Compliance Resources

The risk of non-compliance can lead to penalties and loss of funding and accreditation.
Here are key updates in The Joint Commission's requirements, which became effective on January 1, 2009 and updated January 1, 2010.

Standard TS.03.01.01

The hospital uses standardized procedures for managing tissues.

Elements of Performance for TS.03.01.01
  
A 1. The hospital assigns responsibility to one or more individuals for overseeing the acquisition, receipt, storage, and issuance of tissues throughout the hospital.
Note: Responsibility for this oversight involves coordinating efforts to provide standardized practices throughout the hospital. A hospital may have a centralized process (one department responsible for the ordering, receipt, storage, and issuance of tissue throughout the hospital) or a decentralized process (multiple departments responsible for the ordering, receipt, storage, and issuance of tissue throughout the hospital).

A 2. The hospital develops and maintains standardized written procedures for the acquisition, receipt, storage, and issuance of tissues. (See also TS.03.02.01, EP 5)  

A 3. The hospital confirms that tissue suppliers are registered with the U.S. Food and Drug Administration (FDA) as a tissue establishment and maintain a state license when required. (1)
Note: This Element of Performance does not apply to autologous tissue or cellular-based products considered tissue for the purposes of these standards but classified as medical devices by the FDA.

A 4. The hospital coordinates its acquisition, receipt, storage, and issuance of tissues throughout the hospital.

A 5. The hospital follows the tissue suppliers’ or manufacturers’ written directions for transporting, handling, storing, and using tissue. 

C 6. The hospital documents the receipt of all tissues. (See also TS.03.02.01, EPs 3 and 6)  

C 7. The hospital verifies at the time of receipt that package integrity is met and transport temperature range was controlled and acceptable for tissues requiring a controlled environment. This verification is documented. (See also TS.03.02.01, EP 6)
Note: If the distributor uses validated shipping containers, then the receiver may document that the shipping container was received undamaged and within the stated time frame.

C 8. The hospital maintains daily records to demonstrate that tissues requiring a controlled environment are stored at the required temperatures. (See also TS.03.02.01, EP 5) Note: Types of tissue storage include room temperature, refrigerated, frozen (for example, deep freezing colder than -40°C), and liquid nitrogen storage.

A 9. The hospital continuously monitors the temperature of refrigerators, freezers, nitrogen tanks, and other storage equipment used to store tissues. Note 1: Continuous temperature recording is not required, but may be available with some continuous temperature monitoring systems. Note 2: For tissue stored at room temperature, continuous temperature monitoring is not required.

A 10. Refrigerators, freezers, nitrogen tanks, and other storage equipment used to store tissues at a controlled temperature have functional alarms and an emergency back-up plan. Note: For tissue stored at room temperature, alarm systems are not required.   

A 11. The hospital complies with state and/or federal regulations when it acts as a tissue supplier.(2)
Note: The U.S. Food and Drug Administration (FDA) considers the routine policy or practice of shipping tissue to another facility as distribution which requires FDA registration. Returning unused tissue back to the tissue supplier is not considered distribution and does not require FDA registration.

Footnotes:
(1) For U.S. Food and Drug Administration (FDA) registration, the supplier registration status may also be checked annually by using the FDA's online database: http://www.fda.gov/cber/tissue/tissregdata.htm

(2) Please refer to the following Web site: http://www.fda.gov/cber/tissue/tisreg.htm

Standard TS.03.02.01

The hospital traces all tissue bi-directionally.

Elements of Performance for TS.03.01.01  

A 1. The hospital’s records allow any tissue to be traced from the donor or tissue supplier to the recipient(s) or other final disposition, including discard, and from the recipient(s) or other final disposition back to the donor or tissue supplier.

C 2. The hospital identifies, in writing, the materials and related instructions used to prepare or process tissues.

C 3. The hospital documents the dates, times, and staff involved when tissue is accepted, prepared, and issued. (See also TS.03.01.01, EP 6)

A 4. The hospital documents in the recipient’s medical record the tissue type and its unique identifier.

A 5. The hospital retains tissue records on storage temperatures, outdated procedures, manuals, and publications for a minimum of 10 years. If required by state and/or federal laws, hospitals may have to retain tissue records longer than 10 years. (See also TS.03.01.01, EPs 2 and 8)

A 6. The hospital retains tissue records for a minimum of 10 years beyond the date of distribution, transplantation, disposition, or expiration of tissue (whichever is latest). If required by state and/or federal laws, hospitals may have to retain tissue records longer than 10 years. Records are kept on all of the following:

- The tissue supplier.
    Note: For medical devices, the manufacturer may be the tissue supplier.
- The original numeric or alpha-numeric donor and lot identification.
- The name(s) of the recipient(s) or the final disposition of each tissue.
- The expiration dates of all tissues.
    (See also TS.03.01.01, EPs 6 and 7)

A 7. The hospital completes and returns tissue usage information cards requested by the tissue supplier.*

* According to Health Insurance Portability and Accountability Act (HIPAA) regulations regarding protected health information, “a covered entity may disclose protected health information for public health activities or other purposes to a person subject to the jurisdiction of the Food and Drug Administration (FDA) for the following purposes:

-To track products if the disclosure is made to a person required or directed by the FDA to track the product
-To enable product recalls, repairs, or replacement (including locating and notifying individuals who have received product recalls, withdrawals, or other problems” (45 CFR 164.512(b) (iii) (B) and (C)).

Standard TS.03.03.01

The hospital investigates adverse events related to tissue use or donor infections.

Elements of Performance for TS.03.03.01

A 1. The hospital has a written procedure to investigate tissue adverse events, including disease transmission or other complications that are suspected of being directly related to the use of tissue.

A 2. The hospital investigates tissue adverse events, including disease transmission or other complications that are suspected of being directly related to the use of tissue. (See also IC.01.03.01, EP 3)

A 3. As soon as the hospital becomes aware of a post-transplant infection or other adverse event related to the use of tissue, it reports the infection or adverse event to the tissue supplier.

A 4. The hospital sequesters tissue whose integrity may have been compromised or that is reported by the tissue supplier as a suspected cause of infection.

A 5. The hospital identifies and informs tissue recipients of infection risk when donors are subsequently found to have human immunodeficiency virus (HIV), human T-lymphotropic virus-I/II (HTLV-I/II), viral hepatitis, or other infectious agents known to be transmitted through tissue.

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