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Based on record review and interviews, the hospital failed to follow its policy for obtaining informed consent for treatment, do not resuscitate, anesthesia, and blood administration by having incomplete consents, consents not witnessed, and absence of patient signature on the consent for 6 of 6 emergency department patients from a total sample of 35 patients (#5, #6, #7, #8, #14, #15), 2 of 4 patients receiving blood from a total sample of 35 patients (#17, #22), 2 of 2 patients with an order for do not resuscitate from a total sample of 35 patients (#17, #22), and 1 of 12 surgery charts reviewed for completed anesthesia consents from a total sample of 35 patients (#35). Findings:

Consent for treatment:
Review of the "Emergency Room Record" of Patients #5, #6, #7, and #8 revealed they presented for treatment on 12/20/10. Further review revealed Patients #5, #6, #7, and #8 signed their consent with no documented evidence of the time the consent was signed. Further review revealed no documented evidence of a witness to the patients' signatures.

Review of the "Emergency Room Record" of Patient #14 revealed he presented to the ED (emergency department) on 12/18/10. Further review revealed Patient #14 signed his consent with no documented evidence of the time the consent was signed and no documented evidence of a witness to Patient #14's signature.

Review of the "Emergency Room Record" of Patient #15 revealed Patient #15 presented to the ED on 12/16/10. Review of the section of the consent titled "signature of patient" revealed notation of "pt. (patient) refused". The witness section was signed with initials with no documented evidence of the name or title of the individual signing as a witness.

In a face-to-face interview on 12/20/10 at 11:20am, ED RN (registered nurse) Manager S15 indicated the ED staff do not witness any ED consents if a patient was able to sign for themself.

Consent for blood administration:
Patient #17
Review of Patient #17's medical record revealed she was admitted on 12/05/10 with diagnoses of cardiac arrest, respiratory failure, anoxic brain injury, chronic obstructive pulmonary disease, hypertension, hepatitic C virus, and congestive heart failure. Review of the "Physician's Orders" revealed an order on 12/05/10 at 1200 (12:00pm) to type and cross match two units PRBCs (packed red blood cells) and then transfuse each over two hours.
Review of Patient #17's "Transfusion of Blood and Blood Components" consent revealed no documented evidence of the signature of Patient #17 or her representative, and the physician signed and timed the consent on 12/06/10 at 9:30am, the day after the blood was administered. Further review revealed no documented evidence the following sections were completed as evidenced by a blank line: description, nature of the treatment / procedure; patient's diagnosis, description of the nature of the condition or ailment for which the medical treatment, surgical procedure or other therapy described in item number 2 is indicated and recommended; and the physician / provider authorized to administer or perform the medical treatment, surgical procedures or other therapy in item 2.

Patient #22
Review of Patient #22's medical record revealed he presented to the ED on 10/30/10 with complaints of altered mental status with a temperature of 103 degrees and a history of hepatitis C, diabetes mellitus, hypertension, and hypothyroidism. Review of Patient #22's "Physician's Orders" revealed an order on 10/31/10 at 8:25am to type and match two units PRBC and transfuse one unit now.
Review of Patient #22's "Transfusion of Blood and Blood Components" consent revealed in the section titled "patient or person authorized to consent" a notation of "emergency" with no documented evidence of the date and time it was witnessed by the RN. Further review revealed the physician signed the consent on 10/31/10 with no documented evidence of the time the physician signed the consent. Further review revealed no documented evidence the following sections were completed as evidenced by a blank line: description, nature of the treatment / procedure; patient's diagnosis, description of the nature of the condition or ailment for which the medical treatment, surgical procedure or other therapy described in item number 2 is indicated and recommended; and the physician / provider authorized to administer or perform the medical treatment, surgical procedures or other therapy in item 2.

Do Not Resuscitate:
Patient #17
Review of Patient #17's medical record revealed she was admitted on 12/05/10 with diagnoses of cardiac arrest, respiratory failure, anoxic brain injury, chronic obstructive pulmonary disease, hypertension, hepatitic C virus, and congestive heart failure.
Review of the "Physician's Orders" signed by Physician S22 on 12/07/10 at 11:00am revealed an order for "Do Not Resuscitate".
Review of Patient #17's "Progress Notes" revealed an entry by Physician S22 on 12/07/10 of "discuss with family poor prognosis, will make DNR (do not resuscitate)". Further review revealed no documented evidence of the time the entry was written and the names and relationship of the family members with whom Physician S22 spoke regarding Patient #17's poor prognosis.

Patient #22
Review of Patient #22's medical record revealed he presented to the ED on 10/30/10 with complaints of altered mental status with a temperature of 103 degrees and a history of hepatitis C, diabetes mellitus, hypertension, and hypothyroidism. Review of his admit orders revealed diagnoses of severe sepsis, diabetes mellitus, hepatitis C virus, cirrhosis, and acute confusional state. Review of the physician orders revealed an order on 11/01/10 at 6:10pm by Physician S23 for "Do Not Resuscitate".
Review of the physician progress notes revealed an entry on 11/01/10 at 6:10pm by Physician S23 of "case discussed with pt sister who would like pt to be made DNR - transition to hospice care". Further review revealed no documented evidence of the name of the sister and the number of siblings who had to consent for the DNR order as stated in hospital policy.

Patient #28
Review of the medical for Patient #28 revealed she was admitted to the hospital on 12/06/10 with complaints of abdominal pain with a history of Sickle Cell Anemia. Further review revealed upon examination the patient exhibited rebound tenderness and a decision was made to perform an exploratory laparotomy to see if there was any abdominal bleeding.

Review of the " Patient Consent to Medical Treatment or Surgical Treatment for Intravenous Injection of Radiopaque Contrast Media (Both ionic and nonionic) " dated 12/07/10 by the physician revealed no documented evidence of the date/time the document had been signed by the patient or that the patient ' s signature had been witnessed.

In a face-to-face interview on 12/22/10 at 11:10am, Director of Nursing S20 could offer no explanation for the consent policy not being implemented for consents for treatment, blood administration, and do not resuscitate.

Review of the hospital policy titled "Consents", policy number 06-13-002, revised 08/08, and submitted by ED RN Manager S15 as their current policy for consents, revealed, in part, "...The General Consent for Medical Treatment is signed when a patient presents to the facility for emergency services or is admitted to the facility. ... This consent provides consent for reasonable and necessary services including, but not limited to: 1) Emergency cases 2) Administration of approved drugs 3) Nursing care... The witness to the consent shall be hospital personnel. Two (2) witnesses are required for a "mark", if patient is unable to write. ...Special Situations 1. Emergency Consent a. In an emergency situation, when the patient or someone authorized to consent for the patient is not able or available to give written, telephone, facsimile, or email consent, two licensed independent practitioners must sign the consent. The nature of the emergency must be documented in the patient's progress notes. ...Transfusion of blood or Blood Components ... a. Transfusion of blood or blood components shall be obtained only in the case of probability of the need for transfusion as determined by the physician / surgeon. ... Persons who may consent to medical or surgical treatment: 1. Any adult for himself 2. The judicially appointed tutor or curator of the patient, if one has been appointed. 3. An agent acting pursuant to a valid mandate, specifically authorizing the agent to make health care decisions 4. The patient's spouse not judicially separated. 5. An adult child of the patient. 6. Any parent, whether adult or minor, for his minor child. 7. The patient's sibling. 8. The patient's other ascendants or descendants. 9. Any person temporarily standing in loco parentis, whether formally serving or not, for the minor under his care and any guardian for his ward. ... Consent shall be implied where an emergency exists. The physician shall document the nature of the emergency in the medical record. 12. If there is more than one person within the above named class in section 7 a, the consent for surgical or medical treatment shall be given by a majority of those members of the class available for consultation...".

Review of the hospital policy titled "Blood Administration", policy number 06-08-001, revised 06/10, and submitted by administration as their current policy for blood administration, revealed, in part, "...Transfusion of Blood and Blood Components Consent Form ... is required prior to administration (see Consent policy). If more than one unit may be transfused, the consent must indicate multiple transfusions...".

Review of the hospital policy titled "No Code - Do Not Resuscitate", policy number 06-13-001, revised 12/98, and submitted by administration as their current policy for do not resuscitate, revealed, in part, "...There should exist adequate communication among those involved in the patient's care. ... When the patient is incompetent, this decision will be reached consensually by the appropriate family member(s) and physician. If a competent patient disagrees or, in the care of an incompetent patient, the family member(s) disagrees, a DNR order will not be implemented. 5. A DNR position should not be taken until extensive measures have been taken to contact responsible family members...".

Consent for Anesthesia:
Review of the medical record for Patient #35 revealed she was admitted to the hospital on 09/12/10 with the diagnosis of a perforated duodenal ulcer. Review of the medical record revealed the patient was sent to surgery on 09/12/10 at 4:00p.m. for an emergency exploratory laparotomy. Further review revealed the patient received general anesthesia during the surgical procedure.

Review of Patient #35's preoperative checklist revealed, in part, "4. Anesthesia/Moderate Sedation Consent Signed, Dated, Timed and Witnessed- C. Operating Room Circulating Nurse- Emergency Consent". Review of the entire medical record revealed no documented evidence that an emergency consent for anesthesia was obtained.

In interview on 12/22/10 at 10:30a.m. CRNA Supervisor, S18, indicated that 2 physicians should sign a consent for the emergency administration of anesthesia. S18 further indicated that if 2 physician's signatures cannot be obtained prior to the emergency surgery, then a progress note should be written by the anesthesia provider regarding why the anesthesia consent was waived. Review of the entire medical record revealed no documented evidence of a progress note written by the anesthesia provider regarding why the consent was waived.

Review of the hospital policy titled "Consents", policy number 06-13-002, revised 08/08, and submitted by ED RN Manager S15 as their current policy for consents, revealed, in part, "Special Situations 1. Emergency Consent a. In an emergency situation, when the patient or someone authorized to consent for the patient is not able or available to give written, telephone, facsimile, or email consent, two licensed independent practitioners must sign the consent. The nature of the emergency must be documented in the patient's progress notes."

Review of the hospital policy titled "Obtaining Anesthesia Consent", effective 05/07, revealed, in part, "II. Policy: 4. Emergency cases also require consent, but in those circumstances where the patient is unable to respond or understand, the consent may be waived". Further review revealed the policy failed to address obtaining emergency consent with the signature of two licensed independent practioners and documenting the nature of the emergency in the patient's progress notes.

Based on record review and interview the Registered Nurse failed to supervise and evaluate the nursing care for each patient by failing to assess a patient after a change in status including disorientation, low blood pressure and seizure activity. This was evident by finding the patient unresponsive, pulseless and rigid 1 hour and 40 minutes after the change in the patient's condition. (Patient #4) Findings:

The medical record for Patient #4 was reviewed. Documentation revealed Patient #4, 56 year old male, was admitted on 11/12/2010 and expired on 11/13/2010. Review of the Emergency Room Record revealed Patient #4 presented to the hospital Emergency Department (ED) with history of intractable nausea and vomiting and some diarrhea. The patient had a colonoscopy to rule out volvulus, while in the ED, and the Final Diagnosis was Ileus and Intractable Vomiting. Patient #4 was transferred to the Medical/Surgical unit (2 North) 11/12/10 2010 (8:10pm) .
The nursing assessment documentation on the 7p to 7a shift 11/13/10 at 1:52 am revealed the patient was hysterical and stated his nerves were bad and he's shaking. The Registered Nurse (RN) documented the patient was not shaking and he was oriented back to correct state of mind. There was no documented evidence of system assessments or vital signs. At 1:59am the RN documented the patient vomited 30cc of liquid and his skin was clammy and cool to touch. The patient was administered Zofran 4 mg IV for nausea. There was no documented evidence of system assessments or vital signs.
S8, Nurse Manager Medical/Surgical Unit (2 North) was interviewed face to face on 11/21/10 at 11am. She reviewed the record for Patient #4 and confirmed there was no documented evidence of system assessments or vital signs after the patient's change in mental and physical status.
The Nursing Assessment dated and timed 11/13/10 12:40 (12:40pm) revealed the patient's brother and wife stated Patient #4 was having a seizure. Patient #4's blood pressure (B/P) reading was documented as 95/75, Pulse 95 and Respiration Rate 18. The Patient was trembling in bed clinching fist tightly. Further documentation revealed the patient's brother indicated Patient #4 was an alcoholic and substance abuser. Further the physician was notified at 12:55pm and orders were received for Banana Bag and Ativan. The Registered Nurse (RN) documented at 1337 (1:37pm) the Patient was in bed with eyes closed with his wife at the bedside. There was no documented evidence of a follow up assessment of the patient's vital signs including the B/P, Pulse and rate of respirations. Documentation at 14:20 (2:20pm) (1 hour and 40 minutes after the abnormal BP reading), revealed the RN entered the room and found Patient #4 lying still with eye's closed and fist clenched. Attempts were made to verbally arouse the patient but he was unresponsive to verbal stimuli. The carotid pulse was unattainable and a code was called and chest compressions started. The patient was pronounced dead at 1435 (2:35pm).

The Death Summary dated 11/13/10 5:57pm and signed by the physician was reviewed. Documentation revealed in part, "The patient was seen by the entire primary team at approximately 10:30am on 11/13/10. The patient again was in stable condition and tolerating his care very comfortably and very well. The patient was still NPO (nothing by mouth). The patient had not passed any flatus at that time and had not had a bowel movement at that time. The patient was instructed to ambulate if possible to aid in passing out flatus as well a bowel movement. At approximately 12:30pm the MD was called by the nurse saying that the patient's family had relayed the message that the patient was a long time alcohol user and abuser and needed to be mentioned to the MD staff and team. Therefore it was mentioned to the MD and at that time, an order was made to place the patient on Ativan 0.5mg IVq 6 hr. daily to prevent delirium tremens and at that time, it was noted that the patient had very mild tremors to bilateral hands. No other vital sign changes were noted. The patient was given fluids as well as previous order as mentioned. There were no signs of hypotension, bradycardia or oxygen desaturation. At this time it was discussed with the nurse that if any changes in the vital or any worsening condition present that the MD should be called. So again the patient was in stable condition, tolerating care very well with no questions or complaints at this time. At approximately 14:20 (2:20pm) the medicine hospital team, the code blue team was called to the bedside for code blue. The patient was found to be in asystole. The patient received 2 amps each of epinephrine and atropine. The patient received approximately 20 minutes of chest compressions. The patient was still without pulse and still in asystole per the note of the code blue team. Compressions were continued by the staff. The time of death was noted at 14:35". (2:35pm)
S1, MD Surgery Resident was interviewed face to face on 12/20/10 at 3:25pm. S1 reviewed the medical record for Patient #4. S1 indicated he had been consulted to evaluate Patient #4 in the ED on 11/12/10 for a massively distended colon and a colonoscopy was done to rule out a colonic volvulus. Findings were significant for a pseudo obstruction but no sigmoid volvulus or obstruction was noted. Further Patient #4 was left NPO and admitted for observation. Further he had seen the patient on 11/13/10 in the am and his abdomen was soft and not distended. Further he had been called to a code in the pm and noted the patient was stiff and did not look like he had just coded. Further Patient #4 was asystole, no respirations and no verbal response.
S2, RN was interviewed face to face on 12/20/10 at 3:45pm. S2 indicated she had been assigned to Patient #4 from 7a to 7p on 11/13/10. Further her date of employment was 3 months prior to the assignment and she received her RN license 10/2010. Further on 11/13/10 at 8:35am she had received a critical lab value potassium chloride level (KCL) of 2.9 and had informed the MD and received orders for oral and intravenous (IV) potassium. The patient at this time was off the unit for an x-ray and the order was changed at 11:30am by the physician. Further she had been told by the patient's brother the patient had a history of alcohol/substance abuse and seizures. Further she had taken Patient #4's blood pressure at 12:40pm and it was 95/75; he was clinching is fists and was disoriented. Further she had notified the patient's physician and had hung a bag of Lactated Ringers and KCL. The Lactated Ringers was to be given bolus at 999ml/hour and the KCL at 125ml per hour which she initiated at 1337 (1:37pm) (57 minutes after the assessment for the BP of 95/75 and changes in physical and mental status). At this time as she hung the IV fluids the patient's wife indicated to her Patient #4 was sleeping so she thought by observation he was sleeping and she had not repeated the assessment of the patient's vital signs. S2 confirmed at 2:20pm she returned to patient #4's room and he was unresponsive, stiff and did not have a pulse. Further the patient's wife was in the bathroom. S2 indicated she began chest compressions and a Code Blue was called.
S8, Nurse Manager for the Medical/Surgical Unit (2 North) was interviewed face to face on 11/21/10 at 11am. She confirmed there was no reassessment of Patient 4's vital signs and systems after the reported BP of 95/75 and change in the patient status of clinched fists, trembling and disorientation. Further she indicated the hospital policy is to perform assessments as often as necessary.
Review Review of the Policy entitled Vital Signs #06-03-003 presented as the hospital's current policy revealed in part, "Purpose: A. To assure standardization, and clarification. B. To assess patient's condition on admission, to determine baseline values for future comparisons, to detect as early as possible any deviation in patient's status and to communicate with other members of the health team observations relative to the patient's well being. Policy: B. Routine vital signs shall be monitored and recorded in the patient's medical record every 12 hours unless the physician requests increased frequency or patient's condition warrants more frequent assessment/reassessment. D. The physician's order/unit standard/nursing judgment may include pulse oximetry and orthostatatic testing as routine part of the patient's vital signs".
Review of the hospital policy entitled Charting and Documentation System #06-03-002 presented as the hospital's current policy revealed in part, "V. Reassessments will be continuous and ongoing and will be based upon outstanding nursing diagnosis, problems, need and goals. Time frames for reassessment of patients are as follows 5. As often as necessary according to change in condition or progress toward goal outcomes."

Based on record review and interview the hospital failed to: 1) ensure that the nursing staff developed a care plan that included past history of alcohol abuse and seizures for 1 of 35 sampled patients. (Patient # (4); 2) ensure blood was administered per physician's orders as evidenced by 2 patients with orders for blood to be given over a 2 hour period receiving blood over 2 1/2 hours (#28) and within 45 minutes (#17) and 2 patients with no ordered time receiving blood in 2 hours 15 minutes (#22) and 3 hours 30 minutes (#34) for 4 of 4 patient reviewed with orders for blood from a total of 35 sampled patients; 3) ensure incentive spirometer treatments were performed as ordered by the physician as evidenced by no documented evidence any incentive spirometer treatments were performed by the patient or staff (#33) for 1 of 1 patients with orders for incentive spirometry out of 35 sampled patients; 4) ensure a care plan was developed to include altered nutrition for a patient with a mandibular abscess who had ben assessed as a high risk for nutrition (#33) for 1 of 1 nutritional high risk patients out of 35 sampled patients; and 5) ensure a respiratory treatment was given as ordered as evidenced by a patient (#34) with a diagnosis of empyema failing to receive Spiriva for 1 of 1 patients with Spiriva ordered of 35 sampled patients. Findings:

1) ensure that the nursing staff developed a care plan that included past history of alcohol abuse and seizures
The medical record for Patient #4 was reviewed. Review of the Emergency Room (ER) record dated 03/18/08 revealed an admit with presenting problems for seizures, alcohol abuse and admitting diagnosis of alcohol withdrawal. Review of the ER record dated 07/03/09 revealed "+(positive) Chronic Alcoholic". Review of the ER record dated 08/17/09 revealed Past Medical History Chronic Seizures; Social History 1/5 whiskey." Review of the ER record dated 11/12/10 revealed Patient #4 presented to the ER with complaint of nausea and vomiting, history of crohn's and reports of a fall and complaint of knee pain. Social History revealed ETOH (alcohol) every other day). Further documentation revealed a colonoscopy was done in the ER with Final diagnosis 1) Ileus 2) Intractable vomiting.
Review of the Moderate Sedation Flowsheet dated 11/12/10 revealed "Abuse: Substance "Alcohol every other day" .Review of the Admission Assessment dated 11/12/10 2016 (8:16pm) and completed by the RN revealed, Drinks Alcohol "Yes" was checked "Type beer Last drink yesterday evening 11/11/10."

Review of the Plan of Care dated 11/12/10 revealed Patient #4's past history of Seizure Disorder, with a potential for seizures, and Alcohol Abuse, with a potential for alchohol withdrawal, was not identified.

S8, Nurse Manager of 2-North was interviewed face to face on 12/21/10 at 11am. She reviewed the record or Patient #4 and confirmed Seizure Disorder and Alcohol Abuse was not care planned.

Review of the policy entitled Charting and Documentation System #06-03-00, presented as the hospital's current policy, revealed in part, "R. The Admission assessment, which includes the completion of the admission assessment record, initiation of Nursing care plan and physical assessment shall be completed by a registered nurse within the following time framed: 1. Medical/Surgical units-initiated upon admission and complete within twenty-four (24) hours. 28. Nursing Care Plan: a. Initiated upon admission by the Registered Nurse based upon data from Admission Assessment Record, physical assessment and Medical Plan of Care. b. Determine long term goal at time of admission and update as indicated during the patient's hospitalization. (RN, LPN)."


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2) ensure blood was administered per physician's orders
Patient #17
Review of Patient #17's medical record revealed she was admitted on 12/05/10 with diagnoses of cardiac arrest, respiratory failure, anoxic brain injury, chronic obstructive pulmonary disease, hypertension, hepatitis C virus, and congestive heart failure. Review of the "Physician's Orders" for 12/05/10 at 12:00pm revealed an order to type and cross match two units of packed red blood cells and transfuse each over 2 hours.
Review of Patient #17's "Patient Transfusion Record" revealed the second unit of packed RBCs was initiated on 12/05/10 at 7:00pm and completed at 7:45pm which indicated the blood was administered over 45 minutes rather than 2 hours as ordered. Further review revealed no documented evidence of the time of the pre-transfusion, 15 minute, and post transfusion vital signs.

Patient #22
Review of Patient #22's medical record revealed he presented to the ED on 10/30/10 with complaints of altered mental status with a temperature of 103 degrees and a history of hepatitis C, diabetes mellitus, hypertension, and hypothyroidism. Review of his admit orders revealed diagnoses of severe sepsis, diabetes mellitus, hepatitis C virus, cirrhosis, and acute confusional state. Review of the "Physician's Orders" for 10/31/10 at 8:25am revealed an order to type and match two units of packed red blood cells and transfuse one unit now.
Review of Patient #22's "Patient Transfusion Record" revealed the first unit of blood was initiated on 10/31/10 at 10:38am and completed at 12:58pm which indicated the blood was administered over 2 hours and 20 minutes rather than 4 hours as required by hospital policy. Further review revealed Patient #22 received a second unit of packed red blood cells on 10/31/10 at 4:00pm which was completed at 6:10pm which indicated the blood was administered over 2 hours and 10 minutes rather than 4 hours as required by hospital policy. Further review revealed no documented evidence of the time of the pre-transfusion, 15 minute, and post transfusion vital signs.

Patient #28
Review of the medical for Patient #28 revealed she was admitted to the hospital on 12/06/10 with complaints of abdominal pain with a history of Sickle Cell Anemia. Review of the Physician's Orders dated/timed 12/06/10 at 2005 (8:05pm) revealed an order to type and match 4 units of PRBC (Packed Red Blood Cells) leukocyte reduced and transfuse 2 units - each over ii (two) hours.

Review of the Patient Transfusion Record for Patient #28 revealed Unit #1 of PRBC was hung at 2445 (12:45am) and completed at 0315 (3:15am) which indicated the blood was given over a time period of 2 1/2 hours. Further review revealed Unit #2 was hung at 0335 (3:45am) and completed at 0615 (6:15am) which indicated the blood was given over a time period of 21/2 hours.

Patient #34
Review of Patient #34's medical record revealed he was admitted on 12/20/10 with diagnoses of pleural effusion and hypoxemia. Review of the "Physician's Orders" for 12/21/10 at 3:00pm revealed an order to transfuse two units of packed red blood cells.
Review of Patient #34's "Patient Transfusion Record" revealed the first unit of blood was initiated on 12/21/10 at 3:15pm and completed at 5:30pm which indicated the blood was administered over 2 hours and 15 minutes rather than 4 hours as required by hospital policy. Further review revealed the second unit of blood was initiated at 5:30pm and completed at 9:00pm which indicated the blood was administered over 3 hours and 30 minutes rather than 4 hours as required by hospital policy. Further review revealed no documented evidence of the time of the pre-transfusion, 15 minute, and post transfusion vital signs.

Review of Policy Number: 06-08-001 last revised 06/10 and submitted as the one currently in use revealed.....P. Regulate flow rate according to physician's order. Documentation: K. Vital signs, blood pressure, pulse, respiration, temperature a. pre-transfusion, b. 15 minute and c. post transfusion. Further review revealed no documented evidence requiring the times the vital signs were taken to ensure performance within the specified timeframes. U. A unit of blood or blood components should be infused within four hours following the initiation of administration". Further review revealed no documented evidence addressing a physician's order which does not specify a time period for the infusion of blood.

In a face to face interview on 12/22/10 at 11:15am Director of Nursing, S20, could offer no explanation as to why the orders had not been carried out by the nursing staff for the administration of blood.


3) ensure incentive spirometer treatments were performed as ordered by the physician
Review of the Review of the medical for Patient #28 revealed she was admitted to the hospital on 12/06/10 with complaints of abdominal pain with a history of Sickle Cell Anemia. Further review revealed an exploratory laparotomy was performed on 12/07/10.

Review of the Physician's Orders dated 12/07/10 at 1455 (2:55pm) when Patient #28 was transferred back to the nursing floor after surgery, revealed an order for incentive spirometer 10x ' s/hr (ten times per hour).

Review of the OB/Gyn Nursing Flow Sheet dated 12/07/10, 12/09/10 and 12/10/10 in the section titled "Treatments - Incentive Spirometer revealed no documented evidence the patient had been educated or assessed for understanding for incentive spirometry. Further review of the nursing narrative notes for 12/07/10- 12/10/10 revealed no documented evidence incentive spirometry had been performed either by the patient or the nursing staff.

4) ensure a care plan was developed to include altered nutrition
Review of the medical record for Patient #33 revealed she was admitted to the hospital on 12/06/10 with an abscess of the right mandible with osteomyelitis. Further review revealed she had an I&D (Incision and Draining) of the right manibular abscess performed on 12/07/10.

Review of the Inpatient Dietitian Notes dated 12/07/10 for Patient #33 revealed she had been assessed as a nutritional high risk and recommendations were made to her diet to advance diet after surgery as tolerated to soft.

Review of the Plan of Care for Patient #33 dated 12/06/10 revealed no documented evidence altered nutrition had been identified as a potential problem. Further review revealed no documented evidence the care plan had been updated after the nutritional consult had been performed.

In a face to face interview on 12/22/10 at 11:15am Director of Nursing, S20, could offer no explanation as to why the care plans were not revised according to the needs of the patients.

5) ensure a respiratory treatment was given as ordered
Patient #34
Review of Patient #34's medical record revealed he was admitted on 12/20/10 with diagnoses of pleural effusion and hypoxemia. Review of the "Physician's Orders" revealed the following:
12/20/10 at 12:00pm - Atrovent neb treatment four times a day; Spiriva inhaler every day;
12/21/10 at 8:25am - discontinue Atrovent nebs and Spiriva inhalers; start Duoneb now every 6 hours; and 12/21/10 at 3:00pm - new orders after surgery: respiratory treatment with Albuterol 2.5 mg inhalation every 6 hours; Atrovent 0.5 inhalation every 6 hours.

Review of the MAR (Medication Administration Record) for Patient #34 revealed the following: 12/20/10 - no documented evidence Spiriva inhalant administered; Atrovent ordered to be given at 1800 (6:00pm) administered at 2009 (8:09pm) two hours late and 12/21/10 - Albuterol 2.5mg inhalant 1st dose ordered at 3:00pm administered at 1922 (7:22pm) four hours after it had been ordered.

In a face to face interview on 12/22/10 at 10:35am Respiratory Manager S17 indicated that new orders are sent through the computer system and sometimes there is a "lag" time in the Pharmacy receiving the orders. The pharmacist has to verify the order and then enter the order into the Pyxis system. Further S17 indicated the codes such as "per protocol" and "Patient preference" which appear on the MAR are computer generated and could not explain the meaning. S17 indicated he was not aware of problems with respiratory treatments not given on time.



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Based on personnel record review and interview the hospital failed to assign the nursing care of each patient in accordance with the patient's needs by failing to ensure a Registered Nurse was retrained and confirmed competent prior to reassignment for use of the Alaris Pump for 1 of 9 personnel records reviewed. (S2, RN). Findings:

The medical record for Patient #4 was reviewed. Documentation revealed Patient #4, 56 year old male, was admitted on 11/12/2010 and expired on 11/13/2010. Review of the Emergency Room Record revealed Patient #4 presented to the hospital Emergency Department (ED) with history of intractable nausea and vomiting and some diarrhea. The patient had a colonoscopy while in the ED and the Final Diagnosis was Ileus and Intractable Vomiting. Patient #4 was transferred to the Medical/Surgical unit (2 North) 11/12/10 2010 (8:10pm).

The Nursing Assessment dated and timed 11/13/10 0835 (8:35am) revealed the RN documented a critical lab value of 2.9 and the MD was notified while on the unit at this time. Review of the Physician's Orders dated 11/13/10 11:30am revealed an order for KCL 20 meq IV x 1.

The Nursing Assessment dated and timed 11/13/10 12:40pm revealed the patient's brother and wife stated Patient #4 was having a seizure. Patient #4's blood pressure (B/P) reading was documented as 95/75, Pulse 95 and Respiration Rate 18. The Patient was trembling in bed clinching fist tightly. Further documentation revealed the patient's brother indicted Patient #4 was an alcoholic and substance abuser. The physician was informed at 12:55pm and orders were given.

Review of the Physician's Order dated 11/13/10 1325 (1:25PM) revealed an order for Bolus of LR (Lactated Ringers) x 1 liter and Ativan 0.5mg IV.

Review of the Medication Administration Record 11/13/2010 revealed Potassium Chloride 20 meq in sodium chloride 0.9 % ML Rate 125ML/HR (rate of flow determine by pharmacy as per policy) was documented as administered. This was initialed by S2, RN as started at 1:37pm.

The Nursing Assessments dated 11/13/10 were reviewed. The following events were documented.
1:37pm;. Order for Potassium Chloride 20 meq in 250ml N/S Normal Saline (no rate documented) IV times 1 and carried out
1:39pm Verbal Order for LR bolus. Times 1 noted and carried out.

S1, MD was interviewed face to face on 12.20/10 at 3:25pm. S1 confirmed he was familiar with the case of Patient #4. Further he had responded to a code on 11/13/10 when Patient #4 was found non responsive and pulse less. Further S2, RN was upset because she thought she had bolused the Potassium Chloride, ordered at 125ml per hour, by accident instead of the LR.

S2, RN was interviewed face to face on 12/20/10 at 3:45pm. S2 indicated she had informed the physician of the critical Potassium value of 2.9 at 8:35am and got orders for Oral and IV KCL and also LRs for patient's history of alcohol abuse and possible alcohol withdrawal. Further the IV KCL was suppose to be started by pump at 125ml per hr and the LR was to be bolused at 999cc/hr which she started at 1:37pm. Further when she had gone to check on the patient at 2:20pm, about 45 minutes after hanging the fluids, she found the patient unresponsive and she noted the KCL had been bolused by gravity instead of 125 ml per hr. Further S2 stated she had put the KCL on the pole as a secondary line then decided to run the LR first since it was a bolus. Further she had forgotten to clamp off the KCL when she started the LR. Further the LR bag had about 200cc's more in the bag which could have indicated the KCL in Normal Saline had gone directly into the LR bag. Further the KCL in Normal Saline bag was empty. Further S2 indicated the physician does not always order the rate of flow for KCL in Normal Saline but the pharmacist sets the rate of flow.

S11, RN House Supervisor was interviewed per telephone on 12/21/10 at 9:40am. S11 indicated she had responded to a code on 2 North on 11/13/10 and when she spoke with S2 she indicated S2, RN thought she had done something wrong and had infused the KCL by gravity instead of the 125ml per hour. Further S11 indicated she had observed the KCL bag and it was empty and the LR looked like it had about 750cc remaining. Further S11 indicated the KCL was not on the pump and she had informed S2 she should have all the lines on a pump.

S6, Program Manager was interviewed face to face on 12/21/10 at 10:35am. S6 indicated the code occurred on 11/13/10, Saturday, and she was called by S11, House Supervisor regarding the incident. S11 indicated S2 RN had informed S11 she thought she had hurt a patient by failing to clamp the KCL and administering via gravity instead of by the pump. Further a Safety Occurrence Report was completed by S2 on 11/13/10. S6 indicated she had investigated the incident and spoke with quality but a sentinel event was not triggered and the event was not considered a medication error but rather an error in the method of medication administration. Further it was determined the KCL was a piggy back set up and the LR was the primary tubing and the KCL looked as though it had backed up into the primary tubing into the LR bag and the KCL would have been even more diluted. Further S6 indicated QA indicators were not implemented to track and trend IV administration because the event was not a system error. Further S2, RN was educated on the use of the pump but she could not present documented evidence of the training or confirmation of her competence in the use of the Alaris Pump and the administration of KCL solution.

The personnel record for S2, RN was reviewed. There was no documented evidence S2 was counseled, educated, retrained and confirmed competent regarding the use of the Alaris Pump or the method for the administration of the KCL.

Review of the Safety Occurrence Report dated and timed 11/13/10 14:20 (2:20pm) and completed by S2, RN revealed in part, "Brief Factual Description. A 1000ml bag of Lactated Ringers hung to be given at bolus rate. A 250 ml of NS with 20 meq of KCL piggy, backed into the primary line to be given after bolus of LR complete. The secondary line was unclamped. The 250ml NS with KCL infused by gravity into the primary line of LR."

Based on observation, record review, and interviews, the hospital failed to ensure drugs and biologicals were stored in a secure area by: 1) having IV and chemotherapy fluids stored in an unlocked medication room and 2) having needles, syringes, and bags of 50 ml (milliliters), 100 ml, and 250 ml intravenous fluids stored on an open shelf in the ED (emergency department) that was accessible to the public. Findings:

1) Having IV and chemotherapy fluids stored in an unlocked medication room:
During observation on 12/20/10 at 10:20am the following was observed. A medication room, assessable to the pubic hallway, on 2-North was observed unlocked and unattended. Approximately 15 1000 cc bags of 0.9% Normal saline; 25 1000cc bags of Lactated Ringers and 1 bag of Chemotherapy 2000cc, labeled handle with care, were stored in the unlocked medication room. This finding was confirmed by S13, RN who indicated the coded lock should lock automatically when staff exit the medication room.

S8, RN was interviewed on 12/20/10 at 10:30am S8 attempted to lock the door but was able to open the door without using a code. S8 indicated the lock was not functioning and she would put in a work order to have it fixed.

Review of the hospital policy entitled "Drug Distribution and Storage" Policy #18-03-10-15 presented as the hospital's current policy was reviewed. Documentation revealed in part, "Medication shall be prepared and stored under conditions that ensure product stability, security and safety".

2) Having needles, syringes, and bags of 50 ml (milliliters), 100 ml, and 250 ml intravenous fluids stored on an open shelf in the ED (emergency department) that was accessible to the public:


25065

Observation of the ED on 12/20/10 at 10:20am revealed a shelf containing intravenous fluids used to dilute medications to be administered intravenously. Further observation revealed the shelf was located in a hallway that faced patient cubicles surrounded by cloth curtains where patients and family members waited for treatment. There were 25 bags containing 50 ml of NaCl (sodium chloride) 0.9 % (per cent), 42 bags containing 100 ml of D5W (dextrose 5% in water), 19 bags containing 100 ml NaCl 0.9%, 7 bags containing 250 ml NaCl 0.9%, and 8 bags containing 250 ml D5W.

In a face-to-face interview on 12/20/10 at 10:20am, ED RN (registered nurse) Manager S15 confirmed she could not ensure the integrity of the fluids that were accessible to the public.

Observation of the ED on 12/20/10 at 10:40am revealed an open cart that contained drawers used to store lab draw supplies, needles, and syringes. Further observation revealed the cart was located next to an area of patient treatment cubicles that were enclosed with drawn curtains. There was no visible staff present to ensure the security and integrity of the supplies.

In a face-to-face interview on 12/20/10 at 10:40am, ED RN Manager S15 indicated family members were allowed behind the curtains in the treatment area with patients. She further indicated the computer area across the hall from the open cart was used by physicians and staff for charting. She confirmed there was no visible staff present to ensure the security of the needles and syringes stored in the open, unlocked cart that was accessible to the public.

In a face-to-face interview on 12/21/10 at 1:20pm, Director of Pharmacy S3 indicated intravenous fluids should be kept in the plastic wrap, because there could be evaporation of fluids.

In a face-to-face interview on 12/21/10 at 1:40pm, Inpatient Pharmacy Director S4 indicated intravenous fluids should be kept in their plastic wrap and should be locked and secure. He further indicated needles and syringes should be secured.

Review of the hospital policy titled "Purchasing And Inventory", policy number 18-03-10-15 and submitted by Director of Pharmacy S3 as their current policy for the security of medications, revealed, in part, "...Purpose: To provide guidelines for the distribution, storage, return, and disposing of drugs. ...Storage of drugs at room temperature on units 1. Medication shall be stored in Pyxis when possible. 2. Medication which can not be stored in Pyxis shall be stored in a locked secured area with the key stored in Pyxis. ... Storage if IV (intravenous) fluids 1. IV fluids shall be stored in an air conditions area...".

Based on observation, interview and record review the hospital failed to ensure 1) the short table in the delivery room suites maintained their sterility after they were opened as evidence by having sterile covered tables in empty labor and delivery suites that were not attended by staff. 2) Staff physicians received annual Tuberculin screening (TB) for 1 of 9 physician files reviewed. Findings:

1. An observation was made on 12/20/2010 at 10:45 a.m. in Suite 3 and 4 on the Labor and Delivery Unit that revealed a short table on the back wall near the patient bed that was covered in a blue sterile drape. Further observation revealed a Vaginal Delivery Instrument Count sheet laying on the bottom shelf of the table that was dated 12/9/10.

An interview was held with S24RN and S25 RN Manager on 12/20/2010 at 10:45 a.m. They both verified the short tables on the back wall and near the patient bed was covered in a blue sterile drapes and contained sterile supplies for a vaginal delivery. S24 RN and S24 RN manager indicated it was hospital practice for the technicians to set up the sterile tables in anticipation for another delivery. They indicated staff were not always present in the Labor and Delivery Suites to ensure the sterility of the instruments on the sterile short tables. S24 RN added the dated documented on the Vaginal Delivry Instrument Count sheet as 12/9/10 should have been documented as 12/19/10.

An interview was held with S9 RN Infection Control on 12/22/2010 at 9:45 a.m about the sterile covered tables in Labor and Delivery Suites 3 and 4. She indicated that it was not good practice for sterile tables to be set up in advance of a delivery. S9 RN added the staff could not ensure the sterility of the field and the supplies on the tables.

Review of the AORN Guidelines for Maintaining a Sterile Field, Recommendation V, revealed, "... 4. A sterile field should be prepared as close as possible to the time of use. The potential for contamination increases with time because dust and other particles present in the ambient environment settle on horizontal surfaces over time. The OR environment can be breached by other vectors, such as insects, that potentially could come into contact with open sterile fields, unobserved, unless the sterile field is monitored. An open sterile field requires continuous visual observation. Direct observation increases the likelihood of detecting a breach in sterility. 5. A Sterile field should not be covered. Although there are no research studies to support or discount the practice, removing a table cover may result in a part of the cover that was below the table level being drawn above the table level or air currents drawing microorganism from a non-sterile area to the sterile field. It is important to continuously monitor all sterile areas for possible contamination..."

Review of the hospital policy titles Delivery Room Set-Up guideline revealed "... D. Sterile table are covered until ready to use. E. Covered sterile table may be rotated from one room to another as necessary..."

2. Review of the Health file for S26 MD revealed he had a Tuberculin screening test (TB) on 12/21/2010. Further review revealed the last TB test that was performed on S26 MD was September 2000.
An interview was held with S9 RN Infection Control. She verified that S26 MD had a TB test on 12/21/2010 and that his last TB skin test had been September 2000. She indicated S25 had received the B.C.G, or bacille Calmette-Guerin, vaccine but added this was not a contraindication to receiving annual TST.
Review of the hospital policy titled Tuberculosis Surveillance Program, Healthcare Workers revealed "... K. A history of B.C.G. does not preclude the TST..."

Based on record review and interview the hospital failed to ensure all patients administered anesthesia received a post-anesthesia evaluation within 48 hours after surgery which included assessment of respiratory function, cardiovascular function, mental status, temperature, pain, presence of nausea and vomiting and post-op hydration according to the current standards of anesthesia care for 5 of 5 surgery charts reviewed out of 35 total sampled medical records. (#23, #26, #27, #28, #29). Findings:

Patient #23
Review of the medical record revealed Patient #23 was admitted to the hospital 10/21/10 after being involved in a MVA (Motor Vehicle Accident) and sustaining a fractured left femur, left closed ankle fracture and left open metatarsal fractures.

Review of the anesthesia record for Patient #23 dated 10/21/10 revealed an I&D (Incision and Drainage) of the left Femur and insertion of an Intramedullary Nail Left Femur was performed. Further review revealed the patient was transferred to PACU (Post-Anesthesia Care Unit) (no time documented) with a blood pressure of 110/60, respirations of 10, pulse of 98, oxygen saturation of 100%, still intubated, no teeth damage, no complications from anesthesia, report given (no documentation of the name of the nurse) and no signature of the CRNA giving report. Further review revealed no documented evidence another assessment of Patient #23 was performed by an anesthesiologist or his/her designee.

Patient #26
Review of the medical record revealed Patient #26 was admitted to the hospital on 12/13/10 via the Emergency Department with complaints of abdominal pain. Further review revealed he was diagnosed with an incarcerated umbilical hernia and consulted by the surgery department who determined immediate surgery was appropriate.

Review of the anesthesia record for Patient #26 revealed a repair of an Incarcerated Umbilical Hernia was performed. Further review revealed the patient was transferred to PACU (no time documented) with a blood pressure of 136/99, respirations of 20, pulse of 97, oxygen saturation of 97%, no teeth damage, no complications from anesthesia, report given with no signature of the CRNA giving report. Further review revealed no documented evidence another assessment of Patient #26 was performed by an anesthesiologist or his/her designee.

Patient #27
Review of the medical record for Patient #27 revealed she was admitted to the outpatient surgery department on 12/17/10 for Right Pars Plana Vitrectomy eye surgery.

Review of the anesthesia record for Patient #27 revealed the patient was transferred to PACU (no time documented) with a blood pressure of 133/89, respirations of 16, pulse of 86, oxygen saturation of 97%, no teeth damage, no complications of anesthesia. Further review revealed no documented evidence another post-anesthesia evaluation of Patient #27 was performed by an anesthesiologist or his/her designee.

Patient #28
Review of the medical record for Patient #28 revealed she was admitted to the hospital on 12/06/10 for abdominal pain and possible bleeding in the abdomen.

Review of the anesthesia record for Patient #28 revealed an Exploratory Laparotomy was performed on 12/02/10 with the post-op findings of a ruptured ovarian cyst. Further review revealed the patient was transferred to PACU with a blood pressure of 121/85, respirations of 24, pulse of 88, oxygen saturation of 99% and with no signature of the CRNA giving report. Further review revealed no documented evidence another assessment of Patient #28 was performed by an anesthesiologist or his/her designee.

Patient #29
Review of the medical record for revealed Patient #29 was admitted to the hospital on 12/06/10 with right facial swelling and pain and was diagnosed with a right draining fistula and osteomyelitis. Further review revealed the plan of care was for debridement and antibiotic therapy.

Review of the anesthesia record for Patient #29 revealed a right mandibular I&D was performed on 12/07/10. Further review revealed the patient was transferred to PACU with a blood pressure of 130/91, respirations of 21, pulse of 96, oxygen saturation of 100%, no teeth damage, no complications from anesthesia, exchanging well, spontaneously, 100mg Fentanyl administered in PACU individual doses. Further review revealed no documented evidence another assessment of Patient #29 was performed by an anesthesiologist or his/her designee.

In a face to face interview on 12/22/10 at 10:30am CRNA Chief, S18, indicated the anesthesia record had recently been changed to include information concerning antibiotic administration. Further, S18 verified the section of the anesthesia record titled "Transferred To" was considered as the post-anesthesia evaluation and verified the form did not include the required information of temperature, airway patency, mental status, pain assessment, presence or absence of nausea/vomiting, post-op hydration and the time the assessment was performed.




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Based on record review and interviews, the hospital failed to ensure respiratory treatments were administered as ordered by the physician as evidenced by no documented evidence of treatments performed as ordered and failure to perform treatments timely for 3 of 4 patients reviewed for respiratory treatments from a total of 35 sampled patients (#17, #33, #34). Findings:

Patient #17
Review of Patient #17's medical record revealed she was admitted on 12/05/10 with diagnoses of cardiac arrest, respiratory failure, anoxic brain injury, chronic obstructive pulmonary disease, hypertension, hepatitis C virus, and congestive heart failure.
Review of Patient #17's "Physician's Orders" of 12/05/10 at 5:59pm revealed an order for Duonebs (Ipratropium - Albuterol 0.5 - 2.5 mg (milligrams) / 3 ml (milliliters) every four hours and Pulmicort nebs twice a day (5 milligrams).
Review of Patient #17's MARs (medication administration record) revealed the following:
12/05/10 - Pulmicort due at 8:00pm given at 11:41pm, 3 hours and 41 minutes after it was due with no documented evidence of a reason it was late or that the physician was notified;
12/06/10 - Duonebs due at 7:30pm were given at 8:27pm, 57 minutes after it was due with the reason documented as "unable to accommodate lead / lag time"; the 11:30pm dose was administered at 3:38am on 12/07/10, 4 hours and 8 minutes after it was due with the late reason documented as "unable to accommodate lead / lag time"; the 3:30am dose of 12/07/10 was documented as omitted with the reason documented as "unable to accommodate lead / lag time"; further review revealed the 11:30pm dose was actually missed; the Pulmicort due at 8:00pm was documented as omitted with the reason of "unable to accommodate lead / lag time";
12/07/10 - Duonebs due at 7:30am was given at 8:54am, 1 hour and 24 minutes after it was due with the reason of "unable to accommodate lead / lag time"; the dose due at 11:30am was given at 1:42pm, 2 hours and 12 minutes after it was due with the reason of "unable to accommodate lead / lag time"; the dose due at 3:30pm was given at 4:48pm, 1 hour and 18 minutes after it was due with the reason documented as "per protocol";
12/08/10 - no documented evidence Pulmicort due at 8:30am was administered and no documented evidence the physician was notified of the missed treatment;
12/09/10 - Duonebs due at 3:30pm were administered at 4:26pm, 56 minutes after it was due with the reason of "unable to accommodate lead / lag time"; the Pulmicort due at 8:30am was given at 7:43am, 17 minutes before it was due to be given with the reason of "unable to accommodate lead / lag time"; no documented evidence the 8:00pm dose of Pulmicort was administered and the physician notified of the missed dose; and
12/10/10 - no documented evidence Duonebs were administered after the 7:30am dose and the physician notified of the missed doses.

Patient #33
Review of the medical record revealed Patient #33 was admitted to the hospital on 11/22/10 with the diagnosis of respiratory failure, a tracheotomy performed and was placed on a ventilator. Review of the Physician ' s Orders dated 11/22/10 revealed an order for Ipratropium-Albuterol 0.5mg-2.5mg/3mL, 3mL nebulizer treatment every 4 hours.

Review of the MAR (Medication Administration Record) for Patient #33 revealed the following:
12/09/10 1530 (3:30pm) administered at 1641 (4:41pm) 1 hour and 11 minutes past due) with the reason given as " Unable to accommodate Lead/Lag time " ; 12/15/10 0730 (7:30am) administered at 0835 (8:35am) 1 hour 5 minutes past due with the reason given as " Unable to accommodate Lead/Lag time " ; 12/15/10 1130 (11:30am) administered at 1314 (1:14pm) 1 hour and 45 minutes past due with the reason given as " Unable to accommodate Lead/Lag time " ; and 12/20/10 1130 (11:30am) administered at 1302 )1:02pm) 1 hour and 32 minutes past due with the reason given as " Unable to accommodate Lead/Lag time " .

Patient #34
Review of Patient #34's medical record revealed he was admitted on 12/20/10 with diagnoses of pleural effusion and hypoxemia. Review of the "Physician's Orders" revealed the following:
12/20/10 at 12:00pm - Atrovent neb treatment four times a day; Spiriva inhaler every day;
12/21/10 at 8:25am - discontinue Atrovent nebs and Spiriva inhalers; start Duoneb now every 6 hours; and 12/21/10 at 3:00pm - new orders after surgery: respiratory treatment with Albuterol 2.5 mg inhalation every 6 hours; Atrovent 0.5 inhalation every 6 hours.

Review of the MAR (Medication Administration Record) for Patient #34 revealed the following: 12/20/10 - no documented evidence Spiriva inhalant administered; Atrovent ordered to be given at 1800 (6:00pm) administered at 2009 (8:09pm) two hours late and 12/21/10 - Albuterol 2.5mg inhalant 1st dose ordered at 3:00pm administered at 1922 (7:22pm) four hours after it had been ordered.

In a face to face interview on 12/22/10 at 10:35am Respiratory Manager S17 indicated that new orders are sent through the computer system and sometimes there is a " lag " time in the Pharmacy receiving the orders. The pharmacist has to verify the order and then enter the order into the Pyxis system. Further S17 indicated the codes such as " per protocol " and " Patient preference " which appear on the MAR are computer generated and could not explain the meaning. S17 indicated he was not aware of problems with respiratory treatments not given on time.

Based on record review and interview the hospital failed to develop indicators for processes of care as evidenced by 1) failing to ensure the Blood Utilization Committee developed indicators to ensure blood was administered in the time ordered by the physician resulting in 4 of 4 blood transfusions reviewed being administered either too fast or too slow and failing to ensure the time patients were assessed had been recorded in the medical record as evidenced by failure to included the time of assessment on the "Blood Transfusion Form" for 4 of 4 blood transfusion patients; 2) failing to ensure Respiratory Services monitored timeliness of respiratory treatments for 3 of 4 patients with respiratory treatments ordered; and 3) failing to ensure Anesthesia Services included post-op assessments performed within 48 hours of administration of anesthesia for 12 of 12 patients reviewed who had received anesthesia and 4) failing to ensure indicators were implemented to track and trend the proper administration of IV fluids after a confirmed error in the method of administration of KCL for 1 of 1 patients reviewed for administration of KCL.

1) failing to ensure the Blood Utilization Committee developed indicators to ensure blood was administered in the time ordered by the physician (See findings in Tag A 0396);

In a face to face interview on 12/22/10 at 11:00am Blood Bank Supervisor S19 indicated the only time monitored in the administration of blood to patients is if the transfusion lasts longer than four hours. Further S19 indicated she performs the audits and does not look at whether the blood had been administered as ordered by the nurse.

2) failing to ensure Respiratory Services monitored timeliness of respiratory treatments (See findings at Tag A1163); and

In a face to face interview on 12/22/10 at 10:35am Respiratory Manager S17 indicated he was not aware of any problems with timeliness of respiratory treatments. Further S17 verified timeliness had not been included as an indicator that was presently being monitored.

3) failing to ensure Anesthesia Services included post-op assessments performed within 48 hours of administration of anesthesia (See findings at Tag A1005).

In a face to face interview on 12/22/10 at 10:30am Chief Certified Registered Nurse Anesthetist S18 indicated the anesthesia record had recently been revised to include antibiotic therapy. Further he verified that at present the space provided for post-anesthesia evaluation does not include all the required assessments nor the time the assessment would be done.

4) failing to ensure indicators were implemented to track and trend the proper administration of IV fluids after a confirmed error in the method of administration of KCL (See findings at Tag A0397)

S6, Program Manager was interviewed face to face on 12/21/10 at 10:35am. S6 indicated the code occurred on 11/13/10, Saturday, and she was called by S11, House Supervisor regarding the incident. S11 indicated S2 RN had informed S11 she thought she had hurt a patient by failing to clamp the KCL and administering via gravity instead of by the pump. Further a Safety Occurrence Report was completed by S2 on 11/13/10. S6 indicated she had investigated the incident and spoke with quality but a sentinel event was not triggered and the event was not considered a medication error but rather an error in the method of medication administration. Further it was determined the KCL was a piggy back set up and the LR was the primary tubing and the KCL looked as though it had backed up into the primary tubing into the LR bag and the KCL would have been even more diluted. Further S6 indicated indicators were not implemented to track and trend IV administration because the event was not a system error.

Surveyor: Aycock, Glenda
Based on record review and interview the hospital failed to ensure medications were administered as ordered as evidence by infusing Potassium Chloride 20 meq in Sodium Chloride 0.9% 250ml by gravity instead 20 meq IV pump at the the rate of 125ml/hr for 1 of 35 sampled patients. (Patient #4) Findings:

The medical record for Patient #4 was reviewed. Documentation revealed Patient #4, 56 year old male, was admitted on 11/12/2010 and expired on 11/13/2010. Review of the Emergency Room Record revealed Patient #4 presented to the hospital Emergency Department (ED) with history of intractable nausea and vomiting and some diarrhea. The patient had a colonoscopy while in the ED and the Final Diagnosis was Ileus and Intractable Vomiting. Patient #4 was transferred to the Medical/Surgical unit (2 North) 11/12/10 2010 (8:10pm) .

Review of routine chemistry for Patient #4 dated 11/12/10 revealed a Potassium level of 3.6 and 11/13/10 of 2.9.

The Nursing Assessment dated and timed 11/13/10 0835 (8:35am) revealed the RN documented a critical lab value of 2.9 and the MD was notified while on the unit at this time. Review of the Physician's Orders dated 11/13/10 11:30am revealed orders for K Dur 40 meg 1 by mouth and KCL 20 meq IV x 1. Review of the Medication Administration Record 11/13/2010 revealed Potassium Chloride 40 meq was administered po at 12:17pm by S2, RN. Review of the Medication Administration Record 11/13/2010 revealed Potassium Chloride 20 meq in sodium chloride 0.9 % ML Rate 125ML/HR (rate of flow determined by pharmacy as per policy) was documented as administered. This was initialed by S2, RN as started at 1:37pm.

The Nursing Assessment dated and timed 11/13/10 12:40pm revealed the patient's brother and wife stated Patient #4 was having a seizure. Patient #4's blood pressure (B/P) reading was documented as 95/75, Pulse 95 and Respiration Rate 18. The Patient was trembling in bed clinching fist tightly. Further documentation revealed the patient's brother indicted Patient #4 was an alcoholic and substance abuser. The physician was informed at 12:55pm and orders were given.

Review of the Physician's Order dated 11/13/10 1325 (1:25PM) revealed an order for Bolus of LR (Lactated Ringers) x 1 liter and Ativan 0.5mg IV.

The Nursing Assessments dated 11/13/10 were reviewed. The following events were documented.
12:17pm; Potassium chloride 40 meq PO was administered.
1:37pm;. Order for Potassium Chloride 20 meq in 250ml N/S Normal Saline (no rate documented) IV times 1 and carried out
1:39pm Verbal Order for LR bolus. Times 1 noted and carried out.

S1, MD was interviewed face to face on 12.20/10 at 3:25pm. S1 confirmed he was familiar with the case of Patient #4. Further he had responded to a code on 11/13/10 when Patient #4 was found non responsive and pulse less. Further S2, RN was upset because she thought she had bolused the Potassium Chloride, ordered at 125ml per hour, by accident instead of the LR. S1,MD indicated he had told S2,RN even if she had bolused the KCl at 999ml/hr it would not have been enough to cause an overdose because of the dilution in 250ml of Normal Saline.

S2, RN was interviewed face to face on 12/20/10 at 3:45pm. S2 indicated she had informed the physician of the critical Potassium value of 2.9 at 8:35am and got orders for Oral and IV KCL and also LRs for patient's history of alcohol abuse and possible alcohol withdrawal. Further the IV KCL was suppose to be started by pump at 125ml per hr and the LR was to be bolused at 999cc/hr which she started at 1:37pm. Further when she had gone to check on the patient at 2:20pm, about 45 minutes later, and found the patient unresponsive she noted the KCL had been bolused by gravity instead of 125 ml per hr. Further S2 stated she had put the KCL on the pole as a secondary line then decided to run the LR first since it was a bolus. Further she had forgot to clamp off the KCL when she started the LR. Further the LR bag had about 200cc's more in the bag which could have indicated the KCL in Normal Saline had gone directly into the LR bag. Further the KCL in Normal Saline bag was empty. Further S2 indicated the physician does not always order the rate of flow for KCL in Normal Saline but the pharmacist sets the rate of flow.

S4, Director of Hospital Pharmacy, was interviewed face to face on 12/21/10 at 8:50am. S4, Director of Hospital Pharmacy indicted the KCL order is entered into the electronic system and defaults to the 20meq per hour and is infused over a 2 hr period. (125ml per hour) This factor is set up in the electronic computer system. Further he indicated this is a pharmacy standard but if a physician makes a request the pharmacy will dispense according to the specific physician request.

S11, RN House Supervisor was interviewed per telephone on 12/21/10 at 9:40am. S11 indicated she had responded to a code on 2 North on 11/13/10 and when she spoke with S2 she indicated S2, RN thought she had done something wrong and had infused the KCL by gravity instead of the 125ml per hour. Further S11 indicated she had observed the KCL bag and it was empty and the LR looked like it had about 750cc remaining. Further S11 indicated the KCL was not on the pump and she had informed S2 she should have all the lines on a pump.

Review of the hospital policy entitled Intravenous Admixtures Policy #18-02-15-10 presented as the hospital's current policy revealed in part, "Potassium Chloride Inj. Limited to concentrations of 20 meq/100ml diluents and an infusion rate of 20 meq/hr."