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Based on interviews, documentation in 1 of 10 medical records reviewed (Patient #7), and review of policies and procedures, it was determined that the hospital failed to ensure the patient's right to safe care through a coordinated, interdisciplinary effort to evaluate and manage the care of the patient who was administered medication to which he/she had a known allergy. Although the patient was admitted with skin alterations from an allergic reaction, the patient received a drug to which he/she had a known allergy, and the hospital failed to fully implement its own policies and procedures related to drug review and safety.


Findings include:

1. Review of the medical record reflected Patient #7 was admitted on 12/04/2012 at 1003 with a history of advanced dementia and an admission diagnosis of urinary tract infection.

The initial "HISTORY AND PHYSICAL EXAMINATION" documented by the physician on 12/04/2012 reflected that the patient was admitted with a rash associated with the previous administration of Bactrim (sulfa antibiotic) and had allergies which included Amoxicillin (penicillin antibiotic). The report identified that the patient's skin "has diffuse rashes...peripheral purpura...diffuse rashes on the anterior chest and the left forearm." The physician's assessment was the patient had a urinary tract infection and the plan included intravenous (IV) Zosyn (penicillin antibiotic), a pharmacy consult, and a wound care consult for the skin alteration. The physician documented that "I have discussed the plan in detail with...the patient's [family member] face to face." There was no documentation in the history and physical to reflect rationale for the administration of Zosyn to this patient who had identified allergies to penicillin antibiotics.

"General Admission Orders" signed and dated by the physician on 12/04/2012 at 1040 identified that the patient had "many" allergies and had orders for IV Zosyn 2.25 grams every eight hours. The orders also included a pharmacy consult and a wound care consult.

On a form titled "PROVIDER'S ADDITIONAL ORDER SHEET," dated 12/4/2012 at 1201, a pharmacist documented and signed an increase of the Zosyn 2.25 gram to every six hours and "Pharmacy to monitor and dose." There was no documentation in the medical record by pharmacists to reflect an assessment of or rationale for the administration of Zosyn, and for increasing the frequency of the Zosyn, to this patient who had identified allergies to penicillin antibiotics.

Page one of a form titled "PRESCRIBER ORDER FORM AND MEDICATION RECONCILIATION" was signed and dated by a registered nurse (RN) on 12/04/2012 at 1230. The RN listed the following drugs that the patient had a known allergy to as: potassium, Codeine, hydrochlorothiazide, Ceclor, Glyburide, Depakote, Lisinopril, and Amoxicillin. The "Reaction" for all of those was documented as "rashes."

An Assessment Report completed by an RN, dated 12/04/2012 at 1239, documented the initial skin assessment as "has drug rash all over body with some blisters noted on wrists [left] hip arms legs [at] various stages some open [right] neck red with irritation back has red rash not blistered."

There was no documentation in the medical record to reflect that RNs questioned the physician's orders for Zosyn in light of the patient's identified allergy to penicillin antibiotics and existing skin rash.

Documentation in physician and RN notes in the record reflected that the patient continued to exhibit skin eruptions, blistering, and alterations on 12/05/2012, 12/06/2012, 12/07/2012, and 12/08/2012. The documentation does not clearly or objectively describe the extent or worsening of the patient's skin condition.

The medication administration documentation reflected that Zosyn was administered every six hours as ordered on 12/05/2012, 12/06/2012, 12/07/2012, and 12/08/2012.

An order documented and signed by a pharmacist on 12/08/2012 at 1535 reflected that the Zosyn dosage was further increased to 3.375 grams intravenously and was to continue every six hours. There was no documentation by the pharmacist to reflect assessment or rationale for the increased dosage of the Zosyn.

The medical record reflected that a family nurse practitioner (FNP) who was on duty in the hospital on 12/08/2012 documented that the urinary tract infection was susceptible to ampicillin and to nitrofurantoin (macrolide antibiotic). The FNP documented that "after 5 days of dosing, switched from IV Zosyn to [oral] nitrofurantoin...Diffuse erythemic blistering with bullae rash noted to have some erythema and 1 blister around the mouth...Greater than 50% of [his/her] body surface are covered." Documentation in the record reflected that the FNP wrote an order to discontinue the Zosyn on 12/08/2012 at 1835.

There was no documentation in the medical record to reflect that the wound consult ordered by the physician had been conducted.

There was no documentation in the record to reflect that all disciplines involved in the care of the patient had coordinated their efforts in relation to administration of Zosyn to which the patient had identified allergies and existing skin diffuse rashes.

2. A procedure titled "Medication: Monitoring Effects of Medications," effective 06/27/2012, reflected "Each patient's response to his or her medication is monitored according to the clinical needs of the patient, and the patient's response to the prescribed medication and actual or potential medication-related problems...B. The nurse shall assess the patient every shift, or more often as indicated by the patient's condition or in accordance to a specific procedure such as pain assessment. C. Adverse effects of medications shall be documented in the nurses' notes or clinical record as a note or an annotation. This shall include both adverse effects noted by the nurse or voiced by the patient. D. The nurse shall educate patients/family members on medications new to them during their hospitalization and document in the patient's medical record."

A hospital guideline titled "Medication Administration General Guidelines," authorized 04/14/2011, reflected "5. Allergies: The patient's allergies must be checked each and every time prior to administration of medications."

A policy titled "Drug Therapy Monitoring and Lab Values," effective 06/10/2012 reflected, "A. Drug therapy monitoring shall be an ongoing, prospective or concurrent quality improvement process to assure effective, appropriate, and safe drug therapy...B. Prior to entering the physician/prescriber's orders and dispense first dose, at minimum, a pharmacist shall review the patient's profile (allergies, drug therapy, open interventions, notes, labs, etc.)...C. Drug therapy monitoring by the pharmacist shall include a review of the patient's drug regimen for: 1. Potential interactions...2. Contraindications, 3. Allergies...11. Drugs prescribed in anticipation of an adverse consequence (ADE)...D. All drug therapy monitoring findings shall be noted and the correct action taken...H. The patient's medical record, which contains physician orders, patient history, laboratory findings, etc., and the pharmacy profile shall serve as primary data bases for monitoring drug therapy. Pharmacist should document, in the pharmacy system in clinical interventions findings and actions taken, if appropriate. This information, will [be] part of the Hand Off Communication between pharmacists during shift changes, and breaks."

A policy titled, "Antimicrobial Stewardship Program," effective 05/2010, reflected "PURPOSE: A. Develop and implement initiatives to ensure rational and appropriate use of antimicrobial agents...F. Develop proactive strategies to optimize antimicrobial use and improve patient outcomes; such as prospective pharmacist review of antimicrobial regimens and recommendation to the prescriber as appropriate...CORE STRATEGIES: A. 2. Routine antibiotic usage review by pharmacists for appropriateness of drug selection, dosing, therapy duration, route, renal clearance, and potential for adverse reactions. Pharmacist recommendations to providers as appropriate."

3. During a telephone interview on 02/13/2013 at 1520 with the RN who admitted Patient #7, he/she started the medication reconciliation process was started during the admission process utilizing nursing home information sent with the patient and from the patient's family member. The RN stated that at the time of admission, the patient's family member stated the patient had blisters as a result of taking antibiotics, especially Amoxicillin. The RN further indicated that he/she asked the physician how he/she determined the type of antibiotic to use when the patient had so many allergies and he/she stated that the physician responded "I think [he/she] has taken Zosyn before." The RN acknowledged that he/she neglected to document that interaction in the patient's medical record.

During a telephone interview on 02/14/2013 at 1515 with the RN assigned to the patient on 12/06/2012, he/she stated that the patient had a rash over most of his/her body. The RN stated the patient's family member informed the RN that the patient had an allergy to Amoxicillin. The RN stated that he/she could not remember if he/she realized that the prescribed Zosyn was a penicillin antibiotic or not.

A telephone interview with the Pharmacy Manager on 02/11/2013 at 1615 reflected that for patients who were on antibiotics, the pharmacists were to provide monitoring and management of the patient's response to those antibiotics. He/she indicated that the practice for the pharmacists was to read patients' charts but they did not make direct observations or have direct communications with patients and/or family members. He/she further indicated that the pharmacists were directed to document the ongoing monitoring and management of antibiotics in the Pharmacy Department documentation system. The Pharmacy Manager stated that he/she could not find documentation about Patient #7 in the Pharmacy Department system.

4. These findings were shared with hospital administrative staff during a telephone conference conducted on 02/14/2013 and no additional information was provided.

Based on the review of documentation in the medical record of 1 of 1 patient who was placed in restraints (Patient #7), it was determined that the hospital failed to ensure a physician or other licensed independent practitioner assessed the patient and wrote a new restraint order every 24 hours per this regulation.

Findings include:

The medical record for Patient #7 reflected a need for mitt restraints on 12/05/2012 at 1235. The nurse documented "patient placed in mitt restraints [due to] scrating (sic) self [related to] severe rash." A physician's order was obtained for the restraints on 12/05/2012 at 1300.

Further review of the medical record confirmed the patient continued to need mitt restraints until 12/10/2012 at 0614. The nurse documented on 12/10/2012 at 0500 "when mitts removed, [patient] [immediately] begins scratching in various places, especially face/chest/abdomen, skin has bled at times." The chart contained physician/provider orders for restraints for each day the patient was in mitt restraints except for 12/07/2012.

The chart lacked a physician's order for the patient's mitt restraints for 1 of 6 days that the patient was restrained for patient safety concerns.

Based on review of documentation in 1 of 1 medical record of a patient who experienced an extensive adverse skin reaction (Patient #7), and e-mail documentation it was determined that the hospital failed to ensure the results of the wound consultant were included in the medical record.

Findings include:

1. Review of a guideline titled "Wound Care: Assessment and Treatment Guideline," dated 06/07/2012, reflected "1. The Wound Care Nurse will assess the wound and complete the Wound Care Nurse Plan Order and Wound Assessment forms...The [Wound Ostomy Continence Nurse] will fill out the order set form for the Physician, outlining the wound care plan and place it in the Physician order section for signature."

2. Review of the medical record of Patient #7 reflected the admitting physician requested a wound consultation on 12/04/2012 at 1126. The medical record lacked documentation of the completion of a wound care consultative evaluation per physician order. The medical record also lacked documentation of wound care specialist's findings or documentation of the findings discussed with the patient's provider or nursing staff.

3. An e-mail correspondence with the Risk Manager, on 02/25/2013 at 1248, reflected a wound care consultation had taken place but the consultative evaluation was not documented in the medical record of Patient #7 per this regulation and per hospital policy.