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Based on interview and record review, the facility failed to follow its grievance policy when it failed to investigate all grievance allegations, and failed to completely investigate the allegations, for two of five grievances reviewed, (grievances of Complainant 2 and Patient 1).

Findings:

1. During a review on July 26, 2011, of the investigation of a health plan complaint submitted to the facility regarding facility treatment of Complainant 2, the complainant felt that the patient received inadequate treatment from a Physician Assistant (PA 3) in the Emergency Department (ED). No evidence was seen that PA 3 was interviewed as part of the complaint investigation.

An interview was conducted with the Patient Advocate on July 26, 2011, at 3:45 p.m. The Patient Advocate reviewed the complaint and stated the chart was reviewed in response to the complaint, but there was no evidence that PA 3 had been interviewed. She stated that PA 3 should have been interviewed as part of the complaint investigation. A response letter to the health plan was sent on June 8, 2011.

2. The grievance regarding the care of Patient 1, sent from the health plan to the facility on April 12, 2011, was reviewed. Patient 1's allegations were related to an inpatient stay February 8, 2011, to February 11, 2011, and subsequent emergency room visits. The allegation related to his inpatient stay was that he found a urinary catheter (a tube extending from the bladder to the outside of the body) uncomfortable, and physicians were "not handling the issue."

The facility's April 12, 2011, written response to the health plan regarding the inpatient stay allegation included excerpts from Patient 1's inpatient medical record indicating the patient complained of discomfort and the physician's statement that he would come to see the patient. In the response to the health plan, the excerpts from the inpatient chart were followed by the sentence, "Case referred to Medical Staff Office for peer review, tracking and trending. Medical record to be provided by the Health Information Department."

The medical record of Patient 1 during his inpatient stay from February 8, 2011, until February 11, 2011, was reviewed. The nursing documentation indicated on February 10, 2011, Patient 1 complained of discomfort related to the urinary catheter, and that the physician had been contacted and stated he (the physician) would come to see the patient. However, there was no documentation that the physician came to see the patient. Patient 1 complained of pain 10/10 (on a scale of one to ten, with ten the highest level of pain) during the night, and was discharged the next day, February 11, 2011, with the catheter still in place.

Patient 1's grievance was reviewed with the Chief Medical Officer, (CMO) on July 28, 2011, at 9 a.m., and he concurred that the physician who stated he would come to see Patient 1, should have gone to assess the patient in response to Patient 1's complaint about discomfort.

During an interview with the Director of Risk Management, (DRM) on July 28, 2011, at 10:30 a.m., she stated the physician who stated he was coming to see the patient in response to his (Patient 1) complaint of discomfort should have gone to assess the patient. The DRM stated the physician who was the object of the inpatient allegation had not been subjected to peer review. She concurred the grievance process had not addressed the inpatient allegation in the complaint.

The facility policy, "Grievance: Customer Complaint" (revised May, 2011), was reviewed on July 29, 2011, and read in part, "A concern is considered resolved when the patient is satisfied with the actions taken on their behalf, or the investigation has been completed, actions taken and the patient has been notified in writing of the grievance investigation and the Committee's conclusions," and "Grievance Committee is responsible for ensuring grievances are managed timely, that investigations are as complete as possible, and that actions and resolutions are appropriate."

Based on interview and record review, the facility failed to ensure that patient advance directives (desires for medical care in the event that they could not speak for themselves) were requested and documented for one of 73 sampled patients (Patient 7). This failed practice had the potential to create the risk that healthcare decisions could be made contrary to the patients' wishes.

Findings:

The medical record of Patient 7 was reviewed on July 25, 2011. The record contained a Patient Self Determination Record which requested information about whether the patient had an advanced directive and other questions related to self-determination, but the form was not completed.

During an interview with NM 2 on July 25, 2011, at 9:45 a.m., she reviewed Patient 7's incomplete "Patient Self Determination Record", and stated that it was to be filled out by the admitting department.

Based on observation, interview, and record review, the facility failed to maintain the personal privacy for one of 73 sampled patients (Patient 58) when the patient was interviewed by an RN in the waiting area off of the elevator on the second floor Women's Center. This failed practice provided the opportunity for other visitors in the waiting area to hear Patient 58's personal medical information.

Findings:

On July 25, 2011, at 2:35 p.m., Patient 58 was observed in the waiting area off of the elevator on the second floor Women's Center being interviewed by RN 5. RN 5 was asking Patient 58 questions to complete the "Women's Services - OB Intake" to include Patient 58's name, the number of pregnancies, number of live children, the date the infant was due, the reason for Patient 58's visit, any current medical problems, and previous cesarean sections (delivery of the infant through the abdomen). There were three other individuals in the waiting area to include another pregnant patient and two visitors. The interview conducted by RN 5 was overheard by individuals waiting in this area and individuals passing through this area.

On July 26, 2011, at 8:20 a.m., an interview was conducted with RN 6. She stated obstetrical patients were "verbally assessed in the waiting area if the patient care rooms were completely full or labor nurses were not available."

On July 26, 2011, at 1:50 p.m., an interview was conducted with RN 7. She stated she would not interview obstetrical patients in the waiting area because it could be a privacy issue. In addition, RN 7 stated she would take the obstetrical patient to a room and interview the patient in private.

The facility policy and procedure titled "Patient's Rights and Responsibilities" reviewed December 2010, indicated "... The patient has the right within the law to personal and informational privacy. Case discussion, consultation, examination and treatment are confidential and should be conducted discreetly. ..."

Based on interview and document review, the facility failed to implement a process for identifying and analyzing adverse events such as the death of one of 73 sampled patients(Patient 3). This failed practice had the potential to create the risk of substandard healthcare for all patients receiving care at the facility.

Findings:

The medical record of Patient 3 was reviewed on July 26, 2011, through August 2, 2011. Patient 3 came to the ED on January 14, 2011, at 9:42 p.m., via ambulance with complaints of weakness and leg pain. The medical record showed that lab samples were obtained, and a critical potassium level of 8.8 mmol/L (normal 3.6-5.1 mmol/L, elevated potassium can cause fatal heart rhythms) was reported on January 15, 2011, at 12:50 a.m. MS 2 provided treatment orders between 1:18 a.m., and 1:20 a.m. However, the medical record showed that the medications were not administered until hours later, from 3 a.m. to 4:30 a.m. Other medication orders were not carried out prior to the patient expiring at 6:20 a.m.

The medical record of Patient 3 also showed that nursing assessments were not documented as frequently as the patient's condition warranted. There was a delay in obtaining a bed for the patient, and nurse communication with the admitting physician was not carried out and documented per physician orders (see A1112).

In an interview with NM 7 on July 26, 2011, at 9:30 a.m., she stated she could not explain the delay in administration of medications to Patient 3. She stated there was no documentation in the progress notes of any delay in the ED receiving the medications, and that the time frame of administering the medications was not acceptable. NM 7 stated the vital signs of Patient 3 at 12:50 a.m. were very concerning, and that waiting until 2:30 a.m. to recheck them was too long. She stated for patients with critical conditions, the vital signs should be checked as often as every 15 minutes.

According to the medical record the ED physician, MS 2, was walking by the bed of Patient 3 in the ED and noted that she had agonal (dying) respirations. Patient 3 was the subject of a code blue (emergency response) at 5:50 a.m., and was pronounced dead at 6:20 a.m.

During an interview with the Chief Nursing Officer, (CNO) on July 27, 2011, at 3:20 p.m., she stated Patient 3's care was sent to the ED for review by that department's nursing leadership. The CNO stated she thought RN 17 had not been documenting the patient's condition because he had difficulty using the new computer system. When asked if RN 17 was provided with additional education regarding use of the computer system, she stated that the nurses had already been educated on the use of the computer system at that time.

Documentation of the interview, dated February 9, 2011, with RN 17 regarding Patient 's care was reviewed on July 27, 2011. RN 17 explained the delays in care given to Patient 3 by saying he was unfamiliar with the new (in place for 10 days) computer system, and that he was very busy the night he cared for Patient 3. He stated he notified the charge (supervising) nurse that he needed assistance, but did not receive adequate assistance.

During an interview with NM 7 on July 26, 2011, at 9:30 a.m., she stated RN 17 was an experienced, detailed and thorough nurse.

A written interview of the charge nurse by NM 7 on February 10, 2011, was reviewed on July 27, 2011. In the interview, the charge nurse on the night of Patient 3's ED stay recalled RN 17 had asked for help several times due to his "heavy assignment."

NM 7, in an interview on July 26, 2011, at 9:30 a.m., was asked regarding processes for nursing oversight in the ED. She stated that the charge nurse provided oversight by making rounds every 4 hours. She stated the charge nurse provided assistance or obtained assistance to meet patient care needs. She was not able to explain why Patient 3's care had not received oversight by the charge nurse.

The facility process for coping with increases in patient care needs in the ED was reviewed with NM 7 on July 26, 2011, at 9:30 a.m. She stated the charge nurse should respond to the need for the patient to be changed to critical status, and for the need for additional nurse time for the patient. NM 7 stated when the charge nurse was unable to provide the required assistance, nursing staff was to go up the chain of command to obtain needed assistance.

In an interview with the CNO, on July 26, 2011, at 10 a.m., she stated that the ED staffing during patient care increases was a process that had been informally in place for a year.

During an interview with the ED Director on July 29, 2011, at 8:45 a.m., she stated that the chain of command had not been activated while Patient 3 was in the ED. She was not able to explain why RN 17 did not activate the chain of command to obtain assistance. She stated that the nurse staffing during Patient 3's stay on January 14, to January 15, 2011, in the ED had not been subject to analysis.

During a review of the facility policy, Patient Flow and Capacity Management: Hospital Wide (revised December, 2010, reviewed March, 2011) on July 29, 2011, conditions that signified a "yellow" status included, "Patients are holding in the ED or Post Anesthesia Care Unit...ED wait time to bed > (greater than) 2 hours." The actions to be taken during a "yellow" status read in part, "Call Emergency bed Huddle after paging Joint Leadership...Charge nurse to take patients...Per Diem (paid by the day) and regular staff to be called in."

During an interview with the CNO on July 29, 2011, at 8:45 a.m., she reviewed hospital records from the night of January 14, 2011, and the morning of January 15, 2011, when Patient 3 was in the ED, and stated that no emergency bed huddle had been held.

The ED quality review committee, (QRC) was given Patient 3's case on February 8, 2011, and asked the single question, "Were orders appropriate and timely?" The QRC decided that orders were appropriate and timely. However, the ED QRC noted a delay in the nurse carrying out the orders. The case was forwarded to the nursing department for review of that issue. The ED quality review committee did not identify the failure to perform and document timely assessments, the failure to obtain a bed within facility time goals, or the failure of the nurse to notify the admitting physician promptly of the patient's worsening respiratory distress.

The May 10, 2011, ED QRC minutes indicated that in response to the delay in medication administration, "the Nurse Manager of ED has educated nursing staff," and the matter was labeled "closed." The content of the education was not described, and there was no monitoring or any other follow-up activity mentioned.

During an interview with the Director Of Regulatory Compliance (DRC) on August 2, 2011, at 11:45 a.m., she stated the facility had two systems for reviewing incidents-the department quality assurance and the risk management/quality management system. She stated that all deaths were reviewed by a quality assurance department nurse, using criteria, to determine if there were quality of care issues, and if triggered by the criteria, the case was reviewed by quality assurance or risk management departments. She stated that all incidents that were the subject of an occurrence notification were reviewed by the risk department.

On July 29, 2011, a review of the facility policy, Occurrence Notification Process, (review date December, 2010), read in part, "An occurrence is any event, which is not consistent with the routine operation of the hospital or the routine care of a particular patient. The results of this event require or could have required (near miss) unexpected medical intervention, unexpected intensity of care, or causes or had the potential to cause an unexpected physical or mental impairment."

The DRC stated on August 2, 2011, at 11:45 a.m., that she hoped an incident that involved delays in assessment and treatment for a patient who subsequently died would be the subject of an occurrence notification.

During an interview with the Director Of Risk Management, (DRM) on August 2, 2011, at 12:30 p.m., she stated no occurrence notification had been filed regarding Patient 3.

During an interview with the Chief Medical Officer, (CMO) and the Medical Director of the ED, they stated that the death of Patient 3 had been reviewed, using criteria, by a QA nurse. The nurse reviewed the care as appropriate, so it was not subject to further review by the quality department, but, as with all deaths in the ED, the case was sent to the ED for quality review by the ED QRC.

On July 27, 2011, the DRC supplied the criteria used by the QA department nurse in the review of patient deaths to determine if quality of care issues occurred. The criteria were listed on a piece of paper, but there was no associated policy, and no evidence of approval by the facility, and no date on the criteria when they were approved or implemented.

The mortality review criteria included: "surgery/invasive procedure within 24 hr of death, death related to healthcare associated infection, hp (history and physical exam) on chart within 24 hrs, If in ICU, was the required consultations obtained?, were consultations done timely?, death report completed by nursing, OPO (organ procurement organization) called within 1 hr of death, coroner's office called, death summary/DC summary by MD within 14 days, pain management addressed appropriately, patient support measures provided, family support measures provided." The mortality review criteria did not have the capability of identifying quality of care problems such as the timeliness or adequacy of nursing assessments, nor the timeliness or correctness of treatments administered, nor nursing failure to notify physician of a change in the patient's condition, nor whether necessary consultations had been obtained in areas other than the ICU, nor for delays in bed availability.

During an interview with the CNO on July 27, 2011, at 12 p.m., she stated there had been no quality assurance follow-up to determine if the QA mortality review criteria were being accurately assessed.

Based on interview and record review, the Governing Body failed to ensure that the process for mortality review was defined and implemented as part of a quality assurance process to reduce medical errors. This failed practice could potentially result in the risk of an ineffective mortality review process and substandard healthcare for all patients using the facility.

Findings:

During an interview with the Management Consultant on July 26, 2011, at 11:20 a.m., she stated the quality review committee was reviewing all deaths related to the ED since January 5, 2011.

The medical record of Patient 3 was reviewed on July 26, 2011, through August 2, 2011. Patient 3 came to the ED on January 14, 2011, at 9:42 p.m., via ambulance with complaints of weakness and leg pain. The medical record of Patient 3 showed there were delays in providing treatment to Patient 3, nursing assessments were not documented as frequently as the patient's condition warranted, there was a delay in obtaining a bed for the patient, and nurse communication with the admitting physician was not carried out and documented per physician orders. Patient 3 expired at 6:20 a.m. in the ED (see A1112).

During an interview with the Chief Medical Officer (CMO), and the ED Medical Director, they stated the death of Patient 3 had been reviewed, using criteria, by a QA nurse. The nurse reviewed the care as appropriate, so it was not subject to further review by the quality department, but, as with all deaths, the case was sent to the ED for quality review. The ED Quality Review Committee (QRC) was presented with the case and the single question for evaluation, "Were orders appropriate and timely?" The ED QRC was not asked to evaluate other aspects of Patient 3's care such as the failure to perform and document timely assessments, the failure to obtain a bed within facility time goals, or the failure of the nurse to notify the admitting physician promptly of the patient's worsening respiratory distress.

On July 27, 2011, the Director Of Regulatory Compliance (DRC), supplied the criteria used by the QA department nurse in the review of patient deaths to determine if quality of care issues occurred. The criteria were listed on a piece of paper, but there was no associated policy, and no evidence of approval by the facility, and no date on the criteria when they were approved or implemented.

The mortality review criteria included: surgery/invasive procedure within 24 hr of death, death related to healthcare associated infection, hp (history and physical exam) on chart within 24 hrs, If in ICU, was the required consultations obtained?, were consultations done timely?, death report completed by nursing, Organ Procurement Organization (OPO) called within 1 hr of death, coroner's office called, death summary/DC summary by MD within 14 days, pain management addressed appropriately, patient support measures provided, family support measures provided.

The mortality review criteria did not have the capability of identifying quality of care problems such as the timeliness or adequacy of nursing assessments, nor the timeliness or correctness of treatments administered, nor nursing failure to notify physician of a change in the patient's condition, nor whether necessary consultations had been obtained in areas other than the ICU, nor for delays in bed availability.

In an interview with the Director Of Risk Management (DRM), on August 2, 2011, at 10:55 a.m., she stated that she did not know where the mortality review criteria came from.

In an interview with the DRC on August 2, 2011, at 11:00 a.m., she stated she was not sure of the origins of the mortality review criteria. She stated that the goal of the mortality review criteria was to identify quality of care issues. She concurred that quality of care issues such as treatment errors, or delay or omission of assessment and treatment, or failure to notify the physician of a change in the patient's condition, or failure to obtain a necessary consult outside of the ICU, were not included in the mortality review criteria, and hence might not be sent for the quality department to review. She concurred that Patient 3's care was not identified by the criteria for quality assurance review.

During an interview with representatives of the Governing Board on August 2, 2011, at 12:40 p.m., the Board members were asked if they were aware of the criteria for mortality review in the facility, and if they were aware that there was no facility policy regarding mortality review. The CMO stated that he believed the criteria had been in place for many years. Board Member 1 stated the subject of morbidity and mortality had come up for discussion a year and a half prior, but more pressing concerns had supervened. He stated that since then, there had been only informal discussion regarding morbidity and mortality.

Based on interview and record review, for one of nine members of the Medical Staff reviewed, Physician Assistant (PA) 1, there was no documented evidence of ongoing professional practice evaluations being completed. This failed practice had the potential for the risk of substandard healthcare for patients receiving services from PA 1.

Findings:

During a review of the medical staff files for PA 1, the file did not contain evidence of ongoing professional practice evaluation. The form, "Ongoing Professional Practice Evaluation Executive Summary-Addendum to Profile" (OPPE) for PA 1 contained only two pieces of data regarding post-operative infections and transfusion reactions. The sections for interpersonal and communication skills, medical and clinical knowledge, and professionalism contained no data on PA 1's performance. The UHS (United Health Services) Medication Variance Profile had only "0's" adjacent to the categories for medication errors and potential errors.

The facility policy, Professional Practice Evaluation, (revised May, 2011), was reviewed on July 29, 2011. The policy defined ongoing professional practice evaluation as "The routine monitoring and evaluation of current competency for members of the medical staff, and the use of that information for ongoing evaluation for the purposes of determining whether to continue, limit or revoke any existing privileges and reappointment." The criteria listed included, "review of operative and other clinical procedures performed and their outcomes."

During an interview with the Director of Medical Staff on July 26, 2011, at 2:30 p.m., she stated PA 1 was a surgery assistant. The OPPE had not been completed on PA 1 because of difficulty extracting the data from the computer system. She stated that OPPE was to occur each six months, and that the system had been in place for two years. She stated that the data from PA 1 would need to be collected manually, and this had not been done yet.

Based on observation, interview and record review the facility's medical staff failed to adopt and enforce bylaws by failing to:

1. Ensure the basic responsibilities of the medical staff were implemented for one of 73 sampled patients (Patient 22). This failed practice resulted in the lack of follow up with an order for a urinalysis (a urine test), potentially contributing to the patient's readmission three days later with a diagnosis of urinary sepsis and bacteremia (severe infection manifested by the presence of bacteria in the blood).

2. Ensure the outpatient medical screening exam (MSE) or the nonstress test (NST), performed by the perinatal nurse, were authenticated by the physician to determine if patients' exams was appropriate and patients were appropriately discharged for 23 of 24 outpatient perinatal visits. This failed practice had the potential for a pregnant patient to have been seen at the facility and not to have been appropriately discharged from care.

3. Ensure the physician assessed the patient when the patient reported discomfort and concerns about a Foley catheter (tube draining urine from the bladder) for one of 73 sampled patients (Patient 1). This failed practice had the potential of creating the risk of unnecessary patient discomfort and a poor health outcome for Patient 1.

4. Ensure the physician documented the continued need for a Foley catheter for one of 73 sampled patients (Patient 1). This failed practice had the potential of creating the risk of unnecessary catheter use and the attendant risks of pain and infection.

5. Ensure the physician submitted a pathology specimen to the laboratory for one of 73 sampled patients (Patient 9). This failed practice had the potential of creating the risk of an undiscovered health condition due to tissue not being inspected.

Findings:

1. On July 25, 2011, at 9:20 a.m. Patient 22 was observed lying in bed in the ED. The patient was moaning aloud, stating, "my sides hurt." Patient 22 was subsequently diagnosed with urinary sepsis and bacteremia, with gram negative rods, (a bacteria which is highly resistant to antibiotics).

A family member seated next to the patient stated Patient 22 was at the facility July 21, and 22, 2011, and will now be readmitted.

A review of Patient 22's July 21 to 22, 2011, admission was conducted. Patient 22 presented to the ED on July 21, 2011, at 1:43 p.m., with a chief complaint of syncope (fainting). A urinalysis (a urine test) was ordered by the ED physician on July 21, 2011, at 2:06 p.m.

A review of the July 21, 2011, ED note indicated, "Nursing Procedure:Urine Collection...Indication for catheter: (tube which empties urine from the bladder) unable to void. Procedure performed at 3 p.m. Straight cath (catheter) performed using 8 fr (french-catheter size) kit in 1 attempt. Amount 15, ml (milliliters). Specimen labeled and sent to lab (laboratory)."

Further record review of Patient 22's July 21, 2011, admission failed to show a lab result for the urine specimen obtained on July 21, 2011.

An interview was conducted with the Laboratory Assistant on July 26, 2011, at 1:55 p.m., who stated when the ED physician enters an order into the system for a urinalysis, the label prints automatically and sometimes the lab receives urine specimens without orders, and sometimes the lab receives orders with no urine specimen.

An interview was conducted with RN 12 on July 27, 2011, at 12:30 p.m., who stated, "If a urinalysis is ordered and completed it is the nurse's as well as the physician's responsibility to follow up with the result."

An interview was conducted with the Supervisor of Clinical Lab Services (SCLS) on July 27, 2011, at 4 p.m., who stated after reviewing the laboratory specimen log and speaking with the lab courier, the urinalysis was ordered for Patient 22 on July 21, at 2 p.m., but the urine specimen never reached the lab and the order was cancelled July 23, 2011, at 12 p.m., after the patient was discharged.

An interview was conducted with the SCLS on August 2, 2011, at 8:30 a.m., who stated, if the lab receives an order for a urinalysis and no urine specimen arrives the lab assistant would call to the floor and follow up with the order, however this process is not tracked or documented.

An interview was conducted with MD 1 on July 28, 2011, at 10:30 a.m. MD 1 stated when one of his patients is transferred from the ED to the hospital as an inpatient, he would call the physician who is admitting the patient and communicate with him regarding the status of all outstanding orders. The situation with Patient 22 was a flaw in the process.

A review of the facility's 2011 "Medical Staff Bylaws," indicate the basic responsibilities of medical staff membership include, "providing patients with the quality of care meeting the professional standards of the Medical Staff of this Hospital."

Patient 22 was re-admitted to the facility three days later, on July 25, 2011, complaining of side and back pain. The patient was subsequently diagnosed with urinary sepsis and bacteremia (critical urine infection that spread into the bloodstream).


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2a. On July 28, 2011, the record for Patient 51 was reviewed. Patient 51 was seen at IVMC Women's Center on:

i. April 28, 2011, at 4:35 p.m., with a chief complaint of no fetal movement for 24 hours. The "OB Outpatient Record" dated April 28, 2011, indicated Patient 51 was evaluated by the RN and discharged home at 5:20 p.m. There was no indication the physician evaluated the outpatient record and fetal monitor strips by signing the "OB Outpatient Record."

ii. May 4, 2011, at 11:14 p.m., with a chief complaint of pain in lower back and vagina to butt, and 6 uterine contractions in an hour. The records dated May 4, 2011, indicated Patient 51 was evaluated by the RN and discharged home at 1:06 a.m. There was no indication the physician evaluated the outpatient record and fetal monitor strips by signing the "OB Outpatient Record."

iii. May 21, 2011, at 6:30 p.m., with a chief complaint of green yellow vaginal discharge and cramps. The "OB Outpatient Record" dated May 21, 2011, indicated Patient 51 was evaluated by the RN and discharged home at 9 p.m. There was no indication the physician evaluated the outpatient record and fetal monitor strips by signing the "OB Outpatient Record."

iv. June 3, 2011 at 4:35 p.m., with a chief complaint of pain to right lower back and cramping. The "OB Outpatient Record" dated June 3, 2011, indicated Patient 51 was evaluated by the RN and discharged home June 4, 2011, at 1:10 a.m. There was no indication the physician evaluated the outpatient record and fetal monitor strips by signing the "OB Outpatient Record."

v. June 4, 2011 at 7:15 p.m., with a chief complaint of back pain and vaginal pressure. The "OB Outpatient Record" dated June 4, 2011, indicated Patient 51 was evaluated by the RN and discharged home at 11 p.m. There was no indication the physician evaluated the outpatient record and fetal monitor strips by signing the "OB Outpatient Record."

vi. June 24, 2011 at 11:10 p.m., with a chief complaint of low back pain and occasional cramps. The "OB Outpatient Record" dated June 24, 2011, indicated Patient 51 was evaluated by the RN and discharged home at 1:40 a.m. The physician evaluated the outpatient record and fetal monitor strips by signing the "OB Outpatient Record," but not until July 11, 2011, 17 days after the visit.

vii. June 25, 2011 at 11:30 p.m., with a chief complaint of worsening pain. The "OB Outpatient Record" dated June 25, 2011, indicated Patient 51 was evaluated by the RN and discharged home at 12:55 a.m. There was no indication the physician evaluated the outpatient record and fetal monitor strips by signing the "OB Outpatient Record."

viii. July 6, 2011 at 8:51 p.m., with a chief complaint of uterine cramping and not feeling good. The "OB Outpatient Record" dated July 6, 2011, indicated Patient 51 was evaluated by the RN and discharged home at 11:30 p.m. There was no indication the physician evaluated the outpatient record and fetal monitor strips by signing the "OB Outpatient Record."

ix. July 12, 2011 at 7:57 p.m., with a chief complaint of uterine contractions and no fetal movement all day. The records dated July 12, 2011, indicated Patient 51 was evaluated by the RN and discharged home at 9:35 p.m. There was no indication the physician evaluated the outpatient record and fetal monitor strips by signing the "OB Outpatient Record."

2b. On July 28, 2011, the record for Patient 52 was reviewed. Patient 52 was seen at IVMC Women's Center on:

i. May 19, 2011 at 4:47 p.m., with a chief complaint of uterine contractions. The "OB Outpatient Record" dated May 19, 2011, indicated Patient 52 was evaluated by the RN and discharged home at 10:15 p.m. There was no indication the physician evaluated the outpatient record and fetal monitor strips by signing the "OB Outpatient Record."

ii. June 8, 2011 at 4:35 p.m., with a chief complaint of uterine contractions every 30 min, cramping, dizziness, nausea and vomiting. The "OB Outpatient Record" dated June 8, 2011, indicated Patient 52 was evaluated by the RN and discharged home at 2:45 a.m. There was no indication the physician evaluated the outpatient record and fetal monitor strips by signing the "OB Outpatient Record."

iii. June 10, 2011 at 5:35 p.m., with a chief complaint of contractions in the lower back. The "OB Outpatient Record" dated June 10, 2011, indicated Patient 52 was evaluated by the RN and discharged home at 9 p.m. There was no indication the physician evaluated the outpatient record and fetal monitor strips by signing the "OB Outpatient Record."


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2c. On July 26, 2011, the records for patient 56 were reviewed. Patient 56 was seen as an outpatient in the labor and delivery department on:

i. June 7, 2011, at 5:53 p.m., with a diagnosis of "vaginal bleeding." The "OB Outpatient Record" dated June 7, 2011, indicated Patient 56 was evaluated by the nurse and discharged home on June 7, 2011, at 9:55 p.m. There was no indication the physician had evaluated the written outpatient record and fetal monitor strips by signing the "OB Outpatient Record."

ii. July 16, 2011, at 4:18 p.m., with a diagnosis of "preterm labor (contractions prior to the 37th week of pregnancy)." The "OB Outpatient Record" dated July 16, 2011, indicated Patient 56 was evaluated by the nurse and discharged home on July 16, 2011, at 5:20 p.m. There was no indication the physician had evaluated the written outpatient record and fetal monitor strips by signing the "OB Outpatient Record."

2d. On July 26, 2011, the records for patient 57 were reviewed. Patient 57 was seen as an outpatient in the labor and delivery department on:

i. May 8, 2011, at 9:30 a.m., with diagnosis of premature contractions. The "OB Outpatient Record" dated May 8, 2011, indicated Patient 57 was evaluated by the nurse and discharged home on May 8, 2011, at 4:45 p.m. There was no indication the physician had evaluated the written outpatient record and fetal monitor strips by signing the "OB Outpatient Record."

ii. May 11, 2011, at 11:50 a.m., with a diagnoses of mild contractions, nonstress testing (monitoring to aid in the determination of fetal well-being) and administration of betamethasone (a medication used to mature fetal lungs). The "OB Outpatient Record" dated May 11, 2011, indicated Patient 57 was evaluated by the nurse and discharged home on May 11, 2011, at 2:45 p.m. There was no indication the physician had evaluated the written outpatient record by signing the "OB Outpatient Record."

iii. May 12, 2011, at 2:25 p.m., with diagnosis of "fetal monitoring." The "Nursing Flowsheets" dated May 12, 2011, indicated Patient 57 was evaluated by the nurse and discharged home on May 12, 2011, at 3:30 p.m. There was no indication the physician had reviewed and initialed the fetal monitor strips.

iv. May 16, 2011, at 9:10 a.m., with diagnosis of nonstress testing (NST) for preterm labor. The "Nursing Flowsheets" dated May 16, 2011, indicated Patient 57 was evaluated by the nurse and discharged home on May 16, 2011, at 9:45 a.m. There was no indication the physician had reviewed and initialed the fetal monitor strips.

v. May 19, 2011, at 9:05 a.m., with diagnosis of nonstress testing for preterm labor. The "Nursing Flowsheets" dated May 19, 2011, indicated Patient 57 was evaluated by the nurse and discharged home on May 19, 2011, at 9:45 a.m. There was no indication the physician had reviewed and initialed the fetal monitor strips.

vi. May 23, 2011, at 9:25 a.m., with diagnosis of nonstress testing for preterm labor. The "Nursing Flowsheets" dated May 23, 2011, indicated Patient 57 was evaluated by the nurse and discharged home on May 23, 2011, at 10:05 a.m. There was no indication the physician had reviewed and initialed the fetal monitor strips.

vii. May 27, 2011, at 10:12 a.m., with diagnosis of nonstress testing for preterm labor. The "Nursing Flowsheets" dated May 27, 2011, indicated Patient 57 was evaluated by the nurse and discharged home on May 27, 2011, at 11:30 a.m. There was no indication the physician had reviewed and initialed the fetal monitor strips.

viii. May 30, 2011, at 4:03 p.m., with diagnosis of nonstress testing for preterm labor. The "Nursing Flowsheets" dated May 30, 2011, indicated Patient 57 was evaluated by the nurse and discharged home on May 30, 2011, at 4:50 p.m. There was no indication the physician had reviewed and initialed the fetal monitor strips.

ix. June 3, 2011, at 3:55 p.m., with diagnosis of nonstress testing for preterm labor. The "Nursing Flowsheets" dated June 3, 2011, indicated Patient 57 was evaluated by the nurse and discharged home on June 3, 2011, at 5:40 p.m. There was no indication the physician had reviewed and initialed the fetal monitor strips.

On July 27, 2011, at 2:15 p.m., an interview was conducted with the Director of Health Information Management (DHIM), Nurse Manager (NM) 2, and Educator 1. They stated the physician was supposed to sign the outpatient record . In addition, they stated the physician should sign an NST within 24 hours of the test occurring and authenticate a medical screening exam performed by the perinatal nurse within 48 hours of the examination occurring.

During an interview with Educator 1, on July 27, 2011, at 4:30 p.m., she reviewed the clinical records for Patients 56 and 57, and was not able to find documentation that the physicians had reviewed and initialed the fetal monitor strips for nonstress testing outpatient visits or had evaluated the written outpatient record and fetal monitor strips by signing the "OB Outpatient Record" for MSE visits.

The facility "Medical Staff Bylaws 2011" dated June 23, 2011, indicated "Basic Responsibilities of Medical Staff Membership ... (b) abiding by the Medical Staff bylaws, Medical Staff rules and regulations, and policies and Medical-Staff approved Hospital policies and procedures, ... (d) preparing and completing in timely fashion medical records for all the patients to whom the member provides care in the Hospital ..."

The facility policy and procedure titled "Standardized Procedure: EMTALA-2-Perinatal Medical Screening Exam" reviewed July 2011, indicated "... The primary physician shall evaluate the written outpatient record and any fetal monitor strips obtained during the observation period. The physician will countersign his telephone orders and sign the outpatient record. ..."

The facility policy and procedure titled "Nonstress Test" dated November 2010, indicated "... The physician must review and initial the NST within twenty-four (24) hours of completion of the test. This may be done remotely via the electronic documentation system (OBTVUE). ..."


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3. Patient 1 submitted a grievance regarding care received at the facility to the health plan, which sent it to the facility. Patient 1's allegations related to an inpatient stay February 8 to February 11, 2011, and subsequent emergency room visits. The allegation related to his inpatient stay was that he found a urinary catheter (a tube extending from the bladder to the
outside of the body) uncomfortable, and physicians were not handling the issue.

The medical record for Patient 1 during his inpatient stay from February 8 until February 11, 2011, was reviewed. The nursing documentation showed that Patient 1 complained on February 10, 2011, of discomfort he related to the urinary catheter, and the physician had been contacted and stated he would come to see the patient. However, there was no documentation that the physician came to see the patient. Patient 1 complained of pain 10/10, (on a scale of one to ten, with ten being the highest level of pain) during the night, and was discharged the next day, February 11, 2011, with the catheter still in place.

Portions of the medical record for Patient 1 were reviewed with the Chief Medical Officer (CMO) on July 28, 2011, at 9 a.m. The CMO concurred that the physician, who stated he would come to see Patient 1 in response to Patient 1's concern about the catheter and discomfort, should have gone to see Patient 1.

During an interview with the Director Risk Management (DRM) on July 28, 2011, at 10:30 a.m., she stated the physician who stated he was coming to see the patient in response to his complaint of discomfort should have gone to assess the patient.

The Medical Staff Bylaws (dated June 23, 2011), reviewed on July 28, 2011, read in part, "Except for the honorary and retired staff the ongoing responsibilities of each member of the Medical /Staff include: providing patients with the quality of care meeting the professional standards of the Medical /Staff of this Hospital. ..."

4. Review of the medical record of Patient 1 on July 26, 2011, showed that Patient 1 had a Foley catheter (a tube extending from the bladder to outside the body to drain urine) placed prior to surgery on February 8, 2011. The medical record contained three stickers placed in the "Physician's Orders" section of the chart, for documentation of the medical necessity of central lines (tubes extending from a major blood vessel to outside the body) and Foley catheters. The pre-printed stickers contained check-boxes on which the existence of central lines or a Foley catheter were to be documented, and boxes to indicate the reason for the lines or catheter.

The first such sticker in Patient 1's medical record was inserted on February 9, 2011, and had no boxes checked, was unsigned, and the pre-printed sticker was left blank. The second sticker was placed on February 10, 2011, had the box "medical condition prohibits use of bedpan or bedside commode" checked, and the physician's signature, but no date or time signed. Review of the Patient Progress Notes on February 10, 2011, showed Patient 1 ambulated in the hallway on that date. There was no documentation provided in the medical record that Patient 1 was unable to use a bedpan or commode. A third sticker regarding the medical necessity of central lines and Foley catheters was placed in the "Physicians Orders" on February 11, 2011, and that sticker had one checkmark to indicate that the patient continued to have a Foley catheter, but no check mark to indicate the reason the catheter was present, and no physician signature. Patient 1 was discharged to a skilled nursing facility on February 11, 2011, with the Foley catheter still in place, and returned to the ED on February 13, 2011, with a complaint of abdominal discomfort, and on February 18, 2011, with a urinary tract infection.

During an interview with the CMO on July 28, 2011, at 9 a.m., he reviewed the medical record of Patient 1 and stated that if the patient continued to have a Foley catheter, the medical necessity stickers should have been filled out by the physician.

The facility policy, "Urinary Catheter: Preventing Infections" (issued December 2010, revised March 2011) was reviewed on July 28, 2011. The policy stated in part, "Review urinary catheter necessity daily and remove promptly by using the Medical Necessity of Central Lines and Foley Catheters (text was followed by a picture of the sticker)."

5. During a review of the medical record for Patient 9 on July 26, 2011, the anesthesiology record indicated that the procedures performed included, "excision of r (right) leg mass," and the operative documentation indicated that a right leg skin lesion was removed. However, the July 26, 2011, operating room nurse note indicated, "No specimen sent to pathology per (MS 5)."

During an interview with Nurse Manager (NM) 5 on July 28, 2011, at 11:15 a.m., she concurred that there was no description of the skin lesion removed, and no documentation of a specimen sent to pathology.

During a review on July 27, 2011, of the facility policy, "Specimen Collection: Pathology," the policy read in part, "In compliance with regulatory guidelines, all anatomical parts, tissue and foreign objects removed by an operation/procedure will be delivered to the pathology department for examination with the exception of the ?do not submit list (see Examination section below)." The examination list was reviewed, and the list did not include a "skin lesion" or "skin mass" in the list of specimens that did not need to be sent to pathology. Below the exemption list, the policy reiterated in all capital letters: "ALL OTHER SPECIMENS MUST BE SENT TO PATHOLOGY FOR EXAMINATION."

The Medical Staff Bylaws (dated June 23, 2011), reviewed on July 28, 2011, read in part, "Except for the honorary and retired staff, the ongoing responsibilities of each member of the Medical Staff include: (b) abiding by the Medical Staff bylaws, Medical Staff rules and regulations, and policies and Medical-Staff approved Hospital policies and procedures, including those related to the security of electronic health records ..."

Based on interview and record review, for one of 73 sampled patients (Patient 9), the facility failed to ensure a complete and accurate pre-operative history and physical examination was completed by the surgeon. This failed practice potentially could create the risk of a poor health outcome for Patient 9 due to failure to review the patient's medical needs.

Findings:

During a review of medical record of Patient 9 on July 26, 2011, discrepancies were noted when comparing the patient's history and physical documentation by the pre-admitting nurse, the surgeon and the anesthesiologist. On the pre-admitting nursing assessment dated July 21, 2011, Patient 9 was described as having a 12 year history of limb girdle muscular dystrophy (a disorder affecting muscle strength), a 10 year history of sleep apnea (pauses in breathing during sleep, a condition that can give rise to significant health problems, including heart damage) morbid obesity, and a surgical history that included three surgeries under general anesthesia,

The surgeon's History and Physical Examination, dated July 26, 2011, was reviewed on July 26, 2011. The medical history included degenerative joint disease, gastroesophageal reflux disease and morbid obesity, but "otherwise negative for cardiac, pulmonary, GI, or neuroskeletal disease." Also the surgeon documented on the line for past surgical history, "none."

The anesthesiologist's "Preoperative Anesthesia Evaluation" for the July 26, 2011, surgery indicated that Patient 9 had limb girdle muscular dystrophy, gastroesophageal reflux, sleep apnea for which he used CPAP (a machine to help with breathing).

None of the assessments provided a description of a right leg mass or lesions, although one was removed during surgery, and not sent to the laboratory.

During an interview with the Director Of Risk Management (DRM) on July 28, 2011, at 10:30 a.m., she concurred that there were discrepancies between Patient 9's preoperative history and physical exam and the pre-admitting history and the anesthesiologist's history information.

During an interview with NM 5 on July 28, 2011, at 11:15 a.m., she agreed that there were multiple discrepancies between the nurse, anesthesiologists, and the surgeon's history and physical examination. She concurred that the failure to describe the skin lesion that was removed, especially in light of the fact that it was not sent to pathology, presented a risk to the patient.

The Medical Staff Rules and Regulations (June, 2011) read in part, "The patient's attending physician and each practitioner involved in the care of the patient shall be responsible for preparing a complete and legible medical record for each patient. Admitting physician, or his designee, is responsible for the completion of the patient's H & P and discharge /transfer summary," and "A history and physical examination shall be dictated/legible written and include chief complainant and admitting diagnosis, details of present illness, past history (including allergies, current medications, and conditions), inventory of body systems, relevant past/social/family history and psychosocial history, relevant physical exam ..."

Based on interview and record review, for 1 of 9 credential files reviewed (PA 2), the facility failed to identify specific privileges that the PA was granted. This failed practice potentially created the risk of PA 2 attempting to perform services for which he was not deemed competent, and hence the risk of substandard services for patients cared for by PA 2.

Findings:

During a review of the credential file of PA 2, who worked in the ED, on July 26, 2011, at 2:30 p.m., with the Director of the Medical Staff (DMS), no documentation was found to show that specific privileges were requested or granted for PA 2. During a concurrent interview with the DMS, she stated that PAs had been given general privileges in accordance with their license and supervisory agreement. She stated that new privilege sheets had been implemented in the facility in early 2011, but they had not yet been put into place for PA 2.

During a review of the Medical Staff Bylaws (multiple approval dates January through June, 2011), the bylaws read in part, "Each application for appointment and reappointment to the Medical Staff must contain a request for the specific clinical privileges desired by the applicant."

Based on observation, interview, and record review, the facility failed to provide nursing service to meet the needs of all patients by:

1. Failing to ensure all licensed nurses administered medications in accordance with the facility's policy and procedure consistent with accepted standards of practice. RN 1 administered an excessive dose of an injectable medication (desmopressin- a medication to decrease urination. It is used to treat diabetes insipidus, which is a condition in which the kidneys are unable to conserve water.) and did not use a filtered needle while withdrawing the medication out of a glass ampul. RN 1 also administered an injectable medication (Protonix-medication used to reduce stomach acid production to prevent heartburn and gastrointestinal ulcers) at a rate faster than manufacturer's recommendations.

This resulted in medication errors which potentially placed the patient (Patient 11) at risk for serious harm by not following manufacturer's recommendations and the facility's policy and procedure for preparing intravenous injectable medications, the effect of which would not be easily reversible. In addition, the facility failed to respond timely to address the serious medication errors and immediately implement preventive actions to minimize the impact to patients.

Due to the facility's failure to administer injectable medications in ICU (Intensive Care Unit) and failure to take steps to prevent further medication errors, the survey team called an .immediate jeopardy on July 26, 2011, at 6:55 p.m., in the presence of the CEO, CNO, CMO, and DRM.

The survey team accepted the facility's plan of action to resolve the immediate jeopardy situation on July 27, 2011, at 1:50 p.m. Refer to A0404.

2. Failing to ensure a registered nurse supervised and evaluated the nursing care for 8 of 73 sampled patients (Patient 8, 9, 18, 21, 22, 23, 31, and 39) by failing to ensure physician's orders were carried out, patients were fully assessed, and/or nutritional consultations were obtained. Refer to A0395 and A0404.

The cumulative effect of these systemic problems resulted in the failure of the facility to provide adequate nursing care and services, which had the potential to result in serious harm, injury, and/or death.

Based on observation, interview, and record review, the facility failed to ensure a registered nurse supervised and evaluated the nursing care for 7 of 73 sampled patients (Patient 8, 9, 18, 21, 22, 31, and 39) by:

1. Failing to ensure physician's orders for a urinalysis (urine test to check for infection) were implemented as ordered for Patient 22. This failure potentially contributed to Patient 22's readmission to the facility three days later with a diagnosis of urinary sepsis (severe urinary infection which causes an infection in the blood).

2. Failing to ensure the RN assessed an indwelling urinary catheter (a tube placed into the bladder to drain urine.) for Patient 31. This had the potential to result in Patient 31 acquiring an infection.

3. Failing to ensure the nursing evaluation of Patient 9 was communicated to the surgeon. This had the potential of creating the risk of a substandard health outcome for that patient.

4. Failing to ensure the nursing staff provided and documented repositioning for Patient 8. This may have contributed to Patient 8's developing a pressure ulcer (an area of skin breakdown primarily caused by pressure on the area).

5. Failing to ensure a nutritional consult was ordered and entered into the computer system to inform the Registered Dietician (RD) of the need to evaluate Patient 18. This led to a delay in communication to the RD concerning Patient 18's care needs.

6. Failing to ensure the Admission Database included the patient's recent history of nausea and vomitting for Patient 21. This contributed in Patient 21 not receiving a nutritional consult.

7. Failing to ensure a nutritional consult was implemented for Patient 39, with multiple large infected wounds. This led to a delay of service potentially worsening the patient's wound status.

Findings:

1. On July 25, 2011, at 9:20 a.m. Patient 22 was observed lying in bed in the ED. The patient was moaning aloud, stating, "my sides hurt." Patient 22 was diagnosed with urinary sepsis and bacteremia with gram negative rods (a bacteria in the blood which is highly resistant to antibiotics).

A family member seated next to the patient stated the patient was at the facility July 21, and 22, 2011, and will now be readmitted.

A review of Patient 22's prior admission was conducted. During the prior admission, Patient 22 presented to the ED on July 21, 2011, at 1:43 p.m., with a chief complaint of syncope (fainting). A urinalysis (a test of the urine) was ordered by the ED physician on July 21, 2011, at 2:06 p.m.

A review of the July 21, 2011, ED note indicated, "unable to void. Procedure performed at 3 p.m. Straight cath (catheter-tube which empties urine from the bladder) performed...in 1 attempt. Amount 15 ml (milliliters). Specimen labeled and sent to lab (laboratory)."

There was no urinalysis results in the medical record for the urine sample obtained July 21, 2011.

An interview was conducted with the Laboratory Assistant on July 26, 2011, at 1:55 p.m., who stated when the ED physician enters an order into the system for a urinalysis, the label prints automatically and sometimes the lab receives urine specimens without orders, and sometimes the lab receives orders with no urine specimen.

An interview was conducted with RN 12 on July 27, 2011, at 12:30 p.m., who stated, "If a urinalysis is ordered and completed it is the nurse's as well as the physician's responsibility to follow up with the result."

An interview was conducted with the SCLS on July 27, 2011, at 4 p.m., who stated after reviewing the laboratory specimen log and speaking with the lab courier, the urinalysis was ordered for (Patient 22) on July 21, 2011 at 2 p.m., but the specimen never reached the lab and the order was cancelled July 23, 2011, at 12 p.m., after the patient was discharged.

An interview was conducted with MD 1 on July 28, 2011, at 10:30 a.m., MD 1 stated when one of his patients is transferred from the ED to the hospital as an inpatient he would call the physician who is admitting the patient and communicate with him regarding the status of all outstanding orders. The situation with Patient 22 was a flaw in the process.

A review of the facility document, "Clinical Practice Providing Care-Physician's Orders (Reviewed: 12/2010) indicates the purpose, "To establish guidelines for obtaining and processing physician's orders to ensure prompt quality patient care is provided."

The procedure indicates, "At least every 24 hours, all written orders will be checked to ensure they were implemented as ordered."

Patient 22 was re-admitted to the facility three days later, on July 25, 2011, complaining of side and back pain. The patient was subsequently diagnosed with urinary sepsis and bacteremia.



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2. On July 25, 2011, at 9:50 a.m., Patient 31 was observed in the PCU (Progressive Care Unit), with an indwelling urinary catheter. In a concurrent interview with RN 14, she stated Patient 31 was admitted from the ED (Emergency Department) on July 24, 2011.

On July 26, 2011, Patient 31's record was reviewed. The patient was admitted through the ED on July 24, 2011, with chief complaint of drug overdose.

The "Emergency Record" timed at 1 a.m. (July 24, 2011), indicated Patient 31 was unable to urinate and that was the purpose for the indwelling urinary catheter.

The "Admitting/Intra-Facility Transfer Orders" dated July 24, 2011, at 7:22 a.m., indicated a transfer to the ICU (Intensive Care Unit). The record had a section indicating if Patient 31 needed a indwelling urinary catheter. The section was blank.

During the review of the ICU Flow Sheet and records, there was no documented evidence of an assessment of Patient 31's indwelling urinary catheter.

The "Admitting/Intra-Facility Transfer Orders" dated July 24, 2011, at 5:50 p.m., indicated a transfer from the ICU to the PCU. The record had a section indicating if Patient 31 needed a indwelling urinary catheter. The section was also blank.

During the review of the PCU Flow Sheet and records, there was no documented evidence of an assessment Patient 31's indwelling urinary catheter.

A review of the "Physician's Order Sheet" dated July 25, 2011, at 5:30 p.m., indicated, "...D/C (Discontinue) F/C (indwelling urinary catheter)."

On July 26, 2011, at 10:10 a.m., Patient 31's record was reviewed with RN 14. She stated, while the patient was in the PCU, Patient 31 had a F/C. The F/C was discontinued when the physician ordered it, prior to the transfer to the M/S/T west unit. The RN was unable to find any documented evidence that an assessment was conducted of the F/C in the PCU records.

On July 26, 2011, at 10:20 a.m., Patient 31's record was reviewed with RN 1. She stated Patient 31 was admitted to the ICU, from the ED, and was transferred to the PCU with a F/C. RN 1 was unable to find documented evidence that an assessment was conducted of the F/C in the ICU.

On July 26, 2011, at 10:30 a.m., the CNO stated there should have been documentation of an assessment of the F/C in the ICU and PCU.

The facility policy titled, "Urinary Catheters," issued December 2010, was reviewed and indicated, "Purpose: To provide criteria to reduce the incidence of hospital acquired, catheter associated urinary tract infections..."

The policy titled, "Assessment/Reassessment of Patient," reviewed October 2010, was reviewed and indicated, "Assessment of Patient...An initial assessment of each patient's physical...functional status...is completed by a Registered Nurse at time of admission..."

The policy further indicated, "...The initial assessment is used to determine...The need for care or treatment..."




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3. During a review of the record for Patient 9 on July 26, 2011, discrepancies were noted in the patient's history and physical documentation by the pre-admitting nurse, the surgeon and the anesthesiologist.

The following was noted on the pre-admitting nursing assessment dated July 21, 2011, Patient 9 was described as having a 12 year history of limb girdle muscular dystrophy (a disorder affecting muscle strength), a 10 year history of sleep apnea (pauses in breathing during sleep, a condition that can give rise to significant health problems, including heart damage) morbid obesity, and a surgical history that included three surgeries under general anesthesia.

The surgeon's "History and Physical Examination", dated July 26, 2011, indicated the medical history included degenerative joint disease, gastroesophageal reflux disease, and morbid obesity, but no muscular dystrophy, sleep apnea or the history of previous surgeries was listed.

The anesthesiologist's "Preoperative Anesthesia Evaluation" for the July 26, 2011 surgery, indicated that Patient 9 had limb girdle muscular dystrophy, gastroesophageal reflux, sleep apnea for which he used a CPAP (a machine to help with breathing).

During an interview with the NM 5 on July 28, 2011, at 11:15 a.m., she confirmed there were multiple discrepancies between the nurse, the surgeon and the anesthesiologist's history and physical examinations. She stated that it was the pre-operative and operative nurses' responsibility to ensure that the surgeon was aware of the conditions identified by the pre-admitting nurse, and there was no evidence that such a communication occurred.

During a review of the facility policy, "Admission, Perioperative Services" (revised February 2009, reviewed November 2010), the policy read in part, "It is the responsibility of the OR circulating nurse to determine that the patient record is in order and all pertinent information is present before the patient is taken into the Operating Room."

4. During a review of the record for Patient 8, an inpatient in the medical-surgical unit, on July 25, 2011, the patient's record showed that he was admitted on July 17, 2011, was 86 years old, and had been having loose stools and weakness due to a gastrointestinal infection.

The "Patient Care Flow Sheets" sheets contained a grid in which patient care information related to nutrition, hygiene, activity, pain and fall prevention would be entered. The flow sheet dated July 19, 2011, showed that Patient 8 was assisted with turning in bed at 1 a.m., but there was no further entry on the data sheet after 1 a.m. through 6 a.m. There was no documentation to indicate whether Patient 8 was turned, or was assisted to turn, or was observed turning himself during those hours.

The E-Z Graph Wound Assessment Mounting Form dated July 20, 2011, was reviewed and showed that Patient 8 had a 13.5 cm by 3 cm stage 1 pressure ulcer (reddened area on the skin that is the first sign of breakdown due to pressure) on the sacrum (lower back) and buttocks area documented on July 20, 2011. Review of the medical record did not show documentation of the pressure ulcer prior to that date.

The "Patient Care Flow Sheet" dated July 22, 2011, was reviewed. The sheet showed that Patient 8 was observed to be turning himself until 10 p.m. After that time, there was no information documented about turning through the end of the shift at 6 a.m. The Hygiene section indicated that the patient required complete assistance with bathing, and total assistance with other hygiene activities. The Skin section indicated that the patient had excoriations on the buttocks and a reddened peri-rectal area, but the wound/skin section of the chart did not include a description of the pressure ulcer.

During an interview with NM 8 on July 25, 2011, at 10:30 a.m., she concurred that the nursing documentation about turning Patient 8 should have been completed every two hours.

Review on July 29, 2011, of the facility policy, "Wound Care: Prevention, Staging, and Treatment of Pressure Ulcers", reviewed December 2010, indicated "Prevention Techniques, Reposition every two (2) hours or more frequently if indicated...Daily Documentation..Turning/positioning schedule."


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5. The medical record for Patient 18 was reviewed on July 26, 2011 at 2:00 p.m. The patient was admitted to the hospital on July 18, 2011, with diagnoses that included end-stage kidney disease, and borderline diabetes.

On July 23, 2011, a physician's order for parenteral nutrition (PN, intravenous nutrition that goes directly into the vein) was noted. The "Parenteral Nutrition (PN) Order Form - Adult" dated July 23,2011, indicated that a dietary consult was ordered as part of the automatic orders on the form.

A review of the hospital's policy titled, "Nutrition Assessment: Standards of Care," dated March 2010, indicated to provide optimal nutritional support and recommendations...through the daily planning, implementation and evaluation of the nutrition care spectrum...Nutritional consultations ordered by the Nursing or the physician are addressed within 24 hours of receipt of the consult."

A review of the Nutrition Progress Notes for Patient 18 showed that a Nutrition Assessment was completed by Registered Dietitian 2 (RD 2) on July 21, 2011. The assessment indicated recommendations for the nutrition care of the patient and the RD was to follow-up in 2-4 days to monitor (the patient's) renal indices (labs related to kidney function), blood glucose test results (for diabetes) and the patient's food intake and weight trends.

Further review of the Nutrition Progress Notes showed that the next RD note was dated July 25, 2011, 2 days after the order was written for Parenteral Nutrition that included an order for a dietary consult. RD 2 indicated that the PN had been ordered and was providing 1610 kilocalories and 90 grams of protein a day. The follow-up note also indicated that the patient had eaten well for dinner the day before and breakfast that morning. Under the Assessment and Plan section of the follow-up note, RD 2 indicated, "Inappropriate use of PN as related to intact GI (gastrointestinal) tract as evidenced by the patient is able to take p.o. (oral) meds (medications) and consume (meal) tray. Patient is without any overt (obvious)signs and symptoms of malabsorption (problems with absorbing nutrients)." The note further recommended to discontinue the PN.

During an interview with the Nurse Manager (NM 1) for Patient 18 on July 26, 2011 at 2:45 p.m., she stated that the dietary consult ordered on July 23, 2011 was never entered in the computer system designed to inform the RD of the consult. During a concurrent interview with RD 2 she confirmed that the order was not communicated to the dietary department. RD 2 further stated that the RD's depend on the communication of the dietary consults to know which patients have been started on PN, in order to assess the nutrition status of those patients within 24 hours of initiation.

The hospital policy titled. "Chart Check: 24 Hour" (dated December 2010) was reviewed. The purpose of the policy was to outline a method to assure that physician orders are carried out in a timely manner. It further states that all charts will be checked a minimum of every 24 hours...the Registered Nurse (RN) will compare all orders on the physician's order sheet from the previous chart check. In the event that there is a discrepancy between the order and the transcription, the error should be corrected at this time to prevent further delay in service or continuing error. This system did not detect and correct the omission of the dietary consult communication to the RD.

Further review of the Physician Orders for Patient 18 revealed an order to taper off and discontinue the PN on July 26, 2011, according to RD 2's recommendations. There was the potential that this could have occurred sooner if the dietary consult was communicated according to the hospital policy, to avoid overfeeding the patient.

6. The medical record for Patient 21 was reviewed on July 28, 2011 at 9:40 a.m. The patient was admitted to the hospital on July 23, 2011, with diagnoses that included morbid obesity, sleep apnea, perforated diverticular abscess and small bowel obstruction. The patient underwent an exploratory laparotomy (abdominal surgery) with a colon resection on July 23, 2011.

A review of the Emergency Record for Patient 21 revealed that the patient complained of having nausea, vomiting and abdominal pain for 4 days. It further stated that the patient reported a pain level of 10 (on a scale of 0 - 10 with 10 being high). The Emergency Report indicated that the nurse from the emergency department gave a report to the PCU (Progressive Care Unit) nurse regarding the patient's history and condition of the patient on July 23, 2011 at 3:00 a.m. The patient was admitted to the PCU on July 23, 2011 at 3:45 a.m. from the Emergency Department.

The Admission Database (nursing admission assessment) dated July 23, 2011 at 3:45 a.m. for Patient 21 was reviewed. The database showed the Nutrition Screen included a box to be checked if the patient had vomiting and/or diarrhea for 3 or more days. The box was not checked. The only information contained in the Nutrition Screen was the patient's appetite was listed as "Good" and his diet at home was "Regular." The instructions for the Nutrition Screen stated, "Any boxes marked require a nutritional consult." No nutritional consult was ordered for Patient 21 despite being brought to the hospital via ambulance with complaints of nausea, vomiting and abdominal pain for 4 days.




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7. On July 25, 2011, at 9:45 a.m. a review of Patient 39's record was conducted. Patient 39 was a 65 year old male admitted to the facility on July 24, 2011, at 2:59 a.m., through the ED with complaints of generalized weakness. During the physician's initial assessment, the physician documented the patient had multiple large infected wounds.

On July 24, 2011, at 10:10 a.m., the RN completed the Admission Data Base, a form used to determine the need for a nutritional consult. The document indicated the patient had a poor appetite. However, the patient's large infected wounds were not listed and therefore a nutritional consult was not triggered and not completed.

On July 25, 2011, at 10:35 a.m., an interview was conducted with RD 1. After reviewing photos of the patient's wounds, she stated, "Absolutely. I agree. I could have started some vitamins and zinc."

In an interview with RN 2, at 10:45 a.m. that same day, she stated, "The patient should have been referred to the RD on admission."

Based on interview and record review, the facility failed to ensure an individualized plan of care was implemented for one of 73 sampled patients (Patient 18). This failed practice potentially caused a delay in a dietary referral for this nutritionally compromised patient.

Findings:

The medical record for Patient 18 was reviewed on July 26, 2011 at 2:00 p.m. The patient was admitted to the hospital on July 18, 2011, with diagnoses that included acute respiratory insufficiency, end-stage renal (kidney) disease, and borderline diabetes.

A review of the Nutrition Progress Notes for Patient 18 showed that a Nutrition Assessment was completed by Registered Dietitian 2 (RD 2) on July 21, 2011, 3 days after admission. The assessment indicated that the patient's family member reported that the patient had a poor appetite for 3 - 4 days. It further indicated that the patient's recorded meal intakes were only 10 to 40 % of her meals.

Review of the physician's order showed an order for peripheral parenteral nutrition (PPN, intravenous nutrition that goes directly into the vein) was noted on July 23. The record indicated that the patient was on PN from July 23 through 26 when it was tapered off and discontinued. The "Parenteral Nutrition (PN) Order Form - Adult" dated July 23 indicated that a dietary consult was ordered as part of the automatic orders on the form. There was no record that the dietary consult order was communicated to the RD.

A review of the "Interdisciplinary Plan of Care: Potential/Actual Alteration in Nutrition," dated July 21 indicated that RD 2 had initiated the nutrition plan of care for the patient 3 days after the patient was admitted. At the time the plan of care was initiated, the patient had had 3 - 4 days of poor appetite and poor meal intake. The plan of care indicated that the only intervention for the patient's alteration in nutrition status was, "Special Diet." There was no indication in the interdisciplinary plan of care that the patient had been on PN for 3 days or that a dietary referral had been made.

During an interview with the Nurse Manager (NM 1) of the Intensive Care Unit (ICU), where the patient was located on July 26, 2011, at 3:00 p.m. she stated that the nutrition plan of care should have been initiated by the nurse caring for the patient on admission. She further stated that the plan of care should also indicate that one of the nutrition interventions the patient received was PN. Also, if the interventions section of the plan of care had been completed, a dietary referral would have generated a more timely assessment of the patient when the PN was initiated.

A review of the hospital's policy titled, "Care Planning: Patient," (dated January, 2011) indicated that the purpose of the policy was to provide the interdisciplinary healthcare team with guidelines for developing and prioritizing an individualized patient plan of care. It further stated that the Registered Nurse shall be responsible for the initiation of a plan of care based on the nursing process within 24 hours of admission. It also stated that the patient's care plan shall be revised/updated to reflect changes in patient status, as evaluated and assessed by the Registered Nurse and other members of the healthcare team.

Based on interview and record review, the facility failed to complete a 90 day performance evaluation for RN 1 until the employee had been at the facility for seven months. This failed practice had the potential for the facility not to know if the employee was competent to perform her duties.

Findings:

On July 27, 2011, the employee record for RN 1 was reviewed. RN 1's hire date was November 16, 2010.

The "90-Day Staff Performance Appraisal" was signed by RN 1 and dated June 20, 2011, and indicated the next review date was "June 2011."

RN 1's annual "Formal Performance Evaluation" was reviewed with RN 1 on June 20, 2011.

The facility policy and procedure titled "Performance Evaluations" reviewed December 2010, indicated "... Conduct an initial written performance evaluation on or before the first 90 days of employment. ..."

On July 28, 2011, at 8:50 a.m., an interview was conducted with the Director Human Resources (DHR) and the Human Resources Generalist (HRG) II. They stated the facility "Performance Evaluations" policy and procedure affects all facility employees to include perdiem employees. The HRG II stated the "90-Day Staff Performance Appraisal" should be completed 90 days after the date of hire, and if an extension was given an explanation for why the extension was given should be written under "Summary." In addition, the HRG II stated RN 1 should of had either a 90 day evaluation completed in late February or early March, or an extension should have been documented with the reason for the extension.

A subsequent interview was conducted with the DHR, the HRG II, and the Director Critical Care Services (DCCS), on July 28, 2011, at 3:30 p.m. They stated they were unable to find documentation of a "90-Day Staff Performance Appraisal" being given to RN 1 before June 20, 2011.

Based on observation, interview, and record review, the facility failed ensure medications were administered in accordance with the facility's policy and procedure consistent with accepted standards of practice for 2 of 73 sampled patients (Patient 11 and 23).

1. For Patient 11, RN 1 administered an excessive dose of an injectable medication (desmopressin- a medication to decrease urination. It is used to treat diabetes insipidus, which is a condition in which the kidneys are unable to conserve water) and did not use a filtered needle while withdrawing the medication out of a glass ampul. RN 1 also administered an injectable medication (Protonix-medication used to reduce stomach acid production to prevent heartburn and gastrointestinal ulcers) at a rate faster than manufacturers recommendations.

These failed practices resulted in medication errors which potentially placed the patient at risk for serious harm by not following manufacturer's recommendations and the facility's policy and procedure for preparing intravenous injectable medications, the effect of which would not be easily reversible.

In addition, the facility failed to respond timely to address the serious medication errors and immediately implement preventive actions to minimize the impact to patients.

2. For Patient 23, the facility RN failed to follow a physician's order to administer a medication to lower blood pressure. Failure to administer medication for high blood pressure could potentially lead to complications such as stroke, heart attack and/or kidney failure.

Findings:

1. Medication pass observation was conducted with RN 1 on July 26, 2011, starting at 9:16 a.m. RN 1 prepared and administered four medications during the time of observation for Patient 11, and the following medication errors were observed:

a. RN 1 prepared Protonix (medication used to reduce stomach acid production to prevent heartburn and gastrointestinal ulcers) IV (intravenous) 40 mg injection vial, diluted with 10 ml (milliliters) of normal saline, but failed to administer via IV over a period of at least two minutes. Instead, RN 1 was observed to administer the 40 mg dose of Protonix IV push over 11 seconds;

b. RN 1 prepared and administered an injectable dose from 1-ml glass ampul of Desmopressin (medication used ) 4 mcg/ml (microgram per milliliter) without using a filter needle to withdraw the medication from the glass ampul after opening it by breaking the top portion of the glass ampul;

c. RN 1 was observed to withdraw and administer 0.8 ml from the 1-ml glass ampul of Desmopressin 4 mcg/ml (total dose of 3.2 mcg Desmopressin).

Review of Patient 11's record indicated the physician order written on July 24, 2011, was for 2 mcg Desmopressin to be administered via IV every 12 hours.

The manufacturer's package insert for Protonix stated, "Two Minute Infusion. PROTONIX I.V. for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP, to a final concentration of approximately 4 mg/mL. The reconstituted solution may be stored for up to 24 hours at room temperature prior to intravenous infusion and does not need to be protected from light. PROTONIX I.V. for Injection should be administered intravenously over a period of at least 2 minutes."

During the interview on July 26, 2011, at 9:45 a.m., RN 1 stated that she was not aware of the two minute infusion time for Protonix IV and acknowledged that the Protonix infusion for the patient took significantly less than two minutes.

RN 1 acknowledged that she knew she should have used the filtered needle to withdraw
the Desmopressin dose but admitted that she did not use the filtered needle to withdraw the medication after breaking the glass ampul.

RN 1 also stated that she meant to withdraw 1 ml (equal to 4 mcg) of Desmopressin from the glass ampul but was only able to withdraw 0.8 ml (equal to 3.2 mcg) into the syringe because some of the medication was spilled.

On July 26, 2011, at 10 a.m., the medication errors that were made by RN 1 were discussed with the DP (Director Pharmacy), Pharmacist 4, and Nurse Manager (NM) 3.

On July 26, 2011, at 6 p.m., it was observed RN 1 was continuing to care for patients in the ICU.

Review of the ICU shift schedule indicated RN 1 was assigned two ICU patients including Patient 11 during her shift.

On July 26, 2011, at 6 p.m., during an interview, NM 3 stated that she had spoken to RN 1 about the medication errors made that morning but did not address the Desmopressin dosing error with RN 1.

NM 3 stated that she thought 1 ml of Desmopressin equaled 2 mcg and failed to realize the dosing error was made until she saw the concentration of 4 mcg/ml on the glass ampul of Desmopressin, the physician order for Desmopressin IV 2 mcg, and the morning dose of Desmopressin 3.2 mcg administered to Patient 11 by RN 1. NM 3 failed to investigate and respond to the full extent the dosing error and its potential consequences.

Record review for Patient 11 indicated he was a 32 year old male admitted from the Emergency Room with a chief complaint of altered mental status and generalized weakness due to severe hypernatremia (high sodium blood level) caused by his condition of diabetes insipidus (condition in which kidneys are unable to conserve water). His home medication included DDAVP (Desmopressin).

Review of Patient 11's MAR revealed the precautionary comment for Protonix was missing from the MAR.

During an interview on July 29, 2011, at 10 a.m., the DP explained that the pharmacy order entry into the computer system for Protonix IV could be done in two ways: (1) By use of PCO, preset order form for Protonix IV or (2) Manual pick of the drug, Protonix IV from the list of drugs. The DP stated that by manually picking the drug, the pharmacist who was entering the order in the computer system would have to manually enter precautions/warnings in the comment field for it to print on the MAR. The DP further stated that she had identified two pharmacists who were manually picking the drug and not entering the precautionary comment to be printed on the MAR to alert the nurses of the administration time that was included in the PCO for Protonix IV.

The DP acknowledged that there were inconsistencies in drug order entries and stated that 90 percent of the time the MAR would have the intended printed comments.

The facility's document titled, "Guidelines for the Administration of Intravenous Medications, Adult" was reviewed and it stipulated in foot notes on each page of the document,

"Use filter needle for all ampuls."

On July 28, 2011, at 10 a.m., during an interview, NM 4 stated that the above document was available on her nursing unit as a resource.

On August 2, 2011, at 2 p.m., during an interview, the DP stated that "Guidelines for the Administration of Intravenous Medications, Adult" was an attachment to the facility's IV guideline policy and stated that on the front page of the attachment was added, "When withdrawing medication contained in a glass ampule, a filter needle must be used."

The facility's policy and procedure titled, "Intravenous Therapy" was reviewed and it stated,

"B. Intravenous Medications Given by Registered Nurses
1. Registered nurses may give medications IV push or IV infusion according to the 'Guidelines for Administration of Intravenous Medications.'"

The facility's policy and procedure titled, "Clinical Resource - Lippincott" was reviewed and it stated,

"Purpose:
To establish guidelines to outline process for approved nursing reference materials.
Policy ...
E. Reference: Lippincott's Nursing Procedures; Lippincott Williams & Wilkins, is available electronically through the hospital intranet navigation menu, and hard copy text on nursing units and in administration."

The printout of the section on "Mixing drugs in a syringe using two ampules" of the electronically available reference, Lippincott's Nursing Procedures stated the following:

"Insert a syringe (with a filter needle attached) to filter out any glass splinters" into the ampule without allowing the needle to come in contact with the rim of the ampule ..."

American Society of Health-Systems Pharmacists (ASHP), a nationally recognized pharmacy organization, published a guideline titled, "ASHP Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products" was reviewed which stated,

"Solutions from ampuls should be properly filtered to remove particles ..."

The facility's failure to use best practices for safe and effective administration of injectable medications in ICU (Intensive Care Unit) and avoid medication misadventures, the survey team called an .immediate jeopardy on July 26, 2011, at 6:55 p.m., in the presence of the CEO, CNO, CMO, and DRM.

The survey team accepted the facility's plan of action to resolve the immediate jeopardy situation on July 27, 2011, at 1:50 p.m., and ongoing observations, interviews, and record reviews revealed that the facility implemented the following action plan:

"1. The assigned nurse and nurse manager notified the patient's physician concerning the Protonix and Desmopressin medication administration, and of the patient's clinical status.
2. The physician informed the patient and family of the medication errors.
3. RN 1 and NM 3 were placed on immediate administrative leave.
4. The policies related to medication administration and intravenous therapy were reviewed to ensure they reflect medications would be administered in accordance with physician orders and manufacturer's recommendations including the use of filtered needles with glass ampules.
5. All bedside Registered Nurses (RN), including registry and traveling RNs, would be re-inserviced through a read and sign on medication administration with special emphasis on administration of IV medications in accordance with manufacturer recommendations for preparation and rate of administration.
6. The Pharmacy would add a pop up alert in Pyxis (automated drug dispensing cabinet: ADC) to administer Protonix IV over two minutes per manufacturer's recommendations.
7. All Clinical Managers and Clinical Directors would be reinserviced on the Medication Error Reporting Policy with special emphasis on their responsibility in investigating, reporting, and instituting follow up actions to ensure patient safety."

The immediate jeopardy situation was removed on July 28, 2011, at 2:15 p.m.





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2. On July 25, 2011, Patient 23's medical record was reviewed. A physician telephone order, on July 22, 2011, at 10:45 p.m., indicated, "Hydralazine (medication used to lower blood pressure) 5 mg every four hours intravenous as necessary for a systolic blood pressure greater than 150, diastolic over 90."

The documentation in the "Patient Progress Note", on July 22, 2011, at 10:45 p.m., indicated the physician was informed of the patient's blood pressure, 152/72, and orders were made and carried out.

According to the "Graphic & Fluid Balance Record", Patient 23's blood pressure was over 150 systolic during the following times.
152/72 8 p.m. July 22, 2011
165/81 12 a.m. July 22, 2011
170/83 4 p.m. July 23, 2011
184/89 8 p.m. July 23, 2011

A report from Pyxis (automated drug dispensing cabinet) was reviewed between July 22, 2011, at 7:13 a.m., and July 23, 2011, at 10:36 p.m. The report indicated Hydralazine was first removed from Pyxis on July 23, 2011, at 6:51 p.m. There was no documentation in the medical record to indicate whether Patient 23 received the medication, Hydralazine 5 mg between the hours of 8 p.m. and 12 midnight, on July 22, 2011, as ordered by the physician. There was no documentation to indicate why the medication was not given.

In an interview and concurrent review of the medical record on July 25, 2011, at 2:10 p.m., RN 9 agreed that there was no documentation in the medical record to indicate the medication was administered during these times.

In an interview on July 25, 2011, at 3:15 p.m., RN 9 stated there was no documentation of Patient 23's vital signs other than what was documented on the vital signs record and on the Patient Progress Note. The manager stated, "there was no documentation to indicate the medication was given."

Based on interview and record review, the facility failed to ensure medical records were accurate, complete, and/or accessible for 9 of 73 sampled patients (Patients 4, 7, 32, 33, 34, 53, 54, 55, and 56), by failing to ensure:

1. A complete medical record is provided by the medical records department to ED patients upon their request post discharge for Patients 33, and 34.

2. Their medication reconciliation policy was implemented for Patient 32.

3. The dose, as indicated by "UR," was clarified with the physician when an order was written on the "Medication Reconciliation Admission Orders, Inpatient" on July 25, 2011, at 9:40 a.m., until the next day for Patient 53.

4. The "Outpatient Home Medication List" was signed at discharge by the patient/representative for Patients 54, 55, 56, and 57.

5. The echocardiogram ordered for Patient 4, on July 24, 2011, was performed or a cancellation order was obtained and recorded.

6. That the "Labor and Delivery Summary" Patient 7, accurately reflected the patient's labor medications.

These failed practices could potentially impact the provision of medical care for patients and their providers regarding medication management and their medical needs across the continuum of care.

Findings:

1. A review of Patient 34's record viewed through the facility's main electronic record system was conducted. Patient 34 was admitted to the facility on July 5, 2011, with a diagnosis of abdominal pain, cause unknown, and was discharged on the same day. The record failed to reflect the patient's discharge instructions.

A review of Patient 33's record viewed through the facility's main electronic record system was conducted. Patient 33 was admitted to the facility on July 15, 2011, with a diagnosis of a kidney cyst (tumor) and a urinary track infection. Patient 33 was discharged the same day. The record failed to reflect the patient's discharge instructions.

A review of the facility document, "Documentation Content: Medical Record (Reviewed: 12/2010)," indicated the purpose as, "To establish guidelines to ensure complete, timely and legible medical records for all patients admitted or accepted for treatment." The procedure indicated the ED medical record shall consist of, "Discharge instructions to provide the education to the patient/family, including discharge medications."

A review of the facility document, "Authorization For Use Or Disclosure Of Health Information, (undated)," indicated when an individual authorizes the use and/or disclosure of health information choosing box "a" indicates a request for, "All health information pertaining to my medical history..." There was no area on the document which notifies the individual requesting their medical records that the discharge information from the ED must be requested specifically.

An interview was conducted with the Director Of Health Information Management (DHIM) on August 2, 2011, at 9 a.m. The DHIM stated, "The discharge section of the ED record is in a separate electronic system called 'Exit Rider', which does not interface with the rest of the electronic record. If a patient wants a copy of their discharge instructions they would have to request that document specifically. The staff would then go to the ED and print it, otherwise the patient requesting their medical record would not receive it."

2. A review of Patient 32's record was conducted on July 26, 2011, at 9:30 a.m. Patient 32 was admitted to the facility on July 21, 2011, at 7:50 p.m., with a diagnosis of chronic obstructive lung disease.

A review of Patient 32's "Medication Reconciliation Admission Orders, Inpatient," (a listing of which medications that the patient was taking prior to admission that the patient will or will not continue to take during the hospital stay), indicated the document was approved and reconciled by Patient 32's physician on July 25, 2011, at 3:55 p.m., four days after admission. There was no documentation to show the Medication Reconciliation document was faxed or scanned to the pharmacy.

An interview was conducted with RN 11 on July 26, 2011, at 10:45 a.m., who stated Patient 32's Medication Reconciliation form was not completed upon admission nor was it scanned to the pharmacy.

Patient 32 was discharged to a skilled nursing facility on July 27, 2011, at 10 a.m. Further record review failed to show that the Medication Reconciliation form was completed upon discharge, or faxed to the receiving facility.

A review of the facility document, "Medication Reconciliation Across The Continuum Of Care, (Issued 5/2011)," indicated the purpose, "To minimize the risk of medication errors by obtaining patient medication histories and reconciling medications on admission, at each level of care, and on discharge."

The procedure indicates, " At admission to all units of (the facility), a licensed caregiver will obtain from the patient or caregiver the current medications used at home...The completed form is now a physician's admitting order and will be faxed to the pharmacy and placed in the medical record in front of the physician's orders...If the patient is being transferred to another facility, the reconciliation sheet and Discharge Form will be faxed or transferred with the patient to that facility."


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3. On July 26, 2011, the record for Patient 53 was reviewed. Patient 53 was admitted to the facility on July 25, 2011, with diagnosis of surgical laparoscopic hysterectomy (removal of the uterus through an abdominal scope).

The "Medication Reconciliation Admission Orders, Inpatient" indicated the home medications taken by the patient prior to admission was gathered by the nurse on June 25, 2011, at 6:30 a.m. The medications "Robitussin DM" and "Pepcid" had "UR (unable to recall)" for the "Dose." The physician signed the order on July 25, 2011, at 9:40 a.m., and indicated "Physician Medication Order - Continue Medication" and the box for "Yes" was checked for "Robitussin DM" and "Pepcid." RN 3 noted the orders on July 25, 2011, at 5 p.m.

A second "Medication Reconciliation Admission Orders, Inpatient" indicated the home medications prior to admission information was gathered by the nurse on June 25, 2011, at 5 p.m. The medication "Robitussin DM" indicated two tablespoons for the dose and the medication "Pepcid" indicated 20 milligrams for the dose. The order was a telephone order taken by RN 3 on July 25, 2011, at 5 p.m.

The "Medication Administration Record (MAR)" dated July 25, 2011, did not include "Robitussin DM" or "Pepcid."

On July 26, 2011, at 1:10 p.m., an interview was conducted with RN 3. She stated she "scanned" the orders to the pharmacy on July 25, 2011, at 5 p.m., but she did not clarify the orders with the physician until July 26, 2011, sometime in the morning, even though the "revised" "Medication Reconciliation Admission Orders, Inpatient" indicated she had taken a telephone order from the physician on July 25, 2011, at 5 p.m., clarifying the "Dose" orders for both "Robitussin DM" and "Pepcid." In addition, RN 3 stated she should have clarified the dose orders for both "Robitussin DM" and "Pepcid" with the physician on July 25, 2011, before she noted the order, and she should have dated the "revised" "Medication Reconciliation Admission Orders, Inpatient" with the date she actually wrote the order or wrote the order as a "late entry."

The facility policy and procedure titled "Physician's Orders" reviewed December 2010, indicated "To establish guidelines for obtaining and processing physician's orders to ensure prompt quality patient care is provided. ... Physician's orders will be accurately processed and promptly followed. ... Written orders will be transcribed and implemented promptly. ... If the order is not complete, the ordering physician will be called to clarify the order. ..."

4a. On July 26, 2011, the record for Patient 54 was reviewed. Patient 54 was seen as an outpatient in the labor and delivery department for possible leaking of vaginal fluid on July 25, 2011, at 4:50 p.m.

The "Nursing Flowsheet" dated July 25, 2011, indicated Patient 54 received a medical screening examination by a nurse and was discharged home in stable condition with instructions on July 25, 2011, at 9:10 p.m.

The "Outpatient Medication Reconciliation and Physician's Order" dated July 25, 2011, indicated "As a result of this visit, home medications will not be changed" was marked. The "Outpatient Medication Reconciliation and Physician's Order" indicated "I have received this list of my home medications and the importance of managing my medication information has been explained to me including ... " was not signed by Patient 54 or her representative.

b, On July 26, 2011, the record for Patient 55 was reviewed. Patient 55 was seen as an outpatient in the labor and delivery department for decreased fetal movement on July 25, 2011, at 10:05 p.m.

The "Nursing Flowsheet" dated July 25, 2011, indicated Patient 55 received a medical screening examination by a nurse who determined there was "no emergency medical condition." Patient 54 was discharged home on July 25, 2011, at 12:44 a.m., and discharge instructions were given.

The "Outpatient Medication Reconciliation and Physician's Order" dated July 25, 2011, indicated "As a result of this visit, home medications will not be changed" was marked. The "Outpatient Medication Reconciliation and Physician's Order" indicated "I have received this list of my home medications and the importance of managing my medication information has been explained to me including ... " was not signed by Patient 55 or her representative.

c. On July 26, 2011, the record for Patient 56 was reviewed. Patient 56 was seen as an outpatient in the labor and delivery department for vaginal bleeding on June 7, 2011, at 5:53 p.m.

The "Nursing Flowsheet" dated June 7, 2011, indicated Patient 56 received a medical screening examination by a nurse and was discharged home on June 7, 2011, at 9:50 p.m., with discharge instructions.

The "Outpatient Home Medication List" dated June 7, 2011, indicated "No change to your current home medications. If you have any questions, please contact your doctor." was marked. The area "I have reviewed this information & provided the list to the (check box) patient (check box) __________" was not marked and the "Outpatient Home Medication List" was not signed by Patient 56 or her representative.

d. On July 26, 2011, the record for Patient 57 was reviewed. Patient 57 was seen as an outpatient in the labor and delivery department for mild contractions, nonstress testing (monitoring to aid in the determination of fetal well-being) and administration of betamethasone (a medication used to mature fetal lungs) on May 11, 2011, at 11:50 a.m.

The "Nursing Flowsheet" dated May 11, 2011, indicated Patient 57 was "discharge to home undelivered and stable" and "written discharge instructions given" on May 11, 2011, at 2:45 p.m.

The "Outpatient Home Medication List" dated May 11, 2011, indicated neither "No change to your current home medications. If you have any questions, please contact your doctor." nor "Change the following: ____" were marked. The area "I have reviewed this information & provided the list to the (check box) patient (check box) __________" was not marked and the "Outpatient Home Medication List" was not signed by Patient 57 or her representative.

On July 26, 2011, at 1:50 p.m., an interview was conducted with RN 7. She stated for outpatients, the discharge instructions and home medications lists were signed by the patient and a copy of both were given to the patient upon discharge.

The facility policy and procedure titled "Medication Reconciliation Across the Continuum of Care" issued 2008, revised April 2011, indicated "... Upon discharge, the nurse will review the Medication Reconciliation form. ... The copy will be given to the patient and the patient will sign the form indicating that they have received the list and that the importance of medication information has been explained to them. ..."



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5. During a review of the medical record of Patient 4 on July 26, 2011, an order for an echocardiogram (ultrasound of the heart), was seen dated July 24, 2011. However, there was no notation that the test had been performed, and there was no echocardiogram found that was done in response to the July 24, 2011, order.

In an interview with RN 11 on July 26, 2011, at approximately 1 p.m., she stated that the echocardiogram technologist had called a physician who was on-call for the patient ' s condition. That physician cancelled the order for the echocardiogram. RN 11 stated that the cancellation should have been recorded in an order from the physician.

6. During a review of the medical record of Patient 7 on July 25, 2011, the record contained a form titled, "Labor and Delivery Summary." The pre-printed form had boxes to be checked to indicate which conditions and treatments applied to Patient 7. The box for "Augmentation" (the act of accelerating the labor process) and "Pitocin" a medication that can induce or accelerate labor) were checked. A review of the medical record failed to reveal an order for Pitocin for augmentation, and there was no documentation in the medication records or the progress notes to indicate that Pitocin had been given during labor.

The facility policy, "Documentation: Labor and delivery Room Procedures and Care", reviewed 12/2010, was seen on July 27, 2011, and included the directive, "Documentation of the labor patient's assessment and ongoing care shall occur in both the paper and electronic patient record."

During an interview with RN 10 on July 25, 2011, at 9:45 a.m., she stated that the right column on the form was for post-partum medications, and that the terms "augmentation" and "Pitocin" appeared to have been marked in error. She stated there was no record of Pitocin being ordered prior to the delivery of the infant.

Based on interview and record review, the facility:

1. Failed to ensure perinatal medical screening exams (MSE) and nonstress tests (NST) were evaluated by the physicians, and the outpatient records were signed by the physicians per facility policies and procedures for four of 73 sampled patients, (Patients 51, 52, 56, and 57). This failed practice prevented the physician from authenticating the perinatal outpatient records and evaluating the services provided by the nurse for a MSE or NST.

2. Failed to ensure the physician's orders were noted "promptly" by the nurse per facility policy and procedure for one of 73 sampled patients (Patient 53). This failed practice had the potential to delay care to Patient 53 as ordered by the physician.

Findings:

1a. On July 28, 2011, the medical record for Patient 51 was reviewed. Patient 51 was seen as an outpatient in the labor and delivery department on ten occasions from April 28 through July 12, 2011. The "OB Outpatient Record" was reviewed for each visit. The documents indicated a medical screening exam was completed by an RN on each visit. One of ten visits, dated June 14, 2011, was signed by the physician within 48 hours to authenticate the physicians review and approval of the medical screening exam completed by the RN. Two of ten visits, dated May 4 and June 24, 2011, were signed by a physician, but not within the required 48 hours after the examination was completed. Seven visits, dated April 28, June 3, 4, 25, July 6 and 12, 2011, did not contain a physician signature to authenticate the medical screening exam.

The fetal monitoring strips were reviewed for all ten visits. None of the fetal monitoring strips were signed by the physician to indicate review and approval of the medical screening exams by the RN.

The electronic nursing documentation was reviewed for all ten visits. There was no electronic signature by the physician to indicate review and approval of the medical screening exams by the RN.

b. On July 28, 2011, the medical record for Patient 52 was reviewed. Patient 52 was seen as an outpatient in the labor and delivery department on three occasions on May 19, June 8, and 10, 2011. The "OB Outpatient Record" was reviewed for each visit. The documents indicated a medical screening exam was completed by a RN on each visit. All three medical screening exams were not signed by the physician to authenticate the physicians review and approval of the medical screening exam completed by the RN.

The fetal monitoring strips were reviewed for all three visits. None of the fetal monitoring strips were signed by the physician to indicate review and approval of the medical screening exams by the RN.

The electronic nursing documentation was reviewed for all three visits. There was no electronic signature by the physician to indicate review and approval of the medical screening exams by the RN.


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c. On July 26, 2011, the records for Patient 56 were reviewed. Patient 56 was seen as an outpatient in the labor and delivery department on June 7, 2011, and July 16, 2011. The "OB Outpatient Record," "Nursing Flowsheets," and fetal monitoring strips were reviewed for each visit. The documents indicated a medical screening examination was completed by a perinatal nurse on each visit. There was no indication the physician had evaluated the written outpatient records and fetal monitor strips by signing the "OB Outpatient Record."

d. On July 26, 2011, the records for Patient 57 were reviewed. Patient 57 was seen as an outpatient in the labor and delivery department for a medical screening exam (MSE) on May 8 and 11, 2011, and for nonstress testing (NST) on May 12, 16, 19, 23, 27, 30, and June 3, 2011. The "OB Outpatient Record," "Nursing Flowsheets," and fetal monitoring strips were reviewed for MSE visits. The documents indicated a medical screening examination was completed by a perinatal nurse on each visit. There was no indication the physician had evaluated the written outpatient records and fetal monitor strips by signing the "OB Outpatient Record."

The "Nursing Flowsheets" and fetal monitoring strips were reviewed for each NST visit. The documents indicated a nonstress test was completed by a perinatal nurse on each visit. There was no indication the physician had reviewed and initialed the fetal monitoring strips in either writing or electronically.

On July 27, 2011, at 2:15 p.m., an interview was conducted with the Director of Health Information Management (DHIM), Nurse Manager (NM 2), and Educator 1. They stated the physician was supposed to sign the outpatient record. In addition, they stated the physician should sigh a NST within 24 hours of the test occurring and authenticate a medical screening exam performed by a perinatal nurse within 48 hours of the examination occurring.

On July 27, 2011, at 3:30 p.m., an interview was conducted with Health Information Management Coordinator (HIMC 1). She stated for the perinatal outpatient records, HIM flags the physician's orders and progress notes, if there were any. In addition, she stated HIM did not flag the "OB Outpatient Record" or the fetal monitor strips for the physician's signature.

During an interview with Educator 1, on July 27, 2011, at 4:30 p.m., she reviewed the clinical records for Patients 56 and 57, and she was not able to find documentation (for the 11 outpatient visits) that the physicians had reviewed and initialed the fetal monitor strips for nonstress testing outpatient visits or had evaluated the written outpatient record and fetal monitor strips by signing the "OB Outpatient Record" for MSE visits.

The facility "Medical Staff Bylaws 2011" dated June 23, 2011, indicated "Basic Responsibilities of Medical Staff Membership ... (b) abiding by the Medical Staff bylaws, Medical Staff rules and regulations, and policies and Medical-Staff approved Hospital policies and procedures, ... (d) preparing and completing in timely fashion medical records for all the patients to whom the member provides care in the Hospital ..."

The facility policy and procedure titled "Standardized Procedure: EMTALA-2-Perinatal Medical Screening Exam" reviewed July 2011, indicated "... The primary physician shall evaluate the written outpatient record and any fetal monitor strips obtained during the observation period. The physician will countersign his telephone orders and sign the outpatient record. ..."

The facility policy and procedure titled "Nonstress Test" dated November 2010, indicated "... The physician must review and initial the NST within twenty-four (24) hours of completion of the test. This may be done remotely via the electronic documentation system (OBTVUE). ..."

2. On July 26, 2011, the record for Patient 53 was reviewed. Patient 53 was admitted to the facility on July 25, 2011, with diagnosis of surgical laparoscopic hysterectomy (removal of the uterus through an abdominal scope).

The "Medication Reconciliation Admission Orders, Inpatient" dated July 25, 2011, at 9:40 a.m., indicated Claritin 20 mg po (by mouth) daily for allergies, Robitussin DM "UR (unable to recall dose)" po prn (as needed) for allergies, and Pepcid "UR" po prn for indigestion, and the three boxes for "Continue Medication" were checked "Yes." RN 3 "noted" the order on June 25, 2011, at 5 p.m.

The "Medication Administration Record (MAR)" dated July 25, 2011, did not indicate the three medications were available for administration to Patient 53.

On July 26, 2011, at 1:10 p.m., an interview was conducted with RN 3 and RN 4. They stated when a physician's medication order was written, the record with the order went to the unit secretary who "scanned" the medication orders to the pharmacy. They stated the record then went to the charge nurse, or the patient's nurse, who "noted" the orders and wrote the medication order on the MAR. In addition, RN 3 and RN 4 stated "a nurse should note physician's orders within two hours of the time they were written."

The facility policy and procedure titled "Physician's Orders" reviewed December 2010, indicated "To establish guidelines for obtaining and processing physician's orders to ensure prompt quality patient care is provided. ... Physician's orders will be accurately processed and promptly followed. ... Written orders will be transcribed and implemented promptly. ... If the order is not complete, the ordering physician will be called to clarify the order. ..."

Based on interview and record review, the facility failed to ensure telephone/verbal orders were authenticated within 48 hours for 6 of 73 sampled patients, (Patients 7, 17, 51, 52, 56 and 57). This failed practice could potentially result in errors with medication management or a delay in treatment and care to the patient.

Findings:

1. During a review of the medical record of Patient 7 on July 25, 2011, the file contained a form titled, "Outpatient Observation Orders." The pre-printed form had orders for performing a sterile vaginal exam to determine cervical status, and an order for PO (oral) hydration. The telephone orders were dated July 22, 2011, at 7 p.m., but the physician did not sign them until July 25, 2011, at 8 a.m., 59 hours later.

During an interview with the CMO on July 25, 2011, at 10 a.m., he looked at the Outpatient Observation Orders of Patient 7 and concurred that the orders had not been signed within 48 hours and that the policy was for the physician to sign within 48 hours.

The facility policy, "Physician's Orders" (revised March, 2010), was reviewed on July 28, 2011. The policy read in part, "Verbal/Telephone orders are to be authenticated within 48 hours by the physician giving the order."

2. A review of Patient 17's record was conducted on July 25, 2011. Patient 17 was admitted to the facility on July 7, 2011, with a diagnosis of diabetes mellitus.

There was no physician authentication completed within 48 hours on the following seven dates and times when a verbal/telephone order was received from the physician by the licensed nurse;

July 14, 2011, 2:40 p.m.,
July 16, 2011, 9:30 p.m.,
July 17, 2011, 8:30 a.m.,
July 17, 2011, 11:30 a.m.,
July 17, 2011, 7:33 p.m.,
July 18, 2011, at 4:30 p.m., and
July 21, 2011, 11:30 a.m.

A review of the facility policy, "Clinical Practice Providing Care (Title: Physician's Orders (Reviewed 12/2010)," indicated, "Verbal/Telephone orders are to be authenticated within 48 hours by the physician giving the order."

An interview was conducted with the Nurse Manager (NM 3) on July 25, 2011, at 2:30 p.m., who stated physician's orders need to be signed within 48 hours.


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3. Patient 51 was seen as an outpatient at the IVMC Women's Center on ten occasions from April 28 through July 12, 2011. Patient 51 was evaluated by a RN, who called the physician after the examination and received telephone orders. During a review of the physician orders of the outpatient visits, the following was noted:

i. An "Outpatient Physician Orders" sheet for an outpatient visit dated April 28, 2011, was electronically signed by the physician on May 9, 2011. The signature was made 11 days after the outpatient visit.

ii. An "Outpatient Physician Orders" sheet for an outpatient visit dated May 4, 2011, was electronically signed by the physician on May 22, 2011. The signature was made 18 days after the outpatient visit.

iii. An "Outpatient Physician Orders" sheet for an outpatient visit dated May 21, 2011, was electronically signed by the physician on May 31, 2011. The signature was made 10 days after the outpatient visit.

iv. An "Outpatient Observation Orders" sheet for an outpatient visit dated June 3, 2011, was electronically signed by the physician on June 13, 2011. The signature was made eight days after the outpatient visit.

v. An "Outpatient Observation Orders" sheet and a "Physician's Order Sheet" dated June 4, 2011, were electronically signed by the physician on June 13, 2011. The signature was made nine days after the outpatient visit.

vi. An "Outpatient Observation Orders" sheet dated June 14, 2011, was electronically signed by the physician on June 23, 2011. The signature was made nine days after the outpatient visit.

vii. An "Outpatient Observation Orders" sheet dated June 25, 2011, was electronically signed by the physician on July 11, 2011. The signature was made 16 days after the outpatient visit.

viii. An "Outpatient Observation Orders" sheet, "Discharge Orders" dated June 26, 2011, had an electronic signature by the physician on July 11, 2011. The signature was made 15 days after the outpatient visit.
The admission portion of the "Outpatient Observation Orders" and an "Outpatient Medication Reconciliation and Physician's Order" sheet dated June 26, 2011, were not signed by the physician.

ix. An "Outpatient Observation Orders" sheet dated July 6, 2011, was electronically signed by the physician on July 20, 2011. The signature was made 14 days after the outpatient visit.
The "Discharge Orders" and an "Outpatient Medication Reconciliation and Physician Orders" sheet dated July 6, 2011, were not signed by the physician.

x. An "Outpatient Observation Orders, Discharge Orders" dated July 12, 2011, was electronically signed by the physician on July 22, 2011. The signature was made 14 days after the outpatient visit.
The admission portion of the form did contain orders for fetal monitoring and PO hydration, but there was no signature for the admission orders by the nurse or physician.
An "Outpatient Medication Reconciliation and Physician's Order" dated July 12, 2011, was not signed by the physician.

4. Patient 52 was seen as an outpatient at the IVMC Women's Center on three occasions from May 19, through June 10, 2011. Patient 52 was evaluated by a RN, who called the physician after the examination and received telephone orders. During a review of the physician orders of the outpatient visits, the following was noted:

i. An "Outpatient Physician Orders" sheet and a "Physician's Order Sheet dated May 19, 2011, was electronically signed by the physician on June 15, 2011. The electronic signature was made 27 days after the outpatient visit.

ii. An "Outpatient Observation Orders" sheet and a "Physician's Order Sheet dated June 9, 2011, were electronically signed by the physician on June 28, 2011. The electronic signature was 19 days after the outpatient visit.
An "Outpatient Medication Reconciliation and Physician's Order" sheet dated June 9, 2011, was not signed by the physician.

iii. An "Outpatient Observation Orders" sheet and a "Physician Order Sheet dated June 10, 2011, was electronically signed by the physician on June 28, 2011. The electronic signature was 18 days after the outpatient visit.

An "Outpatient Medication Reconciliation and Physician's Order " sheet dated June 9, 2011, was not signed by the physician.


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5. On July 26, 2011, the records for Patient 56 were reviewed. Patient 56 was seen as an outpatient in the labor and delivery department on June 7, 2011, for vaginal bleeding and on July 16, 2011, for premature labor (contractions prior to the 37th week of pregnancy).

There was no physician authentication completed for verbal/telephone orders received by the RN from the physician on the following dates and times within 48 hours:

June 7, 2011, at 9:50 p.m. - Outpatient Observation Orders;
June 7, 2011, at 9:50 p.m. - Discharge Orders; and
July 16, 2011, at 5:20 p.m. - Discharge Orders.

6. On July 26, 2011, the records for Patient 57 were reviewed. Patient 57 was seen as an outpatient in the labor and delivery department on:
May 8, 2011, for premature contractions;
May 11, 2011, for mild contractions, nonstress testing (monitoring to aid in the determination of fetal well-being) and administration of betamethasone (a medication used to mature fetal lungs);
May 12, 2011, for fetal monitoring;
May 16, 2011, for nonstress testing (NST) for preterm labor;
May 19, 2011, for NST for preterm labor;
May 23, 2011, for NST for preterm labor;
May 27, 2011, for NST for preterm labor;
May 30, 2011, for NST for preterm labor; and
June 3, 2011, for NST for preterm labor.

There was no physician authentication completed for verbal/telephone orders received by the RN from the physician on the following dates and times within 48 hours:

May 8, 2011, at 10:18 a.m.;
May 8, 2011, at 12:40 p.m.;
May 8, 2011, at 2:42 p.m.;
May 8, 2011, at 3:57 p.m.;
May 11, 2011, at 12:00 p.m.;
May 11, 2011, at 1:29 p.m.;
May 11, 2011, at 2:15 p.m.;
May 12, 2011, at 3:25 p.m. (testing orders);
May 12, 2011, at 3:25 p.m. (discharge orders);
May 16, 2011, at 9:34 a.m.;
May 19, 2011, at 9:30 a.m.;
May 23, 2011, at 10 a.m.;
May 27, 2011, at 11:20 a.m.;
May 30, 2011, at 4:36 p.m. (Outpatient Observation Orders);
May 30, 2011, at 4:36 p.m. (Discharge Orders);
June 3, 2011, at 4:10 p.m.; and
June 3, 2011, at 5:30 p.m.

On July 27, 2011, at 2:20 p.m., an interview was conducted with the Director Health Information Management (DHIM). She stated the physicians were supposed to authenticate their telephone and verbal orders within 48 hours of the time the order was written.

The "Medical Staff Rules and Regulations" dated July 28, 2011, indicated "... Verbal Orders ... The responsible practitioner shall countersign, date and time the order within 48 hours from the time the order was written. ..."


26881

6. During a review of the medical record of Patient 7 on July 25, 2011, the file contained a form titled, "Outpatient Observation Orders." The pre-printed form had orders for performing a sterile vaginal exam to determine cervical status, and an order for PO (oral) hydration. The telephone orders were dated July 22, 2011, at 7 p.m., but the physician did not sign them until July 25, 2011, at 8 a.m., 59 hours later.

During an interview with the CMO on July 25, 2011, at 10 a.m., he looked at the Outpatient Observation Orders of Patient 7 and concurred that the orders had not been signed within 48 hours and that the policy was for the physician to sign within 48 hours.

The facility policy, "Physician's Orders" (revised 3/2010), was reviewed on July 28, 2011. The policy read in part, "Verbal/Telephone orders are to be authenticated within 48 hours by the physician giving the order."

Based on observation, interview, and record review, the facility failed to provide pharmaceutical services that meet the needs of the patients as evidenced by the facility's failure to:
1. Maintain and implement a system with accurate records of receipt and disposition capable of readily identifying diversion of all controlled substances in such a manner as to minimize the extent of diversion. (A494)

2a. Conduct monthly audit of the Drug Diversion Report in accordance with the facility's policy and procedure;
b. Conduct monthly audit of Drug Diversion Report using Standard Deviation (SD) greater than two instead of three in accordance with the facility's policy and procedure;
c. Conduct review of controlled substance wastage in accordance with the facility's policy and procedure; and,
d. Conduct review of manual entry of ED patients for potentially inappropriate access to controlled substances by caregivers in accordance with the facility's policy and procedure. (A500)

3. Address potential delay in timely administration of medications caused by missing documentation of communication within pharmacy and other departments. (A500)

4. Have enough sterile water to mix the 36 vials of dantrolene 20 mg during an emergency. (A500)

5. Update the facility's policy and procedure that reflected the content of the Adult Crash Cart. (A500)

6. Conduct the annual review of the hospital formulary in accordance with the facility's policy and procedure. (A500)

7. Ensure an unusable medication was not available for patient use. (A505)

The cumulative effect of the systemic problems resulted in the hospital's failure to ensure the provision of pharmaceutical services in a safe environment that met the needs of the patients.

Based on observation, interview, and record review, the facility failed to maintain and implement a system with accurate records of receipt and disposition, capable of readily identifying diversion (unapproved removal and/or use) of all controlled substances in such a manner as to minimize the extent of the diversion.

Findings:

During an interview on July 27, 2011, at 4 p.m., Nurse Manager (NM 6) stated that there were two incidences of controlled substance drug diversion that were identified and investigated that involved two Registered Nurses (RN 15 and RN 16) that worked in the Emergency Department (ED).

NM 6 stated a patient (Patient 74), who was admitted to the hospital through the ED reported that the pain medications the patient received while in ED administered by RN 15 were not as effective as the pain medications received while in the inpatient nursing unit. This prompted an investigation that led to the identification of RN 15 diverting controlled substances.

According to the electronic mail (e-mail) sent to several of the facility's leadership members dated July 14, 2011, by NM 6,

"I received a patient complaint regarding (RN 15)'s care. The patient stated that she was cold and needed blankets but (RN 15) did not provide them. That her pain was uncontrolled for several hours, (RN 15) did not introduce herself or explain what she was doing, was rude and condescending, and the environment was dirty. The patient stated that she did not feel the effects of the morphine (narcotic pain medication) that (RN 15) gave her, but did feel the effects of morphine that other nurses gave her. These complaints prompted me to review (RN 15)'s narcotic activity for five 12 hour shifts ..."

NM 6's investigation of narcotic activity from July 3, 2011, to July 11, 2011, revealed that RN 15 accessed, from the Pyxis MedStation (automated drug dispensing cabinet: ADC) in ED, three 1 mg injectable Dilaudid (narcotic pain medication) without physician orders, two 0.5 mg doses from 1 mg injectable Dilaudid without documented wastage, and two doses of injectable morphine (one 4 mg and one 8 mg dose) from which the patient did not feel the effect.

NM 6 stated that RN 15 started on June 29, 2011, and her last day was July 12, 2011.

During the same interview with NM 6, she stated that an investigation and identification of drug diversion occurred for RN 16 due to the report from the Charge Nurse on June 30, 2011, that RN 16, while on duty in the ED, was observed by ED staff in the ED nurse's lounge, during work hours, to be behaving strangely, and looked, "spaced out."

NM 6's investigation of RN 16's narcotic activity spanned from June 29 and June 30, 2011, revealed that RN 16 accessed from the Pyxis MedStation in ED thirteen doses of 2 mg injectable Dilaudid without physician orders, two 1 mg doses and one 0.5 mg dose from 2 mg injectable Dilaudid without documented wastage.

During an interview on July 27, 2011, at 1:40 p.m., the DP stated that the she was informed of the two drug diversion cases by NM 6 who requested the narcotic activity report from the Pharmacy. The DP stated that she provided NM 6 the reports printed from the Pyxis Reporter that listed high users of controlled substances and the patient names from CareFusion (Pyxis analytics software that provides statistics and analysis).

The DP stated the investigation was conducted by NM 6 and there was no further investigation done by the Pharmacy. When asked about the narrow time frame of narcotic activity by the two RNs reviewed by NM 6, the DP acknowledged that the investigation could have been more thorough.

Review of the facility's policy and procedure titled, "Automated Drug Dispensing Systems" revealed the following:

"K. Reports.
1. Open Discrepancies: Will be used to ensure that all discrepancies are resolved in a timely manner ...
2. Discrepancy Report: Will be used by the unit charge nurses to verify with the following shift unit charge nurse that there are no unresolved discrepancies ...
4. Profile Override: Will be used to verify that all medications that were obtained from the Pyxis MedStation (Automated Drug dispensing Cabinet: ADC) via "override" have an order written and entered into the pharmacy computer system.
5. Diversion Reports:
a. Will be generated monthly by the Pharmacy Managers documenting employees that show 2 or more standard deviations over the average removal rate of controlled substances for a particular nursing unit.
b. The report will be distributed to the Nurse Managers for review, investigation and follow up.
c. The Nursing Manager will state whether there is further study indicated or no further analysis is required and all data checks out and return the report to the Director of Pharmacy."

During the same interview, the DP acknowledged that she did not know that the monthly diversion reports had to be generated using the standard deviation (SD) of greater than 2 rather than 3. Standard Deviation (SD) - is a measurement calculation used to show how much variation there is from the average amount. Using the standard deviation number of 3, instead of the number required in the facility policy which is 2, caused the facility to miss the deviations that would've been on the report had they followed their policy.

During an interview on July 27, 2011, at 2 p.m., Pharmacist 1 stated that the monthly diversion reports were run using SD greater than 3 since July 2010, and the SD greater than 3 had been used because it was the system default and admitted he was not able to change the parameters.

When Pharmacist 1 was able to run the diversion report for the month of April 2011, using SD of greater than 2, it was noted that the name of RN 16 appeared on the report with the SD of 2.9 and 30 doses of injectable hydromorphone (generic name for Dilaudid).

The April diversion report using the SD of greater than 2 and greater than 3 were compared and it was noted that in ED alone the number of users that appeared on the report increased from 7 users (for SD greater than 3) to 18 users (for SD greater than 2).

During an interview on July 27, 2011, at 3:30 p.m., the DP acknowledged that the earlier detection of the drug diversion by RN 16 could have been possible had the facility used the SD greater than 2 rather than 3 and that additional investigation would be needed.

Review of the facility's policy and procedure titled, "Controlled Substances" revealed the following:

"Policy:
A. General ...
3. There will be a perpetual accountability of all controlled substances including waste, discrepancies, and inventories through review of Pyxis generated reports.

Procedure ...
F. Miscellaneous Information ...
2. The pharmacy monitors the use of the MedStation system by running daily reports. The reports are reviewed for any discrepancies, wrong patients entered into the system, and any other potential abuses to circumvent the system from its original intent i.e., entering fictitious patient numbers or names to gain access to the system.
3. Pharmacy Managers will distribute "diversion" reports to nursing managers at least every 2 months that show the frequency of access of caregivers to controlled substances in relation to unit averages. Those individuals with the highest rates of access on the reports should be evaluated (i.e. random chart reviews) to assess diversion issues by the Nurse managers ..."

During the same interview, the DP was asked if controlled substances wastage report was generated and reviewed by the Pharmacy. The DP stated that other than the monthly diversion report there were no other pharmacy generated reports that were reviewed.

On July 28, 2011, at 11:30 a.m., during an interview, Pharmacist 2 stated that only the charge nurses would be able to enter patients into the Pyxis MedStation and the Pharmacy did not monitor and review the list of patients that were manually entered in to the Pyxis MedStation.

Review of the document called, "Entered ADT (admit, discharge, transfer) Information" revealed that all RNs, staff and charge nurses could enter patients manually in order to access any medications available in the Pyxis MedStation.

Review of the monthly diversion reports from July 2010, to present, indicated that the facility failed to consistently review the reports monthly, as some of the monthly reports were either not completed or incomplete.

On August 2, 2011, at 2 p.m., during an interview, the DP acknowledged that monthly reviews of the diversion reports were not done consistently.

The facility's failure to monitor controlled substances in the ED in accordance with the facility's policy and procedure resulted in the delay of drug diversion detection.

Based on observation, interview, and record review, the facility failed to ensure that drugs were controlled and distributed in accordance with the facility's policy and procedure and acceptable standards of practice by failing to:

1. a. Conduct monthly audit of Drug Diversion Report in accordance with the facility's policy and procedure.
b. Conduct monthly audit of Drug Diversion Report using Standard Deviation (SD) greater than two instead of three in accordance with the facility's policy and procedure;
c. Conduct review of controlled substance wastage in accordance with the facility's policy and procedure; and,
d. Conduct review of manual entry of ED patients for potentially inappropriate access to controlled substances by caregivers in accordance with the facility's policy and procedure.

2. Address potential delay in timely administration of medications caused by missing documentation of communication within pharmacy and other departments.

3. Have enough sterile water to mix the 36 vials of dantrolene 20 mg during emergency.

4. Update the facility's policy and procedure that reflected the content of the Adult Crash Cart.

5. Conduct the annual review of the hospital formulary in accordance with the facility's policy and procedure.

6. Ensure the Protonix (medication for the stomach) was substituted with the equivalent medication, according to the facility policy. The failed practice had the potential to result in medication administration error.

7. Clarify the physician's "Medication Reconciliation Admission Orders, Inpatient" written on July 25, 2011, at :9:40 a.m., when "UR (unable to recall)" was written for dose, until July 26, 2011, for one of 73 patients (Patient 53). This failed practice had the potential to delay treatment to the patient as ordered by the physician.

Findings:

1. During an interview on July 27, 2011, at 4 p.m., Nurse Manager (NM) 6 stated that there were two incidences of controlled substance drug diversion that were identified and investigated that involved two RNs (RN 15 and RN 16) that worked in the Emergency Department (ED).

The NM 6 stated that it was reported by a patient (Patien74) that was admitted to an inpatient unit through the ED that the pain medications the patient received while in ED administered by RN 15 were not as effective as the pain medications received while in the inpatient nursing unit. This prompted an investigation that led to the identification of RN 15 diverting controlled substances.

According to the electronic mail (e-mail) sent to several of the facility's leadership members dated July 14, 2011, by the NM 6,

"I received a patient complaint regarding (RN 15)'s care. The patient (Patient 74) stated that she was cold and needed blankets but (RN 15) did not provide them. That her pain was uncontrolled for several hours, (RN 15) did not introduce herself or explain what she was doing, was rude and condescending, and the environment was dirty. The patient stated that she did not feel the effects of the morphine (narcotic pain medication) that (RN 15) gave her, but did feel the effects of the morphine that other nurses gave her. These complaints prompted me(NM 6) to review (RN 15)'s narcotic activity for five 12 hours shifts ..."

NM 6's investigation of narcotic activity from July 3, 2011, to July 11, 2011, revealed that RN 15 accessed from the Pyxis MedStation (automated drug dispensing cabinet: ADC) in ED three 1 mg injectable Dilaudid (narcotic pain medication) without physician orders, two 0.5 mg doses from 1 mg injectable Dilaudid without documented wastage, and two doses of injectable morphine (one 4 mg and one 8 mg dose) from which the patient did not feel the effect.

NM 6 stated that RN 15 started on June 29, 2011 and her last day was July 12, 2011.

During the same interview with NM 6, she stated that investigation and identification of drug diversion occurred for RN 16 due to the report by the ED charge nurse on June 30, 2011, that RN 16 was observed to be behaving strangely.

NM 6's investigation of RN 16's narcotic activity spanned from June 29 and June 30, 2011, revealed that RN 16 accessed from the Pyxis MedStation in ED thirteen doses of 2 mg injectable Dilaudid without physician orders, two 1 mg doses and one 0.5 mg dose from 2 mg injectable Dilaudid without documented wastage.

During an interview on July 27, 2011, at 1:40 p.m., the DP stated that the she was informed of the two drug diversion cases by NM 6 who requested the ED narcotic activity report from the Pharmacy. The DP stated that she provided NM 6 the reports printed from the Pyxis Reporter that listed high users of controlled substances with the patients' names, and from CareFusion (Pyxis analytics software that provides statistics and analysis).

The DP stated the investigation was conducted by NM 6 and there was no further investigation done by the Pharmacy. When asked about the narrow time frame of narcotic activity by the two RNs reviewed by NM 6, the DP acknowledged that the investigation could have been more thorough.

Review of the facility's policy and procedure titled, "Automated Drug Dispensing Systems" revealed the following:

"K. Reports.
1. Open Discrepancies: Will be used to ensure that all discrepancies are resolved in a timely manner ...
2. Discrepancy Report: Will be used by the unit charge nurses to verify with the following shift unit charge nurse that there are no unresolved discrepancies ...
4. Profile Override: Will be used to verify that all medications that were obtained from the Pyxis Medstation (Automated Drug dispensing Cabinet: ADC) via "override" have an order written and entered into the pharmacy computer system.
5. Diversion Reports:
a. Will be generated monthly by the Pharmacy Managers documenting employees that show two or more standard deviations over the average removal rate of controlled substances for a particular nursing unit.
b. The report will be distributed to the Nurse Managers for review, investigation and follow up.
c. The Nursing Manager will state whether there is further study indicated or no further analysis is required and all data checks out and return the report to the Director of Pharmacy."

During the same interview, the DP acknowledged that she did not know that the monthly diversion reports had to be generated using the standard deviation (SD) of greater than 2 rather than 3. Standard Deviation (SD) - is a measurement calculation used to show how much variation there is from the average amount. Using the standard deviation number of 3, instead of the number required in the facility policy which is 2, caused the facility to miss the deviations that would've been on the report had they followed their policy.

During an interview on July 27, 2011, at 2 p.m., Pharmacist 1 stated that the monthly diversion reports were run using SD greater than 3 since July 2010, and the SD greater than 3 had been used because it was the system default and admitted he was not able to change the parameters.

When Pharmacist 1 was able to run the diversion report for the month of April 2011, using SD of greater than 2, it was noted that the name of RN 16 appeared on the report with the SD of 2.9 and 30 doses of injectable hydromorphone (generic name for Dilaudid).

The April diversion report using the SD of greater than 2 and greater than 3 were compared and it was noted that in the ED alone the number of users that appeared on the report increased from 7 users (for SD greater than 3) to 18 users (for SD greater than 2).

During an interview on July 27, 2011, at 3:30 p.m., the DP acknowledged that the earlier detection of the drug diversion by RN 16 could have been possible had the facility used the SD greater than 2 rather than 3 and that additional investigation would be needed.

Review of the facility's policy and procedure titled, "Controlled Substances" revealed the following:

"Policy:
A. General ...
3. There will be a perpetual accountability of all controlled substances including waste, discrepancies, and inventories through review of Pyxis generated reports.

Procedure ...
F. Miscellaneous Information ...
2. The pharmacy monitors the use of the MedStation system by running daily reports. The reports are reviewed for any discrepancies, wrong patients entered into the system, and any other potential abuses to circumvent the system from its original intent i.e., entering fictitious patient numbers or names to gain access to the system.
3. Pharmacy Managers will distribute "diversion" reports to nursing managers at least every 2 months that show the frequency of access of caregivers to controlled substances in relation to unit averages. Those individuals with the highest rates of access on the reports should be evaluated (i.e. random chart reviews) to assess diversion issues by the Nurse managers ..."

During the same interview, the DP was asked if controlled substances wastage report was generated and reviewed by the Pharmacy. The DP stated that other than the monthly diversion report, no other pharmacy generated reports were reviewed.

On July 28, 2011, at 11:30 a.m., during an interview, Pharmacist 2 stated that only the charge nurses would be able to enter patients into the Pyxis MedStation and the Pharmacy did not monitor and review the list of patients that were manually entered into the Pyxis MedStation.

Review of the document called, "Entered ADT (admit, discharge, transfer) Information" revealed that all RNs, staff and charge nurses could enter patients manually in order to access any medications available in the Pyxis MedStation.

Review of the monthly diversion reports indicated that they were not consistently reviewed monthly as some of the monthly reports were either not completed or incomplete.

On August 2, 2011, at 2 p.m., during an interview, the DP acknowledged that monthly reviews of the diversion reports were not done consistently.

American Society of Health-Systems Pharmacists (ASHP), a nationally recognized pharmacy organization, published a guideline titled, "ASHP Statement on the Pharmacist's Role in Substance Abuse Prevention, Education and Assistance" was reviewed which stated,

"Substance abuse by employees of health care organizations leads to reduced productivity, increased absenteeism, drug diversion, and almost certainly, increased accidents and medication misadventures."

2. During inspection of the Pharmacy located at the Rancho Springs Campus on July 25, 2011, 11:15 a.m., it was observed there were, on the computer screen of the Pharmacy Computer System, physician orders on queue to be processed. Some of these physician orders on queue were assigned "on hold" status.

During concurrent interview, Pharmacist 5 stated that physician orders that were assigned "on hold" status because the orders required additional information necessary for the Pharmacy order processing and needed clarification and follow-up.

Review of one of the physician orders that were assigned "on hold" status indicated there was one of the medication orders written on the preprinted form titled, "Medication Reconciliation Admission Orders, Inpatient" on July 24, 2011, at 7:20 a.m., for "Copaxone (medication used for multiple sclerosis: an inflammatory, demyelinating disease of the central nervous system that leads to physical disability ) "UR" subcutaneously every night at bedtime."

Pharmacist 5 was not sure what "UR" meant and could not tell if any of the pharmacists made any attempt to communicate the need for the missing information for Pharmacy order processing to the nurse who received the telephone order from the physician or the ordering physician. Pharmacist 5 stated that there was no documentation as to which pharmacist contacted whom and when. Pharmacist 5 also was not sure who should have been responsible for follow-up and how often.

Review of the preprinted form indicated "UR" stood for "unable to recall."

During concurrent interview, the DP acknowledged that without initial documentation and follow-up by the pharmacy the patient might not be able to get needed medication timely.

The Pharmacy computer screen that showed "on hold" physician orders were reviewed with Pharmacist 5 on July 26, 2011, at 11:45 a.m., in the Pharmacy at the Inland Valley Campus. It was observed that five out of seven orders that were assigned "on hold" status were incomplete orders that were written on the preprinted form titled, "Medication Reconciliation Admission Orders, Inpatient." The medications listed on this form were taken by the patient at home before being admitted to the facility.

The review of the preprinted order forms indicated staff nurses were gathering medication information, filling out the preprinted form with home medications, and receiving telephone physician orders for medications taken by the patient at home. The preprinted forms would become physician orders for pharmacy processing and dispensing. Each of the five "on hold" preprinted orders reviewed had incomplete information that required clarification by the ordering physicians, such as no strength or frequency for medications that were ordered to continue by the ordering physicians as indicated by the check in the "yes" to continue box.

One of the orders was written on July 24, 2011, two days prior, for gabapentin (medication used for seizure and nerve pain) "unsure dose" by mouth once a day for stomach pain.

During the same interview, the DP also confirmed that the completed forms were actual orders that the Pharmacy could process. The DP stated the listed medications on the forms could be continued at the hospital or the physician could choose to not continue while patients were in the facility. The DP also stated that this process of completing the form meant the Pharmacy was an active part of ensuring that important home medications were continued during the patient stay at the facility.

The DP acknowledged that the system was not perfect as of now and the facility was in the initial stages during which time date(data) would be collected.

According to the facility's policy and procedure titled, "Medication Reconciliation Across the Continuum of Care,"

"Procedure:
1. At admission to all units of SWHCS a licensed caregiver will obtain from the patient or caregiver the current medications used at home, including OTC and herbal products within 8 hours of admission ...
d)This information will be recorded on the Medication Reconciliation form ...
2. For Inpatients, the admitting a physician will consider whether to continue or discontinue the medications on admission ...
b) The completed form is now a physician's admitting order and will be faxed to the pharmacy and placed in the medical record in front of the physician's orders.
i. The medication reconciliation form will remain the chart throughout the patient's stay."

3. During inspection of the Malignant Hyperthermia (MH) Cart located in PACU (Post Anesthesia Care Unit) on July 25, 2011, at 3:30 p.m., it was noted that the MH Cart contained two 1000-ml injectable bags of sterile water.

MH crisis is a biochemical chain reaction response, "triggered" by commonly used general anesthetics and the paralyzing agent succinylcholine, within the skeletal muscles of susceptible individuals. The general signs of the MH crisis include tachycardia, a greatly increased body metabolism, muscle rigidity and/or fever that may exceed 110 degrees F. Severe complications include: cardiac arrest, brain damage, internal bleeding or failure of other body systems. Thus, death, primarily due to a secondary cardiovascular collapse, can result.

Review of the content list for the MH Cart indicated there should be 2, 1000-ml bags of sterile water.

Review of the facility's policy and procedure titled, "Emergency/Urgent/Specialty Drug Supplies-Kits" was reviewed and it indicated one 2000-ml injectable bag of sterile water in the MH Cart.

The MH Cart contained 36 vials of Dantrolene (drug used to treat malignant hyperthermia) 20 mg that would need 60 ml of sterile water to mix the powder in each of the 36 vials should there be a need. This would require a total of 2160 ml of sterile water and the facility's MH Cart contained only 2000 ml of sterile water.

During a concurrent interview the DP acknowledged that the MH Cart did not have enough sterile water to mix all 36 vials of Dantrolene 20 mg.

4. During tour of Medical/Surgical/Telemetry Unit One West on July 25, 2011, at 9:20 a.m., it was observed that the facility's Adult Crash Cart contained 4 vials of a medication called Atropine (ET tube) 0.4 mg/ml that was not listed as one of the medications approved to be included in the Cart.

Review of the facility's policy and procedure titled, "Emergency/Urgent/Specialty Drug Supplies-Kits" indicated that Atropine (ET tube) 0.4 mg/ml was not included in the Adult Crash Cart content list.

During concurrent interview, the DP agreed that the facility's policy and procedure did not include the drug and stated the policy and procedure needed to be updated.

5. The facility's Pharmacy and Therapeutics Committee Meeting Minutes from January 2010, to June 2011, were reviewed and it was noted that the minutes did not indicate the annual review of the hospital's drug formulary was discussed during the meetings.

During an interview on July 28, 2011, at 12 p.m., the DP acknowledged that the meeting minutes did not indicate the discussion of the annual review of the formulary and was not able to recall the last time the formulary was reviewed.

Review of the facility's policy and procedure titled, "Medication: Formulary" indicated, "To maintain a viable formulary, the Pharmacy and Therapeutics Committee will annually review classes of drugs based on emerging safety and efficacy data in the clinical literature ..."

6. On July 25, 2011, Patient 29's record was reviewed. The patient was admitted to the Medical-Surgical unit on July 24, 2011, with orders that included, "Protonix 40 mg po BID."

The "Physician's Order Sheet" dated July 25, 2011, at 7:50 a.m., indicated, "(in printed form) Prilosec 40 mg po daily is auto subs for Protonix 40 mg po daily."

On July 25, 2011, at 3:25 p.m., Patient 29's record was reviewed with Pharmacist 3. The Pharmacist stated the pharmacy department automatically substituted Protonix to Prilosec. He stated he was the pharmacist that processed the "autosub" order. He stated he typed in the order and stamped it in the "Physician's Order Sheet." He stated the frequency of the Prilosec should be equivalent with the Protonix order, twice a day, not once a day.

On July 25, 2011, Patient 29's MAR (Medication Administration Record) was reviewed. The MAR indicated the order for Protonix 40 mg, to be given twice daily, was replaced by Prilosec 40 mg, to be given once daily.

The facility policy titled, "Automatic Therapeutic Substitution," reviewed December 2010, was reviewed and indicated, "Substitution of a therapeutically equivalent drug for an ordered drug under an approved protocol shall be done with a clinically equivalent dose regimen and the same route of administration intended in the original order..."



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7. On July 26, 2011, the record for Patient 53 was reviewed. Patient 53 was admitted to the facility on July 25, 2011, with diagnosis of surgical laparoscopic hysterectomy (removal of the uterus through an abdominal scope).

The "Medication Reconciliation Admission Orders, Inpatient" dated July 25, 2011, at 9:40 a.m., indicated Claritin 20 mg po (by mouth) daily for allergies, Robitussin DM "UR (unable to recall dose)" po prn (as needed) for allergies, and Pepcid "UR" po prn for indigestion, and the three boxes for "Continue Medication" were checked "Yes." RN 3 "noted" the order on June 25, 2011, at 5 p.m. In addition, the "Medication Reconciliation Admission Orders, Inpatient" had a stamp in red on the form that read "Scanned."

A second "Medication Reconciliation Admission Orders, Inpatient" indicated the home medications prior to admission information was gathered by the nurse on June 25, 2011, at 5 p.m. The medication
"Robitussin DM" indicated two tablespoons for the dose and the medication "Pepcid" indicated 20 milligrams for the dose. The order was a telephone order taken by RN 3 on July 25, 2011, at 5 p.m., from the physician.

The "Medication Administration Record (MAR)" dated July 25, 2011, did not indicate Robitussin DM, Claritin, and Pepcid were available for administration to Patient 53.

The "MAR" dated July 26, 2011, indicated the orders for Robitussin DM, Claritin, and Pepcid but they were hand written on the "MAR" versus generated from the computer software system.

On July 26, 2011, at 1:10 p.m., an interview was conducted with RN 3. She stated she "scanned" the orders to the pharmacy on July 25, 2011, at 5 p.m., but she did not clarify the orders with the physician until July 26, 2011, sometime in the morning, even though the "revised" "Medication Reconciliation Admission Orders, Inpatient" indicated she had taken a telephone order from the physician on July 25, 2011, at 5 p.m., clarifying the "Dose" orders for both "Robitussin DM" and "Pepsid." In addition, RN 3 stated she should have clarified the dose orders for both "Robitussin DM" and "Pepsid" with the physician on July 25, 2011, before she noted the order, and she should have dated the "revised" "Medication Reconciliation Admission Orders, Inpatient" with the date she actually wrote the order which was July 26, 2011, or wrote the order as a "late entry."

The facility policy and procedure titled "Physician's Orders" reviewed December 2010, indicated "To establish guidelines for obtaining and processing physician's orders to ensure prompt quality patient care is provided. ... Physician's orders will be accurately processed and promptly followed. ... Written orders will be transcribed and implemented promptly. ... If the order is not complete, the ordering physician will be called to clarify the order. ..."

The facility policy and procedure titled "Medication Reconciliation Across the Continuum of Care" issued 2008, revised April 2011, indicated "... Clarifications of missing or erroneous information will be written on the physician's order sheet, not the medication reconciliation sheet. The pharmacist will contact the physician regarding further clarification if needed. ..."

Based on observation, interview, and record review, the facility failed to ensure an unusable medication was not available for patient use.

Findings:

During an inspection of the Pharmacy located on the Rancho Springs Campus on July 25, 2011, at 10:45 a.m., it was noted in the Pharmacy's medication refrigerator there was an open injectable vial of potassium phosphate (electrolyte supplement) SDV (single dose vial) 50 ml with the open date of July 16, 2011.

During a concurrent interview, the DP agreed that SDV vials should have been discarded immediately after use and should not have been kept in the medication refrigerator.

The facility's policy and procedure titled, "Drug admixture/Sterile Parenteral Solutions Guidelines" was reviewed and it stated,

"...Single-use sterile drugs and devices shall not be reused. Unused portions of single-use sterile drugs shall not be saved for later use ..."

Based on interview and record review, the facility:
1. Failed to ensure an employee in the surgery department had a radiation monitoring device; and
2. Failed to retrieve an employee's radiation monitoring device when it was not turned into the Nuclear Medicine Technologist at the end of the first quarter for 2011.

These failed practices had the potential to prevent the employee and the facility from knowing the radiation hazards facility personnel were exposed to.

Findings:

1. On July 25, 2011, at 2:50 p.m., a tour of perioperative services was conducted.

On July 25, 2011, at 3:45 p.m., an interview was conducted with RN 8, who was assigned to circulate in the operating rooms. When RN 8 was asked about the location of her radiation monitoring device, RN 8 stated she did not have a radiation monitoring device and had never been issued a radiation monitoring device. In addition, RN 8 stated her employment at the facility started on June 6, 2011, and she was a full time employee.

On July 25, 2011, at 3:55 p.m., an interview was conducted with Nurse Manager (NM) 1. She stated the completion of the form for RN 8 to obtain a radiation monitoring device had not been done or submitted to the nuclear medicine technologist.

On July 26, 2011, at 9:20 a.m., an interview was conducted with Manager 1 and Nuclear Medicine Technologist (NMT) 1. They stated each employee who worked in surgery should have a radiation monitoring device. NMT 1 stated a radiation monitoring device was never requested for RN 8 and a radiation monitoring device had never been issued to RN 8.

2. On July 26, 2011, at 9:20 a.m., an interview was conducted with Manager 1 and Nuclear Medicine Technologist (NMT) 1. They stated a list of employees who had been assigned a radiation monitoring device was maintained, and on the first day of a new quarter all badges were turned into NMT 1 and a new radiation monitoring device was issued to the employee. In addition, they stated the "new" radiation monitoring device was given to the employee before the "old" radiation monitoring device was turned into NMT 1.

On July 26, 2011, at 9:30 a.m., the "Radiation Dosimetry Report" for the monitoring period of January 15, 2011, through April 14, 2011, was reviewed with Manager 1 and NMT 1. The "Radiation Dosimetry Report" indicated the radiation monitoring device for OR/Surgical Technologist 1 was "absent." NMT 1 stated the designation of "absent" on the report indicated the radiation monitoring device had never been given to her at the end of the quarter.

On July 26, 2011, at 9:45 a.m., an interview was conducted with NM 5. She stated surgery employees should wear their radiation monitoring devices when radiation was involved in the surgical case. NM 5 stated she had never been informed that a radiation monitoring device from a surgery employee had not been turned into NMT 1 at the end of a quarter. In addition, NM 5 stated she was never informed OR/Surgical Technologist 1 had not given her radiation monitoring device to NMT 1 at the end of the first quarter for 2011.

On July 27, 2011, at 2:50 p.m., an interview was conducted with NMT 1 and Director Imaging Services (DIS). They stated there were no systems currently in place to notify the employee or the employee's manager/director of an "absent" badge. In addition, they stated the manager/director for any employee hired by surgery or specials (interventional radiology) were to inform NMT 1 that a radiation monitoring device was required for that employee.

The facility policy and procedure titled "Radiation Monitoring Devices: Personnel (Film Badges)" revised April 2011, indicated "To insure appropriate staff have radiation monitoring devices. The Imaging Department will provide radiation monitoring film badges at no charge to those employees who are subject to possible occupational exposure to radiation. ... The nuclear medicine technologist is responsible for the issuance of film badges, and for maintaining the appropriate records. ..."

Based on staff interviews and record review, the hospital failed to have a therapeutic diet manual that was specific to the diets that the hospital routinely ordered, and provided guidance to the medical, nursing and food service staff for the ordering and preparation of patient. This failed practice had the potential to result in inaccurate diets being served to patients in a hospital system with a licensed bed capacity for 252 patients.

Findings:

During an interview with the Director of Nutritional Services (DNS), on July 26, 2011, at 12:45 p.m., she stated the hospital used the American Dietetic Association (ADA) online Nutrition Care Manual (NCM) as their diet manual. She stated that the NCM provided nutrition information regarding many different diets for many different specific diagnoses, whether or not the hospital used those diets for their patients.

The DNS further stated that although the NCM provided information about some of the diets the hospital routinely provided, it didn't define many of the typical diets the hospital uses, such as: Soft diets, 2000 ADA diets, the American Heart Association (AHA) diet, the facility's specific Gastric Bypass clear liquid diet and how the hospital specifically defines their Renal diet (in terms of amount of protein, grams of sodium, potassium and phosphorus) when the physician orders it without those parameters defined. The DNS was unable to state how the NCM could be consistently used as guidance for ordering and preparing patient diets.

A concurrent review of the ADA NCM on the hospital's computer system with the DNS revealed that these above diets were not present or were not specifically defined as being consistent with what the hospital provided on these diets.

A review of the hospital's policy titled, "Diet Manual" (dated November, 2010) revealed that the purpose of the diet manual was to provide criteria to standardize nutritional care throughout the hospital. It further states that the (diet manual) served as a guide to ordering diets, and that served menus would be consistent with the requirements in the manual.

Based on observation, interview, and record review, the facility failed to ensure the calibration of the Vaisala wall monitors (the device that is mounted on the wall for purpose of measuring the temperature and humidity of the room) in the surgery areas in Inland medical Center and in the Women's Center at Rancho Springs Hospital were being completed as recommended by the manufacturer.

In addition, facility failed to ensure the Vaisala equipment was maintained to ensure acceptable level of safety and quality, by not having a system in place to ensure the accuracy of the humidity readings in the surgery areas in Inland medical Center and in the Women's Center at Rancho Springs Hospital.

These failed practices potentially placed the patients at risk for infections and of fire in an oxygen rich environment.

Findings:

A tour of the surgery department, including the Sterile Processing Department was done on July 25, 2011,starting at 1:30 p.m.

A concurrent interview was conducted with the Surgery Manager and RN 13, on July 25, 2011, at 3 p.m. The Surgery Manager stated the temperature and humidity of the Vaisala wall monitor is monitored and noted in the morning at 6 a.m., and prior to each surgery. The Surgery Manager further stated she believed the Vaisala devices were calibrated on a regular basis. The temperature/humidity and calibration logs were requested for review.

On July 26, 2011, at 10 a.m., the Accreditation Manager was notified the survey team had not received the calibration logs requested the day before, on July 25, 2011. The policy and procedure for monitoring temperature and humidity was requested along with the manufacturer's instructions for the Vaisala device.

On July 26, 2011, at 3:30 p.m., the Accreditation Manager was notified the survey team had not received the calibration logs for the Vaisala devices.

Review of the the Vaisala manufacturer's instructions was completed on July 26, 2011. The Vaisala manufacturer's instructions indicated under CALIBRATION, "It is recommended that the humidity calibration is performed at least once a year...Humidity calibration...we recommend recalibration at least once a year..."

On July 26, 2011, at 3:45 p.m., during an interview with the Plant Operations Manager, he stated the facility had not calibrated any of the Vaisala devices in the facility. The Plant Operations Manager further stated he was not aware that the Vaisala equipment had to be calibrated. The Plant Operations Manager stated he thought the calibration was done at the factory and that the equipment did not require recalibration. The Plant Operations Manager stated he did not know that Vaisala equipment had to be re-calibrated, "until now, after fully reading the manufacturer's instructions." The Plant Operations Manager stated the Vaisala had been installed in the facility about eight to fifteen months ago. Documentation of date the Vaisalas were installed in the facility were requested.

Document review was conducted on July 27, 2011. The calibration certificates for IVMC indicated the Vaisala had been calibrated at the factory, on July and August 2009, prior to be shipped to the facility. The Service Work Order for Rancho Springs Hospital indicated that the Vaisala had been installed at the Women's Center on September 22, 2009.

In a interview with the Chief Operating Officer, on July 28, 2011, at 10 a.m., the Chief Operating Officer stated the Vaisala devices had not been calibrated since installed in the facility in 2009. The Chief Operating Officer stated the Vaisala devices at IVMC were connected to plant operations. Plant operations had the capability to monitor the temperature and humidity in the areas with the Vaisala wall-mounted devices, but plant operations was not currently monitoring the data. The Chief Operating Officer stated the facility reviewed the temperature and humidity logs, but did not have a system in place to compare and validate the data being written down by staff. The Chief Operating Officer Staff did not use the temperature and humidity data being recorded by plant operations or a hand held fluke to validate an accurate reading of the Vaisala wall-mounted devices.

The Temperature and Humidity policy and procedures were reviewed on July 28, 2011:
a) The policy and procedure titled, "Temperature/Humidity: Control of Hospital," was received at IVMC. The policy and procedure received at IVMC was incomplete. The policy addressed hand held flukes, but not the Vaisala wall-mounted devices being used in surgery and Sterile Processing Department.

b) The policy and procedure titled, "Temperature Humidity Monitoring: Perioperative Services, Women's Services and Cardiovascular Services," was received at Rancho Springs Hospital. The policy and procedure reviewed at Rancho Springs Hospital were inaccurate. The policy and procedure indicated, "Hand held devices (flukes) will be changed annually per recommended manufacturer's guidelines by plant operations...Electronic temperature and humidity gauges are self calibrating..."

The facility failed to ensure the calibration of the Vaisala wall monitors in the surgery areas in Inland medical Center and in the Women's Center at Rancho Springs Hospital were being completed as recommended by the manufacturer.

The facility failed to ensure the Vaisala equipment was maintained to ensure acceptable level of safety and quality, by not having a system in place to ensure the accuracy of the humidity readings in the surgery areas in Inland medical Center and in the Women's Center at Rancho Springs Hospital.

Based on interview and record review, the facility failed to develop and implement a policy to screen physician's for hepatitis (communicable liver infection). This failed practice could potentially create an increased risk of the spread of infection to patients in the facility from unscreened physicians.

Findings:

During an interview with the Director of the Medical Staff on July 28, 2011, at 3:45 p.m., she stated that she did not believe there was a policy requiring hepatitis screening for physicians on the Medical Staff.

During an interview with the Management Consultant on July 29, 2011, at 11:00 a.m., she stated that there was no hepatitis screening for physicians on the Medical Staff.

During a review of the facility policy, "Pre-employment Screening and Immunizations" (issued December, 2010), and the Medical Staff Bylaws on July 29, 2011, there was no requirement for hepatitis screening for physician members of the Medical Staff.

During a review of the Medical Staff files for physicians MS 2, MS 6, MS 7, MS 8, MS 9, MS 10, and MS 11 on July 28, 2011, the files did not contain evidence that the physicians receiving screening for communicable hepatitis. The physicians were not asked about a medical history of hepatitis or a history of hepatitis vaccination, and there were no laboratory results regarding hepatitis seen for those members of the Medical Staff.

During a review of the Center for Disease Control "Guideline for infection control in health care personnel," 1998 "Hepatitis B vaccination of health care personnel who have contact with blood and body fluids can prevent transmission of HBV and is strongly recommended...The OSHA bloodborne pathogen standard mandates that hepatitis B vaccine be made available, at the employer's expense, to all health care personnel with occupational exposure to blood or other potentially infectious materials.27

Based on interview and record review, the facility failed to ensure;

1. The risk of infection was minimized for one of 73 sampled patients (Patient 1), when facility staff failed to assess the necessity for Patient 1's indwelling urinary catheter (a tube leading from the bladder to outside the body to drain urine). This failed practice could potentially result in the possibility of an unnecessary indwelling urinary catheter and the increased risk of infection; and

2. The ice machine in the kitchen was maintained in a sanitary manner.

These failed practices could potentially lead to an increased risk of infection for patients.

Findings:

1. Review of the medical record of Patient 1 on July 26, 2011, indicated Patient 1 had a indwelling urinary catheter placed prior to surgery on February 8, 2011. The medical record contained three stickers placed in the "Physician's Orders" section of the chart, for documentation of the medical necessity of central lines (tubes extending from a major blood vessel to outside the body) and indwelling urinary catheters. The pre-printed stickers contained check-boxes on which the existence of central lines or a indwelling urinary catheter were to be documented, and boxes to indicate the reason for the lines or catheter.

The first such sticker in Patient 1's medical record was inserted on February 9, 2011, and has no boxes checked and was unsigned-the pre-printed sticker was left blank. The second sticker was placed on February 10, 2011, has the box "medical condition prohibits use of bedpan or bedside commode" checked, and the physician's signature, but no date or time signed. Review of the Patient Progress Notes on February 10, 2011, indicated Patient 1 ambulated in the hallway on that date. There was no documentation provided in the medical record that Patient 1 was unable to use a bedpan or commode. A third sticker regarding the medical necessity of central lines and indwelling urinary catheters was placed in the "Physicians Order " on February 11, 2011, and that sticker had one checkmark to indicate that the patient continued to have a indwelling urinary catheter, but no check to indicate the reason the catheter was present, and no physician signature. Patient 1 was discharged to a skilled nursing facility on February 11, 2011, with the indwelling urinary catheter still in place, and returned to the ED twice with catheter related complaints-on February 13, 2011, with a complaint of abdominal discomfort, and on February 18, 2011, with a urinary tract infection.

During an interview with the CMO on July 28, 2011, at 9 a.m., he reviewed the medical record of Patient 1 and stated that if the patient continued to have a indwelling urinary catheter, the medical necessity stickers should have been filled out.

The facility policy, " Urinary Catheter: Preventing Infections " (issued 12/2010, revised 3/2011) was reviewed on 7/28/11. The policy stated in part, " Review urinary catheter necessity daily and remove promptly by using the Medical Necessity of Central Lines and indwelling urinary Catheters (text was followed by a picture of the sticker).


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2. During the initial tour of the kitchen at Rancho Springs Medical Center (RSMC), on July 25, 2011, at 9:30 a.m., a clean, white paper towel swipe of the interior of the ice machine produced a moderate build-up of a brown, black residue along the ice contact surface of the chute where the newly formed ice drops into the storage bin. Also a clean, white paper towel swipe of the interior of the ice machine along the storage bin walls produced more brown, black residue. The finding was verified by the Director of Nutritional Services (DNS) and the Kitchen Supervisor (KS).

During a concurrent interview with the DNS, she stated that the hospital used an outside service to clean the interior of the ice machine on a quarterly basis. She further stated that the Food Service Manager (FSM) checked the cleanliness of the ice machine and documented her checks on a weekly sanitation checklist. She stated that the residue was not noted on these weekly checks. She was unable to explain how the build-up of the residue was not detected before this observation.

During an observation and concurrent interview with the Director of Plant Operations (DPO) on July 25, 2011, at 2:40 p.m., he confirmed that the hospital used an outside service to clean the interior of the ice machines. He further stated that the last time the machine was cleaned by this service was in June of this year. Again, a clean, white paper towel swipe of the interior of the ice machine produced more brown, black residue along the ice contact surface of the chute where the new ice drops into the storage bin. He stated that the residue was not desirable and further stated, "I'm not OK with that, it is not good." He stated that he confirmed the cleanliness of the ice machine after the outside company cleaned it to verify it was clean in June.

Also during this observation, the ice scoop was noted to be stored sitting on the ice inside the ice machine. During a concurrent interview with the DNS, she stated that the scoop should be stored outside the ice machine in a container on the wall adjacent to the ice machine.

A review of the hospital's policy titled, "Ice Handling" (dated May 2011) stated that the purpose of the policy was to provide criteria to prevent contamination during the process of handling ice. It further stated that the Nutritional Services Department prepared, handled and served ice under sanitary practices and procedures. It stated that the ice machines were thoroughly cleaned on a quarterly basis in the kitchen. It also stated that the ice scoop was to be stored on the outside of the ice machine.

A review of the manufacturer's instruction manual for the ice machine, dated December 11, 2006, revealed that the manufacturer recommended cleaning the unit at least once a year, but more frequent cleaning may be required in some existing water conditions.

A review of the contracted ice machine cleaning company's Service Order Invoice, dated June 9, 2011, showed that service was performed for the ice machine located in the dietary department at RSMC on that date. It stated that the ice machine was chemically cleaned, flushed and sanitized during this service.

During an interview with the technician from the contracted ice machine cleaning company, who performed the cleaning of the ice machine, on July 26, 2011, at 8:05 a.m., he stated that it was his experience that some ice machines would have a buildup of a brown, black substance in as little as 2 days after he serviced the machine. The buildup depended on the conditions of the environment surrounding the ice machine.

During an interview with the Infection Control Practitioner (ICP) on July 27, 2011, he stated that he conducted weekly sanitation rounds with the FSM which included observation of the ice machine in RSMC kitchen. He further stated that inspection of the ice machine consisted only of the cleanliness of the outside of the ice machine. He stated that during the weekly sanitation rounds, the interior of the ice machine was not observed. He was unable to state how the ice contact surface of the ice machine could be monitored by observing only the outside of the machine.

A review of the hospital's policy titled, "Infection Control - Nutritional Services" (dated April 2011) revealed that the purpose of the policy was to maintain a clean and sanitary work environment, including equipment, for the safe and sanitary handling of food supplies in accordance with health department standards. The policy acknowledged that maintenance of high sanitation standards in a hospital dietary department was of utmost importance due to the extra responsibility which was placed on a heath care institution who served a highly susceptible population. It further stated that the Nutritional Services staff was responsible for the routine cleaning of the ice machine which included the reachable interior, exterior surface areas and the ice scoop dispenser of the ice machine in the kitchen.

Based on interview and record review, the facility failed to ensure adequate nurse staffing in the ED to care for Patient 3. This failed practice could potentially result in substandard healthcare for Patient 3.

Findings:

The medical record of Patient 3 was reviewed on July 26, 2011, through August 2, 2011. Patient 3 came to the ED on January 14, 2011, at 9:42 p.m. via ambulance with complaints of weakness and leg pain. The medical record showed that lab samples were obtained, and a critical potassium level of 8.8 mmol/L (normal 3.6-5.1 mmol/L, elevated potassium can cause fatal heart rhythms) was reported on January 15, 2011, at 12:50 a.m. MD 2 ordered Kayexalate, calcium gluconate, insulin and dextrose in water (medications to reduce potassium or to reduce the effect of elevated potassium) between 1:18 a.m. and 1:20 a.m. However, the medical record showed that the medications were not administered until hours later (Kayexalate at 4:30 a.m., calcium gluconate at 4:05 a.m., insulin at 3 a.m., and dextrose and water at 3:03 a.m.).

The medical record for Patient 3 showed disposition notes by the ED physician (MS 2), at 1:23 a.m., indicating that care was being transferred to MS 7, the admitting physician. Admitting orders, including medication orders for Albuterol and Atrovent for shortness of breath, aspirin, Lopressor, Lasix, Kayexalate, Nitroglycerin (three times as needed for chest pain) and normal saline at 100 ml per hour were telephoned by MS 7 to ED RN 1 at 1:23 a.m. A handwritten nurse note on the admission order form indicated that ED RN 1 initiated the Lasix order at 4:45 a.m. There was no documentation that the aspirin, Lopressor, Albuterol, Atrovent or normal saline IV fluid were given before Patient 3 expired at 6:20 a.m.

In an interview with ED Manager on July 26, 2011, at 9:30 a.m., she stated that she could not explain the delay in administration of medications to Patient 3. She stated there was no documentation in the progress notes of any delay in the ED receiving the medications, and that the time frame of administering the medications was not acceptable.

During a review on July 29, 2011, of the facility policy, "Physician's Orders" (revised March, 2010, reviewed December, 2010), indicated, "Physician's orders will be accurately processed and promptly followed."

The ED physician recorded in the ED record at 1:23 a.m., that the patient required critical care and was to be admitted to the ICU (intensive care unit). The record showed that Patient 3 had the following vital signs at 12:50 a.m., blood pressure 200/55 (normal is approximately 120/75), a respiratory rate of 36 (normal is 12-22), pain of 9/10, and oxygen saturation of 79% (normal is greater than 95%). The next time Patient 3 ' s vital signs were documented as being assessed was 2:30 a.m., one hour and forty minutes later. The medical record for Patient 3 showed that she had vital signs assessments at 3:40 a.m., and at 4:10 a.m.

During an interview with NM 7 on July 26, 2011, at 9:30 a.m., she stated that the vital signs of Patient 3 at 12:50 a.m. were very concerning, and that waiting until 2:30 a.m. to recheck them was too long. She stated for patients with critical conditions, the vital signs should be checked as often as every 15 minutes.

During a review on July 29, 2011, of the facility policy, "Assessment and Reassessment in the Emergency Department " (issued May, 2010, reviewed September, 2010), the policy read in part, If a patient (Adult or Pediatric) is unstable, reassess blood pressure, pulse, respirations and condition at least every fifteen (15) minutes until stable."

The orders of MS 7, telephoned to ED RN 2 at 1:23 a.m., indicated the doctor was to be informed of abnormal vital signs, including a blood pressure above 180, a heart rate above 100, and for chest pain. At 2:30 a.m., Patient 3's blood pressure was 213, and her heart rate was 101, and she had 9 (out of a scale from 1 to 10, 10 being worst) chest pain, but there was no evidence that MS 7 was informed of those abnormalities. There was no evidence that MS 7 was contacted regarding Patient 3's deteriorating condition until 4:58 a.m., when the nurse called the admitting physician "to consider changing DOU (unit providing a level of care between a regular medical bed and the intensive care unit) to ICU status."

Orders to admit Patient 3 to the DOU/intermediate care unit were written by the admitting physician at 1:20 a.m. At 3:56 a.m., a bed in the intended unit was available, however, by that time, according to bed control documents, the patient had become more unstable due to respiratory distress, and required an ICU bed. The medical record showed that at 4:58 a.m., more than an hour later, the nurse called the admitting physician "to consider changing DOU to ICU status." The medical record showed that Patient 3 remained in the ED.

During an interview with NM 7 on July 26, 2011, at 9 a.m., she stated the ED boards ICU patients at times. She stated once the patient is admitted, the admitting physician assumed care of the patient, but the ED nurse continued nursing care.

According to the medical record the ED physician, MS 2, was walking by the bed of Patient 3 in the ED and noted that she had agonal (dying) respirations. Patient 3 was the subject of a code blue (emergency response) at 5:50 a.m., and was pronounced dead at 6:20 a.m.

During an interview with the Chief Nursing Officer, (CNO) on July 27, 2011, at 3:20 p.m., she stated Patient 3's care was sent to the ED for review by that department's nursing leadership. She stated that she thought ED RN 1 had not been documenting the patient's condition because he had difficulty using the new computer system. When asked if ED RN 1 was provided with additional education regarding use of the computer system, she stated that the nurses had already been educated on the use of the computer system at that time.

Documentation of the facility's interview, dated February 9, 2011, with ED RN 1 regarding Patient 3's care was reviewed on July 27, 2011. At that time, ED RN 1 explained the delays in care given to Patient 3 by saying he was unfamiliar with the new (in place for 10 days) computer system, and that he was very busy the night he cared for Patient 3. He stated he notified the charge (supervising) nurse that he needed assistance, but did not receive adequate assistance.

There was no evidence that ED RN 1's difficulty using the computer system was identified or addressed pursuant to a review of the care given to Patient 3 s on January 14, 2011, and January 15, 2011. During an interview with the ED Manager on July 26, 2011, at 9:30 a.m., she stated that ED RN 1 still worked in the facility's ED.

A written interview of the charge nurse by the ED Manager on February 10, 2011, was reviewed on July 27, 2011. In the interview, the charge nurse on the night of Patient 3's ED stay recalled that ED RN 1 had asked for help several times due to his "heavy assignment."

NM 7, in an interview on July 26, 2011, at 9:30 a.m., was asked regarding processes for nursing oversight in the ED. She stated that the charge nurse provided oversight by making rounds every 4 hours. She stated that the charge nurse provided assistance or obtained assistance to meet patient care needs. She was not able to explain why Patient 3's care had not received oversight by the charge nurse.

The facility process for coping with increased patient care needs in the ED was reviewed with the ED Manager on July 26, 2011, at 9:30 a.m.. She stated that the charge nurse should respond to the need for the patient to be changed to critical status, and for the need for additional nurse time for the patient. NM 7 stated that when the charge nurse was unable to provide the required assistance, nursing staff was to go up the chain of command to obtain needed assistance.

In an interview with the CNO on July 26, 2011, at 10 a.m., she stated the ED staffing during patient care surges was a process that had been informally in place for a year.

During an interview with the ED Director on July 29, 2011, at 8:45 a.m., she stated that the chain of command had not been activated while Patient 3 was in the ED. She was not able to explain why/ ED RN 1 did not activate the chain of command to obtain assistance. She stated that the nurse staffing during Patient 3's stay on January 14, 2011, to January 15, 2011, in the ED had not been subject to analysis.

During a review of the facility policy, Patient Flow and Capacity Management: Hospital Wide (revised December, 2010, reviewed March, 2011) on July 29, 2011, conditions that signified a "yellow" status included, "Patients are holding in the ED or Post Anesthesia Care Unit.," and "ED wait time to bed > (greater than) 2 hours. "The actions to be taken during a "yellow" status read in part, "Call Emergency bed Huddle after paging Joint Leadership...Charge nurse to take patients." and "Per Diem (paid by the day) and regular staff to be called in."

During an interview with the CNO on July 29, 2011, at 8:45 a.m., she reviewed hospital records from the night of January 14, 2011, and the morning of January 15, 2011, when Patient 3 was in the ED, and stated no emergency bed huddle had been held.