The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

UNIVERSITY OF TEXAS M D ANDERSON CANCER CENTER,THE 1515 HOLCOMBE BLVD HOUSTON, TX Nov. 1, 2019
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on interview and record review, the facility failed to ensure there was a clear and concise policy and/or Standard Operating Procedure (SOP) in place that would prevent transport of sterile surgical instruments to an off-site facility in a manner that would compromise sterility of the instruments. The facility transported sterile surgical instruments in a cargo van when the temperature/humidity levels were out of range or not documented in 11 of 38 days reviewed.

This deficient practice had the likelihood to cause harm to all patients having surgery at the off-site surgical facility.

Findings include:

During a tour of the materials management back dock on October 29, 2019 after 1:00 p.m., an interview was conducted with Staff #3 and Staff #6. Staff #6 was noted as the driver on the facility document titled, "MDACC Sterile Equipment Transport checklist - AM Delivery on 10-24-2019." Staff #6 was asked to confirm the humidity reading documented as the initial level prior to transport. Staff #6 confirmed it was 76.7 %. Staff #6 was asked why the instruments were transported when the humidity was out of range. Staff #6 stated, "Well I tried for over an hour with the air conditioning running to get the truck into range. The off-site facility was calling and upset because they did not have the instruments. I went to the shift supervisor for materials that day and was told to transport them, so I did." Staff #3 was asked if he was aware that sterile surgical instruments were transported when the temperature and humidity was out of range. Staff #3 confirmed he was not aware of that transport. Staff #3 said he had been made aware of some out of range temperature and humidity levels and he had just implemented a hard stop to staff members that no sterile instruments would be transported when levels for temperature and humidity were out of range. Staff #3 was asked what day that information was given to staff members. Staff #3 confirmed he had started the hard stop on October 29, 2019. Staff #3 was asked if all his drivers had been reeducated. Staff #3 said he was in the process of completing that.

Review of the facility documents titled, "MDACC Sterile Equipment Transport checklist - AM delivery" revealed the following:

9-4-2019 - No humidity readings were documented prior to transport.
9-5-2019 - No humidity readings were documented prior to transport. There was a comment noted that said, "Thermometer not working".
9-19-2019 - The humidity level documented at the destination after transport was 65.3%.
10-9-2019 - The humidity level documented as the initial reading prior to transport was 65.5 %.
10-10-2019 - The humidity level documented as the initial reading prior to transport was 69.5 %.
10-11-2019 - The humidity level documented as the initial reading prior to transport was 75.9 %.
10-14-2019 - The humidity level documented as the initial reading prior to transport was 70.1 %.
10-21-2019 - The humidity level documented as the initial reading prior to transport was 63.6 %.
10-23-2019 - The humidity level documented as the initial reading prior to transport was 63.6%.
10-24-2019 - The humidity level documented as the initial reading prior to transport was 76.7 %.
10-25-2019 - The humidity level documented as the initial reading prior to transport was 67.8 %.
10-25-2019 - The humidity documented at the destination after transport was 70.9%.


Review of the facility SOP titled, "Preparing Vehicle before the AM Run" revealed the following:

"Cool or Hot - get the temperature and humidity within range prior to loading the vehicles to a max of 75 degrees and a max humidity of 60 degrees ....

Before loading clean case carts - Make sure that the vehicle is at the temperature of a max of 75 degrees and max humidity of 60 degrees before loading the case carts that are ready for transporting."

There were no instructions in the SOP for the employees to follow when the level of the temperature and humidity were out of range.

Staff #3 and #58 confirmed the above findings on humidity levels in the transport cargo van.


Review of the ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities revealed the following:

"11.3 Transport of sterile packaged items

11.3.1 General considerations
Sterile items should be transported in a manner that will protect the items from puncture and from contamination by moisture, excessive humidity, condensation caused by exposure to temperature extremes, insects, vermin, dust and dirt, excessive air pressures, and microorganisms."