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Based on review of 2 of 3 randomly selected complaints, Patient #14 and Patient #15 and the Hospital's response to the complaints, it was determined the Hospital failed to address each point raised in the Complainant's letter as part of the investigation of the grievance.

Findings included:

1) Review of the complaint file for Patient #14 indicated that a complaint letter, dated 5/4/11, was received by the Hospital. The complaint was regarding medical care received in the Hospital's ED on 4/17/11 and in addition, the co-pay for the ED visit. Documentation indicated an acknowledgement letter was sent to the complainant on 5/9/11 and stating that an investigation would be performed. The letter/written response to the Complainant from the chief of Emergency Medicine did not include what the outcome of the investigation was regarding the quality of medical care. The response addressed the co-pay issue.

2) Review of the complaint file for Patient #15 indicated a complaint letter, dated 5/2/11, was received regarding the quality of medical care received in the ED on 2/25 and 2/26/11 and a dispute regarding the co-payment. Documentation indicated an acknowledgement letter was sent to the complainant on 5/3/11. The letter/written response to the complainant on 5/4/11 from the Chief of Emergency Medicine addressed the co-pay issue and not the quality of medical care that was provided.

Based on observations on 8/24/11 at 8:10, interviews and record review regarding patient safety measures such as A-medication alerts, B -patient on aspiration precautions, C-infection control and D- Fall precautions, it was determined the Hospital failed to ensure safety measures were implemented to protect patients from identified safety risk factors.

Findings include:

A. Medication Alerts: The Director of the Pharmacy was interviewed in person on 8/24/11 at 2:00 PM and on 8/25/11 at 10:55 AM. Please refer to Tag 490 Condition for Pharmacy Services for additional information,

The VP Chief Information and Innovation Officer was interviewed in person on 8/29/11 at 9:00 AM. The VP Chief Information and Innovation Officer said the automated computerized provider order entry (CPOE) was deactivated for the dosage range alert (electronic support system that identified drug dosage warnings).

B. Patient on Aspiration Precautions

During a tour of S2 on 8/24/11 at 8:10 AM, it was observed that CNA #2 was feeding Patient #13 who was on aspiration precautions without using safe swallowing strategies. CNA #2 was standing to the side above the patient, rather than at eye level, and did not watch, look and assess that Patient #13 swallowed before more food was provided to the patient.

Review of CNA #2's education and personnel file did not contain documentation of competencies for feeding patients on aspiration precautions.

C. Infection Control

During a tour of S2 on 8/24/11 at 8:10 AM, it was also observed that a sink in the medication room had dried spillage and rust stains. Surface dust was seen on stacked plastic storage containers and there was a buildup of dirt along the edges of the floor.

D. Fall Precautions

Medical record review of Patient #1's admission assessment dated 7/5/11 indicated that Patient #1 was alert and oriented and assessed at risk for falls with a score of 60 points, which according to the assessment tool used, classified Patient #1 as high risk. Review of Nurse #4's note dated 7/9/11 indicated that Patient #1 was found repeatedly attempting to get out of bed, did not call for assistance when getting out of bed to the commode to void, was observed to be unsteady and wobbled side to side, needed to be supported while sitting on the commode and complained of feeling dizzy. Review of Nurse #4's note dated 7/10/11 at 5:24 AM indicated Patient #1 was found lying face down on the floor next to her/his bed.

Nurse #4, who cared for Patient #1 during the night shift from 7/8 into 7/9/11 and 7/9 into 7/10/11 was interviewed in person on 8/25/11 at 7:15 AM. Nurse #4 said Patient #1 would get up out of bed without calling for assistance. Nurse #4 said Patient #1 told her that she/he had a commode at her/his bedside at home because of frequency and urgency with voiding. Nurse #4 said the first night she cared for Patient #1, she moved the commode from the bathroom to Patient #1's bedside. Nurse #4 said the second night she cared for Patient #1, the commode was moved from the bedside to the corner of Patient #1's room. Nurse #4 said because of Patient #1's impulsivity and high risk for falling, Nurse #4 thought Patient #1 needed 1:1 supervision (safety sitter) because of the increased potential for a fall. Nurse #4 said she did not ask/report to the charge nurse or the nursing supervisor of the need for the 1:1 supervision for Patient #1 because former requests were met with resistance.

Hospital policies/procedures related to fall risk/prevention indicated that if a patient was identified to be a high risk for falls, then the need for an Observation Assistant (1:1) supervision will be considered. The policy did not address a protocol for determining the need for 1:1.

CNA #1, who cared for Patient #1 during the night shift from 7/9 into 7/10/11, was interviewed in person on 8/25/11 at 3:15 PM. CNA #1 said Patient #1's commode was at Patient #1's bedside. CNA #1 denied he moved Patient #1's commode from the bedside to the corner of the room. CNA #1 said heard there had been shortages of safety sitters.

Based on review of documentation regarding patient fall data, the hospital's internal investigation and interviews, the Hospital failed to ensure that data collected related to falls which is used to identify opportunities for patient improvement were thoroughly analyzed and was accurate.

Findings include:

Review of the incident report, dated 7/10/11, indicated that Patient #1 was found laying face down on the floor next to her/his bed minutes after being assisted to bed from using a commode. The incident report failed to identify Patient #1's fall risk status and nursing falls risk assessment data.

Review of nursing assessments dated 7/5/11, 7/6/11, 7/8/11 indicated Patient #1 was identified to be at high risk for falls using the Morse Falls Risk Assessment Tool.

Quality Improvement Nurse #2 was interviewed in person on 8/24/11 at 12:15 PM. Quality Improvement Nurse #2 said the incident report regarding Patient #1's fall on 7/10/11 was not complete nor accurate. Quality Improvement Nurse #2 said she reviews all reports related to falls and if the reports are not completed, she will at times, edit/enter the data to complete the reports. Quality Improvement Nurse #2 said information from the incident reports generate summary data for falls.

Review of the Hospital's data summary for falls, dated 7/1/11 to 7/31/11 indicated the data from incident reports, but review of the incident report regarding Patient #1's fall indicated it was not complete and accurate.

Review of documentation for the Hospital's internal investigation/ root cause analysis regarding Patient #1's fall indicated a meeting was held on 7/16/11 and the pharmacy staff were not asked to attend and as a result, not all of Patient #1's medications and dosages were reviewed by a pharmacist to determine if medications and dosages were a factor in placing the patient at increased risk for falls.

The Hospital's root cause analysis failed to identify the following issues: 1) Patient #1 began to get up without calling for assistance and no additional nursing measures were implemented/documented to protect Patient #1's safety after identifying non-compliance with requesting assistance in ambulating. Nursing staff failed to request 1:1 observation for safety. 2) The incorrect information was conveyed to the medical team that Patient #1 had a 3 centimeter subarachnoid hemorrhage, when in fact it was a very small 3 millimeter sized hemorrhage. As a result, additional concerns for Patient #1's neurological status were implemented such as med-flighted the patient to a Tertiary Care Hospital. 3.) Pharmacy staff/Director of the Pharmacy was not asked to attend the root cause analysis meeting. There was no active discussion during the RCA which may have identified the above therapeutic dose of Lamictal ordered for Patient #1.

Based on interview, documentation and medical record review for 6 out of a total of 10 patients records sampled from the list of patient falls, [Patient #1, #2, #5, #8, #9, #10] the Hospital failed to ensure that the nursing staff developed and kept current, plans of care for each patient.

Findings included:

1.) Review of Patient #1's medical record documentation dated 7/5/11-7/10/11 indicated the patient had a problem of urinary incontinence and frequency, especially at night. Patient #1 was admitted after falling at home while rushing to a commode/bathroom during the night to void. A urinary drainage catheter was placed at admission and was discontinued 7/7/11. However, Patient #1's plan of care did not identify a revised plan to ensure increased monitoring based on discontinuing the urinary catheter. A nursing care plan dated 7/5/11 indicated Patient #1's mobility deficit was identified, but the interventions were not individualized to the patient's specific needs and issues.

2.) Review of Patient #2's medical record documentation, dated 5/10/11, indicated Patient #2 resided in a nursing home with a history of falls, came to the ED and was then admitted to the Hospital at 10:38 PM. Shortly after admission, at 11:00 PM, Patient #2 was found on the floor. Review of Patient #2's plan of care indicated a problem list that identified an Alteration in Activities of Daily Living. Review of the nursing interventions listed were to perform a fall risk assessment, but plan of care was not individualized for Patient #2.

3.) Review of Patient #5's medical record documentation, dated 6/26/11- 6/30/11, indicated Patient #5 was alert, but confused at times. Patient #5 had weakness and used a bedside commode. On 6/28/11, Patient #5 was found trying to get out of bed unassisted. On 6/30/11, Patient #5 attempted to stand without nursing assistance and was found on the floor on her/his right knee. Review of Patient #5's plan of care indicated a problem list that identified an Alteration in Activities of Daily Living. The nursing intervention listed was to perform a fall risk assessment. The plan of care was not individualized for Patient #5 needs.

4.) Review of Patient #8's medical record documentation, dated 7/6-7/18/11, indicated Patient #8 was admitted to the hospital with a history of being unsteady on his/her feet with falls and being totally dependent for personal care needs. Review of Patient #8's plan of care did not include nursing interventions required to meet activities of daily living for Patient #8 specific needs. Documentation dated 7/17/11 indicated Patient #8 was found sitting on the floor. Patient #8 stated he/she needed to go to the bathroom and tried to get his/her walker, but instead tripped over it. Patient #8 stated he/she hit their head on the wall.

5.) Review of Patient #9's medical record documentation, dated 7/23-7/26/11 and review of Patient #10's medical record, indicated that both Patient #9's and Patient #10's plan of care was not individualized and updated after their falls to reflect increased safety measures.

Based on review of the Physician's orders, the MAR and the Pharmacist's acknowledgment of the order for dispensing the medication, Lamictal, it was determined that Patient #1 received 800 mg of Lamictal daily on 7/6-7/9/11. The doses were not administered by the nursing staff with consistent accepted standards of practice.

Findings include:

1) See also Tag 490 Condition for Pharmacy Services

2) Review of Hospital policies and procedures related to the administration of medication indicated that personnel administering medications are responsible for knowing the actions, effects of the medication and normal doses.

3) Review of Patient #1's medical record indicated she/he received 9 doses of Lamictal that was ordered, prescribed and administered outside the normal dose range.

The condition for Pharmacy Services was not met.

Findings include:

Based on observations, record review and interview with nursing staff, the Director of Pharmacy and the Vice President/Chief Information & Innovation Officer, the pharmaceutical service was not aware that the drug dosage alert was deactivated when electronic documentation was incorporated into the Hospital's Computer System and as a result one of one sampled patients (Patient #1) received higher than normal dosages of Lamictal on 7/6-7/9/11. The facility failed to have policies/procedure in place to ensure clarification was obtained when dispensing medications that are prescribed outside/beyond the normal dosing range.

1.) Review of computerized provider order entry (CPOE) dated 7/5/11 at 4:48 PM indicated Hospitalist #1 ordered 400 mg of Lamictal twice a day for Patient #1.

2.) Review of the Hospital's data source for dosing information for Lamictal was normal dose = 300 milligrams (mg)-500 mg per day in 2 divided doses, or a maximum daily dose of 500 mg up to 700 mg. Patient #1 received 800 mg daily during her hospitalization.

3.) Review of Patient #1's medical record dated 7/11/11 indicated a neurology consult was obtained and it was determined that Patient #1 was receiving more than her baseline of Lamictal. Patient #1 reported to the neurologist he/she took 200 mg twice a day.

4.) Review of the Medication Administration Record documentation indicated Patient #1 received 400 mg of Lamictal on 7/5/11 at 7:46 PM; 400 mg on 7/6/11 at both 8:34 AM and 8:35 PM; 400 mg on 7/7/11 at both 8:31 AM and 8:14 PM; 400 mg on 7/8/11 both at 8:32 AM and 9:08 PM; and 400 mg on 7/9/11 at both 8:37 AM and 8:38 PM.

5.) The Director of the Pharmacy was interviewed in person on 8/24/11 at 2:00 PM and on 8/25/11 at 10:55 AM. The Director said the CPOE system was used to identify patient's at home list/prescribed medications and ensure all information regarding those medications were included/updated in the automated patient information system. The Director said the computerized system has integrated drug safety alerts. An example would be drug to drug interactions and the interactions are categorized according to different severity levels. A pharmacist can then document electronically in a comment field if a drug to drug to drug interaction was noted and the final decision/recommendation made by the pharmacist if the drugs were allowed for clinical administration. The Director of the Pharmacy said she was not aware, until this Surveyor asked for drug and dose information during the onsite investigation, that the computer's dose range alert was not live (turned on) and was noted to be inactivated (turned off) when the automated physician ordering system was implemented. The Director of the Pharmacy said if the dose alert had been activated, a pharmacist who saw the out of range dose alert, would comment what action to take before dispensing a medication on the intervention screen.

6) The VP Chief Information and Innovation Officer was interviewed in person on 8/29/11 at 9:00 AM. The VP Chief Information and Innovation Officer said there was an informal discussion in the beginning of the implementation process in the fall of 2010 regarding the automated computerized provider order entry to deactivate the dose range alerts (electronic support system that identify drug dosage warnings). The dose range alert was off for all staff involved in the administration of medications to patients because an informal decision was made to turn the alert off without obtaining the approval of the Executive Leadership the hospital.

Based on review of documentation, the Physician's medication order, the MAR and interviews, the Hospital failed to ensure that Pharmacy Services informed Hospitalist #1 regarding a high dose of Lamictal that was ordered for one of ten sampled patients (Patient #1).

Findings include:

The Pharmacy's policies/procedures related to clarifications of medication orders indicated that any questionable medication orders (unclear, illegible or incomplete) are clarified with the prescriber before any medication is dispense from the pharmacy. The policy/procedure did not include that the responsibility shall also include questioning the dispensing of medications outside of normal dose range/a high dose and along with documentation of actions taken by the pharmacist.

Review of the CPOE documentation indicated that Hospitalist #1 orders, dated 7/5/11 for Patient #,1 included Lamictal 400 milligrams (mg) twice a day, was acknowledged by a pharmacist. However, there was no evidence that the Pharmacist alerted Hospitalist #1 and/or took actions to clarify the medication dose ordered which was outside the normal dosing range/ high dose.

Based on review of documentation, the MAR and interviews, the Hospital failed to ensure that a higher than therapeutic dose of Lamictal and other medications ordered with a high dosage range were clarified and cleared by a Pharmacist before the medications were dispensed from the Pharmacy.

Findings include:

The Director of the Pharmacy was interviewed in person on 8/24/11 at 2:00 PM and on 8/25/11 at 10:55 AM. The Director of the Pharmacy said the dose range alert was not live (turned on), it was inactivated (turned off) when the automated physician ordering system was implemented. The Director of the Pharmacy said if the dose alert had been activated, a pharmacist who saw the out of range dose alert would comment what action they took (when viewing, acknowledging and dispensing a medication with a dose alert) on the intervention screen.

Review of the electronic documentation dated 7/5/11 at 4:48 PM indicated Lamictal 400 mg twice a day, was ordered for Patient #1 and was acknowledged by a pharmacist at 5:21 PM. There was no documentation/comment by a pharmacist that dispensed the medication from the pharmacy that this drug was outside the normal dosing range.

Based on review of 2 of 3 randomly selected complaints, Patient #14 and Patient #15 and the Hospital's response to the complaints, it was determined the Hospital failed to address each point raised in the Complainant's letter as part of the investigation of the grievance.

Findings included:

1) Review of the complaint file for Patient #14 indicated that a complaint letter, dated 5/4/11, was received by the Hospital. The complaint was regarding medical care received in the Hospital's ED on 4/17/11 and in addition, the co-pay for the ED visit. Documentation indicated an acknowledgement letter was sent to the complainant on 5/9/11 and stating that an investigation would be performed. The letter/written response to the Complainant from the chief of Emergency Medicine did not include what the outcome of the investigation was regarding the quality of medical care. The response addressed the co-pay issue.

2) Review of the complaint file for Patient #15 indicated a complaint letter, dated 5/2/11, was received regarding the quality of medical care received in the ED on 2/25 and 2/26/11 and a dispute regarding the co-payment. Documentation indicated an acknowledgement letter was sent to the complainant on 5/3/11. The letter/written response to the complainant on 5/4/11 from the Chief of Emergency Medicine addressed the co-pay issue and not the quality of medical care that was provided.

Based on observations on 8/24/11 at 8:10, interviews and record review regarding patient safety measures such as A-medication alerts, B -patient on aspiration precautions, C-infection control and D- Fall precautions, it was determined the Hospital failed to ensure safety measures were implemented to protect patients from identified safety risk factors.

Findings include:

A. Medication Alerts: The Director of the Pharmacy was interviewed in person on 8/24/11 at 2:00 PM and on 8/25/11 at 10:55 AM. Please refer to Tag 490 Condition for Pharmacy Services for additional information,

The VP Chief Information and Innovation Officer was interviewed in person on 8/29/11 at 9:00 AM. The VP Chief Information and Innovation Officer said the automated computerized provider order entry (CPOE) was deactivated for the dosage range alert (electronic support system that identified drug dosage warnings).

B. Patient on Aspiration Precautions

During a tour of S2 on 8/24/11 at 8:10 AM, it was observed that CNA #2 was feeding Patient #13 who was on aspiration precautions without using safe swallowing strategies. CNA #2 was standing to the side above the patient, rather than at eye level, and did not watch, look and assess that Patient #13 swallowed before more food was provided to the patient.

Review of CNA #2's education and personnel file did not contain documentation of competencies for feeding patients on aspiration precautions.

C. Infection Control

During a tour of S2 on 8/24/11 at 8:10 AM, it was also observed that a sink in the medication room had dried spillage and rust stains. Surface dust was seen on stacked plastic storage containers and there was a buildup of dirt along the edges of the floor.

D. Fall Precautions

Medical record review of Patient #1's admission assessment dated 7/5/11 indicated that Patient #1 was alert and oriented and assessed at risk for falls with a score of 60 points, which according to the assessment tool used, classified Patient #1 as high risk. Review of Nurse #4's note dated 7/9/11 indicated that Patient #1 was found repeatedly attempting to get out of bed, did not call for assistance when getting out of bed to the commode to void, was observed to be unsteady and wobbled side to side, needed to be supported while sitting on the commode and complained of feeling dizzy. Review of Nurse #4's note dated 7/10/11 at 5:24 AM indicated Patient #1 was found lying face down on the floor next to her/his bed.

Nurse #4, who cared for Patient #1 during the night shift from 7/8 into 7/9/11 and 7/9 into 7/10/11 was interviewed in person on 8/25/11 at 7:15 AM. Nurse #4 said Patient #1 would get up out of bed without calling for assistance. Nurse #4 said Patient #1 told her that she/he had a commode at her/his bedside at home because of frequency and urgency with voiding. Nurse #4 said the first night she cared for Patient #1, she moved the commode from the bathroom to Patient #1's bedside. Nurse #4 said the second night she cared for Patient #1, the commode was moved from the bedside to the corner of Patient #1's room. Nurse #4 said because of Patient #1's impulsivity and high risk for falling, Nurse #4 thought Patient #1 needed 1:1 supervision (safety sitter) because of the increased potential for a fall. Nurse #4 said she did not ask/report to the charge nurse or the nursing supervisor of the need for the 1:1 supervision for Patient #1 because former requests were met with resistance.

Hospital policies/procedures related to fall risk/prevention indicated that if a patient was identified to be a high risk for falls, then the need for an Observation Assistant (1:1) supervision will be considered. The policy did not address a protocol for determining the need for 1:1.

CNA #1, who cared for Patient #1 during the night shift from 7/9 into 7/10/11, was interviewed in person on 8/25/11 at 3:15 PM. CNA #1 said Patient #1's commode was at Patient #1's bedside. CNA #1 denied he moved Patient #1's commode from the bedside to the corner of the room. CNA #1 said heard there had been shortages of safety sitters.

Based on review of documentation regarding patient fall data, the hospital's internal investigation and interviews, the Hospital failed to ensure that data collected related to falls which is used to identify opportunities for patient improvement were thoroughly analyzed and was accurate.

Findings include:

Review of the incident report, dated 7/10/11, indicated that Patient #1 was found laying face down on the floor next to her/his bed minutes after being assisted to bed from using a commode. The incident report failed to identify Patient #1's fall risk status and nursing falls risk assessment data.

Review of nursing assessments dated 7/5/11, 7/6/11, 7/8/11 indicated Patient #1 was identified to be at high risk for falls using the Morse Falls Risk Assessment Tool.

Quality Improvement Nurse #2 was interviewed in person on 8/24/11 at 12:15 PM. Quality Improvement Nurse #2 said the incident report regarding Patient #1's fall on 7/10/11 was not complete nor accurate. Quality Improvement Nurse #2 said she reviews all reports related to falls and if the reports are not completed, she will at times, edit/enter the data to complete the reports. Quality Improvement Nurse #2 said information from the incident reports generate summary data for falls.

Review of the Hospital's data summary for falls, dated 7/1/11 to 7/31/11 indicated the data from incident reports, but review of the incident report regarding Patient #1's fall indicated it was not complete and accurate.

Review of documentation for the Hospital's internal investigation/ root cause analysis regarding Patient #1's fall indicated a meeting was held on 7/16/11 and the pharmacy staff were not asked to attend and as a result, not all of Patient #1's medications and dosages were reviewed by a pharmacist to determine if medications and dosages were a factor in placing the patient at increased risk for falls.

The Hospital's root cause analysis failed to identify the following issues: 1) Patient #1 began to get up without calling for assistance and no additional nursing measures were implemented/documented to protect Patient #1's safety after identifying non-compliance with requesting assistance in ambulating. Nursing staff failed to request 1:1 observation for safety. 2) The incorrect information was conveyed to the medical team that Patient #1 had a 3 centimeter subarachnoid hemorrhage, when in fact it was a very small 3 millimeter sized hemorrhage. As a result, additional concerns for Patient #1's neurological status were implemented such as med-flighted the patient to a Tertiary Care Hospital. 3.) Pharmacy staff/Director of the Pharmacy was not asked to attend the root cause analysis meeting. There was no active discussion during the RCA which may have identified the above therapeutic dose of Lamictal ordered for Patient #1.

Based on interview, documentation and medical record review for 6 out of a total of 10 patients records sampled from the list of patient falls, [Patient #1, #2, #5, #8, #9, #10] the Hospital failed to ensure that the nursing staff developed and kept current, plans of care for each patient.

Findings included:

1.) Review of Patient #1's medical record documentation dated 7/5/11-7/10/11 indicated the patient had a problem of urinary incontinence and frequency, especially at night. Patient #1 was admitted after falling at home while rushing to a commode/bathroom during the night to void. A urinary drainage catheter was placed at admission and was discontinued 7/7/11. However, Patient #1's plan of care did not identify a revised plan to ensure increased monitoring based on discontinuing the urinary catheter. A nursing care plan dated 7/5/11 indicated Patient #1's mobility deficit was identified, but the interventions were not individualized to the patient's specific needs and issues.

2.) Review of Patient #2's medical record documentation, dated 5/10/11, indicated Patient #2 resided in a nursing home with a history of falls, came to the ED and was then admitted to the Hospital at 10:38 PM. Shortly after admission, at 11:00 PM, Patient #2 was found on the floor. Review of Patient #2's plan of care indicated a problem list that identified an Alteration in Activities of Daily Living. Review of the nursing interventions listed were to perform a fall risk assessment, but plan of care was not individualized for Patient #2.

3.) Review of Patient #5's medical record documentation, dated 6/26/11- 6/30/11, indicated Patient #5 was alert, but confused at times. Patient #5 had weakness and used a bedside commode. On 6/28/11, Patient #5 was found trying to get out of bed unassisted. On 6/30/11, Patient #5 attempted to stand without nursing assistance and was found on the floor on her/his right knee. Review of Patient #5's plan of care indicated a problem list that identified an Alteration in Activities of Daily Living. The nursing intervention listed was to perform a fall risk assessment. The plan of care was not individualized for Patient #5 needs.

4.) Review of Patient #8's medical record documentation, dated 7/6-7/18/11, indicated Patient #8 was admitted to the hospital with a history of being unsteady on his/her feet with falls and being totally dependent for personal care needs. Review of Patient #8's plan of care did not include nursing interventions required to meet activities of daily living for Patient #8 specific needs. Documentation dated 7/17/11 indicated Patient #8 was found sitting on the floor. Patient #8 stated he/she needed to go to the bathroom and tried to get his/her walker, but instead tripped over it. Patient #8 stated he/she hit their head on the wall.

5.) Review of Patient #9's medical record documentation, dated 7/23-7/26/11 and review of Patient #10's medical record, indicated that both Patient #9's and Patient #10's plan of care was not individualized and updated after their falls to reflect increased safety measures.

Based on review of the Physician's orders, the MAR and the Pharmacist's acknowledgment of the order for dispensing the medication, Lamictal, it was determined that Patient #1 received 800 mg of Lamictal daily on 7/6-7/9/11. The doses were not administered by the nursing staff with consistent accepted standards of practice.

Findings include:

1) See also Tag 490 Condition for Pharmacy Services

2) Review of Hospital policies and procedures related to the administration of medication indicated that personnel administering medications are responsible for knowing the actions, effects of the medication and normal doses.

3) Review of Patient #1's medical record indicated she/he received 9 doses of Lamictal that was ordered, prescribed and administered outside the normal dose range.

The condition for Pharmacy Services was not met.

Findings include:

Based on observations, record review and interview with nursing staff, the Director of Pharmacy and the Vice President/Chief Information & Innovation Officer, the pharmaceutical service was not aware that the drug dosage alert was deactivated when electronic documentation was incorporated into the Hospital's Computer System and as a result one of one sampled patients (Patient #1) received higher than normal dosages of Lamictal on 7/6-7/9/11. The facility failed to have policies/procedure in place to ensure clarification was obtained when dispensing medications that are prescribed outside/beyond the normal dosing range.

1.) Review of computerized provider order entry (CPOE) dated 7/5/11 at 4:48 PM indicated Hospitalist #1 ordered 400 mg of Lamictal twice a day for Patient #1.

2.) Review of the Hospital's data source for dosing information for Lamictal was normal dose = 300 milligrams (mg)-500 mg per day in 2 divided doses, or a maximum daily dose of 500 mg up to 700 mg. Patient #1 received 800 mg daily during her hospitalization.

3.) Review of Patient #1's medical record dated 7/11/11 indicated a neurology consult was obtained and it was determined that Patient #1 was receiving more than her baseline of Lamictal. Patient #1 reported to the neurologist he/she took 200 mg twice a day.

4.) Review of the Medication Administration Record documentation indicated Patient #1 received 400 mg of Lamictal on 7/5/11 at 7:46 PM; 400 mg on 7/6/11 at both 8:34 AM and 8:35 PM; 400 mg on 7/7/11 at both 8:31 AM and 8:14 PM; 400 mg on 7/8/11 both at 8:32 AM and 9:08 PM; and 400 mg on 7/9/11 at both 8:37 AM and 8:38 PM.

5.) The Director of the Pharmacy was interviewed in person on 8/24/11 at 2:00 PM and on 8/25/11 at 10:55 AM. The Director said the CPOE system was used to identify patient's at home list/prescribed medications and ensure all information regarding those medications were included/updated in the automated patient information system. The Director said the computerized system has integrated drug safety alerts. An example would be drug to drug interactions and the interactions are categorized according to different severity levels. A pharmacist can then document electronically in a comment field if a drug to drug to drug interaction was noted and the final decision/recommendation made by the pharmacist if the drugs were allowed for clinical administration. The Director of the Pharmacy said she was not aware, until this Surveyor asked for drug and dose information during the onsite investigation, that the computer's dose range alert was not live (turned on) and was noted to be inactivated (turned off) when the automated physician ordering system was implemented. The Director of the Pharmacy said if the dose alert had been activated, a pharmacist who saw the out of range dose alert, would comment what action to take before dispensing a medication on the intervention screen.

6) The VP Chief Information and Innovation Officer was interviewed in person on 8/29/11 at 9:00 AM. The VP Chief Information and Innovation Officer said there was an informal discussion in the beginning of the implementation process in the fall of 2010 regarding the automated computerized provider order entry to deactivate the dose range alerts (electronic support system that identify drug dosage warnings). The dose range alert was off for all staff involved in the administration of medications to patients because an informal decision was made to turn the alert off without obtaining the approval of the Executive Leadership the hospital.

Based on review of documentation, the Physician's medication order, the MAR and interviews, the Hospital failed to ensure that Pharmacy Services informed Hospitalist #1 regarding a high dose of Lamictal that was ordered for one of ten sampled patients (Patient #1).

Findings include:

The Pharmacy's policies/procedures related to clarifications of medication orders indicated that any questionable medication orders (unclear, illegible or incomplete) are clarified with the prescriber before any medication is dispense from the pharmacy. The policy/procedure did not include that the responsibility shall also include questioning the dispensing of medications outside of normal dose range/a high dose and along with documentation of actions taken by the pharmacist.

Review of the CPOE documentation indicated that Hospitalist #1 orders, dated 7/5/11 for Patient #,1 included Lamictal 400 milligrams (mg) twice a day, was acknowledged by a pharmacist. However, there was no evidence that the Pharmacist alerted Hospitalist #1 and/or took actions to clarify the medication dose ordered which was outside the normal dosing range/ high dose.

Based on review of documentation, the MAR and interviews, the Hospital failed to ensure that a higher than therapeutic dose of Lamictal and other medications ordered with a high dosage range were clarified and cleared by a Pharmacist before the medications were dispensed from the Pharmacy.

Findings include:

The Director of the Pharmacy was interviewed in person on 8/24/11 at 2:00 PM and on 8/25/11 at 10:55 AM. The Director of the Pharmacy said the dose range alert was not live (turned on), it was inactivated (turned off) when the automated physician ordering system was implemented. The Director of the Pharmacy said if the dose alert had been activated, a pharmacist who saw the out of range dose alert would comment what action they took (when viewing, acknowledging and dispensing a medication with a dose alert) on the intervention screen.

Review of the electronic documentation dated 7/5/11 at 4:48 PM indicated Lamictal 400 mg twice a day, was ordered for Patient #1 and was acknowledged by a pharmacist at 5:21 PM. There was no documentation/comment by a pharmacist that dispensed the medication from the pharmacy that this drug was outside the normal dosing range.