House File 508 - Introduced
HOUSE FILE
BY MASCHER
Passed House, Date Passed Senate, Date
Vote: Ayes Nays Vote: Ayes Nays
Approved
A BILL FOR
1 An Act relating to the licensure of clinical laboratories and
2 imposing penalties.
3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
4 TLSB 2324HH 81
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PAG LIN
1 1 Section 1. NEW SECTION. 135M.1 TITLE.
1 2 This chapter shall be known and may be cited as the "Iowa
1 3 Clinical Laboratory Law".
1 4 Sec. 2. NEW SECTION. 135M.2 APPLICATION OF CHAPTER ==
1 5 EXEMPTIONS.
1 6 This chapter applies to all clinical laboratories within
1 7 this state, except all of the following:
1 8 1. A clinical laboratory operated by the United States
1 9 government.
1 10 2. A clinical laboratory that performs only waived tests
1 11 and has received a certificate of exemption from the
1 12 department under section 135M.11.
1 13 3. A clinical laboratory operated and maintained
1 14 exclusively for research and teaching purposes that do not
1 15 involve patient or public health service.
1 16 Sec. 3. NEW SECTION. 135M.3 CLINICAL LABORATORIES
1 17 OPERATED BY PRACTITIONERS FOR EXCLUSIVE USE == LICENSURE AND
1 18 REGULATION.
1 19 1. A clinical laboratory operated by one or more
1 20 practitioners licensed under chapter 148, 149, 150, 150A, 151,
1 21 152, or 153, exclusively in connection with the diagnosis and
1 22 treatment of their own patients, shall be licensed under this
1 23 chapter and shall comply with the provisions of this chapter,
1 24 except that the department shall adopt rules for staffing;
1 25 personnel, including education and training of personnel;
1 26 proficiency testing; and construction standards relating to
1 27 the licensure and operation of the laboratory based upon and
1 28 not exceeding the standards contained in the Act as defined in
1 29 section 135M.4.
1 30 2. Subsection 1 does not apply to a clinical laboratory
1 31 operated by one or more practitioners who hold the facilities
1 32 of the laboratory out as available for the performance of
1 33 diagnostic tests for other practitioners or their patients.
1 34 3. This chapter applies to any clinical laboratory that
1 35 receives any referred work or performs any work for patients
2 1 referred by another practitioner.
2 2 Sec. 4. NEW SECTION. 135M.4 DEFINITIONS.
2 3 As used in this chapter, unless the context otherwise
2 4 requires:
2 5 1. "Act" means the federal Clinical Laboratory Improvement
2 6 Amendments of 1988, Pub. L. No. 100=578. "Act" includes the
2 7 federal regulations adopted pursuant to the Act.
2 8 2. "Clinical laboratory" means the physical location in
2 9 which one or more of the following services are performed to
2 10 provide information or materials for use in the diagnosis,
2 11 prevention, or treatment of a disease or the identification or
2 12 assessment of a medical or physical condition:
2 13 a. Anatomic laboratory services.
2 14 b. Clinical laboratory services.
2 15 c. Cytology laboratory services.
2 16 3. "Clinical laboratory examination" means a procedure
2 17 performed to deliver the services defined in subsection 2,
2 18 including the oversight or interpretation of such procedures.
2 19 4. "Clinical laboratory proficiency testing program" means
2 20 a program approved by the department for evaluating the
2 21 performance of clinical laboratories.
2 22 5. "Collection station" or "branch office" means a
2 23 facility operated by a clinical laboratory where materials or
2 24 specimens are withdrawn or collected from patients or
2 25 assembled after being withdrawn or collected from patients
2 26 elsewhere, for subsequent delivery to another location for
2 27 examination.
2 28 6. "Department" means the Iowa department of public
2 29 health.
2 30 7. "Hospital laboratory" means a laboratory located in a
2 31 hospital that provides services solely to that hospital and
2 32 that is owned by the hospital and governed by the hospital
2 33 medical staff or governing board.
2 34 8. "Licensed practitioner" means a physician licensed
2 35 under chapter 148, 148D, 150, or 150A; a podiatrist licensed
3 1 under chapter 149; a dentist licensed under chapter 153; a
3 2 chiropractor licensed under chapter 151; or an advanced
3 3 registered nurse practitioner licensed under chapter 152.
3 4 9. "Waived test" means a test that the federal health care
3 5 financing administration has determined qualifies for a
3 6 certificate of waiver under the federal Act.
3 7 Sec. 5. NEW SECTION. 135M.5 POWERS AND DUTIES OF
3 8 DEPARTMENT.
3 9 The department shall adopt rules as necessary to implement
3 10 this chapter. The rules shall include, but not be limited to,
3 11 all of the following:
3 12 1. LICENSING AND QUALIFICATIONS. The department shall
3 13 provide for biennial licensure of all clinical laboratories
3 14 meeting the requirements of this chapter and shall prescribe
3 15 the qualifications necessary for such licensure. A license
3 16 issued for operating a clinical laboratory, unless sooner
3 17 suspended or revoked, expires on the date set forth by the
3 18 department on the face of the license.
3 19 2. STANDARDS OF PERFORMANCE IN THE EXAMINATION OF
3 20 SPECIMENS. The department shall prescribe all of the
3 21 following:
3 22 a. Overall standards of performance that comply with the
3 23 Act, for a comprehensive quality assurance program.
3 24 b. Standards of performance in the examination of
3 25 specimens for clinical laboratory proficiency testing programs
3 26 using external quality control procedures.
3 27 3. SHIPMENT OF SPECIMENS. The department shall adopt
3 28 requirements for collecting, transporting, handling, and
3 29 storing specimens shipped by common carrier from clinical
3 30 laboratories or collection stations.
3 31 4. CONSTRUCTION OF CLINICAL LABORATORIES. A clinical
3 32 laboratory shall comply with all applicable local, county,
3 33 state, and federal standards for the construction, renovation,
3 34 maintenance, and repair of clinical laboratories, including
3 35 standards for plumbing, heating, lighting, ventilation, and
4 1 electrical services, and similar services.
4 2 5. SAFETY AND SANITARY CONDITIONS. The department shall
4 3 establish standards relating to safety and sanitary conditions
4 4 within a clinical laboratory and its surroundings, including
4 5 standards for water supply; sewage; handling of specimens;
4 6 identification, segregation, and separation of biohazardous
4 7 wastes; storage of chemicals; workspace; fire safety; and
4 8 general measures that will protect the public health.
4 9 6. EQUIPMENT. The department shall establish minimum
4 10 standards for clinical laboratory equipment essential to its
4 11 proper operation, its calibration, and its adequacy for
4 12 testing procedures.
4 13 7. POLICY AND PROCEDURE MANUAL. The department shall
4 14 require that each clinical laboratory adopt and maintain a
4 15 written policy and procedure manual. The manual shall be
4 16 readily available to laboratory personnel and shall be
4 17 followed by laboratory personnel. The manual shall address,
4 18 but not be limited to, the following topics:
4 19 a. The performance of all analytical methods used by the
4 20 clinical laboratory, including specimen collection and
4 21 preservation.
4 22 b. Instrument calibration.
4 23 c. Quality control systems, measures, and remedial
4 24 actions.
4 25 d. Equipment performance evaluations.
4 26 e. Test performance.
4 27 f. Maintenance and filing of required records and reports.
4 28 g. Channels of communication.
4 29 h. Space, equipment, and supply requirements.
4 30 8. STANDARDS FOR PATIENT TEST MANAGEMENT. The department
4 31 shall adopt rules that prescribe standards for patient test
4 32 management, including requirements for record retention and
4 33 patient test reporting.
4 34 9. ALTERNATE=SITE TESTING. The department shall adopt
4 35 rules for alternate=site testing to be performed under the
5 1 supervision of a clinical laboratory director.
5 2 Sec. 6. NEW SECTION. 135M.6 INSPECTION OF CLINICAL
5 3 LABORATORIES.
5 4 1. The department shall ensure that each clinical
5 5 laboratory subject to this chapter is inspected either onsite
5 6 or offsite as deemed necessary by the department. However,
5 7 each clinical laboratory shall be inspected at least every two
5 8 years, for the purpose of evaluating the operation,
5 9 supervision, and procedures of the facility to ensure
5 10 compliance with this chapter. Collection stations and branch
5 11 offices may be inspected either onsite or offsite, as deemed
5 12 necessary by the department. The department may conduct
5 13 announced or unannounced inspections at any reasonable time,
5 14 however, to the extent practicable inspections shall be
5 15 scheduled so as to cause the least disruption to the
5 16 practitioner's scheduled patients.
5 17 2. The department may accept, in lieu of its own periodic
5 18 inspections for licensure, the survey of or inspection by a
5 19 private accrediting organization which is approved by the
5 20 department, which performs inspections of clinical
5 21 laboratories accredited by such organization, including
5 22 postinspection requirements imposed by the department.
5 23 a. The department shall accept inspections performed by
5 24 such an organization if the accreditation is not provisional,
5 25 if such organization performs postinspection activities
5 26 required by the department and provides the department with
5 27 all necessary inspection and postinspection reports and
5 28 information necessary for enforcement, if such organization
5 29 applies standards equal to or exceeding standards established
5 30 and approved by the department, and if such accrediting
5 31 organization is approved by the federal centers for Medicare
5 32 and Medicaid services to perform such inspections.
5 33 b. The department may conduct complaint investigations
5 34 made against laboratories inspected by an accrediting
5 35 organization.
6 1 c. The department may conduct sample validation
6 2 inspections of laboratories inspected by an accrediting
6 3 organization to evaluate the accreditation process used by an
6 4 accrediting organization.
6 5 d. The department may conduct a full inspection of a
6 6 clinical laboratory if an accrediting survey has not been
6 7 conducted within the previous twenty=four months.
6 8 e. The department shall adopt criteria by rule for
6 9 accepting inspection and postinspection reports of an
6 10 accrediting organization in lieu of conducting a state
6 11 licensure inspection.
6 12 Sec. 7. NEW SECTION. 135M.7 CLINICAL LABORATORY LICENSE.
6 13 A person shall not conduct, maintain, or operate a clinical
6 14 laboratory in this state, except a laboratory that is exempt
6 15 under section 135M.2, unless the clinical laboratory has
6 16 obtained a license from the department. A clinical laboratory
6 17 shall not send a specimen drawn within this state to a
6 18 clinical laboratory located outside the state for examination
6 19 unless the out=of=state laboratory has obtained a license from
6 20 the department. A license is valid only for the person or
6 21 persons to whom it is issued and may not be sold, assigned, or
6 22 transferred, voluntarily or involuntarily, and is not valid
6 23 for any premises other than those for which the license is
6 24 issued. However, a new license may be secured for a new
6 25 location before the actual change in location if the
6 26 contemplated change complies with this chapter and the rules
6 27 adopted under this chapter. Application for a new clinical
6 28 laboratory license must be made sixty days before a change in
6 29 the ownership of the clinical laboratory.
6 30 Sec. 8. NEW SECTION. 135M.8 APPLICATION FOR LICENSE.
6 31 1. An application for a clinical laboratory license shall
6 32 be made by the owner or director of the clinical laboratory or
6 33 by the public official responsible for operating a state,
6 34 municipal, or county clinical laboratory or institution that
6 35 contains a clinical laboratory, upon forms provided by the
7 1 department.
7 2 2. An applicant for licensure shall comply with the
7 3 following requirements:
7 4 a. Upon receipt of a completed, signed, and dated
7 5 application, the department shall require a background check
7 6 of the managing director or other similarly titled individual
7 7 who is responsible for the daily operation of the laboratory
7 8 and of the financial officer, or other similarly titled
7 9 individual who is responsible for the financial operation of
7 10 the laboratory, including billings for patient services. The
7 11 department may require background screening of any other
7 12 individual who is an applicant if the department believes the
7 13 person has been convicted of a crime that relates to the
7 14 person's ability to work in a clinical laboratory.
7 15 b. An applicant shall submit to the department, with its
7 16 application, a description and explanation of any exclusions,
7 17 permanent suspensions, or terminations of the applicant from
7 18 the Medicare or Medicaid programs. Proof of compliance with
7 19 the requirements for disclosure of ownership and control
7 20 interests under the Medicare or Medicaid programs may be
7 21 accepted in lieu of this submission.
7 22 c. The department shall not grant a license to an
7 23 applicant if the applicant has been found guilty of any crime
7 24 which would relate to that applicant's ability to work in a
7 25 clinical laboratory.
7 26 Sec. 9. NEW SECTION. 135M.9 ISSUANCE AND DISPLAY OF
7 27 LICENSE.
7 28 1. A license is valid for a period of two years and shall
7 29 be issued to a clinical laboratory to perform only those
7 30 clinical laboratory procedures and tests that are within the
7 31 specialties or subspecialties in which the clinical laboratory
7 32 personnel are qualified. A license shall not be issued unless
7 33 the department determines that the clinical laboratory is
7 34 adequately staffed and equipped to operate in conformity with
7 35 the requirements of this chapter and the rules adopted under
8 1 this chapter.
8 2 2. A license shall be issued authorizing the performance
8 3 of one or more clinical laboratory procedures or one or more
8 4 tests in each specialty or subspecialty. A separate license
8 5 is required of all laboratories maintained on separate
8 6 premises even if the laboratories are operated under the same
8 7 management. Upon receipt of a request for an application for
8 8 a clinical laboratory license, the department shall provide to
8 9 the applicant a copy of the rules relating to licensure and
8 10 operations applicable to the laboratory for which licensure is
8 11 sought.
8 12 3. A license shall specify, on its face, the names of the
8 13 owner or operator and directors of the laboratory; the
8 14 procedures, specialties, or subspecialties authorized; the
8 15 period for which it is valid; and the location at which such
8 16 procedures may be performed. The clinical laboratory license
8 17 and the licenses of all personnel in the laboratory shall be
8 18 displayed at all times in a prominent place in the clinical
8 19 laboratory where the licenses may be viewed by the public.
8 20 Sec. 10. NEW SECTION. 135M.10 ADMINISTRATIVE PENALTIES
8 21 == LICENSE SANCTIONS == CONTESTED CASE HEARING.
8 22 1. The department may deny, suspend, revoke, limit, or
8 23 deny renewal of a license or impose an administrative fine,
8 24 not to exceed one thousand dollars per violation, for the
8 25 violation of any provision of this chapter or rules adopted
8 26 pursuant to this chapter. In determining the penalty to be
8 27 imposed, the following factors shall be considered:
8 28 a. The severity of the violation, including the
8 29 probability that death or serious harm to the health or safety
8 30 of any person will result or has resulted, the severity of the
8 31 actual or potential harm, and the extent to which the
8 32 provisions of this chapter were violated.
8 33 b. Actions taken by the licensee to correct the violation
8 34 or to remedy complaints.
8 35 c. Any previous violation by the licensee.
9 1 d. The financial benefit to the licensee of committing or
9 2 continuing the violation.
9 3 2. The department may take any action described in
9 4 subsection 1, based on grounds which have been adopted by
9 5 rule. Such grounds shall include, but not be limited to:
9 6 a. Making a fraudulent statement on an application for a
9 7 clinical laboratory license or any other document required by
9 8 the department.
9 9 b. Permitting unauthorized persons to perform technical
9 10 procedures or to issue reports.
9 11 c. Demonstrating incompetence or making consistent errors
9 12 in the performance of clinical laboratory examinations and
9 13 procedures or erroneous reporting.
9 14 d. Performing a test and rendering a report thereon to a
9 15 person not authorized by law to receive such services.
9 16 e. Knowingly having professional connection with or
9 17 knowingly lending the use of the name of the licensed clinical
9 18 laboratory or its director to an unlicensed clinical
9 19 laboratory.
9 20 f. Violating or aiding and abetting in the violation of
9 21 any provision of this chapter or the rules adopted under this
9 22 chapter.
9 23 g. Failing to file any report required by the provisions
9 24 of this chapter or the rules adopted under this chapter.
9 25 h. Reporting a test result for a clinical specimen if the
9 26 test was not performed on the clinical specimen.
9 27 i. Performing and reporting tests in a specialty or
9 28 subspecialty in which the laboratory is not licensed.
9 29 j. Knowingly advertising false services or credentials.
9 30 k. Failing to correct deficiencies within the time
9 31 required by the department.
9 32 3. Except as provided in section 17A.18A any action or
9 33 sanction imposed by the department shall be preceded by notice
9 34 and the opportunity for an evidentiary hearing as set out in
9 35 chapter 17A.
10 1 Sec. 11. NEW SECTION. 135M.11 APPLICATION FOR A
10 2 CERTIFICATE OF EXEMPTION.
10 3 An application for a certificate of exemption shall be made
10 4 by the owner or director of a clinical laboratory that
10 5 performs only waived tests. A certificate of exemption
10 6 authorizes a clinical laboratory to perform waived tests. A
10 7 laboratory maintained on a separate premises and operated
10 8 under the same management may apply for a single certificate
10 9 of exemption or multiple certificates of exemption. The
10 10 department shall, by rule, specify the process for biennially
10 11 issuing certificates of exemption.
10 12 Sec. 12. NEW SECTION. 135M.12 LICENSE FEES.
10 13 1. Each application for a license shall be accompanied by
10 14 the annual license fee prescribed by this section, subject to
10 15 refund to the applicant if the license is denied, which fee
10 16 shall be deposited in the general fund of the state.
10 17 2. The department shall establish a biennial license fee
10 18 schedule by rule. The fee schedule shall base the fee for
10 19 licensure on the number of tests annually performed by the
10 20 applicant and the fees shall be calculated to approximate the
10 21 actual cost of administering this chapter.
10 22 3. The department shall assess a biennial fee of one
10 23 hundred dollars for a certificate of exemption and a one
10 24 hundred dollar license fee for a facility inspected by an
10 25 approved accrediting organization.
10 26 Sec. 13. NEW SECTION. 135M.13 BRANCH OFFICES ==
10 27 REPRESENTATION OF OTHER LABORATORIES.
10 28 A person may not represent or maintain an office or
10 29 collection station or other facility for the representation of
10 30 any clinical laboratory situated in this state or any other
10 31 state which makes examinations in connection with the
10 32 diagnosis and control of diseases unless the clinical
10 33 laboratory meets or exceeds the minimum standards of the
10 34 department and the rules adopted under this chapter.
10 35 Sec. 14. NEW SECTION. 135M.14 CRIMINAL PENALTIES.
11 1 A person who violates a provision of this chapter is guilty
11 2 of a simple misdemeanor.
11 3 Sec. 15. NEW SECTION. 135M.15 REBATES PROHIBITED ==
11 4 PENALTIES.
11 5 1. A person shall not pay or receive any commission,
11 6 bonus, kickback, or rebate or engage in any split=fee
11 7 arrangement in any form whatsoever with any dialysis facility,
11 8 physician, surgeon, organization, department, or person,
11 9 either directly or indirectly, for patients referred to a
11 10 clinical laboratory licensed under this chapter.
11 11 2. The department shall adopt rules that assess
11 12 administrative penalties for acts prohibited by subsection 1.
11 13 In the case of a clinical laboratory, other entity, or
11 14 licensed practitioner licensed by the department, such
11 15 penalties may include any disciplinary action available to the
11 16 department under the appropriate licensing laws. In the case
11 17 of a person not licensed by the department, such penalties may
11 18 include any of the following:
11 19 a. A fine not to exceed one thousand dollars.
11 20 b. If applicable, a recommendation by the department to
11 21 the appropriate licensing board that disciplinary action be
11 22 taken.
11 23 Sec. 16. NEW SECTION. 135M.16 INJUNCTION.
11 24 The operation or maintenance of an unlicensed clinical
11 25 laboratory or the performance of any clinical laboratory
11 26 procedure or operation in violation of this chapter is
11 27 unlawful. The department, or the county attorney may, in
11 28 addition to other remedies provided in this chapter, bring an
11 29 action for an injunction to restrain such violation, or to
11 30 enjoin the future operation or maintenance of any such
11 31 clinical laboratory or the performance of any laboratory
11 32 procedure or operation in violation of this chapter, until
11 33 compliance with this chapter or the rules adopted pursuant to
11 34 this chapter has been demonstrated to the satisfaction of the
11 35 department.
12 1 Sec. 17. NEW SECTION. 135M.17 JUDICIAL REVIEW.
12 2 Judicial review of an action of the department may be
12 3 sought pursuant to the Iowa administrative procedure Act,
12 4 chapter 17A.
12 5 EXPLANATION
12 6 This bill requires the Iowa department of public health to
12 7 issue biennial licenses to clinical laboratories. The
12 8 requirements apply to facilities which examine tissue, fluids,
12 9 or cells in order to diagnose, prevent, or treat a disease or
12 10 to identify or assess a medical or physical condition. The
12 11 department is empowered to set standards for these
12 12 laboratories and make inspections to ensure compliance.
12 13 The bill also requires the department to set up a licensure
12 14 process for the evaluation of applicants, the issuance of
12 15 licenses, and the imposition of sanctions. Fees are to be set
12 16 by rule on a sliding scale based on the volume of business and
12 17 on the actual cost of administering the program. The bill
12 18 sets out a number of grounds for which license sanctions may
12 19 be imposed. Sanctions include a fine up to $1,000 or the
12 20 suspension or revocation of a license or the denial of an
12 21 initial license application or a renewal. Except in emergency
12 22 circumstances, these sanctions must be preceded by notice and
12 23 hearing.
12 24 Any violation of the provisions of the bill, or rules
12 25 adopted pursuant to the bill, is a simple misdemeanor. The
12 26 bill specifically prohibits fee splitting, rebates, or similar
12 27 activity. The department or any county attorney is empowered
12 28 to seek an injunction to halt any violation of these
12 29 provisions.
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