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Based on staff interview and record review the hospital was unable to provide a written contract for care and maintenance of ventilators. This had the potential for inadequate functioning of the ventilators to go unnoticed.

Findings:

During an interview on 7/7/11 at 2:45 p.m. and on 7/13/11 at 2 p.m., Administrative Staff P stated the hospital did not have a written contract with the ventilator company, but had a service agreement as part of the purchase agreement which included a two year warranty. He stated the warranty included a full inspection with preventive maintenance every 10,000 hours per each ventilator, and any repairs of any of the ventilators on as needed basis.

During an interview on 7/13/11 at 1 p.m., Administrative Staff J stated the Biomed Instrumentation Department did the immediate servicing of the ventilators at the hospital along with the regular required maintenance of the ventilators. She stated as far as she knew the service agreement came as part of the purchase agreement, but she was not aware of a written contract with the ventilator company.

The Puritan Bennett All-Inclusive Coverage- Terms and Conditions was received on 7/15/11, after the exit conference, revealed an unsigned service agreement between the vendor and the facility.

Based on observation, interview, and document review, the hospital failed to assure there was a hospital wide Quality Assessment and Performance Improvement Plan, (QAPI), as evidenced by:

1. The hospital's quality assurance program failed to identify and reduce medication errors when the quality program failed to evaluate 3,918 of 3,918 medication discrepancies in order to reduce medication errors.
(See A0266).

2. The hospital's failed to have a process for monitoring the effectiveness of their Root Cause Analysis and to develop an effective Action Plan for ventilator care, following an adverse event that may have contributed to a patient (Patient 11) death. (See 267)



3. The hospital failed to track performance improvement following the administration of IV Labetalol 100 mg. instead administing Ceftriaxone 2 gm, to Patient 21 on 2/16/11. (See A0290)


4. The hospital failed to provide oversight and performance improvement
of contracted services to ensure that they had a contract with the vendor and the ventilators had the necessary equipment and were functioning properly. (See A0083)

5. The nursing staff did not evaluate a patient following placement on a ventilatory device for respiratory support that may have directly contributed to a patient's death. (Patient 11). (See A385 and A395.)

6. A respiratory therapist (Respiratory Therapist K) did not check that a ventilator was functioning properly before and after being connected to the ventilator. (See A1151 and A1160)


The cumulative effect of these systemic problems resulted in the hospital's inability to provide effective oversight and prevention of the following areas: medication administration errors, contracted services, ventilator care in the intensive care unit and respiratory care of the ventilated patient. These failures may have directly contributed to two patient deaths and had the potential to effect the health and safety of other patients in the hospital.

Based on interview and document review the hospital quality assurance program failed to identify and reduce medication errors when the quality program failed to evaluate 3,918 of 3,918 medication discrepancies in order to reduce medication errors.

Findings:

Automated dispensing cabinet (ADC) medication discrepancies are when the count of the medication is different from what is expected. This occurs from misuse of the ADC when medications are not correctly placed, taken, or entered into the computer. Discrepancies could indicate that a patient received the wrong medication, extra dose, or missed a dose of medication.

During an interview on 07/14/11 at 9:43 am Administrative Staff A stated that the quality program did not review discrepancies (excludes narcotics). She also stated, referring to Patient 21's medication error which contributed to Patient 21's death, that the nurse grabbed the wrong medication from the ADC which would have caused a discrepancy. She acknowledged that evaluating medications discrepancies would reduce medication errors.

A review of the ADC generated discrepancy report listed discrepancies (excluding narcotics) from 02/17/11 to 07/10/11 indicated that there were 3,918 discrepancies. Each discrepancy had extra doses or missing doses of unaccounted medication.

Based on record review, the facility failed to have a process for monitoring the effectiveness of the Root Cause Analysis and to develop an effective Action Plan for ventilator care, following an adverse event that may have directly contributed to a patient death. (Patient 11).

Findings:

The Quality Improvement/Peer Review document, dated 5/12/11, indicated
a Root Cause Analysis and Action Plan, was developed following the death of Patient 11 while on a ventilator. Action Item #1 indicated a time out procedure and tool was initiated; (there was no explanation of what the tool was). A monitoring tool was developed to audit respiratory therapies documentation with a completion date of 7/31/11. There were no specific indicators that were going to be used for measuring and tracking of the information.

Action #2 indicated that all ventilators would be checked, after being cleaned and a sticker attached indicating that this action had been completed. The plan further specified that Action #2 was ongoing. The plan did not specify how they were going to check and clean the ventilators, and there were no measurable goals and outcomes.

During an interview on 6/30/11, Respiratory Therapist T stated that in the past the ventilator checks done prior to patient use were not necessarily written down.

During an interview on 7/6/11, Administrative Staff J stated the ventilator checks had usually been done from memory, and were not always written down.


Action Item #3 indicated ventilator competency was measured and monitored in the ICU and completed by June 2011. There was no documented evidence of oversight or monitoring of performance improvement post intubation and post extubation provided.

During interviews on 7/7/11 at 2 p.m., when asked about the plan for ventilator safety, Administrative Staff A and Administrative Staff V stated there was now a plan for "time- out" documentation. There were no further quality indicators identified, and no indication of on-going efforts to increase ventilator safety.

Review of the Medical Executive Committee Meeting Minutes, dated 5/16/11, on 7/7/11, indicated that following a discussion of the death of Patient 11 in ICU, a "in-depth Culture of Safety effort" would be re-instituted for all staff under the leadership of Administrative Staff V. The minutes reflected the Medical Executive Committees support of such an effort. "Culture of Safety" was not defined and it was not specified in the Root Cause Analysis dated 5/12/11.

Review, of Department of Medicine, Pulmonary Division Meeting minutes, dated 6/9/11, indicated that the death of Patient 11 on 5/5/11, was a deviation of the standard of practice for nursing and respiratory care. There was no indication that the physician had deviated from the standard of practice, however the minutes refer to future discussion in peer review. The minutes indicated that Administrative Staff J and Administrative Staff V discussed changes to be made in the facility policy for changes in ventilator settings and disconnects.

Based on observation, interview, and record review, the facility failed to track performance and measure improvements in medication administration practice, following changes made in response to a sentinel medication error.

Findings:

During interview, on 7/7/11, Administrative Staff A stated following the accidental administration of IV Labetalol 100 mgm instead Ceftriaxone 2 gm, to Patient 21 on 2/16/11, the hospital immediately changed some medication administration practices.

The changes were: Bar coding was begun when staff removed drugs from the Automated Dispensing Cabinet (ADC). ADC were moved to quieter areas to decrease staff distractions when removing medications. Medications were moved into "cubbie" drawers, a single medication in a compartment, many compartments to the drawer. Only the cubbie with the medication requested pops open.

During observation, on 7/7/11 at 3:30 p.m., in the ICU, one ADC remained in full view, at the nurses station, where distractions could continue. While Administrative Staff U demonstrated the use of a second ADC, in the supply room behind the nurses station, ICU staff came and went from the room.

During interview, on 7/7/11 at 4 p.m., DOP said he had ordered IV Labetalol in small vials and IV Labetalol would no longer be available in 100 mgm multi-dose bottles, however, on 7/12/11 at 4 p.m., a 20 ml multidose bottle of IV Labetalol was observed in the PACU, stored as floor stock. (See A0500).

Based on staff interview and record review the hospital did not ensure that the medical staff was accountable to the governing body for quality of care provided for one patient ( Patient 11), when a physician (Physician I) did not ensure that the ventilator was providing adequate oxygenation for Patient 11, that may have contributed to Patient 11's death.

Findings:

Review of Patient 11's medical record, Physician I's critical care notes, dated 5/5/11, indicated Patient 11, a 52 year old female was admitted to the facility 4/17/11 with multiple diagnoses including respiratory failure due to pneumonia and acute respiratory distress syndrome. Patient 11 was unable to breathe on her own so was placed on a ventilator. Several attempts had been made to wean Patient 11 off the ventilator but had failed. It was stated that Patient 11 had improved in the last couple of days with aggressive chest physiotherapy ( a type of respiratory care used for loosening and removing lung secretions), and that Patient 11 was extubated ( removed from the ventilator). She was placed on bilevel positive airway pressure ( Bi-Pap, a non-invasive form of breathing assistance).

Physician I's Discharge Summary, dated 5/5/11, indicated that Patient 11 had struggled breathing after extubation on 5/5/11 despite being on the Bi-Pap and successfully re-intubated 5/5/11 at 5:08 p.m. Physician I's notes stated Patient 11 tolerated the procedure well , her oxygen levels were greater than 92%, ( normal range - 90% - 100%), blood pressure was stable and she was placed on the ventilator. A chest x-ray was ordered, and ventilator orders were written. The chest x-ray was done at 5:18 p.m. and at that time Patient 11 started to develop bradycardia ( a slowing of the heart rate). At 5:24 p.m., Licensed Nurse L noted the heart rate to be dropping down drastically. When Physician I entered Patient 11's room he noted the oxygen level was 64% and Patient 11 had no pulse. He also noted the ventilator had no waveforms and there was no ventilation of Patient 11. Physician I immediately disconnected Patient 11 from the ventilator and started bag/mask manual ventilations, and a chemical code, (emergency medications were given), was initiated. Despite the emergency medications given, Patient 11 did not improve and after discussion with the physician from Patient 11's health care facility, it was decided not to initiate further life saving measures because of her Do Not Resuscitate status. The code was started at 5:24 p.m., and was called ( ended) at 5:37 p.m. Cause of Death: hypercapnic respiratory failure ( elevated levels of carbon dioxide in the blood due to inadequate ventilation).

During an interview on 6/30/11 at 11 a.m., Physician I stated he and Respiratory Therapist K had listened to Patient 11's lungs immediately following intubation to confirm placement of the endotracheal and he had adjusted the settings on the ventilator and instructed Respiratory Therapist to connect the ventilator. He stated a chest x-ray was ordered and X-ray tech came immediately so he went back out to the desk area to finish charting. Physician I stated usually the respiratory therapist connects the ventilator to the patient and then stays to make sure the ventilator is functioning properly. He stated he usually relied on the respiratory therapists to take care of the ventilators unless there was a problem, then he would be called upon. He stated apparently when radiology came in the room to do the chest x-ray, Respiratory Therapist K left the room, and did not return until the code was called.

Review of the Intensive Care Department Plan of Provision of Care, dated 2011, indicated Physician's responsibilities were to: Monitor patient outcomes to treatment, in addition to writing orders.

During interview, on 7/14/11 at 2:15 p.m., Physician H said that the usual process was that the physician wrote the orders and the respiratory therapist was responsible to connect the ventilator, however "everybody in the room had responsibility".

Based on observation, interview, and record review, the hospital failed to ensure that each patient was evaluated by a registered nurse, that a plan of care was developed for each patient, that medications were administered in accordance with physicians orders and accepted standards of practice as evidenced by:

1. The nursing staff did not evaluate a patient following placement on a ventilatory device for respiratory support that may have directly contributed to a patient's death. (Patient 11). See A395)

2. The nursing staff did not develop or keep current a plan of care for co-existing medical issues including fluid restriction for one patient with the potential for excessive fluid intake and subsequent weight gain. (Patient 1 ). (See A396)

3. The nursing staff did not administer medications in accordance with physician orders resulting in the administration of medication that contributed to a patient's death.(Patient 21)
(See A404).

4. The hospital failed to ensure safe medication usage when a nurse administered intravenous hydration at 31 ml/hr and the physician's orders were for 100 ml/hr. (See A404)

The cumulative effects of these systemic problems resulted in the hospital's inability to provide safe and effective nursing services as follows: to evaluate a patient following placement on a ventilatory device for respiratory support, to develop a nursing plan of care for a patient who required a fluid restriction, physician's orders were not followed and a patient was given Labetolol 100 mg. instead Ceftriaxone 2 gm, and a nurse administer intravenous fluid at 31 ml/hr instead of 100 ml/hr. These failure may have contributed to two patient deaths and had the potential to effect the health and safety of other patients.

Based on staff interviews and facility document review the hospital failed to ensure that nursing services provided on-going assessments, and evaluations in accordance with accepted professional nursing standards of practice, intensive care unit's provision of care and hospital policy for one patient (Patient 11) when: 1. Three intensive care registered nurses did not provide on-going assessments and re-evaluations of Patient 11's respiratory status after intubation and placed on a ventilator; 2. Three ICU RNs did not follow ICU'S plan of provision of care, and the hospital's policy and procedure for post intubation/ ventilator care. These failures may have directly contributed Patient 11's death.

Findings:

Review of Patient 11's medical chart indicated Patient 11, a 52 year old female, was admitted to the hospital 4/17/11, with diagnoses to include respiratory failure due to pneumonia, kidney failure, sepsis and seizure disorder. Patient 11 was unable to breathe on her own and was placed on a ventilator (a mechanical device used to provide artificial ventilations (breaths).

During an interview on 6/30/11, Licensed Nurse L stated Patient 11 had been in the Intensive Care Unit (ICU) since April and had been on a ventilator most of that time, and there had been a few attempts to wean Patient 11 from the ventilator but without success. She stated on 5/5/11 the decision was made to try again to wean Patient 11 off the ventilator, to see if she could breathe on her own. Patient 11 was extubated around 10 a.m., and placed on BI-PAP ( an non-invasive form of breathing assistance) but continued to have difficulty breathing through out the day. The decision was made to re-intubate Patient 11 and put her back on the ventilator. Licensed Nurse L assisted with the intubation since Patient 11's primary nurse ( Licensed Nurse N) was caring for another patient. She stated she gave the medications prior to the intubation. Licensed Nurse L stated Respiratory Therapist K and Physician I (who performed the intubation) and herself were present in the room. the whole procedure took about 5 minutes; Licensed Nurse M and Licensed Nurse N came back into the room, and Licensed Nurse L gave report to Licensed Nurse N. Licensed Nurse L stated she left the room to break the monitor technician at the desk, and the x-ray technician had arrived to do the chest x-ray at 5:18 p.m., to confirm correct placement of the ET tube. At that point everyone left the room while the x-ray was being done. Licensed Staff M and Licensed Staff N returned to the room after the x-ray was done, Physician I was at the desk as well as Licensed Staff L. She stated Respiratory Therapist K had not returned to the room at that time. At 5:20 p.m., she stated Patient 11's cardiac monitor started to alarm indicating Patient 11's heart rate was low, around 40's ( normal rate 60 - 80) and her oxygen level was also low at 60% ( normal ranges 95%-100%). Licensed Nurse L stated she yelled to Licensed Staff N and Licensed Nurse M who were in the room, and when she got no response she and Physician I ran into the room. She stated she looked at the ventilator monitor which read " waiting to connect to patient." no ventilator alarms were sounding, and Patient 11 was a dusky, blue color. Physician I immediately removed the ventilator from Patient 11's ET tube and began manual breathing by bag/mask, and a chemical code was called , (emergency medications were given). The code began at 5:24 p.m. and ended at 5:37 p.m. with the death of Patient 11.

When Licensed Nurse L was asked if she looked at the ventilator monitor, she stated she had not, until she went back into the room at 5:20 p.m. stated that she had given report to Licensed Nurse N right after intubation, and that Respiratory Therapist K was still manually bagging Patient 11 when she left the room. She stated Patient 11 had looked okay right after intubation, with the heart rate in the 80's. She stated the ventilator set up and connecting to the patient is the responsibility of the respiratory therapists, and usually the respiratory therapist will remain in the room post - intubation to monitor the patient and to make sure the ventilator is functioning properly.

When Licensed Nurse L was asked what the nurses' responsibilities were post-intubation, she stated the primary nurse should make sure the chest rises and falls, listen to the lung sounds, observe the ventilator monitor to make sure it is providing ventilations to the patient, observe respiratory wave forms on the monitor, make sure ET tube is secure, make sure oxygen levels are within normal limits.

During an interview on 7/5/11 at 2 p.m., Licensed Nurse M stated he was the Resource Nurse on 5/5/11 and was helping Licensed Nurse N with her other patient around 5 p.m., and then they went into Patient 11's room. The intubation procedure had just been successfully completed, around 5:08 p.m. Present in the room were Physician I, Licensed Nurse L, and Respiratory Therapist K. The x-ray technician arrived to do the chest x-ray and they all left the room while it was being done. Licensed Nurse M stated he and Licensed Nurse N returned to the room to reposition Patient 11. Physician I and Licensed Nurse L came running into the room, as Patient 11's heart rate was low. At that point it was discovered that the ventilator was not working and was on stand by. No one knew where the respiratory therapist went. Licensed Nurse N started suctioning the patient while the doctor disconnected the ventilator and began manual bag/mask breathing for Patient 11. The code was called at around 5:24 p.m., and ended at 5:37 p.m.

When Licensed Nurse M was asked if he had looked at the ventilator monitor or checked to see if Patient 11 was breathing he stated he had not, until Physician I and Licensed Nurse L came back into the room.

When asked what were nurses' responsibility post-intubation, Licensed Nurse M stated to listen to the patients' breath sounds, make sure the ventilator is giving ventilations to the patient, observe the patient's chest for rise and fall, look at the ventilator monitor for respiratory waves, and monitor blood pressure, heart rate, respiratory rate, and oxygen levels.

During an interview on 7/25/11 at 2:45 p.m., Licensed Nurse N stated on 5/5/11 she was the primary nurse for Patient 11. She stated Patient 11 was extubated around 10 a.m. that morning, but continued to struggle breathing throughout the day so the physician decided to re-intubate Patient 11. The intubation was completed at 5:08 p.m. and Respiratory Therapist K connected the patient to the ventilator and radiology arrived immediately after to do the chest x-ray. At that time everyone left the room while the chest x-ray was being done. Licensed Nurse N stated around 5:20 p.m., the alarms at the desk indicated Patient 11' s' heart rate was low as well as her oxygen level. She stated they all rushed back into the room and Physician I noted immediately that the ventilator was on "stand by". She stated a code was called. She stated she had not looked at the ventilator monitor before as she was standing across the room, and had not assessed Patient 11's breathing after the ventilator was connected, but she had listened to Patient 11's lung sounds immediately following the intubation while Respiratory Therapist K was still providing manual breathing for Patient 11.

Review of the Hospital's Critical Care Services - Patient Care Protocol- Respiratory Care Standards, dated 2/2000, indicated the RN/RT were to reassess and document lung sounds before and after procedure, patient's skin color before and after the procedure.

Review of the Hospital's Critical Care Services Patient Care Protocol - Intubation, Assisting with- dated 3/2010, indicated for Registered Nurse( RN), and Respiratory Therapist ( RT), to reassess and document Post- Procedure assessment including pulmonary status and patient response to the procedure.

Review of the Hospital's Patient Care Protocol- In-Patient Assessment, dated 4/16/2009, indicated under V. Specific Procedural Information - Re-assessment of inpatients will be done every shift or any change in patient's condition, prior to and after procedures. Unit-Specific Patient Assessment Guidelines for ICU- post - procedure assessment to be immediate.

Review of the Hospital's ICU Plan of Provision of Care , dated 2001, indicated a RN will complete a patient reassessment at least every 15 minutes and with changes in patient conditions and will assure the patient's safety throughout their stay.

Review of the Respiratory Care Services Manual for the Critical Care Department, dated 3/2008, indicated on page 4, that the patient was to be monitored closely for respratory failure.


Review of Fundamentals of Nursing , Third Edition, Lippincott, 2000; Chapter 11 titled "NURSING ASSESSMENT", indicated the first phase of the nursing process, called assessment, is the collection of data for nursing purposes to assist nurses in the care of the patient. The purpose of assessments includes determining the presence or absence of dysfunction. assessments. Basic assessments include the patient's vital signs; blood pressure, heart rate and respiratory rate, and physical assessments.

Based on staff interview and document review, the hospital failed to ensure nursing staff developed and kept current a nursing care plan for fluid restriction when Patient 1, who had kidney failure and required hemodialysis, was not put on a fluid restriction resulting in a 26.4 lb. weight gain in 3 days with ongoing nausea, vomiting, and shortness of breath with activity.
Findings:

1. Patient 1 was admitted on 7/8/2011 with diagnoses of end stage renal disease on dialysis, and diabetes.

Physician orders dated 7/8/11 for daily weights and fluid restriction 1200 cc in 24 hours.

On 7/13/11 at 10:00 a.m., Patient 1's medical record was reviewed and Administrative Staff E and Licensed Nurse C were interviewed regarding Patient 1's fluid intake. Administrative Staff E stated she was developing a care plan for Patient 1 after patient requested ice chips in the morning meeting. Administrative Staff E stated there was no care plan developed from admission on 7/8/11. Administrative Staff E stated she did not know how the physician ordered fluid restriction was being monitored. Licensed Staff C stated Patient 1 was accessing fluids. She stated she could not document fluid intake because patient was sneaking fluids.

Administrative Staff E stated some RN staff documented fluid intake on the MAR (Medicine Administration Record) and nursing notes.

Review of nursing notes and MAR from admission to 7/13/11 showed no documentation of patient fluid intake.

RD G stated on 7/8/11 at 12:10 a.m. the dietary policy for 1200 cc fluid restriction would be no fluids on the patient tray. Review of the dietary policy on 7/13/11 at 10:30 a.m., showed the remaining allowed fluids will be distributed vie nursing.

Review of the I&O (intake and output) dated 7/8 showed one entry for 120 cc at 1800 hours, 7/9 one entry 100 cc milk and 60 cc at 1600 hours, and 7/10 and 7/11 were blank- no fluid intake was recorded.

The care plan for co-existing medical issued showed a 7/13/11 entry to maintain fluid restriction 1200 cc including ice chips and record on document.

Administrative Staff E and Administrative Staff D stated on 7/13/11 at 10:30 a.m., there was no nursing policy regarding monitoring, documenting fluid intake when fluid restrictions are ordered to ensure physician order for fluid restriction was maintained.

Dialysis Reports indicated the following:
On 7/9/11 Patient 1 weighed 75.4 kg/165.88 lbs. after dialysis. On 7/12/11, Patient 1's pre dialysis weight was 86.8kg/190.96 lbs, a weight gain of 12.0kg/26.4 lbs in three days.

There is a potential of patient gaining weight from excess fluids and medical complications. Going over prescribed fluid allowance can lead to too much fluid building up in patient ' s body between treatments. This build up causes swelling and increases blood pressure, which can increase heart work stress. Too much fluid can build up in the lungs, making it difficult to breathe.
The nursing note dated 7/12/11 timed at 6:15 p.m., stated fluid restriction enforced. Review of nursing note dated 7/12/11 at p.m., showed Patient 1 complaining of nausea and emesis at 1 p.m., and ongoing nausea and short of breath when getting in the wheelchair to go to dialysis at 3 p.m..

Administrative Staff E on 7/13/11 at 11:00 a.m., confirmed there was no system to develop the care plan for co-existing medical conditions like fluid restriction on admission. There was no system to monitor and document co-existing medical conditions like fluid intake on the unit.

In addition, on 7/13/11 at 11:00 a.m., RD G was interviewed regarding the interdisciplinary care plan for the unit. She stated the nutrition care plan was written on the RD note. She stated the nutrition care plan was not integrated in the multidisciplinary care plan in the behavioral unit.

Based on observation, interview, and document review the hospital failed to prepare and administer medications in accordance to accepted standards of practice as evidence by:

1. The hospital failed to ensure that medications were administered in accordance with physician orders when licensed staff administered an antihypertension medication to Patient 21, instead of the prescribed antibiotic which resulted in renal failure and dry gangrene of his feet and two fingers, which contributed to Patient 21's death.

2. The hospital failed to ensure safe medication usage when a nurse administered intravenous hydration at 31 ml/hr and the physician ' s orders were for 100 ml/hr.

3. The hospital failed to ensure safe medication usage in accordance to accepted standards of practice when a physician prepared intravenous Succinylcholine greater then one hour from the time needed to administer.


Findings:

1. Review, on 7/7/11, of Medical Executive Committee Minutes, dated 5/16/11, indicated a "second reportable event had occurred in the ICU", since the beginning of 2011. During interview, on 7/7/11, Administrative Staff A, stated in ICU, on 2/16/11, Patient 21 received a dose of Labetalol, an antihypertensive medication, instead of an antibiotic ordered by the physician

The clinical record for Patient 21 was reviewed on 7/7/11 at 11:30 a.m., and 7/9/11 at 8:30 a.m.

Physician Progress Notes, dated 2/15/11, indicated Patient 21 was admitted on 2/14/11, with a diagnosis of sepsis due to pneumonia. ( a systemic inflammatory response to a usually localized infection.) Patient 21 was treated in the ICU with antibiotics, oxygen therapy, and medications to maintain his blood pressure at normal levels.

Physician Progress Notes, dated 2/16/11 indicated Patient 21 had improved. He was able to maintain a normal blood pressure without medications,

The Intensive Care Flow Record for 2/16/11, indicated that at 3 p.m., Patient 21's blood pressure dropped from 112/65 to 81/42. At 3:30 p.m., Patient 21's blood pressure dropped to 51/30. Patient 21's heart rate also dropped, from the 90's to the 50's. (Normal blood pressure range from 90/60-130/80. Severely low blood pressure reduces blood flow which, in turn, reduces the supply of oxygen and nutrients to the brain, kidneys, and other organs.)

Patient 21 was intubated and placed on a ventilator, to support respirations, and medications were restarted to raise Patient 21's blood pressure. Three hours later, at 6 p.m., Patient 21's blood pressure had finally reached 133/82.

During an interview, on 7/7/11, Administrative Staff A said at approximately 7 p.m., on 2/16/11, Licensed Nurse Q discovered an empty bottle of Labetalol 100 milligrams (mgm), an antihypertensive medication, hanging attached to Patient 21's IV tubing. Administrative Staff A said Licensed Nurse R had pulled the incorrect medication from the Automated Drug Cabinet. Licensed Nurse R was unavailable for interview.

Review of Physician Orders and the Drug Administration Record (MAR), for Patient 21, dated prior and up to 2/16/11, revealed no order for Labetalol, for Patient 2.

Review, of Physician Progress Notes for Patient 21, dated 2/17/11, indicated the dose of Labetalol caused Patient 21 to develop prolonged low blood pressure and heart rate which resulted in cardiovascular shock. The observation that Patient 21 had stopped making urine, and changes in blood tests, indicated Patient 21 was in acute renal, (kidney), failure, due to the prolonged low blood pressure.

Review of of Physician Progress Notes, dated 2/18/11, indicated that Patient 21's liver function blood tests continued to deteriorate indicating his liver had also been affected by the prolonged period of low blood pressure, resulting in shock liver, (ischemic hepatitis).

Physicians Progress Notes, dated 2/20/11, indicated that hemodialysis was started for continuing renal failure. Hemodialysis is a procedure for removing metabolic waste products from the bloodstream by filtering the blood through a dialysis machine.

A Vascular Surgery Consult Note, also dated 2/20/11, indicated Patient 21 was discovered to have purple to blue discoloration to the base of the toes, approaching mid foot, of both lower extremities. The consultation indicated Patient 21 had only one pulse in the left lower extremity. Additionally, Patient 21 had discoloration in the fingertips of the left hand, all signs of impending gangrene, (death of soft tissue).

Review, of a Neurology Consultation report, dated 2/21/11, indicated Patient 21 was fully alert but had was confused, and had poor attention and concentration, likely due to the lack of oxygen he sustained, and also due to the build up of toxic elements due to kidney failure and shock liver.

Physician Progress Notes, dated 2/23/11 to 2/26/11, indicated Patient 21's confusion was less, and blood tests indicated liver function was improving. However, Patient 21 continued to require hemodialysis for kidney failure. The discoloration of Patient 21's fingers and toes continued.

Physician Progress Notes, dated 2/26/11, indicated that Patient 21 could not bear weight because of the pain in his gangrenous toes.

During a Psychosocial Assessment dated 3/1/11, Patient 21 rated his emotional pain as 10, (on a scale of 0-10), about 98% of the time. Physician Progress Notes, also dated 3/1/11, indicated Patient 21 required IV Dilaudid to control the pain of his gangrenous toes and fingers. Patient 21 and his family discussed withdrawal of care with the physician.

Review of Physician Progress Notes, dated 3/3/11, indicated Patient 21 expressed the wish to just go to sleep. Faced with a lifetime of continued dialysis, and with increasing pain from gangrenous toes and fingers, Patient 21 and his family decided to stop all treatment. Patient 21 died on 3/3/11.

During observation and concurrent interview, on 7/7/11 at 4 p.m., bottles of Labetalol and Ceftriaxone were seen to be approximately the same size. The Labetalol was a liquid and the Ceftriaxone was a powder, which would require mixing with a liquid before administration. The labels were different colors, Labetalol pink, the Ceftriaxone was blue. The Labetalol bottle had the name of the drug clearly printed, as well as the dose, on the left side of the label on a light colored background. The Ceftriaxone name was printed with smaller letters while the dose was printed in larger letters inside a colored circle.

Administrative Staff U said Labetalol was only given IV in small doses. The Director of Pharmacy concurred and said Labetalol was only given IV push, in small increments, not as a drip, as had been done.

Review of the facility Housewide Clinical Manual Patient Care Protocol entitled Medication Administration, last revised 8/10, indicated on page 4, step 8, the facility staff would observe the five rights of medication administration: "the right drug to the right patient...".

Licensed Nurse R failed to follow the hospital Patient Care Protocol for Medication Administration.


26917

2. On 07/12/11 at 3:07 pm it was observed in the post operative anesthesia care unit (PACU) Patient 2 was on intravenous (IV) fluids without an IV pump. In order to determine the rate you would have to count drops and calculate the rate. The observed calculated rate was 31 ml/hr. The clinical record indicated there were physician ' s orders for 100 ml/hr. Nurse 2 stated the rate was 50 ml/hr.

The IV fluids were not administered in accordance to physician ' s orders.

3. According to the United States Pharmacopeia (USP) Chapter 797 Pharmaceutical
Compounding-Sterile Preparations, a nationally recognized resource, indicates that medications that are prepared outside of an IV hood (ISO class 5) setting should be administered one hour from the completed preparation.

According to the Association for Professionals in Infection Control (APIC), a nationally recognized professional organization, in the entitled document APIC position paper: Safe injection, infusion, and medication vial practices in heath care indicates " The APIC does not support the advance preparation (the night before or hours before administration) of immediate-use IV bags or syringes. The APIC supports the practice of preparing parenteral medications as close as possible to the time of administration ...ASEPTIC TECHNIQUE: IN LESS THAN AN ISO 5 ENVIRONMENT ...Never store or transport syringes in clothing or pockets ...Prepare syringes as close to administration as feasible "

During an interview on 07/13/11 at 3:59 pm Physician 1 stated it was his practice to prepare IV Succinylcholine (anesthesia medication) in a syringe in the morning and then use it when he needed to start a procedure. It was then observed that he proceeded to take out of his pocket a prepared syringe of Succinylcholine. He then stated he carried it in his shirt pocket and would often administer hours after preparing the syringe.

Based on record review, document review, and interview, the hospital failed to ensure that all medical entries were legible, dated, and timed in 4 of 22 records reviewed, potentially interfering with accurate evaluation of the patients by staff.

Findings:

Review of 22 medical records on 7/11/11 and 7/12/11 demonstrated that the records of Patients 31, 33, and 52 contained illegible entries. Patient 31's preoperative history and physical (H&P) report contained multiple illegible entries. Patient 33's preoperatiove H&P report contained multiple illegible entries. Patient 52's preoperative H&P report contained multiple illegible entries.

Review of Patient 34's record on 7/12/11 demonstated that it contained four untimed progress notes.

Review of the hospital's medical staff rules and regulations on 7/13/11 demonstrated the requirement that the hospital and the attending physician "shall be responsible in the area of their respective responsibility for the preparation of a complete, accurate and legible medical record for each patient."

On 7/13/11 at 11:00 am, Administrative Staff A acknowledged that the records of Patients 31, 33, and 52 contained illegible entries.

Based on medical record review and document review, the hospital failed to ensure that all orders, including verbal orders, were dated, timed, and authenticated by the ordering practitioner in 2 of 22 records reviewed.

Findings:

On 7/12/11, review of the records of Patients 33 and 34 demonstrated that Patient 33's record contained two unauthenticated verbal orders and Patient 34's record contained one untimed and unauthenticated order.

Review of the hospital's rules and regulations on 7/13/11 demonstrated the requirement that "all orders shall be written or typed and signed, dated, and timed" and "all verbal orders shall be authenticated by the responsible practitioner or the attending physician within 48 hours."

Based on observation, interviews and document reviews the hospital failed to ensure the provision of pharmaceutical services and care that meets the needs of the patients as evidenced by:

1. The hospital medication error reduction program did not review a sentinel medication error which contributed to Patient 21's death when the program did not review for over a five month period a medication error in which a nurse misused the automated dispensing cabinet and administered Labetalol instead of Ceftriaxone (see A500).

2. The hospital pharmacy failed to account for medication discrepancies in the automated dispensing cabinet which would indicate misuse and/or medication errors (extra doses, missing doses administered or wrong medication given) when 3,918 of 3,918 discrepancies over a five month period were not accounted for by the pharmacy (see A 500, A266).

3. The hospital pharmacy failed to ensure the safe preparation and administration of emergency medications for the neonatal emergency code cart when hospital approved neonatal emergency medication protocols were not available for use (see A500).

4. The hospital pharmacy failed to account for intravenous Labetalol, a high alert medication, when the pharmacy distributed Labetalol from the automated dispensing cabinets and then hospital staff restored Labetalol as floor stock (see A500).

5. The hospital failed to ensure safe medication usage when nurse administered intravenous hydration at 31 ml/hr and the physician ' s orders were for 100 ml/hr (see A404).

6. The hospital failed to ensure safe medication usage in accordance to accepted standards of practice when a physician prepared intravenous Succinycholine greater then one hour from the time needed to administer (see A404).

The cumulative effects of these systemic problems resulted in the hospital's inability to provide pharmaceutical services and care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Pharmaceutical Services.







27533

Based on observation, interview, and document review the hospital pharmacy failed to control medications consistent with standards of practice in order to provide patient safety as evidence by:

1. The hospital medication error reduction program did not review a sentinel medication error which contributed to Patient 21's death when the program did not review for over a five month period a medication error in which a nurse misused the automated dispensing cabinet and administered Labetalol instead of Ceftriaxone.

2. The hospital pharmacy failed to account for medication discrepancies (missing and extra doses) in the automated dispensing cabinet which would indicate misuse and/or medication errors (extra doses, missing doses administered or wrong dose given) when 3,918 of 3,918 discrepancies over a five month period were not accounted.

3. The hospital pharmacy failed to ensure the safe preparation and administration of emergency medications for the neonatal emergency code cart when hospital approved neonatal emergency medication protocols were not available for use.

4. The hospital pharmacy failed to account for intravenous (IV) Labetalol, a high alert medication, when the pharmacy distributed IV Labetalol from the automated dispensing cabinets and then hospital staff restocked IV Labetalol as floor stock.

Findings:

1. According to the Institute of Safe Medication Practice (ISMP), a nationally recognized medication resource which focuses on medication error prevention and safe medication use, indicates in the entitled document ISMP's List of High Alert Medications, " High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. We hope you will use this list to determine which medications require special safeguards to reduce the risk of errors."The list includes Labetalol a medication which is used to lower blood pressure.

A review of clinical record indicated Patient 21 was 82 years of age. He was admitted to the hospital for sepsis (bacterial blood infection) secondary to pneumonia. He had physician orders for intravenous (IV) Ceftriaxone 2 gms every 24 hours for sepsis and pneumonia. On 02/16/11 a nurse administered IV Labetalol 100 mgm instead of IV Ceftriaxone 2 gm.

During an interview on 07/14/11 at 11:03 a.m., Administrative Staff A stated Patient 21, prior to the medication error, showed signs of improvement in symptoms of sepsis and pneumonia. After the medication error, Patient 1 had showed signs of significant decline which resulted in dialysis and then death.

The medication error reduction program (MERP) is a pharmacy run quality program. The MERP 's primary purpose is to reduce medication errors.

In an interview on 07/14/11 at 9:59 a.m., the DOP stated the MERP had not discussed Patient 21's medication error. He also stated there was no documentation in the minutes that Patient 21's medication error was reviewed and evaluated by the MERP.

The hospital did not provide evidence indicating that the MERP reviewed Patient 21's medication error. The MERP had not reviewed or evaluated Patient 21's medication error which occurred 5 months ago.

2. An automated dispensing cabinet (ADC) is a computerized medication dispensing machine. The ADC is similar to a vending machine in that the user enters what they want and the machine opens dispensing the product. There are several different types of ADCs one type that will be further discussed is the open matrix drawer ADC. These ADCs have a drawer that opens up with several open pockets for the user to pick the product from one of the pockets.

An interview on 07/12/11 at 9:33 a.m., the DOP stated Patient 21's med error was partly due to the misuse of the matrix ADC. He said that the nurse had taken the wrong medication (Labetalol instead of Ceftriaxone) from the matrix ADC. The nurse had taken from the wrong pocket.

ADC medication discrepancies are when the count of the medication is different from what is expected. This occurs from misuse of the ADC when medications are not correctly placed, taken, or entered into the computer. Discrepancies also occur when there are medication errors for example Patient 21's medication error would have showed a discrepancy of an extra dose of Ceftriaxone and a missing dose of Labetalol. Discrepancies could indicate that a patient received the wrong medication, extra dose, or missed a dose of medication.

During an interview on 07/12/11 at 10:00 a.m., the DOP stated that the pharmacy did not review discrepancies (excluding narcotics). He also stated that discrepancies could indicate medication errors and misuse of ADCs. He said for Patient 21 there was a discrepancy of an extra dose of Ceftriaxone and a missing dose of Labetalol. He also said that he could generate a discrepancy report; these discrepancies were not reviewed for med errors by the pharmacy.

A review of the ADC generated discrepancy report listed discrepancies (excluding narcotics) from 02/17/11 to 07/10/11 indicated there were 3,918 discrepancies. Each discrepancy had one or more extra doses; or one or more missing doses.

The day after Patient 21's medication error until 07/10/11 the pharmacy had not accounted for 3,918 medication discrepancies which would have indicated further medication related errors.

3. In an interview on 07/13/11 at 3:09 p.m., the DOP stated that the neonatal emergency crash carts should have an emergency medication protocol sheet attached to the cart. The sheet would be used during an emergency to ensure appropriate medication doses for a neonate.

An observation on 07/13/11 at 3:09 p.m., in the antepartum nursing unit of the neonatal emergency crash cart there was no neonatal emergency medication protocol sheet. The sheet was not found on or around the crash cart.

An observation on 07/13/11 at 3:30 pm it was observed in the neonatal intensive care unit (NICU) an emergency medication protocol sheet attached to the cart. The DOP stated that the sheet was not approved by the pharmacy and therapeutics committee. He said it was not a hospital approved sheet. RN B stated that the sheet did not reflect the most current guidelines.

A review of the emergency medication protocol sheet entitled Medications for Neonatal Resuscitation indicated the sheet was based on the Nursing Resuscitation Program (NRP) guidelines 2006. The sheet was not based on the most up to date NRP guidelines. The most recent NRP guidelines are 2010.

4. It was observed on 07/12/11 at 4:00 p.m., in the post operative anesthesia care unit (PACU) nursing unit cabinet a 20 ml vial of Labetalol. The Labetalol vial was being stored as floor stock.

During an interview on 07/12/11 at 4:00 p.m., the DOP stated all the PACU medications were dispensed through the ADC and the Labetalol should not be in the cabinet as floor stock. He also stated that the pharmacy was not aware of the Labetalol vial stored as floor stock. He said someone must have taken the vial out of the ADC and then stored it in the cabinet.

The pharmacy could not account for Labetalol, a high alert medication, found as floor stock.

Based on medical record review and document review, the hospital failed to ensure that the operative report was written or dictated immediately following one patient's surgery.

Findings:

Record review on 7/11/11 demonstrated that Patient 33 underwent a surgical procedure on 6/16/11, but the medical record was absent a report of the operation describing techniques and findings.

In interview on 7/13/11 at 10:30 am, Administrative Staff A confirmed that the medical record department had not received Patient 33's dictated operative report.

On 7/13/11, review of the hospital's medical staff rules and regulations demonstrated that "all operations performed shall be fully described by the operating surgeon ... or dictated immediately following the procedure." "The full operative report must be dictated within 24 hours after surgery."

Based on observation, staff interviews, and review of facility documents, the hospital failed to ensure the following:

1) Patient 11 needs were met with acceptable standards of practice and in a safe environment when a respiratory therapist (Respiratory Therapist K) did not check that a ventilator was functioning properly before and after being connected to the ventilator.

2. Provide re-assessments and on-going monitoring of Patient 11's respiratory status post-intubation, according to the hospital's Patient Care Protocol. The respiratory therapist did not provide continued documentation of respiratory care given, including the intubation procedure and Patient 11's response to the procedure. These failures may have directly contributed to Patient 11's death.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the health and safety of a patient that required respiratory care in accordance with acceptable standards of practice.

Based on observation, staff interviews, and review of facility documents, the hospital failed to ensure one patient's needs ( Patient 11) were met with acceptable standards of practice and in a safe environment when a respiratory therapist ( Respiratory Therapist K): 1. Did not check that a ventilator was functioning properly before and after being connected to Patient 11. 2. Provide re-assessments and on-going monitoring of Patient 11's respiratory status post-intubation, according to the hospital's Patient Care Protocol. 3. Did not provide continued documentation of respiratory care given, including the intubation procedure and Patient 11's response to the procedure. These failures may have directly contributed to Patient 11's death.

Findings:

Review of Patient 11's medical chart on 6/30/11, indicated Patient 11, a 52 year old female, was admitted to the facility on 4/17/11, with diagnoses including respiratory failure due to pneumonia, kidney failure, seizure disorder, sepsis, and required to be placed on a ventilator ( a mechanical device used to provide artificial ventilations ( breaths) as she was unable to breathe on her own.

During an interview on 6/30/11 at 10 a.m., Administrative Staff A stated on 5/5/11 at 5:08 p.m., Patient 11, who was unable to breath on her own, was intubated ( meaning an endotracheal tube was placed into the trachea via the mouth to provide an open airway), and a ventilator was connected to the endotracheal tube following the verification of correct placement of the endotracheal tube by the physician and the respiratory therapist. The following staff were present in the room during the procedure: three Intensive Care Registered Nurses (RN's), ( Licensed Staff L, Licensed Staff M, and Licensed Staff N); a respiratory therapist ( Respiratory Therapist K), and a physician ( Licensed Physician I, who performed the intubation.). A chest x-ray was ordered to confirm additional correct placement of the endotracheal tube. At 5:18 p.m., when the x-ray technician came to the room , the staff left the room while the chest x-ray was being taken. Licensed Staff N and Licensed Staff M returned to the room to reposition Patient 11 after the chest x-ray was done. Licensed Staff L and Licensed Physician I returned to the Nurses's Station. It was unclear where Respiratory Therapist K had gone.

At 5:20 p.m. Patient 11's cardiac monitor alarmed . The monitor was reading Patient 11's heart rate to be low, in the 40's ( normal range 60 - 80's) and her oxygen levels were about 60% ( normal range- 95% - 100%). Licensed Staff L and Physician I, who were at the desk ran to the room and noted the ventilator monitor screen said "waiting to be connected to patient," which meant the ventilator was on "Stand By" and was not providing breaths to Patient 11. Physician I immediately disconnected the ventilator from the endotracheal tube and initiated bag/mask manual breathing, and a chemical code was called ( only emergency medications were given). The code was started at 5:24 p.m. and ended at 5:37 p.m. resulting in Patient 11's death.

During an interview on 6/30/11 at 10:45 a.m., Licensed Staff L stated when the decision was made to intubate Patient 11 on 5/5/11 at 5 p.m., the primary nurse, Licensed Staff N was busy with her other patient so Licensed Staff L assisted with the intubation. Licensed Staff L stated the intubation went well, she then gave report to Licensed Staff N who had returned to the room. Licensed Staff L stated when she left the room Respiratory Therapist K was taping the endotracheal tube( ET ) and then connected the ventilator to the ET tube. She stated at that point the x-ray technician had arrived to do a chest Xray, so they left the room including Respiratory Therapist K. Licensed Staff L stated she did not know where the Respiratory Therapist K went, and she did not see him again until 5:20 - 5:24 p.m., when they called the code. Licensed Staff L stated she had not looked at the ventilator monitor until she returned to the room at 5:20 p.m. She stated it was then she looked at the monitor and saw no respiratory wave forms and the monitor read" waiting to be connected to patient". She also stated none of the ventilator alarms had sounded which indicated to her that the ventilator was not working. Licensed Staff L stated the respiratory therapists are responsible for the functioning of the ventilators, including setting the alarms.

During an interview on 6/30/11 at 10:15 a.m., Physician I stated after Patient 11 was intubated, he and Respiratory Therapist K checked the lung sounds and checked the carbon dioxide ( CO2) monitor and every thing was okay so he instructed Respiratory Therapist K to connect the ventilator to Patient 11's ET tube. Physician I stated he then left the room, and went back to the desk to complete his charting. Physician I stated he did not look at the ventilator monitor at that time. He stated usually the respiratory therapists stays in the room to make sure the ventilator is functioning properly.

During additional interview on 6/30/11, Administrative Staff A stated Respiratory Therapist K no longer worked at the hospital. Several attempts( 6/30/11, 7/5/11 and 7/22/11) were made by telephone to contact Respiratory Therapist K without success.

Administrative Staff A stated on 5/6/11 the ventilator in question was examined by the hospital's Biomed engineers and the company who serviced the ventilators and was found to be in good working condition.

During an interview on 7/7/11, Administrative Staff J stated their own investigation revealed
the thermometer probe had been removed from the ventilator and the tubing had not been recapped which alerted the ventilator to go on stand by mode.

During observation on 7/7/11, Administrative Staff J demonstrated how the ventilators are checked for proper functioning, it was noted that when the cap was open on the thermometer probe tubing, the ventilator stopped and the monitor repeatedly flashed in large yellow letters, "waiting to connect to patient"

When Administrative Staff J was asked if there was a ventilator check off sheet used when the ventilators were checked prior to use, she stated before the incident with Patient 11 the check off was done by memory.

Review of the Respiratory Therapist flow sheet for Patient 11 dated 5/5/11, indicated Respiratory Therapist K's only documentation was at 7:30 a.m., 5/5/11. No other documentation was found.

During interview on 7/5/11 at 10 a.m., Respiratory Therapist O stated they are required to document on the respiratory flow sheet, and the ventilator flow sheet every two hours and as needed. This was confirmed also by Administrative Staff J, who stated she did not know why Respiratory Therapist K had only documented once on 5/5/11.

Review of the Hospital's Critical Care Patient Care Protocol for Assisting with Intubation, dated 3/2010, page 2, indicated that pre-procedure and post -procedure assessments should be documented and also the patient's response to the procedure, as well as re-assessments of pulmonary, cardiovascular, and neurological status. No timeframes for re-assessment were specified in the document.