HospitalInspections.org

Based on policy and procedure review, medical record review, staff interviews and review of an administrative investigation, the hospital's leadership failed to provide oversight and have systems in place to ensure the protection of patients' rights and failed to have an organized nursing service to ensure the provision of patient care in a safe environment.

The findings include:

1. The hospital's nursing staff failed to follow established policy and procedures for safe medication administration preventing the administration of Lidocaine to 1 of 1 patients' (#2) with a known allergy to the medication resulting in ananaphylactic reaction.

~cross refer to 482.13 (c) (2) Patient Rights Standard: Tag A0144

2. The hospital's nursing staff failed to prevent administration of Lidocaine to 1 of 1 patients (#2) with a known allergy to Lidocaine resulting in anaphylactic reaction.

~cross refer to 482.23(b)(4) Nursing Services Standard: Tag A0395

Based on policy and procedure review, medical record review, staff interviews and review of an administrative investigation, the hospital failed to protect and promote patients' rights for a safe environment by failing to follow established policy and procedures for safe medication administration.

The findings include:

1. The hospital's nursing staff failed to follow established policy and procedures for safe medication administration preventing the administration of lidocaine to 1 of 1 patients (#2) with a known allergy to the medication resulting in anaphylactic reaction.

~cross refer to 482.13 (c) (2) Patient Rights Standard: Tag A0144

Based on policy and procedure review, medical record review, staff interviews and review of an administrative investigation, the hospital's nursing staff failed to follow established policy and procedures for safe medication administration preventing the administration of lidocaine to 1 of 1 patients' (#2) with a known allergy to the medication resulting in anaphylactic reaction.

The findings include:

Review of the hospital's policy "Medication Reconciliation" revision date of 07/2012 revealed medication reconciliation is to be be completed at each encounter/admission during which medication will be administered or prescribed and "...prior to ordering any new medications, the patient's allergies...must be entered into the electronic medical record..."

Review of the hospital's policy "Medication Administration" dated 01/2012 revealed "all medication orders are scanned or faxed to pharmacy...nurses are never to leave medications or unlocked medication cart unattended..." Review of the policy revealed no documentation of assessing the patient for medication allergies prior to medication administration.

Review of the hospital's policy "Pharmacy essential of Patient Information for Medication Dispensing and Administration" last review date of 11/29/2012 revealed "Medications are not dispensed, unless delay would cause patient harm, until Pharmacy Department staff receive at least the following information...medication allergies and intolerances..."

Review of the Preop Manual Procedure Standard "IV Start Policy (Lidocaine)" revision date of 04/2012 revealed "To use 1% Lidocaine with every IV start unless patient refuses or if there is contraindication for Lidocaine use..."

Review of the hospital's policy "Medication/Solution Labeling" last review date of 12/27/2012 revealed "...each medication is labeled as soon as it is prepared, unless it is immediately administered..."

Closed record review of Patient #2 revealed a 46 year old female (Patient #2) scheduled for an elective hysterectomy on 12/04/2013. Review of the record revealed the patient presented for a preoperative assessment on 11/12/2013. Review of the Preoperative Assessment Record revealed a list of allergies which included "Lidocaine". Continued review revealed an Anesthesiologist's Anesthesia Preop screening dated 11/25/2013 at 1540 that revealed a documented allergy to "Lidocaine with anaphylaxis". Review of the admitting physician's history and physical (H&P) dated 12/04/2013 at 0658 revealed a documented allergy to Lidocaine.

Continued review revealed on 12/04/2013 at 0855 the patient presented for admission to the hospital's preoperative surgery unit for a scheduled hysterectomy. Review of the Nursing Surgical Services Pre Procedure Checklist completed by RN (Registered Nurse) #1, dated 12/04/2013 at 0855, revealed "VS (vital signs) BP 143/90 (slightly elevated); Pulse 79 (normal), Respirations 18 (normal)...lung sounds clear". Review of the Medication Administration Record (MAR) dated 12/04/2013 revealed a documented allergy to Lidocaine.

Continued review of the Nursing Pre Procedure checklist revealed at 0923 RN #1 administered Lidocaine 1% 0.1 ml (milliliter) subcutaneously as a numbing agent prior to starting the patient's IV (intravenous). Further record review of RN #1's documentation revealed "Pt (patient) became anxious after 0.1ml lidocaine 1% given to numb the IV site. States she is allergic to Lidocaine. IV established...LR (lactated ringers) infusing. Dr. (doctor) (name of anesthesiologist) in to see patient immediately. Pt became flushed, anxious, clearing throat. O2 (oxygen) started at 3 LPM (liters per minute). Albuterol (bronchodilator) Nebulizer given. Benadryl (antihistamine), Decadron (steroid), Epinephrine (adrenaline), Solumedrol (steroid) given as ordered. Pt HR (heart rate) increased with anxiety level to 124. NSR (normal sinus rhythm). SAO2 (oxygen saturations) stayed at 100% at all times. Flushing, anxiety resolved after above treatments. At 0955 Pt stable. At 1000 Dr. (name of surgeon) in to see pt. cancel surgery today. Observation for S/P (status post) anaphylaxis."

Review of the MAR dated 12/04/2013 revealed the patient received at 0925 Epinephrine 1:1000 ml (milliters) ampule IV and Decadron 10 mg (milligrams) IV; at 0926 Epinephrine 0.3 ml SQ (subcutaneous), Benadryl 25 mg IV, Epinephrine 0.1 ml IV and Solumedrol 125 mg IV; at 0930 Benadryl 25 mg IV and Albuterol 2.5 mg/3ml Nebulizer breathing treatment.

Review of the Anesthesiologist's Progress Notes dated 01/22/2014 at 1940 revealed "Addendum note for events of 12/04/2013...pt seen in preop at 0906. called back to see pt after it was realized that pt was given lidocaine for IV start despite lidocaine allergy..pt was anxious, flushed, but didn't have typical hives however with her history....gave Benadryl (antihistamine) 25 mg, Decadron (steroid) 10 mg IV. After a minute or two she began to have vagal changes. Benadryl repeated. O2 at 3 LPM NC (nasal cannula) initiated earlier...Solumedrol (steroid) 125 mg was given......pt's voice became strained, and she was clearing her throat. She began to exhibit wheezing. Albuterol (bronchodilator) nebulizer was started...epinephrine (adrenaline) was administered IV 0.3 mg...after 1 or 2 minutes the IV epinephrine was repeated. Pt began to improve clinically about this point. Voice returned, wheezing diminished..." Pt continued to improve and was moved to ICU under the care of the Hospitalist.

Review of the Hospitalist Physician's History &Physical dated 12/04/2013 at 2259 revealed "I have admitted (name of patient #2) from the preop area after she inadvertently received Lidocaine to which she is highly allergic. She developed anaphylaxis from which she has recovered under aggressive steroid H1 and H2 blockade (antihistamine medication). She remains in the Intensive Care Unit for close monitoring."

Interview on 01/23/2014 at 0835 with RN #1 revealed as part of the nurse's routine she had prepared the patient's room prior to arrival of the patient. Interview revealed preparation of the room included assembling the IV equipment including a tuberculin (TB) syringe with Lidocaine 1%, 0.1 ml used for numbing the skin prior to the IV stick. Interview confirmed the syringe was not labeled and was left in the patient's room unattended while the nurse went to the waiting room to bring the patient back to the preop room. Interview revealed the Lidcaine is is drawn up from a multidose vial and is suppose to be labeled prior to administration. Continued interview revealed RN #1 had been informed by the patient upon admission that she was allergic to Lidocaine with the reaction being anaphylaxis shock. Interview revealed the RN labeled the front of the chart and applied the patient's allergy band then returned to the nurses station. Interview revealed upon return to the patient's room the nurse proceeded to start the IV. Interview revealed RN #1 administered the Lidocaine 1% 0.1ml subcutaneously as "part of her normal routine, without thinking". Interview confirmed RN #1 administered Lidocaine after being informed the patient was allergic to the medication. Interview revealed RN #1 failed to follow the hospital's policy for safe administration of medication.

Interview on 01/22/2014 at 1400 with the hospital's Nursing Services Leadership staff revealed a Root Cause Analysis (RCA) had not been initiated. Interview revealed an incident report was completed. Interview revealed an investigation of the incident was initiated on 12/04/2013. Further interview revealed their investigative findings revealed the preop nurse had administered Lidocaine 1%, 0.1ml for numbing prior to starting the patients IV for surgery and "the nurse administering the medication displayed distractive behavior related to personal problems at home". Interview confirmed RN #1 administered Lidocaine to the patient after being informed the patient was allergic to the medication. Interview confirmed RN #1 failed to follow the hospital's policy for safe administration of medication.

Based on policy and procedure review, medical record review, staff interviews and review of an administrative investigation, the hospital's nursing staff failed to have an effective nursing service providing oversight of day to day operations by failing to prevent administration of medication to a patient with a known allergy to the medication.

The findings include:

1. The hospital's nursing staff failed to prevent administration of Lidocaine to 1 of 1 patients' (#2) with a known allergy to Lidocaine resulting in anaphylactic reaction.

~cross refer to 482.23(b)(4) Nursing Services Standard: Tag A0395

Based on policy and procedure review, medical record review, staff interviews and review of an administrative investigation, the hospital's nursing staff failed to prevent administration of Lidocaine to 1 of 1 patients' (#2) with a known allergy to Lidocaine resulting in anaphylactic reaction.

The findings include:

Review of the hospital's policy "Medication Reconciliation" revision date of 07/2012 revealed medication reconciliation is to be be completed at each encounter/admission during which medication will be administered or prescribed and "...prior to ordering any new medications, the patient's allergies...must be entered into the electronic medical record..."

Review of the hospital's policy "Medication Administration" dated 01/2012 revealed "all medication orders are scanned or faxed to pharmacy...nurses are never to leave medications or unlocked medication cart unattended..." Review of the policy revealed no documentation of assessing the patient for medication allergies prior to medication administration.

Review of the hospital's policy "Pharmacy essential of Patient Information for Medication Dispensing and Administration" last review date of 11/29/2012 revealed "Medications are not dispensed, unless delay would cause patient harm, until Pharmacy Department staff receive at least the following information...medication allergies and intolerances..."

Review of the Preop Manual Procedure Standard "IV Start Policy (Lidocaine)" revision date of 04/2012 revealed "To use 1% Lidocaine with every IV start unless patient refuses or if there is contraindication for Lidocaine use..."

Review of the hospital's policy "Medication/Solution Labeling" last review date of 12/27/2012 revealed "...each medication is labeled as soon as it is prepared, unless it is immediately administered..."

Closed medical record review on 01/22/2014 revealed a 46 year old female (Patient #2) scheduled for an elective hysterectomy on 12/04/2013. Review of the record revealed the patient presented for a preoperative assessment on 11/12/2013. Review of the Preoperative Assessment Record revealed a list of allergies which included "Lidocaine". Continued review revealed an Anesthesiologist's Anesthesia Preop screening dated 11/25/2013 at 1540 revealed a documented allergy to "Lidocaine with anaphylaxis". Review of the admitting physician's history and physical (H&P) dated 12/04/2013 at 0658 revealed a documented allergy to Lidocaine.

Continued review revealed on 12/04/2013 at 0855 the patient presented for admission to the hospital's preoperative surgery unit for a scheduled hysterectomy. Review of the Nursing Surgical Services Pre Procedure Checklist completed by RN #1 dated 12/04/2013 at 0855 revealed "VS (vital signs) BP 143/90 (slightly elevated); Pulse 79 (normal), Respirations 18 (normal)...lung sounds clear". Review of the Medication Administration Record (MAR) dated 12/04/2013 revealed a documented allergy to Lidocaine.

Continued review of the Nursing Pre Procedure checklist revealed at 0923 RN #1 administered Lidocaine 1% 0.1 ml subcutaneously as a numbing agent prior to starting the patient's IV (intravenous). Further review revealed the patient's allergy to Lidocaine was identified and reviewed with the patient by RN #1. Further review revealed RN #1 applied the allergy bracelet to the patient's wrist. Further record review of documentation by RN #1 revealed "Pt (patient) became anxious after 0.1ml lidocaine 1% given to numb IV site. States she is allergic to Lidocaine. IV established...LR (lactated ringers) infusing. Dr. (doctor) (name of anesthesiologist) in to see patient immediately. Pt became flushed, anxious, clearing throat. O2 (oxygen) started at 3 LPM (liters per minute). Albuterol (bronchodilator) Nebulizer given. Benadryl (antihistamine), Decadron (steroid), Epinephrine (adrenaline), Solumedrol (steriod) given as ordered. Pt HR (heart rate) increased with anxiety level to 124. NSR (normal sinus rhythm). SAO2 (oxygen saturation) stayed at 100% at all times. Flushing, anxiety resolved after above treatments. At 0955 Pt stable. At 1000 Dr. (name of surgeon) in to see pt. cancel (ed) surgery today. Observation for S/P (status post) anaphylaxis."

Review of the MAR dated 12/04/2013 revealed the patient received at 0925 Epinephrine 1:1000 ml (milliters) ampule IV and Decadron 10 mg (milligrams) IV; at 0926 Epinephrine 0.3 ml SQ (subcutaneous), Benadryl 25 mg IV, Epinephrine 0.1 ml IV and Solumedrol 125 mg IV; at 0930 Benadryl 25 mg IV and Albuterol 2.5 mg/3ml Nebulizer breathing treatment..."

Review of the Anesthesiologist's Progress Notes dated 01/22/2014 at 1940 revealed "Addendum note for events of 12/04/2013...pt seen in preop at 0906. called back to see pt after it was realized that pt was given lidocaine for IV start despite lidocaine allergy..pt was anxious, flushed, but didn't have typical hives however with her history....gave Benadryl (antihistamine) 25 mg, Decadron (steroid) 10 mg IV. After a minute or two she began to have vagal changes. Benadryl repeated. O2 at 3 LPM NC (nasal cannula) initiated earlier...Solumedrol (steroid) 125 mg was given......pt's voice became strained, and she was clearing her throat. She began to exhibit wheezing. Albuterol (bronchodilator) nebulizer was started...epinephrine (adrenaline) 1:1000 was administered IV 0.3 mg...after 1 or 2 minutes the IV epinephrine was repeated. Pt began to improve clinically about this point. Voice returned, wheezing diminished..." Pt continued to improve and was moved to ICU under the care of the Hospitalist.

Review of the Hospitalist Physician's H&P dated 12/04/2013 at 2259 revealed "I have admitted (name of patient #2) from the preop area after she inadvertently received Lidocaine to which she is highly allergic. She developed anaphylaxis from which she has recovered under aggressive steroid H1 and H2 blockade (antihistamine). She remains in the Intensive Care Unit for close monitoring." Continued review revealed the patient was transferred to the telemetry unit on 12/06/2013. Continued review revealed the patient was discharged "in stable" condition to home on 12/08/2013.

Interview on 01/23/2014 at 0835 with RN #1 revealed as part of the nurse's routine she had prepared the patient's room prior to arrival of the patient. Interview revealed preparation of the room included assembling the IV equipment including a tuberculin (TB) syringe with Lidocaine 1%, 0.1 ml used for numbing the skin prior to the IV stick. Interview confirmed the syringe was not labeled and was left in the patient's room unattended while the nurse went to the waiting room to bring the patient back to the preop room. Continued interview revealed RN #1 had been informed by the patient upon admission that she was allergic to Lidocaine with the reaction being anaphylaxis shock. Interview revealed the RN labeled the front of the chart and applied the patient's allergy band then returned to the nurses station. Interview revealed upon return to the patient's room the nurse proceeded to start the IV. Interview revealed RN #1 administered the Lidocaine 1% 0.1ml subcutaneously as "part of her normal routine, without thinking". Interview confirmed RN #1 administered Lidocaine after being informed the patient was allergic to the medication. Interview revealed RN #1 failed to follow the hospital's policy for safe administration of medication.

Interview on 01/22/2014 at 1400 with the hospital's Nursing Services Leadership staff revealed a Root Cause Analysis (RCA) had not been initiated. Interview revealed an incident report was completed. Interview revealed an investigation of the incident was initiated on 12/04/2013. Further interview revealed their investigative findings revealed the preop nurse had administered Lidocaine 1%, 0.1ml for numbing prior to starting the patients IV for surgery and "the nurse administering the medication displayed distractive behavior related to personal problems at home". Interview confirmed RN #1 administered Lidocaine to the patient after being informed the patient was allergic to the medication. Interview revealed RN #1 failed to follow the hospital's policy for safe administration of medication.

NC00094198