SERVICE TERMS AND CONDITIONS
Pacific BioLabs is an independent testing laboratory. Testing services are our only business. We maintain strict confidentiality of all client information. We will execute your confidentiality agreements or we can provide you with copies of our standard agreement.
Some companies require quality agreements with their key vendors. We will review and execute your quality agreement or we can provide you with a copy of our standard agreement. Our sales or QA staff can make arrangements to execute quality agreements.
QUOTES FOR TESTING SERVICES
Custom quotes are required for most sample submissions. Pacific BioLabs sales staff promptly issues quotes. To receive a quote for your testing needs please complete the online Request for Quotation form.
For new clients prepayment is required before testing can be initiated. We also require a payment schedule for certain larger studies, especially in toxicology (e.g. 50% at initiation, 40% at completion of inlife phase, 10% at issue of final report).
Our terms are net 10 days upon receipt of our invoice. We accept checks drawn on U.S. banks, wire transfer or Visa and MasterCard Credit Cards. A 1.5% per month surcharge will be assessed on accounts not paid within 30 days. Past due accounts must be made current before new work will be accepted.
Complete documentation is required to facilitate the shipping process for samples sent to the U.S. from other countries. Shipping documents should identify the shipment contents as “SAMPLES FOR TESTING ONLY – NOT FOR HUMAN USE.” Any customs related fees are the responsibility of the client. All invoices are payable in U.S. Dollars. To minimize banking fees, we suggest payment by wire transfer to our bank account.
The fees listed in the PBL fee schedule are for tests in which routine procedures are used. Products which require extraordinary handling (e.g. unusual sample preparation, unique laboratory supplies, extra safety measures, disposal of excess hazardous samples, etc.) will incur additional charges.
Revisions to USP, international compendia, ISO and other standards may affect test procedures, and consequently test fees, at any time. All fees in the PBL fee schedule are subject to change without notice.
Rush service may incur a surcharge. For regular clients, we try to accommodate occasional special requests to expedite turnaround time for routine tests without assessing any additional charge. However, many rush requests require overtime, weekend or holiday work and result in costly operating inefficiencies and cause significant disruption of our testing schedule. On these occasions, there will be a minimum of $100 or 50% additional charge.
Volume discounts are available for many of the tests listed. Please call for a quotation on your volume testing requirements.
Some studies that will be submitted to EPA or FDA must be performed according to Good Laboratory Practice regulations. It is the responsibility of the test sponsor to request GLP treatment prior to the initiation of testing. GLP treatment includes a custom protocol approved by the sponsor, observation of the performance of the testing procedure by our Quality Assurance Department, Q.A. review of all test data, and a detailed final report. GLP fees are generally an additional 10 to 20%. The minimum GLP fee is $250.00 per procedure. GLP treatment will generally add 3 to 7 work days to standard turnaround times for routine tests.
Special precautions must be taken to safely test hazardous samples. Handling fees will be added to all projects which require work with hazardous or biohazardous agents. These fees will vary depending on the material, the nature of the hazard, and the project protocol. There may also be a fee for sample disposal. We reserve the right to return all hazardous samples to the test sponsor. For hazardous sample return, there is a minimum Hazmat processing fee of $35.00. Shipping charges are additional.
Pacific BioLabs has an extensive library of SOPs for commonly performed tests. Most Pacific BioLabs SOPs are based on USP procedures, ANSI/AAMI/OSP standards or other recognized references. Our library includes the most current editions of the USP, BP, EP, and JP. We welcome client methods. If test methods are not available, we offer method development and validation services.
A method transfer is a study that is performed to verify that a test method developed in one lab can be accurately performed in another lab. The GMP regulations have been interpreted to require method transfer studies for many non compendial test methods. Please call for a quote for a method transfer study for your specific test method.
VALIDATION OF TESTING PROCEDURES
USP procedures for products listed in the USP are generally considered to be validated. Many other test procedures should be validated for the particular products being tested. It is the client’s responsibility to insure that the validation status of test procedures used on their products is approved by their quality assurance department. The test fees listed in this schedule do not include the validation of that test for the sample that is submitted. Pacific BioLabs offers test procedure validation services. Please call any of our technical managers to discuss validation issues regarding the test procedures used for your products.
Retesting is generally governed by our SOP for handling out-of-specification findings. Client authorized retesting will be billed accordingly.
All test results are issued on a clear and accurate Report of Analysis. Pacific BioLabs’ reporting system allows us substantial flexibility in the preparation of reports. We can generate customized reports to meet special client requirements. Reports will be sent out via First Class Mail unless otherwise requested by the client.
Reports are submitted for exclusive use by our clients. No reference to the work, the results, or to Pacific BioLabs may be made in any form of advertising, news release or other public announcement without written authorization.
Lab reports can be sent via email. The report will be an electronic image of the final signed paper copy of the report. The fee for this service is $6.00 per report.
MINIMUM REPORT FEE
The minimum fee for testing a sample and issuing a lab report is $70.00.
There is a $50.00 minimum charge for a reissued report.
SAMPLE RETENTION AND RETURN
Following completion of testing, Pacific BioLabs will generally discard excess samples in accordance with our sample retention SOP (< 30 days). When requested, we will return remaining samples to the client. There is a minimum fee of $10.00 plus shipping expenses for the return of samples. Fees vary according to quantity and weight of samples, special handling or packaging requirements and whether the sample is hazardous. For any single or group of samples submitted concurrently, valued over $100.00, and for which return is required, the client must include a declared value. If no value is declared, Pacific BioLabs cannot be held liable for any amount in excess of $100.00 for any loss of samples, whether at Pacific BioLabs or lost in transit.
For GLP studies, all unused sample will be held for approximately one month after completion of testing, then returned (unless you instruct us otherwise). The test sponsor is responsible for retaining reserve samples in accordance with FDA and EPA GLP regulations. If the sponsor is unable to meet these requirements, Pacific BioLabs can store small amounts of reserve sample. The minimum sample storage fee is $15.00 per month.
For environmental and/or cost reasons, many clients request that the cooler boxes in which they ship their samples be returned to them. If you want your cooler returned, please note it on your sample submission documents. To cover our expenses, Pacific BioLabs charges only the return shipping costs plus a $5.00 repackaging fee. Alternatively, we can have the shipping charges billed to your UPS account if you provide us with your UPS shipper number.
For all studies, Pacific BioLabs retains all report related data and documentation for one year. After 1 year, all paper documentation may be retained upon request of the client, otherwise it will be destroyed.
Clients who need data and documentation for greater than 1 year can request copies of data at the time of sample submission. There is an additional charge for raw data collection and copying.
Pacific BioLabs welcomes prospective client audits of our laboratories and quality systems. There is no charge for an initial audit of up to one full day. We also recognize our clients’ need to re-audit their contract service providers in accordance with their company SOPs. We welcome re-audits of our laboratories. In most cases, there is no fee related to re-audits. Under certain circumstances for extended audit times, an hourly fee will be assessed for hours beyond a preset schedule. If applicable, our QA managers will discuss this when the audit is scheduled.
POLICY ON ALTERNATIVE METHODS
Pacific BioLabs encourages the use of non-animal alternatives where available and supports the application of the three R’s – reduction, refinement and replacement. It is a policy at Pacific BioLabs to keep clients abreast of current testing guidelines as they relate to the prudent use of animals. A senior member of the in vivo testing staff is available to consult with clients regarding alternative methods. Please contact client services at 510/964-9000 with inquiries regarding alternative methods.
CONDITIONS OF SALE, WARRANTY AND LIMIT OF LIABILITY
Pacific BioLabs provides services to its clients on a fee-for-service basis. All services are performed by Pacific BioLabs in accordance with the service notes, terms and conditions specified in this fee schedule. Any deviation to the terms must be agreed to in writing by Pacific BioLabs’ executive management prior to the performance of service.
The only warranty that Pacific BioLabs offers is that it will perform its services with due care in accordance with Pacific BioLabs procedures and generally prevailing industry standards and applicable government regulations. The only remedy for breach of this warranty will be to require Pacific BioLabs to repeat the services or to be credited for fees paid for services performed.
Test results are not necessarily indicative of the characteristics of any other samples from the same or any other lots. Pacific BioLabs assumes no responsibility for any purpose for which a client chooses to use test results. Pacific BioLabs or its subsidiary companies shall not be liable under any circumstances for any amount in excess of the cost of the test performed.