§ 252.304. Personnel requirements.
(a) General requirements for technical staff.
(1) An environmental laboratory shall have sufficient personnel with the necessary education, training, technical knowledge and experience for their assigned functions.
(2) Each member of the environmental laboratory technical staff shall be responsible for complying with quality assurance and quality control requirements that pertain to the member’s organizational or technical function.
(3) Each environmental laboratory technical staff member shall have a combination of experience and education to adequately demonstrate a specific knowledge of the member’s particular function and a general knowledge of laboratory operations, test methods, quality assurance and quality control procedures and records management.
(4) If a method, regulation or program requires more stringent qualifications for education or experience, or both, the laboratory technical staff shall meet the more stringent requirement.
(b) Laboratory management responsibilities. The environmental laboratory management shall be responsible for:
(1) Defining the minimal level of qualification, experience and skills necessary for all positions or work cells in the environmental laboratory.
(2) Ensuring and documenting that the environmental laboratory technical staff members or work cells have demonstrated capability in the activities for which they are responsible. This documentation must include:
(i) An identification of the analysts involved in the preparation or analysis, or both.
(ii) The sample matrix.
(iii) The analyte, class of analyte or measured parameter.
(iv) An identification of the test method performed.
(v) An identification of the laboratory-specific standard operating procedure used for analysis, including revision number and effective date.
(vi) The dates of preparation or analysis, or both.
(vii) The summary of analyses, including results.
(3) Ensuring and documenting that the training and competency of each member of the environmental laboratory technical staff is kept up to date by maintaining records demonstrating the following:
(i) That each employee has read, understood and is using the latest version of the environmental laboratory’s quality manual that relates to each employee’s job responsibilities.
(ii) That each employee has read, understood and is using the latest versions of the environmental laboratory’s standard operating procedures that relate to each employee’s job responsibilities.
(iii) Participation in training courses or workshops on specific equipment, analytical techniques or laboratory procedures that relate to each employee’s job responsibilities.
(iv) Participation in training courses in ethical and legal responsibilities including the potential liabilities for improper, unethical or illegal actions.
(v) That each employee has read, understood and acknowledged his personal ethical and legal responsibilities including the potential punishments and penalties for improper, unethical or illegal actions.
(vi) An initial demonstration of capability for each method that relates to the employee’s job responsibilities has been performed. The initial demonstration of capability requirements are as follows:
(A) An initial demonstration of capability is required prior to the use of any method.
(B) An initial demonstration of capability shall be completed each time there is a change in instrument type, personnel or method.
(C) An initial demonstration of capability must include all sample preparation and analytical steps contained in the method.
(D) If the method or State or Federal regulations specify a procedure for the initial demonstration of capability, that procedure shall be followed; otherwise, an initial demonstration of capability shall be performed as follows:
(I) The analyte shall be diluted in a volume of clean matrix sufficient to prepare four aliquots at the concentration specified in the method. If the method does not specify a concentration, the concentration must be in the lower half of the calibration range or at or below the maximum contaminant level for Safe Drinking Water Act compliance testing, whichever is lower.
(II) At least four aliquots of the quality control sample shall be prepared and analyzed consecutively according to the method. The preparation or analysis, or both, may occur on a single day or over the course of multiple days.
(III) Using all of the results, calculate the individual recovery, the mean recovery and the standard deviation of the mean recovery for the population sample in the same units used to report environmental samples. When it is not possible to determine mean and standard deviation, such as for presence-absence and logarithmic values, the environmental laboratory shall assess method performance using criteria from the method or other established and documented criteria.
(IV) Compare the information from subclause (III) to the corresponding acceptance criteria for precision and accuracy in the method. If the method or regulation does not specify acceptance limits, the % Relative Standard Deviation must be less than 20%. To be considered acceptable, an initial demonstration of capability must meet all acceptance criteria.
(E) When a method has been in use by an environmental laboratory prior to January 1, 2005, and there have been no changes in instrument type, personnel or method, the environmental laboratory shall have records on file to demonstrate that an initial demonstration of capability is not required.
(F) The laboratory shall retain all data necessary to reproduce the initial demonstration of capability.
(G) The work cell as a unit shall meet the following requirements:
(I) When a member of a work cell changes, the new work cell shall demonstrate capability by means of acceptable quality control performance checks on four consecutive batches. The acceptable performance shall be documented. If any quality control performance check within the four consecutive batches following the change in personnel fails to meet acceptance criteria, an initial demonstration of capability shall be completed.
(II) If the entire work cell is changed, an initial demonstration of capability shall be completed.
(vii) A demonstration of continued proficiency by at least one of the following every 12 months for each method that relates to the employee’s job responsibilities:
(A) Another initial demonstration of capability.
(B) Acceptable performance of blind performance samples (single blind to the analyst).
(C) Successful analysis of blind proficiency test samples on a similar test method using the same technology (for example—GC/MS volatiles by purge and trap for EPA Methods 524.2, 624 or 5030/8260 would require documentation for only one of the test methods).
(D) At least four consecutive laboratory control samples with acceptable levels of precision and accuracy as required by the initial demonstration of capability described in subparagraph (vi).
(E) Analysis of at least ten authentic samples with results statistically indistinguishable from those obtained by another trained analyst. The samples must include samples free of the analyte of interest and samples containing the analyte of interest at measurable concentrations.
(4) Supervising personnel employed by the laboratory.
(5) Establishing and implementing procedures and processes for permitting departures from documented policies and procedures.
(6) Ensuring that sample acceptance criteria are verified and that samples are logged into the sample tracking system and properly labeled and stored.
(7) Developing a proactive program for prevention and detection of improper, unethical or illegal actions. Components of this program may include the following:
(i) Internal proficiency testing (single and double blind).
(ii) Postanalysis electronic data and magnetic tape audits or reviews.
(iii) Separate standard operating procedures identifying appropriate and inappropriate laboratory and instrument manipulation practices.
(c) An environmental laboratory shall maintain records on initial demonstrations of capability, demonstrations of continued proficiency, proficiency test samples for each laboratory method and the qualifications, training, skills and experience of the laboratory technical staff members.
Authority The provisions of this § 252.304 amended under 27 Pa.C.S. § § 4103(a), 4104 and 4105; and section 1920-A of The Administrative Code of 1929 (71 P.S. § 510-20).
Source The provisions of this § 252.304 amended April 9, 2010, effective April 10, 2010, 40 Pa.B. 1898; amended July 28, 2017, effective July 29, 2017, 47 Pa.B. 4085. Immediately preceding text appears at serial pages (352728) and (348799) to (348802).
Cross References This section cited in 25 Pa. Code § 252.401 (relating to basic requirements).
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