RULES AND REGULATIONS
Title 25—ENVIRONMENTAL PROTECTION
ENVIRONMENTAL QUALITY BOARD
[ 25 PA. CODE CH. 252 ]
Environmental Laboratory Accreditation
[40 Pa.B. 1898]
[Saturday, April 10, 2010]
Order The Environmental Quality Board (Board) amends 25 Pa. Code Chapter 252 (relating to environmental laboratory accreditation). The final-form rulemaking clarifies existing requirements, eliminates unnecessary requirements and proposes additional requirements necessary for laboratory accreditation. The final-form rulemaking also revises the fee structure found in 25 Pa. Code § 252.204 (relating to fees).
This proposal was adopted by the Board at its meeting of December 15, 2009.
A. Effective Date
These final-form rulemaking amendments will go into effect upon publication in the Pennsylvania Bulletin.
B. Contact Persons
For further information, contact Aaren S. Alger, Chief, Laboratory Accreditation Program, P. O. Box 1467, Harrisburg, PA 17105-1467, (717) 346-8212; or Michelle Moses, Assistant Counsel, Bureau of Regulatory Counsel, P. O. Box 8464, Rachel Carson State Office Building, Harrisburg, PA 17105-8464, (717) 787-7060. Persons with a disability may use the Pennsylvania AT&T Relay Service by calling (800) 654-5984 (TDD users) or (800) 654-5988 (voice users). This proposal is available electronically through the Department of Environmental Protection's (Department) web site, http://www.dep.state.pa.us.
C. Statutory Authority
This final-form rulemaking is being made under the authority of 27 Pa.C.S. § 4103(a) (relating to establishment of program), which directs the Department to establish an accreditation program for environmental laboratories, 27 Pa.C.S. § 4104 (relating to powers and duties) which directs the Department to establish, administer and enforce an environmental laboratory accreditation program (Program) which includes the standards necessary for a state certification program, 27 Pa.C.S. § 4105 (relating to powers and duties of Environmental Quality Board), delegating the Board the power to adopt the regulations of the Department to implement 27 Pa.C.S. §§ 4101—4113 and section 1920-A of The Administrative Code of 1929 (71 P. S. § 510-20), authorizing and directing the Board to adopt regulations necessary for the proper performance of the work of the Department.
D. Background and Purpose
The regulations governing environmental laboratory accreditation in Chapter 252 became effective on January 28, 2006. While completing the first round of laboratory assessments under these regulations, the Program discovered various provisions that are unclear or where the rules are overly restrictive and cost prohibitive to the regulated community. The Program also determined that several necessary standards for accreditation were missing.
Under 27 Pa.C.S. § 4104(6), the accreditation fees must be ''in an amount sufficient to pay the Department's cost of implementing and administering the accreditation program.'' In addition, § 252.204(b) requires the Department to recommend to the Board regulatory changes to the accreditation fees every 3 years to address any disparity between the Program income generated by the fees and Program costs. In accordance with this requirement, the Program performed a workload analysis to evaluate the costs associated with the Program. Based on this workload analysis, the Department determined that the accreditation fees in § 252.204 were not sufficient to recover the Department's costs to implement the Program. These final-form regulations provide a new fee structure to cover the costs of the Program.
The Department worked with the Laboratory Accreditation Advisory Committee (LAAC) to amend Chapter 252 in a manner that ensures appropriate requirements for environmental laboratory accreditation. The Department and the LAAC ensured that the interests, concerns and needs of the regulated community were considered and implemented as appropriate. The LAAC met throughout 2008 and 2009 to review and comment on the Chapter 252 amendments presented by the Department. On September 10, 2009, the LAAC unanimously voted to recommend the final-form Chapter 252 amendments for presentation to the Board.
E. Summary of Changes Made in the Final-form Rulemaking
Subchapter A. General Provisions § 252.1 (relating to definitions). At final rulemaking, the term and definition for ''laboratory notebook'' was reinstated throughout the chapter in response to a comment by the Independent Regulatory Review Commission (IRRC) concerning recordkeeping format. A definition for proficiency test reporting limit was also added at final rulemaking. This definition was necessary because the proposed NELAC Institute (TNI) standard does not mandate that proficiency testing samples be evaluated to this level. This term was used in § 252.501 (relating to proficiency test study requirements).
§ 252.5 (relating to NELAP/TNI equivalency). The requirement of NELAP or TNI laboratories to adhere to the provisions of Subchapter E (relating to proficiency test study requirements) was included at final rulemaking. Because TNI's proposed standard does not require NELAP laboratories to meet the Safe Drinking Water Act (SDWA) requirements, it was necessary for the Department to include this requirement at final rulemaking.
Subchapter B. Application, Fees and
Supporting Documents§ 252.205 (relating to out-of-State laboratories). At final rulemaking, all of the terms ''accrediting authority'' were changed to ''accreditation body'' to be consistent with the terms used by TNI. The requirement for secondarily accredited laboratories to submit copies of their proficiency testing studies was deleted.
Subchapter C. General Standards for Accreditation § 252.301 (relating to laboratory supervisor). Clarification was made at final rulemaking to subsection (g) to specify that a temporary absence of a laboratory supervisor requires notification to the Department within 30 calendar days.
§ 252.304 (relating to personnel requirements). Based on comments received the Department revised § 252.304 to included specific recordkeeping requirements that laboratories must meet to demonstrate that an analyst has demonstrated capability. Additionally, the requirement of a new member of a work cell to work with an experienced member of the work cell has been deleted from the proposed rulemaking.
§ 252.306 (relating to equipment, supplies and reference materials). Editorial changes were made to this section at final rulemaking, such as changing all of the terms ''standardization'' to ''calibration.'' Subsection (h) was amended to specify that the laboratory may choose to use reagents, standards or reference materials past their expiration dates as long as they are reevaluated and validated by a procedure approved by the Department. The Department will evaluate each laboratory-developed procedure on a case-by-case basis and determine acceptability.
Subchapter D. Quality Assurance and Quality Control Requirements § 252.401 (relating to basic requirements). Subsections (j), (k) and (m) were amended at final rulemaking by making minor editorial revisions that provide greater clarity to the regulatory requirements.
§ 252.404 (relating to essential quality control requirement—microbiology). Minor editorial changes and amendments were made throughout this section at final rulemaking. These changes include reinstating the term ''laboratory notebook'' and clarification to subsection (g) by instructing the laboratory that a sterility blank must be filtered through each membrane filtration unit after every ten samples.
Subchapter E. Proficiency Test Study Requirements § 252.501 (relating to proficiency test study requirements). Subsections (n) and (o) were added at final rulemaking to specify that laboratories seeking to obtain or maintain accreditation in the drinking water matrix must also meet the proficiency testing requirements of the SDWA and 40 CFR Part 141 (relating to national primary drinking water regulations). Laboratories must also continue to report proficiency testing results to the proficiency test reporting limit (PTRL) established by the Department. These PTRLs will be published in the Pennsylvania Bulletin.
Subchapter G. Miscellaneous Provisions § 252.703 (relating to suspension). Clarification to subsection (c)(3) was made at final rulemaking to point the reader to the personnel requirements for a laboratory supervisor.
§ 252.704 (relating to voluntary relinquishment). Subsection (a) was amended at final rulemaking to specify that in addition to a laboratory wishing to voluntarily relinquish its accreditation in full, a laboratory wishing to voluntarily relinquish accreditation for a particular field of accreditation must notify the Department in writing. An editorial change was made to subsection (b) at final rulemaking to change the term ''insure'' to ''ensure.''
§ 252.705 (relating to use of accreditation). The requirement to post the fields of accreditation listing in the laboratory was removed at final rulemaking.
§ 252.706 (relating to recordkeeping). Subsection (b) was amended at final rulemaking to include proficiency test studies, initial demonstration of capability, and demonstration of continued proficiency to those records that must be maintained in a manner that allows reconstruction of all laboratory activities. These additions will aid the regulated community in understanding the Department's intent. These additions do not impose additional requirements, but more clearly instruct the reader.
§ 252.708 (relating to reporting and notification requirements). Editorial changes were made throughout this section at final rulemaking. These include changing the terms ''inorganic and wet chemistry'' to ''trace metals and inorganic nonmetals'' in subsection (a)(2), adding the term ''radiochemistry'' to subsection (a)(3), clarifying that the laboratory supervisor notification in subsection (b) relates to a permanent change, and changing the term ''accrediting authority'' to ''accreditation body'' in subsection (f).
F. Summary of Comments and Responses on the Proposed Rulemaking
The Board approved publication of the proposed rulemaking at its April 21, 2009, meeting. The proposed rulemaking was published at 39 Pa.B. 3051 (June 20, 2009), with a 30-day public comment period. Comments were received from two commentators, including IRRC, as a result of the public comment period. Several comments were received regarding the laboratory supervisor qualifications and recordkeeping requirements. Most of the comments received were requests for clarification.
A description of the comments received and the Department's response follows:
Laboratory Supervisor: One commentator stated that the current regulations should allow additional time to replace a laboratory supervisor. The revised regulations should extend the time to at least 90 days instead of the current 30 days to find a supervisor. Small wastewater treatment laboratories that do not have several chemists with bachelor's degrees on staff do not have the depth to name a person on staff as a supervisor with the resignation of a supervisor. As the current ''grandfathered'' supervisors retire or seek other positions, or both, it will be harder for the municipal sector to quickly hire qualified applicants.
The Department disagrees with the commentator's argument. The regulation requires designation of an alternate laboratory supervisor for temporary absences greater than 16 days but does not require that the Department be notified unless the temporary absence is greater than 30 days. An absence of a laboratory supervisor for greater than 16 days could adversely affect the quality of the data produced by the laboratory, especially in the case of a laboratory that operates 7 days a week. The Department believes that allowing a laboratory to continue to operate unsupervised for longer than 16 days would create a situation that could result in unacceptable data generation. In the case of permanent changes to a laboratory supervisor, the Department expects the laboratory to provide notification within 20 days of the change. The notification of a permanent change within 20 days allows the Department to be made aware earlier in the replacement process and available to offer guidance to the laboratory with regard to the laboratory supervisor qualification requirements.
One commentator requested that consideration should be made to allow supervisors to take a test in the laboratory methods to be certified as a supervisor. The Operator Certification Program does not have anything to do with the current job responsibilities of a laboratory supervisor. There needs to be a way to certify supervisors with a specific laboratory test to allow those with extensive experience to be qualified.
The Department agrees with the commentator. The Department is currently developing the laboratory supervisor subclassification under the Water and Wastewater Systems Operators' Certification Act (63 P. S. §§ 1001—1015.1). The provision in § 252.302(h)(2) and (3) (relating to qualifications of the laboratory supervisor) is included because the regulations authorizing the subclassification are also in the regulatory development process and are expected to be completed in the near future.
One commentator stated that the current regulations require extensive education for the laboratory supervisor or the operator's exam, stating that additional education has been added to § 252.302 to require that supervisors have 4-semester hours of general microbiology, and that now supervisors must have educational credits in microbiology as well as chemistry. Thus placing an additional burden on wastewater treatment plants that now have one person in charge of the laboratory.
The Department disagrees with the commentator. Section 252.302(d) does not include additional requirements. The Department made the educational requirements more lenient by changing the requirement for semester credit hours in ''general microbiology'' to ''biology.''
Record Retention and Documentation: One commentator stated that several sections of this chapter require record retention or recording of information, but are unclear in regard to a specific method of retention or recording and that the duration of the required retention is not set forth.
The Department agrees with the commentator. Section 252.706(d) requires that all records that are required by Chapter 252 regulations be maintained for a minimum of 5 years. The Department reinstated the definition for a ''laboratory notebook'' and included the phrase ''in a laboratory notebook'' where the proposed rulemaking deleted these phrases.
One commentator stated that § 252.304(b)(3)(vi)(F) requires labs to retain ''all data necessary'' to reproduce the initial demonstration of capability and suggested that the regulation include the specific recordkeeping requirements necessary to meet this requirement.
The Department agrees with the commentator. The Department added the specific documentation to be maintained by the laboratory to document initial demonstration of capability and demonstrations of continued proficiency. Section 252.706(b) requires each ''environmental laboratory to maintain records that allow reconstruction of all laboratory activities associated with the testing or analysis of environmental samples.'' The Department added ''proficiency test study samples, initial demonstrations of capability and demonstrations of continued proficiency'' to this section.
General Comments: One commentator stated that the quality control requirements in the regulations are extensive. The Department should consider additional training to allow the small water and wastewater treatment plants to continue to operate their laboratories. The requirements may be forcing plants to abandon their laboratories and contract work out at a high cost to the utility customers. There needs to be a balance on quality control. There should be consideration for more outreach to help the small laboratories.
The Department agrees with the commentator. The Department continues to develop and provide training courses to assist applicant laboratories in remaining compliant with the laboratory accreditation requirements. These courses are approved for continuing education credits for the Operators' Certification Program. Further opportunities for assistance are available through the Program's web site, direct contact with the laboratory's accreditation officer, and the onsite assessment process.
One of the commentators stated that § 252.304(b)(3) (vi)(E) allows laboratory methods used prior to January 1, 2005, to be exempt from the initial demonstration of capability and asked why this date was chosen.
The Department disagrees. This language is the same language from the January 28, 2006, version of Chapter 252; it has been relocated to this section to keep all demonstration of capability requirements located in the same section of the regulation. The January 1, 2005, date was chosen because it was 1 year before the environmental laboratory accreditation rulemaking was originally promulgated.
One of the commentators stated that under the provisions of § 252.304(b)(3)(vi)(G)(I), a new employee in a work cell must work with an experienced analyst, but does not include a specified time frame for how long this must occur.
The Department agrees with this commentator and deleted § 252.304(b)(3)(G)(I).
One of the commentators stated that § 252.304(b)(3)(vi) (G)(II) mentions ''acceptable'' quality control performance checks but does not instruct the regulated laboratory as to an acceptable procedure.
The Department disagrees with the commentator. The term ''acceptable'' refers to the requirements of the specific method, regulation, laboratory standard operating procedures, or client-specific requirement. The next sentence in this clause specifies that the quality control must meet acceptance criteria. ''Acceptable quality control'' is a term that is well understood by environmental laboratory personnel and must be defined in each laboratory standard operating procedure.
One of the commentators requested clarification for § 252.306(f)(9)(i), asking what is an ''appropriate'' method for checking delivery volumes of mechanical volumetric dispensing devices?
The Department agrees with the commentator and deleted the phrase, ''using an appropriate method.''
One commentator requested clarification regarding § 252.306(h)(6) and the term ''Department approved procedure'' used to reevaluate and validate certain materials used past their expiration date.
The wording was changed to clarify that it is not a procedure developed by the Department, but a laboratory-developed procedure that is approved by the Department. A laboratory would apply for permission by submitting a request in writing to the Department. The Department is not requiring a specific format at this time to allow laboratories the flexibility to use laboratory-developed procedures. The method for validation of an expired chemical would be dependent upon the chemical. The Department will notify the laboratory by mail of its decision.
G. Benefits, Costs and Compliance
Benefits
The most significant benefit of these final-form regulations will be the benefit of clear, concise and improved regulations for the regulated community. The final-formamendments will allow for better understanding and increased compliance with the requirements and thus result in an improvement in the overall quality of the data produced by environmental laboratories.
Improved data quality will allow the Department, the regulated community, and the citizens of this Commonwealth to make better decisions concerning the protection of the environment and the protection of public health, safety and welfare. Accurate laboratory results are critical to achieving the goals of the environmental laws.
Compliance Costs
The direct costs of the final-form regulations will be payment of the required fees. The Department is required to set fees in an amount sufficient to cover the cost of establishing and maintaining a laboratory accreditation program. These costs will vary depending upon the type of testing and analyses that the environmental laboratory chooses to perform. Laboratories that require extensive staff time to accredit such as large commercial laboratories and NELAP laboratories will pay a higher accreditation fee. The final-form regulations contain a fee structure that is responsive to the needs of small laboratories. Categories of testing for basic drinking water parameters and for basic wastewater parameters have been increased by only $50 per category. These smallest environmental laboratories currently pay $1,200 annually and the final-form fee structure will require an annual fee of $1,250. In addition, changes to the fee structure include payment of fees based on the number of matrices requested rather than a fee for a specific type of matrix. This structure allows for a laboratory performing a combination of matrices to pay a lower fee.
Compliance Assistance Plan
The final-form amendments are minor and in most cases clarify existing requirements or eliminate unnecessary requirements. As such, the Department does not believe that a compliance assistance plan tailored to the final-form regulations is necessary. However, the Department will continue its ongoing compliance assistance efforts.
The ultimate goal of the compliance assistance effort will be improving an environmental laboratory's ability to produce valid and defensible data for use by the Department, the regulated community, and the public. Several areas where compliance assistance is necessary are general laboratory operation, correct performance of specific test procedures, and documentation of laboratory activities. Compliance assistance in these areas has been made available to all environmental laboratories regardless of size throughout this Commonwealth.
H. Sunset Review
These regulations will be reviewed in accordance with the sunset review schedule published by the Department to determine whether the regulations effectively fulfill the goals for which they were intended.
I. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), the Department submitted a copy of the notice of proposed rulemaking, published at 39 Pa.B. 3051, to IRRC and to the House and Senate Environmental Resources and Energy Committees (Committees) for review and comment.
Under section 5(c) of the Regulatory Review Act, IRRC and the Committees were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing these final-form regulations, the Department has considered all comments from IRRC, the Committees and the public.
Under section 5.1(j.2) of the Regulatory Review Act, on February 24, 2010, these final-form regulations were deemed approved by the Committees. Under section 5.1(e) of the Regulatory Review Act, IRRC met on February 25, 2010, and approved the final-form regulations.
J. Findings of the Board
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968, (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and regulations promulgated there under at 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law, and all comments were considered.
(3) These regulations do not enlarge the purpose of the proposal published at 39 Pa.B. 3051.
(4) These regulations are necessary and appropriate for administration and enforcement of the authorizing acts identified in Section C of this order.
K. Order of the Board
The Board, acting under the authorizing statutes, orders that:
(a) The regulations of the Department, 25 Pa. Code Chapter 252, are amended by amending §§ 252.4, 252.6, 252.202, 252.204, 252.307, 252.402, 252.403, 252.405, 252.601 and 252.707 to read as set forth at 39 Pa.B. 3051; and by amending §§ 252.1, 252.5, 252.205, 252.301, 252.302, 252.304, 252.306, 252.401, 252.404, 252.501, 252.703, 252.704, 252.706 and 252.708 to read as set forth in Annex A, with ellipses referring to the existing text of the regulations.
(b) The Chairperson of the Board shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General for review and approval as to legality and form, as required by law.
(c) The Chairperson of the Board shall submit this order and Annex A to IRRC and the Committees as required by the Regulatory Review Act.
(d) The Chairperson of the Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau, as required by law.
(e) This order shall take effect immediately.
JOHN HANGER,
Chairperson
Environmental Quality Board(Editor's Note: The amendment of §§ 252.703 and 252.704 was not included in the proposal at 39 Pa.B. 3051.)
(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 40 Pa.B. 1471 (March 13, 2010).)
Fiscal Note: Fiscal Note 7-434 remains valid for the final adoption of the subject regulations.
Annex A
TITLE 25. ENVIRONMENTAL PROTECTION
PART I. DEPARTMENT OF ENVIRONMENTAL PROTECTION
Subpart D. ENVIRONMENTAL HEALTH AND SAFETY
ARTICLE VI. GENERAL HEALTH AND SAFETY
CHAPTER 252. ENVIRONMENTAL LABORATORY ACCREDITATION
Subchapter A. GENERAL PROVISIONS § 252.1. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
* * * * * Accreditation body—A territorial, State or Federal agency having responsibility and accountability for environmental laboratory accreditation and which grants accreditation.
* * * * * Action level—The concentration of a contaminant which, if exceeded, triggers a treatment or other requirement which a water system must follow.
* * * * * Laboratory notebook—A chronological record of observations, results of testing or analysis, equipment maintenance or calibration or other environmental laboratory data. A laboratory notebook may be maintained in an electronic format.
* * * * * NELAP accreditation body—An accreditation body that has been recognized as meeting the requirements of the NELAC Standard or the TNI Standard and has the authority to grant NELAP or TNI accreditation.
Nonpotable water—
(i) Any aqueous sample excluded from the definition of drinking water matrix.
(ii) The term includes wastewater, ambient water, surface water, groundwater, effluents, water treatment chemicals and leachates.
* * * * * Primary accreditation—Accreditation received from the Department that is not based upon accreditation from another accreditation body.
Proficiency test reporting limit—The value that corresponds to the lowest acceptable result that could be obtained from the lowest spike level for each analyte in a proficiency test sample.
* * * * * Secondary accreditation—Accreditation received from the Department based upon the accreditation status granted by another accreditation body.
* * * * * TNI—The NELAC Institute or its successor organization/Standard.
* * * * * § 252.5. NELAP/TNI equivalency.
(a) An environmental laboratory may apply to the Department for NELAP accreditation for the fields of accreditation for which the Department offers accreditation.
(b) An environmental laboratory seeking NELAP accreditation shall:
(1) Submit a complete application as provided in Subchapter B (relating to application, fees and supporting documents).
(2) Comply with Subchapter E (relating to proficiency test study requirements).
(3) Comply with Subchapter F (relating to onsite assessment requirements).
(4) Comply with Subchapter G (relating to miscellaneous provisions).
(5) Comply with the current edition of the NELAC Standard or TNI Standard.
(c) An environmental laboratory receiving NELAP accreditation from the Department may apply for accreditation under the remainder of this chapter for the fields of accreditation that are not included in NELAP accreditation and for which the Department offers accreditation.
(d) An environmental laboratory receiving NELAP accreditation from the Department may only test or analyze environmental samples within the fields of accreditation authorized by the accreditation received from the Department.
Subchapter B. APPLICATION, FEES AND SUPPORTING DOCUMENTS § 252.205. Out-of-State laboratories.
(a) Out-of-State environmental laboratories may apply for primary accreditation or secondary accreditation from the Department.
(1) Primary accreditation. Out-of-State environmental laboratories may apply to the Department for primary accreditation under this chapter.
(2) Secondary accreditation.
(i) The Department will recognize accreditation granted by a primary NELAP/TNI accreditation body for the same fields of accreditation for which the Department is a primary NELAP/TNI accreditation body.
(ii) The Department may recognize the accreditation of an environmental laboratory by another state accreditation body if the standards for accreditation are substantially equivalent to those established under this chapter and the laboratory is physically located within the state granting accreditation.
(iii) An environmental laboratory seeking secondary accreditation from the Department shall:
(A) Submit a properly completed application on forms provided by the Department.
(B) Pay the appropriate fee.
(C) Submit a copy of a valid accreditation certificate from the primary accreditation body.
(D) Submit a copy of all onsite assessment reports conducted by the primary accreditation body within the last 3 years.
(E) Submit any other material relevant to accreditation, upon request of the Department.
(b) The Department may conduct an onsite assessment or require analysis of a proficiency test study by an out-of-State environmental laboratory seeking secondary accreditation for reasons which may include addressing complaints from the public or Department personnel, discrepancies with environmental sample results, onsite assessment deficiencies, frequent errors in reporting data to the Department and suspicions of fraud regarding data quality. If the Department determines that an onsite assessment is required, the environmental laboratory shall pay the Department's travel costs associated with the onsite assessment in accordance with § 252.206 (relating to out-of-State onsite reimbursement).
(c) If any portion of the out-of-State environmental laboratory's accreditation is denied, revoked or suspended by the primary accreditation body, the laboratory's authorization to perform testing or analysis is automatically revoked for the same fields of accreditation.
Subchapter C. GENERAL STANDARDS FOR ACCREDITATION § 252.301. Laboratory supervisor.
(a) The Department will consider the laboratory supervisor of an environmental laboratory as the individual listed on the laboratory's application for accreditation for which the Department has reviewed and approved the individual's qualifications.
(b) Testing, analysis and reporting of data by an environmental laboratory shall be under the direct supervision of a laboratory supervisor.
(c) The laboratory supervisor shall certify that each test or analysis is accurate and valid and the test or analysis was performed in accordance with all conditions of accreditation. A laboratory supervisor may certify a test or analysis by signing the final laboratory report. A laboratory may use other mechanisms to certify a test or analysis, provided the mechanism is documented in the laboratory quality manual.
(d) The laboratory supervisor shall ensure that the records required by this chapter are maintained.
(e) The Department may disqualify a laboratory supervisor who is responsible for the submission of inaccurate test or analysis results.
(f) The Department will disqualify a laboratory supervisor convicted of any crime or offense related to violations of State or Federal laws or regulations related to the provision of environmental laboratory services or reimbursement for the services.
(g) An environmental laboratory may appoint one or more laboratory supervisors for the appropriate fields of accreditation for which they are seeking accreditation.
(h) An environmental laboratory shall designate another staff member meeting the qualifications of a laboratory supervisor to temporarily perform this function when a laboratory supervisor is absent for a period of time exceeding 16 consecutive calendar days. If this temporary absence exceeds 30 consecutive calendar days, the environmental laboratory shall notify the Department in writing under § 252.708 (relating to reporting and notification requirements).
(i) An individual may not be the laboratory supervisor of more than one environmental laboratory without authorization from the Department. Circumstances to be considered in the decision to grant the authorization will include at least the following:
(1) The extent to which operating hours of the laboratories to be supervised overlap.
(2) The adequacy of supervision in each laboratory.
§ 252.302. Qualifications of the laboratory supervisor.
* * * * * (c) A laboratory supervisor of an environmental laboratory engaged in microbiological or biological analysis shall have the following qualifications:
(1) A bachelor's degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering.
(2) At least 16-college semester credit hours in general microbiology or biology.
(3) At least 2 years of experience in the testing or analysis of environmental samples in representative microbiological or biological fields of accreditation for which the environmental laboratory seeks to obtain or to maintain accreditation. A master's or doctoral degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering may be substituted for 1 year of experience.
(d) A laboratory supervisor of an environmental laboratory engaged in microbiological analysis limited to fecal coliform, total coliform and heterotrophic bacteria shall have the following qualifications:
(1) At least an associate's degree in chemistry, biochemistry, physics, environmental science, biology, microbiology, physical sciences or engineering.
(2) A minimum of 4-college semester credit hours in biology.
(3) At least 2 years of equivalent and successful college education, including a minimum of 4-college semester credit hours in biology may be substituted for the associate's degree.
(4) At least 2 years of experience in the testing or analysis of environmental samples in representative fields of accreditation for which the environmental laboratory seeks to obtain or to maintain accreditation.
* * * * * § 252.304. Personnel requirements.
* * * * * (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 labora- tory'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 approximately ten times the detection limit.
(II) At least four aliquots of the quality control sample shall be prepared and analyzed according to the method.
(III) Using all of the results, calculate 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. 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.
* * * * * § 252.306. Equipment, supplies and reference materials.
* * * * * (f) The following pieces of equipment shall be maintained according to this subsection.
* * * * * (2) Working thermometers.
(i) Working thermometers must have appropriate graduations and a range that spans the requirements of the method.
(ii) Working thermometers may be glass, dial or electronic and shall be calibrated against a certified NIST-reference thermometer as follows:
(A) Glass, liquid filled thermometers shall be calibrated every 12 months at the temperature used.
(B) Dial and electronic thermometers shall be calibrated every 3 months at the temperature used. Electronic thermometers accompanied by a valid NIST traceable certificate of acceptance may be used for 12 months from the date of receipt before re-calibration.
(C) An environmental laboratory shall maintain records in a laboratory notebook for each working thermometer that document the date of calibration, NIST reference thermometer identification, working thermometer identification, reference thermometer temperature reading, working thermometer temperature reading, correction factor and the initials of the individual conducting the calibration.
(D) Working thermometers shall be uniquely identified and labeled with the date of calibration and correction factor.
(iii) The fluid column in glass thermometers may not be separated.
(iv) A working thermometer that differs by more than 2.0°C from the reference thermometer may not be used.
(3) ASTM class 1, 2 or 3 (Class S or S-1), or better certified reference weights.
(i) The mass of ASTM class 1, 2 or 3 (Class S or S-1), or better certified reference weights shall be recertified at least once every 5 years.
(ii) An environmental laboratory shall retain a certificate documenting traceability of the calibration to ASTM standards.
(4) Analytical or pan balances.
(i) Analytical or pan balances must provide sufficient accuracy and sensitivity for the weighing needs of the method.
(ii) An environmental laboratory shall verify the calibration of a balance daily or before each use, whichever is less frequent.
(iii) A reference weight that is damaged or corroded may not be used for calibration of balances.
(iv) Balance calibration shall be verified using a minimum of three ASTM class 1, 2 or 3 (Class S or S-1) certified reference weights that bracket the effective range of the balance's use.
(v) An environmental laboratory shall maintain records in a laboratory notebook of balance calibrations that document the balance identification, date of calibration verification, reference weights used and initials of the individual performing the calibration.
(vi) A qualified person shall service and calibrate analytical balances at least once per year.
(vii) Records of annual service shall be maintained and the service date shall be recorded on the balance.
(5) pH meter.
(i) A pH meter must be equipped with an appropriate electrode and have scale graduators and accuracy appropriate to the method.
(ii) An environmental laboratory shall utilize either a thermometer or a temperature sensor for automatic compensation to make corrections for pH measurements.
(iii) The pH meter shall be calibrated daily or before each use, whichever is less frequent, by one of the following:
(A) With at least three standard buffers which are at least three pH units apart and which bracket the expected pH range of the samples.
(B) Use a pH 7.0 and either a pH 4.0 or 10.0 standard buffer; whichever range covers the desired pH range of use.
(iv) Aliquots of standard buffers may not be used for longer than 1 analysis day.
(v) Records of pH meter calibration shall be maintained in a laboratory notebook that document the date of calibration, calibration buffers used and initials of the individual conducting the calibration.
(6) Conductivity meter.
(i) A conductivity meter must have a probe of sufficient sensitivity for the method. The scale must have readability in appropriate units, for example micromhos or microsiemens per centimeter.
(ii) An in-line conductivity meter that cannot be calibrated may not be used.
(iii) An environmental laboratory shall calibrate the conductivity meter daily or before each use whichever is less frequent, by one of the following:
(A) With certified and traceable standard solutions within the range of interest.
(B) By determining the cell constant utilizing the method described in currently approved editions of Standard Methods for the Examination of Water and Wastewater (available from American Public Health Association, 1015 Fifteenth Street NW, Washington, D.C. 20005.)
(iv) Records of conductivity meter calibrations shall be maintained in a laboratory notebook that documents the date of calibration, standards used, results of calibration or cell constant determined and the initials of the individual conducting the calibration.
* * * * * (8) Incubators, water baths, heating blocks and ovens.
(i) An environmental laboratory shall control and monitor the temperature of incubators, water baths, heating blocks and ovens in accordance with the method or as specified by regulations.
(ii) An environmental laboratory shall maintain a minimum of one thermometer per incubator, water bath, heating block or oven immersed in liquid or sand for ovens (except electronic thermometers) to the appropriate immersion line. When used as an incubation unit for microbiology, a minimum of one working thermometer shall be on the top and bottom shelf of the use area in each incubator.
(iii) When used as an incubation unit for microbiology, a water bath must be equipped with a gable cover and a pump or paddles to circulate the water.
(iv) Calibration-corrected temperatures for each incubator, water bath, heating block or oven shall be recorded once a day for each day in use for all laboratory activities. When used as an incubation unit for microbiology, the calibration-corrected temperature shall be recorded at least twice per day in use with the readings separated by at least 4 hours. The incubator, water bath, heating block or oven identification, date, time, calibration corrected temperature and the initials of the responsible individual shall be recorded.
(9) Volumetric dispensing devices.
(i) Except for Class A glassware, mechanical volumetric dispensing devices including burettes, autopipetors and dilutors, must be of sufficient sensitivity for the application. Delivery volumes of mechanical volumetric dispensing devices shall be checked at least once every 3 months.
(ii) Verification will be considered acceptable if the accuracy of the volumetric dispensing device is within 2.5% of expected values. Volumetric dispensing devices that do not meet this criterion may not be used.
(10) Graduated sample containers.
(i) Except for Class A glassware, when graduation marks on filter funnels, sample bottles or labware are used to measure sample volume, an environmental laboratory shall verify and document the accuracy of the volume of use for each lot or at least once per year, whichever is more frequent.
(ii) Verification will be considered acceptable if the accuracy of the graduated sample container is within 2.5% of expected values. Graduated sample containers that do not meet this criterion may not be used to measure sample volumes.
(g) An environmental laboratory shall maintain records for all reference materials, reagents and support services utilized by the laboratory for testing or analysis.
(h) Reference materials, reagents, media and laboratory supplies that are essential to obtain analytical results (such as filters, solid-phase extraction disks/cartridges, presterilized filtration units, certified precleaned laboratory supplies, disposable volumetric equipment, prepreserved sample containers) must meet the following minimum requirements:
(1) Analytical reagent grade chemicals or equivalent are acceptable, unless a method specifies other reagent purity grade requirements.
(2) Standard, reagent and laboratory supply receipt records shall be maintained. These records must include vendor, lot number, amount received, date of receipt, expiration date and certificates of analysis or purity, if available.
(3) Purchased chemicals, solutions, standards, media and laboratory supplies shall be labeled with date of receipt, expiration date and the date when the container is opened. Purchased chemicals, solutions and standards without an expiration date on the original container shall be discarded after 10 years from the date of receipt.
(4) An environmental laboratory shall maintain records of standard, reagent and media preparation. Standard and reagent preparation records must contain identification of the compound, manufacturer, lot number, concentration, amount prepared, date prepared, final pH if used for microbiology testing, initials of the individual preparing the solution and expiration date.
(5) Reagent and standard solution containers shall be labeled with identification of the compound, traceability to the preparation record, such as unique identifier, and expiration date.
(6) Standards, reagents and media may not be used past the date of expiration unless reevaluated and validated by a procedure approved by the Department prior to use.
(7) Reagent and standard solutions shall be checked regularly for signs of decomposition and evaporation. Reagent and standard solutions exhibiting signs of decomposition or evaporation shall be discarded.
(8) When reagents are removed from a container, the amount removed shall be used entirely or the unused portion discarded.
(9) Compressed gases must be of commercial grade, unless a method specifies other requirements.
(i) Plastic and glassware shall be cleaned to meet the sensitivity of the test method. Any cleaning and storage procedures that are not specified by the method shall be documented in a laboratory standard operating procedure.
Subchapter D. QUALITY ASSURANCE AND QUALITY CONTROL REQUIREMENTS § 252.401. Basic requirements.
(a) An environmental laboratory shall develop and maintain a quality manual appropriate to the type, range and volume of testing and analysis of environmental samples. The quality manual shall be available to and used by environmental laboratory personnel. The quality manual must contain the following:
(1) The full name and physical address of the laboratory.
(2) The name, address (if different from paragraph (1)), and telephone number of the laboratory supervisors.
(3) A revision number and effective date.
(4) A table of contents, and applicable lists of references, glossaries and appendices.
(b) The quality manual must state the environmental laboratory's policies, operational procedures, protocols and practices established to meet the requirements of this chapter. These policies and procedures must include:
(1) An ethics policy statement as specified in subsection (d).
(2) A document control system as specified in subsection (c).
(3) Recordkeeping as specified in § 252.706 (relating to recordkeeping).
(4) The procedures for termination of operations and transfer of records as specified in § 252.706.
(5) The procedures for detecting and permitting departures from established procedures as specified in subsections (i) and (h).
(6) The procedures for detecting and preventing improper practices as specified in § 252.304 (relating to personnel requirements).
(7) The sample handling and acceptance procedures as specified in subsections (f) and (g).
(8) The reporting of analytical results as specified in subsection (j).
(9) The monitoring of the quality of analysis as specified in subsection (l).
* * * * * (d) An environmental laboratory shall develop and maintain an ethics policy statement relevant to the employee's duties and responsibilities under the act.
(1) The laboratory shall implement procedures for educating and training personnel in their ethical and legal responsibilities under the act.
(2) The laboratory shall provide training in ethical and legal responsibilities within 2 months of employment to the laboratory and at least every 14 months thereafter for all employees.
* * * * * (f) An environmental laboratory shall establish procedures for handling environmental samples.
(1) The environmental laboratory shall implement procedures for checking the thermal or chemical, or both, preservation and the sample container. The results of these checks shall be recorded.
(2) The laboratory shall utilize a recordkeeping system that meets the requirements of § 252.706 to document receipt of all sample containers. The recordkeeping system must include the following:
(i) The client/project name.
(ii) The date, time and location of sample collection, name of sample collector and field identification code.
(iii) The date and time of laboratory receipt.
(iv) Any comments resulting from inspection for sample rejection shall be linked to the laboratory ID code.
(v) A unique laboratory ID code that corresponds to the information required by this paragraph.
(vi) An identification of the person making the entries.
* * * * * (j) An environmental laboratory shall develop procedures for reporting results of testing or analysis of environmental samples. Each test report must include at least the following information, except as specified in subsection (k).
(1) The name and address of the laboratory.
(2) The total number of pages in the report, including any addendums, in the format of Page x of y.
(3) The name and address of the client.
(4) An identification of the test method used.
(5) An identification of the samples including the client identification code.
(6) The date and time of sample collection.
(7) The date of sample analysis.
(8) The time of sample preparation or analysis, or both, if the holding time requirement for either activity is less than or equal to 72 hours.
(9) The test results and units of measurement.
(10) The quantitation limit.
(11) The names, functions and signatures of the persons authorizing the test report.
(12) An identification of results reported on a basis other than as received (for example, dry weight).
(13) An identification of testing or analysis results not covered by the laboratory's scope of accreditation.
(14) An identification of results that do not meet the requirements of this chapter.
(15) An identification of subcontracted results.
(k) Tests performed by an environmental laboratory operated by a facility that provides results to the facility management for compliance purposes do not need to be reported under subsection (j) regarding procedures for reporting results, provided the information required by subsection (j) is maintained under § 252.706.
(l) An environmental laboratory shall implement procedures or practices to monitor the quality of the laboratory's analytical activities. Examples of the procedures or practices are:
(1) Internal quality control procedures using statistical techniques.
(2) Participation in proficiency testing, other interlab- oratory comparisons, or round robin testing.
(3) Analysis of split samples by different laboratories.
(4) Use of certified reference materials or in-house quality control using secondary reference materials, or both.
(5) Replicate testing using the same or different test methods.
(6) Retesting of retained samples.
(7) Correlation of results for different but related analysis of a sample (for example, total phosphorus should be greater than or equal to orthophosphate).
(m) To the extent possible, results of testing or analysis of environmental samples shall be reported only if all quality control, analytical testing and sample acceptance measures are acceptable. If a quality control, analytical testing or sample acceptance measure is found to be out of control and the results of the testing or analysis of environmental samples are to be reported, all environmental samples associated with the failed quality control measure shall be documented and the results flagged in an unambiguous manner on the sample analysis report with the appropriate data qualifiers.
(n) Policies, procedures, protocols and practices specified in this section must be in writing and be followed.
§ 252.404. Essential quality control requirement—microbiology.
* * * * * (c) The following pieces of equipment shall be maintained according to this subsection:
(1) Autoclave.
(i) An environmental laboratory shall use autoclaves that meet specified temperature tolerances of the method. Because of safety concerns and difficulties with operational control, pressure cookers should not be used. Pressure cookers may not be used for sterilization of media.
(ii) A continuous temperature-recording device or a maximum-temperature-registering thermometer shall be used during each autoclave cycle.
(iii) An environmental laboratory shall verify the sterilization capability of each autoclave by utilizing appropriate biological indicators (for example, spore strips or ampoules) once a month. Records of biological indicator tests shall be maintained in a laboratory notebook and include the autoclave identification, date, incubation time and temperature, results and initials of the responsible individual.
(iv) An environmental laboratory shall verify the mechanical timing device, if used, for each autoclave every 3 months. Records of mechanical timer verification shall be maintained in a laboratory notebook and include the autoclave identification, date, mechanical timing device time, actual time and initials of the responsible individual. Correction factors shall be documented and used.
(v) Autoclaves shall be properly cleaned and maintained. Copies of service contracts or internal maintenance protocols and maintenance records shall be kept.
(vi) Required times for autoclaving items at 121°C are set forth in this subparagraph. The following items must be at temperature for the required amount of time. Except for membrane filters and pads and carbohydrate-containing media, indicated times are minimum times and may necessitate adjustment depending upon volumes, containers and loads. For autoclave runs that include membrane filters and pads and media, the total cycle time may not exceed 45 minutes. Autoclaved membrane filters and pads and media shall be removed immediately after completion of the autoclave cycle.
(vii) Records of each autoclave run shall be maintained in a laboratory notebook and include the date, contents, sterilization time and temperature, total cycle time (recorded as time in and time out) and initials of the responsible individual.
(viii) If an autoclave cycle fails to meet any requirement, corrective action shall be documented. Media may not be reautoclaved.
(2) Hot air oven.
(i) An environmental laboratory shall maintain a thermometer, graduated in 10°C increments or less with the bulb placed in sand, in each hot air oven.
(ii) An environmental laboratory shall verify the sterilization capability of each hot air oven by utilizing appropriate biological indicators (for example, spore strips) once a month. Records of biological indicator tests shall be maintained in a laboratory notebook and include the hot air oven identification, date, incubation time and temperature, results and initials of the responsible individual.
(iii) An environmental laboratory shall sterilize items in a hot air oven maintaining a temperature of 170°—180°C for a minimum of 2 hours. Only dry items may be sterilized in a hot air oven.
(iv) Records of each hot air oven operation shall be maintained and include the date, contents, sterilization time and temperature, and initials of the responsible individual.
(3) Inoculating equipment.
(i) An environmental laboratory shall use appropriate sterile inoculating equipment.
(ii) Metal loops and needles must be made of nickel alloy or platinum.
(iii) Wooden applicator sticks must be sterilized using dry heat.
(iv) For oxidase tests, nickel alloy loops may not be used.
(4) Membrane filtration equipment.
(i) Membrane filtration funnels must be stainless steel, glass, porcelain or autoclaveable or presterilized plastic. Membrane filtration funnels may not be scratched or corroded and may not leak.
(ii) Membrane filtration units shall be sterilized before the beginning of a filtration series. A filtration series ends when 30 minutes or longer elapses after a sample is filtered.
* * * * * (v) An environmental laboratory using an ultraviolet sanitation lamp to sanitize filtration funnels between successive filtrations shall test the ultraviolet sanitation lamp every 3 months for effectiveness with an appropriate UV light meter or by plate count agar spread plates. Records of ultraviolet lamp tests shall be maintained and bulbs shall be replaced if output is less than 70% of original for light tests or if count reduction is less than 99% for a plate containing 200 to 300 organisms.
(5) Culture dishes.
(i) Culture dishes must be presterilized plastic or sterilizable glass and of appropriate size for the method.
(ii) Stainless steel canisters, aluminum canisters or a wrap of heavy aluminum foil or char-resistant paper, shall be used for autoclave sterilization of glass culture dishes.
(iii) Loose-lid culture dishes shall be incubated in a tight fitting container containing a moistened paper towel.
(iv) Opened packs of disposable culture dishes shall be resealed between use periods.
(6) Culture tubes and closures. Culture tubes and containers must be of sufficient size to contain medium and sample without being more than three quarters full. Tube closures must be stainless steel, aluminum, plastic or a screw cap with a nontoxic liner.
(7) Pipettes.
(i) Pipettes must have legible markings and may not be chipped or etched and must be accurate to within 2.5% tolerance.
(ii) Stainless steel canisters, aluminum canisters or a wrap of heavy aluminum foil or char-resistant paper shall be used for autoclave sterilization of pipettes.
(iii) Opened packs of disposable sterile pipettes shall be resealed between use periods.
(8) Sample containers.
(i) Sample containers must be sterile plastic bags or wide-mouth plastic or noncorrosive glass bottles with nonleaking ground glass stoppers or caps with nontoxic liners that can withstand repeated sterilization. Sample containers must be capable of holding sufficient volume of sample for all required tests while maintaining adequate air space for mixing.
(ii) Glass stoppers must be covered with aluminum foil or char-resistant paper for sterilization.
(iii) Glass and plastic bottles that have not been presterilized shall be sterilized by autoclaving. Glass bottles may be sterilized by dry heat. Empty containers shall be moistened with several drops of water prior to autoclaving.
(9) Plastic and glassware washing procedure.
(i) Prior to the initial use of a lot of detergent or washing procedure, an environmental laboratory shall perform an inhibitory residue test utilizing the method described in the currently approved editions of Standard Methods for the Examination of Water and Wastewater (available from American Public Health Association, 1015 Fifteenth Street NW, Washington, D.C. 20005). Records of inhibitory residue tests shall be maintained and include the detergent identification, date, calculations, results and initials of responsible individual.
(ii) Washed plastic and glassware shall be tested at least once each month for possible acid or alkaline residue by testing at least one piece of plastic and glassware with a suitable pH indicator such as 0.04% bromothymol blue. Records of pH tests shall be maintained.
(10) Ultraviolet lamp. An environmental laboratory shall use a 365-nm, 6-watt ultraviolet lamp in a darkened room to view sample fluorescence.
(11) Quanti-TrayTM Sealer.
(i) An environmental laboratory shall perform a sealer check on each Quanti-Tray Sealer once a month by adding a dye to a water sample and performing the sealing procedure.
(ii) Records of the sealer check shall be maintained and include the sealer identification, date, results and initials of responsible individual. If dye is observed outside the wells, the Quanti-Tray Sealer may not be used.
(d) The requirements for reagent water are as follows:
* * * * * (4) The metals analyses may only be performed by an environmental laboratory accredited under this chapter for those fields of accreditation.
* * * * * (6) The bacteriological water quality test need not be performed if the environmental laboratory can supply documentation to show that their laboratory pure water or reagent water meets the criteria, as specified in section 1080 of the currently approved editions of Standard Methods for the Examination of Water and Wastewater (available from American Public Health Association, 1015 Fifteenth Street NW, Washington, D.C. 20005), for Type I (high-quality) or Type II (medium-quality) reagent water.
(e) The requirements for dilution/rinse water are as follows:
(1) Stock buffer solution or peptone water shall be prepared as specified in the currently approved editions of Standard Methods for the Examination of Water and Wastewater (available from American Public Health Association, 1015 Fifteenth Street NW, Washington, D.C. 20005).
(2) Stock buffers shall be autoclaved or filter-sterilized. Stock buffers shall be refrigerated and must be free from turbidity.
(3) Dilution/rinse water solutions shall be prepared as specified in the currently approved editions of Standard Methods for the Examination of Water and Wastewater (available from American Public Health Association, 1015 Fifteenth Street NW, Washington, D.C. 20005).
(f) The requirements for media are as follows:
(1) An environmental laboratory shall use dehydrated or commercially manufactured prepared media. Dehydrated media shall be stored in a cool, dry location. Caked or discolored dehydrated media shall be discarded.
(2) An environmental laboratory that prepares media from dehydrated stock shall follow method specifications.
(3) Media may not be reautoclaved.
(4) After preparation, media shall be stored and maintained as follows:
(i) Stored away from sources of direct light.
(ii) Prepared plates shall be stored in sealed plastic bags or containers.
(iii) Each bag, container or rack of broth or agar media shall be labeled with the date prepared or expiration date.
(iv) Fermentation media stored in a refrigerator shall be incubated overnight at room temperature before use. Media that shows growth or bubbles may not be used.
(v) Prepared liquid media shall be discarded if evaporation exceeds 10% of the original volume.
(vi) Poured agar plates and broth in tubes, bottles or flasks with loose-fitting closures shall be discarded if not used within 2 weeks of sterilization unless otherwise specified by the method.
(vii) Broth in tightly closed screw-cap tubes, bottles or flasks shall be discarded if not used within 3 months of sterilization unless otherwise specified by the method.
(g) An environmental laboratory shall demonstrate that the filtration equipment and filters, sample containers, media and reagents have not been contaminated through improper handling or preparation, inadequate sterilization or environmental exposure as follows:
(1) A sterility blank shall be analyzed for each lot of preprepared, ready-to-use medium and for each batch of medium prepared in the laboratory prior to first use of the medium. Records shall be maintained and include media identification, date, results and initials of responsible individual. If sterility blank indicates contamination, the media may not be used.
(2) For each reusable membrane filtration unit used during a filtration series, the laboratory shall prepare at least one sterility blank at the beginning and at the end of the series. A series is considered ended when more than 30 minutes elapses between filtrations. The laboratory shall insert a sterility blank after every 10 samples filtered through each membrane filration unit or sanitize filtration units by UV light after each sample filtration in addition to the regular rinsing procedure. Records of sterility blank results must be maintained. If sterility blanks indicate contamination, the laboratory must treat each affected sample according to program requirements.
(3) For presterilized single use filtration funnel units, a sterility check shall be performed on one funnel unit per lot.
* * * * * (h) The requirements for positive and negative culture control checks are as follows:
(1) Each preprepared, ready-to-use lot of medium and each batch of medium prepared in the laboratory shall be tested by the laboratory with at least one pure culture of a known positive reaction prior to first use of the medium. Records shall be maintained and include the date, media lot or batch number, type of media, positive culture control organism identification, results and initials of responsible individual. If positive culture control checks do not meet expected results, the affected media may not be used.
(2) Each preprepared, ready-to-use lot of selective medium and each batch of selective medium prepared in the laboratory shall be tested by the laboratory with at least one pure culture of a known negative reaction prior to first use of the medium. Records shall be maintained and include the date, media lot or batch number, type of media, negative culture control organism identification, results and initials of the responsible individual. If negative culture control checks do not meet expected results, the affected media may not be used.
* * * * * (5) Culture controls may be single use or cultures maintained by the laboratory using a documented procedure that maintains the purity and viability of the organisms.
(6) For cultures maintained by the laboratory, the following criteria must be met:
(i) Reference control cultures may be revived and subcultured once to provide reference stocks.
(ii) Reference stocks shall be preserved using a method which maintains the characteristics of the organism strains. If reference stocks are thawed, they may not be refrozen and reused.
(iii) Working stocks shall be prepared from reference stocks for routine laboratory work.
(iv) If the laboratory sequentially cultures working stocks, the laboratory shall prepare a second working stock. Sequential culturing may not be performed from a working stock that has been used for routine laboratory work
(v) Working stocks may not be used for more than 30 days.
(vi) Working stocks may not be sequentially cultured more than five times and may not be subcultured to replace reference stocks.
(vii) Secondary working stocks shall be used to prepare sequential working stocks.
(i) For test methods that specify colony counts, duplicate counts shall be performed monthly on one positive sample for each month that the test is performed. If the laboratory has two or more analysts, each analyst shall count typical colonies on the same plate. Counts may not differ by more than 10%. In an environmental laboratory with only one analyst, the analyst shall count the same plate twice. Counts may not differ by more than 5%.
(j) Records of all equipment, reference materials, reagents, media and supplies shall be maintained in accordance with § 252.306 (relating to equipment, supplies and reference materials).
Subchapter E. PROFICIENCY TEST STUDY REQUIREMENTS § 252.501. Proficiency test study requirements.
* * * * * (l) An environmental laboratory shall direct the proficiency test study provider to report the proficiency test study performance results directly to the Department's Laboratory Accreditation Program at the same time that the provider reports the results to the environmental laboratory.
* * * * * (n) An environmental laboratory seeking to obtain or maintain accreditation in the drinking water matrix shall participate in proficiency test studies that meet the requirements of 40 CFR Part 141 (relating to national primary drinking water regulations).
(o) An environmental laboratory shall evaluate and report the analytical result of each proficiency test study sample to the proficiency test reporting limit for each field of accreditation, when available, as outlined in subsection (a).
Subchapter G. MISCELLANEOUS PROVISIONS § 252.703. Suspension
(a) Denial of access to the Department during normal business hours will result in immediate suspension of accreditation for all fields of accreditation. Upon notice from the Department, the laboratory shall immediately cease testing or analysis of environmental samples.
(b) The Department will suspend an environmental laboratory's accreditation in total or in part for one or more of the following reasons:
(1) The Department finds that protection of the environment or the public health, safety or welfare requires emergency action.
(2) The environmental laboratory fails to successfully complete a proficiency test study within the previous 12 months.
(3) The environmental laboratory fails two consecutive proficiency test studies for a field of accreditation.
(c) The Department may suspend a laboratory's accreditation in total or in part for one or more of the following reasons:
(1) Failure to comply with the reporting and notification requirements as specified in § 252.708 (relating to reporting and notification requirements).
(2) Failure to implement a quality assurance program.
(3) Failure to employ staff that meets the personnel qualifications for education, training and experience as specified in § 252.302 (relating to qualifications of the laboratory supervisor).
(d) A laboratory may continue to test or analyze environmental samples for those fields of accreditation not affected by the suspension.
(e) Within 72 hours of receiving notice of the suspension of accreditation from the Department, the environmental laboratory shall notify each of its customers affected by the suspension in writing of the suspension on a form approved by the Department.
§ 252.704. Voluntary Relinquishment.
(a) An environmental laboratory wishing to voluntarily relinquish its certificate of accreditation or accreditation for fields of accreditation shall notify the Department in writing.
(b) An environmental laboratory that voluntarily relinquishes its certificate of accreditation shall ensure records are maintained in accordance with § 252.706 (relating to recordkeeping).
(c) Within 72 hours of voluntarily relinquishing its certificate of accreditation, the laboratory shall notify each of its customers affected by the voluntary relinquishment in writing of the relinquishment on a form approved by the Department.
§ 252.706. Recordkeeping.
(a) An environmental laboratory shall maintain records in an organized manner accessible by the Department.
(b) An environmental laboratory shall maintain records, including original handwritten data, that allow reconstruction of all laboratory activities associated with the testing or analysis of environmental samples, proficiency test studies, initial demonstration of capability, or demonstration of continued proficiency.
(c) All generated data, except data generated by automated data collection systems, shall be recorded promptly and legibly in permanent ink or in an electronic format. Changes to records shall be made so that the original entry remains visible. The individual making the change shall sign or initial and date the correction. These criteria also shall apply to electronically maintained records.
(d) Records required under this chapter shall be maintained for a minimum of 5 years unless otherwise specified.
(e) An environmental laboratory shall have a written plan that specifies how records will be maintained or transferred if the laboratory transfers ownership or terminates operations.
§ 252.708. Reporting and notification requirements.
(a) An environmental laboratory conducting testing or analysis of drinking water under Chapter 109 (relating to safe drinking water) shall:
(1) Meet the reporting and notification requirements of that chapter.
(2) Review all sample analysis data within 24 hours of acquisition of the initial sample results for microbilogical, inorganic nonmetals and trace metals analyses. The 24-hour deadline may be extended to a maximum of 72 hours to accommodate a holiday or weekend when the laboratory is closed for business.
(3) Review all sample analysis data within 7 days of acquisition of the initial sample results for organic and radiochemical analyses.
(b) An environmental laboratory shall notify the Department, in writing, within 20 calendar days of a permanent change in laboratory supervisor.
(c) An environmental laboratory shall notify the Department, in writing, within 30 calendar days of a change in the legal name of the laboratory.
(d) An environmental laboratory shall notify the Department, in writing, within 30 calendar days of a change in any item contained on the application for accreditation.
(e) An environmental laboratory shall notify the Department, in writing, if a change in the laboratory's capability to produce valid analytical results persists for more than 90 calendar days for any field of accreditation listed on the laboratory's scope of accreditation.
(f) An out-of-State environmental laboratory with either primary or secondary accreditation from the Department shall notify, in writing, the Department within 48 hours of any changes in the laboratory's accreditation status from any other primary accreditation body.
(g) The Department may require additional information or proof of continued capability to perform the testing or analysis for affected fields of accreditation upon receipt of notification under this subsection.
(h) The Department may require an onsite assessment under § 252.601 (relating to onsite assessment requirements) upon receipt of notification under this subsection.
[Pa.B. Doc. No. 10-638. Filed for public inspection April 9, 2010, 9:00 a.m.]
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