation service plans for clients.
				The HIP Peer Review Committee (Committee) shall advise the Department on best
				practices to be followed in offering services to clients.
(b)
Procedures
.
(1) The Committee shall meet quarterly and
				review selected client charts, including charts for at least one client from
				each provider providing services at the time of the quarterly meeting, to
				evaluate the appropriateness of provision of services and client
				progress.
(2) Within 30 days after
				it completes its review, the Committee shall provide to the Department, in
				writing, recommendations regarding the provision of services by each
				provider.
(3) A member of the
				Committee may not participate in a review conducted by the Committee that
				presents a conflict of interest for that member. Examples of conflicts include,
				but are not limited to, participating in a review conducted by the Committee
				for one of the following:
(i) A service
				provided to a client of that member, that member's employer or that member's
				immediate family.
(ii) A service
				provided by a person who is in the immediate family of the member.
(4) The Division will notify the
				Committee of any actions taken on the recommendations of the
				Committee.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 4 - HEAD INJURY PROGRAM › Section 4.15 - Administrative review

Current through Register Vol. 54, No. 28, July 13, 2024
(a)
Reconsideration by Division
.
(1) An applicant, client or authorized
				representative may file with the Division a request for it to reconsider any of
				the following decisions made by the Division:
(i) An applicant is not eligible for an
				assessment.
(ii) An assessed
				applicant is not eligible for enrollment.
(iii) A disapproval or revision of a
				rehabilitation service plan.
(iv) A
				client is to be discharged from HIP prior to the date specified in the client's
				rehabilitation service plan.
(v)
				Alternative financial resources are available so that the client must pay for
				HIP services.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › GENERAL PROVISIONS › Section 5.1 - Definitions

Current through Register Vol. 54, No. 28, July 13, 2024
The following words and terms, when used in this chapter,
					 have the following meanings, unless the context clearly indicates
					 otherwise:
Act
-The Clinical Laboratory Act
					 (35
					 P. S. §§
											2151-2165).
Advisory committee
-A group of persons as
					 designated by the act who are experienced in the clinical laboratory field and
					 appointed by the Secretary for the purpose of advising the Secretary in matters
					 relating to the administration of the act. At least one member shall be
					 qualified in the discipline of anatomic pathology and one in clinical pathology
					 and licensed to practice medicine in this Commonwealth or eligible for
					 licensure, one shall be qualified in the field of clinical chemistry, and one
					 shall be qualified in the field of clinical microbiology.
Clinical Laboratories Improvement Act of 1967
					 (CLIA)
-Section 353 of the act of July 1, 1944, Pub. L. No.
					 90-174(42 U.S.C.A. §
											263), and the regulations which apply
					 thereto.
Clinical laboratory
-Clinical laboratory
					 includes the following:
(i) A place,
				  establishment or institution organized and operated primarily for the
				  performance of bacteriological, biochemical, microscopical, serological or
				  parasitological tests by the practical application of one or more of the
				  fundamental sciences to material originating from the human body, by the use of
				  specialized apparatus, equipment and methods, for the purpose of obtaining
				  scientific data which may be used as an aid to ascertain the state of health.
				  The term includes, but is not limited to, independent, hospital, industrial,
				  state, county and municipal laboratories and clinical laboratories operated in
				  private offices and clinics of practitioners of the healing arts.
(ii) The term does not apply to the office or
				  clinic of a licensed practitioner of the healing arts who performs only the
				  following procedures as part of his or her examinations of the patient to
				  obtain results which are essential for the immediate diagnosis and therapy of
				  the patient:
(A) Chemical examinations of
				  urine by "Dipstik" or tablet methods or both.
(B) Microscopic examination of urine
				  sediment.
(C) Pregnancy
				  tests.
(D) Red and white blood cell
				  counts.
(E) Sedimentation rate of
				  blood.
(F) Gram stain.
(G) Primary culturing for transmittal to a
				  licensed laboratory including pre-incubation, if required.
(H) Qualitative chemical examination of stool
				  specimens.
(I) Test for
				  pinworms.
(J) Test for Trichomonas
				  vaginalis.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › GENERAL PROVISIONS › Section 5.2 - Scope and exception

Current through Register Vol. 54, No. 28, July 13, 2024
This chapter is applicable to all clinical laboratories
					 operating within this Commonwealth except those specifically excluded under
					 section 13 of the act (35 P. S. §
											2163). A licensed laboratory approved to
					 perform tests for syphilis under the act is also an approved laboratory to
					 perform these tests under sections 12 and 13 of the Disease Prevention and
					 Control Act of 1955 (35 P. S. §§
											521.12
					 and 521.13).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › PERMITS › Section 5.11 - Permit, requirements, application and conditions

Current through Register Vol. 54, No. 28, July 13, 2024
(a) No person, organization or establishment
				  may operate a clinical laboratory in this Commonwealth without first obtaining
				  a permit from the Department.
(b)
				  Application for a permit to operate a clinical laboratory shall be made by the
				  director thereof on forms provided by the Department. The application shall be
				  accompanied by a filing fee of $25 payable to the Department; the fee will be
				  retained by the Department.
(c) The
				  application shall include the following information:
(1) The name and address of the owner or his
				  authorized agent and information regarding the owner as may be
				  required.
(2) The name and address
				  of the clinical laboratory director and other technical personnel to be
				  employed.
(3) Name and address of
				  the clinical laboratory for which the permit is requested and a description and
				  plan of the premises to be occupied for the operation of the
				  laboratory.
(4) A list of the major
				  laboratory equipment to be utilized, including the manufacturer's name and
				  model number, and other pertinent specifications as may be required on the
				  application form.
(5) The tests to
				  be performed in the clinical laboratory.
(6) The internal and external quality control
				  systems to be employed in the clinical laboratory.
(7) Answers to other questions required in
				  the completion of the application form provided by the Department.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › PERSONNEL › Section 5.21 - Qualifications of director

Current through Register Vol. 54, No. 28, July 13, 2024
(a) No person
				  shall be a director of a clinical laboratory unless he conforms with one of the
				  following requirements:
(1) He shall hold a
				  doctor of science degree or its equivalent in the basic sciences of chemistry,
				  biology or microbiology or a doctoral degree in public health, medicine,
				  osteopathy, pharmacy, dentistry or veterinary medicine from a college or
				  university recognized by the National Committee of Regional Accrediting
				  Agencies or the Department of Education of the Commonwealth of Pennsylvania,
				  and who has had 2 years' experience in a laboratory acceptable to the
				  Department or is certified by the American Board of Pathology, American
				  Osteopathic Board of Pathology, American Board of Microbiology, American Board
				  of Bioanalysis. American Board of Clinical Chemistry, or other national
				  accrediting board in laboratory specialties acceptable to the
				  Department.
(2) He shall hold a
				  master of science degree or its equivalent in the basic sciences from a college
				  or university recognized by the National Committee of Regional Accrediting
				  Agencies or the Department of Education of the Commonwealth, in chemistry,
				  biology or microbiology, and who has had a minimum of 4 years' experience in a
				  laboratory acceptable to the Department.
(3) He shall hold a bachelor of science
				  degree or its equivalent in the basic sciences from a college or university
				  recognized by the National Committee of Regional Accrediting Agencies or the
				  Department of Education, in chemistry, biology or microbiology, and who has had
				  a minimum of 5 years experience in laboratory work in a laboratory acceptable
				  to the Department.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › PERSONNEL › Section 5.22 - Responsibilities of owner and director

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The owner and director, jointly and
				  severally, shall be responsible for the proper maintenance and ethical
				  operation of the clinical laboratory and for any violations of these and other
				  existing provisions. The Department will be notified in writing within a 30-day
				  period of changes in the directors or general supervisor, and of all other
				  technical personnel changes on a 6-month basis. Significant changes in physical
				  facilities shall be reported to the Department within 30 days after initiation
				  of the changes.
(b) The owner shall
				  be responsible that the clinical laboratory is at all times under the direction
				  of a director acceptable to the Department as set forth in this section.
				  Whenever the designated director is to be on leave from his duties for more
				  than 30-calendar days, the registrant shall so notify the Department in advance
				  and shall designate, subject to approval of the Department, an interim director
				  of the laboratory.
(c) The owner
				  shall notify the Department in advance whenever the designated director is
				  expected to terminate his services with the laboratory. Permission may be
				  granted to continue operation of a clinical laboratory for not more than
				  6-calendar weeks under a general supervisor who does not meet the
				  qualifications of a director. In extenuating circumstances, permission to
				  operate longer without a permanent director may be granted subject to
				  conditions specified in writing by the Department.
(d) The owner and director shall, if
				  different persons, be jointly and severally responsible for the operation of
				  the clinical laboratory in compliance with this section and with other
				  pertinent regulatory and statutory requirements. They shall be responsible for
				  the employment of personnel meeting qualifications specified in this chapter.
				  They shall submit to the Department, on forms provided by the Department, an
				  annual report of the number and types of laboratory examinations performed
				  during the preceding year.
(e) The
				  director shall be responsible for the proper performance of all tests in the
				  laboratory. He shall direct and supervise such tests and be responsible for the
				  work of subordinates. He shall be responsible for the continuous application of
				  quality control procedures to the work in accordance with recommendations and
				  directives of the Department. Laboratory records of all work performed shall
				  indicate the name of the director, and be signed by or otherwise indicate the
				  person who actually performed the test.
(f) No person may act as a director of more
				  than two clinical laboratories.
(g)
				  A director shall be present for a reasonable period of each working day in each
				  laboratory for which he is director.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › PERSONNEL › Section 5.23 - Qualifications of a supervisor

Current through Register Vol. 54, No. 28, July 13, 2024
(a) No
				  person shall be a supervisor in a clinical laboratory unless he conforms with
				  one of the following requirements:
(1) He
				  shall have an earned doctoral degree from an accredited institution and shall
				  have gained at least 2 years' experience acceptable to the Department in one or
				  more of the applicable categories in the clinical laboratory.
(2) He shall hold a M.A. or M.S. degree from
				  an accredited institution with a major in medical technology or one of the
				  biological, physical or chemical sciences and shall have had at least 4 years'
				  experience acceptable to the Department in one or more of the applicable
				  categories in the clinical laboratory.
(3) He shall hold a B.S. or A.B. degree from
				  an accredited institution with a major in medical technology or one of the
				  biological, physical or chemical sciences and shall have had at least 6 years'
				  experience acceptable to the Department in one or more of the applicable
				  categories in the clinical laboratory.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › PERSONNEL › Section 5.24 - Qualifications of technical personnel

Current through Register Vol. 54, No. 28, July 13, 2024
(a) A
				  clinical laboratory technologist shall perform clinical laboratory tests with
				  minimal supervision by the director or supervisors, while working in those
				  areas in which he is qualified by education or experience. A clinical
				  laboratory technologist shall have the following qualifications:
(1) A baccalaureate degree in medical
				  technology or in a chemical, physical or biological science and clinical
				  education in a program accredited by an agency recognized by the Department
				  which includes 1 year of experience acceptable to the Department.
(2) An individual without the baccalaureate
				  degree may become qualified as a technologist according to the provisions of
				  section 241 of Title XI of the Social Security Amendments of 1972 Public Law
				  92-603(42 U.S.C.A. §
												1320a-2).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › PHYSICAL FACILITIES › Section 5.31 - Working space and lighting

Current through Register Vol. 54, No. 28, July 13, 2024
Working space and lighting shall be adequate. Sufficient
					 equipment in good condition and in working order shall be available for the
					 tests performed. A preventive maintenance program for equipment shall be
					 maintained, and appropriate records kept. Adequate fire prevention and other
					 safety factors shall be present which meet applicable local building codes and
					 ordinances.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › PHYSICAL FACILITIES › Section 5.32 - Library

Current through Register Vol. 54, No. 28, July 13, 2024
A current library of books and journals shall be available
					 to the director and other personnel to enable them to keep informed of advances
					 in laboratory medicine. Approved procedural manuals for the work performed
					 shall be immediately available to technical personnel in the laboratory working
					 area.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › PROCEDURES › Section 5.41 - Acceptance and collection of specimens

Current through Register Vol. 54, No. 28, July 13, 2024
(a) Specimens shall be accepted or collected
				  from patients by a clinical laboratory only when tests are requested on the
				  specimens by a member of the healing arts licensed to practice in this
				  Commonwealth, or other persons authorized by statute, or authorized agents of
				  the foregoing.
(b) No specimen
				  shall be collected by an owner, an employe or other person associated with the
				  clinical laboratory except under one of the following conditions:
(1) The person is a member of the healing
				  arts licensed in this Commonwealth or a laboratory director qualified under the
				  Clinical Laboratory Act of 1951 (P. L. 1539) (35 P. S. §
												2151 et seq.).
(2) The person is collecting the specimen
				  under the direction of a member of the healing arts licensed in this
				  Commonwealth or a laboratory director qualified under the Clinical Laboratory
				  Act.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › PROCEDURES › Section 5.42 - Transportation of specimens

Current through Register Vol. 54, No. 28, July 13, 2024
Procedures used for transporting specimens from collection
					 points to the testing facilities of the clinical laboratory shall be such that
					 the physical integrity and composition of the specimen remain intact, and
					 changes do not occur in the specimen which will interfere with the validity of
					 subsequent results. This includes factors of time, temperature and other
					 environmental factors which are critical to the preservation of the
					 specimen.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › PROCEDURES › Section 5.43 - Identification of specimens

Current through Register Vol. 54, No. 28, July 13, 2024
Every specimen received for testing shall be numbered,
					 listed in an accession book or otherwise marked so that it may be identified
					 definitely and related to the patient, and the submitting member of the healing
					 arts or the referring laboratory. An appropriate dated record of its receipt,
					 disposition and examination, findings obtained, and charges assigned shall be
					 made and kept on file for the minimum period required by statute. The records
					 shall be available for inspection by authorized representatives of the
					 Department.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › PROCEDURES › Section 5.44 - Examination of specimens

Current through Register Vol. 54, No. 28, July 13, 2024
(a) No specimen
				  shall be examined if unsuitable for testing because of improper collection,
				  improper preservation, apparent spoilage, excessive time lapse between
				  collection and examination, when applicable, or other reason sufficient to
				  render the findings of doubtful validity.
(b) No specimen of excised tissue shall be
				  subjected to pathological examination except by a person qualified in the field
				  of anatomic pathology. No specimen of exfoliated tissue or cells shall be
				  examined except under the supervision and review of a person qualified in
				  cytopathology. Ten percent of negative cytology preparations and positive or
				  suspicious preparations shall be reviewed by a person qualified in
				  cytopathology. Technical procedures employed in a laboratory shall be the
				  standard procedures which are generally accepted and approved by the
				  Department. Proof that procedures varying from those commonly employed in
				  laboratory practice are accurate may be required by the Department.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › PROCEDURES › Section 5.45 - Onsite testing

Current through Register Vol. 54, No. 28, July 13, 2024
A clinical laboratory shall be prepared during the normal
					 working hours to accept, perform and report promptly on specimens submitted by
					 the Department for purpose of testing the adequacy and accuracy of its
					 procedures.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › PROCEDURES › Section 5.46 - Reagents and equipment

Current through Register Vol. 54, No. 28, July 13, 2024
Reagents, procedures or equipment which have been
					 demonstrated to be inadequate for clinical laboratory use as evidenced by
					 reliable data from generally acceptable scientific testing and evaluating
					 sources shall be prohibited for use by clinical laboratories upon specific
					 notification by the Department. Also, reagents, equipment and procedures which
					 do not have substantial proof of efficacy either by trial or extended use
					 experience shall be prohibited for routine use.
This section cited in 28 Pa. Code §
												5.103 (relating to blood tests for
						blood alcohol content).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › PROCEDURES › Section 5.47 - Report of findings

Current through Register Vol. 54, No. 28, July 13, 2024
Reports of clinical laboratory findings shall be made only
					 to the person submitting the specimen or requesting the analysis, or his
					 authorized agent. Nothing in this section shall prohibit the issuance of
					 reports of clinical laboratory findings to town, city, borough or Commonwealth
					 health officials as required by statute or the inspection or impounding of
					 records of the reports by an authorized representative of the
					 Department.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › PROCEDURES › Section 5.48 - Disclosure of charges

Current through Register Vol. 54, No. 28, July 13, 2024
A notification of charges for laboratory tests performed
					 for the patient shall be sent to the patient by the clinical laboratory unless
					 the patient has been billed directly or otherwise notified of the charges by
					 the laboratory.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › PROCEDURES › Section 5.49 - Reportable diseases

Current through Register Vol. 54, No. 28, July 13, 2024
The director of a clinical laboratory shall report to the
					 Department all laboratory findings which indicate the presumptive presence of
					 any disease required to be reported by the provisions set forth in §
										27.22 (relating to reporting of
					 cases by clinical laboratories), or as required by other statutes or
					 regulations of the Commonwealth or by Federal statutes.
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › PROCEDURES › Section 5.50 - Approval to provide special analytical services

Current through Register Vol. 54, No. 28, July 13, 2024
(a) The Department will approve qualified
				  laboratories to perform certain specialized laboratory services. The
				  Department's Bureau of Laboratories will, from time to time, establish
				  prerequisite requirements for admission to approval programs based on an
				  evaluation of the personnel, equipment and procedures employed in the applicant
				  laboratory. After the prerequisite requirements are satisfied, admission to
				  approval programs will require demonstration of acceptable capability in the
				  analysis of test samples. Continued approved status will require satisfactory
				  performance in periodic evaluations conducted to monitor the reliability of
				  participating laboratories.
(b)
				  Lists of laboratories approved under this section to provide special analytical
				  services will be prepared semiannually and will contain the names, addresses
				  and directors of the facilities. Only approved facilities are permitted to
				  offer the specified determinations to clients in this Commonwealth. If an
				  approval is revoked or limited for reasons of unsatisfactory performance,
				  reinstatement of approval will require demonstration of proficiency over a
				  testing period not to exceed 6 months.
This section cited in 7 Pa. Code §
												203.73 (relating to testing); 7
						Pa. Code §
												203.74 (relating to test results);
						28 Pa. Code §
												5.102 (relating to equipment and
						methods for laboratory analysis of breath samples); 28 Pa. Code §
												5.103 (relating to blood tests for
						blood alcohol content); 58 Pa. Code §
												15.1 (relating to definitions); 58
						Pa. Code §
												188.3 (relating to testing); and
						58 Pa. Code §
												188.4 (relating to test
						results).
Pennsylvania Code › Title 28 - HEALTH AND SAFETY › Part I - General Health › Chapter 5 - CLINICAL LABORATORIES › RECORDS › Section 5.51 - Retention of reports

Current through Register Vol. 54, No. 28, July 13, 2024
Each clinical laboratory shall keep a record of the results
					 of tests performed on each specimen. In cases in which the clinical laboratory
					 is part of a hospital, the permanent laboratory record may be a part of the
					 patient's medical record.