Section 149.47. Laboratory test reports.

 

(1)   General provisions, format and content .

(a) The results of each test performed by a laboratory shall be reported in accordance with any requirements or instructions specified in approved methods or by the department.

(b) Laboratory test reports shall have formats that facilitate conveying or reviewing the content elements specified in this section, unless otherwise provided by pars. (c) , (d) and (e) . Content elements may be presented in narrative, tabular, schematic or graphical form, in hard copy or electronic media.

(c) When tests are performed for internal clients, or when a laboratory has a written agreement with a client, laboratory reports may be issued by the laboratory without all the content elements specified in this section. However, the laboratory shall retain and make available to the department, upon request, records that include the content elements specified in this section.

(d) Laboratories that are operated by a facility whose function is to provide data to monitor the facility's compliance with department programs covered by this chapter shall retain and make available to the department, upon request, records that include the content elements specified in this section. Laboratory reports with all the content elements specified in this section are not required to be issued if:

1. The laboratory is responsible for preparing regulatory reports in a specified format to the department.

2. The laboratory provides information to another individual within the facility for preparation of regulatory reports in a specified format to the department.

(e) Unless otherwise specified by department programs that receive data on behalf of facilities, directly from laboratories, or when provided by pars. (c) and (d) , test reports from laboratories shall include at least the following information.

1. The name, address and telephone of the laboratory where tests were performed, as well as the name of a contact.

2. The laboratory's certification or registration identification number.

3. The name and address of the client or entity whose samples were analyzed.

4. The sample codes or identifiers provided by the client or collector.

5. Identification of or reference to the methods used for analysis.

6. The collection date of the samples.

7. The date of receipt of the samples.

8. For samples submitted to pretreatment steps, such as digestions or extractions, with identified holding times in department regulations, the date in which such steps were performed.

9. The date of analysis.

10. Results of analyses with their respective measurement and reporting units.

a. For sample results requiring adjustment for dilutions, the dilution factors.

b. For sample results reported on a dry weight basis, the solids content and a statement or flag indicating that results have been adjusted for the solids content of the corresponding samples.

11. For tests for which the department requires reporting to the limit of detection, the limits of detection and quantitation of the associated results.

a. For sample results requiring adjustment for dilutions, an indication of whether the detection and quantitation limits have been adjusted for the corresponding sample dilutions.

b. For sample results reported on a dry weight basis, an indication of whether the detection and quantitation limits have been adjusted for the solids content of the corresponding samples.

12. The names and signatures of responsible parties authorizing reported results.

13. Descriptions of any deviations encountered by the laboratory from chapter requirements or procedures referenced in approved methods, when the deviations affect the validity or the defensibility of reported results.

a. Description of these deviations may be communicated through narratives, flags or qualifiers.

b. When flags or qualifiers are used to declare these deviations, the laboratory shall include a key to describe the meaning of all used flags and qualifiers.

14. The date of the test report.

(2)   Amendments to laboratory test reports.

(a) Amendments to test reports already issued by a laboratory shall be made by an authorized laboratory representative in a manner that clearly identifies the reasons for the amendment and that references the original laboratory test report.

(b) Amended reports shall comply with the requirements of this section.

(3)   Test results obtained from subcontractors.

(a) When reports contain results of tests performed by subcontractors, the associated results shall include any qualifiers noted by the subcontract laboratory and shall be identified with the subcontractors' facility identification codes.

(b) Subcontractors shall provide upon request of the originating laboratory or the department all the information contained in this section.

History: CR 06-005 : cr. Register April 2008 No. 628 , eff. 9-1-08.