NR 149.03(56)
(56) “
Quality assurance” means an integrated system of activities involving planning, control, assessment, reporting, and improvement to ensure that a product or service meets defined standards of quality.
NR 149.03(57)
(57) “
Quality control” means the overall system of technical activities designed to measure and control the quality of a product or service that meets the stated needs of users.
NR 149.03(58)
(58) “
Quality control limit” means the acceptance criteria used to evaluate quality control samples. Quality control limits may be those published by the department, referenced in a method or calculated by a laboratory. In this chapter, quality control limits calculated by a laboratory will be referred to as generated in-house control limits.
NR 149.03(59)
(59) “
Quality system” means a structured and documented management arrangement describing the policies, objectives, principles, organizational authority, responsibilities, accountability, and implementation plan of an organization for ensuring quality in its work processes, products, and services.
NR 149.03(60)
(60) “
Raw data” means any original information from a measurement activity or study recorded in media that allows the reconstruction and evaluation of the activity or study. “Raw data” include absorbance, emission counts, area counts, peak heights, abundance, and millivolts. Raw data may be stored in hard copy or electronically.
NR 149.03(61)
(61) “
Reagent water” means water which has been treated to remove any impurities that may affect the quality of an analysis.
NR 149.03(62)
(62) “
Reference material” means a material that has one or more sufficiently well-established properties that can be used for calibrating or verifying the calibration of support equipment or analytical instruments.
NR 149.03(63)
(63) “
Registration” or “registered” means registration under s.
299.11 (8), Stats., of laboratories that perform tests solely on its own behalf or that of a subsidiary under common ownership or control in accordance with the standards and requirements of this chapter. Registered laboratories do not perform drinking water testing.
NR 149.03(64)
(64) “
Relative standard error” or “RSE” means the standard error divided by the mean for a set of calibration data and expressed as a percentage. The RSE is calculated according to the following formula:
xi = true amount of analyte in calibration level
i, in mass or concentration units.
x‵i = measured amount of analyte in calibration level i, in mass or concentration units.
p = number of terms in the fitting equation.
NR 149.03 Note
Note:
average = 1, linear = 2, quadratic = 3, cubic = 4
n = number of calibration points.
NR 149.03(66)
(66) “
Relocation” means a move by a laboratory resulting in a change in the laboratory's physical address.
NR 149.03(67)
(67) “
Replicate” means two or more substantially equal aliquots analyzed independently for the same analyte.
NR 149.03(68)
(68) “
Residual” means the difference, expressed as a percent, between the theoretical concentration of a calibration standard and the value derived from the calibration function from the measured response of the calibration standard.
NR 149.03(69)
(69) “
Result” means the quantitative or qualitative output of an analysis, including measurements, determinations, and information obtained or derived from tests.
NR 149.03(70)
(70) “
Revocation” means cancellation of a laboratory's accreditation.
NR 149.03(71)
(71) “
Second source standard” means a standard procured from a supplier or manufacturer different from the supplier or manufacturer of a laboratory's calibration standards, or a standard obtained from the same supplier or manufacturer of a laboratory's calibration standards from a lot verifiably different from the lot of the calibration standards.
NR 149.03(72)
(72) “
Sensitivity” means the capability of a method or instrument to discriminate between measurement responses representing different levels of analyte, or the capability of a method or instrument to detect an analyte at or greater than a stated quantity.
NR 149.03(74)
(74) “
Subcontract” means the act of procuring analytical services from a certified laboratory.
NR 149.03 Note
Note:
Registered laboratories only do testing for their own facility. Another facility, under the same ownership, can procure analytical services from a registered laboratory.
NR 149.03(75)
(75) “
Support equipment” means devices that may not be analytical instruments, but that are necessary to support laboratory tests and operations. “Support equipment” includes autoclaves, balances, ovens, refrigerators, freezers, incubators, water baths, temperature measuring devices, sample preparation devices, and volumetric dispensing devices when quantitative results depend on the accuracy of the support equipment.
NR 149.03(76)
(76) “
Surrogate” means a substance unlikely to be found in environmental samples, with properties similar to those of analytes of interest, which is used to evaluate the bias of an analysis in the fortified sample.
NR 149.03(77)
(77) “
Suspension” means a temporary cancellation of a laboratory's certification.
NR 149.03(78)
(78) “
Temperature blank” means a sample container, of at least 40 mL capacity, filled with water and transported with each shipment of collected samples to determine the temperature of other samples in the shipment on arrival at a laboratory.
NR 149.03(79)
(79) “
Test” means any chemical, biological, physical, radiological, or microscopic assay, examination, or analysis conducted by a laboratory on water, wastewater, groundwater, a biosolid, a waste material, a hazardous substance, or any other matrix analyzed to determine compliance with a covered program.
NR 149.03(80)
(80) “
X-intercept” means the point at which the plot of the calibration function crosses the x-axis.
NR 149.03 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21; corection in (38), (48), (60) made under s. 35.17, Stats., Register February 2021 No. 782. NR 149.05(1)(1)
All laboratories submitting data to the department for a covered program or generating data to determine compliance with a covered program, shall be accredited under this chapter for the fields of accreditation corresponding to the submitted or generated data, unless this chapter or a covered program exempts a test from requiring accreditation.
NR 149.05(2)
(2) The department may not accept data from a laboratory that is not properly accredited under this chapter, except as provided in s.
NR 149.11.
NR 149.05(3)
(3) The department may initiate enforcement action against a laboratory which maintains accreditations under this chapter but performs testing for analytes for which it does not hold the appropriate accreditation and for which the department offers accreditation when that data will be reported to the department.
NR 149.05(4)
(4) A laboratory may not transfer its accreditation to any other entity unless the department expressly approves the transfer by the process specified in s.
NR 149.14 (1) (a).
NR 149.05 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.06(1)(1)
The department shall issue certificates to accredited laboratories indicating or referring to the specific fields of accreditation for which laboratories have been granted accreditation. The department shall issue certificates annually, whenever the fields for which a laboratory is accredited change, and when a laboratory relocates or changes its name.
NR 149.06(2)(ag)
(ag) The department shall issue certificates to the owner or legally responsible party of a laboratory.
NR 149.06(2)(ar)
(ar) The department may not issue certificates to anyone who is not the owner or legally responsible party of a laboratory.
NR 149.06(2)(b)
(b) The department may indicate in a certificate that a laboratory is managed by an outside contractor.
NR 149.06(3)
(3) Certificates are the property of the department and shall be returned to the department upon request.
NR 149.06(4)
(4) A laboratory may not alter or modify certificates issued by the department. A laboratory that alters or modifies a certificate, or that misrepresents the fields of accreditation contained or referenced in a certificate, may be subject to revocation of all its accreditations.
NR 149.06 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21; renum. (2) (intro.), (a) to (2) (ag), (ar) under s. 13.92 (4) (b) 1., Stats., Register February 2021 No. 782. NR 149.08
NR 149.08
Acceptance of other accreditations, licenses, or approvals. NR 149.08(1)(1)
Agriculture, trade, and consumer protection agreement. The department shall accept the accreditation, licensure, or approval by the department of agriculture, trade, and consumer protection for microbiological testing performed by a laboratory submitting or generating data for a covered program.
NR 149.08(2)
(2)
Laboratories accredited, licensed, or approved by other governments. NR 149.08(2)(a)
(a) The department may negotiate with and attempt to enter into agreements with federal agencies and agencies of other states to reciprocally accept accreditations of laboratories under this chapter.
NR 149.08(2)(b)
(b) The department may accept the accreditation, licensure, or approval of a laboratory by another state or an agency of the federal government if the standards used for the qualification of a laboratory are substantially equivalent to those established in this chapter.
NR 149.08(2)(c)
(c) The department may not accept the accreditation, licensure, or approval of a laboratory by another state or an agency of the federal government, unless that state or federal agency accepts laboratories accredited under this chapter.
NR 149.08(3)(a)
(a) The department may enter into agreements with private not-for-profit organizations to accept accreditation of laboratories under this chapter.
NR 149.08(3)(b)
(b) The department may accept the accreditation, licensure, or approval of a laboratory by a private not-for-profit organization if the organization's standards used for the qualification of a laboratory are substantially equivalent to those established in this chapter.
NR 149.08 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.09
NR 149.09
Certification standards review council. NR 149.09(1)(1)
The council shall advise the department on the standards used to certify, register, suspend, and revoke laboratories.
NR 149.09(2)
(2) The council shall advise the department on training and outreach activities that the department may offer or sponsor to facilitate compliance of laboratories with this chapter.
NR 149.09(3)
(3) The council shall advise the department on the frequency and scope of evaluations necessary to determine compliance of laboratories with this chapter.
NR 149.09(4)
(4) The department shall seek the advice of the council before requiring the analysis of additional PT samples and approving PT sample providers.
NR 149.09(5)
(5) The department shall seek the advice of the council before implementing changes in the fees assessed to laboratories.
NR 149.09(6)
(6) The department shall seek the advice of the council in granting variances.
NR 149.09(7)
(7) The department shall prepare annually the following for review by the council:
NR 149.09(7)(b)
(b) A list of required PT samples and available PT sample providers.
NR 149.09(7)(c)
(c) A summary of fees scheduled to be assessed to laboratories.
NR 149.09 History
History: CR 17-046: cr. Register February 2021 No. 782, eff. 6-29-21. NR 149.10(1)(1)
Administrative procedures. A laboratory's accreditation is valid until it expires, is suspended, or is revoked. If, after opportunity for a contested case hearing, the department finds that an accredited laboratory materially and consistently failed to comply with the provisions of this chapter, the department may suspend or revoke a laboratory's accreditation in whole or in part by matrix, analytical technology, method, analyte, or analyte group. Contested case hearings for out-of-state laboratories regulated under this chapter shall be held in Madison, Wisconsin.
NR 149.10(2)
(2)
Suspension or revocation of certified laboratories. NR 149.10(2)(a)(a) Causes for suspension of certification include any of the following:
NR 149.10(2)(a)1.
1. Material and consistent failure to comply with the requirements of this chapter.
NR 149.10(2)(a)2.
2. Reporting data to the department after a laboratory is deemed temporarily incapable of performing analysis in any matrix, analytical technology, method, analyte, or analyte group.
NR 149.10(2)(a)3.
3. Suspension of certification, accreditation, license, or approval by another state or agency of the federal government for which the laboratory holds certification if the grounds for suspension are substantially equivalent to any of those listed in this paragraph.
NR 149.10(2)(b)
(b) Causes for revocation of certification include any of the following:
NR 149.10(2)(b)1.
1. Material and consistent failure to maintain records as required in this chapter.
NR 149.10(2)(b)2.
2. Failure to allow the department to perform on-site evaluations as specified in subch.
VI.
NR 149.10(2)(b)3.
3. Material and consistent failure to comply with the requirements of this chapter.
NR 149.10(2)(b)4.
4. Material and consistent failure to submit requested records to the department.
NR 149.10(2)(b)5.
5. Material and consistent failure to follow specified procedural or quality control requirements prescribed in methods.
NR 149.10(2)(b)6.
6. Falsification of analytical results, testing dates, or any other information submitted to the department by the laboratory. Falsification includes alteration or modification of a certificate.
NR 149.10(2)(b)7.
7. Failure of two consecutive PT samples for any method and analyte or analyte group combination for laboratories holding certification in the drinking water matrix.
NR 149.10(2)(b)8.
8. Revocation of certification, registration, accreditation, license, or approval by another state or agency of the federal government for which the laboratory holds certification if the grounds for revocation are substantially equivalent to any of those listed in this paragraph.
NR 149.10(3)
(3)
Revocation of registered laboratories. Causes for revocation of registration include any of the following:
