Genetic Testing

Ongoing advances in genetic testing and associated regulations frequently require additional patient information and documentation of the patient’s consent.  In many cases, prior authorization is required by health insurance providers before testing can be performed; otherwise, the costs associated with testing may not be fully covered.

If the required information is not provided at the time of specimen submission, Cleveland Clinic Laboratories will contact the submitting facility to obtain the documentation before forwarding the specimen to the testing laboratory.

Health and Human Services (HHS) / Office of Inspector General (OIG) Compliance

Cleveland Clinic Laboratories is committed to complete and accurate billing for all services provided to patients. Our organization actively participates in a comprehensive compliance plan that follows the regulations set forth as outlined by the Office of Inspector General (OIG).

Healthcare professionals and staff, including all ordering physicians, are required to comply with the government compliance program and requirements that include, but are not limited to, the following practices, policies, and procedures:

Service & Test Ordering
Physicians shall only order services and tests that are consistent with the generally accepted medical standards for diagnosis or treatment of disease and are determined by the professional to be medically necessary and appropriate.

Patient Request for Services
Patients may request services that are not covered by their benefits. Such services may be provided as long as the patient has been given advance notice and has agreed to pay for the services.

Advance Beneficiary Notice
An Advance Beneficiary Notice (ABN) must be completed by all Medicare beneficiaries when it is believed that Medicare will deny some or all of the items requested due to medical necessity or frequency limitations.

Screening Diagnosis Limitations
The Centers for Medicare and Medicaid only allow screening diagnoses on a limited amount of tests. If the ordering physician provides a screening diagnosis that is non-coverable, an Advance Beneficiary Notice (ABN) must accompany the specimen for the billing office to be reimbursed for these services.

Organ and Disease Panels
When an Organ and Disease Panel is ordered, medical necessity must be present for each test component within the panel. If all component tests within a panel do not meet the criteria of medical necessity, a physician should order individual tests or a more appropriate panel. Refer to our Test Panels / Profiles and Reflex Test Overview for more information.

Reflex Testing
A reflex test is a specific laboratory test in which an abnormal result causes one or more additional tests to be automatically ordered, resulted, and billed. Reflex tests are reviewed and approved by Cleveland Clinic’s governing administrative body each year. All tests are identified in the Cleveland Clinic Laboratories Test Directory. Refer to our Test Panels / Profiles and Reflex Test Overview for more information.

HIPAA – Confidentiality of Results

Cleveland Clinic Laboratories is committed to maintaining the confidentiality of patient information and to compliance with all privacy, security, and electronic transaction code requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). All services provided that involve joint efforts will be done in such a way that our clients are compliant with requirements defined by HIPAA and the College of American Pathologists (CAP).

To ensure compliance with HIPAA for the appropriate release of patient results, we have adopted the following policy:

• For the laboratory to release information regarding patient results by phone or email, the patient must sign the HIPAA release form.
• Federal regulations permit the release of results only to ordering physicians or healthcare providers responsible for the individual patient’s care. Third parties requesting results, including requests directly from the patient, are directed to the ordering facility.

Lead & Heavy Metal Testing

State Departments of Health mandate that testing laboratories report specific patient demographics and heavy metal results directly to the state. Cleveland Clinic Laboratories conforms to all such requirements and provides a separate Heavy Metals Requisition (Demographics Form) for use by the client when ordering testing for lead, cadmium, arsenic, or mercury.

Clients must provide all requested information at the time of specimen submission to enable the laboratory to meet these requirements.

Required information for testing includes the following:

Nucleic Acids

Cleveland Clinic Laboratories only accepts isolated or extracted nucleic acids for which isolation or extraction of nucleic acids for clinical testing is performed in a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by the College of American Pathologists (CAP) and/or the Centers for Medicare & Medicaid Services (CMS).

Cancellation of Tests

Cancellations received before test setup are honored at no charge; however, we cannot accommodate cancellation requests received following test setup. A report will be issued automatically and charged as indicated.

Confidentiality of Results

Cleveland Clinic Laboratories is committed to maintaining the confidentiality of patient information and to compliance with all privacy, security, and electronic transaction code requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). All services provided that involve joint efforts are performed in such a way that our clients are compliant with requirements defined by HIPAA and the College of American Pathologists (CAP).

To ensure compliance with HIPAA for the appropriate release of patient results, we have adopted the following policy:

• For the laboratory to release information regarding patient results by phone or email, the patient must sign the HIPAA release form.

Federal regulations permit the release of results only to ordering physicians or healthcare providers responsible for the individual patient’s care.

Third-parties requesting results, including any requests directly from the patient, are directed to the ordering facility.

Critical Results & Values

Critical results & values are defined as those that indicate the patient is in danger of death unless treatment is initiated immediately.

These results require immediate interruptive notification of the responsible licensed caregiver who can initiate the appropriate clinical action for the patient.

Client Services or laboratory personnel are responsible for reporting critical results within 30 minutes of the result being known.

Cleveland Clinic Laboratories will immediately notify the individual who requested a test when any result indicates an imminent, life-threatening condition. This policy is compliant with CLIA regulation 493.1109 (f).

Urgent Results & Values

Urgent results & values are test results that fall outside of a normal range. These results represent a significant finding for the patient or indicate a need for infection control precautions to be initiated.

Urgent results/values require prompt communication to, and attention from, the patient’s caregiver.

Results are provided by Client Services immediately after any pending critical values are called. While there is no national standard for calling urgent values, every effort is made to call urgent values within approximately two hours from result availability.

Urgent values are reported to a responsible licensed caregiver, and an accurate readback of the communication is requested. All actions are documented.

Infectious Material

All specimens are handled as though they are infectious. The greatest dangers to healthcare workers exposed to blood and body fluids are hepatitis B, hepatitis C, and HIV viruses.

Cleveland Clinic Laboratories has an extensive safety policy that adheres to guidelines provided by the Occupational Safety and Health Administration (OSHA), the Department of Labor, and the Department of Health and Human Services. Written exposure control plans are in place.

In addition, the Centers for Disease Control (CDC) has listed organisms/diseases that require the use of special packaging and labeling. Shipping regulations require that infectious substances affecting humans be shipped in a particular manner.  Review our Shipping Information for details regarding the collection and transportation of these materials.

Details regarding current regulations are available through the International Air Transport Association.

Physician Contact Information Requests

Our goal is to deliver accurate, high-quality, and timely results to our clients so that diagnostic and treatment decisions can be made as quickly as possible.

At times, Cleveland Clinic Laboratories may need to contact the ordering physician directly. We require the ordering physician’s name and phone number to clarify requested services, interpret a test result, or consult with as necessary.

Proficiency Testing

Cleveland Clinic Laboratories has a strict policy regarding proficiency testing (PT) to comply with CMS regulations.

Cleveland Clinic Laboratories will neither accept nor perform testing on proficiency testing material submitted by a client that originates from the College of American Pathologists (CAP) or any other CLIA-approved proficiency testing provider.

If proficiency testing material is submitted to our laboratories by a client and the proficiency testing period is in progress, the samples will be returned to the client, and our accreditation agency for CLIA certification (CAP) will be immediately notified.

Samples sent for testing that appears to be proficiency survey samples will be held until the client is contacted to verify their nature.

Cleveland Clinic Laboratories will neither communicate nor share with clients any proficiency testing survey results that are actively in progress.

Cleveland Clinic Laboratories will cooperate in alternate assessment programs with other laboratories, as allowed by federal regulation.

Quality Assurance

Extensive proficiency testing and quality control measures ensure that each specimen submitted to our laboratories receives the full benefits of in-house quality, expertise, and knowledge.

Staff pathologists, PhDs, laboratory scientists, and technologists are all highly experienced in handling complex tests. The Medical Directors, Laboratory Directors, and supervisory personnel monitor performance indicators for all laboratory services.

Performance improvement initiatives are regularly instituted and reviewed as part of an aggressive ongoing quality improvement program. Client Services’ telephone calls are monitored and recorded for quality assurance.

Radioactive Specimens

Cleveland Clinic Laboratories does not routinely test specimens for background radioactivity. This radioactivity may interfere with the results of radioimmunoassay; therefore, specimens from patients receiving radioactive tracers or material should be labeled as such.

Record Retention

Cleveland Clinic Laboratories retains all test requisitions for 15 years.  Patient test results are retained indefinitely.

A copy of the original report can be reconstructed and will include reference ranges, interpretive comments, flags, and footnotes with the source system as the Robert J. Tomsich Pathology and Laboratory Medicine Institute’s laboratory information system.

Referral Testing

Cleveland Clinic Laboratories may select and utilize external reference laboratories to perform any tests not available at Cleveland Clinic. Outside performing laboratories are identified based on many factors, including, but not limited to, testing methodology, turnaround time, customer service, reporting format, and range of services offered.

Clients may, for medical reasons, request that a test be referred to a specific laboratory other than Cleveland Clinic or one that is routinely utilized by Cleveland Clinic Laboratories. Following consultation with the client regarding such requests, Cleveland Clinic Laboratories will honor the client’s request and forward the specimen. Prices are subject to change without notice.

Approved reference laboratories:

Rejection Criteria

Specimens will be rejected under the following conditions:

Reportable Diseases

Cleveland Clinic Laboratories complies with state health department requirements regarding reportable diseases. We submit our reports by fax, by phone, or electronically, depending upon the individual state’s health department regulations.  Reports are made to the state listed in the client’s address.

Clients are responsible for compliance with any state-specific statutes concerning reportable conditions including, but not limited to, chromosomal abnormality registries.

Specimen Shipping

Specimens are only acceptable for processing when they are collected and submitted appropriately.

Refer to our Specimen Collection & Transport resources for more information.

Test Panels, Profiles & Reflex Tests

These details are designed to assist both the laboratory user and the laboratory in complying with federal regulations and are provided as part of our overall compliance program.

The U.S. Office of the Inspector General (OIG) has recommended that laboratories inform physicians and other providers who use their services.

Reflex Testing

A reflex test is a specific laboratory test in which an abnormal result causes one or more additional tests to be automatically ordered, resulted, and billed.

Reflex tests are reviewed and approved by Cleveland Clinic’s governing administrative body each year. All tests, including reflexes, are identified in the Test Directory.

Time-Sensitive Specimens

Please contact Client Services before sending a specimen for testing of a time-sensitive nature and have the following information available:

• Contact name and phone number
• Facility name
• Account number/client ID or mnemonic
• Two patient identifiers, such as the patient’s name, date of birth, MRN, or accession number
• Name of the test ordered
• The date to be sent to our laboratories
• Shipping/tracking information

To ensure specimen integrity, place the specimen in a bag with a label indicating the specimen transport temperature and properly store it for pick-up.

Turnaround Time

Cleveland Clinic Laboratories defines turnaround time (TAT) as the analytical test time required. Our laboratories’ turnaround time is monitored closely and compared to standardized laboratory metrics for continuous quality improvement.

For details regarding turnaround times for specific tests, please refer to the Test Directory or contact Client Services.