1. A. Open for Inspection. A permit holder shall allow an on-site inspection by the OHCQ, or any designee by OHCQ, at any time during the tissue bank's regular hours of operation, to evaluate the tissue bank's compliance with the applicable requirements, conditions, and standards of this chapter.

2. B. Content of Inspection. An inspection may include, but is not limited to, observation and examination of:

   1. (1) Tissue bank facilities and physical security;
   2. (2) Equipment;
   3. (3) Quality assurance and quality control policies and records;
   4. (4) Operating procedures, policies, and records;
   5. (5) Personnel and personnel records;
   6. (6) Donor documentation and records; and
   7. (7) Other records and files pertinent to this chapter.
3. C. Access to Records. Tissue bank employees shall make data and records accessible within a reasonable time during an inspection by OHCQ or any designee by OHCQ.

4. D. Permitted Tissue Bank. A permit holder operating a tissue bank under a provisional permit or a permit shall be subject to:

   1. (1) An initial inspection conducted by the OHCQ;
   2. (2) Periodic inspections by the OHCQ; and
   3. (3) Other inspections by the OHCQ to determine if the tissue bank is in compliance with licensure requirements.

5. E. Accredited Tissue Bank. An accredited tissue bank is subject to:

   1. (1) An initial inspection by an accreditation organization or the OHCQ;
   2. (2) Periodic inspections by an accreditation organization or the OHCQ; and
   3. (3) Other inspections by the OHCQ to determine if the tissue bank is in compliance with licensure requirements.

6. F. Notice of Deficiencies. If a survey identifies noncompliance with a requirement, the Department shall:

   1. (1) Issue a written Statement of Deficiencies that cites each deficiency;
   2. (2) Require the tissue bank to submit an acceptable plan of correction within 10 calendar days of receipt of the Statement of Deficiencies;
   3. (3) Notify the tissue bank of any sanctions imposed or that failure to correct the violation may result in sanctions; and
   4. (4) Offer the tissue bank the opportunity for informal dispute resolution (IDR).

7. G. Plan of Correction.

   1. (1) The tissue bank shall submit a written plan of correction to the OHCQ in response to a Statement of Deficiencies documenting the steps the permit holder will take to come into compliance, including:

      1. (a) How the tissue bank will correct each deficiency;
      2. (b) The date by which each deficient practice will be corrected;
      3. (c) How the tissue bank will prevent the deficient practice from recurring; and
      4. (d) Who will be responsible for ensuring the deficiency will not reoccur.
   2. (2) Failure of the tissue bank to return an acceptable plan of correction within 10 calendar days after receipt of a Statement of Deficiencies may result in a sanction.
   3. (3) A tissue bank’s request for an IDR does not change the tissue bank's requirement to submit a plan of correction for all deficiencies within 10 calendar days after receipt of the Statement of Deficiencies.
   4. (4) If an immediate jeopardy is identified during a survey, the tissue bank’s plan of correction shall completely correct all noncompliance associated with the immediate jeopardy.

8. H. Immediate Jeopardy.

   1. (1) Declaration of Immediate Jeopardy.

      1. (a) When the Department identifies a situation in which immediate corrective action is necessary because the tissue bank's noncompliance with one or more licensure requirements has already caused, is causing, or is likely to cause, at any time, serious harm or death, to individuals served by the tissue bank or to the health or safety of the general public, an immediate jeopardy will be declared.
      2. (b) The Department shall provide the tissue bank a written notice that includes a description of the situation that constitutes an immediate jeopardy.

   2. (2) Removal Plan. The tissue bank shall submit a written removal plan to the Department that includes:

      1. (a) The immediate corrective action a tissue bank will take to prevent serious harm from occurring or recurring;
      2. (b) All actions to remove past, present, and future jeopardy; and
      3. (c) The date by which the entity asserts the likelihood for serious harm to any recipient or the general public will no longer exist.

   3. (3) The Department’s Review of the Removal Plan.

      1. (a) The OHCQ staff shall review the tissue bank's removal plan to determine if the removal plan, if implemented appropriately, will remove the likelihood that serious harm will occur, or recur.
      2. (b) The OHCQ shall verify that the tissue bank has implemented the removal plan.
   4. (4) The Department’s Approval of the Removal Plan. The Department shall approve the removal plan after verifying that all actions the tissue bank took were effective in removing the likelihood that serious harm or death would occur or recur.

9. I. Informal Dispute Resolution (IDR).

   1. (1) A tissue bank may request an IDR to dispute one or more deficiencies in a Statement of Deficiencies.
   2. (2) The tissue bank shall submit the request for an IDR to the OHCQ within 10 calendar days of receiving the Statement of Deficiencies.

   3. (3) The written request for an IDR shall:

      1. (a) Fully describe the disagreement with the Statement of Deficiencies; and
      2. (b) Include all accompanying evidence for the OHCQ’s consideration.
   4. (4) At the discretion of the OHCQ, the IDR may be held in person, by telephone, by video conference, or in writing.
   5. (5) IDRs are informal in nature and may not be attended by legal counsel representing the tissue bank or the Department.
   6. (6) The IDR process may not delay the effective date of any enforcement action.
   7. (7) In the event a tissue bank requests an IDR for a Statement of Deficiencies written by a designee of the Department, the Department shall request the designee to participate in the IDR process.
   8. (8) There is no appeal of the Department’s decision in an IDR.
10. J. Process of Filing a Complaint. The tissue bank shall have a written process that describes how donors and recipients of tissue bank services are notified of how to file a complaint with the OHCQ and, if applicable, an accreditation organization.

Authority: Health-General Article, Annotated Code of Maryland

Effective date: July 1, 1970

Regulations .01—.12 repealed and new Regulations .01—.06 adopted effective May 5, 1986 (13:9 Md. R. 1030)

Regulation .03 amended effective March 20, 1989 (16:5 Md. R. 629)

Regulation .06B amended effective June 11, 1990 (17:11 Md. R. 1343)

Regulation .06D amended effective March 20, 1989 (16:5 Md. R. 629); amended and recodified to Regulation .07 effective June 11, 1990 (17:11 Md. R. 1343)

Regulation .06E adopted effective March 20, 1989 (16:5 Md. R. 629); recodified to Regulation .06D effective June 11, 1990 (17:11 Md. R. 1343)

Regulation .08 adopted effective June 11, 1990 (17:11 Md. R. 1343)

COMAR 10.10.02 recodified to COMAR 10.50.01 effective December 13, 1999 (26:25 Md. R. 1897)

Regulations .01—.08 repealed and new Regulations .01—.12 adopted effective March 15, 2004 (31:5 Md. R. 449)

Regulation .03B amended effective April 4, 2011 (38:7 Md. R. 432); September 15, 2025 (52:18 Md. R. 923)

Regulation .04B amended effective April 4, 2011 (38:7 Md. R. 432); August 15, 2016 (43:16 Md. R. 901); September 15, 2025 (52:18 Md. R. 923)

Regulation .05 repealed effective September 15, 2025 (52:18 Md. R. 923)

Regulation .06 amended effective November 25, 2013 (40:23 Md. R. 1934)

Regulation .06 repealed and new Regulation .06 adopted effective September 15, 2025 (52:18 Md. R. 923)

Regulation .07B amended effective September 15, 2025 (52:18 Md. R. 923)

Regulation .07D adopted effective September 15, 2025 (52:18 Md. R. 923)

Regulation .08 recodified to be Regulation .09 effective September 15, 2025 (52:18 Md. R. 923)

Regulation .08 adopted effective September 15, 2025 (52:18 Md. R. 923)

Regulation .09 repealed effective September 15, 2025 (52:18 Md. R. 923)

Regulation .09 recodified from Regulation .08 effective September 15, 2025 (52:18 Md. R. 923)

Regulation .10 amended effective September 15, 2025 (52:18 Md. R. 923)

Regulation .10C amended effective January 9, 2012 (38:27 Md. R. 1764)

Regulation .11A amended effective September 15, 2025 (52:18 Md. R. 923)

Regulation .11A, C amended effective April 4, 2011 (38:7 Md. R. 432)