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Based on record review, policy review, staff interview, and an interview with a patient's legal representative, it was determined the hospital failed to protect and promote patient rights. This resulted in patients being placed in immediate jeopardy from the potential for suffering serious harm, impairment, or death from administering medications that were known allergens. The findings include:

1. Refer to A 131 as it relates to the hospital's failure to ensure a legal patient representative was allowed to make informed decisions regarding the care of a patient.

2. Refer to A 144 as it relates to the hospital's failure to ensure patients with known allergies received care in a safe setting.

Note: On 4/04/11 at 1:30 PM, the CEO, VP of Clinical Services, Vice President of Patient Care Services, Quality and Risk Officer, and Accreditation Manager were notified by telephone of the immediate jeopardy related to the hospital's failure to ensure patients with known allergies received care in a safe setting.

A plan of correction was received, reviewed, and accepted on 4/06/11. The immediate jeopardy was abated and the Director of Risk Management Quality was notified by telephone at 3:30 PM.

The abatement plan included development and implementation of a comprehensive Medication Safety Watch Program. The plan was developed in coordination with nursing leadership, directors from the Emergency Department, individual patient units, and the pharmacy, physician representatives, and additional staff.

An audit and reconciliation of allergies and medications was conducted on 100% of patients that were hospitalized at the time of the audit. All discrepancies were clarified with patients' physicians and the clarifications were documented in patients' charts. Ongoing compliance and monitoring was planned to provide safety for patients.

In addition, the Family Practice Residency Program implemented immediate changes to their process for medication ordering and allergy documentation to add an addition layer of protection to the safety net the hospital provides for patients.

Based on record review and interviews with staff and a patient's legal representative, it was determined the hospital failed to ensure a legal representative was allowed to make informed decisions regarding the care of a patient for 1 of 4 sample patients (#2) whose records documented legal representatives. This resulted in a patient being discharged with a prescription for a medication that the legal representative expressed concern about prior to patient discharge. This had the potential to lead to adverse patient outcomes. It was also a violation of patient rights. Findings include:

Patient #2 was a 74 year old developmentally delayed female who was admitted to the intensive care unit of the hospital on 2/18/11 after transfer from a rehabilitation facility. Patient #2 was represented by a DPOA, as evidenced by a signed and witnessed "DURABLE POWER OF ATTORNEY FOR HEALTH CARE" document, dated 6/11/07. Her admitting diagnoses included sepsis secondary to urinary tract infection, supratherapeutic INR (a condition that increases bleeding tendency), and atrial fibrillation.

Patient #2's "HISTORY AND PHYSICAL," completed by the physician, dated and transcribed on 2/18/11, stated the supratherapeutic INR may have been caused by an interaction between the anticoagulation treatment (Coumadin) and an antibitiotic (Ciprofloxacin). A physician "CONSULTATION," dated and transcribed on 2/18/11, also stated Patient #2's supratherapeutic INR may have been related to the interaction between Coumadin and Cipro, an antibiotic Patient #2 was taking for a urinary tract infection at the time of admission. The report described Patient #2 as "arousable, but lethargic." Her INR was over 10 when she presented in the Emergency Department. According to www.labtestsonline.org, the normal range for INR is 2.0 to 3.0 for patients on anticoagulant medications, such as Patient #2. A lab result of 10 could result in uncontrolled bleeding.

"Patient Discharge Instructions," dated 2/20/11, included directions for Patient #2 to take Ciprofloxacin every 12 hours for urinary tract infection. There was a handwritten question mark next to Ciprofloxacin and a handwritten note "Family has concern regarding this medication. Please address with primary physician."

The surveyor called the DPOA for Patient #2 on 3/31/11 at 2:30 PM to inquire if her concerns regarding the medication had been addressed by Patient #2's physician prior to discharge. She said she was asked to sign discharge instructions. The DPOA explained an ICU nurse had told her earlier in Patient #2's hospital stay that the Cipro caused Patient #2's problems (elevated INR). The DPOA said she did not understand why the medication was being ordered at discharge considering the information provided by the ICU nurse. She also stated Patient #2 looked puffy in the face and she was concerned about an allergic reaction. She told the discharging nurse she wanted to talk to Patient #2's doctor before signing the discharge instructions and approving the plan to discharge Patient #2 on Cipro. She stated the discharging nurse told her to sign the discharge instructions and promised to contact a physician for her after the fact. The DPOA stated she reluctantly signed the form and hand wrote a note at the top of the form and placed a question mark next to the Cipro medication. Based on the nurse's promise to call the doctor, she expected to receive a call that day. She stated no physician called her to discuss the Cipro. The following day, she saw the doctor at the rehabilation facility Patient #2 transferred to and had been prior to the hospital admission. When she told the physician of her concern, he stated the hospital had not contacted him and he did not know Patient #2 had been ordered Cipro. He immediately discontinued the medication and put Patient #2 on another medication.

The RN who discharged Patient #2 on 2/20/11 was interviewed on 3/30/11 at 3:30 PM. She stated she remembered the DPOA expressing concerns about Cipro. She did not recall clearly but thought she had talked with a resident physician about the Cipro. After reviewing Patient #2's record, she confirmed there was no documentation present in Patient #2's record to indicate the DPOA's concern and request to talk with a physician about the Cipro order had been addressed.

An undated "Patient Guide," given to every patient on admission, listed the patient rights. The information included the right to ask for and receive relevant, current, and understandable information concerning their diagnosis, treatment, and prognosis from their physicians and other direct caregivers. It also included the right to consent to or refuse a treatment, as permitted by law and hospital policy, and in case of such refusal, the right to other appropriate care and services that the Center provides or transfer to another facility.

The DPOA was not provided with requested information to make an informed decision regarding the plan to discharge Patient #2 on Ciprofloxacin, a medication of concern to the DPOA.

Based on staff interview, record review, and policy review, it was determined the hospital failed to ensure patients with known allergies received care in a safe setting for 3 of 8 patients with known allergies (#2, #7, and #13) whose records were reviewed. This resulted in 2 patients receiving medications previously identified as allergens and 1 patient with conflicting allergy information. These failures placed patients in immediate jeopardy of serious harm, impairment, or death. Findings include:

1. Patient #2 was a 74 year old female who was admitted to the intensive care unit of the hospital on 2/18/11 after transfer from a rehabilation facility. Her admitting diagnoses included sepsis secondary to urinary tract infection, supratherapeutic INR (a condition that increases risk of uncontrolled bleeding), atrial fibrillation, and developmental delay.

A physician "CONSULTATION," dated and transcribed on 2/18/11, stated Patient #2 had a history of heparin-induced thrombocytopenia (a condition that can lead to a blood clot). Similarly, the "HISTORY AND PHYSICAL," dated and transcribed on 2/18/11, documented Patient #2's allergy to heparin, secondary to thrombocytopenia.

Physician orders for Patient #2, dated 2/19/11 at 7:15 AM, included an order for Heparin 5000 units every 12 hours subcutaneously. A nursing "Medication Administration Record," dated 2/19/11 at 9:00 AM documented administering the heparin. A second time listed at 9:00 PM did not document whether the heparin was given or held. An undated, untimed physician's order discontinued the heparin.

A hospital policy "MEDICATION ADMINISTRATION," revised 12/08, stated that before administering a medication, the person administering the medication would discuss any unresolved significant concerns about the medication with the patient's physician or prescriber (if different from the physician) and/or relevant staff involved with the patient's care, treatment, and service. It also stated that staff would verify that the patient had no contraindications to the medication, such as an allergy or serious side effect.

There was no documentation in Patient #2's record to indicate nursing staff alerted the physician to the heparin allergy.

On 3/31/11 4:05 PM, an ICU RN who worked in Quality Management, reviewed Patient #2's record. He stated it looked like the prescribing physician made an ordering error and the nurse made an error in administering the medication. He said he would expect to see documentation the nurse was aware of the allergy and had contacted the physician for clarification. He confirmed there was no documentation to indicate this had been done.

In the "Medical Staff Rules and Regulations," revised 12/15/09, under the section "PHARMACY AND THERAPEUTICS," it stated if a physician's order appeared inappropriate, Pharmacy staff would contact the physician for clarification. There was no documentation in Patient #2's record to indicate pharmacy staff had contacted the physician who prescribed heparin to Patient #2 to clarify the order.

During an interview with a pharmacist on 3/31/11 at 9:00 AM, she explained that when a medication is ordered that has been identified as a potential allergen, a flashing light appears on the computer to alert the pharmacist. She stated it had been the practice of pharmacy staff to call the nursing staff to determine the type of reaction the patient had in the past to the allergen. She stated they typically wrote notes on paper about any clarification obtained. After patient discharge, the pharmacy staff discarded the paper notes. She stated it was also possible to write free text in the computer related to interventions taken but they did not consistently do so.

During an interview on 4/01/11 at 1:35 PM, another pharmacist reviewed Patient #2's electronic record for the 2/18/10 admission. He confirmed there was no pharmacy documentation related to heparin other than the notation of the allergy.

The physician resident who prescribed the heparin was interviewed on 3/31/11 at 5:00 PM. He stated when he ordered the heparin he did not realize Patient #2 had a heparin allergy. The following day when he was reviewing Patient #2's record in preparation for transfer out of ICU, he realized his mistake and wrote an order immediately to discontinue the heparin. When asked if nursing staff or pharmacy staff had contacted him to alert him to the allergy, he stated he did not receive a call from either.

The ICU RN who administered the heparin was interviewed on 4/01/11 9:05 AM. She stated the pharmacy normally called nursing staff about medications ordered that were on the list of allergies. She stated she did not recall getting a telephone call from pharmacy staff related to the heparin order for Patient #2. She stated she talked with the ordering physician who asked what reaction Patient #2 had to the heparin. She reportedly told him the severity of the reaction was unknown. She stated the physician proceeded to order the medication. She confirmed she did not document her conversation with the ordering physician or write a clarification order. She confirmed an incident report was not completed, stating it probably should have been. She stated some time the same day after giving the dose of heparin, the attending physician alerted her to Patient #2's history of heparin-induced thrombocytopenia, and the 9:00 PM dose was not given. She stated she thought the attending physician had written an order to discontinue the heparin.

The ICU RN explained that, generally speaking, pharmacy called nursing staff to alert them to medications listed as allergens and to inquire as to the type of reaction. If the severity of a reaction was unknown, nursing or pharmacy staff contacted the physician and verified the order, and wrote a clarification order. She stated when pharmacy staff talk directly to a physician and obtain approval to administer the medication, pharmacy staff directs nursing staff to give the medication. However, they do not necessarily write a clarification order. If the physician directs staff not to administer the medication, a new order would be written.

The CNO was interviewed on 4/01/11 at 1:05 PM. He stated he would expect nursing staff and/or pharmacy staff to contact the physician for clarification of an allergy order and to document the clarification. He stated the ultimate decision remained with the physician.

Physician staff, pharmacy staff, and nursing staff did not intervene appropriately to prevent Patient #2 from being ordered and administered a medication listed as an allergy, putting Patient #2 at risk for serious harm or death.

2. Patient #13 was an 89 year old current patient who was admitted to the hospital on 3/31/11 via the ED. Admitting diagnoses included gastroenteritis, dehydration, and diabetes.

A "HISTORY AND PHYSICAL," dated and transcribed on 3/31/11, documented Patient #13 was intolerant or allergic to Caltrate, Codeine, and Fosamax. The same allergy information was hand written on the "MEDICATION ADMINISTRATION RECORD," dated 3/31/11 through 4/01/11 and in large letters on the outside of Patient #13's inpatient medical record.

In contrast, a computer generated "MEDICATION ADMINISTRATION RECORD," dated 3/31/11 through 4/01/11, and a "Home Medication Reconciliation Order Form," dated 3/31/11, for Patient #13 did not list allergies to Caltrate, Codeine, or Fosamax. Rather, the forms listed allergies to Bumex, Lasix, and Sulfa (Sulfonamide Antibiotics).

During an initial interview on 4/01/11 at 9:50 AM, the Director of the Medical Floor stated the allergies to Caltrate, Codeine, and Fosamax were incorrect. Rather the allergies to Bumex, Lasix, Sulfa were correct. A few minutes later, she returned and said the allergy band on Patient #13's wrist listed Caltrate, Codeine, and Fosamax, the medications she had moments earlier stated were incorrect.

The RN who admitted Patient #13 was interviewed on 4/01/11 beginning at 10:00 AM. She stated neither Patient #13 nor her family were good historians at the time Patient #13 was admitted. She stated the ward clerk put the allergy information on the outside of the chart, on the handwritten MAR and on Patient #13's wrist band. She stated the ward clerk must have transcribed the allergy information for Patient #13 from the physician's H&P. Upon surveyor request, the RN called physicians for clarification of Patient #13's allergies. She first called the physician who performed the H&P, who explained he got the information on the allergies from reading the ED record. The physician referred the RN to Patient #13's primary physician. The RN then called the primary physician who reportedly stated he was not aware of any allergies to Caltrate, Codeine, or Fosamax. His records indicated Patient #13 had allergies to Bumex, Lasix, Sulfa, and Atenolol (this medication was not listed in the hospital record). Upon surveyor request, the RN wrote a clarification order and stated she would go change Patient #13's wrist band to reflect the correct allergy information.

During an interview on 4/01/11 at 10:40 AM, the Director of the Medical Floor stated she had just learned that the allergy to Atenolol was new as of 3/15/11, based on visit note information faxed to her from Patient #13's primary physician.

The Director of the ED was interviewed at 4/01/11 at 10:20 AM. He explained the software used in the ED, called IBEX, did not integrate with the inpatient software, called PARAGON. He stated ED staff did not review information from the inpatient software system when patients presented to the ED. They did, however, review information that existed in IBEX that contained information from previous ED visits. During the interview, the Director of the ED accessed online information stored in IBEX related to Patient #13's ED visits, which totalled 6 visits since 2005, including the most recent ED visit on 3/31/11. All of the visit notes indicated allergies to Caltrate, Codeine, and Fosamax. He confirmed none of the visit notes documented allergies to Bumex, Lasix, Sulfa, or Atenolol.

During an interview on 4/01/11 at 10:40 AM, the Chief Quality and Risk Officer stated that since the ED system (IBEX) did not integrate with the inpatient system (PARAGON), the IBEX ED record was printed and went to the inpatient unit for reference and review in the medical record. She also stated the hospital converted to the PARAGON software system in May, 2010, and the previous system (ESSENTRIS) also did not communicate with the ED system (IBEX). She referred to IBEX as a stand-alone system.

During a second interview on 4/01/11 at 1:00 PM, the Chief Quality and Risk Officer stated nurses were expected to update medication lists and this was not done in regard to Patient #13.

The hospital did not have a written policy or procedure that communicated the expectation nursing staff were specifically expected to review the ED record and compare the allergy information in the ED record with the allergy information in the inpatient records to ensure they matched.

A pharmacist and the Director of Pharmacy were interviewed together on 4/01/11 at 11:00 AM. They explained the inpatient pharmacy did not have access to the software system (IBEX) used in the ED. They would not know if the allergy information provided in the ED differed from inpatient record information. They were not involved with evaluating medications ordered in the ED and they did not routinely release medications to the ED, only by special request. In the case of Patient #13, they did not know about allergies to Caltrate, Codeine, or Fosamax. Their records showed allergies to Bumex, Lasix, and Sulfa.

The Director of HIM was interviewed on 4/01/11 at 12:30 PM. She stated patient demographic information and financial information transferred from PARAGPM into IBEX. She confirmed clinical information did not transfer from PARAGON into IBEX and no information transferred from IBEX to PARAGON. She stated there was no medical record expectation for staff to look at patient information in PARAGON while in the ED.

The ED's clinical information did not integrate with inpatient nursing units and the inpatient pharmacy, putting Patient #13 at risk for harm.



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3. Patient #7 was a 69 year old male admitted on 2/23/11 to the surgical floor of the hospital after surgery for a left total knee arthroplasty. On admission, the "Combined Home Medications and Inpatient Medication Reconciliation Order Form" dated 2/23/11 at 4:45 PM and signed by the physician, listed allergies that included Demerol and Morphine.

The "ORTHOPEDIC INPATIENT POST-OP ORDERS," signed by the physician and dated 2/23/11 at 4:45 PM, showed "Morphine sulfate 4-10 mg IM/IV q 3 hr PRN pain" and "Demerol 50-100 mg IM/IV q 3 hr PRN pain with Vistaril" was ordered for Patient #7. Morphine and Demerol were listed on Patient #7's allergy profile found on the medication reconciliation form.

On 2/23/11 at 9:45 PM, the MAR showed that 50 mg of Demerol with 25 mg of Vistaril were given to Patient #7 by the nurse. There was no documentation of clarification with the physician prior to the nurse giving the Demerol.

In an interview with two staff pharmacists in the inpatient pharmacy on 4/01/11 at 1:30 PM, one pharmacist pulled up Patient #7's medication profile online from his 2/23/11 admission. The profile showed Patient #7's reaction to Demerol was hallucinations. No pharmacy comments were noted about contacting the RN or physician regarding Patient #7 being allergic to Demerol.

In an interview on 4/01/11 at 1:05 PM, the CNO stated his expectation was if a medication was ordered that a patient was allergic to, it should be challenged by the RN and the pharmacist. The ultimate decision to give the medication was the physicians. The physician needed to be consulted. The CNO further stated his expectation was a call should be made to clarify a medication regardless of the side effect. Also, whether the pharmacist or RN made the call, there should be permanent documentation of the communication with the physician.

Patient #7 was administered a medication he was identified as being allergic to, placing his health and safety in immediate jeopardy.

Based on record review, staff interview, and review of incident reports, it was determined the hospital failed to track incidents related to giving medications that were known allergens for 2 of 2 patients (#2 and #7) who were administered medications listed as allergies whose records were reviewed. This interfered with the ability of hospital Quality staff to analyze the incidents for performance improvement processes. Findings include:

A hospital policy, "INCIDENT REPORTING," revised September 2010, described an "incident" as an event not consistent with the desired operation of the Center that results in or has the potential of resulting in an adverse outcome to the patient. It further stated each incident is documented in a separate Incident Report by the person having knowledge of the event.

A second hospital policy, "REPORTING MEDICATION VARIANCE, ADVERSE DRUG REACTIONS AND FOLLOW-UP," revised August 2010, stated when a medication variance is found, an electronic incident report is completed. A medication variance included a failure to identify patient allergies.

In the following two examples, hospital staff failed to identify allergies, resulting in administration of medications that had been identified in the medical records as allergies:

1. Patient #2 was a 74 year old female who was admitted to the intensive care unit of the hospital on 2/18/11 after transfer from a rehabilitation facility. Her admitting diagnoses included sepsis secondary to urinary tract infection, supratherapeutic INR (a condition that can lead to uncontrolled bleeding), atrial fibrillation, and developmental delay.

A physician "CONSULTATION," dated and transcribed on 2/18/11, stated Patient #2 had a history of heparin-induced thrombocytopenia (a condition that can lead to a blood clot). The "HISTORY AND PHYSICAL," dated and transcribed on 2/18/11, also documented Patient #2's allergy to heparin, secondary to thrombocytopenia.

Physician orders, dated 2/19/11 at 7:15 AM, included an order for Heparin 5000 units every 12 hour subcutaneously. A nursing "Medication Administration Record," dated 2/19/11 at 9:00 AM, documented administering the heparin. An undated, untimed physician's order discontinued the heparin.

On 3/31/11 4:05 PM, a former ICU nurse, working in Quality Management, reviewed Patient #2's record. He stated it looked like the prescribing physician made an ordering error and the nurse made an error in administering the medication. He would have expected to see documentation the nurse was aware of the allergy and had contacted the physician for clarification and that an incident report had been filed. He confirmed there was no documentation to indicate these steps had been taken.

The physician resident who prescribed the heparin was interviewed on 3/31/11 at 5:00 PM. He stated when he ordered the heparin he did not realize Patient #2 had a heparin allergy. The following day when he was reviewing Patient #2's record in preparation for transfer out of ICU, he noticed Patient #2's allergy to heparin. He realized his mistake and wrote an order immediately to discontinue it. When asked if nursing or pharmacy staff had contacted him to alert him to the allergy, he stated he did not receive a call from either. There was no incident report filed by the physician for incorrectly ordering the heparin for Patient #2 .

The ICU RN who administered the heparin was interviewed on 4/01/11 9:05 AM. She stated she did not file an incident report and "probably should have."

During an interview 3/31/11 at 4:00 PM, the Chief Quality and Risk Officer confirmed no incident report was filed, either by the physician or RN, related to administering heparin to Patient #2.

Hospital staff did not file Incident reports related to the prescribing error or the administration error.



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2. Patient #7 was a 69 year old male admitted on 2/23/11 to the surgical floor of the hospital after surgery for a left total knee arthroplasty. On admission, the "Combined Home Medications and Inpatient Medication Reconciliation Order Form" dated 2/23/11 at 4:45 PM and signed by the physician, listed allergies that included Demerol and Morphine.

On 2/23/11 at 9:45 PM, the MAR showed that 50 mg of Demerol was given by the nurse (a medication on the list of allergies). There was no documentation of clarification with the physician prior to the nurse giving Demerol, a medication that Patient #7 had on his allergy list. There was no incident report related to the medication error.

In an interview on 4/05/11 at 11:25 AM, the Chief Quality and Risk Officer confirmed that no incident report was filed in relation to Patient #7.

Hospital staff did not file Incident reports related to the prescribing error or the administration error.

Based on record review, policy review, and staff interview, it was determined the hospital failed to ensure nursing service had a well-organized process for integrating allergies identified in the ED with the inpatient record. It also did not ensure nursing staff complied with policies to clarify inappropriate medication orders with physicians. This had the potential to interfere with patient safety and cause harm. Findings include:

1. Refer to A 395 as it related to the hospital's failure to ensure the registered nurse evaluated the nursing care related to patient allergies.

2. Refer to G 404 as it related to the hospital's failure to ensure drugs were administered in accordance with accepted standards of practice as it related to patient allergies.

Based on record review, policy review, and staff interview, it was determined the hospital failed to ensure the registered nurse evaluated nursing care related to patient allergies for 3 of 8 patients (#2, #7, and #13) whose records documented allergies. This resulted in 2 patients receiving medications they were identified as being allergic to and the potential for another patient to receive medications to which she was identified as being allergic to. The negative practices had the potential to harm all patients with known drug allergies. Findings include:

1. Patient #2 was a 74 year old female who was admitted to the intensive care unit of the hospital on 2/18/11 after transfer from a rehabilitation facility. Her admitting diagnoses included sepsis secondary to urinary tract infection, supratherapeutic INR, atrial fibrillation, and developmental delay.

The "HISTORY AND PHYSICAL," dated and transcribed on 2/18/11, documented Patient #2's allergy to heparin, secondary to thrombocytopenia.

Physician orders, dated 2/19/11 at 7:15 AM, included an order for Heparin 5000 units every 12 hour subcutaneously. A nursing "Medication Administration Record," dated 2/19/11 at 9:00 AM documented administering the heparin.

A hospital policy "MEDICATION ADMINISTRATION," revised 12/08, stated that before administering a medication, the person administering the medication would discuss any unresolved significant concerns about the medication with the patient's physician or prescriber (if different from the physician) and or relevant staff involved with the patient's care, treatment, and service. It also stated that staff would verify that the patient had no contraindications to the medication, such as an allergy or serious side effect.

There was no documentation in Patient #2's record to indicate nursing staff was aware of the heparin allergy or discussed the concern with Patient #2's physician prior to administration.

The physician resident who prescribed the heparin was interviewed on 3/31/11 at 5:00 PM. He stated when he ordered the heparin he did not realize Patient #2 had a heparin allergy. The following day when he was reviewing Patient #2's record in preparation for transfer out of ICU, he realized his mistake and wrote an order immediately to discontinue it. When asked if nursing staff had contacted him to alert him to the allergy, he stated he did not receive a call.

During an interview on 4/01/11 at 1:05 PM, the CNO stated he would expect nursing staff to contact the physician for clarification of an allergy order and document the clarification. He stated the physician should make the ultimate decision.

A former ICU RN who was working in Quality Management was interviewed on 9/31/11 at 4:05 PM. He reviewed Patient #2's record and stated it looked like the prescribing physician made an ordering error and the nurse made an error in administering the medication. He would have expected to see documentation the nurse was aware of the allergy and had contacted the physician for clarification. He confirmed there was no documentation to indicate this had been done.

Nursing staff did not evaluate the nursing needs of Patient #2 prior to administration of heparin, a known allergen.

2. Patient #13 was an 89 year old current patient who was admitted to the hospital on 3/31/11 via the ED. Admitting diagnoses included gastroenteritis, dehydration, and diabetes.

A "HISTORY AND PHYSICAL," dated and transcribed on 3/31/11, documented Patient #13 was intolerant or allergic to Caltrate, Codeine, and FoSamax. The same allergy information was hand written on the "MEDICATION ADMINISTRATION RECORD," dated 3/31/11 through 4/01/11 and in large letters on the outside of Patient #13's medical record.

In contrast, a computer generated "MEDICATION ADMINISTRATION RECORD," dated 3/31/11 through 4/01/11, and a "Home Medication Reconciliation Order Form," dated 3/31/11, for Patient #13 did not list allergies to Caltrate, Codeine, or Fosamax. Rather, the forms listed allergies to Bumex, Lasix, and Sulfa (Sulfonamide Antibiotics).

During an initial interview on 4/01/11 at 9:50 AM, the Director of the Medical Floor stated the allergies to Caltrate, Codeine, and Fosamax were not correct. Rather the allergies to Bumex, Lasix, Sulfa were correct. A few minutes later, she returned and said the allergy band on Patient #13's wrist listed Caltrate, Codeine, and Fosamax (the medications she had stated were incorrect).

The RN who admitted Patient #13 was interviewed on 4/01/11 beginning at 10:00 AM. She stated Patient #13 or her family were not good historians at the time Patient #13 was admitted. She stated the ward clerk put the allergy information on the outside of the chart, on the handwritten MAR and on Patient #13's wrist band. She stated the ward clerk must have transcribed the allergy information on Patient #13 from the physician's H&P. Upon surveyor request, the RN called physicians for clarification of Patient #13's allergies. She first called the physician who performed the H&P. He stated he got the information on the allergies from reading the ED record. He referred the RN to Patient #13's primary physician. The RN then called the primary physician who reportedly stated he was not aware of any allergies to Caltrate, Codeine, or Fosamax. His records indicated Patient #13 had allergies to Bumex, Lasix, Sulfa, and Atenolol (this medication was not listed in the hospital record). Upon surveyor request, the RN wrote a clarification order and stated she would go change Patient #13's wrist band to reflect the correct allergy information.

During an interview on 4/01/11 10:40 AM, the Director of the Medical Floor stated she had just learned that the allergy to Atenolol was new as of 3/15/11, based on visit note information faxed to her from Patient #13's primary physician.

During an interview on 4/01/11 at 1:00 PM, the Chief Quality and Risk Officer stated nurses were expected to update medication lists and this was not done in regard to Patient #13.

Nursing staff failed to evaluate all sources of documentation of patient allergies and integrate the information appropriately.



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3. Patient #7 was a 69 year old male admitted on 2/23/11 to the surgical floor of the hospital after surgery for a left total knee arthroplasty. On admission, the "Combined Home Medications and Inpatient Medication Reconciliation Order Form" dated 2/23/11 at 4:45 PM and signed by the physician, listed allergies that included Demerol and Morphine.

The "ORTHOPEDIC INPATIENT POST-OP ORDERS," signed by the physician and dated 2/23/11 at 4:45 PM, showed "Morphine sulfate 4-10 mg IM/IV q 3 hr PRN pain" and "Demerol 50-100 mg IM/IV q 3 hr PRN pain with Vistaril" were ordered for Patient #7. Morphine and Demerol were listed on Patient #7's allergy profile found on the medication reconciliation form.

On 2/23/11 at 9:45 PM, the MAR showed that 50 mg of Demerol with 25 mg of Vistaril were given to Patient #7 by the nurse. There was no documentation of clarification with the physician prior to the nurse giving the Demerol.

In an interview on 4/01/11 at 1:05 PM, the CNO stated his expectation was if a medication was ordered that a patient was allergic to, it should be challenged by the RN and the pharmacist. The ultimate decision to give the medication was the physicians. The physician needed to be consulted. The CNO further stated his expectation was a call should be made to clarify a medication regardless of the side effect. Also, whether the pharmacist or RN made the call, there should be permanent documentation of the communication with the physician.

In an interview on 4/01/11 at 8:40 AM, an ICU RN was asked about what she would document after clarifying a medication a patient was allergic to that the physician still wanted to give. The ICU RN stated that she would just go ahead and give it. She further stated that the physician had already written the order and it did not require a new order based on that type of clarification.

In an interview on 4/01/11 at 9:05 AM, an ICU RN stated if a medication was ordered the patient was allergic to and the patient's reaction was nausea/vomiting, "sometimes I won't call the physician. I will just give the medication."

The nursing staff did not effectively supervise the care of Patient #7. Patient #7 received Demerol to which Patient #7 was identified as allergic to.

Based on record review, staff interview, and policy review, it was determined the hospital failed toensure drugs were administered in accordance with accepted standards of practice for 2 of 8 patients (#2 and #7)who had known allergies. This resulted in 2 patients receiving medications they were identified as being allergic to and the potential for another patient to receive medications to which she was identified as being allergic to. The negative practices had the potential to harm all patients with known drug allergies. Findings include:

1. Patient #2 was a 74 year old female who was admitted to the intensive care unit of the hospital on 2/18/11 after transfer from a rehabilitation facility. Her admitting diagnoses included sepsis secondary to urinary tract infection, supratherapeutic INR, atrial fibrillation, and developmental delay.

The "HISTORY AND PHYSICAL," dated and transcribed on 2/18/11, documented Patient #2's allergy to heparin, secondary to thrombocytopenia.

Physician orders, dated 2/19/11 at 7:15 AM, included an order for Heparin 5000 units every 12 hour subcutaneously. A nursing "Medication Administration Record," dated 2/19/11 at 9:00 AM documented administering the heparin.

A hospital policy "MEDICATION ADMINISTRATION," revised 12/08, stated that before administering a medication, the person administering the medication would discuss any unresolved significant concerns about the medication with the patient's physician or prescriber (if different from the physician) and or relevant staff involved with the patient's care, treatment, and service. It also stated that staff would verify that the patient had no contraindications to the medication, such as an allergy or serious side effect.

There was no documentation in Patient #2's record to indicate nursing staff was aware of the heparin allergy or discussed the concern with Patient #2's physician prior to administration.

The physician resident who prescribed the heparin was interviewed on 3/31/11 at 5:00 PM. He stated when he ordered the heparin he did not realize Patient #2 had a heparin allergy. The following day when he was reviewing Patient #2's record in preparation for transfer out of ICU, he realized his mistake and wrote an order immediately to discontinue it. When asked if nursing staff had contacted him to alert him to the allergy, he stated he did not receive a call.

During an interview on 4/01/11 at 1:05 PM, the CNO stated he would expect nursing staff to contact the physician for clarification of an allergy order and document the clarification. He stated the physician should make the ultimate decision.

A former ICU RN who was working in Quality Management was interviewed on 9/31/11 at 4:05 PM. He reviewed Patient #2's record and stated it looked like the prescribing physician made an ordering error and the nurse made an error in administering the medication. He would have expected to see documentation the nurse was aware of the allergy and had contacted the physician for clarification. He confirmed there was no documentation to indicate this had been done.

Nursing staff administration of heparin to Patient #2, a medication listed as an allergen.

2. Patient #7 was a 69 year old male admitted on 2/23/11 to the surgical floor of the hospital after surgery for a left total knee arthroplasty. On admission, the "Combined Home Medications and Inpatient Medication Reconciliation Order Form" dated 2/23/11 at 4:45 PM and signed by the physician, listed allergies that included Demerol and Morphine.

The "ORTHOPEDIC INPATIENT POST-OP ORDERS," signed by the physician and dated 2/23/11 at 4:45 PM, showed "Morphine sulfate 4-10 mg IM/IV q 3 hr PRN pain" and "Demerol 50-100 mg IM/IV q 3 hr PRN pain with Vistaril" were ordered for Patient #7. Morphine and Demerol were listed on Patient #7's allergy profile found on the medication reconciliation form.

On 2/23/11 at 9:45 PM, the MAR showed that 50 mg of Demerol with 25 mg of Vistaril were given to Patient #7 by the nurse. There was no documentation of clarification with the physician prior to the nurse giving the Demerol.

In an interview on 4/01/11 at 1:05 PM, the CNO stated his expectation was if a medication was ordered that a patient was allergic to, it should be challenged by the RN and the pharmacist. The ultimate decision to give the medication was the physicians. The physician needed to be consulted. The CNO further stated his expectation was a call should be made to clarify a medication regardless of the side effect. Also, whether the pharmacist or RN made the call, there should be permanent documentation of the communication with the physician.

In an interview on 4/01/11 at 8:40 AM, an ICU RN was asked about what she would document after clarifying a medication a patient was allergic to that the physician still wanted to give. The ICU RN stated that she would just go ahead and give it. She further stated that the physician had already written the order and it did not require a new order based on that type of clarification.

In an interview on 4/01/11 at 9:05 AM, an ICU RN stated if a medication was ordered the patient was allergic to and the patient's reaction was nausea/vomiting, "sometimes I won't call the physician. I will just give the medication."

Nursing staff administered Demerol to Patient #7, a medication listed as an allergen.

Based on staff interviews, record review, and hospital policies, it was determined the hospital failed to ensure pharmaceutical services followed established policies to minimize drug errors and integrated allergy information between pharmacy and the ED. This affected 3 of 8 patients (#2, #7 and #13) with documented allergies whose records were reviewed. This contributed to the administration of inappropriate medications to 2 patients with known allergies. It had the potential to result in negative patient outcomes for all patients with identified allergies. Findings include:

1. Patient #13 was an 89 year old current patient who was admitted to the hospital on 3/31/11 via the ED. Admitting diagnoses included gastroenteritis, dehydration, and diabetes.

A "HISTORY AND PHYSICAL," dated and transcribed on 3/31/11, documented Patient #13 was intolerant or allergic to Caltrate, Codeine, and Foxamax. The same allergy information was hand written on the "MEDICATION ADMINISTRATION RECORD," dated 3/31/11 through 4/01/11 and in large letters on the outside of Patient #13's medical record.

In contrast, a computer generated "MEDICATION ADMINISTRATION RECORD," dated 3/31/11 through 4/01/11, and a "Home Medication Reconciliation Order Form," dated 3/31/11, for Patient #13 did not list allergies to Caltrate, Codeine, or Fosamax. Rather, the forms listed allergies to Bumex, Lasix, and Sulfa (Sulfonamide Antibiotics).

During an initial interview on 4/01/11 at 9:50 AM, the Director of the Medical Floor stated the allergies to Caltrate, Codeine, and Fosamax were not correct. Rather the allergies to Bumex, Lasix, and Sulfa were correct. A few minutes later, she returned and said the allergy band on Patient #13's wrist listed Caltrate, Codeine, and Fosamax (the medications she had stated were incorrect).

The RN who admitted Patient #13 was interviewed on 4/01/11 beginning at 10:00 AM. She stated Patient #13 or her family were not good historians at the time Patient #13 was admitted. She stated the ward clerk put the allergy information on the outside of the chart, on the handwritten MAR and on Patient #13's wrist band. She stated the ward clerk must have transcribed the allergy information on Patient #13 from the physician's H&P. Upon surveyor request, the RN called physicians for clarification of Patient #13's allergies. She first called the physician who performed the H&P. He stated he got the information on the allergies from reading the ED record. He referred the RN to Patient #13's primary physician. The RN then called the primary physician who reportedly stated he was not aware of any allergies to Caltrate, Codeine, or Fosamax. His records indicated Patient #13 had allergies to Bumex, Lasix, Sulfa, and Atenolol (this medication was not listed in the hospital record). Upon surveyor request, the RN wrote a clarification order and stated she would go change Patient #13's wrist band to reflect the correct allergy information.

During an interview on 4/01/11 10:40 AM, the Director of the Medical Floor stated she had just learned that the allergy to Atenolol was new as of 3/15/11, based on visit note information faxed to her from Patient #13's primary physician.

The Director of the ED was interviewed at 4/01/11 at 10:20 AM. He explained the software used in the ED, called IBEX, did not integrate with the inpatient software, called PARAGON. He stated ED staff did not review information from the inpatient software system when patients presented to the ED. They did, however, review information that existed in IBEX that contained information from previous ED visits. He logged on to a computer and accessed Patient #13's ED visit information, finding a total of 6 ED visits since 2005, including the most recent visit on 3/31/11. All of the visit notes indicated allergies to Caltrate, Codeine, and Fosamax. He confirmed none of the visit notes documented allergies to Bumex, Lasix, Sulfa, or Atenolol.

During an interview on 4/01/11 at 10:40 AM, the Chief Quality and Risk Officer stated that since the ED system (IBEX) did not integrate with the inpatient system (PARAGON), the IBEX ED record was printed and went to the inpatient unit for reference and review in the medical record. She also stated the hospital went to the PARAGON system in May, 2010, and the previous system (ESSENTRIS) also did not communicate with the ED system (IBEX). She referred to IBEX as a stand-alone system.

During a second interview on 4/01/11 at 1:00 PM, the Chief Quality and Risk Officer stated nurses were expected to update medication lists and this was not done in regard to Patient #13. However, there was no written policy or procedure that communicated the expectation nursing staff were expected to review the ED record and compare the allergy information in the ED record with the allergy information in the inpatient records to ensure they matched.

A pharmacist and the Director of Pharmacy were interviewed together on 4/01/11 at 11:00 AM. They explained the inpatient pharmacy did not have access to the software system (IBEX) used in the ED. They would not know if the allergy information provided in the ED differed from inpatient record information. They were not involved with evaluating medications ordered in the ED and they did not routinely release medications to the ED, only by special request. In the case of Patient #13, they did not know about allergies to Caltrate, Codeine, or Fosamax. Their records showed allergies to Bumex, Lasix, and Sulfa.

The Director of HIM was interviewed on 4/01/11 at 12:30 PM. She stated patient demographic information and financial information would transfer from PARAGON into IBEX. She confirmed clinical information would not transfer from PARAGON into IBEX and no information would transfer from IBEX to PARAGON. She stated there was no medical record expectation for staff to look at patient information in PARAGON while in the ED.

The pharmacy did not have a policy or process to integrate allergy information obtained in the ED with inpatient record information.

2. Under the section "PHARMACY AND THERAPEUTICS" of the "Medical Staff Rules and Regulations," revised 12/15/09, it stated if a physician's order appeared inappropriate, Pharmacy staff would contact the physician for clarification.

In the examples that follow, there was no evidence pharmacy staff contacted the physician for clarification:

a. Patient #2 was a 74 year old female who was admitted to the intensive care unit of the hospital on 2/18/11 after transfer from a Rehabilitation facility. Her admitting diagnoses included sepsis secondary to urinary tract infection, supratherapeutic INR (a condition that can increase the risk of bleeding), atrial fibrillation, and developmental delay.

A physician "CONSULTATION," dated and transcribed on 2/18/11, stated Patient #2 had a history of heparin-induced thrombocytopenia (which can increase the risk of a blood clot).

The "HISTORY AND PHYSICAL," dated and transcribed on 2/18/11, documented Patient #2's allergy to heparin, secondary to thrombocytopenia.

Physician orders, dated 2/19/11 at 7:15 AM, included an order for Heparin 5000 units every 12 hour subcutaneously. A nursing "Medication Administration Record" for Patient #2, dated 2/19/11 at 9:00 AM documented administering the heparin.

There was no documentation in Patient #2's record to indicate pharmacy staff had contacted the physician who prescribed heparin to Patient #2 to clarify the order.

During an interview on 4/01/11 at 1:35 PM, a pharmacist reviewed Patient #2's electronic record for the 2/18/10 admission. He confirmed there was no pharmacy documentation pharmacy staff had contacted the prescribing physician regarding the heparin order.



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b. Patient #7 was a 69 year old male admitted on 2/23/11 to the surgical floor of the hospital after surgery for a left total knee arthroplasty. On admission, the "Combined Home Medications and Inpatient Medication Reconciliation Order Form" dated 2/23/11 at 4:45 PM and signed by the attending physician, listed allergies for Patient #7 that included Demerol and Morphine.

The "ORTHOPEDIC INPATIENT POST-OP ORDERS," showed "Morphine sulfate 4-10 mg IM/IV q 3 hr PRN pain" and "Demerol 50-100 mg IM/IV q 3 hr PRN pain with Vistaril" were ordered for Patient #7. The orders were signed on 2/23/11 at 4:45 PM by the same attending physician. Morphine and Demerol were listed on Patient #7's allergy profile found on the medication reconciliation form.

On 2/23/11 at 9:45 PM, the MAR showed that 50 mg of Demerol with 25 mg of Vistaril were given to Patient #7 by the nurse. There was no documentation of clarification with the physician prior to the nurse giving the Demerol. Although the morphine was ordered, it was not administered.

In an interview with two staff pharmacists in the inpatient pharmacy on 4/01/11 at 1:30 PM, the two staff pharmacists stated if a medication was clarified, the pharmacist would write a comment in the allergy profile as their documentation. The pharmacist pulled up Patient #7's medication profile from his 2/23/11 admission. The profile showed Patient #7's reaction to Demerol was hallucinations, but no comments were noted about contacting the physician regarding Patient #7 being allergic to Demerol.

The pharmacy staff did not follow "Medical Staff Rules and Regulations" requiring pharmacists to clarify inappropriate orders with physicians to minimize drug errors.

3. The following interviews illustrate the inconsistency of pharmacy staff practice of clarifying inappropriate medications directly with the physicians.

a. On 4/01/11 at 1:30 PM, in an interview with two staff pharmacists working in the inpatient pharmacy, they both verbalized agreement that "about 90% of the time," the RN would call the physician to clarify a medication. The two pharmacists stated if a medication was clarified with a physician, the pharmacists would generally try to write a comment in the allergy profile as their documentation.

b. In an interview on 4/01/11 at 8:40 AM, an ICU RN stated if a pharmacist called the physician and the physician told the pharmacist it was okay to go ahead and give the medication despite the allergy, then the pharmacist would call and tell the RN to give the medication. The ICU RN stated a pharmacist would write a clarification order if the physician changed the order based on the call.

c. On 4/01/11 at 9:25 AM, a charge RN on the Medical Floor stated, "every once in a while, a pharmacist would call the physician," but usually the RN would clarify an order with the physician.

Pharmacy staff did not consistently clarify inappropriate medication orders with physicians.

Based on record review and staff interview, it was determined the hospital failed to ensure the ED was sufficiently integrated with inpatient nursing and pharmacy services as it related to patient allergies. This directly impacted 1 of 1 current patient (#13) whose allergies listed in the ED did not match inpatient records. It had the potential to impact all patients visiting the ED who were subsequently admitted to the hospital. Findings include:

Patient #13 was an 89 year old current patient who was admitted to the hospital on 3/31/11 via the ED. Admitting diagnoses included gastroenteritis, dehydration, and diabetes.

A "HISTORY AND PHYSICAL," dated and transcribed on 3/31/11, documented Patient #13 was intolerant or allergic to Caltrate, Codeine, and Foxamax. The same allergy information was hand written on the "MEDICATION ADMINISTRATION RECORD," dated 3/31/11 through 4/01/11 and in large letters on the outside of Patient #13's medical record.

In contrast, a computer generated "MEDICATION ADMINISTRATION RECORD," dated 3/31/11 through 4/01/11, and a "Home Medication Reconciliation Order Form," dated 3/31/11, for Patient #13 did not list allergies to Caltrate, Codeine, or Fosamax. Rather, the forms listed allergies to Bumex, Lasix, and Sulfa (Sulfonamide Antibiotics).

During an initial interview on 4/01/11 at 9:50 AM, the Director of the Medical Floor stated the allergies to Caltrate, Codeine, and Fosamax were not correct. Rather the allergies to Bumex, Lasix, Sulfa were correct. A few minutes later, she returned and said the allergy band on Patient #13's wrist listed Caltrate, Codeine, and Fosamax (the medications she had stated were incorrect).

The RN who admitted Patient #13 was interviewed on 4/01/11 beginning at 10:00 AM. She stated Patient #13 or her family were not good historians at the time Patient #13 was admitted. She stated the ward clerk put the allergy information on the outside of the chart, on the handwritten MAR and on Patient #13's wrist band. She stated the ward clerk must have transcribed the allergy information on Patient #13 from the physician's H&P. Upon surveyor request, the RN called physicians for clarification of Patient #13's allergies. She first called the physician who performed the H&P. He stated he got the information on the allergies from reading the ED record. He referred the RN to Patient #13's primary physician. The RN then called the primary physician who reportedly stated he was not aware of any allergies to Caltrate, Codeine, or Fosamax. His records indicated Patient #13 had allergies to Bumex, Lasix, Sulfa, and Atenolol (this medication was not listed in the hospital record). Upon surveyor request, the RN wrote a clarification order and stated she would go change Patient #13's wrist band to reflect the correct allergy information.

During an interview on 4/01/11 10:40 AM, the Director of the Medical Floor stated she had just learned that the allergy to Atenolol was new as of 3/15/11, based on visit note information faxed to her from Patient #13's primary physician.

The Director of the ED was interviewed at 4/01/11 at 10:20 AM. He explained the software used in the ED, called IBEX, did not integrate with the inpatient software PARAGON. He stated ED staff did not review information from the inpatient software system when patients presented to the ED. They did, however, review information that existed in IBEX that contained information from previous ED visits. He went on the computer and pulled up Patient #13's ED visit information and found a total of 6 ED visits since 2005 including the most recent visit on 3/31/11. All of the visit notes indicated allergies to Caltrate, Codeine, and Fosamax. He confirmed none of the visit notes documented allergies to Bumex, Lasix, Sulfa, or Atenolol.

During an interview on 4/01/11 at 10:40 AM, the Chief Quality and Risk Officer stated that since the ED system (IBEX) did not integrate with the inpatient system (PARAGON), the IBEX ED record was printed and went to the inpatient unit for reference and review in the medical record. She also stated the hospital went to the PARAGON system in May, 2010, and the previous system (ESSENTRIS) also did not communicate with the ED system (IBEX). She referred to IBEX as a stand alone system.

During a second interview on 4/01/11 at 1:00 PM, the Chief Quality and Risk Officer stated nurses were expected to update medication lists and this was not done in regard to Patient #13. However, there was no written policy or procedure that communicated the expectation nursing staff were expected to review the ED record and compare the allergy information in the ED record with the allergy information in the inpatient records to ensure they matched.

A pharmacist and the Director of Pharmacy were interviewed together on 4/01/11 at 11:00 AM. They explained the inpatient pharmacy did not have access to the software system (IBEX) used in the ED. They would not know if the allergy information provided in the ED differed from inpatient record information. They were not involved with evaluating medications ordered in the ED and they did not routinely release medications to the ED, only by special request. In the case of Patient #13, they did not know about allergies to Caltrate, Codeine, or Fosamax. Their records showed allergies to Bumex, Lasix, and Sulfa.

The Director of HIM was interviewed on 4/01/11 at 12:30 PM. She stated patient demographic information and financial information would transfer from PARAGON into IBEX. She confirmed clinical information would not transfer from PARAGON into IBEX and no information would transfer from IBEX to PARAGON. She stated there was no medical record expectation for staff to look at patient information in PARAGON while in the ED.

The ED's clinical information did not integrate with inpatient nursing units and inpatient pharmacy.