Cleveland Clinic Laboratories’ policies and procedures help ensure the consistent quality testing and results that our clients expect.
For questions or additional details regarding the information described here, please contact Client Services.
We do not accept animal specimens for laboratory testing.
Cancellation of Tests
Cancellations received prior to test setup will be honored at no charge. We cannot accommodate cancellation requests received following test setup. A report will be issued automatically and charged as indicated.
Cleveland Clinic Laboratories complies with all applicable laws and regulations, such as the Clinical Laboratory Improvement Amendments (CLIA), by developing, implementing, and monitoring appropriate policies, procedures, and processes. Compliance is overseen by several regulatory agencies, including the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Admin-istration (FDA), and the Department of Transportation (DOT).
Our clients are responsible for their compliance with regulations related to patient confidentiality, diagnosis coding, anti-kickback statutes, professional courtesy, CPT-4 coding, CLIA proficiency testing, and other similar regulatory requirements.
Analyte Specific Reagents
Analyte specific reagents (ASRs) are reagents such as chemicals or antibodies that may be purchased by clinical laboratories for use in the development of in-house tests for the diagnosis and management of various conditions. Tests which utilize these reagents undergo full analytical validation within the laboratory, and are reported with a comment identifying them as incorporating ASRs.
Ongoing advances in genetic testing and associated regulations frequently require additional patient information and/or documentation of the patient’s consent. If required information is not provided at the time of specimen submission, Cleveland Clinic Laboratories will contact the submitting facility to obtain the documentation prior to forwarding the specimen to the testing laboratory.
Lead and 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 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 includes the following:
- Patient’s date of birth, race, complete address, telephone number, sample type (venous or capillary)
- Guardian’s name and phone number (children only)
- Name and address of patient’s place of employment
- Referring physician’s name, address, telephone number and UPIN
Specimens received without the required information will not be tested. The client will be contacted and asked to submit the missing information. If such information is not received within one week of specimen submission, the specimen will be discarded.
HHS/OIG Compliance Policies
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:
- 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 profession to be medically necessary and appropriate.
- 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.
- 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.
- The Centers for Medicare and Medicaid only allows screening diagnoses on a limited amount of tests. In the event that the ordering physician provides a screening diagnosis that is non-coverable, an ABN must be received with the specimen in order for the billing office to be reimbursed for these services.
- 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.
- 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.
Confidentiality of Results
Cleveland Clinic Laboratories is committed to maintaining 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 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.
We appreciate your assistance in helping Cleveland Clinic Laboratories preserve patient confidentiality.
Critical Result Notification
Cleveland Clinic Laboratories will immediately notify the individual who requested a test when any result indicates an imminent, life-threatening condition. This policy is compliance with CLIA regulation 493.1109 (f). Critical values of certain tests will be reported immediately by phone to the client who ordered the test, regardless of the time of day.
All specimens are handled as though they are infectious. The greatest dangers to healthcare workers exposed to blood and body fluids are the 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 special manner.
A copy of the regulations is available on the International Air Transport Association website or by calling 514-399-6770.
Physician Name and Number Requests
Our goal is always to deliver accurate, high quality, timely results so that diagnostic and treatment decisions can be made as quickly as possible for patient care. At times, Cleveland Clinic Laboratories needs to contact the ordering physician directly, particularly when we are conducting esoteric tests.
At times, we need the ordering physician’s name and phone number to clarify requested services, interpret a test result, or otherwise consult with the ordering physician as necessary. If this information was not provided on the test order where indicated, Cleveland Clinic Laboratories may request this information from our client. We appreciate your rapid assistance in supplying us with the ordering physician’s name and phone number so that we may contact him or her as needed. Working together, we can provide your patients with the highest quality testing services in the shortest possible time.
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 from the College of American Pathologists (CAP) or any other CLIA-approved PT provider. If proficiency testing material is submitted to Cleveland Clinic Laboratories by a client and the proficiency testing period is in progress, the samples will be returned and the CAP (our accreditation agency for CLIA certification) will be notified.
Samples sent for testing that appear to be proficiency survey samples will be held until the client is contacted to verify the nature of the sample. Additionally, Cleveland Clinic Laboratories will neither communicate nor share with clients any proficiency testing survey results that are actively in progress.
Cleveland Clinic will cooperate in alternate assessment programs with other laboratories as allowed by federal regulation.
Extensive proficiency testing and quality control measures assure that each specimen is provided 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 Director, and supervisory personnel monitor performance indicators for all laboratory services. Performance improvement initiatives are regularly instituted and reviewed as part of an aggressive on-going quality improvement program. Client Services’ telephone calls are monitored and recorded for quality assurance.
Cleveland Clinic Laboratories does not routinely test specimens for background radioactivity. This radioactivity may interfere with the results of radioimmunoassasy; therefore, specimens from patients receiving radioactive tracers or material should be labeled as such.
Cleveland Clinic Laboratories retains all test requisitions for 15 years and patient test results are retained indefinitely. A copy of the original report can be reconstructed including reference ranges, interpretive comments, flags, and footnotes with the source system as the Pathology and Laboratory Medicine Institute’s laboratory information system.
Referral Testing Policy
Cleveland Clinic Laboratories serves our clients by selecting and using qualified, licensed reference laboratories to perform any tests not available at Cleveland Clinic. Laboratories are identified based on many factors including (but are 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 which 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.
Some tests, under certain conditions, may result in an order for an additional test(s) placed by and at the discretion of the clinical pathologist. Please refer to the Reflex Testing List for a listing of these specific tests.
Cleveland Clinic Laboratories strives to comply with state health department requirements regarding reportable diseases. We submit our reports electronically, by fax, or by phone, depending upon the individual state’s health department regulations. Reports are made to the state listed in the client address. Clients are responsible for compliance with any state-specific statutes concerning reportable conditions including, but not limited to, chromosomal abnormality registries.
Specimens are only acceptable for processing when they are collected and submitted in the appropriate containers. If you have any questions on what type of container to use for a particular test or specimen, please refer to the specimen requirements on our online Test Directory or contact Client Services.
Shipping supplies, sterile specimen containers, transport media, and other supplies are available through our Supply Storefront.
All specimens must be labeled with 2 unique patient identifiers. If a requisition is sent with the specimen, then the 2 unique patient identifiers on the requisition and the specimen container must match. This information will ensure positive identification and optimum integrity of patient specimens from the time of collection until the completion of testing.
If a specimen is inappropriately or completely unlabeled, the client will be notified and the order will be canceled.
Please see the Specimen Rejection Criteria section for more information.
Specimen Rejection Criteria
Specimens will be rejected and the tests and charges canceled under the following conditions:
- 2 unique patient identifiers on specimen container do not match those on requisition or electronic order
- Hemolysis (test dependent)
- Improper specimen transport temperature
- Incorrect specimen submitted for test requested
- Insufficient volume (QNS: Quantity Not Sufficient)
- Specimen submitted without a written or electronic order
- Specimen is unlabeled or incompletely labeled
- Unacceptable specimen age (test dependent)
- Unacceptable containers:
- Glass container
- Syringe with needle attached
- Broken or leaking container
Specific specimen volume requirements for each test are provided in our online Test Directory. If you have concerns about a lower volume of a specimen being submitted, please contact Client Services to discuss the test and specimen. A laboratory representative can advise you whether an alternative technique is available that can accommodate the available specimen volume.
When a specimen is submitted to our laboratories with inadequate volume, the test will be canceled and indicated as “QNS” (Quantity Not Sufficient). The laboratory will store the QNS sample and contact the client to request that the specimen be recollected.
As a general rule, the volume of blood drawn should equal 2-1/2 times the amount of serum plasma required. For example, to obtain 4mL serum or plasma, draw at least 10mL blood.
Test Result Call-Backs
Clients may request results to be delivered by telephone. The request for a phone report may be made on the Test Request Form or by calling Client Services.
Please contact Client Services before sending a specimen for testing of a time-sensitive nature. We will ask for the following information:
- caller’s name and phone number
- facility name
- client ID/mnemonic
- the two patient identifiers submitted with the specimen, such as:
- the patient’s name
- the patient’s birthday
- MRN and/or Cleveland Clinic Laboratories accession number
- name of the test ordered
- date to be sent
- shipping information (tracking number)
Please make sure to place the specimen in a separate Cleveland Clinic Laboratories temperature-appropriate bag and follow any additional instructions provided by Client Services.
Turnaround Time (TAT)
At Cleveland Clinic Laboratories, our “Patients First” philosophy guides every aspect of patient care activities. Through our extensive test menu and our commitment to the most rapid TAT possible, Cleveland Clinic Laboratories strives to carry out this commitment to excellent patient care.
We define TAT as the analytical test time required. It is monitored closely and compared to standardized laboratory metrics for continuous quality improvement.