(a) Facilities shall submit HAI and designated PAE data according to the following schedule in Table 1.
Attached Graphic
  (1) HAI and designated PAE data for device days and procedures occurring between January 1 and March 31 shall be submitted no later than May 31 of the same calendar year.
  (2) HAI and designated PAE data for device days and procedures occurring between April 1 and June 30 shall be submitted no later than August 31, of the same calendar year.
  (3) HAI and designated PAE data for device days and procedures occurring between July 1 and September 30 shall be submitted no later than November 30 of the same calendar year.
  (4) HAI and designated PAE data for device days and procedures occurring between October 1 and December 31 shall be submitted no later than February 28 of the following calendar year.
(b) If any of the dates in subsection (a) of this section fall on a weekend or holiday, facilities shall submit on the following business day.
(c) Reporting of deaths shall follow the same reporting time line as HAI and PAE reporting in this section.
(d) Health care facilities shall begin reporting TxHSN-reported PAEs data as outlined starting on January 1, 2015.
  (1) Facilities will report the following PAEs effective January 1, 2015.
    (A) Surgeries or invasive procedures involving a surgery on the wrong site, wrong patient, wrong procedure or a foreign object retained after surgery.
    (B) Patient death or severe harm associated with unsafe administration of blood or blood products.
    (C) Patient death or severe harm associated with a fall in a health care facility resulting in a fracture, dislocation, intracranial injury, crushing injury, burn or other injury.
    (D) Post-operative death of an ASA Class 1 Patient.
    (E) Discharge or release of a patient of any age, who is unable to make decisions, to someone other than an authorized person.
    (F) Perinatal death or severe harm (maternal or neonatal) associated with labor or deliver in a low-risk pregnancy while being cared for in a health care facility.
    (G) Patient death or severe harm resulting from failure to follow up or communicate laboratory, pathology or radiology test results.
    (H) Any incident in which systems designated for oxygen or other gas to be delivered to a patient contains no gas, wrong gas, or are contaminated by toxic substances.
    (I) Patient death or severe harm associated with use of physical restraints or bedrails while being cared for in a health care facility.
    (J) Abduction of a patient of any age.
    (K) Sexual abuse or assault of a patient within or on the grounds of a health care facility.
    (L) Patient death or severe harm of a patient resulting from a physical assault that occurs within or on the grounds of a health care facility.
    (M) Patient death or severe harm resulting from the irretrievable loss of an irreplaceable biological specimen.
  (2) Facilities will report the following PAEs effective January 1, 2016.
    (A) Stage III, Stage IV or Unstageable pressure ulcer acquired after admission/presentation to a health care facility.
    (B) Patient death or severe harm associated with patient elopement.
    (C) Patient suicide, attempted suicide or self-harm that results in severe harm, while being cared for in a health care facility.
    (D) Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist or other licensed health care provider.
    (E) Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) after total knee replacement or after hip replacement.
    (F) Patient death or severe harm associated with an electric shock while being cared for in a health care facility.
    (G) Patient death or severe harm associated with a burn incurred from any source while being cared for in a health care facility.
    (H) Iatrogenic Pneumothorax with venous catheterization.
    (I) Patient death or severe harm associated with the introduction of a metallic object into the MRI area.
  (3) Facilities will report the following PAEs effective January 1, 2017.
    (A) Patient death or severe harm associated with intravascular air embolism that occurs while being cared for in a health care facility.
    (B) Poor glycemic control: diabetic ketoacidosis.
    (C) Poor glycemic controls: nonketonic hyperosmolar coma.
    (D) Poor glycemic control: hypoglycemic coma.
    (E) Poor glycemic control: secondary diabetes with ketoacidosis.
    (F) Poor glycemic control: secondary diabetes with hyperosmolarity.
    (G) Artificial insemination with the wrong donor sperm or wrong egg.
    (H) Patient death or severe harm associated with the use of contaminated drugs/devices or biologics provided by the health care facility.
    (I) Patient death or severe harm associated with the use or function of a device in patient care, in which the device is used or functions other than as intended.
    (J) Patient death or severe harm associated with a medication error.
    (K) Surgical site infections following a spinal procedure, shoulder procedure, elbow procedure, laparoscopic gastric bypass, gastroenterostomy, laparoscopic gastric restrictive surgery or cardiac implantable electronic device.
  (4) Amendments to this list of PAEs may be adopted at the discretion of the executive commissioner as recommended by CMS and NQF.

Source Note: The provisions of this §200.7 adopted to be effective May 4, 2011, 36 TexReg 2729; amended to be effective August 7, 2012, 37 TexReg 5793; amended to be effective April 21, 2013, 38 TexReg 2363; amended to be effective September 17, 2014, 39 TexReg 7340; amended to be effective January 18, 2015, 40 TexReg 245