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800 W CENTRAL ROAD

ARLINGTON HEIGHTS, IL 60005

ORDERS FOR DRUGS AND BIOLOGICALS

Tag No.: A0409

Based on document review and interview, it was determined that for 1 of 1 patient clinical record reviewed (Pt. #1) for a patient receiving self-administered patient controlled analgesia (pain relief), the Hospital failed to ensure that patient monitoring was completed as required by policy.

Findings include:

1. On 11/28/18 at 12:30 PM, the Hospital's policy titled, "Patient Controlled Analgesia (PCA)" (revised 10/5/18), was reviewed. The policy required, "'D. Assessment: 1. Assess the patient's ability to self-administer PCA before initiating use of PCA and during use of PCA... 2. Assess vital signs including RASS (Richmond Agitation and Sedation Scale) [a measure of patient level of alertness and agitation], pain level, quality of respirations, and ETCO2 [end-tidal carbon dioxide - the amount of carbon dioxide in exhaled air - to determine hyperventilation, decreased cardiac output, or poor pulmonary perfusion]... a. Baseline (prior to initiation of PCA), b. Initiation or change of drug: i. Every 15 minutes for 1 hour, ii. Every 1 hour for 4 hours, iii. Then every 2 hours..."

2. On 11/26/18 at 10:00 AM, the clinical record of Pt. #1 was reviewed. Pt. #1 was a 21 year old female, admitted on 9/3/18, with a diagnosis of severe preeclampsia (a pregnancy complication characterized by high blood pressure and signs of damage to other organ systems).

- The Discharge Summary, dated 9/10/18, included, "Hospital Course: The patient was admitted and diagnosed with severe preeclampsia. The plan was to induce [artificially start the birth process with medication and/or stimulation] at 34 weeks, however, on hospital day number 3, the patient developed a headache and it was felt that the preeclampsia was progressing... The patient did not make any further change... The patient underwent a cesarean section on 9/6/18 without complications..."

- A physician's order dated 9/6/18 at 11:07 PM, included Hydromorphone (dilaudid) (narcotic pain medication), via a PCA pump (a device to provide self-administered pain relief at a prescribed dose, for limited time periods), 0.2 mg (milligrams), every 10 minutes. The PCA pump was started on 9/6/18 at 11:30 PM and continued until 9/8/18 at 7:08 AM. RASS assessment documentation was not completed from 9/7/18 at 12:00 AM to 9/7/18 at 3:30 AM. Pain assessment documentation was not completed from 9/6/18 at 11:45 PM to 9/7/18 at 1:30 AM and from 9/7/18 at 6:00 AM to 9/7/18 at 8:30 AM. Respiratory quality assessment was not documented until 9/8/18 at 12:30 AM (1 day and 1 hour after initiation). ETCO2 monitoring was not documented from 9/6/18 at 11:30 PM to 9/8/18 at 7:08 AM.

3. On 11/28/18 at 12:30 PM, an interview was conducted with a Clinical Nursing Transformational Leader (E#13). E#13 stated that ETCO2 is measured by a tube worn near the patient's nose. The tube can be uncomfortable and patients often take it off. PCA pumps are not frequently used on the Mother Baby Unit and the nurses are not as familiar with PCA pumps as nurses in the Intensive Care Unit. E#13 reviewed Pt. #1's clinical record and stated that Pt. #1's RASS, pain level, quality of respiration, and ETCO2 were not completed as required, and that more nursing education on the Mother Baby Unit would be done.

BLOOD TRANSFUSIONS AND IV MEDICATIONS

Tag No.: A0410

Based on document review and interview, it was determined that for 1 of 3 patient records reviewed (Pt. #1) for an allergic reaction, the Hospital failed to ensure that the patient's allergy list was updated.

Findings include:

1. The Hospital's policy titled, "Medication Administration" (revised 11/1/18), was reviewed on 11/28/18 and required, " ... Any ADR [Adverse Drug Reaction] must be reported to the physician and recorded on the patient's medical record ..."

2. The clinical record of Pt. #1 was reviewed on 11/26/18. Pt. #1 was a 21 year old female, admitted on 9/3/18, with a diagnosis of severe preeclampsia [pregnancy complication characterized by high blood pressure].

- A physician's order, dated 9/7/18 at 8:54 PM and again at 10:10 PM included, "Hydralazine [medication to treat high blood pressure] 5 mg [milligrams] STAT [immediately]."

- The Medication Administration Record indicated that 5 mg of hydralazine was administered on 9/7/18 at 9:00 PM and 10:15 PM.

- An Obstetrician/Gynecologist's (MD#3) progress note, dated 9/7/18 at 11:51 PM, included, " ...Subjective: [Pt. #1] C/O [complains of] feeling throat swelling after recent dose of Hydralazine... Impression: Allergic rxn [reaction] to Hydralazine or narcotics ?? Early anaphylaxis [life threatening allergic reaction]??..."

- The Initial Discharge Assessment, dated 9/10/18 at 12:29 PM, included, "...possible allergic reaction to hydralazine..."

- The Allergy List as of 9/10/18 did not include hydralazine.

3. An interview was conducted with the Vice President Chief Quality Officer (E#14) on 11/28/18 at 12:59 PM. E#14 confirmed that hydralazine was never added to Pt. #1's allergy list. E#14 stated that the allergy to hydralazine was not added to the list because it was never validated. When asked whether Pt. #1's allergy list should have been updated to include a potential reaction to hydralazine, E#14 stated that, "it should have been updated" to caution future use of the medication.