Introduced by Representative Howrigan of Fairfield

BILL AS INTRODUCEDH.71

2001Page 1

H.71

Introduced by Representative Howrigan of Fairfield

Referred to Committee on

Date:

Subject:Health and welfare; profession and occupations; clinical laboratories; clinical laboratory personnel licensure

Statement of purpose: This bill proposes to establish a system for licensing clinical laboratories operating in Vermont and clinical laboratory personnel.

AN ACT RELATING TO LICENSURE OF CLINICAL LABORATORIES AND CLINICAL LABORATORY PERSONNEL

It is hereby enacted by the General Assembly of the State of Vermont:

Sec. 1. 18 V.S.A. chapter 58 is added to read:

CHAPTER 58. LICENSING OF CLINICAL LABORATORIES

§ 2511. DEFINITIONS

As used in this chapter:

(1) “Clinical laboratory” means a laboratory where examinations are performed on materials or specimens taken from the human body to provide information or materials for use in the diagnosis, prevention or treatment of a disease or the assessment of a medical condition.

(2) “Clinical laboratory proficiency testing program” means a program approved by the agency for evaluating the performance of clinical laboratories.

(3) “Collection station” or “branch office” means a facility operated by a clinical laboratory where materials or specimens are withdrawn or collected from patients or assembled after being withdrawn or collected from patients elsewhere, for subsequent delivery to another location for examination.

(4) “Department” means the department of health.

(5) “Hospital laboratory” means a laboratory located in a hospital licensed under chapter 43 of this title that provides services solely to that hospital and that is owned by the hospital and governed by the hospital medical staff or governing board.

(6) “Licensed practitioner” means a physician licensed under chapter 23 or chapter 33 of this title, a dentist licensed under chapter 13 of this title, or a nurse practitioner licensed under chapter 28 of this title.

(7) “Validation inspection” means an inspection of a clinical laboratory by the department to assess whether a review by an accrediting organization has adequately evaluated the clinical laboratory according to state standards.

(8) “Waived test” means a test that the federal Health Care Financing Administration has determined qualifies for a certificate of waiver under the federal Clinical Laboratory Improvement Amendments of 1988, and the federal rules adopted under that act.

§ 2512. LICENSE REQUIRED

(a) A person may not conduct, maintain or operate a clinical laboratory in this state, except a laboratory that is exempt under section 2514 of this title, unless the clinical laboratory has obtained a license from the department.

(b) A clinical laboratory may not send a specimen drawn within this state to any clinical laboratory outside the state for examination unless the outofstate laboratory has obtained a license from the department.

(c) A license is valid only for the person to whom it is issued and may not be sold, assigned or transferred, voluntarily or involuntarily, and is not valid for any premises other than those for which the license is issued. A separate license is required of all laboratories maintained on separate premises even if the laboratories are operated under the same management. However, a new license may be secured for the new location before the actual change, if the contemplated change complies with this chapter and the rules adopted under this chapter.

(d) Application for a new clinical laboratory license must be made 60 days before a change in the ownership of the clinical laboratory.

§ 2513. CLINICAL LABORATORIES OPERATED BY PRACTITIONERS FOR EXCLUSIVE USE OF OWN PATIENTS

(a) A clinical laboratory operated by one or more licensed practitioners, exclusively in connection with the diagnosis and treatment of their own patients, must be licensed under this chapter and must comply with the provisions of this chapter, except that the department shall adopt rules for staffing, proficiency testing and construction standards relating to the licensure and operation of the laboratory based upon, and not exceeding, the same standards contained in the federal Clinical Laboratory Improvement Amendments of 1988 and the federal regulations adopted under that act.

(b) Subsection (a) of this section does not apply to a clinical laboratory operated by one or more practitioners who hold the facilities of the laboratory out as available for the performance of diagnostic tests for other practitioners or their patients. All provisions of this chapter apply to a clinical laboratory that receives any referred work or performs any work for patients referred by another practitioner.

§ 2514. EXEMPTIONS

This chapter applies to all clinical laboratories within this state, except:

(1) A clinical laboratory operated by the United States government.

(2) A clinical laboratory that performs only waived tests, and has received a certificate of exemption from the department under section 2517 of this title.

(3) A clinical laboratory operated and maintained exclusively for research and teaching purposes that does not involve patient or public health services.

§ 2515. POWERS AND DUTIES OF THE DEPARTMENT; RULES

(a) The department shall adopt rules to implement this chapter, including rules related to the following:

(1) Biennial renewal of licenses granted under this chapter and the qualifications necessary for renewal. A license issued under this chapter, unless sooner suspended or revoked, expires on the date set forth by the department on the face of the license.

(2) Overall standards of performance that comply with the federal Clinical Laboratory Improvement Amendments of 1988, and the federal rules adopted thereunder, for a comprehensive quality assurance program. The purpose of the quality assurance program is to monitor and evaluate the ongoing and overall quality of a laboratory’s total testing process.

(3) Standards of performance in the examination of specimens for clinical laboratory proficiency testing programs using external quality control procedures. As part of a clinical laboratory proficiency testing program, clinical laboratory personnel may be required to analyze test samples and report on the results of such analyses. The department may accept proficiency testing reports of organizations approved by the department, if the department finds that the standards of such organizations are equal to or exceed those of the department. The department shall establish, by rule, criteria for satisfactory performance for a clinical laboratory that participates in an approved proficiency testing program.

(4) Requirements for collecting, transporting, handling and storing specimens shipped by common carrier from clinical laboratories or collection stations. Each specimen shall be sent to a laboratory for analysis as rapidly as possible, but no later than 12 hours after collection unless appropriate measures are taken to preserve the specimen, provided that this 12-hour requirement does not apply to blood banks or to plasmapheresis centers in shipping samples. Specimens may be sent to any out-of-state clinical laboratory for examination if the laboratory holds a current license issued by the department. When the specimen has been referred for examination to another laboratory, the report must include a clear statement that such findings were obtained in another laboratory, and must specify its name and location.

(5) Standards for the construction, renovation, maintenance and repair of clinical laboratories, including standards for plumbing, heating, lighting, ventilation, electrical services and similar conditions, designed to ensure that laboratories will be operated in a manner that will protect the public health.

(6) Establish standards relating to safety and sanitary conditions within a clinical laboratory and its surroundings, including standards for water supply, sewage, the handling of specimens, the identification, segregation and separation of biohazardous wastes, storage of chemicals, workspace, fire safety and general measures that will protect the public health.

(7) Minimum standards for clinical laboratory equipment essential to its proper operation, its calibration and its adequacy for testing procedures.

(8) Standards for patient test management, including requirements for record retention and patient test reporting.

(9) In consultation with the director of the office of professional regulation and the advisors appointed under section 4504 of Title 26, the criteria for alternate-site testing to be performed under the supervision of a clinical laboratory director. The elements addressed in the rule shall include: a hospital internal needs assessment; a protocol of implementation, including tests to be performed and who will perform the tests; criteria to be used in selecting the method of testing to be used for alternate-site testing; minimum training and education requirements for those who will perform alternate-site testing, such as documented training, licensure, certification or other medical professional background not limited to laboratory professionals; documented in-service training as well as initial and ongoing competency validation; an appropriate internal and external quality control protocol; an internal mechanism for identifying and tracking alternate-site testing by the central laboratory; and recordkeeping requirements. Alternate-site testing locations shall register when the clinical laboratory applies to renew its license. For purposes of this subdivision, the term “alternate-site testing” means any laboratory testing done under the administrative control of a hospital, but performed out of the physical or administrative confines of the central laboratory.

(b)(1) The department shall require that each clinical laboratory adopt and maintain a written policy and procedure manual that must address, but not be limited to:

(A) The performance of all analytical methods used by the clinical laboratory, including specimen collection and preservation.

(B) Instrument calibration.

(C) Quality control systems, measures and remedial actions.

(D) Equipment performance evaluations.

(E) Test performance.

(F) Maintenance and filing of required records and reports.

(G) Channels of communication.

(H) Space, equipment and supply requirements.

(2) The policy and procedure manual must be readily available to laboratory personnel and must be followed by laboratory personnel.

(c) The department shall:

(1) License clinical laboratories that comply with the requirements of this chapter.

(2) Discipline licensees.

(d) The department of health may establish a technical advisory panel to assist the department in the development of rules to be adopted under this chapter. This advisory input should be sought to expand public participation in department decisions and to draw on the expertise of representatives from the various segments of health care which have an interest in laboratory procedures.

§ 2516. APPLICATION FOR CLINICAL LABORATORY LICENSE

(a) The owner or operator of the clinical laboratory or the public official responsible for operating a public clinical laboratory or institution that contains a clinical laboratory may apply to the department for a license under this chapter. Applications shall be upon forms provided by the department, accompanied by the required fee.

(b) Upon receipt of a request for an application for a clinical laboratory license, the department shall provide the applicant with a copy of the rules relating to licensure and operations applicable to the laboratory for which licensure is sought.

§ 2517. APPLICATION FOR EXEMPTION

An application for a certificate of exemption must be made by the owner or operator of a clinical laboratory that performs only waived tests as defined in section 2511 of this chapter. A certificate of exemption authorizes a clinical laboratory to perform waived tests. Laboratories maintained on separate premises and operated under the same management may apply for a single certificate of exemption or multiple certificates of exemption. The department shall, by rule, specify the process for biennial renewal of certificates of exemption. Sections 2514, 2520, 2521, 2526 and 2527 of this title apply to a clinical laboratory that obtains a certificate of exemption under this section.

§ 2518. LIMITATIONS ON LICENSURE

A license may be issued to a clinical laboratory to perform only those clinical laboratory procedures and tests that are within the specialties or subspecialties in which the clinical laboratory personnel are qualified. A license may not be issued unless the department determines that the clinical laboratory is adequately staffed and equipped to operate in conformity with the requirements of this chapter and the rules adopted under this chapter.

§ 2519. DISPLAY OF LICENSES

A clinical laboratory license shall specify, on its face, the names of the owner or operator and directors of the laboratory, the procedures, specialties or subspecialties authorized, the period for which it is valid and the location at which such procedures must be performed. The clinical laboratory license and the licenses of all personnel in the laboratory must be displayed at all times in a prominent place in the clinical laboratory where the licenses may be viewed by the public.

§ 2520. FEES

(a) Applicants and licensees shall pay the following fees:

(1) Application$100.00.

(2) Biennial renewal:

(A) If a laboratory performs not more

than 2,000 tests annually$400.00.

(B) If a laboratory performs not more

than three categories of procedures

with a total annual volume of more

than 2,000 but not more than 10,000 tests$965.00.

(C) If a laboratory performs at least four

categories of procedures with a total

annual volume of not more than 10,000 tests$1,294.00.

(D) If a laboratory performs not more than

three categories of procedures with a total

annual volume of more than 10,000 but not

more than 25,000 tests$1,592.00.

(E) If a laboratory performs at least four

categories of procedures with a total annual

volume of more than 10,000 but not more

than 25,000 tests$2,103.00.

(F) If a laboratory performs a total of more

than 25,000 but not more than 50,000

tests annually$2,364.00.

(G) If a laboratory performs a total of more

than 50,000 but not more than 75,000

tests annually$2,625.00.

(H) If a laboratory performs a total of more

than 75,000 but not more than 100,000

tests annually$2,886.00.

(I) If a laboratory performs a total of more

than 100,000 but not more than 500,000

tests annually$3,397.00.

(J) If a laboratory performs a total of more

than 500,000 but not more than one million

tests annually$3,658.00.

(K) If a laboratory performs a total of more

than one million tests annually$3,919.00.

(b) The department shall assess a biennial renewal fee of $100.00 for a certificate of exemption and a $100.00 license fee for facilities surveyed by an approved accrediting organization.

(c) Until the department is granted state exemption status by the Health Care Financing Administration, laboratories that are licensed under the Clinical Laboratory Improvement Amendments of 1988 may not be assessed the fees specified in subsections (a) and (b) of this section by the department. During that period, a fee shall be assessed to those laboratories to cover the cost of state activities beyond those required under the Clinical Laboratory Improvement Amendments of 1988. This fee is $100.00 biennially.

(d) The department shall assess an inspection fee which shall be in an amount sufficient to cover the costs of conducting the inspection.

§ 2521. ACCEPTANCE, COLLECTION, IDENTIFICATION AND EXAMINATION OF SPECIMENS

(a) A clinical laboratory may examine human specimens at the request only of a licensed practitioner or other person authorized by law to use the findings of clinical laboratory examinations. An individual forwarding a sample of the individual’s own blood to a clinical laboratory, when such blood sample has been taken pursuant to a home access HIV test kit approved by the U. S. Food and Drug Administration, shall be considered a person authorized to request and use a clinical laboratory test for human immunodeficiency virus, for the purposes of this chapter.

(b) The results of a test must be reported directly to the licensed practitioner or other authorized person who requested it. The report must include the name and address of the clinical laboratory in which the test was actually performed, unless the test was performed in a hospital laboratory and the report becomes an integral part of the hospital record.

(c) The results of clinical laboratory tests performed by a clinical laboratory complying with this chapter and performed before a patient’s admission to a facility licensed under chapter 43 of this title shall be accepted in lieu of clinical laboratory tests required upon a patient’s admission to the facility and in lieu of tests that may be ordered for patients of the facility, except that the facility may not be required to accept transfusion compatibility test results. The department shall establish, by rule, standards for accepting laboratory test results to specify acceptable time frames for such laboratory tests to assure that the time frames do not adversely affect the accuracy of the test.

(d) All specimens accepted by a clinical laboratory must be tested on the premises, except that specimens for infrequently performed tests may be forwarded for examination to another clinical laboratory approved under this chapter. This subsection does not prohibit referring specimens to a clinical laboratory exempt under section 2514 of this title. However, the clinical laboratory director of the referring clinical laboratory must assume complete responsibility.

§ 2522. BRANCH OFFICES; REPRESENTATION OF OTHER LABORATORIES

A person may not represent or maintain an office or specimen collection station or other facility for the representation of any clinical laboratory situated in this state or any other state which makes examinations in connection with the diagnosis and control of diseases unless the clinical laboratory meets or exceeds the minimum standards of the department and the rules adopted under this chapter.

§ 2523. INSPECTION OF CLINICAL LABORATORIES

(a) The department shall ensure that each clinical laboratory, collection station and branch office subject to this chapter is inspected when deemed necessary by the department, but at least every two years, for the purpose of evaluating the premises, operation, supervision and procedures of the facility to ensure compliance with this chapter. The department may conduct or cause to be conducted the following announced or unannounced inspections at any reasonable time:

(1) An inspection conducted at the direction of the federal Health Care Financing Administration.

(2) A licensure inspection.

(3) A validation inspection.

(4) A complaint investigation, including a full licensure investigation with a review of all licensure standards as outlined in rule. Complaints received by the department from individuals, organizations or other sources are subject to review and investigation by the department. If a complaint has been filed against a laboratory or if a laboratory has a substantial licensure deficiency, the department may inspect the laboratory annually or as often as the department considers necessary. However, for laboratories operated under section 2513 of this title, biennial licensure inspections shall be scheduled so as to cause the least disruption to the practitioner’s scheduled patients.