Md. Code Regs. 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. (1) Retains the services of either a:
  1. (a) Laboratory director who meets the qualifications in COMAR 10.10.07.04B(1); or
  2. (b) Technical supervisor who meets the qualifications in COMAR 10.10.07.05B(4);
2. (2) Maintains applicable records and reports; and
3. (3) Effectively processes and stores specimens, slides, and tissue.
B. Standards.
1. (1) Maintenance of Records, Reports, Tissue, and Slides.
  1. (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.
  2. (b) A system of documentation may include:
    1. (i) A laboratory specimen log book; or
    2. (ii) Accession sheets or records.
  3. (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:
    1. (i) Patient name, age, and sex;
    2. (ii) The dates of specimen collection and processing;
    3. (iii) The source or anatomic site of a specimen;
    4. (iv) A gross description of the specimen;
    5. (v) A description of the tissue, for example, bisected, submitted in total, number of blocks, or that only representative sections were submitted;
    6. (vi) The diagnosis or observed results of the test or examination;
    7. (vii) The examining physician's name, signature, and date of report;
    8. (viii) If appropriate, the clinical impression or differential diagnosis; and
    9. (ix) Other pertinent or essential patient history that may affect the accuracy or reliability of the report.
  4. (d) A licensee shall ensure that a laboratory retains:
    1. (i) Records and reports for at least 10 years for final reports and 2 years for other laboratory records;
    2. (ii) Wet tissue or tissue remnants for 2 weeks after a final report is issued;
    3. (iii) A specimen or tissue in a paraffin block for 5 years from the date of examination; and
    4. (iv) Slides for 10 years from the date of examination.
  5. (e) A licensee shall ensure that specimens, slides, and tissues are:
    1. (i) Processed in a facility licensed under this chapter;
    2. (ii) Appropriately fixed for the tests performed;
    3. (iii) Properly labeled with at least the patient's name or other cross-referenced identifier, such as a case or accession number; and
    4. (iv) Adequately stored and effectively filed to allow easy access and retrieval.
2. (2) Quality Control. When a slide or specimen is processed or stained in the laboratory, the licensee shall ensure that:
  1. (a) A staining container is labeled and covered when not in use;
  2. (b) A stain and a working solution are changed at appropriate intervals; and
  3. (c) Routine employee access is provided to flowcharts and other written procedures that accurately reflect the procedures in use.

Authority: Health-General Article, §§17-202, 17-202.1, 17-214, and 17-504, Annotated Code of Maryland

Effective date: November 18, 1985 (12:23 Md. R. 2217)

Regulations .01—.06, Physicians' Group Practice Laboratories in Maryland, repealed effective August 6, 1990 (17:15 Md. R. 1859)

Regulations .01—.28, Physician Office and Other Point-of-Care Laboratories, adopted effective August 6, 1990 (17:15 Md. R. 1859)

Regulation .03B amended effective September 16, 1991 (18:18 Md. R. 2005)

Regulation .08C amended effective September 16, 1991 (18:18 Md. R. 2005)

Regulation .09B amended effective September 16, 1991 (18:18 Md. R. 2005)

Regulation .25 amended effective September 16, 1991 (18:18 Md. R. 2005)

Chapter, Physician Office and Other Point-of-Care Laboratories, repealed and new chapter, Medical Laboratories—Quality Assurance, adopted effective December 13, 1999 (26:25 Md. R. 1897)

Regulation .01 amended effective June 1, 2009 (36:11 Md. R. 787)

Regulation .02A amended effective July 22, 2002 (29:14 Md. R. 1074); April 1, 2013 (40:6 Md. R. 473)

Regulation .02B amended effective April 16, 2012 (39:7 Md. R. 492); March 1, 2026 (52:24 Md. R. 1198)

Regulation .02C amended effective June 1, 2009 (36:11 Md. R. 787)

Regulation .03 amended effective June 1, 2009 (36:11 Md. R. 787)

Regulation .03B amended effective July 24, 2000 (27:14 Md. R. 1340); January 13, 2011 (38:1 Md. R. 11)

Regulation .04B adopted effective June 1, 2009 (36:11 Md. R. 787)

Regulation .04B amended effective April 16, 2012 (39:7 Md. R. 492)

Regulation .05 amended effective June 1, 2009 (36:11 Md. R. 787)

Regulation .05-1 adopted effective June 1, 2009 (36:11 Md. R. 787)

Regulation .06 repealed effective March 1, 2026 (52:24 Md. R. 1198)

Regulation .07B amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198)

Regulation .08 amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198)

Regulation .08B amended effective July 24, 2000 (27:14 Md. R. 1340)

Regulation .09 repealed effective June 1, 2009 (36:11 Md. R. 787)

Regulation .10 amended effective June 1, 2009 (36:11 Md. R. 787)

Regulation .10B amended effective July 24, 2000 (27:14 Md. R. 1340)

Regulation .12 amended effective July 22, 2002 (29:14 Md. R. 1074); April 1, 2013 (40:6 Md. R. 473)

Regulation .12B amended effective April 16, 2012 (39:7 Md. R. 492); March 1, 2026 (52:24 Md. R. 1198)

Regulation .13B amended effective March 1, 2026 (52:24 Md. R. 1198)

Regulation .14B amended effective June 1, 2009 (36:11 Md. R. 787)

Regulation .15 amended effective June 1, 2009 (36:11 Md. R. 787); April 1, 2013 (40:6 Md. R. 473)

Regulation .15B amended effective July 24, 2000 (27:14 Md. R. 1340)

Regulation .16 repealed effective April 1, 2013 (40:6 Md. R. 473)

Regulation .16A amended effective June 1, 2009 (36:11 Md. R. 787)