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1550 FIRST COLONY BOULEVARD

SUGAR LAND, TX null

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on interview and record review, the facility failed to uphold the right of one (1) of 10 sampled patients / patient's representative (Patient # 10 ) to make informed decisions regarding her care.

Physician # 18 failed to obtain informed consent that included a discussion of risks with family, prior to inserting a triple-lumen catheter into Patient # 10.

Patient # 10 suffered a cardiopulmonary arrest during the procedure.

Findings include:

TX 00216388

Record review of the clinical record of Patient # 10 revealed she was an 87 year old female admitted to the facility on 02-26-15 for medical treatment of ventilator-dependent respiratory failure, acute renal failure, and management of gastrointestinal bleeding.

Record review of facility form titled "Procedure Checklist," dated 03-12-15, listed procedure as "Quinton catheter...Start time: 1652; Finish Time:1755." Further review of this same form under section "Procedure Checklist," there was a check mark under the "YES" column for "Correct Consent and Signed."

Record review of "Code Blue Flowsheet" dated 03-12-15, revealed Patient # 10 suffered a cardiopulmonary arrest at 1755. Cardiac compressions were initiated; Atropine, Epinephrine, and Bicarb were administered. Code sheet documented at 1800 "survived." Patient # 10 coded again at 1808 and was pronounced dead at 18:35.

Record review of Consent Form, dated 03-12-15 for Patient # 10 "Quinton Catheter Placement" revealed the consent was incomplete/ not valid. There was no documentation of who would be performing the procedure; type of anesthesia; or indication it was a telephone consent. There was no physician certification of discussion of "...risks/benefits, consequences /alternatives..."

Interview on 06-04-15 at 11:15 a.m.. with Resource Chief Clinical Officer (CCO) # 1 ; she stated the facility began an investigation immediately after the event with Patient # 10 occurred. They had identified there was no consent and began staff in-services shortly thereafter.

Record review of facility policy titled: "Informed Consent," release date 02/2014, read:"...Procedure: Obtaining Informed Consent. a The physician performing ..the surgical procedure or his designee shall be responsible for obtaining informed consent...b. during the informed consent discussion, the following should be discussed with the patient: i. a description of the proposed procedure... including the anesthesia/sedation to be used...material risks and benefits related to the procedure...documentation of the informed consent must be completed prior to the procedure and documented in the patient's medical record..."

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on interview and record review, the facility failed to ensure that nursing staff administered medication according to facility policy for 1 of 10 sampled patients ( Patient # 7).

Registered Nurse (RN) # 19 failed to reassess Patient #7 after administration of a bolus dose of Dextrose 50 % for a low blood glucose level.

Within 1 and 1/ 2 hours of the administration of the Dextrose, Patient # 7 developed a critically low blood glucose level and subsequently suffered a cardiopulmonary arrest. Despite the administration of additional Dextrose and Atopine, Patient # 7 expired.

Findings include:

TX # 00216388

Record review of Patient # 7's clinical record revealed she was a 66 year old female patient admitted to the facility on 01-14-15. Her diagnoses included : Sepsis related to Infected Decubitus Ulcers; Diabetes Mellitus; and End Stage Renal Disease.

Continued review of Patient # 7's clinical record revealed a physician order dated 01-16-15 that read : "finger stick glucose every 6 hours." Patient # 7 also had standing orders for "sliding scale " insulin based upon the blood sugar results.

Review of Patient # 7's blood glucose results were:

02-09-15 ( 12:43 a.m) : 85 milligrams/deciliter (mg/dL) [ facility reference range is 60-100 mg/dL]

02-09-14 ( 8:15 a.m.) : 44 mg/dL ("critical low") .

02-09-15 (8:32 a.m): 1 amp of Dextrose 50 % intravenous (IV) administered by RN # 19.

On 02-09-15 at 10:10 a.m., Patient # 7 suffered a cardiopulmonary arrest. Her blood sugar at this time was documented as 15 mg/dL.

Additional administration of 1 amp Dextrose 50 % IV (twice) elevated the blood sugar only to 32 mg/dL. Patient # 7 was pronounced dead at 11 a.m. on 02-09-15.

Interview on 06-04-15 at 2:45 p.m. with Resource Chief Clinical Officer (CCO) # 1 ; she reviewed the clinical record of Patient # 7 and was unable to locate documentation of a reassessment by RN #19 after he administered the Dextrose 50 % at 8:38 a.m. CCO # 1 stated RN # 19 should have rechecked Patient #7's blood sugar to assess the effectiveness of the dextrose. She went on to say this was a clinical nursing judgement and it did not require a physician order.

Record review of facility policy titled "Administration of Medications," release date 05/2015, read: "...3 Documentation...c. Effectiveness /post assessment of medication will be documented in the medical record for all PRN and any other medication that warrants a post assessment..."

Record review of facility policy titled "Assessment/Re-Assessment-Interdisciplinary Patient," release date 05/2015, read: "...Procedure Assessment/Reassessment.....3 Nursing Department:...g.Patient reassessment is based on but not limited to the following: i. To evaluate patient response to care, treatment, and services, ii. To respond to a significant change in status and/ or diagnosis or condition..."