Md. Code Regs. 10.10.06.11

Current through Register Vol. 51, No. 26, December 27, 2024

Section 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.

Md. Code Regs. 10.10.06.11

Regulations .11, Physician Office and Other Point-of-Care Laboratories, adopted effective August 6, 1990 (17:15 Md. R. 1859)