Dates of On-Site Assessment:
Assessor (Initials) Completing Checklist: / Interviewees:
Onsite
COMPLIANT
/Documents COMPLIANT
/ DocumentLocation / Comments and Corrective Actions
CHECKLIST “A” / Y / N / na / Y / N / na
5.11 Sample Handling, Sample Acceptance Policy and Sample Receipt
5.11.1 Sample Tracking
5.11.1 (a) Does the laboratory have a documented system for uniquely identifying the items to be tested, to ensure that there can be no confusion regarding the identity of such items at any time? Does this system include identification for all samples, subsamples and subsequent extracts or digestates?
5.11.1 (a) Does the laboratory assign a unique identification (ID) code to each sample container received in the laboratory?
5.11.1 (b) Does this laboratory code maintain an unequivocal link with the unique field ID code assigned each container?
5.11.1 (c) Is the laboratory ID code placed on the sample container as a durable label?
5.11.1 (d) Is the laboratory ID code entered into the laboratory records and used as the link that associates the sample with related laboratory activities such as sample preparation or calibration?
5.11.2Sample Acceptance Policy
5.11.2 (Opening Paragraph) Does the laboratory have a written sample acceptance policy that clearly outlines the circumstances under which samples will be accepted? Are the data from any samples which do not meet the following criteria flagged in an unambiguous manner clearly defining the nature and substance of the variation? Is this sample acceptance policy made available to sample collection personnel and include, but not limited to, the following areas of concern:
5.11.2(a) Proper, full, and complete documentation, which shall include sample identification, the location, date and time of collection, collector's name, preservation type, sample type and any special remarks concerning the sample?
5.11.2(b) Proper sample labeling to include unique identification and a labeling system for the samples with requirements concerning the durability of thelabels (water resistant) and the use of indelible ink?
5.11.2(c) Use of appropriate sample containers;
5.11.2(d) Adherence to specified holding times;
5.11.2(e) Adequate sample volume. Sufficient sample volume must be available to perform the necessary tests; and
5.11.2(f) Procedures to be used when samples which show signs of damage or contamination..
5.11.3Sample Receipt Protocols
5.11.3(a)Upon receipt, is the condition of the sample , including any abnormalities or departures from standard condition as prescribed in the relevant method, recorded? Are all items specified in 5.11.2 (Sample Acceptance Policy) above checked?
5.11.3(a)(1) Are all samples which require thermal preservation considered acceptable only if the arrival temperature is within +/-2oC of the required temperature or the method specified range? For samples with a specified temperature of 40C, are only samples with a temperature ranging from just above the freezing temperature of water to 60C considered acceptable? When the samples are hand delivered, are they considered acceptable only if there is evidence that the chilling process has begun such as arrival on ice? /
5.11.3(a)(2) Has the laboratory implemented procedures for checking chemical preservation using readily available techniques, such as pH or free chlorine prior to sample preparation or analysis?
5.11.3(b) Are the results of all checks recorded?
5.11.3(c) Where there is any doubt as to the item's suitability for testing, where the sample does not conform to the description provided, or where the test required is not fully specified, does the laboratory consult the client for further instruction before proceeding?
5.11.3(c) Does the laboratory establish whether the sample has received all necessary preparation, or whether the client requires preparation to be undertaken or arranged by the laboratory?
5.11.3(c) If the sample does not meet the sample receipt acceptance criteria listed in 5.11.3.a, 5.11.3.b or 5.11.3.c, does the laboratory either:
5.11.3(c)(1) retain correspondence and/or records of conversations concerning the final disposition of rejected samples; or
5.11.3(c)(2) fully document any decision to proceed with the analysis of compromised samples:
5.11.3(c)(i ). Is the condition of these samples, at a minimum, noted on the chain of custody or transmittal form and laboratory receipt documents?
5.11.3(c)(ii). Is the analysis data appropriately qualified on the final report?
5.11.3(d) Does the laboratory utilize a permanent, chronological record, such as a log book or electronic database, to document receipt of all sample containers?
5.11.3(d)(1) Does the sample receipt log record the following:
5.11.3(d)(1)(i) Client/Project Name
5.11.3(d)(1)(ii) Date and time of laboratory receipt;
5.11.3(d)(1)(iii) unique laboratory ID code (see 5.11.1);
5.11.3(d)(1)(iv)Signature or initials of the person making the entries.
5.11.3(d)(2) During the log in process, is the following information unequivocally linked to the log record or included as part of the log? If such information is recorded/documented elsewhere, the records shall be part of the laboratory’s permanent records, easily retrievable upon request and readily available to individuals who will process the sample?
5.11.3(d)(2)(i)The field ID code which identifies each container must be linked to the laboratory ID code in the sample receipt log.
5.11.3(d)(2)(ii) The date and time of sample collection must be linked to the sample container and to the date and time of receipt in the laboratory.
5.11.3(d)(2)(iii) The requested analysis (including applicable approved test methods numbers) must be linked to the laboratory ID code.
5.11.3(d)(2)(iv) Any comments resulting from inspection for sample rejection shall be linked to the laboratory ID code.
5.11.3(e) Is all documentation, such as memos or transmittal forms, that is transmitted to the laboratory by the sample transmitter retained?
5.11.3(f) Is a complete chain of custody record (Section 5.12.4), if utilized, maintained?
5.11.4Storage Conditions
5.11.4 (Opening Paragraph) Does the laboratory document procedures and appropriate facilities to avoid deterioration, contamination, or damage to the sample during storage, handling, preparation, and testing, and are any relevant instructions provided with the item followed? Where items have to be stored or conditioned under specific environmental conditions, are these conditions maintained, monitored and recorded where necessary (NA)?
5.11.4(a) Are samples stored according to the conditions specified by preservation protocols?
5.11.4(a)(1) Are samples which require thermal preservation stored under refrigeration which is +/- 2o of the specified preservation temperature unless method specific criteria exist? For samples with a specified storage temperature of 4oC, is storage acceptable only if the temperature is between above the freezing point of water to 6oC?
5.11.4(a)(2) Are samples stored away from all standards, reagents, food and other potentially contaminating sources including highly contaminated samples? Are samples stored in such a manner as to prevent cross contamination?
5.11.4(b) Are sample fractions, extracts, leachates and other sample preparation products stored according to 5.11.4.a above or according to specifications in the test method?
5.11.4(c) Where a sample or portion of the sample is to be held secure (for example, for reasons of record, safety or value, or to enable check calibrations or tests to be performed later), does the laboratory have storage and security arrangements that protect the condition and integrity of the secured items or portions concerned?
5.10.3 Sample Aliquots
5.10.3 Where sampling (as in obtaining sample aliquots from a submitted sample) is carried out as part of the test method, does the laboratory use documented procedures and appropriate techniques to obtain representative subsamples?
5.11.5Sample Disposal
5.11.5 Does the laboratory have standard operating procedures for the disposal of samples, digestates, leachates and extracts or other sample preparation?
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/ Laboratory Name and ID:Dates of On-Site Assessment:
Assessors Completing Checklist:
Citations taken: EPA 815-B-97-001, March 1997 Manual for the Certification of Laboratories Analyzing Drinking Water, 4th Ed. /
Documents COMPLIANCE
/ DocumentLocation / Comments and Corrective Actions
CHECKLIST “B” / Y / N / na
NELAC 5.12: If a client specifies that a sample will be used for evidentiary purposes, then a laboratory shall have a written SOP for how that laboratory will carry out legal chain of custody for example, ASTM D 4840-95 and Manual for the Certification of Laboratories Analyzing Drinking Water, March 1997, Appendix A.
Legal or Evidentiary Custody Procedures
App. A, A Does the chain of custody records establish an intact, contiguous record of the physical possession, storage and disposal of sample containers, collected samples, sample aliquots, and sample extracts or digestates?
Is a sample considered to be in someone’s custody only if:
App. A, A (1) It is in one’s actual physical possession;
App. A, A (2) It is in one’s view, after being in one’s physical possession;
App. A, A (3) It is in one’s physical possession and then locked up so that no one can tamper with it;
App. A, A (4) It is kept in a secured area, restricted to authorized personnel only.
Does the COC records account for all time periods associated with the samples?
App. A, C (1) Does the COC records include signatures of all individuals who physically handled individual samples?
App. A, B (1) In order to simplify record keeping, is the number of people who physically handle the sample minimized?
App. A, B (1) Does the organization attempt to limit the number of documents that are required to establish COC?
App. A, B (2) C (3) Does the COC forms remain with the samples during transport or shipment?
App. A, C (6) If samples are submitted with sample custody seals, and any seals are not intact, does the laboratory note this in the chain of custody?
App. A, C (4) Are mailed packages registered with return receipt requested?
App. A, C (4) If packages are sent by common carrier, are receipts retained as part of the permanent chain-of-custody documentation?
App. A, D (7) Once received in the laboratory, are laboratory personnel responsible for the care and custody of the sample and prepared to testify that the sample was in their possession view of secured in the labored at all times from the moment it was received from the custodian until the time that the analyses are completed or the sample is disposed?
Required Information in Custody Records
App. A, D (2) time of day and calendar date of each transfer or handling procedure?
all information necessary to produce unequivocal, accurate records that document the laboratory activities associated with sample receipt, preparation, analysis and reporting?
Controlled Access to Samples
App. A, D (3) Is a clean, dry, isolated room, building, and/or refrigerated space that can be securely locked from the outside designated as a custody room?
App. A, D (1,5) Where possible, is distribution of samples to the analyst performing the analysis made by the custodian(s)?
App. A, D (6) Is the laboratory area maintained as a secured area, restricted to authorized personnel only?
App. A, D (8) Once the sample analyses are completed, is the unused portion of the sample, together with all identifying labels, returned to the custodian?
App. A, D (8) Is the returned tagged sample retained in the custody room until permission to destroy the sample is received by the custodian or other authority?
Transfer of Samples to Another Party
App. A, D (2) Is transfer of samples, subsamples, digestates or extracts to another party subject to all of the requirements for legal chain of custody?
Sample Disposal
If the sample is part of litigation, disposal of the physical sample shall occur only with the concurrence of the affected legal authority, sample data user and/or submitter of the sample.
App. A, D (9) All conditions of disposal and all correspondence between all parties concerning the final disposition of the physical sample shall be recorded and retained.
App. A, D (9) Records shall indicate the date of disposal, the nature of disposal (such as sample depleted, sample disposed in hazardous waste facility, or sample returned to client), and the name of the individual who performed the task.
Page 1 of 2
/ Laboratory Name and ID:Dates of On-Site Assessment:
Assessor (Initials) Completing Checklist: / Interviewees:
Onsite
COMPLIANT
/Documents COMPLIANT
/ DocumentLocation / Comments and Corrective Actions
CHECKLIST “C” / Y / N / na / Y / N / na
5.5.4 Essential Quality Control Procedures
5.5.4(a)(8) measure to assure constant and consistent test conditions (both instrumental and environmental) where required by the test method such as temperature, humidity, light, or specific instrument conditions?
5.5.4(b) Are all quality control measures assessed and evaluated on an on-going basis?
5.7 PHYSICAL FACILITIES-Accommodation and Environment
5.7.1(a) Are laboratory accommodation, test areas, energy sources, lighting, hearing and ventilation adequate to facilitate proper performance of tests?
5.7.1(b) Is the environment in which these activities are undertaken such that it does not invalidate the results or adversely affect the required accuracy of measurement? Is particular care taken when such activities are undertaken at sites other than the permanent laboratory premises?
5.7.1(c) Does the laboratory provide for the effective monitoring, control and recording of environmental conditions as appropriate?
5.7.1(d) In instances where monitoring or control of any of the above mentioned items are specified in a test method or by regulation, does the laboratory meet and document adherence to the laboratory facility requirements?
5.7.2 Work Areas
5.7.2(a) Is there effective separation between neighboring areas when the activities therein are incompatible including culture handling areas or volatile organic chemicals handling areas?
5.7.2(b) Is access to and use of all areas affecting the quality of these activities defined and controlled?
5.7.2(c) Are adequate measures taken to ensure good housekeeping in the laboratory and to assure that any contamination does not adversely affect data quality?
5.7.2(d)(1-5) Is enough work space available to ensure an unencumbered work area? Work areas include access and entryways to the laboratory, sample receipt areas, sample storage areas, chemical and waste storage areas, and data handling and storage areas.
5.8 EQUIPMENT AND REFERENCE MATERIALS
5.8(a) Is the laboratory furnished with all items of equipment (including reference materials) required for the correct performance of tests for which accreditation is sought? In those cases where the laboratory needs to use equipment outside its permanent control does it ensure that the relevant requirements of this Standard are met?
5.8(b) Is all equipment properly maintained, inspected and cleaned? Are maintenance procedures documented?
5.8(c) Is any item of the equipment which has been subjected to overloading or mishandling, or which gives suspect results, or has been shown by verification or otherwise to be defective, taken out of service, clearly identified and wherever possible stored at a specified place until it has been repaired and shown by calibration, verification or test to perform satisfactorily? Has the laboratory examined the effect of this defect on previous calibrations or tests?
5.8(d) Is each item of equipment including reference materials, when appropriate, labeled, marked or otherwise identified to indicate its calibration status?
5.8(e) Are records maintained of each major item of equipment and all reference materials significant to the analytical tests performed? Do these records include documentation on all routine and nonroutine maintenance activities and reference material verifications? Do the records include:
5.8(e)(1) the name of the item of equipment;
5.8(e)(2) the manufacturer's name, type identification, and serial number or other unique identification;
5.8(e)(3) date received and date placed in service (if available);
5.8(e)(4) current location, where appropriate;
5.8(e)(5) if available, condition when received (e.g. new, used, reconditioned);
5.8(e)(6)copy of the manufacturer's instructions, where available;
5.8(e)(7) dates and results of calibrations and/or verifications and date of the next calibration and/or verification; and/or verification;
5.8(e)(8) details of maintenance carried out to date and planned for the future; and
5.8(e)(9) history of any damage, malfunction, modification or repair?
5.9 MEASUREMENT TRACEABILITY AND CALIBRATION
5.9.1 General Requirements
5.9.1 Are all measuring and testing equipment having an effect on the accuracy or validity of tests calibrated and/or verified before being put into service and on a continuing basis? Does the laboratory have an established program for the calibration and standardization of its measuring and test equipment? Does this include balances, thermometers and control standards?
5.9.2 Traceability of Calibration
5.9.2(a) Is the overall program of calibration and/or standardization and validation of equipment designed and operated so as to ensure that, wherever applicable, measurements made by the laboratory are traceable to national standards of measurement where available?
5.9.2(c) Where traceability to national standards of measurement is not applicable, does the laboratory provide satisfactory evidence of correlation of results, for example by participation in a suitable program of interlaboratory comparisons, proficiency testing, or independent analysis?
5.9.3Reference Standards
5.9.3(a) Are reference standards of measurement held by the laboratory used for calibration only and for no other purpose, unless it can be demonstrated that their performance as reference standards has not been invalidated.
5.9.3(b) Is there a program of calibration and verification for reference standards?
5.9.3(c) Where relevant, are reference standards and measuring and testing equipment subjected to in-service checks between calibrations and verifications? Are reference materials, where possible, traceable to national or international standards of measurement, or to national or international standard reference materials?
5.9.4Calibration
5.9.4.1Support Equipment: Support equipment include but are not limited to: balances, ovens, refrigerators, freezers, incubators, water baths, temperature measuring devices (including thermometers and themistors) and volumetric dispensing devices (such as Eppendorf or automatic dilutor/dispensing devices) if quantitative results are dependent on their accuracy, as in standard preparation and dispensing or dilution into a specified volume. Are all support equipment:
5.9.4.1(a) maintained in proper working order? Are records of all activities including service calls maintained?
5.9.4.1 (a) Balances
5.9.4.1 (a) Ovens
5.9.4.1 (a) Refrigerators
5.9.4.1 (a) Freezers
5.9.4.1 (a) Water Baths
5.9.4.1 (a) Temperature Monitoring Devices
5.9.4.1 (a) Volumetric dispensing devices
5.9.4.1 (a) Incubators
5.9.4.1(b) calibrated or verified at least annually, using NIST traceable references when available, over the entire range of use?
5.9.4.1 (a) Balances
5.9.4.1 (a) Temperature Monitoring Devices
5.9.4.1 (a) Volumetric dispensing devices
Are the results of such calibration within the specifications required of the application for which the equipment is used or:
5.9.4.1(b)(1) Is the equipment removed from service until repaired?