Sec. 10.10.06.11. Quality Control — Dermatopathology

A. Primary Standard. In addition to meeting the requirements of other applicable regulations of this subtitle, a licensee of a laboratory performing tests in the subdiscipline of dermatopathology shall ensure that the laboratory:

(1) Retains the services of either a:

(a) Laboratory director who meets the qualifications in COMAR 10.10.07.04B(1); or

(b) Technical supervisor who meets the qualifications in COMAR 10.10.07.05B(4);

(2) Maintains applicable records and reports; and

(3) Effectively processes and stores specimens, slides, and tissue.

B. Standards.

(1) Maintenance of Records, Reports, Tissue, and Slides.

(a) A licensee shall ensure that the laboratory maintains a system of documentation to monitor the collection, receipt, handling, transport, processing, testing, and reporting of all specimens.

(b) A system of documentation may include:

(i) A laboratory specimen log book; or

(ii) Accession sheets or records.

(c) A licensee shall ensure that the laboratory generates a written report for each patient specimen that is examined either microscopically or macroscopically. The report shall include:

(i) Patient name, age, and sex;

(ii) The dates of specimen collection and processing;

(iii) The source or anatomic site of a specimen;

(iv) A gross description of the specimen;

(v) A description of the tissue, for example, bisected, submitted in total, number of blocks, or that only representative sections were submitted;

(vi) The diagnosis or observed results of the test or examination;

(vii) The examining physician's name, signature, and date of report;

(viii) If appropriate, the clinical impression or differential diagnosis; and

(ix) Other pertinent or essential patient history that may affect the accuracy or reliability of the report.

(d) A licensee shall ensure that a laboratory retains:

(i) Records and reports for at least 10 years for final reports and 2 years for other laboratory records;

(ii) Wet tissue or tissue remnants for 2 weeks after a final report is issued;

(iii) A specimen or tissue in a paraffin block for 5 years from the date of examination; and

(iv) Slides for 10 years from the date of examination.

(e) A licensee shall ensure that specimens, slides, and tissues are:

(i) Processed in a facility licensed under this chapter;

(ii) Appropriately fixed for the tests performed;

(iii) Properly labeled with at least the patient's name or other cross-referenced identifier, such as a case or accession number; and

(iv) Adequately stored and effectively filed to allow easy access and retrieval.

(2) Quality Control. When a slide or specimen is processed or stained in the laboratory, the licensee shall ensure that:

(a) A staining container is labeled and covered when not in use;

(b) A stain and a working solution are changed at appropriate intervals; and

(c) Routine employee access is provided to flowcharts and other written procedures that accurately reflect the procedures in use.