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Based on record review and interview, the facility failed to ensure two(2) of five sampled patients executed an appropriate and complete informed consent prior to undergoing a lumbar puncture ( Patient # 6, # 10) .

Findings include:

TX 00219100

Record review of five (5) patients who underwent lumbar puncture in the facility Emergency Room (ER) revealed the following:

Patient # 6:

Review of Patient # 6's clinical record revealed she was a 22 year old female who presented to ER on 05-21-15 with complaints of stiff neck, headache, sore back, and chills. Temperature upon arrival was 102.4 degrees

Review of Patient # 6's "Disclosure and Consent " form for a Lumbar Puncture revealed patient's signature but no date and no time. In addition, the sections that indicated the disclosure of risks was left blank and unmarked for "epidural/spinal procedure, including lumbar puncture." The area that delineated procedure risks was not marked by the facility nor documented as acknowledged by Patient # 6.

Patient # 6 underwent a lumbar puncture on 05-21-15 at 1206 .

Patient # 10:

Review of Patient # 10's clinical record revealed she was a 28 year old female who presented to ER on 06-29-15 with complaints of headache, weakness, and dehydration.

Review of Patient # 10's "Disclosure and Consent " form for a Lumbar Puncture revealed the sections that indicated the disclosure of risks was left blank and unmarked for "epidural/spinal procedure, including lumbar puncture." The area that delineated procedure risks was not marked by the facility nor documented as acknowledged by Patient # 6.

Patient #10 underwent a lumbar puncture on 06-30-15 at 0010.

Interview on 07-27-15 at 2:30 p.m. with Director of Quality/Risk # 2, she stated the consents should have dates, times, and applicable risks disclosed and acknowledged.

Record review of facility policy titled "Informed Consent: Surgery/Procedure Consent," review/revised date 11/2012, read:"....In accordance with state and federal law, prior to providing care, treatment , or services, consent will be obtained from either the patient or the patient's surrogate decision maker. A Disclosure and Consent for Medical and Surgical Procedures form must be used to document consent of the patients for performance of any of the procedures falling within the following categories: :...all procedures requiring administration of general, spinal, epidural or regional anesthesia...."

Based on record review and interview, the facility failed to ensure that one of five sampled patients received procedure-specific discharge instructions after undergoing a lumbar puncture ( Patient # 5).

Findings include:

TX 00219100

Record review of five (5) patients who underwent lumbar puncture in the facility Emergency Room (ER) revealed that four of the five(5):

1. received printed discharge instructions titled "Lumbar Puncture" or
2. documented instructions in the medical record of specific content to post lumbar puncture.

Record review of the clinical record of Patient # 5 revealed she was a 35 year old female who presented to the ER on 03-11-15 at 2232 with complaints of acute low back pain, headache, and fever of 100.9 degrees Fahrenheit.

Patient # 5 underwent a lumbar puncture on 03-12-15 at 0135. She was discharged home on 03-12-15 at 0516.

Further review of Patient # 5's ER record revealed she was given printed discharge instructions for "viral meningitis" and none for lumbar puncture. Review of her clinical record read: "...Patient has been given discharge instructions both written and verbally..." No specific mention of lumbar puncture was documented.

Interview on 07-27-15 at 2:30 p.m. with Director of Quality/Risk # 2, she acknowledged Patient # 5 should have received the printed instructions for "lumbar puncture" as did the other patients who had lumbar punctures.

Review of facility policy titled "Emergency Department Discharge Instructions,"revised date 04-15-15, read: "...2. The physician will review the diagnosis and... plan of care post discharge... 3. The registered nurse will review the discharge instructions...5. The signature page of the discharge instruction form is to be kept in the medical record..."