Form 6111, Clinical Laboratory Improvement Amendment Facility Incident Report

Instructions for Opening a Form

Some forms cannot be viewed in a web browser and must be opened in Adobe Acrobat Reader on your desktop system. Click here for instructions on opening this form.


Effective Date: 6/2019


Effective Date: 6/2019



Form 6111 is used to notify Texas Health and Human Services Commission (HHSC) of an incident and the actions taken by the facility. Form 6111 is required for transfusion related fatalities.


Submit as soon as possible and submit each form separately. Do not submit multiple incidents in one document.

Explain how the facility will improve care as a result of the incident. Complete the entire form with all requested attachments so that HHSC may review the incident without requiring additional information or documents.


Submit each completed form by ONE of the following (email, fax or mail):


Fax: 1-833-709-5735 or 512-206-3985
Mail: Texas Health and Human Services Commission
Complaint and Incident Intake
P.O. Box 149030, Mail Code E-249
Austin, TX 78714-9030

Detailed Instructions

Print or type the information and provide as much information as possible. Use the facility name and license number as listed on your license.

Date of Report Enter the report date.

Date of Death Enter the date of death.

Time of Death Enter the time of death and check A.M. or P.M.

Facility License No.Enter the facility license number.

Facility Provider No. (CCN)Enter the facility provider number, which is the Medicare six-digit number.

Facility NameEnter the name of the facility.

Facility AddressEnter the street address, city, state, ZIP code.

TelephoneEnter the area code and telephone number.

Reporter Name and TitleEnter the contact person and title that the surveyor will ask for should a follow-up telephone call be needed.

Primary Phone No. and Secondary Phone No. Enter the area code and telephone numbers.

EmailEnter the email address.

Patient NameEnter the first, middle and last name.

Date of BirthEnter the patient’s date of birth.

Date of TransfusionEnter the date the transfusion date.

Diagnoses (all)Enter the diagnoses.

Where was patient when reaction occurred?Check the box for home, hospital, nursing home, infusion center or other. If other, provide where.

Facility Name and CityEnter the name of the facility and city.


When did you first learn of the incident? Enter the date and time.

On what shift did the incident occur? Check the box for day, evening or night.

Provide a brief summaryEnter what happened and include relevant staff names and titles, dates and time. Include information pertaining to whether or not the patient was transferred prior to death.

Did the patient receive any treatment? Check Yes or No and if yes, provide an explanation of the treatment provided. Attach pertinent treatment documentation, if necessary. 

Provide a narrative report of the investigation Explain how  the incident was handled and what actions  were taken to reduce the potential for similar incidents in the future.

Actions to be taken as a result of this incidentCheck all boxes that apply.

Signature, Printed Name and Date The supervising authority signs, prints his/her name and enters the date. Then, email, fax or mail the completed incident form to the number or address provided above under Transmittal.