Clinical Testing Services

Following World War II there was a surge of federal funding for local health administrations with the passage of the Public Health Assistance Act of 1948, providing federal resources for the establishment of Local Public Health Laboratories across California. By the 1970’s there were 39 LPHLs located throughout California. The original Public Health Laboratory Monterey County was co-located in the County Hospital.

The current public health laboratory facility, commissioned in 2009, is located in the main health department building and was designed from the ground up by and for lab personnel. It includes two BSL 3 suites making it the only laboratory in the tricounty area (Monterey, Santa Cruz, and San Benito) designed for safe handling of aerosol transmissible diseases such as tuberculosis and valley fever. The laboratory facility has media and reagent preparation capabilities allowing it to support an extensive array of high complexity laboratory-developed tests on food samples, environmental samples, and clinical (human) specimens.

As important as infrastructure is, it is through communication and collaboration with other partners in the Department and community that the laboratory achieves its mission. Microbiologists, epidemiologists, public health nurses, infectious disease specialists, infection control nurses, and hospital clinical laboratory scientists collaborate in an interdisciplinary effort to prevent and control emerging infections. Please click on the links below to obtain more information about our clinical laboratory services.

Clinical Laboratory Certification and Fields of Testing

The Monterey County Health Department Laboratory is certified as a public health laboratory by the State Department ofPublic Health’s Laboratory Field Services. The Health Department Laboratory is also certified as a clinical laboratory under the federal Clinical Laboratory Improvement Amendments of 1988. These certifications ensure the quality of analytical data used for patient management. As a high complexity laboratory, we must demonstrate compliance with CLIA’s six areas of regulation: proficiency testing, personnel, inspection, patient test management, quality control and quality assurance. You can download a copy of our CLIA certificate, certified Fields of Testing, and our public health laboratory certificate below.

• State of California License
• CLIA Certificate 9/16/2018 – 9/15/2020

Laboratory tests, fees and customer service

Specimen Submission

All specimens must be accompanied by a written requisition containing the following information:

1. The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. 
2. The patient name or unique patient identifier.
3. The sex and age of date of birth of the patient.
4. The test(s) to be preformed.
5. The source of the specimen, when appropriate
6. The date and, if appropriate, time of specimen collection
7. Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable.

Our laboratory will accept oral requests for laboratory results, only a written or electronic authorization within 30 days of the oral request and maintains the authorization or documentation of its efforts to obtain the authorization. 

• PH Lab Requisition Form 2021
• COVID-19 Supplemental Form

Current laboratory fees are available here: 

• Public Health Lab Fee Schedule 2020
• Lab Fees for Tests Requested from Communicable Disease Unit

Fees may be waived for specimens/tests requested by the Health Department's Communicable Disease Unit. In many instances this requires prior approval, on a case by case basis, by the Communicable Disease Unit.  For questions call the the Communicable Disease Unit at  831-755-4521

The laboratory is committed to proving quality service and testing. We welcome client feedback to better serve our community.  To view a PowerPoint presentation on our recent customer service survey click here

Specimen Collection Instructions

In order to assure the validity of laboratory results, it is important to follow specimen collection instructions.  Please refer to the link below Specimen Criteria and Testing Information summarizing the type of specimens, volumes, hold times, packing and shipping requirements, testing schedule and testing turn around times.  Below you will find specimen collection instructions for the most commonly requested tests. We provide our clients with all appropriate sample collection containers and we are happy to answer any questions regarding specimen collection and analysis. It is important that specimens be collected in proper transport media, at the proper temperature, and submitted within the recommended time frame in order to assure accuracy of results.

Specimen Criteria and Testing Information

Specimen Criteria and Testing Information

Instructions for Test Requests

• Blood specimens for QuantiFERON (latent TB infection)
• Highly Pathogenic Avian Influenza (HPAI) A(H5N1)
• Monkeypox (mpox) specimen collection instructions
• Nasophayryngeal specimens
• Sputum for Tuberculosis Testing
• Stool specimens for viral gastroenteritis
• Stool specimens for Salmonella, Shigella, Campylobacter, or Vibrio
• Stool Specimens for Parasitology

Laboratory Developed Tests

A core function of the Public Health Laboratory has been to introduce tests for diseases and conditions  that are not commercially available as FDA approved kits.  The emergence of the new field of molecular diagnostics has expanded the ability of the laboratory to develop new assays for infectious diseases.  Our laboratory now offers over 20 PCRs for infectious diseases.

These PCRs are often referred to as laboratory developed tests (LTDs) because they have not been approved by the FDA for commercial manufacture and use as medical devices.  Furthermore, the FDA has no regulatory oversight of the manufacturing process.  These tests are not regulated as high complexity tests under CLIA and the laboratory must conduct internal verification and implement quality control systems including quality control of reagents and ongoing verification of accuracy. Unless noted otherwise, these tests may be used for clinical diagnosis when performed on validated specimens.  The various types of LDT used by the Monterey County Health Department (MCHD) Laboratory are described below:

• Laboratory Developed Tests
• PCR Testing Information

Non Diagnostic General Health Assessment (NGHA)

Non-diagnostic general health assessment (NGHA) programs, are programs performing clinical laboratory tests without physician referral (such as community based cholesterol screening). These programs are regulated under the Business and Professions Code.

The intent of this law is to assure the safety and quality of testing performed by NGHA programs. The number of provisions concerning quality assurance, client counseling, and safety. Specific documentation related to the program must be filed with the local health department.

If you are interested in operating a NGHA in Monterey County please complete and submit a registration form 30 days prior to scheduled dates(s) of operation. Registration forms will not be processed unless accompanied by a $100.00 filing fee. Checks should be made payable to Monterey County Health Department. Application will be reviewed and evidence of compliance with the provisions of Chapter 195 of the Clinical Laboratory Act (California Business and Professions Code), a "Verification of Registration" will be issued.

In recent years, NGHA programs have enjoyed popularity as an accessible form of health care. We look working with you to assure the safety and quality of your program.

NGHA Registration Application

Lab Testing Schedule*

*Applies to routine tests. Not applicable to STAT testing and outbreak related testing.  Schedule may vary.   Testing for PCR methods not listed TBD after consultation with lab.

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