HospitalInspections.org

Based on review of medical records, relevant facility documents, and staff interviews, the facility failed to manage a biological, Apligraf, in accordance with acceptable standards of practice and manufacturer recommendations in that the facility failed to tract the flow of Apligraf from entry to the hospital, dispensation and disposal of leftover Apligraf. This deficient practice had potential to cause harm to patients.

Apligraf is created from cells found in healthy human skin. It is used to heal ulcers such as diabetic foot and venous leg ulcers. Apligraf contains two types of cells - an outer layer of protective skin cells, and an inner layer of cells contained within collagen. Both types of cells contain substances similiar to those found in human skin. Apligraf plays an active role in healing by providing to the wound living cells, proteins produced by the cells, and collagen, which are important for healing.


Refer to tags A-0491, A-0500, A-0501

Based on review of medical records, relevant facility documents, and staff interviews, the facility failed to manage a biological, Apligraf, in accordance with acceptable standards of practice and manufacturer recommendations in that the facility failed to tract the flow of Apligraf from entry to the hospital, dispensation and disposal of leftover Apligraf. This deficient practice had potential to cause harm to patients.

Apligraf is created from cells found in healthy human skin. It is used to heal ulcers such as diabetic foot and venous leg ulcers. Apligraf contains two types of cells - an outer layer of protective skin cells, and an inner layer of cells contained within collagen. Both types of cells contain substances similiar to those found in human skin. Apligraf plays an active role in healing by providing to the wound living cells, proteins produced by the cells, and collagen, which are important for healing.


The findings included:

a. Interviews on January 31, 2014, and February 3, 2014 in the facility conference room revealed the following:

1. Staff #2 stated physician #1 would apply Apligraf on patient. Once the physician completed the procedure, staff # 1 would enter information on the medical record that leftover Apligraf was discarded. Physician #1 would then take leftover Apligraf and apply it on a different patient.

2. Staff # 4 stated physician #1 would store leftover Apligraf in the refrigerator and use expired Apligraf on patients # 6, 7, and 8. Review of medical records revealed no documentation of expired Apligraf application.

3. Staff # 5 stated that she saw physician #1 keep leftover Apligraf and take with her. Staff #5 entered information on the medical record that left over Apligraf was discarded. Staff #5 does not know what physician #1 did with leftover Apligraf.


b. Review of the manufacturer precautions on the use of Apligraft include:

1. Apligraf should not be reused, frozen or sterilized after opening.

2. Apligraf should be kept in its tray on the shipping medium in the sealed bag under controlled temperature 68?F-73?F (20?C-23?C) until ready for use.

3. Apligraf should be handled using sterile technique and placed on a prepared wound bed within 15 minutes of opening the package.


c. Above findings were verified by staff # 6 Quality Manager on February 3, 2014.

Based on review of medical records, relevant facility documents, and staff interviews, the facility failed to manage a biological, Apligraf, in accordance with acceptable standards of practice and manufacturer recommendations in that the facility failed to tract the flow of Apligraf from entry to the hospital, dispensation and disposal of leftover Apligraf. This deficient practice had potential to cause harm to patients.

Apligraf is created from cells found in healthy human skin. It is used to heal ulcers such as diabetic foot and venous leg ulcers. Apligraf contains two types of cells - an outer layer of protective skin cells, and an inner layer of cells contained within collagen. Both types of cells contain substances similiar to those found in human skin. Apligraf plays an active role in healing by providing to the wound living cells, proteins produced by the cells, and collagen, which are important for healing.


The findings included:

a. Interviews on January 31 and February 3, 2014 in the facility conference room revealed the following:

1. Staff #2 stated "physician #1 would apply Apligraf on patient using sterile technique. Once the physician completed the procedure, staff # 1 would enter information on medical record that leftover Apligraf was discarded. Physician #1 would then take the leftover Apligraf and apply it on a different patient using sterile technique."

2. Staff # 4 stated "physician #1 would store leftover Apligraf in the refrigerator and use expired Apligraf on patient # 6, 7, and 8." Review of medical records revealed no documentation of expired Apligraf application.

3. Staff # 5 stated that she saw physician #1 keep leftover Apligraf and take with her. She entered information on medical record that left over Apligraf was discarded. She does not know what physician #1 did with leftover Apligraf.



b. Review of the manufacturer precautions on Apligraft include:

1. Apligraf should not be reused, frozen or sterilized after opening.

2. Apligraf should be kept in its tray on the shipping medium in the sealed bag under controlled temperature 68?F-73?F (20?C-23?C) until ready for use.

3. Apligraf should be handled using sterile technique and placed on a prepared wound bed within 15 minutes of opening the package.



c. Above findings were verified by staff # 6 Quality Manager on February 3, 2014.