1. Bureau of Laboratories Environmental Laboratory Certification Program
NELAC Update
News You Can Use
Stephen Arms
Bureau of Laboratories
Environmental Laboratory Certification Program

2. 64E-1, FAC Amendments January 24, 2005
2002 NELAC standards in effect now
2003 NELAC standards take effect July 1
Application is completed by on-site assessment
DW Microbiology PT clarification for total/fecal coliforms

3. NELAC Chapter 5 5.0 - Quality Systems - Introduction 5.1 - Scope
5.2 - References
5.3 - Terms & Definitions
5.4 - Management Requirements
5.5 - Technical Requirements

4. Introduction (’03)
Clarification (“data of known and documented quality”)
Removed reference to PBMS
All references to “calibration laboratories” removed from Chapter 5

5. Management Requirements
Subcontracting
Laboratory is responsible for the subcontractor’s work, except where the client or regulatory agency specifies the subcontractor
Laboratory maintains a register of subcontractors and documents compliance with subcontracting requirements
Gain client’s approval when “possible” not when “appropriate” (’03)

6. Management Requirements
Purchasing Services & Supplies
New language to require policy & procedures (vs. ensuring only) for purchasing services & supplies
Procedures for purchasing, receiving, & storing reagents and consumable materials
Documented evaluation of suppliers

7. Management Requirements
Control of Nonconforming Work (New in '02)
Implement policy & procedures when work does not conform to lab’s own procedures or to client’s requirements
Designate responsibilities & authorities for managing nonconforming work
Take actions immediately when nonconforming work is identified

8. Control of Nonconforming Work (5.4.9 cont’d)
Evaluate significance of nonconforming work
Decide if any nonconforming work is still acceptable
Notify client, rather than recall work when nonconforming work impacts data quality (’03)
Define responsibility for authorizing resumption of work

9. Management Requirements
Corrective Actions (New in '02)
Designate authority to implement corrective actions when non-conforming work or departures from quality system or technical operations are identified
Determine the root cause(s)
Identify potential corrective actions, eliminate the problem & prevent recurrence

10. Corrective Action (5.4.10 cont’d)
Document & implement any changes resulting from corrective actions investigations
Monitor results for effectiveness

11. Management Requirements
Preventive Action (New in '02)
Identify needed improvements & potential problems
Develop, implement, & monitor preventive action plans
Procedures include initiating such actions & applying controls to ensure effectiveness

12. Management Requirements
Technical Records - Retain records (for a defined period) of:
original observations
derived data
sufficient info to establish an audit trail
calibration records
staff records
copy of each test report

13. Technical Records (5.4.12.2 cont’d)
Sufficient to identify factors affecting uncertainty
Sufficient to facilitate test repetition under original conditions
Must identify personnel responsible for sampling, test performance, & checking of results

14. Technical Records ( )
Document reason for error correction if other than for a transcription error (’03)

15. Management Requirements
Internal Audits (New language in '02)
Specify in QM the time frame for notifying client if validity of results is in doubt (e.g., by internal audit findings) (’03)
Audit follow-up must record effectiveness of corrective actions

16. Technical Requirements
Personnel (New language in '02)
Goals for education, training, & skills
Policy & procedures for identifying training needs & providing training
Training program relevant to present & anticipated tasks
Employed or contracted
Ensure supervision, competence, & QS-compliant work

17. Personnel
(c)(3)(iii) - Laboratory must pre-determine on-going DOC acceptance limits when using the “4 consecutive LCS” option (’03)

18. Personnel 5.5.2.7 – Annual data integrity training
Organizational mission as related to honesty and full disclosure
Procedures
Documentation
Consequences
Management support

19. Technical Requirements
Environmental Test Methods & Method Validation
Manufacturer manuals or published methods allowed as SOPs if no changes needed and sufficiently detailed to be used as written (‘03)

20. Test Methods & Method Validation
Selection of Methods
Preferentially use methods published in international, regional, or national standards
Use latest valid edition unless inappropriate or impossible
Supplement with additional details, when necessary, to ensure consistent application
Use any method specified by the client; inform client if this method is inappropriate or out-of-date

21. Method Selection (5.5.4.2 cont’d)
Appropriate validated laboratory-developed methods may be used
Inform client of method chosen
Confirm ability to run the test method properly before analyzing samples
Repeat the confirmation if the test method changes

22. Test Methods & Method Validation
Laboratory-developed Methods (New in '02)
Must plan the use of lab-developed methods
Assign to qualified, adequately equipped personnel
Update plans as method development proceeds
Ensure effective communication

23. Test Methods & Method Validation
Non-Standard Methods (New in '02)
Usability subject to client’s agreement
Must include clear specification of client requirements & test purpose
Method must be validated before use

24. Test Methods & Method Validation
Validation of Methods (New in '02)
Must validate the following cases to confirm fitness for the intended use:
Non-Standard Methods
Laboratory-developed methods
Standard Methods used outside intended scope
Amplifications & modifications to standard methods
Validation must be as extensive as necessary to meet the needs of the given application

25. Validation of Methods (5.5.4.5 cont’d)
Record validation procedures used, results obtained, & statement as to whether the test method is fit for the intended use (Appendix C.3 requirements at a minimum (’03))
Range & accuracy of values must be relevant to the client’s needs

26. Test Methods & Method Validation
Estimation of Uncertainty of Measurement (New in '02)
Laboratory must apply procedures for estimating uncertainty of measurement
If actual calculations of uncertainty cannot be done, attempt to identify all components of uncertainty & make a reasonable estimate based on performance, scope, experience, & validation data

27. Measurement Uncertainty Estimates (5.5.4.6 cont’d)
All uncertainty components must be taken into account using appropriate methods of analysis
NOTE: If well-recognized test method specifies limits to values of major sources of measurement uncertainty and if the form of presentation of calculated results is specified, THEN THE LABORATORY COMPLIES WITH THIS SECTION BY FOLLOWING THE TEST METHOD & REPORTING INSTRUCTIONS

28. Technical Requirements Equipment (5.5.5)
Initial calibration (New language in '02)
Flagged data allowed if i-cal fails acceptance criteria
Single-point i-cal allowed in special cases
Initial calibration (’03)
Flag data above highest i-cal standard as less certain
Flags not required for data within established linear range even if result falls above single-point standard concentration
Standard at or below regulatory limit no longer required

29. Equipment (5.5.5 cont’d)
Uniquely identify each item of equipment & software used for testing & significant to the result
Logs include checks for compliance with specifications, location (’03), but not necessarily future maintenance (’03)
Procedures for safe handling, transport, storage, use, & planned maintenance of equipment

30. Equipment (5.5.5 cont’d) 5.5.5.10 (’03)
Conditions under which CCV must be performed given
CCV concentration need not be varied
Flag data associated with unacceptable CCV (conditions given are now for data usability)

31. Equipment (5.5.5 cont’d)
Procedures to ensure correctly updated copies of calibration correction factors in software
Equipment, computers, & software safeguarded from adjustments that would invalidate test results

32. Measurement Traceability
Reference Standards & Reference Materials (New language in '02)
Defined procedures & schedules for checks needed to maintain confidence in working standards & reference materials
Procedures for safe handling, transport, storage, & use of reference standards & materials to avoid deterioration, protect integrity, & prevent contamination

33. Measurement Traceability
Standards and reference materials must be traceable “where commercially available” not “where possible” (’03)
Requirements for quality and documentation of reagents separated from that of standards and reference materials (’03)

34. Technical Requirements
Handling of Samples (New language in '02)
Procedures for transport, storage, receipt, handling, protection, retention, & disposal of samples
Procedures have all provisions necessary to protect sample integrity & protect interests of the laboratory & client

35. Handling of Samples (5.5.8 cont’d)
Consult client for further instructions & record results of discussion whenever samples are not suitable to the requested test, do not conform to the description provided, or requested test is not specified in sufficient detail
Allowance for no chlorine checks of micro samples from chlorinated water systems

36. Technical Requirements
Reporting the Results (New items in '02)
Allows for “simplified” report format
Where necessary for the interpretation of test results, include:
Opinions & interpretations where appropriate, including basis
Additional information required by clients or by test methods

37. Reporting the Results (5.5.10 cont’d)
Ambiguities due to text such as “where relevant” clarified in test report requirements (’03)
Copy of subcontractor’s report must be made available to client on request (’03)

38. Appendices C.1 (’03) DOC data need not be attached to form
Clarification that DOC is analyte-specific
Analyte concentrations linked to LOQ, not MDL

39. Appendix C.3 Initial Test Method Evaluation (’03)
C Limit of Detection (LOD) applicable to all methods but toxicity and microbiology
Must be verified on every instrument (!)
C Limit of Quantitation (LOQ) applicable to all methods but toxicity and microbiology
C Evaluation of Precision & Bias required for standard and non-standard methods
C Evaluation of Selectivity

40. Appendix D (’03)
D Documented corrective action required for contaminated blanks D
LCS is a “quality system” matrix
New section on LCS acceptance specs

41. Appendix D (cont’d) D.1.2.1 - LOD
Requirement to include all processing steps moved to C.3
Not required if no results are reported outside calibration range (Required nonetheless by FDEP, with exceptions)
Verify LOD annually for each FOA by procedure in C.3 on every instrument to be used for analysis and reporting

42. Tests For Which LOD is Not RequiredpH
BOD/cBOD
Titrimetric determinations
Specific conductance
Turbidity
Residues (TSS, TDS, etc.)
Dissolved Oxygen
Salinity
Ignitibility
Parameters calculated from the results of different tests such as corrosivity, organic nitrogen and unionized ammonia
Organoleptic tests (odor, taste)
Color
Temperature
Chlorophyll

43. Appendix D (cont’d)
D.1.2.2
LOQ must be above LOD
Verify LOQ annually unless LOD is verified
D Retention time windows replaced with general selectivity evaluation

44. Appendices D.3 Microbiology Testing
D.3.1 Filtration sterility checks specified
D.3.6 Laboratory allowed to make media from basic ingredients if better than commercial
D Air LOD specs replaced with section D.1.2.1

45. Improvements and Reminders Technical Director (4.1.1.1)
Grandfathering ended after first round
New TD must meet educational and experience requirements
Exceptions of still apply
Technical Directorship is portable for specific scope
Lab must notify the ELCP of change within 30 days
Lab submits documentation, which will be scrutinized
ELCP evaluates and replies

46. Improvements and Reminders “On-going DOC (5.5.2.6(c))”
Analyst training files must contain documentation of:
Technical training courses
Using latest version of quality documentation and test method
Continued proficiency
Appendix C certificate unnecessary

47. Improvements and Reminders “Latest Version of the Test Method (5. 5. 4
Latest valid edition of a “standard” (e.g., methods published in CFR)
If a choice of editions, use latest
Otherwise, define in document control system
If not defined by lab, must use latest available published version

48. Improvements and Reminders Proficiency Testing Frequency
2 studies per fiscal year per FOPT (matrix-technology/method-analyte)
Matrix-analyte defined by NELAC PT tables (New tables for water effective June 1)
Multiple technologies allowed
Report each DW method once per year even if the same technology
AND < 7 months between studies (measured closing to closing)
> 15 days between studies (measured closing to shipping)

49. Improvements and Reminders Proficiency Testing Types
“Regular” studies required for routine bi-annual testing
“Supplemental” studies allowed only for remedial action or expansion of scope

50. Improvements and Reminders Proficiency Testing Performance
Passing 2 of the latest 3 attempts is acceptable
Non-participation within 7 months counts as a failure
Run PTs like samples (or, if preferred, run samples like PTs)

51. Improvements and Reminders Proficiency Testing Reporting
Report the correct method identifier
Prior to study closing, designate DOH to receive the final report
Unless the fault of the provider, reports cannot be changed after the results are released

52. Web Stuff
Application, Rules, Checklists Information on Certified Laboratories NELAC Standards, PT Tables