HospitalInspections.org

Based on review of the Medical Staff ByLaws, Rules and Regulations, Physician On-Call schedules, Policies and Procedures, Code Arrest documents, patient record reviews, and interviews, it was determined that the Governing Body failed to require:

(A0049) the medical staff be accountable for the quality of care provided to patients;

(A0067) a doctor of medicine or osteopathy be on duty or on call at all times; and

(A0093) the medical staff provided appraisals of emergencies, initial treatment for patients in need.

The cumulative effect of these systemic problems resulted in the inability of the HOSPITAL to be in compliance with the federal regulations for GOVERNING BODY which led to the potential for adverse patient events.

Based on review of adverse incidents including Code Arrests, Medical Staff ByLaws, Policies and Procedures, the hospital's QAPI Plan, patient record reviews, and interviews, it was determined that the QUALITY ASSESSMENT PERFORMANCE IMPROVEMENT program failed to require:

(A0267) a quality process for adverse events including patient code arrests.

The cumulative effect of this systemic problem resulted in the inability of the HOSPITAL to be in compliance with the federal regulations for QUALITY ASSESSMENT PERFORMANCE IMPROVEMENT which led to the potential for adverse patient events.

Based on review of adverse incidents of Code Arrests, Policies and Procedures, ByLaws of the Medical Staff, patient record reviews, and interviews, it was determined that the MEDICAL STAFF failed to require:

(A0340) a physician led peer review process as part of the periodic physician appraisals; and

(A0347) physician accountability for the quality of care provided to patients.

The cumulative effect of these systemic problems resulted in the inability of the HOSPITAL to be in compliance with the federal regulations for MEDICAL STAFF which led to the potential for adverse patient events.

Based on clinical record reviews, policy and procedure reviews and staff interviews, it was determined:

A392: the hospital failed to ensure there were adequate numbers of licensed nursing staff available and assigned to meet the specialized needs of each patient;

A395: for seven patients (Patients #1, 2, 3, 5, 6, 8 and 9), the hospital failed to ensure an RN supervised and evaluated the patients' health status, changes in condition, and responses to interventions on an ongoing basis;

A397: the hospital failed to ensure nursing staff with specialized training and competence were assigned to meet the specific needs of each patient; and

A405: 1. the hospital failed to ensure three patients (Patients #2, 3 and 6) who received pain medications were assessed prior to and/or after the administration of the medications;

2. the hospital failed to ensure two patients (Patients #4 and 9) received medications following physician orders; and

3. the hospital failed to ensure one patient (Patient #6) did not receive a medication he was allergic to.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on Medical Staff ByLaws, Rules and Regulations, Policies and Procedures, record review, and interview, it was determined that the Medical Staff did not ensure the competencies of the hospital staff before accepting and admitting patients.

Findings include:

The hospital Medical Staff Bylaws revealed, in part: "...Section 4.2 Active Staff Responsibilities. Each Member of the Active Staff shall: b. Retain responsibility within his area of professional competence for the daily care and supervision of each patient in the Hospital for whom he is providing services, or arrange a suitable alternative for such care and supervision...."

The hospital Medical Staff Rules and Regulations revealed, in part: "5. Hospital shall retain the right to refuse admission of patients that the hospital is not equipped to handle...."

The hospital Policy and Procedure entitled "Transfer Patient From/To Hospital revealed, in part: "...A. Patient Evaluation 1. When a patient arrives at the hospital who (is): d. Admitted to the hospital as a patient, 2. Then the patient must be: Evaluated by a physician on call who is physically able to reach the patient within 30 minutes, after being informed that a patient is present at the hospital who requires immediate medical attention...."

Patient #9 was admitted to the hospital, on 5/26/12 at 10:50 a.m., via air ambulance from the ICU of an outlying community hospital for "further evaluation and management of his respiratory failure secondary to bilateral pneumonia, CHF (congestive heart failure), pulmonary emboli, and COPD (chronic obstructive pulmonary disease) exacerbation," as well as possible cardiac problems.

The patient was admitted to the 100 Unit, referred to as their "ICU Step Down Unit" in their Acuity Policy and Procedure. (The hospital is licensed for Rehabilitation beds only.)

The admitting physician dictated a History and Physical at 1:38 p.m. on 5/26/12. The Pulmonologist documented on Consult at 3:56 p.m. that the patient was "critically ill." Patient #9's record revealed the patient "wants to be a full code and intubated and treated...." The record revealed the patient was "alert and oriented."

Patient #9's record revealed on 5/28/12 at 2:51 p.m. that the patient's "respiratory failure continued to progress" and that the patient was transferred to an Acute Care Hospital. The record revealed the patient "expired...1 to 2 days later...." The record from the Acute Care Hospital revealed the patient expired on 5/29/12.

The hospital Medical Director was interviewed on 6/12/12 at 1:20 p.m., and acknowledged that all of the physicians on the staff at the hospital did not have competencies for providing emergency level of care to the patients.

Based on review of the Physicians' On-Call Schedules, Rules and Regulations of the Medical Staff, and interviews, it was determined that the Medical Staff failed to require a member was on duty or on call at all times.

Findings include:

The hospital Medical Staff Rules and Regulations revealed, in part: "...C. 2. "All physicians shall provide for appropriate physician coverage for their patients when they are not available to ensure safe and adequate overall quality medical care for their patients...."

The hospital had a physician who was in the building during night time hours which were defined in 3 different ways: from the schedule: 6 p.m. to 6 a.m.; from the night time physicians contract: 7 p.m. to 6 a.m., and from the Chief Clinical Officer: 8 p.m. to 6 a.m. The remaining hours of the 24 hours of each day was covered by a "Physicians On-Call" schedule.

A review was conducted of the Physicians' On-Call Schedules between January 1, 2012 and the time of the survey on 6/12/12. The Assistant Administrator provided the 2012 Schedules upon request. The Schedules revealed there was none for February, 2012. The Assistant Administrator acknowledged that a February Physicians On-Call Schedule had been requested but none had been received.

The Chief Clinical Officer was interviewed on 6/13/12, and acknowledged that if the Assistant Administrator did not have such an On-Call Schedule for February of 2012, then none existed.

The Chief Clinical Officer stated that when a physician was needed for a patient and there was no Physicians On-Call Schedule, the nursing staff would call one of the Answering Services of the "3 main physician groups" who care for patients at the hospital to find out who was covering for the groups. The nursing staff would then call one of the physicians to seek assistance with a patient who needed a physician.

Based on review of the Medical Staff ByLaws, physician delineated privileges, policies and procedures, Code Arrest documents, patient records, and interviews, it was determined that the governing body failed to require written policies and procedures which included delineated privileges regarding competencies to perform emergency appraisals, treatments, and referrals for patients with an emergency.

Findings include:

The hospital's Policy and Procedure entitled "Code Blue" revealed , in part: "...B. The Code Blue page is answered by a Physician, if available, (any physician in-house at the time of the code)...When a Physician is present, he/she will conduct the Code Blue according to the standards of the American Heart Association. All Code Blue activities will occur when he/she generates a verbal order...."

The Medical Staff ByLaws, Rules and Regulations do not include any entry regarding the "any physician who is in house at the time of a code...answers the code...."

The Code Arrest record of Patient #1 revealed that a physician was in the building but "was not prompt in attendance to code." A nurse who was providing care for Patient #1 that day (2/18/12) stated, on interview 6/13/12, that the physician delayed the start of the Code by asking for blood tests to be drawn first on the patient. There was no "Physician On-Call Schedule" for the hospital this day.

The hospital Medical Director stated, on interview 6/12/12, he was aware of the physician problem with Patient #1's Code where the physician who attended the Code asked for blood tests to be drawn before the Code was allowed to start. The hospital Medical Director stated that any physician can "by-pass" or "divert" from the accepted American Heart Association Code Arrest Protocols as the physician is considered in charge of the Code.

The Quality Medical Director stated, on interview 6/13/12, that he has attended to a Code Arrest in the hospital in the past and was grateful to have an R.N. running the Code who "knew more about it than he did." The Quality Medical Director acknowledged that all physicians do not know how to run a Code Arrest and some of the employees are also better at it than others even though the policy requires that "when a physician is present, he/she will conduct the Code...."

The Clinical Privilege Delineations were reviewed for 7 physicians who attend to patients at the facility and none of the seven listed competencies or knowledge for appraisal of emergencies and initial treatment.

The hospital Medical Director stated that different physicians who attend to patients in the facility have different levels of emergency competencies and knowledge with some having more knowledge or competencies than others.

Based on review of Medical Staff ByLaws, Policies and Procedures, record reviews, and interviews, it was determined that the medical staff failed to periodically conduct appraisals of its members through a Peer Review process.

Findings include:

The hospital's Medical Staff ByLaws revealed, in part: "...The purposes of the Medical Staff are...2.1.7 To provide a system for ongoing review and evaluation of the quality of each Practitioner's performance...."

The Peer Review Policy revealed the "Purpose: To determine the circumstances and process under which a focused review of a practitioner's performance shall be conducted...Procedure:...The Medical Executive Committee shall appoint a committee to conduct Peer Reviews...The Committee shall consist of the Medical Director and two Medical Staff Appointees appointed by the Medical Director or by the Chief Executive Officer...."

The hospital's Policy and Procedure entitled "Medical Staff Peer Review" revealed, in part: "...A Peer Review shall be conducted to determine whether the practitioner's performance may require further action to improve under the following circumstances:...b. Patient complications...e. Unplanned discharge of patient...f. Code Blue arrest of patient...."

The Director of Quality Management provided a one-page Chart entitled "Physician Peer Review Process." This Chart revealed the following Types of Physician Peer Reviews: Blood Utilization, Restraints, Respiratory Codes, Mortality, Conscious Sedation/Procedures, Unplanned Acute Care Transfers.

The Director of Quality Management stated, on interview 6/7/12, that she did all the physician patient record reviews that were needed, filling out a form for each record reviewed. The forms revealed multiple questions with boxes on the forms for the answers of "N/A" (not applicable), YES, or NO.

The Medical Director of Quality stated, on interview 6/13/12, that he reviewed the forms with the Director of Quality Management but did not review the patient records. The Medical Director of Quality stated that previously he had reviewed Peer Review patient records, but had not done them since the current Director of Quality Management had been employed. He stated that he reviews the form and signs it with the Director of Quality Management.

A review of Patient #2's Code Arrest and Death revealed that, on 4/9/12 at 2:40 a.m., a family member called out that the patient "was not breathing" and a Code Blue was called. The record documented that the patient was found with "significant amount of coffee ground aspirate in her mouth." Resuscitation was attempted including compressions, medications, 3 attempts to intubate (successful on the third try), and patient was shocked with 120 Joules x 2. The Code was called at 3:04 a.m. which was documented as the "Time of Death." The record revealed a physician was present during the Code.

A Code Review of Patient #2's Code was conducted by a nurse and the Director of Quality Management with no physician signature on the form. A Mortality Review of Patient #2's death was conducted by the Director of Quality Management and signed by the Medical Director of Quality who did not fill out the portion of the form for his analysis of the quality of care given, including: "...no recommended action... reflects quality and continuity of care...physician notified of specific deficiencies...the physician shall be contacted for follow-up and resolution documented in the physician quality filed." All analysis items were blank.

Based on Policies and Procedures, ByLaws of the Medical Staff, adverse events of Code Arrests, record reviews, and interviews, it was determined that the Medical Staff failed to be accountable for the quality of the medical care provided to the patients.

Findings Include:

The hospital Medical Staff Bylaws revealed, in part: "...Section 4.2 Active Staff Responsibilities. Each Member of the Active Staff shall: b. Retain responsibility within his area of professional competence for the daily care and supervision of each patient in the Hospital for whom he is providing services, or arrange a suitable alternative for such care and supervision...."

The hospital Code Blue Policy and Procedure revealed, in part: "...B. The Code Blue page is answered by a Physician, if available, (any physician in-house at the time of the code)...K. When a physician is present, he/she will conduct the Code Blue...."

Patient #1 became "nonresponsive" on 2/18/12 at 1:11 p.m. and a Code Blue was called. The patient was resuscitated unsuccessfully, did not regain consciousness, transported to an Acute Care Hospital and expired. The Code Arrest record of Patient #1 revealed that a physician was in the building but "was not prompt in attendance to code."

A nurse who was providing care for Patient #1 that day (2/18/12) stated, on interview 6/13/12, that the physician delayed the start of the Code by asking for blood tests to be drawn first on the patient. There was no "Physician On-Call Schedule" for the hospital this day.

Patient #5 was found unresponsive, "froth from mouth," unequal pupils," and "erratic blood pressure" on 4/28/12 at 5:45 p.m. and the record documented "the nurse called overhead for Code Blue." The record did not include a Code Arrest Flow Sheet. The patient was given IV medications and remained unresponsive. The record revealed "911 called as patient is not responding to painful /verbal stimuli." The patient was transported via paramedics to an Acute Care Hospital.

Patient #9 was admitted to the hospital, on 5/26/12 at 10:50 a.m., via air ambulance from the ICU of an outlying community hospital for "further evaluation and management of his respiratory failure secondary to bilateral pneumonia, CHF (congestive heart failure), pulmonary emboli, and COPD (chronic obstructive pulmonary disease) exacerbation," as well as possible cardiac problems. The record revealed the patient was "alert and oriented" and revealed the patient "wants to be a full code and intubated and treated...."

Patient #9's record revealed on 5/28/12 at 2:51 p.m., that the patient's "respiratory failure continued to progress" and that the patient was transferred to an Acute Care Hospital. The acute care hospital's Emergency Department physician documentation included: "...The patient is admitted to the ICU in critical condition...." The acute care hospital's record revealed the patient expired the next day, 5/29/12.

Patient #12 was being treated for osteomyelitis and wound care. On 5/23/12 at 4:38 a.m., the patient developed an irregular heart beat with "symptoms." The night shift hospital physician ordered IV medications and to "move the patient to ICU." The record revealed the attending physician on 5/23/12, ordered the patient transferred to the Emergency Department of an Acute Care Hospital at 11:30 a.m..

The hospital Medical Director was interviewed on 6/12/12 at 1:20 p.m., and acknowledged that all of the physicians on the staff at the hospital did not have competencies for providing emergency level of care to the patients.

Based on reviews of the hospital's policies and procedures, reviews of the hospital's staffing records, review of patient clinical records, and staff interviews, it was determined the hospital failed to ensure adequate numbers of licensed nursing staff were available and assigned to meet the individual needs of each patient.

Findings include:

The hospital's policy and procedure titled Staffing Plan/Back to Basics included the following: "Cornerstone Hospital utilizes a nursing staffing plan for each patient care unit. The staffing plan addresses the following components: 1. The staffing system utilized at Cornerstone Hospital is based on patient acuity, staff competency, performance improvement initiatives, census, and staffing matrix guidelines. The Registered Nurse will utilize nursing judgment to assess the needs of the patient and the acuity of the patient's condition. Based on the assessment by the RN and the information conveyed to the DON and/or Charge Nurse, along with the staffing acuity guidelines and staff competency, assignment of nursing care will be determined by the nursing process and will be consistent with patient care needs. 2. The number of Nursing Service personnel, along with the mix and qualifications of the staff needed to meet the individualized needs of the patients is evaluated on a continual basis...DON/Charge Nurses will review staffing levels, projected staffing needs, and projected patient acuity every shift and prn. Census will also be monitored for the current day as well as at least 2-3 days into the future. Staffing levels will be adjusted as needed to ensure adequate skill mix and patient assignments based on patient acuity. The Clinical Coordinator and/or Charge Nurses use the following indicators to make decision on appropriate staffing patterns: patient acuity, prescribed medical regimen, census, patient and nurse preference, infection control practice, geographic location, and the number and competency of the personnel scheduled. Nursing personnel on each shift are trained to care for the medically complex medical-surgical patients who may or may not be on a ventilator...When assigning patient care responsibilities to the nursing staff, the DON and/or Charge Nurse takes into consideration the patient's specific nursing care needs, along with the experience and skill levels required to meet each patient's individualized needs in a competent, safe, and efficient manner...The Charge Nurse and/or DON are responsible for making patent assignments on all nursing units. Charge Nurses and/or DON are responsible for calling in additional personnel when there is a shortage due to acuity needs or patient censure, or due to call outs...The Director of Nursing and/or Charge Nurse will assure that patient care assignments are commensurate with the qualifications of nursing personnel involved, patient acuity, prescribed medical regimens, the staffing mix, patient and personal preference, infection control practice, and geographic location."

The hospital's policy and procedure titled Acuity & Acuity Tool included the following: " ...this tool specifically addressed need for Licensed Nurses (RN)...Point value derived from the attached Acuity Tool determines the level of nursing care required and nurse to patient ratios. The highest level the patient has needs reflected in, is the level of acuity to which that patient will be staffed. No assignment may be greater than a cumulative patient level point score of 10 for ICU Step Down unit for nursing and a cumulative patient level point score of 14 for the Med/Surgical units. The calculations are as follows: Level 1 = 1 point Level 2 = 2 points Level 3 = 3 points Level 4 = 5 points...C.N.A. staffing calculations are as follows: Level 4 = 5:1 Level 3 = 6:1 Level 2 & 1 = 8-10:1...Acuity Assessment: Admissions are planned and there are not the dramatic fluctuations in acuity as seen in the short-term acute care hospitals. Therefore, the DON or designee will assess acuity a minimum of 1x per shift and prn."

A review of the Daily Staffing Records revealed the following:

-2/18/2012: The acuity worksheet completed "7a7p" revealed 7 patients on the 100 unit (ICU Stepdown Unit) with check marks in the Level 4 (5 points) section in addition to check marks in the Level 1, 2 and 3 sections. According the hospital's policy and procedure: "The highest level the patient has needs reflected in, is the level of acuity to which that patient will be staffed." However, the Patient Point Totals for two of the patients were "2" and "3" for 5 of the patients. For example, the patient in Room 107 (Patient #1) had 7 out of 19 areas check in Level 1; 3 out of 13 checks in Level 2; 2 out of 6 areas checked in Level 3 and 2 out of 7 areas checked in the highest acuity Level 4 (5 points). The two areas checked were for "Multiple System Failure" and "Respiratory Instability."

Documentation on the Team Plan 12 hour shift form dated 2/18/2012 for the "7a7p" shift revealed the RN assigned to Patient #1 was also assigned two other patients on that unit who had areas checked in Level 4. Patient #1 had dialysis on that day with noted changes in his condition by the RN and the Dialysis RN. After dialysis and when the dialysis RN was cleaning/removing equipment from the room, she alerted staff (not the patient's RN) that the patient "looked dead." The patient's RN was in another patient's room with the door closed. A code arrest was called which the patient's RN did not hear because she was in another room. The patient was transferred to an acute care hospital where he died. Refer to Tag A-0395 for further details on Patient #1.

There was also documentation on the above Team Plan 12 hour shift form that an RN was assigned to the care of the patient in Room 108 in addition to four patients on the 300 unit hall/unit which was not a unit contiguous with the 100 unit where Room 108 was. In order to provide care to the patients on the 300 unit, the RN needed to leave the 100 unit and in order to provide care to the patient on the 100 unit, the RN need to leave the 300 unit.

-3/11/2012: Documentation on the Team Plan 12 hour shift for 7 a.m. to 7 p.m. revealed there were nine patients on the 100 unit. Five of the nine patients had check marks in the Level 4 section of the acuity worksheet, however, these five patients only had Patient Point Totals of "3" which, according to their policy and procedure, should have been "5." Two RN's were assigned to four patients each and one RN was assigned one patient. There were no CNA's assigned to the unit and documentation on the form revealed the RN's assigned were doing "Primary Care."

-5/28/2012: Documentation on the Team Plan 12 hour shift 7 a.m. to 7 p.m. included eight patients on the 100 ICU Stepdown Unit; nine patients on the 200 Unit; and six patients on the 300 Unit. There were no levels of care documented on any patient. There was no documentation of a CNA assignment on any of the units.

Documentation on the Team Plan 12 hour shift for 7 p.m. to 7 a.m. revealed 8 patients on the 100 Unit. One RN was assigned to four patients and one RN was assigned to two patients including Patient #9 whose condition was declining and was sent to an acute care hospital during that shift. (Refer to Tag A-0395 for more details regarding Patient #9). An LPN was assigned to two patients on the 100 ICU Stepdown Unit in addition to 4 patients on the 200 Unit which was a separate unit. There was no documentation of an RN assigned to the direct oversight of the patients assigned to the LPN. There were no CNA's assigned to the 100 ICU Stepdown Unit.

The CCO was asked during interviews about the discrepancies in the Total Patient Scores on the acuity worksheet and the hospital's policy. The CCO reported that check marks in the Level 4 section did not necessarily mean that was the patient's acuity level. The CCO was also asked about assigning RN's to the care of patients on different units during the same shift and he responded it was common practice and stated the patients on the 300 unit were lower acuity patients even though they were on a different unit. The CCO also stated the Team Plan 12 hour shift sheets were not a part of the hospital's policy and procedure even though it was the only form presented to the surveyors to demonstrate how the hospital followed their policies and procedures for staffing.

Based on record reviews and staff interviews, it was determined for 7 of 12 patients (Patients #1, 2, 3, 5, 6, 8 and 9), the hospital failed to ensure an RN supervised and evaluated the patients' health status, changes in condition, and responses to interventions on an ongoing basis.

Findings include:

1. The hospital's policy and procedure titled Assessment-Reassessment Nursing included the following: "Reassessment: 1. A registered nurse will reassess each patient according to the patient needs and as needed. 2. During the patient stay, each discipline will perform reassessment, utilizing appropriate criteria and time frames. The reassessment data is used to reevaluate and revise the treatment plan and discharge plan. Informal reassessment is performed at every point of patient contact by every discipline. The reassessment is to include pain assessment. 3. The reassessment should include but not be limited to: review of compromised systems, vitals signs, safety/fall risks, and skin assessment, pain assessment, and nutritional intake. 4. In addition, the patient is reassessed to determine the patient's response to treatment (i.e. response to PRN medication or respiratory treatment), when a significant change occurs in the patient's condition or behavior (i.e. onset of anxiety, disorientation, change in level of consciousness, change in vital signs)...5. Reassessment is performed every shift, and PRN changes. Information well-documented on the Nursing notes...."

-Patient #1 was admitted to the hospital on 2/13/2012 with diagnoses including chronic obstructive pulmonary disease with respiratory failure, end-stage renal disease on hemodialysis, chronic atrial fibrillation, pacemaker and essential hypertension. The patient's code status at the time of admission was "Full Code." Documentation in the clinical record revealed the patient had a tracheostomy and was ventilator dependent.

Nursing documentation revealed a nursing assessment was completed on 2/15/2012 at 3:45 a.m., and the RN documented at 3:50 a.m. that the patient was unable to relax, was agitated and was medication with intravenous Ativan (anxiety medication). At 4:50 a.m. the RN documented the patient was not in distress and sleeping comfortably. There was no further nursing documentation until 2/15/2012 at 1 p.m. at which time the RN documented the patient returned from an acute care hospital.

The hospital provided the surveyor with a copy of a Rapid Response Team Record that was dated 2/15/2012. Documentation on that form revealed the Charge Nurse and Respiratory Therapist were called to the patient's room by staff at 6:30 a.m. for "mental status change." The Charge Nurse documented the patient was: "Unresponsive, Skin cool, clammy...100% paced for several minutes." The patient was transferred to an acute care hospital according to the documentation.

The Chief Clinical Officer stated during an interview on 5/31/2012 that the Rapid Response Team Record was not a part of the medical record. He acknowledged there was no nursing assessment or documentation of the patient in the clinical record from 2/15/2012 at 4:50 a.m. when the RN documented the patient was sleeping comfortably until 2/15/2012 at 1 p.m. when an RN documented the patient returned from the hospital.

The surveyor obtained a copy of the patient's 2/15/2012 clinical record from the acute care hospital for review. The physician's Emergency Documentation included: "I called and spoke with the transferring nurse who was really unclear of the underlying reason for the transfer, and I also reviewed the records they transferred along with discussing the patient with the paramedics upon his arrival, but none of this clarified the visit." The patient was determined to be stable at the time of his arrival and during the visit and later discharged back to Cornerstone Hospital.

The RN's assessment of Patient #1 dated 2/18/2012 at 7:40 a.m. included a neurological assessment (Glasgow Coma Scale) that revealed the the patient was alert, spontaneously opened his eyes, and was able to localize pain. The total score of the neurological assessment was "10" indicating a moderate level of consciousness. The RN documented the hemodialysis (HD) RN was at the bedside at that time. At 11:30 a.m., the RN's neurological assessment of the patient revealed he was lethargic, would not open his eyes, and had no motor response. The total score of the assessment was "3" indicating a severe loss of consciousness. The RN's documentation in the Nursing Notes included: "Reassessment complete and documented. Pt very lethargic, not responding to painful stimuli or following any commands. Pt remains on HD, will call MD." At 11:45 a.m. the RN documented: "Spoke with MD regarding (decreased) LOC (level of consciousness). States per son this is pt's baseline. No orders received, no further notification needed per MD." The next nursing note was at 1:11 p.m. and included: "Pt unresponsive, v-paced @ 60 on monitor. Code called." The next entry at 1:20 p.m. was: "MD notified." There was no documentation of what occurred with the patient between 11:30 a.m. and 1:11 p.m. when the patient coded, a period of 1.75 hours. There was no documentation of what occurred during the code or the status of the patient after the code in the clinical record.

Documentation in the hemodialysis record revealed the patient's treatment started at 8:35 a.m. and ended at 12:05 p.m. The dialysis RN's documentation included: "No response by pt throughout run. OD (right eye) deviated slightly to (upper) right. OS (left eye) 'pinpoint' pupil - both non reactive. Non over breathing vent settings. Does not follow simple commands. Chg RN and floor RN aware of condition & states no (change)...Floor nurse talked (with) attending who stated pt @ baseline."

The clinical record contained the patient's telemetry rhythm strips. The rhythm strip dated 2/18/2012 at 8 a.m. revealed the patient's heart rate was 118 beats per minute with atrial fibrillation. At 12 noon, his heart rate was 109 beats per minute. At 1:04 p.m., the patient's heart rate dropped to 56 beats per minute and was being paced by his pacemaker. The Monitor Technician documented he "talked" with the RN on duty, and the RN initialed indicating she reviewed the strip, however, there was no documentation that the RN assessed the patient at that time.

The hospital provided the surveyor with a copy of the Code Flow Sheet dated 2/18/2012 which the Chief Clinical Officer stated was not part of the medical record. The Time of Arrest documented was "1311" (1:11 p.m.) and the documented time CPR was started was "1313" (1:13 p.m.). Documentation in the code record included: "Synopsis of code: pt finished dialysis, nurse (name) from Dialysis company cleaning up room in/out. Went into room, saw pt pale unresponsive; told monitor tech (name) that pt 'looked dead.' (Name of an RN who was on the unit, but not the RN assigned to the patient's care) went into room; (name of monitor technician) immediately called code blue...." Documentation on the code record revealed the patient "expired" however there was also documentation that Emergency Medical Services personnel were present at 1:31 p.m. and the patient was sent out to an acute care hospital at 1:36 p.m.

A copy of the patient's medical record from the acute care hospital was obtained and reviewed by the surveyor. The patient arrived in the Emergency Department at 1:51 p.m. by EMS and resuscitative efforts were continued until 1:58 p.m. when the patient was pronounced dead.

An interview was conducted on 6/13/2012 with the RN who was assigned to the patient's care on 2/18/2012. The RN reported she was in another patient's room with the door closed at the time the patient coded and that she did not hear the code paged overhead. The RN stated she responded to the code when she came out of the room and saw the code cart and staff in Patient #1's room. The RN acknowledged there was a change in the patient's condition between her first assessment at 7:40 a.m. and her next assessment at 11:30 a.m. and that the patient's physician told her that was the patient's "baseline" when she contacted him at 11:45 a.m. The RN confirmed her initials on the telemetry strip dated 2/18/2012 at 1:04 p.m. when the Monitor Technician notified her of a significant change and acknowledged there was no documentation that she reassessed the patient between 11:30 a.m. and when he coded at 1:11 p.m., a period of 1.75 hours.

-Patient #2 was admitted to Cornerstone Hospital on 4/04/2012 for pain control and supportive care related to her primary diagnosis of Stage IV endometrial cancer. The physician admission orders dated 4/04/2012 included an order for the patient to be admitted to the hospital's "medical" unit with telemetry monitoring. There was also an order for the patient to be a "Full Code" at the request of the patient and family.

Nursing documentation dated 4/9/2012 at 12 midnight revealed a nursing assessment was completed and the patient was "resting quietly" at that time. The next entry was at 2:41 a.m., and the RN documented: "Called to pt's room by son. Pt not breathing. Code blue called." Documentation in the Code form revealed the time of the patient's arrest was 2:40 a.m. and ended at 3:04 a.m. when the patient was pronounced dead. The physician's Discharge Summary included: "At 02:40 on 04/09/2012, code was called as the patient was found to be unresponsive, not breathing and pulseless...She was found to have significant amount of coffee ground aspirate in her mouth. It was suspected that precipitating event was either massive aspiration episode versus pulmonary embolism."

There was no documentation in the clinical record that the patient was placed on telemetry monitoring at any time during her admission in accordance with physician orders. The CCO stated during interviews that he was not aware of the order for the patient to be on telemetry monitoring nor why the order was not followed.

-Patient #3 was admitted to the hospital on 12/23/2011 with diagnoses including acute respiratory failure, exacerbation of congestive heart failure, heart murmur, and paroxysmal atrial fibrillation/flutter.

The nursing notes dated 1/6/2012 included the following entries:

-11:40 a.m. "Reassessment complete and documented. Lasix and albumin gtt (drip) infusing as ordered."
-12:30 p.m. "Pt still with (decreased) urine output. Foley hand irrigated with no results, Foley bag changed. Will continue to monitor urine output."
-2 p.m. "MD notified of still (decreased) urine output as well as rhythm changes on cardiac monitor. Cardiologist notified as well and will be in to see pt."
-4 p.m. "Reassessment complete and documented...See flow for full assessment."
-6:20 p.m. "Dobutamine gtt initiated as ordered."
-7:30 p.m. "Upon cleaning pt, HR asystole, code called...Pt transported out @ 1925 (7:25 p.m."

A review of the Physician Progress Notes dated 1/06/12 at 5:30 p.m. revealed documentation by the cardiologist which included: "Developed renal failure...Still gaining a lot of wt. Suggest small dose of Dobutamine...." The physician wrote a corresponding order for Dobutamine Infusion at 5 mcg (micrograms) per kilogram per minute "starting now." Dobutamine is an adrenergic, beta 1 agonist medication used to increased cardiac output. There was no nursing assessment documented prior to or at the time the Dobutamine drip was ordered and started at 6:20 p.m. nor documentation of a nursing assessment of the patient's response to the medication after it was started until over one hour later when the monitor technicians alerted the staff that the patient had gone into asystole (cardiac arrest).

-Patient #5 was admitted to the hospital on 3/14/2012 with diagnoses including uncontrolled diabetes, chronic pain syndrome, narcotic dependence and recurrent hypoglycemia. The nursing notes dated 4/28/2012 included the following:

-1745 (5:45 p.m.): "Pt found unresponsive, snoring (with) white froth on (L) side of mouth. FSBS (finger stick blood sugar) = 16 at this time. Rapid response team called. 1 amp D50 and 1 mg Narcan given."
-1755 (5:55 p.m.): "Pt cont (with) unresponsive state. Decreased gag reflex noted. Pupils uneven (R) pupil 10 mm/(L) pupil 8 mm. BP increased from 138/76 to 204/99 within last few minutes. 911 called as pt is not responding to painful/verbal stimuli. AP (apical pulse 125)."
-1815 (6:15 p.m.): "Pt taken out to (name of acute care hospital) ER via ambulance."

Documentation in the Rapid Response Team Record dated 4/28/2012 included: "Other Interventions...given ice to groin, armpits...."

The physician's Discharge Summary included the following: "She was found to be unresponsive and a _____ (sic) code had been called...She was given Narcan and she ___ (sic) right away. Apparently, it was found that she was having some narcotic pills hidden in her purse. The possibility of narcotic ___, (sic), but in any case, her ____ (sic). She was transferred to (name of acute care hospital)."

There was no documentation in the nursing notes or the Rapid Response Team Record that the patient was found with narcotics in her purse.

A copy of the clinical records from the acute care hospital were obtained and reviewed by the surveyor. The Emergency Medical Services documentation revealed they arrived at the scene at 6:11 p.m. on 4/28/2012 and found the patient to be unresponsive/unconscious. The paramedic's documentation included: "Pt had ice packs on her left flank and right arm pit, pt's nurse did not give a reason for the ice. Pt's nurse stated that they found a pill bottle in the pt's room and did not know if the pt had taken some of the pills in the bottle."

The Emergency Department physician's documentation included: "The patient was found by staff at Cornerstone earlier this evening with decreased level of consciousness and altered mental status. She had a bottle of morphine in her room and it was suspected that she was a morphine overdose. She is prescribed morphine at Cornerstone 30 mg q. 12 h...She was given Narcan by Cornerstone staff and she became agitated afterwards...She was packed in ice by Cornerstone staff noted by the paramedics who removed the ice. It is unclear why the patient was packed in ice."

Patient #5's clinical record was reviewed with the CCO and Director of Quality Management during an interview on 6/12/2012. They reported they were not aware the patient was found with a bottle of narcotics in her room and the possibility of an overdose.

-Patient #6 was admitted to the hospital on 3/8/2012 with diagnoses including respiratory failure, cellulitis, morbid obesity (448.6 pounds), chronic atrial fibrillation, sleep apnea, history of stroke, chronic diastolic heart failure, and hypertension. Documentation in the clinical record revealed he had a tracheostomy, was on a ventilator and had a nasogastric tube (NGT) through which he received continuous tube feeding formula and routine water flushes.

The Nursing Notes dated 3/10/2012 included the following:

-2400 (midnight): "Patient has had a VERY large volume of emesis that looks and smells like tube feeding. However, residual check @ 2100 (9 p.m.) was < (less than) 10 milliliters. Patient had > (greater than) 1000 ml vomitus out total. Severe nausea (with) vomiting but no pain."
-0430 (4:30 a.m.): Patient had no more vomiting after IV phenergan. Tube feedings restarted @ 0330 (3:30 a.m.). No nausea currently. Patient does ask for frequent suctions, both oral and endotracheal. Lungs have some wetness to sound. He has moderate cough effort."

There was no documentation that the RN checked the placement of the NGT after the patient's large volume of emesis at midnight on 3/10/2012 and prior to restarting the tube feeding formula at 3:30 a.m. There was no documentation of a nursing assessment of the patient between 4 a.m. until 9 a.m. and the sections for the assessment of the patient's respiratory status and wound care were blank at that time. The Nursing Notes dated 3/10/2012 included the following:

-0745 (7:45 a.m.): "Took report and saw pt; he has been incontinent of a large liquid brown BM. Bed changed, patient's skin cleansed."
-0900 (9 a.m.): NGT appears to be out too far. Air bolus exits pt's mouth when given. TF off, physician notified." As noted above, the RN on the night shift restarted the patient's continuous tube feeding at 3:30 a.m. without documentation of checking for placement in the patient's stomach, a period of 5.5 hours the tube feeding was running before the NGT was found to be displaced (not in the patient's stomach) and the tube feeding stopped.
-No time documented: "Physician in, new orders written." There was a physician's order dated 3/10/2012 at 9:45 a.m. that included: "CXR (chest x-ray) stat, dobhoff placement, xray (after) dobhoff placement...."
-1700 (5 p.m.): "Dobhoff tube insertion process started." There was no documentation that explained why there was a delay between the time the Dobhoff tube was ordered at 9:45 a.m. and when the "process" was started at 5 p.m., 7.25 hours later.

There was no documentation of a full nursing assessment completed on the patient after 9 a.m. on the day shift of 3/10/2012 until 8 p.m. by the RN on the evening shift, 11 hours later.

The patient was evaluated by a physician on 3/10/2012 at 8:30 p.m. per documentation in the Physician Progress Notes. The physician documented the patient was febrile at 100.5 degrees Fahrenheit and a rapid ventricular rate in the 130's to 140's. The physician wrote orders at that time. At 10:40 p.m. on that date, the RN obtained a telephone order from the physician for "Give Vanco (Vancomycin) 1 gram IV x 1 now." Documentation in the clinical record revealed the patient was admitted with a known allergy to Vancomycin which is an antibiotic. There was no documentation the RN questioned or clarified the order with the physician specific to the patient's documented allergy prior to administering it at 2330 (11:30 p.m.) on 3/10/2012 as documented in the MAR.

The Nursing Progress Notes dated 3/10/2012 included the following sequence of events:

-2045 (8:45 p.m.): "...Several orders: See MAR for times given...Vanco up @ 2330 (11:30 a.m.)...Pt alert and shook head when given explanation as to what medication was for...At 2340 (11:40 p.m.)-Went to answer pt's light - Pt asked for bedpan...Attempt to clean pt but placed pt on bed pan - left room for more supplies, arrived back in room approx 5 min later (with) help to refresh pt. Noted pt's eyes glassy and color ashen, and pt not breathing on his own - Called Tele Tech to get Charge (Nurse) & RT (Respiratory Therapist)...Started CPR at 2400...pt was stabilized and transported out @ 0045 (12:45 a.m.)...." Documentation on the Code Flow Sheet revealed the patient's "Time of Arrest: 2345" and Time CPR started: 2400," however, there was no documentation that clarified why there was a 15 minute delay.

The physician's Discharge Summary included: "Apparently, when I covered him the night before an NG tube was placed, but may not had (sic) been in stomach. He had some nausea and vomiting and IV Zosyn was started for probable aspiration pneumonia."

Interviews were conducted with the CCO on 6/15 and 6/19/2012. The patient's clinical record was reviewed with the CCO during the interviews and he acknowledged the above documentation and had no further documentation or information regarding the RN assessments and lack of assessments of the patient when there were changes in his condition. He also acknowledged the RN administered IV Vancomycin to the patient without first clarifying the order with the physician because of the patient's documented allergy to the medication.

A copy of the patient's clinical record was obtained by the surveyor from the acute care hospital where he was transferred. Documentation in that record revealed the patient was admitted to the Intensive Care Unit where he died on 3/21/2012.

-Patient #8 was admitted on 5/13/2012. The Nursing Notes dated 6/10/2012 at a.m. revealed the patient was "very anxious and agitated." The RN documented she obtained a physician order for: "1 mg Xanax q 8 hr prn" (every 8 hours as needed). Xanax is an anti-anxiety medication. Documentation in the MAR revealed the RN gave the patient a dose of 1 mg Xanax at 8:20 a.m. on 6/10/2012 in addition to 5 mg of Oxycodone IR previously ordered by the physician to be given as needed for pain. The patient's blood pressure documented on the vital signs flow sheet was 105/63 between 7 a.m.-8 a.m. on 6/10/2012 prior to the administration of the medications. The blood pressures recorded after the medications were 82/47 between 11 a.m. - 12 noon and 85/47 between 3 p.m.- 4 p.m. The 24-hour Assessment Flow Record dated 6/10/2012 revealed a nursing assessment was completed at 8 a.m. and not again until 8 p.m., a period of 12 hours. There was no nursing documentation that addressed the drop in the patient's blood pressures.

The patient was evaluated by a physician at 2 p.m. on 6/10/2012 who noted and documented the patient's low blood pressures when he was asleep but increased when he was awake. The physician documented the two medications needed to be spaced out and not given at the same time. The physician's order included: "do not give PRN Xanax and PRN Oxy IR together. Must be at least two hours between doses."

The CCO acknowledged during an interview on 6/12/2012 that policies and procedures were not followed for the nursing reassessments of Patient #8.

-Patient #9 was admitted on 5/26/2012 with diagnoses including acute respiratory failure associated with hypoxemia, pulmonary fibrosis, congestive heart failure, bilateral pneumonia associated with sepsis, bilateral pulmonary emboli, chronic obstructive pulmonary disease exacerbation, anemia, and anticoagulation therapy.

A physician's order dated 5/26/2012 at 1:20 p.m. included an order for "NG placement." There was no nursing documentation in the clinical record that an attempt was made to place the NG tube ordered by the physician. A telephone order dated 5/27/2012 at 8:40 a.m. was received from the physician to: "Start TPN (Total Parenteral Nutrition) per pharmacy protocol." The pharmacist wrote an order at 12:15 p.m.: "TPN will be started after patient evaluated by dietician per protocol." Another pharmacist wrote an order on 5/28/2012 to start TPN at 6 p.m. on that date. The TPN was started on 5/28/2012 at 6 p.m., over 33 hours from when the original physician's order was received to start TPN.

The Nursing Notes revealed the following sequence of events:

-5/28/2012 (12 noon): "No change, resting quietly in bed...."
-5/28/2012 (4 p.m.): "Very restless, pull CPAP off sat dropped to low 80's. CPAP back on, HR 119-139, BP 151/104...." The Respiratory Therapist documented in the Cardiopulmonary Progress Notes at 4:15 p.m.: "RT called into room. Pt became disconnected off BiPAP & O2 SpO2...to < 10's. Immediately placed BiPAP & O2 back on SpO2 quickly (increased) to 80's, SpO2 92%. Pt calming down, I discussed with nurse that we may need a sitter because similar events like this have happened 2 X throughout the day."
-5/28/2012 (5 p.m.): "Pt has been med with Morphine...Metoprolol and enalaprilat given a little early..."
-5/28/2012 (8 p.m.): "Assessment completed. Given report of patient pulling tubes, etc...."
-5/28/2012 (9 p.m.): "Noted blood in urine, no clots noted. Will monitor."

There was a physician's telephone order dated 5/28/2012 at 7:33 p.m. for: "Sitter 24 hours." There was no documentation in the clinical record that a sitter was obtained for the patient. The physician's order that immediately followed the order for a sitter was a telephone order dated 5/28/2012 at "0920" (9:20 a.m.) for: "May initiate soft wrist restraints pulling tubes off." (The CCO reported during an interview that the RN who obtained and signed the order was on the 7 p.m. to 7 a.m. shift, and probably meant to document the time of 9:20 p.m. which would be 2120 military time.) The Cornerstone Hospital Restraint Order Form was not completed in the areas for Assessment of the Need of Restraint Use, Alternatives Attempted, or the Nursing Care Plan for the use of restraints. The Documentation of Assessment & Care Provided section revealed the patient was in restraints between 10 p.m. and 12 midnight. The patient was transferred to an acute care hospital on 5/29/2012 at 1:15 a.m. following physician orders.

The CCO stated during an interview on 6/13/2012, that a sitter was obtained for the patient when the order was received. However, telephone interviews conducted separately with the Charge Nurse who obtained the order on 5/28/2012 and the RN who was assigned to the patient's care from 7 p.m. to 7 a.m. 5/28-29/2012 reported a sitter was not obtained. The CCO acknowledged there was no nursing documentation regarding the physician's order to place an NG tube and why it was not placed; the delay in initiating TPN later ordered by the physician; and the incomplete nursing assessment regarding the application of restraints.

A copy of the patient's clinical records from the acute care hospital were obtained by the surveyor. The physician's Emergency Documentation included: "There is a Foley catheter in place with gross bloody urine noted passing through the Foley catheter...Acute respiratory failure...The patient is admitted to the ICU in critical condition." Physician consultation notes dated 5/29/2012 at 4:54 a.m. revealed the patient's white blood cell count was 27,000, his hemoglobin and hematocrit were 11 and 35 respectively, and his INR was 5.0 at the time of admission. The physician's assessment include: "Respiratory failure secondary to sepsis, severe, questionable intraabdominal abscess." Further documentation revealed the patient died later that day.

Based on reviews of clinical records, hospital policies and procedures, and staffing records and staff interviews, it was determined the hospital failed to ensure nursing staff with specialized training and competence were assigned to meet the specific needs of each patient.

Findings include:

Random interviews were conducted during the survey with the RN staff which revealed all RN's on staff did not have specialized training to provide for the specific needs of all patients they were assigned to, specifically those patients on continuous telemetry monitoring. One RN stated during an interview that she only worked "part time." She reported she did not have telemetry training or certification and acknowledged she was routinely assigned to the care of patient's on continuous telemetry monitoring. During the interview, the RN was asked to review an EKG strip from a patient's record, and she was not able to interpret the strip. The RN was asked how she would handle a code arrest of a patient if the Charge Nurse was not immediately available, and she responded, "I would do the best I can."

A random sample of the hospital's staffing records included those dated 1/6/2012 and 5/22/2012. On both days, the RN was assigned to the care of patients on continuous telemetry monitoring.

The CCO and the Director of Quality stated during an interview on 6/15/2012 that all of the RN's on staff had continuous telemetry monitoring training and that he personally provided the training. Three RN personnel records were reviewed with the CCO and the Director of Quality which had no documentation of the training. The CCO and the Director of Quality then stated the Charge Nurses would not assign the care of patients on continuous telemetry monitoring to an RN who was not trained. When the surveyor reviewed documentation with the CCO that untrained RN's were being assigned to the care of patients on continuous telemetry monitoring, he reported he was not aware of that practice.

Based on reviews of clinical records, hospital policies and procedures, and staff interviews, it was determined:

1. the hospital failed to ensure for 3 patients who received pain medications (Patients #2, 3 and 6), that the patients were assessed prior to and/or after the administration of pain medications;

2. the hospital failed to ensure for 2 patients (Patients #4 and 9), that the patients received medications following physician orders and policies and procedures;

3. the hospital failed to ensure one patient (Patient #6) did not receive a medication he was allergic to; and

4. the hospital failed to ensure policies and procedures were developed and implemented in conjunction with medical staff and pharmacy for timing of medication administration based on the nature of each medication and its clinical application to ensure safe and timely administration.

Findings include:

The hospital's policy and procedure titled, Medication: Administration and Documentation, included: "Patient response to prn (as needed) medications will be assessed 1 hour after administration and documented in the nursing notes. Patient response to prn medications will be documented in nursing notes (or pain flowsheet for pain medications)."

Documentation in the hospital's policy and procedure titled, Pain Assessment and Management, included: "Elements required and the corresponding documentation options available on the pain management flowsheet are as follows: 1. Location 2. Quality/Patterns of radiation 3. Onset, duration, variation 4. Interventions 5. Effects of intervention...If presence of pain is present the RN/LVN will assess the level of pain and seek the appropriate pain management intervention. This may include...prescribed medication administration...Reassessment of pain will occur within a reasonable time after interventions are utilized for pain relief in addition to other regular reassessments."

-Patient #2 was admitted to Cornerstone Hospital on 4/4/2012 with physician's orders for Oxycodone 5 mg by mouth every three hours as needed for mild pain and Oxycodone 10 mg by mouth every three hours as needed for severe pain. On 4/7/2012, the Nurse Practitioner wrote an order for Dilaudid 3 mg IV (intravenously) every three hours as needed for severe pain.

A review of Patient #2's Medication Administration Record (MAR) for the period from 7 a.m. on 4/8/2012 to 6:59 a.m. on 4/9/2012 revealed the patient received the following:

Dilaudid 3 mg IV at 10:20 a.m., 1:15 p.m., 4:30 p.m., and 8:30 p.m.
Oxycodone Immediate Release 10 mg by mouth at 10:30 a.m. and 4:30 p.m.

Documentation in the Pain Management Flowsheet revealed four columns dated "4/8." The first column revealed a pain assessment by the nurse at "1020" (10:20 a.m.), the second column revealed a pain assessment at "1030" (10:30 a.m.), the third column revealed a pain assessment at "0115" (1:15 a.m. which was clarified with staff to be an error and the correct time 1:15 p.m.), and the fourth column had a pain assessment time of "1630 (4:30 p.m.). The Pre-Assessment Scores in all four columns were "UTA" (unable to assess). There was no other documentation in the first three columns including Interventions and Post Intervention Assessments. Documentation in the fourth column was "IV Dilaudid and Oxy 10 mg IR" however there was no post intervention assessment documented.

Oxycodone is an opioid controlled substance schedule II used to treat moderate to severe pain. The Nursing 2010 Drug Handbook (Wolters Kluwer Health / Lippincott Williams & Wilkins) included the following for the administration of Oxycodone (page 757): "Adverse Reactions: respiratory depression...Nursing Considerations: Reassess patient's level of pain at least 15 and 30 minutes after administration...Monitor circulatory and respiratory status. Withhold dose and notify prescriber if respirations are shallow or if respiratory rate falls below 12 breaths/minute." The Adverse Reactions for Dilaudid (page 747) included "respiratory depression" and the Nursing Considerations (page 748) included: "Reassess patient's level of pain at least 15 and 30 minutes after administration...Monitor respiratory and circulatory status...."

The Chief Clinical Officer acknowledged during interviews and record reviews that policies and procedures were not followed for the administration of the two narcotic pain medications including detailed pre-assessment of the patient's pain prior to the administration of medications and a post-assessment of the patient after the administration of the medications.

-Patient #3 was admitted on 12/23/2011 with physician orders including Oxycodone (Immediate Release) 5 mg by mouth every six hours as needed for pain. Documentation on page 4 of the MAR for the period from 1/5/2012 at 7 a.m. to 1/6/2012 at 6:59 a.m. revealed the patient received Oxycodone on 1/5/2012 at "0810" (8:10 a.m.), "1635" (4:35 p.m.), "2245" (10:45 p.m.) and on 1/6/2012 at "0445" (4:45 a.m.). Documentation on the Pain Assessment Flowsheet documented the patient was not reassessed until 9 a.m., almost one hour after the 8:10 a.m. dose; 35 minutes after the 4:35 p.m. dose; and one hour after the 10:45 p.m. dose. There was no documentation that the patient was assessed prior to or after the 4:45 a.m. dose.

There was a later physician's telephone order to change the Oxycodone. The telephone order was not dated or timed by the RN who obtained the order, however it followed the 12-hour chart check on 1/6/2012 at 7 a.m. and was prior to another telephone order obtained on 1/6/2012 at 2:15 p.m. The order read, "Change Oxycodone to 5-10 mg PO (by mouth) Q (every) 4 (hours) prn (as needed) pain." The physician's signature on this telephone order was dated "1/19/12." The order was transcribed onto page 5 of the MAR for the period from 1/6/2012 at 7 a.m. through 1/7/2012 at 6:59 a.m.: "Oxycodone 5-10 mg PO Q 4 (hours) prn pain." The RN who obtained the telephone order to change the Oxycodone documented the medication was administered at "0900" (9 a.m.), "1230" (12:30 p.m.), and "1630" (4:30 p.m.). However, there was no documentation of whether 5 mg or 10 mg of the medication was administered at those times. The pain assessment flowsheet attached to the nursing Assessment Flow Record dated 1/6/2012 was blank. There was no documentation that the patient was assessed prior to or after the administration of the narcotic medication documented above.

-Patient #6 had physician orders for Morphine sulfate 4 mg IV every 4 hours as needed for moderate pain. Documentation in the patient's MAR's revealed he received Morphine 4 mg IV at "2100" (9 p.m.) and again at "0105" (1:05 a.m.) on 3/9/2012. Documentation in the pain assessment flowsheet for the 9 p.m. administration was missing in the sections for the Pre-Assessment Score, Character, Duration, Interventions and Post Intervention Assessment, and there was no documentation of any pre- or post-assessment of the patient specific to the 1:05 a.m. dose on 3/9/2012. On 3/10/2012 at "1325" (1:25 p.m.), the patient received Morphine 4 mg IV per documentation on the MAR. There was no documentation of the date, time and post assessment score of the patient after the morphine was administered.

There was an undated Medication Administration Record in the clinical record. Handwritten documentation on that record revealed the patient received "Warfarin (anticoagulant) 5 mg NG daily" and "toradol 15 mg IV x 1" at "1730" (5:30 p.m.) There were RN initials next to both entries, however, there was no documentation of the date the medications were administered. There was a physician order dated 3/8/2012 at 3:37 p.m. that included orders for those two medications.

The above documentation was reviewed with the CCO during interviews on 6/7/2012 at which time he acknowledged policies and procedures were not followed for the administration of pain medications.

2. The hospital's policy and procedure titled Medication Administration: Times included: "All medications will be scheduled at these specific times unless otherwise specified by the ordering doctor...Standard Drug Administration Times...Abbreviation/Time Schedule...TID 0900 1500 2100."

Patient #4 was admitted to the hospital on 6/8/2012 with diagnoses including new-onset rapid atrial fibrillation and congestive heart failure/pulmonary edema in the setting of rapid atrial fibrillation.

This inpatient's clinical record was reviewed on 6/11/2012 at 11: 20 a.m. A physician's telephone order dated 6/10/2012 at "1835" (6:35 p.m.) included: "Give 50 mg Metoprolol x 1 NOW then give regular scheduled Metoprolol @ 2100 (9 p.m.). Then change to Metoprolol 50 mg TID starting 06/11/12." Documentation on the MAR revealed the patient received Metoprolol 50 mg at 6:35 p.m. but did not receive the 9 p.m. dose. There was no physician's order to hold or discontinue the 9 p.m. dose. Metoprolol is a hypertensive medication.

The MAR's dated 6/11/2012 for the period from 7 a.m. through 6/12/2012 at 6:59 a.m. revealed the Metoprolol 50 mg TID order was transcribed by hand including the times for administration of: "1400" ( 2 p.m.), "2200" (10 p.m.) and "0600" (6 a.m.) which was not the TID times in the hospital's policy and procedure documented above. There was no documentation that the patient received the hypertensive medication as of 11:20 a.m. on 6/11/2012.

An interview was conducted on 6/11/2012 at 11:20 a.m. with the RN assigned to Patient #4's care at that time. The RN reported she transcribed the Metoprolol order documented above including the administration times. The RN was asked about the documented administration times of 1400, 2200 and 0600, and she responded that she thought those were the TID scheduled times. The RN then referenced the hospital policy and acknowledged the times she wrote in were not correct. The RN reported the patient did not receive Metoprolol that morning but he received a dose at 9 p.m. the prior evening which was not correct as there was no documentation the patient received that dose (refer to above documentation).

The Director of Pharmacy stated during a later interview on 6/11/2012 that the TID scheduled times were 0900, 1500, and 2100 and that Patient #4 should have had a dose of Metoprolol 50 mg at 9 a.m. the morning of 6/11/2012.

-Patient #9 had physician orders dated 5/26/2012 that included Novolog insulin coverage following the "Low" Insulin Sliding Scale. The physician wrote a subsequent order on that date at 1:20 p.m. that included: "While NPO (nothing by mouth) Do Not cover FS (fingersticks) less than 150." That order was transcribed onto the Medication Administration Record for the period from 5/26/2012 at 7 a.m. to 7 p.m. 5/27/2012 as: "Do not cover sugars > (greater than) 150+" which was opposite of the physician's order. Documentation on the MAR revealed the patient's fingerstick at 11:30 a.m. was "180" and was "not covered" by insulin. The patient should have received 3 units of insulin at that time in accordance with physician orders.

A physician's telephone order dated 5/28/2012 at 4 p.m. was received by an RN. The order read: "Morphine 1 to 3 mg Q 2 hr PRN." There was no further order that clarified the indication for administering the narcotic pain medication or the route the medication was to be administered, for example by mouth, intravenously, etc. Documentation on the MAR revealed 2 mg of Morphine was given to the patient on 5/28/2012 at 5:15 p.m., however there was no documentation of why it was administered and the route it was administered. The RN documented on 5/28/12 at 4 p.m. that the patient was "Very restless" and documented at 5 p.m. that the patient was medicated with morphine. According to documentation on the Pain Assessment Flowsheet dated 5/28/2012 at 4 p.m., the patient was assessed to have no pain and the next pain assessment was not documented until 8 p.m. at which time he had no pain.

The CCO acknowledged during interviews that policies and procedures were not followed for medication administration to Patient #9 as documented above.

3. The hospital's policy titled Medications included: "Procedure:...2. If a medication order is written on a paper Physician's Order sheet, transcription of that order shall be performed ensuring the five rights of medication administration...At the time of transcription, the medication order will be checked against the patient's allergies...8. All patients' allergies shall be clearly noted in the patient's record and shall be reviewed prior to administration of any medication. Any medication obtained after hours by the charge nurse will be reviewed against documented patient allergies."

-Patient #6 was admitted on 3/08/2012. Documentation in the admission physician orders revealed the patient had allergies to "Vanco" (Vancomycin). There was physician documentation in the History and Physical dated 3/8/2012 that the patient was allergic to Vancomycin. The pharmacy generated Medication Administration Records had Vancomycin documented in the Allergies section of the record.

Documentation in the clinical record dated 3/10/2012 revealed the RN on duty obtained a physician's telephone order at "2240" (10:40 p.m.) to: "Give Vanco 1 gram IV x 1 now." There was no documentation that the order was clarified with the physician prior to its administration by the RN at "2330" (11:30 p.m.) on 3/10/2012. The patient coded at 11:45 p.m. and was transferred to an acute care hospital. Refer to Tag A-395 for further details regarding Patient #6.



22680

4. A review of nursing policies and procedures and pharmacy policies and procedures revealed a Medication Management policy that did not include time critical medications.

The Director of Pharmacy acknowledged during an interview conducted on 06/13/12, she had not initiated the time critical policy for the facility.

Based on document review and staff interview, it was determined the facility failed to activate the Pharmacy and Therapeutic Committee and conduct business as required in policy.

Findings include:

The pharmacy policy Pharmacy and Therapeutics Committee: PH - 106 included: "The Pharmacy and Therapeutics Committee is an advisory group of the medical staff that serves as the liaison between the medical staff and the Pharmacy department. The committee is composed primarily of physicians, pharmacists, and nurses and is selected under the guidance of the medical staff. It is also a policy recommending body to the medical staff and to Administration on all matters relating to the use of drugs. These policies and recommendations shall be reported to the medical staff via the minutes/QA summaries of the committee meetings. The P&T Committee reports through the Professional Practice Committee...2. Organization of Pharmacy and Therapeutics Committee: a. The Pharmacy and Therapeutics Committee should be composed of no less than one physician, a pharmacist, the hospital administrator or representative, and the director of nursing or representative. b. A physician should be the chairman and a pharmacist an official. c. The Committee should meet no less than four times a year. d. The Committee should at times invite persons from within or outside the hospital who can contribute their specialized knowledge or experience. e. An agenda should be prepared and submitted to the members of the Committee in advance of the meeting. The pharmacist or physician may determine the agenda. f. Minutes should be prepared and submitted to the members of the Committee in advance of the meeting (sic)...."

The pharmacy policy: Committee Membership: PH - 105 included: "Policy: The Director of Pharmacy Services must serve on the Pharmacy and Therapeutics Committee as Committee Coordinator...."

The Chief Executive Officer verified during an interview conducted on 06/15/12, the facility did not have P&T Committee minutes to review. She acknowledged the facility did not have a P&T Committee. The Pharmacist presented information to the Medical Executive Committee (MEC) that was entered into the MEC minutes.

Based on document review, and staff interview, it was determined the facility failed to require medication errors were analyzed, investigated, and corrected in collaboration with the Pharmacist, Director or Nursing, and the Quality Manager.

Findings include:

The pharmacy policy: Medication Variance Report: PH - 147; revised on 05/14/09, included: "Pharmacy personnel will complete a Medication Variance Report whenever a discrepancy regarding the ordering, preparation, dispensing or administration of a drug is suspected or identified. Procedure: 1. A Medication Variance Report shall be prepared if any of the following circumstances exist: a. The drug is not administered or dispensed as directed (dose, time, route, etc.). b. The records of administration are not complete (MAR - medication administration record...) c. The drug is administrated without an appropriate order. d. The drug is not prepared as ordered by the Physician..."

The facility policy: Medication Management - Medication Safety Management Plan included: "Goals: The purpose of the Medication Safety Management Plan is to promote patient safety. Reduce practice variation, errors, and misuse; Monitor medication management processes in regard to efficiency, quality, and safety....Responsibility: Implementation, monitoring, and compliance with this plan is assigned to the Director of Pharmacy and the Pharmacy and Therapeutics Committee. Overall responsibility for compliance with this plan is assigned to the Chief Executive Officer....8. Monitoring: a. Patient responses to medications will be monitored by the Medical Executive Committee, Pharmacy and Therapeutics Committee, and Quality Council including: b. Actual or potential medication related problems...f. Medication errors will be trended for look-alike, sound-alike medications and referred to the Pharmacy and Therapeutics Committee for formulary review....9. Evaluation and Competency: ...b. Medication variances, adverse drug reactions, and issues within the medications management system are analyzed for opportunities to improve medication management systems and improve medication safety...."

Review of medication variance reports for the month of April revealed the Pharmacist, Registered Nurse (RN), or Charge Nurse (CN) discovered an error and wrote a variance report. The Director of Nursing (DON) and the Director of Quality would review the variance report and write their comments. Review of the Routing Logs for the variance reports revealed the Pharmacist, DON, and the Director of Quality reviewed the reports on different dates for the reports reviewed.

The variance reports revealed the Physicians were not notified when insulin doses were changed and the wrong dose was administered; or when lipids were found lying on the counter in the med room; not added to the Total Parenteral Nutrition (TPN). The Director of Quality questioned whether the lipids were given from another source but no investigation or follow-up was documented. The DON educated the nurse to give all the medications listed on the Medication Administration Record (MAR).

The Director of Quality acknowledged during an interview conducted on 06/15/12, the Pharmacist, DON, and the Director of Quality did not review the reports together. She verified they did not collaborate as a team to identify, analyze, investigate, evaluate, and resolve the variances.

Based on review of incidents of Code Arrests, Policies and Procedures, Medical Staff ByLaws, patient record reviews, Quality Assessment Performance Improvement Plan, and interviews, it was determined that the hospital failed to measure, analyze, and track the patient adverse events of Code Arrests.

Findings include

The hospital's Policy and Procedure entitled "Code Blue" identified the members of the Code Blue Team, the competencies required of some members, physicians' role, specific "Protocols and Algorithms of The American Heart Association," and equipment needed, among other items. This Policy and Procedure revealed, in part: "...B. The Code Blue page is answered by a Physician, if available, (any physician in-house at the time of the code)...."

The Medical Staff ByLaws do not include any entry regarding the "any physician who is in house at the time of a code...answers the code...."

The hospital's QAPI Plan 2012 revealed, in part, that the hospital "...will monitor the performance of processes that involve risks or may result in adverse events...resuscitation and its outcomes...shall be measured and assessed by the medical staff, through the appropriate committee structure or interdisciplinary performance improvement team on a concurrent basis...."

A request was made, on entrance to the hospital, for all Code Arrests that had occurred in the facility since January 1, 2012. Four Patient Code Arrests were reported to the surveyors: Patients #1, 2, 3 and 6).

Patient #1 became "nonresponsive" on 2/18/12 at 1:11 p.m. and a Code Blue was called. The patient was resuscitated unsuccessfully, did not regain consciousness, transported to an Acute Care Hospital and expired the same day.

Patient #2 "stopped breathing" on 4/9/12 at 2:40 a.m. and a Code Blue was called. The patient was resuscitated unsuccessfully, did not regain consciousness, and the record documented the patient expired.

Patient #3's heart monitor changed to asystole (no cardiac rhythm) on 1/6/12 at 7:10 p.m. and a Code Blue was called. The patient was resuscitated, did not regain consciousness, transported to an Acute Care Hospital and expired the same day.

Patient #6 was found in respiratory distress on 3/11/12 at 11:45 p.m. and a Code Blue was called. The patient was resuscitated and transported via ambulance to an Acute Care Hospital. The patient expired on 3/21/12.

The Code Arrests documents of Patients #1, 2, 3 and 6 each had a separate "Resuscitation & Outcomes Review" sheet of the Codes, but there was not an analysis with tracking and trending or review for common problems over the 4 Codes. Three of the 4 Codes had a separate sheet listing problems that had happened during the Codes. Patient #1's Code had problems listed that the patient's nurse did not hear the code called, the "code was disorganized," and that the patient's tracheostomy tube was supposed to have been changed but had not been done. Patient #2's Code had problems listed that there was no Ambu Bag on the Code Cart. Patient #6's Code had problems listed that the IV pump would not accept the correct rate during the code. There was no evidence of any investigations of problems listed on the Code Review sheets or information regarding solutions to the problems identified.

The Quality Medical Director stated, on interview 6/13/12, that he had not been involved in a quality review of the Codes, but another physician may have been with some of the Codes. None of the 4 Code Review Sheets contained the signature of a physician and 3 of the 4 Review sheets did not contain the signature of the Director of Quality Management. Two of the 4 Codes had a physician Performance Improvement Report, but neither had any signatures including physician signatures on the "Report." The Quality Medical Director acknowledged there was no evidence of a process to measure, analyze, and track adverse patient events such as Code Arrests.

A request was made on 6/7/12 of the Director of Quality Management, for any additional incidents of Codes after the one on 4/9/12. The Director of Quality Management stated there had not been any more Codes. A request was made of the Chief Clinical Officer, on 6/7/12, for any additional Codes after the one on 4/9/12. He responded that he did not know of any additional Codes, but would check and returned with 2 additional Codes: one on 4/28/12 (Patient #5) and one on 5/22/12 (Patient #7). These Codes did not have any Review sheets, physician Performance Improvement Reports, or sheets listing problems.

Patient #5 was found unresponsive, "froth from mouth," unequal pupils," and "erratic blood pressure" on 4/28/12 and the record documented "the nurse called overhead for Code Blue." The patient was given IV Narcan, IV Dextrose, Saline "flushes," and transported via paramedics and ambulance to an Acute Care Hospital. The patient was admitted.

Patient #7 was found unresponsive on 5/22/12 at 4:30 a.m. with a cardiac arrhythmia and a Code Blue was called. The patient was resuscitated including "shocked x 1," regained consciousness, and was transported to an Acute Care Hospital. The patient was admitted.

The Administrator was asked why there had not been a quality process of measuring, analyzing, tracking, and trending of the adverse events of Code Arrests and responded that one nurse had been responsible but she had resigned. The Director of Human Recourses stated, on interview 6/13/12, that the "one nurse's" last day at the hospital had been 3/23/12. This nurse's signature was not present on any of the review sheets of Codes that occurred prior to 3/23/12.

The hospital Medical Director stated, on interview 6/12/12, he was aware of a physician problem with Patient #1 where the physician who attended the Code asked for blood tests to be drawn before the Code was allowed to start. The hospital Medical Director stated that physician was given a letter of concern requesting a response regarding his delay in allowing the Code to start. The Administrator and the Director of Quality Management stated they were not aware of the concern or of any letter directed to the physician who caused the delay.

The hospital Medical Director stated, on interview 6/12/12, that the hospital had a goal of zero Code Arrests and that there should be a process in place for analyzing the Codes for a Process Improvement Program. The hospital Medical Director stated he had never received any reports or information of quality reviews of Codes. The hospital Medical Director acknowledged there was no evidence of a process to measure, analyze, and track adverse patient events of Code Arrests.