Clinical Laboratories in Hawaii

DO I NEED A CLIA CERTIFICATE OR HAWAII CLINICAL LAB PERMIT/LICENSE TO OPERATE A LABORATORY IN HAWAII?

A clinical laboratory in Hawaii that meets the definition below will need a CLIA certificate and MAY need a Hawaii Clinical Lab Permit Class I, Class II, or License.

A laboratory is defined as “any facility that examines human specimens in the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of health of, human beings.”  All laboratories in the United States and its territories must be certified under the Clinical Laboratory Improvement Amendment of 1988 (CLIA’88) passed by Congress on October 31, 1988.  CLIA applies to all entities, not just those billing for Medicare/ Medicaid, and includes entities that do not charge for their laboratory testing.  More information on obtaining CLIA certification is available on www.cms.gov/clia.

There are CLIA EXCEPTIONS. These labs do not need a CLIA certificate:

  1. A facility that only performs testing for forensic purposes, such as alcohol testing or drug testing for employment or sports activities.
  2. Laboratories certified by the Substance Abuse and Mental Health Services Administration (SAMSA) in which drug testing is performed which meets guidelines and regulations. However, all other testing is conducted by a SAMSA-certified laboratory is subject to CLIA.
  3. Research and teaching laboratories that test human specimens but do not report patient specific results for the diagnosis, prevention or treatment of an disease or impairment of, of the assessment of the health of individual patients
  4. Federal laboratories including U.S. Department of Defense laboratories.

 

TYPES OF CLIA CERTIFICATES

There are four types of CLIA certificates – waived, provider performed microscopy procedures (PPMP), compliance, accreditation – depending on the types of tests performed.  The US Federal Drug Administration (FDA) categories laboratory tests into 4 categories:  waived, provider performed microscopy procedures (PPMP), moderate complexity, and high complexity.  Lists of waived and PPMP tests are available on www.cms.gov/clia under “Categorization of Tests.”  Any tests not categorized by US FDA, such as lab developed tests, are considered high complexity tests.  The category of laboratory tests are also listed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm.

Laboratories performing only waived tests must apply for a CLIA Certificate of Waiver.

Laboratories performing only waived and/or provider performed microscopy procedures must apply for a CLIA Certificate of PPMP.

Laboratories performing moderate complexity or high complexity of lab tests must apply for a CLIA Certificate of Compliance or Certificate of Accreditation.

 

Applying for a CLIA Certificate of Waiver

  1. Complete a CLIA Application for Certification (CMS116)
  2. Complete a Disclosure of Ownership and Control Interest Statement (Form 1513)
  3. See below if you need a Hawaii Clinical Lab Permit*

 

Applying for a CLIA Certificate of Provider Performed Microscopy Procedures (PPMP)

  1. Complete a CLIA Application for Certification (CMS116) at
  2. Complete a Disclosure of Ownership and Control Interest Statement (Form 1513)
  3. Complete a Laboratory Personnel Report form (CMS 209) if performing waived and provider performed microscopy procedures.  Personnel performing PPMP must be licensed physicians, physician assistants, or nurse practitioners.  List the names of testing personnel (TP), Hawaii license #, and license expiration dates on the CMS 209 form.  Personnel performing waived tests do not need to be named on the CMS 209.
  4. See below if you need a Hawaii Clinical Lab Permit*

 

Applying for a CLIA Certificate of Compliance

  1. Complete a CLIA Application for Certification (CMS116)
  2. Complete a Disclosure of Ownership and Control Interest Statement (Form 1513)
  3. Complete a Laboratory Personnel Report form (CMS 209).  List the names of testing personnel (TP) performing moderate and/or high complexity tests only.  Personnel performing waived tests do not need to be named on the CMS 209.
  4. Documentation that the laboratory director, technical consultant/ technical supervisor, clinical consultant, general supervisor (for high complexity testing) and testing personnel meet CLIA Personnel Requirements for moderate or high complexity testing.  Personnel licensed in Hawaii as a clinical laboratory director, medical technologist, clinical laboratory specialist, medical laboratory technician, or cytotechnologist meet CLIA personnel requirements.
  5. Hawaii Test Menu form
  6. See below if you need a Hawaii Clinical Lab Permit or License*

 

MAIL ALL FORMS TO: Hawaii Department of Health, Office of Health Care Assurance CLIA Program, 601 Kamokila Blvd., Room 395, Kapolei, Hawaii 96707.

DO I NEED A HAWAII CLINICAL LAB PERMIT/ LICENSE IN ADDITION TO CLIA CERTIFICATION?

The following labs do not need a Hawaii Clinical Lab Permit or License. Hawaii Administrative Rules (HAR) 11-110.1 “Clinical Laboratories and Laboratory Personnel” do not apply to the following laboratories in Hawaii:

  1. All of the CLIA EXCEPTIONS listed previously.
  2. Physician office laboratories certified by CLIA in which the physician is the laboratory director and testing is performed exclusively on the laboratory director’s own patients.
  3. A laboratory certified under CLIA that performs laboratory testing for pulmonary function in a licensed medical facility
  4. A laboratory conducting any study of public health importance with the written approval of the director (of health).

 

PHYSICAN OFFICE LABS (POL) meeting the definition below do not need a Hawaii Clinical Lab Permit or License.

Physician office labs are defined in HAR 110.1-5 as “certified by CLIA pursuant to 42 CFR Part 493 subpart A and operated by a licensed physician at a stated location where clinical laboratory tests are performed exclusively for the physician’s own patients.  The licensed physician shall serve as the laboratory director for this laboratory. ..”

NON-PHYSICIAN OFFICE LABS (group practices, community clinics, FQHC, dialysis centers, skilled nursing facilities, hospitals, ambulatory surgery centers, home health agencies, dialysis centers, mobile test sites, independent labs) need a Hawaii Clinical Lab Permit or License.

Non-physician labs performing only waived tests must obtain a CLIA Certificate of Waiver and Hawaii Clinical Lab Permit Class I.  Submit:

  1. CLIA Application for Certification (CMS 116)
  2. Disclosure of Ownership and Control Interest Statement (Form 1513)
  3. Hawaii Department of Health Application for Clinical Lab Permit/License (OHCA 110.1)

 

Non-physician labs performing waived and/or PPMP must obtain a CLIA Certificate of Provider Performed Microscopy Procedures (PPMP) and Hawaii Clinical Lab Permit Class I.  Submit:

  1. CLIA Application for Certification (CMS 116)
  2. Disclosure of Ownership and Control Interest Statement (Form 1513)
  3. Department of Health Application for Clinical Lab Permit/License (OHCA 110.1)
  4. Laboratory Personnel Report (CMS 209).  Personnel performing PPMP must be licensed physicians, physician assistants, or nurse practitioners.  List the names of Laboratory Director (LD) and testing personnel (TP), their Hawaii license number, and license expiration dates on the CMS 209 form.  Personnel performing waived tests do not need to be named on the CMS 209.

 

Non-physician labs performing moderate complexity tests on a portable instrument in a licensed medical facility must obtain a CLIA Certificate of Compliance and Hawaii Clinical Lab Permit Class II.  Submit:

  1. CLIA Application for Certification (CMS116). Check “Certificate of Compliance”
  2. Disclosure of Ownership and Control Interest Statement (Form 1513)
  3. Department of Health Application for Clinical Lab Permit/ License (OHCA 110.1).  Check “Permit Class II.”
  4. Laboratory Personnel Report (CMS 209).  List the names of the Lab Director (D), Clinical Consultant (CC), Technical Consultant (TC), and testing personnel (TP).  Documentation that these personnel meet CLIA’s Personnel Requirements for moderate complexity testing.
  5. Hawaii Test Menu form

 

Non-physician labs performing moderate complexity on non-portable instruments or high complexity tests must obtain a CLIA Certificate of Compliance or Accreditation and Hawaii Clinical Lab License. Submit:

  1. CLIA Application for Certification (CMS116). Check “Certificate of Compliance” or “Certificate of Accreditation”
  2. Disclosure of Ownership and Control Interest Statement (Form 1513)
  3. Department of Health Application for Clinical Lab Permit/ License (OHCA 110.1). Check “License.”
  4. Laboratory Personnel Report (CMS 209). List the names of the Lab Director (D), Clinical Consultant (CC), Technical Consultant (TC)/ Technical Supervisor (TS), General Supervisor (GS) and Testing Personnel (TP). Documentation that these personnel meet CLIA’s Personnel Requirements for moderate/ high complexity testing. The Lab Director and Testing Personnel must be licensed in Hawaii as clinical laboratory personnel.
  5. Hawaii Test Menu form
  6. For a Certificate of Accreditation:  Documentation that the accrediting organization has accepted your application.

 

MAIL ALL FORMS TO:  Hawaii Department of Health, Office of Health Care Assurance CLIA Program, 601 Kamokila Blvd., Room 395, Kapolei, Hawaii 96707.

CLINICAL LABORATORY PERSONNEL LICENSURE

The Hawaii Department of Health State Laboratories Division licenses clinical laboratory directors, medical technologists, clinical laboratory specialists, medical laboratory technicians, and cytotechnologists.  Application forms and information are available at http://health.hawaii.gov/statelab/.  Licensed clinical lab personnel are required for labs applying for:

  1. CLIA Certificate of Compliance and Hawaii Clinical Lab License
  2. CLIA Certificate of Accreditation and Hawaii Clinical Lab License

 

ARE ON-SITE INSPECTIONS REQUIRED?

On-site surveys every 2 years are required to maintain a CLIA Certificate of Compliance or Accreditation.  The Hawaii Department of Health CLIA surveyor will inspect laboratories with a Certificate of Compliance.  These inspections are announced no more than two weeks in advance.

The accrediting organization will inspect laboratories with a Certificate of Accreditation according to their respective policies and procedures.

CLIA FEES and RENEWAL

Notices to pay CLIA fees for an initial CLIA certificate are mailed about 2 weeks after the CLIA application is accepted by our office.  Once paid, the biennial CLIA certificate is in effect for 2 years, starting from the date the application is accepted by our office.  See the CLIA Certificate Fee Schedule on www.cms.gov/clia and select “How to Apply for a CLIA Certificate.”  The lab can pay the fee by check or follow the instructions to pay on line printed on the notices.

Notices to renew a CLIA certificate are mailed to the facility one year before the current CLIA certificate expires.  The lab can pay by check or follow the instructions printed on the renewal notice to pay on-line.  The new CLIA certificate is mailed to the facility one month before the current certificate expires.

For CLIA Certificates of Compliance and Accreditation, two fees are required.  A compliance fee is billed about one year before the CLIA certificate expires, and must be paid before an onsite survey can take place.  When the onsite survey is completed and finds the laboratory in compliance with CLIA requirements, the lab receives a bill for a certificate fee.  When this certificate fee is paid, a new CLIA certificate is sent to the laboratory.

HAWAII CLINICAL LAB PERMIT OR LICENSE FEES

There are state licensing fees for the Hawaii Clinical Lab Permit Class I, Class II, or License.  Licensing fees are contained in Chapter 11-103-6 Licensure and Certification Fees for Health Care Facilities and Agencies, Hawaii Administrative Rules.  In addition, the laboratory must have paid all required CLIA fees to maintain their CLIA certificate.

Initial and renewal application forms are available on this website and should be mailed to:

State of Hawaii
Department of Health
Office of Health Care Assurance
601 Kamokila Boulevard, Room 395
Kapolei, Hawaii 96707

COLLECTING DEPOTS

CLIA certified laboratories can operate a collecting depot in Hawaii, when specimens for testing are collected and sent to a clinical laboratory at another location for testing.  Collecting depots must obtain written approval from the Hawaii Dept. of Health Office of Health Care Assurance CLIA Program by sending a letter stating the date, hours (if a temporary site), and address of the collecting depot to the Hawaii Department of Health, Office of Health Care Assurance CLIA Program, 601 Kamokila Blvd., Room 395, Kapolei, Hawaii 96707.

FORMS

CMS 116 Application for CLIA Certification:  https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms116.pdf

CMS 209 Laboratory Personnel Report:  https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS209.pdf

Form 1513 Disclosure of Ownership and Control Interest Statement

OHCA 110.1 Application for Hawaii Clinical Lab Permit or License

List of Possible Laboratory Consultants

Hawaii Test Menu

OHCA 110.1 Renewal for Hawaii Clinical Lab Permit or License