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Based on review of facility records, policy and procedure and staff interview, it was determined the facility failed to assess the process of care relating to medication error involving 1 of 4 sampled patients (Patient # 2), and failed to conduct a root cause analysis in order to identify indicators that negatively impacted care for Patient #2 and an additional 3 sampled patients (#5, #6 and #7)

The findings include:

Interview with the Risk Manager (RM) on 10/18/2010 at 4:30 PM confirmed, there was no root cause analysis done on the medication errors reviewed because none of the incidents met the facility's criteria of 1 or 2 incidents in the same category; serious adverse effect from the incident or process change issue. She stated the facility did not determine there was a trend in these errors.

Record review disclosed past performance as it relates to administration of medication by nursing personnel for 4 patients investigated (for whom medication errors occurred #2, #5, #6, # 7) identified continued failure to adhere to the established policies for medication administration. The facility failed to analyze cause/indicators that contributed to the medication error and track and trend the indicators to improve performance in the provision of nursing care. The review also revealed the facility failed to monitor the effectiveness and safety of services and quality of care.

Review of the clinical record for Patient # 2 revealed the patient was administered medication he/she has a known allergy to on two separate occurrences, 4/2/2010 and 4/28/2010. There was no Risk Occurrence Report for the 4/2/2010 administration error. Review of the facility's Risk Occurrence Report for a 4/28/2010 medication error documented Patient # 2 was administered antibiotic medication which patient has an allergy to by history. The patient's pre and post event condition was unconscious. There was no apparent sign and symptoms of allergy response to the medication administered. The review of the occurrence by the managers documented by pharmacy, "the patient has long history of Cipro and Quinolone use recommend clarification of allergy. Patient is likely not allergic reviewed with pharmacist regarding entry of same". Review by the Risk Manager documented "as above".

An interview was conducted on 10/18/2010 beginning at approximately 1:15 PM with the Risk Manager (RM). The RM stated when the nurse completes the patient assessment, the patient's allergies are identified and placed in the hospital's computer system. The patient is to receive a red allergy alert arm band. Once the physician prescribes medication, the nurse notes the order and the order is sent to Pharmacy. Pharmacy receives the order and is to perform a patient profile to ensure the medication prescribed is not contraindicated based on the patient's medications, diagnosis and allergies. When the nurse scans the medication to administer the medication, "an allergy alert pops up in red on the screen". The RM was unable to identify the failure in the hospital system for the patient to receive medication he/she has a known allergy to by history. The RM then stated she forwarded the occurrence to the appropriate manager(s) to investigate and returned to her upon completion. She confirmed she did not conduct a root cause analysis regarding this incident "whether it was because pharmacy stated what they did or because the patient did not have an apparent adverse reaction to the medication, she doesn't know." The RM then contacted the Pharmacy Director (PD) who joined the interview at 1:28 PM. The PD stated the pharmacist is to review the patient's profile for look at the patient's allergies and review before dispensing medications. If there is a conflict, the pharmacist is to contact the patient's nurse and physician to clarify the order. He was unable to confirm this was done. He further stated after the patient received the medication to which he/she had a documented allergic history, they looked at the prior history for administration of the medication. He stated the patient received Levaquin which is the same class of medication in 2003 and five doses intravenously and 3 doses of oral in 2006. It was also documented the patient received Cipro in 2/2008 and 11/2008 for Chronic Bronchitis. Typically if the patient has a medication at least 10 times it will not trigger an allergy thus we interpreted it as not an allergy. He confirmed this was interpreted after the patient was dispensed and received the medication, but he would research to determine if the pharmacist performed a profile prior to dispensing the medication. Additionally, the surveyor, RM and PD reviewed the patient's history and it was revealed the patient was prescribed Cipro in 2/2008. The patient received one dose and the medication was discontinued. There was no documentation to indicate the reason.
The patient was readmitted to the hospital on 11/7/2008. The 11/7/2008 history and physical by the Primary Physician documented concerning allergies, "He/she had some problems with Cipro in the past." Despite this the patient was prescribed and received in 11/2008 one dose of Cipro. The pharmacist admitted in his review, he was unaware the patient had received one dose rather than a course of the antibiotic. Further review revealed the patient was readmitted to the hospital on 4/2/2010. The 4/2/2010 history and physical documented Cipro as the patient's allergy. The Nursing Assessment identified the Cipro allergy and documented a 3/11/2010 date. Despite this identified allergy, the patient was prescribed and received one dose of Cipro on 4/2/2010. There was no Risk Occurrence Report completed for this 4/2/2010 medication error. Additionally, the patient was admitted to the hospital on 4/26/2010. Again the admitting 4/26/2010 history and physical documented the Cipro allergy. The physician prescribed Cipro on 4/26/2010 for Patient # 2. The nurse later on 4/26/2010 contacted the prescribing physician to discontinue the medication secondary to the documented allergy. However, the prescribing physician again prescribed Cipro on 4/28/2010. The pharmacy dispensed the medication and the nurse administered one dose of Cipro on 4/28/2010. The nurse on the next shift documented "shift change report noted the patient was given antibiotic (Cipro). Cipro is listed on the patient allergy profile."

Furthermore in the interview with the RM on 10/18/2010 at 4:30 PM. She stated the facility has identified issues of taking orders from the chart in a timely manner. (It should be noted, the surveyor noted this issue for Patient # 2 receiving medication to which he/she had a known allergy. The physician prescribed CIPRO on the 4/2/2010 admitting orders. However, the physician on 4/2/2010 at 1:20 PM discontinued the medication. According to the Medication Administration Record (MAR) the patient received CIPRO IV on 4/2/2010 at 2:40 PM. The discontinuation order was noted by the nurse at 6:30 PM over 5 hours after the physician prescribed for the medication to be discontinued. This delay in noting this order enabled the patient to receive medication he/she had a known allergy to. Additionally, this is also an occurrence the facility failed to report.

The facility listed 30 medication errors for the time period requested, the specific cause is not identified for 13 occurrences and 2 investigations remain incomplete because they were recently initiated 10/14 and 10/15/2010. However upon review of 4 other medication errors listed 2 additional occurrence investigations remain incomplete; in one occurrence the nurse did not document the waste of a narcotic and, in another occurrence the patient did not receive the prescribed medication.

Random review of the 3 of the the 4 other medication errors revealed the following:

1. Occurrence dated 4/6/2010, the physician prescribed for the patient to receive two antibiotics during outpatient surgery, Random patient #5. The patient received one antibiotic. The second antibiotic was hung but not administered. The error was detected after the patient was discharged from outpatient surgery. The occurrence did not identify the cause of the error. The patient did not have ill effect so a root cause analysis was not done. Review of the occurrence revealed an incomplete investigation. The investigation did not document the time the order was prescribed, the time the patient left outpatient, and there was no determination if the omission was nurse error, dispensing error or patient choice.

2. An occurrence was initiated on 9/28/2010 when it was reported the nurse hung the wrong medication, Random Patient #6. The nurse received a telephone order from the physician. She stated the physician prescribed one antibiotic Cefazolin. The physician stated he told the nurse Mefoxitin. The nurse hung Cefazolin. There was no root cause analysis completed. The RM stated she is awaiting response regarding this medication error.

3. Occurrence initiated on 10/6/2010, the medications ordered prior to transfer were never profiled, Random Patient # 7. The patient and meds were ordered along with transfer to the intensive care unit. The patient was sent to surgery. The meds were never profiled before transfer. All labs were entered in the system. Order sheet were never noted before transfer. The patient missed numerous medications on the day shift. The investigation remains incomplete at this time.

Review of the facility's policy regarding "Risk Management Plan" revealed the RM did not perform her responsibilities as outlined concerning the Risk Management functions/responsibilities to include, "Conducts clinical risk assessment and analysis of complex organizational systems within the facility and facilitates development of corrective action plan; coordinates development of corrective action plan to address identified risk exposures; analyzes incidents/occurrences and identifies patterns as evidence for decision-making; provides trend reports to appropriate facility, medical staff and board committees."

Based on review of facility records and physician interview, it was determined two physicians on the medical staff failed to consistently adhere to their responsibilities as detailed in the bylaws, as evidenced by the failure to ensure they did not prescribe medication for which a patient has a known allergy. This affected 1 of 4 sampled patients (Patient # 2). Rule 64B8 of the Florida Administrative Code, and Chapter 458 of the Florida Statute require the physician to prescribe drugs to meet the patient's immediate needs. Neither record review nor interview with the physicians or pharmacy revealed the substantiated benefit outweighed the risk of the prescription of a medication to a patient who has documented allergic reaction. .
The findings include:

Review of the clinical record for Patient # 2 revealed the patient has had multiple admissions to the hospital for exacerbation of his/her Chronic Obstructive Pulmonary Disease (COPD). According to the History and Physical dated 4/2/2010, the Primary physician documented the patient came to his office this morning with a complaint of some shortness of breath, coughing up phlegm and both feet and leg swelling. The physician ordered for the patient to be admitted directly to the floor. The physician documented the patient's allergy to include "Cipro". Patient # 2 was admitted to the hospital on 4/2/2010 with admitting orders prescribed by the Primary physician which included Zosyn (Piperacillin/Tazobactam 3.375 gm IV (intravenously) every 6 hours AND CIPRO (Ciprofloxacin 400mg IV every 12 hours. The patient has a documented allergy to Cipro.

Further review of the physician orders revealed the physician discontinued the Cipro on 4/2/2010 at 1:20 PM; the order was noted by the nurse at 6:30 PM.

The patient was again admitted to the Hospital on 4/26/2010 for exacerbation of his/her COPD. The History and Physical dated 4/26/2010 documented the patient was brought in to the emergency room by the emergency medical services for shortness of breath and complaint of "cannot breath". Again the primary physician documented the patient allergies which included CIPRO.

Review of 4/26/2010 :9:00 AM orders written by the consultant Pulmonologist prescribed for the patient to receive CIPRO 400 mg IV every 12 hours. The orders were noted by the nurse at 4:02 PM. The nurse contacted the physician and obtained an order to discontinue the medication.

However on 4/28/2010, the consulting Pulmonologist again prescribed for the patient to receive CIPRO 400 mg IV every 12 hours.

Review of the physician prescription revealed a 4/28/2010 9:00 PM telephone order discontinuing the Cipro due to allergy and prescribing Avalox 400 mg IV every day.

An interview was conducted on 10/18/2010 at 3:09 PM with the Primary Physician. He stated the patient has had several exacerbations of his/her Chronic Obstructive Disease (COPD) and one of the protocols for antibiotics is Zosyn and Cipro. He stated he knew the patient has taken Levaquin and Cipro in the past. The patient has taken 1-2 doses of the Cipro in the past and he/she complained of problems with the medications. The physician later stated it was just overlooked because the standing order has the Zosyn and the Cipro together. He then questioned, regarding the hospital pharmacy not identifying the allergy and the prescription or if the computer records reflected the allergy and the nurse didn't recognize the patient's allergies either. The surveyor stated, the computer record has the allergy documented and the physician noted the patient's allergies in his history and physical. He then sated, "We all overlooked it and caught it one dose late". The surveyor explained to the physician the patient was prescribed the Cipro on three different occasions in April, 2010, the nursing assessment has the patient identified with the Cipro allergy since March 11, 2010 and a November 2008 history and physical completed by him, indicated the patient has problems with the Cipro. He doesn't remember the patient's reaction to the medication. His records do not have documentation regarding the patient's reaction to the medication.

An interview was conducted on 10/18/2010 at 3:55 with the Consulting Pulmonologist. He stated he doesn't know if he was aware of the patient's allergy when he prescribed the Cipro. "We missed that". He stated the patient cultured pseudomonas trachea bronchitis, and required two antibiotics. He further stated he did not feel the patient had a true allergy to CIPRO because the patient has received the medication in the past. However, he confirmed he did not have medical documentation to confirm the patient did not have a true allergy before prescribing the medication. He then stated we discontinued the medication and prescribed other antibiotics. He stated after reviewing the record, the nurse contacted him at 9:00 PM and he would not have remembered to document in the progress note the following day regarding discontinuing the medication.

Based on review of facility records, policy and procedure and staff interview, it was determined, the responsible nursing personnel and the Risk Manager failed to evaluate the provision of care for 1 of 4 sampled patients (Patient # 2) to ensure medication administration is in accordance of Hospital policy and accepted standards of practice.

The findings include:

Review of the clinical record for Patient # 2 revealed the patient has had multiple admissions to the hospital for exacerbation of his/her Chronic Obstructive Pulmonary Disease (COPD). According to the History and Physical dated 4/2/2010, the Primary physician documented the patient came to his office this morning with a complaint of some shortness of breath, coughing up phlegm and both feet and leg swelling. The physician ordered for the patient to be admitted directly to the floor. The physician documented the patient's allergy to include "Cipro". Patient # 2 was admitted to the hospital on 4/2/2010 with admitting orders prescribed by the Primary physician which included Zosyn (Piperacillin/Tazobactam 3.375 gm IV (intravenously) every 6 hours and CIPRO (Ciprofloxacin 400mg IV every 12 hours. The patient has a documented allergy to Cipro.

Review of the Medication Administration Record (MAR) revealed the patient received CIPRO IV (intravenously) on 4/2/2010 at 2:40 PM. The nurse documented the patient experienced nausea upon administration.

Further review of the physician orders revealed the physician discontinued the Cipro on 4/2/2010 at 1:20 PM; the order was noted by the nurse at 6:30 PM.

The patient was again admitted to the Hospital on 4/26/2010 for exacerbation of his/her COPD. The History and Physical dated 4/26/2010 documented the patient was brought in to the emergency room by the emergency medical services for shortness of breath and "cannot breath". Again the primary physician documented the patient allergies which included CIPRO.

Review of 4/26/2010 :9:00 AM orders written by the consultant Pulmonologist prescribed for the patient to receive CIPRO 400 mg IV every 12 hours. The orders were noted by the nurse at 4:02 PM. The nurse contacted the physician and obtained an order to discontinue the medication.

However on 4/28/2010, the consulting Pulmonologist again prescribed for the patient to receive CIPRO 400 mg IV every 12 hours.
Review of the MAR revealed the patient received CIPRO 400 mg IV on 4/28/2010 at 9:46 AM. It should be noted at this time the patient is in the intensive care unit receiving artificial ventilation via a ventilator.

Review of the physician prescription revealed a 4/28/2010 9:00 PM telephone order discontinuing the Cipro due to allergy and prescribing Avelox 400 mg IV every day.

Review of the policy for Medication Administration regarding responsibilities in Medication Administration revealed: "Before administering any medication, the administering personnel must know the usual dose and route of administration, the desired effects, special precautions, and any contraindications. To administer medications appropriately, the administering person must know the patient's diagnosis and the disease process involved. Any allergies the patient has should be clearly marked in the record."

An interview was conducted on 10/18/2010 in the afternoon with the Risk Manager. She stated the patient's allergies are clearly marked on the electronic MAR and the patient should not have been administered medication to which he/she has a known allergy.