HospitalInspections.org

Based on observation, interview and document review, the Governing Body did not fulfill its responsibilities in the conduct of the hospital as an institution. The following deficient practices were identified:

1. Based on observations, interviews and record review, the hospital failed to ensure the Rights of the Patients were protected and promoted. (Refer to A-115)

2. The hospital's Quality Assessment and Performance Improvement Program failed to
maintain an effective assessment of the hospital's organization, services and all hospital
departments. (Refer to A-263)

3. The hospital failed to ensure that the Nursing Services were organized and that the delivery of nursing care was supervised. (Refer to A-385)

4. The facility failed to meet the provisions of Pharmacy Services. (Refer to A-490)

5. The facility failed to ensure that Dietary Services met the needs of all patients. (Refer to A-618)

6. The facility failed to provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases in all areas of the hospital. (Refer to A-747)

7. The facility failed to ensure that the hospital's Surgical Services were organized and provided in accordance with acceptable standards of practice which included compliance with all applicable Federal and State laws, regulations and guidelines governing surgical services to ensure the health and safety of patients. (Refer to A-940)

The cumulative effect of these systemic problems resulted in the possibility of patient harm in a universe of 51 patients.

Based on observations, interviews and record review, the hospital failed to ensure the rights of the patients were protected and promoted when the hospital failed to:

1. Ensure that 1 of 32 sampled patients (Patient 31), in a universe of 51 was informed by the anesthesiologist and not a RN (registered nurse) about an epidural (an injection into the spine for pain relief and had side effects which included, numbness of the lower extremities, a drop in blood pressure and severe headache). This failure contributed to Patient 31's rights being violated to be fully informed of her health status, care plan and treatment. (Refer to A-131)

2. Ensure that 1 patient (requested to remain anonymous), in a universe of 51 patients, was given personal privacy by placing the patient in a recliner chair in a hallway of labor and delivery with an external fetal (unborn baby) monitor on her abdomen. This failure resulted in the patient feeling exposed. (Refer to A-143)

3. Ensure that 1 of 32 sampled patients (Patient 43) received care in a safe setting. The patient's baby was premature at 35 weeks (full term baby is 40 weeks) and was delivered by a C-section (Cesarean section, a surgical removal of a baby from the mother) 12 hours after the patient's admission when the hospital did not have a neonatal intensive care unit (NICU, a unit that is specially equipped and had specially trained staff to care for premature infants) or a neonatologist (a physician specialty for the care of the newborn) present for the baby's birth. This failure had the potential to result in an unsafe environment for the premature infant. (Refer to A-144)

4. Ensure that restraints imposed for 1 of 32 sampled patients (Patient 5), in a Universe of 51 patients, may only be used when less restrictive intervention have been determined and were documented to be ineffective to protect the patient. This deficient practice had the potential to interfere with the basic rights of Patient 5 to be free from restraints and to be discontinued at the earliest possible time. (Refer to A-164)


5. Ensure that a physician wrote complete orders for restraints, for 1 of 31 sampled patients (Patient 22) in a universe of 51 a physician wrote an as needed order (PRN) for Patient 22. This failure had the potential to increase the risk of Patient 22's right to be free of unnecessary restraints violated. (Refer to A-169)


The cumulative effect of these systemic failures meant the hospital did not protect and promote the rights of all patients receiving care in the hospital for a universe of 51 patients.

Based on interview and record review, the hospital failed to ensure that 1 of 32 sampled patients (Patient 31), in a universe of 51 was informed by the anesthesiologist and not a RN (registered nurse) about an epidural (an injection into the spine for pain relief and had side effects which included, numbness of the lower extremities, a drop in blood pressure and severe headache). This failure contributed to Patient 31's rights being violated to be fully informed of her health status, care plan and treatment.


Findings:


A record review of Patient 31 was conducted on December 11, 2012 at 2:50 PM. Patient 31 was admitted for induction of labor (to artificially induce labor by the use of medications). A review of a form titled, "Informed Consent and Authorization for Anesthesia" (for an epidural) revealed that the informed consent was signed by Patient 31 and obtained by a RN, on December 11, 2012 at 1:10 AM.

An interview on December 11, 2012 at 3 PM was conducted with Patient 31. The patient stated that she did sign the informed consent for the epidural. Patient 31 also stated that a physician had not spoken to her and that she signed the informed the consent for the epidural because the RN told her to. Patient 31 also stated that she did not know what type of anesthesia she would be receiving.

A record review and a concurrent interview with RN 5 was conducted on December 11, 2012 at 3:15 PM. RN 5 stated that informed consents are supposed to be obtained by the physician and that an RN was not supposed to obtain it.

An interview with RN 3 was conducted on December 11, 2012 at 3:25 PM. RN 3 stated "RNs can fill out part of the information on the informed consent but not to this extent. The physician was supposed to give it."

A record review of the hospital's policy for "Informed Consent" was conducted on December 12, 2012 at 9 AM. The policy indicated the following: "It is the policy of (name of hospital) that any invasive procedure performed by a physician requires documentation of informed consent by the physician." The policy also indicated, "...Every patient has the right to informed consent, which means that the patient has the right to full explanations of diagnostic/therapeutic interventions by a knowledgeable person, as well as the right to give approval or refuse to participate in therapy. It is the treating physician's responsibility to obtain informed consent. Hospital personnel cannot and should not be involved in providing information that is necessary to secure the patient ' s informed consent....It is the physician's duty to disclose the amount of knowledge a patient needs in order to make an informed consent...".

Based on observation and interview the hospital failed to ensure that one (1) patient (who requested to remain anonymous), in a universe of 51 patients, was given personal privacy by placing the patient in a recliner chair in a hallway of labor and delivery with an external fetal (relating to an unborn baby) monitor on her abdomen. This failure resulted in the patient feeling exposed.

Findings:

During a tour of the facility labor and delivery department on December 11, 2012 at 2:40 PM, it was observed that there were 3 recliner chairs with a table next to them with fetal monitoring equipment on the tables. There was one patient sitting in one of the recliners in a hospital gown and covered with a sheet. It was observed that the labor and delivery triage room was empty and available for patient use.

In an interview with the patient in the recliner on December 11, 2012 at 3:30 PM, the patient was asked how she felt about sitting in the recliner in the hallway. The patient stated "I feel exposed. Especially when they hooked me up to the monitor and there was another patient and her family in the chair next to me."

In an interview with Registered Nurse (RN) 3 during the tour of the labor and delivery unit on December 11, 2012 at 2:45 PM, RN 3 acknowledged that the three recliner chairs in the hallway were not licensed beds and created a safety hazard when the chairs were in the reclined position as they were only approximately 10 inches from the wall blocking emergency exiting. RN 3 stated that they used the recliner chairs for patients who were just being observed.

Based on interview and record review, the hospital failed to ensure that 1 of 32 sampled patients (Patient 43) received care in a safe setting. The patient's baby was born premature at 35 weeks (a full term baby is 40 weeks) and was delivered by a Cesarean section (C-section - the surgical removal of a baby from the mother) 12 hours after the patient's hospital admission when the hospital did not have a neonatal intensive care unit (NICU - a unit that is specially equipped and with specially trained staff to care for premature infants) available or a neonatologist (a physician specialty for the care of the newborn) present for the baby's birth. This failure had the potential to result in an unsafe environment for the premature infant.

Findings:

A review of Patient 43's record on December 17, 2012 showed that the patient was admitted to the hospital's labor and delivery unit on May 31, 2012 at 1:03 AM with a diagnosis of pregnancy and abdominal pain.

A review of the physician history and physical with a revision date of August 15, 2012 showed that the patient was pregnant at 35 weeks and that an ultrasound done at 33 weeks was abnormal showing possible hydrocephalus (excess fluid in the skull that may cause pressure on the brain) with congenital brain anomaly (indicating that the baby may have had a brain defect). Patient 43 was having some contractions, the baby was moving, but had irregular heart beats. The physician's plan for the patient was that Patient 43 was "...going to have a cesarean section."

In an interview and review of Patient 43's record with Registered Nurse (RN) 3 regarding Patient 43 on December 18, 2012 at 10:40 AM, RN 3 stated that the patient's initial monitor strips (a record of monitoring the baby's heart beat and the mother's contractions) showed that the mother was having some contractions and that the baby's heart rate was about 150 beats per minute (normal). RN 3 stated that the monitor started showing that the baby's heart beat rate decrease for a few seconds at the end of the mother's contraction at 1:50 AM that could indicate that the baby was having some distress. RN 3 stated that the monitoring strips showed increasing episodes of distress as time went on. RN 3 stated that the physician should have been notified of the monitor strips showing the potential fetal distress. The patient's nurse called the physician at 3:00 AM to notify the physician of urinalysis (urine lab test) results and non stress test (NST - the test that involves attaching one belt to the mother's abdomen to measure fetal heart rate and another belt to measure contractions. Movement, heart rate and "reactivity" of heart rate to movement is measured for 20-30 minutes). There was no documentation of the NST results. (The physician did not come to examine the patient at this time.) The patient's nurse documented that the physician was called at 6:17 AM to report the result of the biophysical exam of 6/8 (an abnormal result) and the result of the NST showed no accelerations (heart rate increases which indicate fetal well-being), the nurse did not inform the physician of the baby's distress on the monitor. (The physician did not come to examine the patient at this time.) When asked why the patient was not transferred to a hospital with a NICU as the C-section was 12 hours after the patient's admission, RN 3 stated that she wasn't a physician, but as a nurse she would have discussed with the physician that the baby was only 35 weeks and had a previous abnormal ultrasound test and that maybe the physician would want to transfer the patient to a hospital with a NICU.

A review of the operative report dated May 31, 2012 showed the following: "Through a low transverse cesarean section, we delivered a live baby; however, the heartbeat went down to 60 right after I clamped the cord and the baby deceased (died) within 5 minutes and was declared dead by the emergency room physician."

Based on interview and record review, the Hospital failed to ensure that restraints imposed for 1 of 32 sampled patients (Patient 5), in a universe of 51 patients, may only be used when less restrictive intervention have been determined and were documented to be ineffective to protect the patient. This deficient practice had the potential to interfere with the basic rights of Patient 5 to be free from restraints and to be discontinued at the earliest possible time.

Findings:

A review of Patient 5's medical record was conducted on December 10, 2012. Patient 5 was admitted to the Hospital on December 3, 2012 with an admitting diagnosis of respiratory failure due to experiencing shortness of breath two days prior to admission. Patient 5 was admitted to the Intensive Care Unit (ICU) on December 3, 2012 and was placed on a ventilator for respiratory support.
A review of Patient 5's medical record revealed on December 3, 2012, Patient 5 was placed in bilateral soft wrists restraints due to his attempts of pulling out the endotracheal tube (plastic tube from his lungs to the respirator facilitating breathing) and being restless while on the ventilator.

A review of Patient 5's Restraint Flow Sheet, dated December 3, 2012, revealed no documented evidence that least restrictive alternatives or options were attempted, and were determined to be ineffective to protect Patient 5.

A review was conducted on December 10, 2012, of the Hospital's policy and procedure, titled: "RESTRAINTS-MEDICAL/SURGICAL", dated May 2011, it stipulated in section C (1) (e): "Alternative interventions should be considered prior to the use of a restraint", and in section C (2) and (3) (a): "Prior to application alternative techniques should be considered as the preferred intervention and the least restrictive type of restraint is always used".

Less restrictive interventions must be determined by staff to be ineffective to protect the patient or others. Alternatives attempted or the rationale for not using alternatives must be documented.

There was no documented evidence that least restrictive interventions were tried and documented, or evidence that alternatives were considered and determined to be insufficient.

During an interview with the Director of the Intensive Care Unit, on December 10, 2012, at approximately 11:20 AM, she confirmed the finding that there was no documented evidence that least restrictive alternatives were deemed ineffective and attempted to protect Patient 5.

Based on interview and record review, the hospital failed to ensure that a physician wrote complete orders for restraints, for 1 of 31 sampled patients (Patient 22) in a universe of 51 a physician wrote an as needed order (PRN) for Patient 22. This failure had the potential to increase the risk of Patient 22's right to be free of unnecessary restraints violated.

Findings:

A record review, on December 10, 2012 at 3 PM, of Patient 22, revealed that the patient was admitted on December 2, 2012 with the diagnosis of "New onset diarrhea."

A record review, on December 10, 2012 at 3 PM, of Patient 22's physician orders (pre-printed), dated December 2, 2012 at 10:34 PM, revealed the following: "Soft restraints if needed ..." During a concurrent interview, RN 9 stated that the physician who wrote the PRN restraints orders typically writes them as PRN because he pre-prints the orders.

During an interview with RN 2, on December 10, 2012 at approximately 3:30 PM, the RN stated that PRN orders for restraints were unacceptable.

A record review, on December 13, 2012 at 10:50 AM, of the hospital's "Medical Staff Bylaws & General Rules & Regulations of Medical Staff, revised on 12/6/11," indicated the following: "Restraining Devices - Use of - Restraints may be used when it is necessary to protect the patient from harm, i.e., confused, combative, intubated patients. This includes limb restraints and vests ....When restrain or seclusion is used, hospital policy and procedure guide's appropriate and safe use for the population and individuals served. It protects and preserves the patient ' s right, dignity and well being during use. Use of restraint or seclusion is initiated by an order of a physician following the organization ' s policy and procedure. In all cases standing and PRN orders are never allowed ..."

Based on observation, interview and record review, the Hospital failed to ensure an effective quality assessment and performance improvement program of the hospital's organization and services were maintained when the Hospital failed to ensure the following:

1. Ensure that the hospital had an ongoing quality appraisal and performance improvement program that included tracking and trending of findings, and integrated interdisciplinary efforts to address deficient practice and effectively implement change to improve patient quality of care. (Refer to A-273)

2. The Hospital failed to ensure that quarterly pharmacy activity reports of adverse drug events, operational, and clinical pharmaceutical activities were reported when a full quorum was convened in order to provide a discussion venue and referral to the Medical Executive Committee. (Refer to A-508)

3. Provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. The Hospital failed to conduct an active surveillance program for the prevention, control, and investigation of infections and communicable diseases in the Sterile Processing Department and Patient Care Areas of the Hospital.

3a. Ensure that all individually packaged sterile surgical instruments (peel pouches/packs) stored on inventory shelves, that the hinged instruments (i.e. clamps, forceps, scissors, needle holders, etc.) blades and tips were sterilized in an open position and not in a closed position as recommended by Nationally Recognized Infection Control Organizational (Industry) standards and according to the manufacturer's recommended instructions.

3b. Ensure that all stored individually packaged sets of sterile instruments containing multiple pieced units, were disassembled prior to sterilization as recommended by Nationally Recognized Infection Control Organizational (Industry) standards and according to the manufacturer's recommended instructions.

3c. Ensure that all surgical hinged instruments (i.e. clamps, forceps, scissors, needle holders, etc.) arranged in sterilized wrapped surgical trays, that the instrument blades were opened and not closed as recommended by Nationally Recognized Infection Control Organizational (Industry) standards and according to the manufacturer's recommended instructions for those instruments found in 5 of 5 sterile surgical trays inspected.

3d. Ensure that the hospital's sterile processing procedures/practices were consistent with recommendations by Nationally Recognized Infection Control Organizations (Industry) standards and guidelines. The hospital failed to provide and maintain an a mechanical cleaning of the surgical instruments (ultrasonic cleaning, washer decontaminators/disinfectors or washer sterilizers) as part of the departments' decontamination and cleaning process of all critical equipment used for surgical or medical care of all patients treated at the hospital.

3e. Ensure that Hospital-Wide Infection Control precautions for the care of patients with Clostridium Difficile infection (antibiotic associated infections) were being followed and implemented throughout the Hospital.
(Refer to A-749)

4. The hospital failed to develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program related to Dietary Services. (Refer to A-620)

The cumulative effect of these systemic problems resulted in the hospital being unable to provide safe and effective patient care.

Based on staff interview and document review, the hospital failed to have an ongoing quality appraisal and performance improvement program that included tracking and trending of findings, and integrated interdisciplinary efforts to address deficient practice and effectively implement change to improve patient quality of care.

Findings:

On December 13, 2012, at 9:55 AM, a review of the Performance Improvement quality assurance data was conducted with the Director of Food and Nutrition Services (DFNS) and the Registered Dietitian (RD).

One of the established performance indicators for clinical nutrition services was, "A copy of computer generated request in the actual chart." The RD explained the indicator reflected nutritional consults that were actually generated by nursing services and forwarded to the RD for follow-up. The desired threshold for compliance was 95%. Review of the documented compliance percentage from May 2012 to November 2012, showed a range from 68% to 85%.

The RD comments in June and July 2012, indicated she provided education to nursing staff through "bed huddles" and 1:1. In October 2012, the RD documented, "Still working with nursing", and in November 2012, the RD documented, "Appeared due to registry staff. Discussed with charge nurses."

The second performance indicator reviewed was, "Patient consumption of breakfast, lunch, dinner, supplements/snacks will be entered in patient charts daily by nursing staff." The RD explained that she relied on this information when assessing/reassessing patients and implementing nutritional recommendations. The desired threshold for compliance was 95%. Review of the documented compliance percentage from May 2012 to November 2012, showed a range from 62% to 90% with two months at 100%.

The RD comments in June, July, September and October 2012, indicated she provided education to nursing staff through "bed huddles" and 1:1. In October 2012, the RD documented, "Mostly dinner misses. Day nursing needs to pass to night nursing."

In a discussion with the RD regarding the performance improvement data, it was noted that there was no detailed analysis documented on the forms submitted to the quality assurance committee delineating the nursing units, days of the week or nursing shifts most often implicated with deficient practice, in order to better determine intervention processes to improve performance. The RD stated she was not sure it was her role to track and trend data that represented nursing deficient practice. She stated that she had discussed her concerns with previous Chief Nursing Officers (CNO), but not the current CNO as she had shortly assumed her position. She stated that intervention by prior CNOs consisted of the CNO being present while the RD provided inservices to nursing staff, which "seemed to help."

In a discussion with the DFNS, he confirmed that the RD did not attend the quality assurance (QA) committee meetings and it was his responsibility to present the performance improvement data to the committee. He stated that committee members would ask, "Why are the numbers low?", but no formal action plans were generated or recommended by QA committee members. He stated suggestions such as possibly including some training related to identified deficient nursing practice in the nursing orientation process were made, but have not been implemented.

On December 13, 2012, at 11:43 AM, in an interview with the Director of Quality and Risk Management, he confirmed that the quarterly QA committee minutes did not include suggestions for improvement or departmental action plans. He stated that in addition to the QA committee, department heads also attend a quality subcommittee, where more detailed discussion of departmental performance is included and suggestions for improvement are provided. Minutes provided were for the "Environment of Care" (EOC) committee meetings. Review of the minutes for November 14, 2012, showed the following action plan for nutritional services, "___(department head) to continue to monitor and report data to the EOC Committee to ensure quality patient care. There was no evidence of integrated interdisciplinary efforts, to address deficient practice as identified by performance improvement data, to ensure improved patient quality of care.



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2. On December 18, 2012, at 3:50 PM, a review of the Performance Improvement quality assurance data was conducted with the Director of Quality and Risk Management (DQRM).

One of the established performance indicators for Surgical Site Infection (SSI) rates was the, "SSI Rate Report". The DQRM explained the indicator reflected the number of surgical site infections that were actually self -reported by the physicians and forwarded to the QA for follow-up. Review of the documented SSI percentage rate from January 2012 to July 2012 showed a rate of 0% (no reported surgical site infections).

The DQRM stated that a letters were mailed to all the physicians who completed surgeries listed as Orthopedics, Obstetrics and General surgery. The letter had asked the physicians to respond with information regarding patient's that have acquired a surgical site infection. The SSI Rate Report noted several hundreds of surgeries conducted for each month from January 2012 to July 2012 and the SSI rate was noted to be 0% for each of the months. The DQRM stated that "We do not feel there is a need for surveillance of the Central Sterilization Department (the area in the hospital that sterilizes the surgical instruments). We go by our Surgical Site Infection rates and our rates are near 0%. We feel this is not an issue".

In a discussion with the DQRM regarding the information gathered to develop the SSI Rate Report and to provide tracking and trending of the SSI results to monitor the quality of the originations, the DQRM confirmed that the number of letters mailed out to the physicians each month, compared to the number of completed responses were not listed on the SSI report. The information regarding letters mailed to the physicians were not tracked and were not trended. The DQRM further stated that a "Quality Sub-Committee" is responsible for tracking and treading the physician's responses to the letters mailed out. The DQRM stated that the Quality Sub-Committee last met together on May 17, 2012. There was no Quality Sub-Committee meeting in September 2012 and no meeting in October 2012. The information reported by the Quality Sub-Committee used to develop a November 2012 report that calculated the 0% surgical site infection rate for the hospital was not available. The DQRM was unable to locate the Quality Sub-Committee ' s November 2012 report for the Survey Team to review.

Based on interview and record review, the hospital failed to ensure that a physician completed and documented a complete and updated patient physical examination prior to performing a caesarean section (c-section; the surgical removal of a live baby from the mother's body) for Patient 41. This failure had the potential to contribute to negative patient outcomes for Patient 41.

Findings:

A record review conducted on December 17, 2012 at 4 PM of Patient 41, revealed that the patient was admitted on November 23, 2012 with the diagnosis of pregnancy contractions. According to "Operating Room Progress Note," Patient 41 had a "Primary cesarean section (a c-section performed on a patient for the first time) on 11/24/12 at 10:30 AM." Patient 41 had premature twin babies which were transferred to another hospital's neonatal intensive care unit (NICU) because the surveyed hospital did not have a NICU.

A record review and a concurrent interview were conducted on December 18, 2012 at 11 AM, with Registered Nurse (RN) 3. The RN stated that there was no prenatal exam by the physician recorded in the medical record. RN 3 stated that the physician documented a general assessment on a "History & Physical Form" on November 24, 2012 at 10 AM but that it did not include anything pertinent to Patient 41's current condition and problem. There was nothing to indicate that the physician performed and documented a vaginal exam to determine if Patient 41 was dilated. Additionally, RN 3 stated that the physician should have performed an updated exam to include the prenatal exam of the patient, "especially if he thought it was an emergency" to perform a c-section on the patient. RN 3 was unable to determine, based on the documentation in Patient 41's medical record, if the patient had active labor prior to the c-section. A review with RN 3, of the general physical examination which was documented by the physician included the following per RN 3, the patient's temperature (normal), the pulse (normal), the respirations (normal), blood pressure (normal), general overall condition ("fairly normal"), HEENT (head, ears, eyes, nose and throat-unable to read physician's writing), chest and lungs (clear), heart (normal) and abdomen (soft). The physician documented, that the patient had "poor prenatal care." RN 3 stated that if the physician thought that the c-section was an emergency, he should have documented an updated exam after he performed the c-section.

A record review, on December 19, 2012 at 1:30 PM, of the hospital's "Medical Staff Bylaws & General Rules & Regulations of Medical Staff, revised on 12/6/11," indicated the following: "...Complete Medical Examination: Shall be made part of the medical record within 24 hours of admission. The report should include findings resulting from an assessment of all pertinent systems of the body, as related to patient's condition, chief complaint, history or present illness, where appropriate assessment of patient's emotional, behavioral and social status, relevant past medical, social and family history...History & Physical Examination: All must be legibly hand-written or dictated within 24 hours of admission, signed, dated and timed...The short history & physical form must include at a minimum: chief complaint, present illness, allergies, past history, vital sings, diagnosis, and an examination to include HEENT, chest and lungs, heart, abdomen and neurological status..." (no neurological exam of Patient 41 was located on the physicians assessment). The "Rules & Regulations" also indicated: "...The short H&P (History and Physical) form may be used for a patient that has an uncomplicated obstetrical stay or newborn infant without complications. A comprehensive History & Physical examination is required for patients that are hospitalized for more than 24 hours..."

Based on observations, interviews and record reviews, the hospital failed to ensure that the nursing services were organized to meet the needs of all patients by failing to:

1. Maintain an adequate number of staff based on the acuity (complexity of level of care) of the patient and level of care required during meal and break times in the Labor and Delivery Unit (L&D) which resulted in inadequate staffing between the hours of 7 AM thru 3:30 PM. This failure had the potential for patients that received care and services in the L&D Unit to not have their assessed needs met in a safe environment. (Refer to A-392)

2. Provide nursing services that were supervised and evaluated by a Registered Nurse (RN) when the facility failed to ensure that 1 of 32 sampled patients (Patient 43) had nursing assessments that accurately assessed and documented the full scope of the patients' condition when the fetal (unborn baby) monitoring indicated that the baby was in distress. This failure had the potential to result in a dangerous condition for the baby. (Refer to A-395)

2a. Ensure that 1 of 32 sampled patients (Patient 25) was monitored according to the patient's level of care needs. This failure had the potential to result in the staff not responding quickly to a patient emergency. (Refer to A-395)

3. Ensure that the nursing staff developed and kept current a nursing care plan for 5 of 32 sampled patients (Patients 5, 22, 24, 25 and 30), in a universe of 51, based upon nursing care needs, ongoing nursing assessments, and responses to interventions. These failures had the potential to affect health outcomes and quality of care for Patients 22, 24 and 30. (Refer to A-396)

4. Ensure that all staff were competent and had the specialized qualifications prior to assigning two (2) registered nurses to care for a patient (Patient 25) who required care by specialized staff Intensive Care Unit -ICU Nurses in a specialized unit (ICU). This failure had the potential to contribute to poor patient outcomes and contribute to the patient not being cared for in a safe setting. (Refer to A-397)

5. Ensure that all continuous intravenous Versed medication drips (medication used to induce sedation when on a ventilator) and all Levophed vasopressor medication drips (medication used to treat low blood pressure) in the Intensive Care Unit were initiated/started and titrated according to the practitioners specific orders or according to approved hospital-wide titration protocol for 2 of 32 sampled patients (Patient 5 and 27).

5a. For Patient 5, ICU Registered Nurses started/initiated Versed Drips without a physicians' order and were interpreting and making judgment decisions when to initiate start rates from a prescribed protocol range.

5b. For patient 27, ICU Registered Nurses started/initiated Versed Drips and Levophed Drips without a physicians' order and were interpreting and making judgment decisions when to initiate start rates from a prescribed protocol range.

These deficient practices had the potential for unsafe dosages being administered affecting the health and safety of those patients in the Intensive Care Unit. (Refer to A-405)

The cumulative effect of these systemic problems resulted in the hospital's failure to deliver patient care in a safe manner and in compliance with the Condition of Participation for Nursing Services.

Based on observation, interview and record review, the facility failed to maintain adequate number of staff based on the acuity (complexity of level of care) of the patient and level of care required during meal and break times in the Labor and Delivery Unit (L&D) which resulted in inadequate staffing between the hours of 7 AM thru 3:30 PM. This failure had the potential for patients that received care and services in the L&D Unit to not have their assessed needs met in a safe environment.

Findings:

During an interview with a patient in L&D (Patient 31), on December 11, 2012 at 2:50 PM, the patient stated that it appeared to her that the nurses were very busy and thought that the nurses could have used more help.

During an interview, on December 11, 2012 at 3 PM, RN 3 stated that L & D was staffed with 7 RNs.

A tour of the L&D Unit, on December 11, 2012 at 3 PM was conducted as well as an interview with RN 5, a charge nurse. The unit had a patient sitting on a recliner chair in the hallway and connected to a fetal monitor and according to RN 5, the unit was full with patients, 5 in L&D rooms and 3 in triage. RN 5 stated that they were not staffed with 7 RNs, they had 3 RNs (from 7 AM to 3 PM), a fourth RN that had started her shift at 3 PM and 3 orientees (RNs in training who did not have their own assignments but were paired off with the 3 RNs). RN 5 stated that the RNs on the L&D unit were typically out of staffing ratio because they did not have enough trained RNs. RN 5 stated that the charge nurses in L&D usually break the nurses for lunch or the nurses break each other. According to RN 5, charge nurses always have assigned patients and still had to break other nurses for lunches. However on the day of the tour, none of the nurses were able to take a lunch (RN 5 demonstrated boxes of pizza on a table in a hallway and stated that was their lunch for the day "Whenever we can get to it." RN 5 was assigned 5 patients with 2 orientee nurses and 3 of her patients were in "Active labor." She also stated that per the hospital's policy, if patients were in active labor the ratio was supposed to be 2:1 however that did not always happen in the unit. RN 5 stated that L&D was usually very busy on Tuesdays and Thursdays because those were the days that 2 physicians typically induced patients (artificially inducing the labor process by the administration of medications) and performed cesarean sections.

During an interview with RN 11, on December 11, 2012 at 3:20 PM, she stated that she had been assigned 3 patients and 2 of those patients were in active labor. RN 11 stated that she did not take a lunch because the unit had been very busy.

During an interview, on December 11, 2012 at 3:45 PM, with a L&D patient, who wished to remain anonymous, stated that the nurses had been very busy and was not sure if they had enough help.

A record review was conducted, on December 11, 2012 at 4 PM, of the facility "Daily Staffing Assignment" for the L&D unit for December 11, 2012. The assignment sheet indicated that from 7 AM to 7:30 PM, the unit was staffed with 3 RNs and 3 orientee RNs.

During an interview, on December 12, 2012 at 11 AM, with a post-partum (had already had the baby), stated that the overall care in post-partum was good however the day before, when she was in L&D, she stated that the nurses seemed to be "overwhelmed" and that "they were really busy."

A record review, on December 12, 2012 at various times, of the hospital policy titled, "Perinatal Patient Classification, revised on 10/12," was conducted. The policy identified and classified a patient who was not in labor (a routine L&D patient) as Level 1, which "Requires 1:4 nurse-to-patient ratio." The policy identified "Latent labor (early stage of labor that is characterized by irregular, infrequent and mild contractions and little or no dilation) with continuous monitoring" and required a "1 licensed nurse to two patients per shift." The policy did not describe active labor which is when the cervix begins to dilate more rapidly, and contractions are longer, stronger, and closer together and often referred to as the last part of active labor.

Based on observation, interview and record review, the facility failed to:

1. Provide nursing services that were supervised and evaluated by a Registered Nurse (RN) when the facility failed to ensure that 1 of 32 sampled patients (Patient 43) had nursing assessments that accurately assessed and documented the full scope of the patient's condition when the fetal (unborn baby) monitoring indicated that the baby was in distress. This failure had the potential to result in a dangerous condition for the baby.

2. Ensure that 1 of 32 sampled patients (Patient 25) was monitored according to the patient's level of care needs. This failure had the potential to result in the staff not responding quickly to a patient emergency.

3. Ensure that nursing staff:

a. Accurately completed the nutrition screen portion of the admission assessment for one patient (Patient 13).

b. Documented daily weights in accordance with physician orders for one patient (Patient 11).

c. Followed-up on significant weight gain for one patient (Patient 22).

d. Developed a policy to accurately implement fluid restriction orders for patients.

Failure to accurately complete nutrition screening, and to complete daily weights could result in a lack of referral of high nutritional risk patients to the dietitian, delayed nutritional intervention and compromised nutritional status of the patients. Failure to develop a fluid restriction policy could result in fluid restriction orders not implemented correctly with possible negative patient outcome.

Findings:

1. A review of Patient 43's record on December 17, 2012 showed that the patient was admitted to the hospital's labor and delivery unit on May 31, 2012 at 1:03 AM with a diagnosis of pregnancy and abdominal pain.

A review of the physician history and physical with a revision date of August 15, 2012 showed that the patient was pregnant at 35 weeks and that an ultrasound done at 33 weeks was abnormal (indicating that the baby may have had a defect). Patient 43 was having some contractions, the baby was moving, but the baby had irregular heart beats. The physician's plan for Patient 43 was that, "she is going to have a cesarean section."

In an interview and review of Patient 43's record with RN 3 regarding Patient 43 on December 18, 2012 at 10:40 AM, RN 3 stated that the patient's initial monitor strips (documentation of monitoring the baby's heart and the mother's contractions) showed that the mother was having some contractions and that the baby's heart rate was about 150 beats per minute (normal). RN 3 stated that the monitor started showing the baby's heart beat rate decreasing for a few seconds at the end of the mother's contraction at 1:50 AM that could indicate that the baby was having some distress. RN 3 stated that the monitoring strips showed increasing episodes of distress as time went on. RN 3 stated that the physician should have been notified of the monitor showing the distress. The patient's nurse called the physician at 3:00 AM to notify the physician of urinalysis (urine lab test) results and non stress test (NST - the test involves attaching one belt to the mother's abdomen to measure fetal heart rate and another belt to measure contractions. Movement, heart rate and "reactivity" of heart rate to movement is measured for 20-30 minutes). There was no documentation of the NST results. (The nurse did not inform the physician of the baby's distress and the physician did not come to examine the patient at this time.) The patient's nurse documented that the physician was called at 6:17 AM to report the result of the biophysical exam of 6/8 (an abnormal result) and the result of the NST showed no accelerations (heart rate increases), the nurse did not inform the physician of the baby's distress noted on the monitor. (The physician did not come to examine the patient at this time.) When asked why the patient was not transferred to a hospital with a Neonatal Intensive Care Unit (NICU) as the Cesarean section (C-section - the surgical removal of a baby from the mother's body) was 12 hours after the patient's hospital admission, RN 3 stated that she wasn't a physician, but as a nurse she would have discussed with the physician that the baby was only 35 weeks and had a previous abnormal ultrasound test and that maybe the physician would want to transfer the patient to a hospital with a NICU.

A review of the operative report dated May 31, 2012 showed the following: "Through a low transverse cesarean section, we delivered a live baby; however, the heartbeat went down to 60 right after I clamped the cord and the baby deceased (died) within 5 minutes and was declared dead by the emergency room physician."

2. A review on December 11, 2012 of Patient 25's record showed that the patient was admitted to the facility on December 4, 2012 with a diagnosis of exacerbation of Chronic Obstructive Pulmonary Disease (COPD - a flare-up of emphysema or a chronic lung disease that causes difficulty breathing). The physician ordered that the patient be transferred to the intensive care unit (ICU) on December 10, 2012 at 7:55 PM. The patient was placed on bi-pap (a machine to deliver oxygen under pressure with a special mask.)

During a tour of the second floor medical-surgical unit on December 11, 2012 at 9:30 AM it was observed that there was a patient (Patient 25) in a room with bi-pap (a machine to deliver oxygen under pressure with a special mask.) on and a nurse in the room.

In an interview with the nurse (RN 7) on December 11, 2012 at 10:15 AM, RN 7 stated that the patient was on ICU status since the previous night but that there were no beds available in the ICU, so the patient was being cared for on the medical-surgical unit with a nurse assigned exclusively to the patient. RN 7 stated that Patient 25's vital signs (temperature, pulse and respirations) were to be checked every one hour. RN 7 stated that she was not able to visually monitor what the patient's heart rhythm displayed on the cardiac monitor because there was no bedside monitor like the patient would have had in the ICU.

In an interview with RN 8 on December 11, 2012 at 9:45 AM, RN 8 stated that she was told that the physician gave orders to transfer the patient to the ICU but that there were no beds available and the facility did not have available nurses to open up the other ICU unit so the physician gave orders to make the patient a "2 to 1" and put the patient on a telemetry monitor. The patient was on ICU status not on telemetry status (a classification that the patient requires remote heart monitoring and the nurse can have up to 4 patients. When a patient is on ICU status, the nurse can have the responsibility of only 2 of these patients for closer monitoring).

A review on December 18, 2012 of the hospital's ICU "Scope of Care" showed the following: "The ICU is set up to provide hemodynamic (the observation of
hemodynamic parameters over time, such as blood pressure and heart rate) and intensive patient monitoring and to respond to emergency situations within short time frames."




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3a. On December 12, 2012, at 10:30 AM, review of the medical record for Patient 13 showed that he was admitted on December 4, 2012, with diagnoses that included diabetes and renal (kidney) disease requiring dialysis (a mechanical process for removing waste and excess water from the blood). A review of the Adult Multidisciplinary Initial Assessment, Nutritional Status Section, completed by the nursing staff, showed that the patient had no swallowing or chewing difficulties and a 20 pound weight loss noted as "intentional". No skin breakdown was noted and no Registered Dietitian (RD) referral was made.

On December 10, 2012, six days after admission, the RD completed a nutritional assessment and documented that the patient had unintentional significant weight loss secondary to renal disease, poor dentition and the inability to chew. The patient also had a wound and an albumin (measure of protein stores) of 1.4 grams per deciliter (g/dl) (normal range 3.4-5.4 g/dl).

A review of the facility policy titled, "Nutrition Screening and Assessment - Approved 6/11", showed, "Nursing staff completes the initial nutrition screening assessment (refer to the Interdisciplinary Assessment policy for further information) ....Upon identification of nutritional risk, nursing staff enters the referral order into the order communication computer system. The Clinical Dietitian responds to referral/consults within 24 hours of notification for further assessment and to initiate the nutritional plan of care as warranted by the patient's status and nutritional risk."

A review of the "Levels of Nutritional Risk and Care" guideline for the facility showed that a patient is considered at "High Risk" when Serum Albumin was <2.1, and an unintentional weight loss of >10% per month. "Medium Risk" criteria included diabetes mellitus and chronic renal failure. The RD was to assess patients identified at "High Risk" within two days of notification and those at "Medium Risk" within three days of notification.

On December 12, 2012, at 10:48 AM, in an interview with the RD, she confirmed that she had not received a Nutrition Consult from the nursing staff based on initial nutrition screening and did not complete her nutrition assessment until December 10, 2012, six days after the patient's admission, when she received a physician consult.

3b. On December 12, 2012, at 9:15 AM, review of the medical record for Patient 11, showed the patient was admitted on December 3, 2012. On admission, the patient's weight was documented at 102 pounds, and the physician ordered daily weights for the patient. As of the time of the record review, there were no additional weights for Patient 11 documented on the nursing flowsheets.
On December 12, 2012, at 9:50 AM, in an interview with RN 20, she stated that it was her first day taking care of Patient 11, and did not know why the weekly weights were not measured. RN 1 proceeded to obtain the weight for Patient 11 and stated that it was 66.2 kilograms (145.6 pounds), a 43.6 pound difference from the patient's admission weight. RN 20 stated she did not know what contributed to the patient's significant weight gain, but thought that perhaps it was the air mattress that the patient was using, and that staff did not "zero" the bed scale after placement of the air mattress. RN 20 did not know how much the air mattress weighed, and what the patient's true weight was.
On December 13, 2012, at 12:10 PM, in an interview with the Director of Intensive Care Unit, she stated that information was obtained from the mattress manufacturer indicating that the air mattress utilized on Patient 11's bed weighed 38 pounds. On December 13, 2012, Patient 11's weight was documented as 67.23 pounds (147.9 pounds). Patient 11 had a documented 9.9 pound weight gain in the 10 days from December 3, 2012 to December 13, 2012. The Director of the Intensive Care Unit further stated that it would be the responsibility of the staff nurse obtaining the weight to follow-up on any significant weight gain and report it to the physician.
3c. On December 12, 2012, at 8:32 AM, review of the medical record for Patient 22 showed the patient was admitted on December 2, 2012. On admission, the patient's weight was documented as 160 pounds. The patient's diagnoses included chronic obstructive pulmonary disease (COPD) resulting in some breathing difficulties and chronic renal failure (progressive loss of kidney function).
Review of the nursing flowheets showed an entry on December 7, 2012, indicating the patient's weight was 180 pounds. This represented a 20 pound weight gain in five days. There was no nursing documentation investigating the possible cause of this significant weight gain. On December 13, 2012 at 12:10 PM, the Director of the Intensive Care Unit further stated that it would be the responsibility of the staff nurse obtaining the weight to follow-up on any significant weight gain and report it to the physician.
3d. On December 11, 2012, at 11:25 AM, during observation of the lunch trayline process, two patient trays were observed with tray cards indicating that the patients were prescribed fluid restrictions. The tray cards were marked with the words: "One Fluid."
On December 12, 2012, at 1:52 PM, in an interview with the Registered Dietitian (RD), she stated that there was no dietary policy addressing fluid restriction. Instead, a "schematic" had been developed by the dietary department, to guide staff as to how much fluid was allowed on patient trays, based on the physician prescribed fluid restriction. Review of the "schematic" showed, for a 1500 milliliter (ml) fluid restriction, Nursing would provide 480 ml of fluid, and dietary would provide the remaining fluid as 480 ml at breakfast, 240 ml at lunch and 240 ml at dinner. When the RD was asked if the schematic was posted at the nursing stations or provided to nursing staff so they would know how the division of fluids would be implemented between nursing and dietary, she stated, "No." The RD was unaware of a nursing policy that addressed nursing's role in collaborating with the dietary department in meeting patients' fluid restriction needs.
On December 13, 2012, at 12:10 PM, in an interview with the Director of Intensive Care Unit, she confirmed that there was no fluid restriction policy that existed at the facility, to guide staff with regards to properly implementing physician prescribed fluid restrictions.

Based on interview and record review, the facility failed to ensure that the nursing staff
developed and kept current a nursing care plan for 5 (Patients 5, 22, 24, 25 and 30) of 32 sampled patients, in a universe of 51, based upon nursing care needs, ongoing nursing assessments, and responses to interventions. These failures had the potential to affect health outcomes and quality of care for Patients 22, 24 and 30.

Findings:

1. A review of Patient 5's medical record was conducted on December 10, 2012. Patient 5 was admitted to the Hospital on December 3, 2012 with an admitting diagnosis of respiratory failure due to experiencing shortness of breath two days prior to admission. Patient 5 was admitted to the Intensive Care Unit (ICU) on December 3, 2012 and was placed on a ventilator for respiratory support.
A review of Patient 5's Physicians' Order sheet, dated December 4, 2012, revealed an order for Naso-gastric tube feedings (NGT-a plastic tube placed through the nose, leading into the stomach, for liquid feeding purposes) and to start Jevity 1.2 feedings continuously at 52 milliliters per hour.

A review of Patient 5's "MULTIDISCIPLINARY PATIENT PLAN OF CARE" forms, dated December 4, 2012 through December 9, 2012, revealed no documented evidence of a nursing care plan addressing Patient 5's nutritional needs of receiving Jevity 1.2 feedings continuously at 52 milliliters per hour through the naso-gastric tube as ordered by the physician on December 4, 2012.

In addition, on page 4 of 8, of Patient 5's multidisciplinary care plan, under the section titled: "NUTRITION/METABOLISM/HYDRATION", the section was found to be incomplete, not filled out and left blank.

There was no documented evidence in Patient 5's medical record or from other hospital sources that the nursing staff had developed a nursing care plan to address Patient 5's nutritional feedings as ordered by the physician on December 4, 2012.

Nursing care plans should be comprehensive and individualized to reflect the condition and needs of the patient. Nursing care plans should be developed with identifiable problems, measurable goals and interventions, and should be time-limited.

A review on December 10, 2012, of the Hospital's policy and procedure titled: "MULTIDISCIPLINARY PLAN OF CARE", dated November 2011, stipulated, "...Each patient will have a comprehensive, integrated multidisciplinary plan of care, which is developed from the initial assessment. The care plan shall include, at minimum, physician and nursing components. The care plan and discharge plan will be initiated within 24 hours of admission. Each discipline is responsible for being knowledgeable and coordinating with the plan (s) of other disciplines in respect to each individual patient..."


During an interview with the Director of the Intensive Care Unit, on December 10, 2012, she confirmed the finding that Patient 5's multidisciplinary plan of care did not address Patient 5's nutritional feedings of receiving Jevity 1.2 feedings via the nasogastric tube continuously.


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2. A record review, on December 10, 2012 at 3 PM, of Patient 22, revealed that the patient was admitted on December 2, 2012 with the diagnosis of "New onset diarrhea."

A record review, on December 10, 2012 at 3 PM, of Patient 22's physician orders dated December 2, 2012, documented the following: "Seizure/DT (due to)/Fall/Head injury precautions" the orders also included to provide a sitter if needed.

A record review of Patient 22's medical record and a concurrent interview with RN 9 were conducted on December 10, 2012 at 3 PM. RN 3 stated that Patient 22 required a sitter because the patient was delusional (a false belief or opinion) and had attempted to pull out a foley catheter (a catheter inserted into the bladder to allow drainage of urine). RN 3 also stated that Patient 22's care plans did not include information related to the sitter and that the care plan should have been revised to include the medical necessity for the sitter because the patient was delusional.

3. A record review of Patient 30 was conducted on December 11, 2012 at 2:15 PM and revealed that the patient (pediatric) was admitted on December 9, 2012 with the diagnosis of exacerbation of asthma (an asthma attack which can cause a sudden constriction of the airways and causes extreme shortness of breath or difficulty breathing). Patient 30's physician documented that the patient had "Obvious respiratory distress and hypoxia with wheezes" (signs and symptoms due to asthma which cause respiratory distress). The physician's plan of care and orders for Patient 30 included steroids (a medication to help the inflammation which could be caused by the asthma), breathing treatments and chest percussions therapy after every breathing treatment (a treatment to help patients breathe more freely and to get more oxygen into the body).

A review of Patient 30's care plan on December 11, 2012 at 2:15 PM, revealed no documented evidence of the plan of care that the physician ordered for Patient 30.

An record review of Patient 30's care plan and a concurrent interview with RN 6 was conducted on December 11, 2012 at 2:30 PM. RN 6 stated that the care plan in Patient 30's medical record was a generic care plan and was not reflective of the patient ' s treatment plan that the physician ordered. Additionally, RN 6 stated that the care plan should have been revised to be more specific to Patient 30.

A record review on December 11, 2012 at 3 PM, of the hospital policy titled "Multidisciplinary Plan of Care, revised on 11/11," indicated the following: "It is the policy of (Name of hospital) to provide comprehensive care to all patients. It is also the policy of (Name of hospital) to describe the mechanism whereby the patient's treatment/care planning is provided and to describe how nursing diagnoses, patient care needs, and standards of care will guide the provision of care for all disciplines through the development and maintenance of the multidisciplinary care plan and discharge planning process ...Each patient will have a comprehensive, integrated multidisciplinary plan of care, which is developed from the initial patient assessment. The care plan shall include, at a minimum, physician and nursing components. The delivery of patient specific care, treatment and rehabilitation requires planning ...Because of the patient ' s unique needs, including those that are dictated by the patient ' s age, expectation and characteristics, the care/treatment planning process is designed to identify, prioritize and incorporate such needs into a multidisciplinary, individualized and appropriate plan of care/treatment ..."




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4. A review of Patient 24's record on December 10, 2012 showed that the patient was admitted to the facility on November 27, 2012 with a diagnosis of altered level of consciousness.

A review of the patient care plan showed that there was no care plan developed to reflect the patient's altered level of consciousness and to identify the patient's care needs.

In an interview on December 10, 2012 at 4:00 PM with RN 1, RN 1 acknowledged that there was no care plan for Patient 24 for altered level of consciousness and that there should have been a care plan for the patient's altered level of consciousness.

A record review on December 11, 2012 at 3 PM, of the hospital policy titled "Multidisciplinary Plan of Care, revised on 11/11," indicated the following: "It is the policy of (Name of hospital) to provide comprehensive care to all patients. It is also the policy of (Name of hospital) to describe the mechanism whereby the patient's treatment/care planning is provided and to describe how nursing diagnoses, patient care needs, and standards of care will guide the provision of care for all disciplines through the development and maintenance of the multidisciplinary care plan and discharge planning process ...Each patient will have a comprehensive, integrated multidisciplinary plan of care, which is developed from the initial patient assessment. The care plan shall include, at a minimum, physician and nursing components. The delivery of patient specific care, treatment and rehabilitation requires planning ...Because of the patient's unique needs, including those that are dictated by the patient's age, expectation and characteristics, the care/treatment planning process is designed to identify, prioritize and incorporate such needs into a multidisciplinary, individualized and appropriate plan of care/treatment ..."

5. A review on December 11, 2012 of Patient 25's record showed that the patient was admitted to the facility on December 4, 2012 with a diagnosis of exacerbation of COPD (flare-up of emphysema-a chronic lung disease that causes difficulty breathing). The physician ordered that the patient be transferred to ICU (intensive care unit) on December 10, 2012 at 7:55 PM. The patient was placed on bi-pap (a machine to deliver oxygen under pressure with a special mask.)

A review of the patient's care plan showed that there was no care plan developed to reflect the change in care needs for an ICU patient. There was no care plan developed to reflect the care needs for a patient receiving bi-pap.

In an interview on December 11, 2012 at 10:00 AM with RN 2, RN 2 acknowledged that there should have been a care plan for the ICU status and the bi-pap that the patient was on.

Based on interview and record review, the facility failed to ensure that all staff was competent and had the specialized qualifications prior to assigning two (2) registered nurses (RNs) to care for a patient (Patient 25) who required care by specialized staff Intensive Care Unit-ICU Nurses in a specialized unit (ICU). This failure had the potential to contribute to poor patient outcomes and contribute to the patient not being cared for in a safe setting.

Findings:

A record review on December 11, 2012 at 10:05 AM revealed that Patient 25 was admitted on December 4, 2012 to the medical surgical unit for exacerbation COPD (Chronic Obstructive Pulmonary Disease - a lung disease characterized by chronic obstruction of lung airflow that interferes with normal breathing).

A record review on December 11, 2012 at 10: 05 AM of Patient 25's physician orders revealed the following: One dated December 10, 2012 at 5:45 PM documented to " Transfer to ICU and titrate oxygen to maintain saturations 92%..." (The amount of oxygen in the blood - normal is typically 92 % or greater) another physician order, dated December 10, 2012 at 5:55 PM, documented, "Transfer patient to ICU when bed available, telemetry for now, inform (name of another physician) and RN with 2:1 ratio for this patient." Telemetry ratio was 4:1 (number of patients to number of nurse) and the ratios for ICU patients were 2:1.

An interview on December 11, 2012 at 10:15 AM with RN 7 was conducted. RN 7 stated that during the evening of December 10, 2012, Patient 25 had difficulty breathing and that her oxygen saturations dropped into the 70's. RN 7 stated that the physician ordered to upgrade the patient's status to ICU but that since there were no beds available in the ICU; he ordered to keep the patient on the medical surgical/telemetry unit. RN 7 stated that the physician ordered to place a telemetry monitor (monitors the heart rhythm) on the patient since there was no bedside monitor available on the medical surgical floor. RN 7 also stated that the patient was an ICU status patient and that the previous nurse who took care of Patient 25 during the evening, after the patient was upgraded to ICU status, was not ICU trained (the name of the nurse was provided RN 8). Additionally, RN 7 stated that the hospitals "Other" ICU (ICU-north) was available however the hospital did not have enough staff to open the unit so that Patient 25 could be transferred. According to RN 7, the hospital needed two RNs to open ICU North and they did not have two ICU nurses available at that time.

A record review of the personnel file for RN 8 and a concurrent interview with the Human Resource Director, were conducted December 10, 2012 at 12 PM. He stated that RN 8 was not an ICU RN and did not have competencies for ICU (ICU training).

An interview was conducted on December 12, 2012 at 9:45 AM with RN 8 (the nurse who cared for Patient 25 after the patient was upgraded to ICU status). RN 8 stated that she received report from another medical surgical RN (RN 10) who was not an ICU nurse. RN 8 stated that Patient 25's oxygen saturations dropped into the 70's and that the physician provided orders to upgrade the patient to ICU status. RN 8 also stated that she had not been given competencies for ICU and that the charge nurse told her that she would "Just baby sit the patient until an ICU RN was able to come in."

A record review of the hospital's policy titled, "Scope of Care, revised on 10/12" for ICU was conducted on December 11, 2012. The policy indicated the following: "It is the policy of (name of hospital) that ICU nurses manage the scope of care for each patient...The ICU provides staff that is competent in the management of complex, critically ill patients who provide quality, compassionate healthcare to the needs of the critically ill patients in our community..."

A record review of the personnel file for RN 10 and a concurrent interview with the Human Resource Assistant were conducted on December 12, 2012 at 11:30 AM. She stated that RN 10 was not an ICU RN and did not have ICU competencies.

Based on staff interview and facility record review, the facility failed to ensure that all continuous intravenous Versed medication drips (medication used to induce sedation when on a ventilator) and all Levophed vasopressor medication drips (medication used to treat low blood pressure) in the Intensive Care Unit were initiated/started and titrated according to the practitioners specific orders or according to approved hospital-wide titration protocol for 2 of 32 sampled patients (Patient 5 and 27).
1. For Patient 5, ICU Registered Nurses started/initiated Versed Drips without a physicians' order and were interpreting and making judgment decisions when to initiate start rates from a prescribed protocol range.
2. For patient 27, ICU Registered Nurses started/initiated Versed Drips and Levophed Drips without a physicians' order and were interpreting and making judgment decisions when to initiate start rates from a prescribed protocol range.

These deficient practices had the potential for unsafe dosages being administered affecting the health and safety of those patients in the Intensive Care Unit.

Findings:

1. A review of Patient 5's medical record was conducted on December 10, 2012. Patient 5 was admitted on December 3, 2012 with an admitting diagnosis of respiratory failure due to experiencing shortness of breath 2 days prior to admission. Patient 5 was admitted to the Intensive Care Unit (ICU) on December 3, 2012 and was placed on a ventilator for respiratory support.
On December 10, 2012, a review of Patient 5's ICU Physician Order sheet, dated December 4, 2012, documented the following orders by the practitioner:
a. At 11:30 PM: Versed drip to maximum 10 mg/min (mg-milligrams per minute). Titrate as per sedation.
b. At 11:45 PM: Versed drip 3 mg-10 mg, titrate for agitation.

A review of Patient 5's ICU Flow Sheet Record, dated December 4, 2012, indicated that RN 1 started/initiated the Versed Intravenous Continuous Medication drip at 4 mg/min.

There was no documented evidence in Patient's 5 medical record (Physician Order Sheet) that the practitioner had specifically ordered RN 1 to start Patient 5's Versed drip at at 4 mg/min.

On December 10, 2012, a review was conducted of the Hospital's policy and procedure titled: "MEDICATION ADMINISTRATION", dated October 2011, it stipulated in section A (1), " All orders for drugs and biological, must be documented and signed by a practitioner who is authorized by hospital policy and in accordance with State Law, and who is responsible for the care of that patient".

In addition, in section 7 (b): "Medication orders must have the following elements:
a. Exact strength and/or concentration.
b. Exact dose, frequency and route.
c. Quantity and duration.
d. Specific instructions for use".

A review of the Hospital's policy and procedure, titled: "INTRAVENOUS MEDICATION POLICY", dated September 2012, it documented the following information for the medication Versed:
a. " Initial dose: 1-5 mg Intravenous Push at 1 mg/min. "
b. " Usual Loading Dose: 2-8 mg Intravenous Push. "
c. " Usual Maintenance Dose: 2-10 mg/hr. "
d. " One or more loading doses may be required. "
e. " Sedation Goal: The sedative bolus or infusion dose is generally titrated to subjective and objective criteria. Using target criteria improves communication about the goals of sedation among caregivers " .

There was no documented evidence in Patient 5's medical record or from other hospital sources that RN 1 had administered Versed Intravenous Continuous drip at 4 mg./min according to hospital approved guidelines for agitation (i.e. Ramsay Sedation Scale) or at a specific targeted level to achieve a desired sedation level while the Patient was on the ventilator.

There was no documented evidence that Patient 5's practitioner had written specific orders for titrating the Versed Drip according to specific agitation-sedation guideline or according to his specific instructions and direction (parameters), including specific time based assessment frequencies with accompanying dosing rates.

There was no documented evidence in the medical record that RN 1 had implemented a hospital-wide ICU flow sheet addressing Patient 5's agitation level according to the " Ramsay Sedation Scale " .

A review on December 10, 2012, of the Hospital's policy and procedure, titled: "RAMSAY SEDATION SCALE", dated April 2012, it documented the following sedation levels of a patients' condition:
a. Level 1: Anxious, agitated, restless.
b. Level 2: Cooperative, oriented, tranquil.
c. Level 3: Drowsy and responds only to commands.
d. Level 4: Brisk response to glabellar tap (Blinking of the eyes when the forehead just above the bridge of the nose is tapped. If blinking of the eyes does not stop with continued tapping, brain disease is suspected) or loud auditory stimuli.
e. Level 5: Asleep with sluggish response to stimuli.
f. Level 6: No response to firm nail bed pressure or other noxious stimuli.

During an interview with the ICU Charge Nurse, on December 10, 2012, at approximately 11:40 AM, when asked if Patient 5's Versed order was ambiguous regarding the starting dosage rate, its titration directions, and whether RN 1 had a direct order by the practitioner specifically start the Versed rate at 4 mg/hr, she stated, " Yes, I would have called the physician to clarify the order for a set starting dosage rate and sedation level. Our protocols have ranges, so we (nurses) have to decide at what starting rate and titration levels we have to keep the patient at. "

During an interview with the Director of the Intensive Care Unit, on December 10, 2012, at approximately 11:45 AM, she confirmed the finding and stated, " Nurses are starting and titrating Versed drips without a physicians order and leaving it up to the individual nurse to decide. "

2a. A review of Patient 27's medical record was conducted on December 10, 2012. Patient 27 was admitted on December 4, 2012 with an admitting diagnosis of pneumonia and was placed on a ventilator on December 6, 2012 due to respiratory failure. Patient 27 was admitted to the Intensive Care Unit (ICU) on December 5, 2012.
On December 10, 2012, a review of Patient 27's ICU Physician Order sheet, dated December 5, 2012, and timed at 12:06 AM, documented the following orders by the practitioner:
a. Versed drip 2-8 mg/hr. PRN (as necessary).
b. If blood pressure doesn't tolerate, start Propofol drip.
c. Maintain drips at Ramsey Scale 4-5.
d. Versed drip PRN sedation for Systolic Blood Pressure less than 100 millimeters of Mercury.

A review of Patient 27's ICU Flow Sheet Record, dated December 6, 2012, indicated that the ICU Registered Nurse started/initiated the Versed Intravenous Continuous Medication drip at 4 mg/min. at 2:30 AM, and increased the rate to 8 mg/hr. at 3:30 AM.

There was no documented evidence in Patient 27's medical record (Physician Order Sheet) that the practitioner had specifically ordered the ICU Registered Nurse to start Patient 27's Versed drip at at 4 mg/min. at 2:30 AM and titrate up to 8 mg/min at 3:30 AM, on December 6, 2012.

On December 10, 2012, a review was conducted of the Hospital's policy and procedure titled: "MEDICATION ADMINISTRATION", dated October 2011, it stipulated in section A (1), " All orders for drugs and biological, must be documented and signed by a practitioner who is authorized by hospital policy and in accordance with State Law, and who is responsible for the care of that patient. "

In addition, in section 7 (b): " Medication orders must have the following elements:
a. Exact strength and/or concentration.
b. Exact dose, frequency and route.
c. Quantity and duration.
d. Specific instructions for use. "

A review of the Hospital's policy and procedure, titled: "INTRAVENOUS MEDICATION POLICY", dated September 2012, it documented the following information for the medication Versed:
a. "Initial dose: 1-5 mg Intravenous Push at 1 mg/min. "
b. "Usual Loading Dose: 2-8 mg Intravenous Push. "
c. "Usual Maintenance Dose: 2-10 mg/hr. "
d. "One or more loading doses may be required "
e. "Sedation Goal: The sedative bolus or infusion dose is generally titrated to subjective and objective criteria. Using target criteria improves communication about the goals of sedation among caregivers " .

A review on December 10, 2012, of the Hospital's policy and procedure, titled: "RAMSAY SEDATION SCALE", dated April 2012, it documented the following sedation levels of a patients' condition:
a. Level 1: Anxious, agitated, restless.
b. Level 2: Cooperative, oriented, tranquil.
c. Level 3: Drowsy and responds only to commands.
d. Level 4: Brisk response to glabellar tap (Blinking of the eyes when the forehead just above the bridge of the nose is tapped. If blinking of the eyes does not stop with continued tapping, brain disease is suspected) or loud auditory stimuli.
e. Level 5: Asleep with sluggish response to stimuli.
f. Level 6: No response to firm nail bed pressure or other noxious stimuli.

During an interview with the ICU Charge Nurse, on December 10, 2012, at approximately 11:40 AM, when asked if Patient 27's Versed medication order was ambiguous regarding the starting dosage rate, and whether the ICU Registered Nurses had a direct order by the practitioner specifically ordering the Versed Drip rate to start at 4 mg/hr, she stated, "Yes, I would have called the physician to clarify the order for a set starting dosage rate. Our protocols have ranges, so we (nurses) have to decide at what starting rate and titration levels we have to keep the patient at. "

The Hospital failed to ensure that ICU Registered Nurses were only starting/initiating Versed medication continuous Intravenous drips by following explicit orders by the physician and not making nursing judgment decisions regarding at what "start" rate the medication should be initiated.

In addition, the Hospital failed to ensure that ICU Registered Nurses incrementally titrated the rates according to protocols approved by the Hospital that specifically directed ICU nurses to follow frequently assessed parameters, at specific time frames, with appropriate dose changes and not titrate the drip to effect.

During an interview with the Director of the Intensive Care Unit, on December 10, 2012, at approximately 11:45 AM, she confirmed the finding and stated, "Nurses are starting and titrating Versed drips without a physicians order and leaving it up to the individual nurse to decide."

2b. A review of Patient 27's medical record was conducted on December 10, 2012. Patient 27 was admitted on December 4, 2012 with an admitting diagnosis of pneumonia and was placed on a ventilator on December 6, 2012 due to respiratory failure. Patient 27 was admitted to the Intensive Care Unit (ICU) on December 5, 2012.
On December 10, 2012, a review of Patient 27's ICU Physician Order sheet, dated December 5, 2012, and timed at 12:04 AM, documented the following orders by the practitioner:
a. Levophed drip titrated to keep Systolic Blood Pressure above 80 milliliters of Mercury (a unit in measuring and describing blood pressure values).
b. Call Attending for further orders.

A review of Patient 27's ICU Flow Sheet Record, dated December 6, 2012, indicated that the ICU Registered Nurse started/initiated the Levophed Intravenous Continuous Medication drip at 20 micrograms per minute at approximately 12:30 AM, and was titrating the drip accordingly to keep the Systolic Blood Pressure above 80 milliliters of mercury.

There was no documented evidence in Patient 27's medical record (Physician Order Sheet) that the practitioner had specifically ordered the ICU Registered Nurse to start Patient 27's Levophed drip at 20 micrograms per minute on December 6, 2012, at 12:30 AM.

On December 10, 2012, a review was conducted of the Hospital's policy and procedure titled: "MEDICATION ADMINISTRATION", dated October 2011, it stipulated in section A (1), " All orders for drugs and biological, must be documented and signed by a practitioner who is authorized by hospital policy and in accordance with State Law, and who is responsible for the care of that patient. "

In addition, in section 7 (b): "Medication orders must have the following elements:
a. Exact strength and/or concentration.
b. Exact dose, frequency and route.
c. Exact Quantity and duration.
d. Specific instructions for use. "

A review of the Hospital's policy and procedure, on December 10, 2012, titled: "INTRAVENOUS MEDICATION POLICY", dated September 2012, it documented the following information regarding Levophed Drips:
a. Standard Dilution: 8 mg. in 250 milliliters of 5 % Dextrose and water.
b. Initial Rate: 8-12 Micrograms/minute.
c. Maintenance Rate: 2-4 Micrograms/minute
d. Titration: 1-2 Micrograms/minute every 2 minutes as needed.

There was no documented evidence that the hospital's policy guidelines for Levophed Drips addressed a specific start rate and dose to initiate the medication. The Hospital's Levophed guidelines provided an initiation range, however, the Registered Nurse must still use her/his judgment at what precise starting dose rate Levophed medication IV drip was to be initiated.

During an interview with the Director of the Intensive Care Unit, on December 10, 2012, at approximately 11:45 AM, she confirmed the finding and stated, "Nurses are starting Levophed Drips without a physicians' order and leaving it up to the individual nurse to decide the starting dosage rate. "

Based on interview and record review, the hospital failed to ensure that 3 of 32 sampled patients (Patients 22, 24 and 41), in a universe of 51, had all of their physician orders authenticated (with the name, date and time) of the ordering practitioner, within 48 hours. This failure had the potential for errors in transcription and the potential to affect patient treatment and safety.

Findings:

1. A record review, on December 10, 2012 at 3 PM, of Patient 22, revealed that the patient was admitted on December 2, 2012 with the diagnosis of "New onset diarrhea." A physician telephone order obtained by a Register Nurse (RN), dated December 2, 2012 at 6:40 PM for oxygen 2 liters to keep saturations at greater than 92%, was not authenticated by the physician who ordered the oxygen. Another telephone order obtained by an RN dated December 5, 2012 at 9:20 PM, for Ativan (A medication used for anxiety) 1 milligram intravenous every 4 hours as needed, was not authenticated by the physician who ordered the medication.

An interview, on December 10, 2012 at 3 PM, with RN 9 was conducted. RN 9 stated that the orders were not signed by the physician and that all telephone orders were supposed to be signed within 48 hours.

2. A record review, on December 17, 2012 at 4 PM, of Patient 41, revealed that the patient was admitted on November 23, 2012 with the diagnosis of pregnancy contractions. Patient 41 was discharged from the hospital on November 26, 2012. Several physician orders dated November 23, 2012 at 6:05 PM, 8:15 PM, 8:25 PM and 10:40 PM (all which included several medication orders, IV fluid orders, diagnostic tests, laboratory tests and a cesarean section [c-section] order), were not authenticated by the ordering physician.

An interview, on December 17, 2012 at 4:15 PM, with RN 4 was conducted. RN 4 stated that there was no physician signatures on any of the telephone orders for Patient 41 and that it was the hospital's policy per the physician rules and regulations to sign every order within 48 hours.

A record review, on December 18, 2012 at 8:30 AM, of the hospital's document, titled "General Rules & Regulations of the Medical Staff, revised on 12/6/11." The rules and regulations indicated the following, "...Verbal orders for medications must be dated and timed by licensed personnel lawfully authorized to receive the order and authenticated, dated and timed by the ordering or attending physician within 48 hours..."


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3. A review of Patient 24's record on December 10, 2012 showed that the patient was admitted to the facility on November 27, 2012 with a diagnosis of altered level of consciousness.

A review of a physician order, dated December 6, 2012, showed a telephone order written by a nurse. The order was as follows: "Keep NPO (nothing by mouth) after midnight for EGD (esophagogastroduodenoscopy - a procedure where the physician puts a tube down the throat and into the stomach of the patient to visualize the structure of the stomach and small intestine for any abnormalities) tomorrow, obtain consent." The order had not been authenticated (signed as ordered by the physician) as of December 10, 2012, 96 hours after the order had been given,

In an interview on December 10, 2012 at 4:00 PM with RN 1, RN 1 stated that the physician orders should have been signed within 48 hours.

A record review was conducted on December 18, 2012 at 8:30 AM, of the hospital's document, titled "General Rules & Regulations of the Medical Staff, revised on 12/6/11." The rules and regulations indicated that, "...Verbal orders for medications must be dated and timed by licensed personnel lawfully authorized to receive the order and authenticated, dated and timed by the ordering or attending physician within 48 hours..."

Based on observations, record reviews, interviews, document reviews, and policy and procedure reviews, the hospital did not provide pharmaceutical services that meet the needs of all of the patients.

1. Pharmaceutical services were not provided according to accepted professional principle. (Refer to A-500, A-501, A-505, A-508 and A-749)

2. Failure to ensure that all drugs and biologicals were stored in a manner to prevent unmonitored access by unauthorized individuals. For 1 of 6 unsampled patients (Patient E), 32 sampled patients and in a universe of 51, the hospital failed to insure that 3 drugs were not kept on top of the bedside table. This failure had the potential for unauthorized individuals to access the drugs. (Refer to A-502)

3. Failure to ensure that unusable drugs and biologicals were not available for use in ICU, Surgery Department, Post Acute Care Unit. (Refer to A-505)

4. The facility failed to ensure that the facility's intravenous preparation area comply with the United States Pharmacopeia (USP) Chapter 797 Compounding-Sterile preparation, which set practice standards to ensure the safety and final quality of all products compounded under sterile conditions. (Refer to A-501)

5. The facility failed to ensure that pharmacy technicians were assigned duties to be in compliance with state regulations to assure quality pharmaceutical services. (Refer to A-500)

6. The facility failed to (a) ensure that pharmacy technician staff was assigned duties to be in compliance with state regulations to assure quality pharmaceutical services, (b) ensure that Patient 1's own medication Lyrica that was brought to the hospital was verified before administration, (c) ensure that Patient 4's allergy profile was correctly identified and (d) ensure that an unapproved abbreviation was not included in Patient 5's medical record, that medication orders were complete for pain to include the intensity of pain treated for Patient 4, ensure to prevent a lack of clear communication to staff when to administer specific pain medications to Patient 7, and to ensure clear communication and guidance for the administration of sliding scale insulin to Patient 3. (Refer to A-500)

7. The facility failed to ensure that quarterly pharmacy activity reports of adverse drug events, operational, and clinical pharmaceutical activities were reported when a full quorum was convened. (Refer to A-508)

8. The facility failed to ensure that (a) the respiratory care practitioner assigned to Patient 2 observed infection control precautions during the course of administering treatment, and (b) the registered nurse RN who administered medication to Patient 3 observe infection control precautions during the course of administering medications. (Refer to A-749)

The cumulative effect of the systemic problems resulted in the hospital's inability to ensure the provision of pharmaceutical services in a safe environment.

Based on interview, record review, and policy and procedure review the facility failed to (a) restrict its Pharmacy Technician's duties to that of non-discretionary tasks. The facility failed to ensure that pharmacy technician staff was assigned duties to be in compliance with state regulations to assure quality pharmaceutical services, (b) ensure that Patient 1's own medication Lyrica that was brought to the hospital was verified before administration, c.the facility failed to ensure that Patient 4's allergy profile was correctly identified, and (d) ensure that an unapproved abbreviation was not included in Patient 5's medical record, that medication orders were complete for pain to include the intensity of pain treated for patient 4, and lack of clear communication to staff when to administer specific pain medications to Patient 7, and clear communication and guidance for the administration of sliding scale insulin to Patient 3.
.

Findings:

a. On 12/12/12 at approximately 11:30 during a tour of the surgery department, the distribution of drugs to malignant hyperthermia (MH) crash cart and (ADC) automated dispensing cabinet was reviewed. It was noted during the review that drugs necessary for immediate use during the code were not stored in the cart, but in the ADC adjacent to the cart. During the inventory check, it was noted that only one opened vial of regular insulin was available. The ADC report indicated that two vials should be available. Sufficient inventory should be available for routine use and unusual events such as a MH code.

The lead pharmacy technician was asked if a pharmacist inspected thus evaluated the use of drugs in the department. She stated that the pharmacy technicians checked for outdates monthly and that the Director of Pharmacy (DOP) stated that the pharmacist inspects the drugs on the units and the pharmacy technicians checks for outdates. Review of the facility ' s policy and procedure titled, ' Medication Area Monthly Inspections ' a pharmacist inspects on a monthly basis.


On 12/13/12 at approximately 1:30 PM, the Director of Pharmacy (DOP) was interviewed regarding drug distribution and inspection of medications stored on patient care units and departments. The DOP reported that designated pharmacists were assigned specific patient care areas, however, medications stored on the nursing units and other areas of the hospital were checked by a pharmacy technician on a monthly basis, after which the pharmacist signs the inspection sheet.

Review of the facility's policy and procedure titled, 'Medication Area Monthly Inspections' a pharmacist inspect on a monthly basis.

Current regulation stipulates as follows, " Drugs maintained on the nursing unit shall be inspected at least monthly by a pharmacist" . And " the supply shall be inspected by a pharmacist at periodic intervals specified in written policies. Such inspections shall occur no less frequently than every 30 days. Records of such inspections shall be kept for at least three years. "

The Board of Pharmacy (BOP) delineated the scope of practice for a Pharmacy Technician to that of non-discretionary tasks. Hence, the facility failed to assure that pharmacy staff assigned duties to be in compliance with state regulations. Such inspections shall occur no less frequently than every 30 days. Records of such inspections shall be kept for at least three years. "

The Board of Pharmacy (BOP) delineated the scope of practice for a Pharmacy Technician to that of non-discretionary tasks. Hence, the facility failed to assure that pharmacy staff assigned duties to be in compliance with state regulations.

b. During the medication observation pass conducted on 12/11/12 at 9:25 AM, RN 16 obtained a bottle containing Lyrica tablets for Patient 1 from the medication room. Inspection of the bottle with the RN revealed that Patient 1 ' s patient label covered the drug name, and strength.

When asked how the pharmacy verifies medications brought to the hospital, RN 16 stated that the medication is taken to the pharmacy and the pharmacist lets the RN know if it can be used. Further inspection of the bottle revealed that it lacked a pharmacy verification label or initials. The RN was unable to explain the lack of the verification label or pharmacist ' s initials.

A review of the medical record on 12/11/12 at 3:02 PM revealed a physician's order on 12/6/12 at 9:05 AM , that stated 'Pt (patient) to bring Lyrica from home. Lyrica 75 mg - continue.

A review of the facility's policy and procedure titled, "Patients Own Medication(s)" documents that the pharmacist attaches the label to the medication container with the patient's name, room number, and a pharmacist's initials. "

Interview with the CNO on 12/11/12 at approximately 9:59 AM confirmed the finding.
Interview with the Director Of Pharmacy (DOP) on 12/13/12 at approximately 12:30 PM, he acknowledged that the verification of medications brought to the hospital must occur before administration.

c. Patient 4 received medications during the medication pass observation conducted on 12/11/12 at approximately 9 AM. Patient 4's medical chart was reviewed on 12/11/12 at 2:50 PM. Documentation on the medication reconciliation form dated 12/7/12 at 10:50 PM documented that Patient 4 was allergic to Geodon " Bactrim " . Geodon and Bactrim have different indications for use.

Geodon is a medication indicated for psychotic illnesses such as schizophrenia, bipolar (manic/depressive) states, and may cause negative cardiac effects. Bactrim is a combination sulfonamide antibiotic (sulfamethoxazole and trimethoprim). Bactrim has a sulfa component which may illicit allergic reactions. Subsequent medication orders dated 12/7/12 at 10:50 PM listed only Bactrim as Patient 4 ' s allergy.

In an interview with the Director of Emergency Department on 12/11/12 at 3:10 PM he acknowledged that an allergy profile should be accurately documented in the medical record.

d. Patient 5 was admitted to the facility via the Emergency Department on 12/3/12 with diagnoses that included chronic obstructive pulmonary disease (COPD), (a lung disease), respiratory failure and was intubated.
A review of Patient 5's medical record on 12/10/12 at approximately 2:35 PM revealed respiratory care orders for Xopenex (levobuterol) 0.63 mg (milligram) via MedNeb (medical nebulizer) q4h (every 4 hours) RTC (around the clock), a medication used to treat the narrowing of airways, and Do not Substitute, Atrovent 0.5 mg via via neb(nebulizer) q4h RTC, Pulmocort 1 mg neb qh, Solu Medrol 100 mg IV q6h. During the transcription of orders Pulmocort was ordered as 1.0 mg which is an unacceptable abbreviation according to the facility's policy and procedure titled, "Unapproved Abbreviations."

Patient 4 received medications during the medication pass observation conducted on 12/11/12 at approximately 9 AM. Patient 4 ' s chart was reviewed on 12/11/12 at 2:50 PM. The review revealed a medication order dated 12/8/12 at 10:50 PM for Dilaudid 1 mg (milligram) IV(intravenous) Q3 (every 3 hours) PRN (as needed) pain, Toradol 30 mg IVP (intravenous push) Q6 PRN pain. These orders as written do not delineate the intensity of pain (mild, moderate, or severe) being treated. The nurse will have to decide which drug to administer to Patient 4 as the physician failed to clearly state when either medication should be administered.

A review of the facility ' s policy and procedure titled, 'Medication Administration' documents that medication orders to include all elements of an order, PRN to include indications.

An interview with the Emergency Department Director on 12/11/12 at 3:10 PM confirmed the finding that medication orders for pain should be complete so that physicians ' orders are not subject to interpretation.


A review of Physician A's standing order titled, "Post-Operative Orders for Dr. A" and dated 12/9/12 (no time) for Patient 7 on 12/12/12 at approximately 12 PM revealed variance order sets for Demerol 50 mg IV Q6h PRN for mild and moderate pain; Toradol 30 mg slow IV every 6 hours PRN for mild and moderate pain, and Tylenol 1 gm (gram) IVPB (IV piggyback) every 6 hours x (times) 4 for mild and moderate pain. The nurse will have to decide which drug to administer to Patient 4 as the physician failed to clearly state when either medication should be administered.

An interview with the post recovery nurse on 12/12/12 at 12:05 PM confirmed the finding that medication orders for pain should be complete so that physicians' orders are not subject to interpretation.

Following the medication pass observation conducted on 12/11/12 at approximately 8:45 AM, Patient 3's medical record was reviewed. Licensed staff received a telephone order dated 12/10/12 at 5:40 PM for Accu Chek ACHS (before each meal and at bedtime) low dose 'ss' insulin for Patient 3. The order was transcribed using an approved abbreviation of 'ss'. However, the facility's policy and procedure titled, Unapproved Abbreviations, and Approved Abbreviations List document on page 18 of 22, that 'ss' is to be interpreted as one-half not sliding scale insulin. An inaccurate abbreviation may contribute to medication errors.

Following the medication pass observation conducted on 12/11/12 at approximately 8:45 AM, Patient 3's medical record was reviewed. On 12/11/12 at 2:50 PM, review of a pre-printed order form titled, "Administration of insulin per sliding scale orders for adults" revealed that the physician's telephone order for insulin, a high risk, high alert medication to be administered based on the nurse's subjective determination of a 'thin' or 'average' weight patient, not a BMI (Body Mass Index). The pre-printed form was re-approved by the facility's medical staff on 3/12. The parameters described are based on low dose, moderate dose and high dose regimens.

Further review of the pre-printed form revealed that the low dose or moderate dose regime was not checked in section 1 to determine which regimen to initiate.

The low dose regimen was circled in section 2, with instructions to check capillary blood glucose using AccuChek point of care testing, and ACHS for patient who are able eat. Information on the form does not instruct nursing to give oral replenishment as the patient is not NPO (nothing by mouth).

The conditional order instructs the nurse select ? amp (ampule) D50W (Dextrose 50%) to be administered and call physician for all regimens with blood glucose of less than 60 mg/dl. The pre-printed order form lacks clear communication to nursing staff for the administration of sliding scale insulin.

In an interview with the Director of Emergency Department on 12/11/12 at 4 PM he acknowledged that the pre-printed form lacked clear communication and guidance to nursing staff for the administration of sliding scale insulin.

Based on observation, document review, and interview, the facility failed to ensure that the facility ' s intravenous preparation area comply with the United States Pharmacopeia (USP) Chapter 797 Compounding-Sterile preparation, which set practice standards to ensure the safety and final quality of all products compounded under sterile conditions..

Findings:

The United States Pharmacopeia (USP) 797 addresses facilities in which compounded sterile products (CSP) are prepared according to the manufacturers' labeling and where manipulations are performed during the compounding of sterile products which increase the potential for microbial contamination of the prepared products. It delineates what training, procedures for transporting products is needed, how the preparation area should be designed, equipment type, and quality control program formalized in writing.

USP 797 governs how any pharmacy is designed to reduce infection transmissions to patients through pharmaceutical products and to protect staff in the course of their exposure to pharmaceuticals.

During an inspection of the facility ' s pharmacy on 12/13 /12 at approximately 11:20 AM, with the ER director, it was observed that the intravenous (IV) preparation area room was not compliant with USP 797 practice standards. Within the current IV room there was a red line surrounding a Laminar Airflow Workbench (LAFW) - approximately 20 inches from the LAFW. The pharmacy technician prepares IV within this space. Also observed was a gown hanging from a shelf inside the room.

During the pharmacy inspection of the IV room, at 11:55 AM, pharmacy technician I opened the door to the IV room, poked her head inside and conversed with pharmacy technician II who was preparing IV solutions for inpatients, thus rendering the room less conducive to the preparation of compounded products.

At 12:05 PM, a pharmacist gowned outside of the IV room in an unclean area, entered the IV room, and left the door slightly ajar.

When asked about the testing/certification processes, policy and procedure, and training of staff with regards to USP 797, the Director of Pharmacy (DOP) stated that a policy and procedure delineating the USP 797 standards had not been developed, that the IV technicians were trained to prepare IVs, that the Laminar Airflow Workbench (LAFW) used to prepare IV solutions for inpatients was tested and certified on 11/29/12. He further stated that microbial environmental sampling was not done in the IV preparation room, therefore, not certified to be in compliant with USP 797 practice standards.


In a concurrent interview with the Director of Pharmacy (DOP on 12/13 /12 at approximately 12:10 PM, he acknowledged that the facility's intravenous preparation area did not comply with the United States Pharmacopeia 797 (USP) standards for Pharmaceutical Compounding of Sterile Preparations. He further acknowledged that financial priorities were a factor resulting in non- compliance with USP 797.

Based on observation, interview and record review, the hospital failed to ensure that all drugs and biologicals were stored in a manner to prevent unmonitored access by unauthorized individuals. For 1 of 6 unsampled patients (Patient E), 32 sampled patients and in a universe of 51, the hospital failed to insure that 3 drugs were not kept on top of the bedside table. This failure had the potential for unauthorized individuals to access the drugs.

Findings:

On December 10, 2012 at 2:25 PM, during a tour of the hospital's Medical Surgical Unit, 3 drugs (Tusson {cough medication and side effects include drowsiness, dizziness and nausea}, Promethazine {used for colds and side effects include drowsiness, dizziness, blurred vision and nausea} and an unlabeled container.

During an interview, on December 10, 2012 at 2:25 PM, RN 1 stated that the drugs were unsampled Patient E's own medications but that they were not supposed to be kept on the bedside table and that the hospital's house supervisor was supposed to keep them locked in the office since the patient did not send them home.

During an interview, on December 10, 2012, at 2:30 PM, RN 2 stated that when a patient brought in their own medications, it was the hospital's policy to log the drugs (a method for tracking) and that either the house supervisor or the pharmacy department kept them locked in a secure area.

A record review, on December 11, 2012 at 8:30 AM, of the hospital policy titled, "Patient's Own Medications (S), revised on 12/11," indicated the following: "It is the policy of (name of hospital), to provide guidelines for safe storage and administration of patient's medications brought from home." The policy also indicated, "The hospital should not assume the legal responsibility for medications not supplied by the Pharmacy. In the event that a patient should bring any of their own medication with them, they should immediately be returned to a member of the family. in the event this is not possible, the medications will be collected, counted and catalogued by nursing personnel and forwarded to the Pharmacy for storage until discharge...Temporary Storage for Medications: Nursing will place the patient's medications in a valuables envelope and itemize each separate medication on the receipt by: Prescription number, Name of medications (or description of medication), quantity of medication...".

Based on observation and interview, the facility failed to ensure that outdated drugs and biologicals were not available for patient use.

Findings:

During a tour of the Intensive Care Unit (ICU) on 12/10/12 at 4:13 PM, six (6) three milliliters Remel Micro Test tubes for transport of viruses and Chlamydia were found in the medication refrigerator. The test tubes expired 8/12/2012. Regulations prohibit (a) the storage of non-medications (diagnostics) in a medication refrigerator, and (b) the storage of expired or otherwise unusable drugs and biologicals. The registered nurse, RN 15, acknowledged that the test tubes expired or unexpired should not be stored in the refrigerator with medications, and moreover not available for patient use.

During a tour of the surgery department on 12/12/12 at approximately 11:05 AM, a multi-dose vial (MDV) of regular insulin found in the refrigerator was not dated when opened. The facility ' s policy and procedure titled, ' Medication Administration ' documents " Insulin vials and all other multi-dose vials must be dated upon opening. The expiration date after opening is 28 days ... "

During a tour of the Post Acute Care Unit (PACU) on 12/12/12 at approximately 11:20 AM, six (6) red top test tubes were found to be expired on 9/12/12. The charge nurse acknowledged during an interview that expired test tubes should not be available for patient use.

Based on document review, and interviews, the facility failed to ensure that quarterly pharmacy activity reports of adverse drug events, operational, and clinical pharmaceutical activities were reported when a full quorum was convened in order to provide a discussion venue and referral to the Medical Executive Committee.

Findings:

On 12/13/12 at 2 PM a review of the Treatment and Surveillance Committee (a medical staff function) minutes revealed that the pharmacist presented required operational and clinical activities including medication errors, adverse drug events, monitoring of drug therapies, formulary changes and requests, and other administrative functions in the absence of a quorum that would include physicians. .

Interview with the DOP on 12/13/12 he stated that he was instructed to present the information even thought a quorum was not present to discuss pertinent operational and clinical activities including medication errors, adverse drug events, monitoring of drug therapies, formulary changes and requests, and other administrative functions.

Further review of the Treatment and Surveillance Committee minutes revealed that a quorum was not available at the 9/15/12 and 11/23/11 meetings. On 6/21/12, the minutes documented that a quorum was present, however, pharmacy reports were not treated as actionable items and not sent forward to the medical executive committee.

In an interview with the medical staff director (PS) on 12/13/12 at 2:45 PM, she confirmed the finding. The medical staff director stated that steps are being taken to reorganize meeting procedures to ensure that a quorum is available when a committee is convened in order to ensure that a department ' s reports are presented for discussion and communication through the leadership channel.

Based on observation, interview and document review the facility failed to ensure that dietary services met the needs of all patients as evidenced by failure to:
1. Ensure policies were monitored for day to day clinical and food service practices. (Refer to A-620, A-630, A-631 and A-749)

2. Ensure the nutritional needs of patients were met as evidenced by the lack of a comprehensive and accurate nutritional analysis of all the menus used at the facility, the inadequacy of registered dietitian coverage, and that meals were not served in accordance with prescribed diet orders. (Refer to A-621, A-628 and A-630)

3. Ensure that the disaster plan addressed the needs of patients prescribed therapeutic diets, and that the integrity of disaster supplies was maintained to ensure adequacy in the event of a disaster as determined by the facility. (Refer to A-620)

4. Ensure that a collaborative effort was evident in addressing performance improvement activities that identified opportunities for improvement.

5. Ensure safe and effective food storage/production practices integrated in the facility's Infection control surveillance system. (Refer to A-749)

The cumulative effect of these systemic problems resulted in the inability of the facility's food and nutrition services to direct and staff in such a manner to ensure that the nutritional needs of the patients were met in accordance with practitioners' orders and acceptable standards of practice. The system problems resulted in the facility's inability to meet the Condition of Participation for Food and Dietetic Services.

Based on observations, interviews and document review, the facility failed to ensure that the Director of Food and Nutrition Services (DFNS):
1) Monitored written procedures/manufacturer recommendations for food service operational processes relating to food safety.

2) Ensured the integrity of disaster food supplies for all patients and staff, and the appropriateness of disaster foods for all therapeutic diets.

3) Ensured that data reported as part of the Quality Assurance Performance Improvement (QAPI) program was tracked and trended for analysis purposes with effective action plans for improved provision of care.

These failures may result in patients being exposed to foodborne illness and cross contamination which may further compromise medical status, inadequate food supplies in the case of a disaster, and lack of intervention in response to quality assurance measures not meeting established thresholds.

Findings:

1) On December 11, 2012, starting at 8:30 AM, during an inspection of the food service operation, the following was noted:

A. In the walk-in refrigerator, a pan containing two five-pound pieces of uncooked meatloaf was noted to be stored on a sheet pan on the top of a storage rack. Stored directly underneath the meatloaf were containers of ready to eat pickles and lettuce. Also noted in the facility's outside refrigerator, three fifteen-pound cases of raw bacon were stored adjacent to cases of cooked sausage and directly above two cases of cooked turkey ham. In a concurrent interview with the Director of Food and Nutrition Services (DFNS), present at the time of the observations, he confirmed that the raw meat products should not have been stored directly above ready to eat food products.

On December 11, 2012, at 3:30 PM, review of the facility policy titled, "Purchasing, Receiving and Storage - approved 6/11", indicated: "When storing raw foods the following top-to-bottom order will be used:

a. Cooked and ready-to-eat foods (top shelf)
b. Raw fish
c. Raw ground beef
d. Raw pork, ham, bacon and sausage
e. Raw ground beef and pork
f. Raw chicken (bottom shelf)"

B. In the main kitchen, a red pail containing a cleaning cloth immersed in a liquid was noted in the cold food preparation area. In an interview with Food Service Worker 1 (FSW 1), she stated that the liquid in the pail was a sanitizer solution (Quaternary Ammonia) obtained from a dispenser in the dishroom, and the cleaning cloth was used to wipe down the food preparation area when food production was complete. FSW 1 was unsure what the sanitizer concentration should be, and stated that she had never utilized a chemical test strip to check the sanitizer concentration. Upon testing the chemical sanitizer, the test strip registered 50 parts per million.

Review of the facility policy titled, "General Cleaning/Sanitizing of Dietary Equipment /Surfaces - Reviews 6/11", showed, "All area surfaces will be cleaned with an approved multi-quat sanitizing solution after each meal." There was no indication of what the concentration of the sanitizer should be. Review of the manufacturer recommendations posted in the dishwashing are, showed that the recommended concentration for the quaternary ammonia sanitizer was 150 to 400 parts per million.

C. Inspection of the ice-machine showed a log indicating that the ice-machine was cleaned/sanitized on a weekly basis by food service staff. The DFNS stated food service staff utilized a quaternary ammonia solution to sanitize the ice machine. This was confirmed in an interview with Food service Worker 2 (FSW 2) on December 12, 2012, at 3:10 PM.

On December 12, 2012, at 3:30 PM, the manufacturer recommendations for sanitizing of the ice machine were provided by facility staff. The recommended chemical was noted to be sodium hypochlorite, a chlorine based chemical. The DFNS acknowledged the discrepancy in the ammonia based chemical currently used to sanitize the ice machine compared to the chlorine based sanitizer recommended by the manufacturer.

D. On December 12, 2012, at 3:20 PM, in an interview with the DFNS, he stated that the facility utilized a "Cooling Log", to monitor potentially hazardous food (PHF) items, such as hot cooked ground beef and turkey, as they were cooled for future use. Review of the facility policy titled, "Hazard Analysis Critical Control Points Program (HACCP) - Approved 06/11", showed, "Hot food must be cooled from 135 degrees F (Fahrenheit) to 70 degrees F within 2 hours and from 70 degrees F to 41 degrees F within 4 hours. Corrective action must be taken if this process is not achieved. Reheating is required to 165 degrees F for at least 15 seconds in 2 hours."

Review of the "Cooling Log" showed an entry on October 6, 2012, for "Turkey". The temperature documented after the initial 2 hours was 90 degrees F. On October 27, 2012, another entry for "Turkey" was noted, with the temperature documented after the initial 2 hours as 79.5 degrees F. There was no documented corrective action noted on the "Cooling Log" or an area for corrective action to be documented. The DFNS acknowledged the lack of documented intervention as related to the PHF items not reaching the recommended temperature of 70 degrees F after the initial 2 hours of cooling.

2) On December 11, 2012, at 8:40 AM, in the outside refrigerator, disaster menu food supplies were noted. Inspection of the disaster foods showed:

A. One case of Cup-A-Soup with an imprinted "Best By" date of November 17, 2007.
Two cases of bulk Cornflakes cereal were imprinted with a manufacturer "Best Buy" date of September 9, 2006.
One case of Tapioca pudding was imprinted with a "Use By" date of December 5, 2012.
Five cases of individual packets of Quaker Oats oatmeal were imprinted with a manufacturing date of November 2006, and two cases of cream of wheat were imprinted with a manufacturing date December 2006.

In a concurrent interview with the DFNS, he stated he was not sure of the shelf life of those products. On December 12, 2012, at 7:15 AM, in a telephone interview with a representative from Quaker Oats, she stated that the "Best Before" date imprinted on oatmeal products was designed for optimal nutritional value, taste and freshness of the product. The representative stated that the recommended storage time for the product was 18 months from manufacturing, however, the product may be kept longer but needs to be monitored for off coloring, off-flavor and changes in texture and odor based on prolonged storage. She further stated that the recommended storage location for the product was the pantry or freezer versus the refrigerator, as the moisture/humidity in the refrigerator may cause the product to clump. This information was discussed with the DFNS on December 12, 2012, at 1:42 PM. The DFNS acknowledged that the facility did not have an established system to monitor the oatmeal beyond the recommended 18 month manufacturer storage date to ensure optimal freshness for use.

Two cases containing four one-pound bags of Cream of Wheat were imprinted with manufacturing dates of November 3, 2006, and November 10, 2006, respectively. In a concurrent interview with the DFNS, he was not sure how long the product can be kept.

Two cases pureed carrots were also noted. The product was imprinted with a manufacturer code that the DFNS could not discern. On December 12, 2012, at 1:42 PM, in an interview with the DFNS, he stated that, upon contacting the manufacturer, he determined the imprinted code as a manufacturing date of November 24, 2009. He stated the manufacturer recommendation for retention of the product was two years from manufacturing date, in this case, November 24, 2011.

Three cases of pureed beef were similarly imprinted with manufacturer codes that the DFNS could not discern. The cases were labeled as having been delivered to the facility on September 15, 2008. The DFNS did not know how long the product could be kept. As of the date of the survey exit, there was no additional information obtained from the manufacturer of the puree beef.

Six cases of one-half ounce individual servings of peanut butter were noted with a manufacturing date of September 22, 2010. The DFNS, present at the time of the observation, was unsure of how long the product should be returned.

B. On December 11, 2012, at 3:30 PM, review of the "Disaster Menu" showed that "Peanut Butter" was to be served to all patients at breakfast on the planned three day disaster menu. The facility policy titled, "Nutritional Services Department Internal Disaster Plan - Approved 6/11", indicated, "The Clinical Dietitian is responsible for determining the food to be served to patients."

On December 12, 2012, at 1:52 PM, in an interview with the DFNS and the Registered Dietitian (RD), the DFNS stated that peanut butter may pose a choking hazard for patients prescribed puree diets. The RD acknowledged that an alternate food item should be recommended for patients prescribed puree diets.

Further review of the "Disaster Menu" showed no plan for patients prescribed renal or low sodium diets, which typically have a sodium restriction of 2000 mg per day. The food items provided on the disaster menu included canned chili beans and canned beef stew. The sodium content for a 3/4 cup portion size as indicated on the disaster menu for those items was as follows:

Chili beans 1102 mg sodium
Beef Stew 750 mg sodium

The chili beans, for example, would provide more than half the allotted sodium content for patients with prescribed sodium restrictions, and represent only one menu item on the planned disaster menu for Day 3 of the disaster plan. The DFNS acknowledged the high sodium content of food items served on the "Disaster Menu", and stated the menu would have to be reviewed for appropriateness for service to patients with prescribed therapeutic diets such as renal and low sodium.

3. On December 13, 2012, at 9:55 AM, a review of the Performance Improvement quality assurance data was conducted with the DFNS and the RD.

One of the established performance indicators for clinical nutrition services was, "A copy of computer generated request in the actual chart." The RD explained the indicator reflected nutritional consults that were actually generated by nursing services and forwarded to the RD for follow-up. The desired threshold for compliance was 95%. Review of the documented compliance percentage from May 2012 to November 2012, showed a range from 68% to 85%.

The RD comments in June and July 2012, indicated she provided education to nursing staff through "bed huddles" and 1:1. In October 2012, the RD documented, "Still working with nursing", and in November 2012, the RD documented, "Appeared due to registry staff. Discussed with charge nurses."

The second performance indicator reviewed was, "Patient consumption of breakfast, lunch, dinner, supplements/snacks will be entered in patient charts daily by nursing staff." The RD explained that she relied on this information when assessing/reassessing patients and implementing nutritional recommendations. The desired threshold for compliance was 95%. Review of the documented compliance percentage from May 2012 to November 2012, showed a range from 62% to 90% with two months at 100%.

The RD comments in June, July, September and October 2012, indicated she provided education to nursing staff through "bed huddles" and 1:1. In October 2012, the RD documented, "Mostly dinner misses. Day nursing needs to pass to night nursing."

In a discussion with the RD regarding the performance improvement data, it was noted that there was no detailed analysis documented on the forms submitted to the quality assurance committee delineating the nursing units, days of the week or nursing shifts most often implicated with deficient practice, in order to better determine intervention processes to improve performance.

In a discussion with the DFNS, he confirmed that the RD did not attend the quality assurance (QA) committee meetings and it was his responsibility to present the performance improvement data to the committee. He stated that committee members would ask, "Why are the numbers low?", but no formal action plans were generated or recommended by QA committee members. He stated suggestions such as possibly including some training related to identified deficient nursing practice in the nursing orientation process were made, but have not been implemented.

On December 13, 2012, at 11:43 AM, in an interview with the Director of Quality and Risk Management, he confirmed that the quarterly QA committee minutes did not include suggestions for improvement or departmental action plans. He stated that in addition to the QA committee, department heads also attend a quality subcommittee, where more detailed discussion of departmental performance is included and suggestions for improvement are provided. Minutes provided were for the "Environment of Care" (EOC) committee meetings. Review of the minutes for November 14, 2012, showed the following action plan for nutritional services, "(department head) to continue to monitor and report data to the EOC Committee to ensure quality patient care." There was no evidence of integrated interdisciplinary efforts, to address deficient practice as identified by performance improvement data, to ensure improved patient quality of care.

Based on document review and staff interview, the hospital failed to ensure that adequate provisions were made for registered dietitian (RD) involvement in the provision of patient nutritional care.

Findings:

During the course of the survey, deficient practice was noted related to appropriate menu nutritional analysis, the lack of recipes and portion sizes for puree diets, inadequacies of the disaster menu in meeting the needs of patients prescribed therapeutic diets, deficits in the patient nutrition assessment process, diet manual utilization in patient care and diets not prepared and served as ordered by the physician. (Cross Reference A620, A628, A630, A631).
On December 11, 2012, at 9:32 AM, in an interview with the Director of Food and Nutrition Services (DFNS), he stated that there was one RD responsible for nutritional care at the hospital who worked five days per week with Sundays and Mondays off. There was no routine coverage provided for the RD on the regular days off. The DFNS stated that the Diet Office staff reported to the RD.
On December 11, 2012, at 3:30 PM, review of the, "Job Description- Clinical Dietitian, Approved 6/11", showed that the RD's primary responsibilities included, "Performance of nutritional assessments, patient nutritional education for inpatients and outpatients, and the development and delivery of staff development programs on nutrition and therapeutic diets." The RD was also to "Function as a liaison between Medical staff, Nursing staff and Dietary staff in matters pertaining to nutritional services." In addition, under "Principle Accountabilities", the RD was expected to, "Assist the Department Manager in teaching, education and intervention involving patient care, food handling and safety for all Nutritional Services staff."
On December 12, 2012, at 10:48 AM, in an interview with the RD, she stated she, "Can use some help." The RD explained that she was the only RD at the hospital and was responsible for all nutritional assessments and follow-ups, consults, patient education, menu review, diet office staff training, collection of quality assurance information related to clinical nutrition care, nursing staff education, policy and procedure and diet manual review. The RD stated that she was unable to attend Environment of Care or Quality Assurance meetings, and her meeting attendance was limited to daily patient "huddles" and intensive care unit (ICU) rounds. The RD stated that she does not supervise the diet office staff, nor perform their performance evaluations and she believed the last time she provided inservice training to the diet office staff was in June 2012. The RD further stated that she was in the process of developing the puree menu and portion size guide, but has not had time to complete the process, and was not involved in oversight of any foodservice or sanitation systems.
The RD stated that she has expressed the need for additional RD coverage to the DFNS, but that it was difficult to recruit employees. On December 13, 2012, at 1:42 PM, in an interview with the DFNS, he acknowledged that the facility was trying to recruit a part-time RD. He stated that a registry service existed but was only used when the RD had a planned absence from the facility. He stated that a 72 hour to a one week notice had to be provided to the registry agency in order to ensure coverage for the RD. He acknowledged the numerous tasks the RD was responsible for and the lack of time available to successfully complete all tasks.

Based on record review and staff interview, the facility failed to ensure the Registered Dietitian(RD) completed the nutritional assessment for one patient (Patient 13) in a timely manner, and comprehensively addressed the nutritional status of one patient (Patient 22) in accordance with the facility diet manual recommendations .

Findings:
1) On December 12, 2012, at 10:30 AM, review of the medical record for Patient 13 showed he was admitted on December 4, 2012, with diagnoses that included diabetes and renal (kidney) disease requiring dialysis (a mechanical process for removing waste and excess water from the blood). Review of the Adult Multidisciplinary Initial Assessment, Nutritional Status Section, completed by nursing staff, showed that the patient had no swallowing or chewing difficulties and a 20 pound weight loss noted as "intentional". No skin breakdown was noted and no Registered Dietitian (RD) referral was made.

On December 10, 2012, six days after admission, the physician requested a dietary consult due to the patient having a wound, diabetic renal insufficiency, and an albumin (measure of protein stores) of 1.4 grams per deciliter (g/dl) (normal range 3.4-5.4 g/dl).

On December 10, 2012, the RD completed the nutritional assessment and documented the patient had unintentional significant weight loss secondary to renal disease, poor dentition, inability to chew. The RD also noted the patient was vision impaired and at high nutritional risk.

Review of the facility policy titled, "Nutrition Screening and Assessment - Approved 6/11", showed, "Nursing staff completes the initial nutrition screening assessment (refer to the Interdisciplinary Assessment policy for further information) ....Upon identification of nutritional risk, nursing staff enters the referral order into the order communication computer system. The Clinical Dietitian responds to referral/consults within 24 hours of notification for further assessment and to initiate the nutritional plan of care as warranted by the patient's status and nutritional risk."

Review of the "Levels of Nutritional Risk and Care" guideline for the facility showed that a patient is considered at "High Risk" when Serum Albumin was <2.1, and an unintentional weight loss of >10% per month. "Medium Risk" criteria included diabetes mellitus and chronic renal failure. The RD was to assess patients identified at "High Risk" within two days of notification and those at "Medium Risk" within three days of notification.

On December 12, 2012, at 10:48 AM, in an interview with the RD, she confirmed that she had not received a Nutrition Consult from nursing staff based on initial nutrition screening and did not complete her nutrition assessment until December 10, 2012, six days after the patient's admission, when she received a physician consult. She stated that this patient "fell through" until she received the physician consult as she was busy responding to other consults and completing other assessments as she was the only RD employed at the hospital.

2) On December 12, 2012, at 8:32 AM, review of the medical record for Patient 22, showed the patient was admitted on December 2, 2012 with diagnoses that included chronic kidney disease. On admission, the patient was prescribed a lactose free, cardiac, high protein, finely chopped diet, with one can of Ensure (nutritional supplement) BID (two times per day).

On December 5, 2012, the RD completed a nutritional assessment and estimated the patient's needs as 2200 calories and 73 grams of protein (1 gram protein per kilogram). The RD acknowledged that the patient had a diagnosis of chronic kidney disease, an albumin of 3.3 g/dl (normal range 3.4-5.4 g/dl) and recommended continuing the same diet and supplement order.

In a concurrent interview with the RD, present at the time of the record review, the RD stated that the cardiac diet provided 90-100 grams of protein. Per the RD, a high protein diet would provide 20% more protein, which would be the equivalent of 108-120 grams of protein. In addition, two cans of Ensure provided an additional 18 grams of protein. That meant Patient 22 would receive between 126 and 138 grams of protein per day.

Review of the facility Diet Manual recommendations for renal disease, showed that for a patient with renal disease, without diabetes and not on dialysis, the recommendation was 60 grams of protein or 0.8-1 grams of protein per kilogram. The RD acknowledged the facility Diet Manual recommendation and stated she "went with" the physician recommendation for a high protein diet, instead of evaluating the appropriateness of the diet for a patient with chronic kidney disease who was not receiving dialysis, and who was receiving close to double his estimated needs for protein, and discussing those issues with the physician for re-evaluation of the prescribed diet order.

Based on staff interviews and document review, the facility failed to ensure that:
1) Standard menus were accurately and comprehensively analyzed for the nutritional components to meet the current national standards including the RDA (Recommended Dietary Allowances) and the DRI (Dietary Reference Intake) of the Food and Nutrition Board of the National Research Council for all diets/populations served at the facility .
2) Patient diets were prepared and served as planned and in accordance with prescribed orders.
This has the potential for the patients in the hospital to not receive adequate nutrition to meet the estimated recommended dietary allowances, in the appropriate texture.
Findings:
1) During the course of the survey from December 11-13, 2012, the patient menu nutrition analysis was reviewed with the following findings:
A. There was one pediatric menu nutritional analysis available. It was unclear what reference RDA/DRI age group was used as a comparison, to determine the nutritional adequacy of the menu. In addition, the facility "Diet Manual" indicated different nutritional needs for: Toddlers 1-4 years, School Age children 5-1 years, and Adolescents 12-18 years. On December 12, 2012, at 1:52 PM, in an interview with the Registered Dietitian (RD), she acknowledged that the nutrition analysis for the Pediatric menu did not include all pediatric age groups and modifications that would be made in accordance with the varying nutritional needs associated with each age group.
B. Review of the regular menu showed that it was used as the basis for service to pregnant and lactating women. Review of the RDA/DRI recommendations for pregnant females showed a recommendation for 600 micrograms(ug) of folate and 27 milligrams (mg) of iron per day, and 500 ug folate for lactating women. Review of the folate and iron amounts provided in the facility regular diet showed 287 ug of folate and 16 mg of iron. There was no documentation of how menus would be modified/enhanced to meet the needs of the pregnant and lactating population served by the facility. This information was reviewed with the RD on December 13, 2012, at 9:55 AM, who acknowledged the deficiencies in folate and iron for pregnant and lactating women as served on the regular menu.
C. Review of the regular menu nutrition analysis showed that it provided 2813 calories. In comparison, the caloric content of the Restricted Protein (50 gram) diet was only 1624 calories. On December 13, 2012, at 9:55 AM, in an interview with the RD, she acknowledged that a physician ordered protein restriction did not necessarily equate to a caloric restriction as well, and that the menus were not adjusted to re-incorporate calories after high protein items were eliminated.
D. Review of the nutrition analysis for the Low Sodium (2000 mg) showed that it provided 2392 calories. Review of the nutritional analysis of individual menu items showed:
Low Sodium Broth 567 calories
Low sodium salad dressing 165 calories
On December 13, 2012, at 9:55 AM, the DFNS provided a copy of the nutritional label for the low sodium broth used at the facility. The label indicated the broth contained 10 calories. The nutritional label for the low sodium dressing showed that 20 calories would be provided based on the provision of 2 containers of low sodium dressing to each patient. This represented a discrepancy of 702 calories between what was actually served to patients, and what the facility calculated on the nutrition analysis. THE DFNS stated that the discrepancy was probably due to the input of incorrect food items in the nutrition analysis program.
2A) On December 11, 2012, at 9:10 AM, in an interview with Cook 1, she stated she was responsible for cooking the food for the patients for the lunch meal on that day, including the preparation of pureed food items. She stated that she prepared pureed chicken using chicken, and then added broth and food thickener as needed to achieve the desired pureed consistency. No recipe was utilized in the preparation of the pureed chicken.
On December 11, 2012, at 9:32 AM, in an interview with the DFNS, he acknowledged the absence of recipes for the preparation of pureed food items and the absence of portion size guidance for the service of pureed foods to ensure consistency among staff and the provision of adequate nutrients to patients prescribed pureed diets.
On December 11, 2012, at 3:30 PM, review of the facility policy titled, "Puree Diet - Reviewed 6/11" showed, "Dietitian: Develops the menu using the puree diet spreadsheet for patients on puree diets ....Recipes for puree diet menu items shall be available in the recipe book. Production Staff: Will prepare pureed foods according to recipe and consistent with the standards set forth by the thickening product used in puree production. Serving sizes for pureed foods will be consistent with standardized portions as indicated by recipe."
B. On December 11, 2012, at 11:25 AM, during an observation of the lunch trayline process, the tray card for Patient 22, showed that the patient's food was to be "Finely Chopped." Review of the tray prepared to be served to the patient showed a bowl that contained whole slices of canned peaches and pears. The fruit bowl was also observed by the DFNS, who acknowledged that the fruit was not "Finely Chopped."
C. On December 12, 2012, at 10:15 AM, review of the medical record for Patient 12, showed a dietary recommendation, implemented by the physician, for a bland, cardiac, 80 gram protein diet. The RD had estimated the patient's caloric needs at 2200 calories.
On December 12, 2012, at 1:15 PM, the Patient 12's diet was reviewed with the Diet Clerk, who was responsible for checking the patient's menu based on the cardex maintained in the diet office and the diet list, generated based on diet orders input by nursing staff. The Diet Clerk stated the current diet received by the diet office for Patient 12 was a bland, low sodium, 80 gram protein diet. There was no "cardiac" diet order. The Diet Clerk demonstrated what the patient would be served based on this diet order. A calculation of the caloric value of the food items that would be served to Patient 12, showed the patient would receive approximately 1400 calories compared to the assessed needs of 2200 calories. The Diet Clerk stated the menu food items did not include restrictions based on "cardiac" recommendations, such as egg beaters versus regular eggs, based on facility Diet Manual recommendations.
On December 13, 2012, at 9:55 AM, in an interview with the RD, she confirmed that the diet list did not accurately reflect the prescribed physician diet order for Patient 12. She stated that the Diet Clerk was instructed to follow the diet list, and was trained to adjust the menu for the restrictions, such as "bland", "low sodium" and protein modifications, but the menu was not reviewed after the modifications are made to ensure the patient's caloric requirements were met.
D. On December 13, 2012, at 11:00 AM, during a review of the diet order for Patient 14, the diet list indicated Patient 14 was prescribed a diabetic, low fat, high protein, 2400 calorie diet. Patient 14's menu for lunch and dinner for December 13, 2012, showed the patient would be served approximately 1140 calories. The RD stated that the patient would also receive a 223 calorie snack, for a total of 1363 calories. This would mean that the patient would have to receive approximately 1040 calories in the third meal in order to meet the physician prescribed order of 2400 calories. The RD confirmed that the patient's menu was reviewed to ensure that the low fat and high protein requirements were met, but no modifications were met to ensure the patient received the prescribed caloric requirements.

Based on interview and document review, the facility failed to ensure that the diet manual included guidance for the service of a "bland" diet that was routinely ordered at the hospital; and adequate guidance for the provision of diets to pregnant and lactating patients.

Findings:
1. On December 11, 2012, at 3:30 PM, review of the facility policy titled, "Diet Manual - Approved 6/11", showed the following, "The Diet Manual utilized is the Manual of Clinical Dietetics from the American Dietetics Association."
On December 12, 2012, at 11:30 AM, in an interview with the Registered Dietitian (RD), she stated that the Diet Manual utilized at the facility was one that was developed by her and approved by the Governing Body in July 2012. The RD stated that the Manual of Clinical Dietetics was only used for educational material for patients.
On December 13, 2012, at 8:30 AM, in an interview with the Director of Food and Nutrition Services (DFNS), he acknowledged that the facility policy regarding the Diet Manual needs to be updated to reflect the use of the in-house developed Diet Manual.
On December 11, 2012, at 11:15 AM, review of the "Tray List", showed that Patient 12 was prescribed a "Bland, Low Sodium, High Protein Diet." Review of the Diet Manual showed no definition or guidelines for the provision of a bland diet.
Further review of the Diet Manual showed guidelines for "Pregnancy" and "Breastfeeding" as 300 extra calories and 500 extra calories respectively. There was no direction as to where the extra calories should come from. Review of the "Academy of Nutrition and Dietetics" guidelines for breastfeeding women included: "Eat at least 2-1/2 cups of vegetables (including at least 1 cup of dark green or orange vegetables). Have at least 1-1/2 cups a day of fruit. Limit juice to 100% fruit juice and only 1 cup a day. Eat at least 6 ounces of grain foods like whole grain bread, cereal, or pasta. At least half your grains should come from whole grains."
On December 13, 2012, at 9:55 AM, in an interview with the RD, she acknowledged that the Diet Manual utilized at the facility did not indicate the level of detail with regards to the nutritional needs of pregnant and lactating women, as delineated in the Academy of of Nutrition and Dietetics guidelines.

Based on observation, interview, and record review, the Hospital failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. The Hospital failed to conduct an active surveillance program for the prevention, control, and investigation of infections and communicable diseases in the Sterile Processing Department and in the Patient Care Areas of the Hospital. The Condition of Participation for Infection Control was not met when the Hospital failed to:

1a. Ensure that all individually packaged sterile surgical instruments (peel pouches/packs) stored on inventory shelves, that the hinged instrument blades and tips (i.e. clamps, forceps, scissors, needle holders, etc.) were sterilized in an open position and not in a closed position as recommended by Nationally Recognized Infection Control Organizational (Industry) standards and according to the manufacturer's recommended instructions. This condition existed for 8 of 10 sampled sterile peel pouches inspected.

1b. Ensure that all stored individually packaged sterile instrument of multiple pieced units, were disassembled prior to sterilization as recommended by Nationally Recognized Infection Control Organizational (Industry) standards and according to the manufacturer's recommended instructions. (Refer to A-749)


2. Ensure that all surgical hinged instruments (i.e. clamps, forceps, scissors, needle holders, etc.) arranged in sterilized wrapped surgical trays, that the instrument blades and tips were opened and not closed as recommended by Nationally Recognized Infection Control Organizational (Industry) standards and according to the manufacturer's recommended instructions for those instruments found in 5 of 5 sterile surgical trays inspected. (Refer to A-749)


3. Ensure that the hospital's sterile processing procedures/practices were consistent with recommendations by Nationally Recognized Infection Control Organizations (Industry) standards and guidelines. The hospital failed to provide and maintain an a mechanical cleaning of the surgical instruments (ultrasonic cleaning, washer decontaminators/disinfectors or washer sterilizers) as part of the departments' decontamination and cleaning process of all critical equipment used for surgical or medical care of all patients treated at the hospital. (Refer to A-749)

4. Ensure that Hospital-Wide Infection Control precautions for the care of patients with Clostridium Difficile infection (antibiotic associated infections) were being followed and implemented throughout the Hospital. (Refer to A-749)

5. Ensure that the infection control officer provided effective infection control oversight into food services when the dietary staff. (Refer to A-749)

6. Ensure that (a) the respiratory care practitioner assigned to Patient 2 observed infection control precautions during the course of administering treatment, and (b) the registered nurse RN who administered medication to Patient 3 observe infection control precautions during the course of administering medications.

The cumulative effect of these deficient practices had the potential for transmission and cross contamination of infectious microorganisms on surgical and medical instruments sterilized in the Sterile Processing Department; affecting the health and safety of those patients receiving surgical and medical treatment in the hospital, in a universe of 51 patients.

Based on observation, interview and record review, the facility failed to provide and maintain a sanitary environment to avoid transmission of infections and communicable diseases in the Sterile Processing Department. The Hospital failed to ensure that all surgical instruments or articles requiring sterilization were sterilized thoroughly according to Nationally Recognized Infection Control and Prevention Recommendations and manufacturers' instructions. The facility failed to ensure the following:

1a. Ensure that all individually packaged sterile instruments (peel pouches/packs) stored on top of inventory shelves, that the instrument blades were sterilized in an open position and not in a closed position as recommended by Nationally Recognized Infection Control Organizational (Industry) standards and according to the manufacturer's recommended instructions. This condition existed for 8 of 10 sampled sterile peel pouches inspected.

1b. Ensure that all stored individually packaged sterile instruments of multiple pieced units, were disassembled prior to sterilization as recommended by Nationally Recognized Infection Control Organizational (Industry) standards and according to the manufacturer's recommended instructions.

2. Ensure that all surgical hinged instruments (i.e. clamps, forceps, scissors, needle holders, etc.) arranged in sterilized wrapped surgical trays, that the instrument blades were opened and not closed as recommended by Nationally Recognized Infection Control Organizational (Industry) standards and according to the manufacturer's recommended instructions for those instruments found in 5 of 5 sterile surgical trays inspected.

3. Ensure that the hospital's sterile processing procedures/practices were consistent with recommendations by Nationally Recognized Infection Control Organizations (Industry) standards and guidelines. The hospital failed to provide and maintain an ultrasonic decontamination cleaning machine as part of the departments' decontamination and cleaning process of all critical equipment used for surgical or medical care of all patients treated at the hospital.
These deficient practices resulted in an "Immediate Jeopardy" situation being declared (called) against the Hospital on December 12, 2012, at approximately 6:05 PM, and was abated on December 13, 2012, at 4:07 PM. The facility's plan of correction included revised policy and procedures for sterilization of the hinged surgical instruments in the open position, the use of an ultrasonic washer and staff education regarding the changes made to sterilization process.

4. Ensure that Hospital-Wide Infection Control precautions for the care of patients with Clostridium Difficile infection (antibiotic associated infections) were being followed and implemented for 2 patients (Patient 27 and Unsampled Patient F) who were on special contact infection control precautions. These failures had the potential to jeopardize the health of patients and contributed to an unsanitary hospital environment.

5. Ensure that the infection control officer provided effective infection control oversight into food services when the dietary staff:

5a. Failed to ensure that raw food items were not stored above ready to eat foods

5b. Failed to ensure that food service surface cleaning surfaces were cleaned with a sanitizer maintained at the correct concentration.

5c. Failed to ensure that the ice machine in the dietary department was cleaned using the manufacturer recommended sanitizer solution.

5d. Failed to ensure that the cooling process for potentially hazardous foods (PHF) reflected appropriate processes.

5e. Failed to ensure that disaster food items were not kept past manufacturer suggested "Best By" dates.

These processes have the potential of promoting food-borne illness if not appropriately implemented/monitored.

6. Ensure that (a) the respiratory care practitioner assigned to Patient 2 observed infection control precautions during the course of administering treatment, and (b) the registered nurse RN who administered medication to Patient 3 observe infection control precautions during the course of administering medications.

Findings:

According to the Healthcare Infection Control Practice Advisory Committee (HICPAC), under the heading, "GUIDELINES FOR DISINFECTION AND STERILIZATION IN HEALTHCARE FACILITIES", dated 2008, "...The aim of Central Processing of medical and surgical instruments are to protect patient from infections while minimizing risks to staff. Ensuring consistency of sterilization practices requires a comprehensive program that ensures operator competency and proper methods of cleaning and wrapping instruments and monitoring of the entire process ..."

During an interview with the Director of Surgical Services and the nurse in charge of the hospital's sterile processing department, on December 12, 2012, at approximately 3:00 PM, when asked what Nationally Recognized Infection Control Organizational standard of practice that was promulgated or was being implemented by the hospital's sterile processing department, they stated concurrently, "The AORN (Association of peri-operative Registered Nurses) standards."

1 (a) (b). During an observation on December 12, 2012, at approximately 10:30 AM, at the hospital's Sterile Processing Department and storage area, inspection of 8 of 10 individually packaged sterile instruments (packaged in transparent peel packs) and multi-pieced units, stored in plastic containers on multiple inventory shelves, the instrument blades/tips were found to be in a closed and locked position, as opposed to be in an open position and not disassembled, as recommended by Nationally Recognized Infection Control Organization guidelines and manufacturer's instructions in order for thorough sterilization to occur.

During an interview with the nurse in charge of the Sterile Processing Department and Central Service Technician A, on December 12, 2012, at approximately 11:45 AM, when asked what position should hinged surgical instrument blades be in for optimal sterilization to take place, they both stated, " It does not matter what position the instrument blades should be in, as long as it passes through the autoclave machine."

According to the Healthcare Infection Control Practice Advisory Committee (HICPAC), under the heading, "GUIDELINES FOR DISINFECTION AND STERILIZATION IN HEALTHCARE FACILITIES", dated 2008, "...Sterilization is defined as a process that destroys all microorganisms and spores on the surface of an article or instrument to prevent disease transmission associated with the use of that item. Proper sterilization includes all instruments to be in an open position, as opposed to being in a closed position, in order for direct steam to reach those surface areas. Multiple pieced instruments must first be disassembled prior to being sterilized."

According to the AORN (Association of Preoperative Registered Nurses), under the title, "Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment", dated 2011, it recommended the following:

a. Section 1(a) (1): "The manufacturer's written instructions should identify requirements related to cleaning equipment and processing methods."
b. Section V (d): "When instruments are composed of more than one piece, they should be opened, disassembled, and arranged in an orderly fashion. Disassembling and opening of instruments minimizes the risk of instrument displacement and improves the efficiency of reprocessing."
c. Section V (d) (2): "Instrument box locks should be fully open and the instruments secured to prevent closing by using stringers (apparatus to prevent instruments from closing)."

According to the Hospital's Sterile Processing Department's resource manual (Miltex Surgical Instruments-Manufacturer's guide), used to identify various surgical instruments in surgery, titled, "CLEANING, STERILIZATION AND MAINTENANCE OF SURGICAL INSTRUMENTS", copy right date 1996, it stipulated, "...Unlock all instruments and sterilize then in an open position. NEVER LOCK AN INSTRUMENT DURING AUTOCLAVING. It will not be sterile as steam cannot reach the metal to metal surfaces. The instrument will develop cracks in hinge areas because of heat expansion during the sterilization cycle ..."

In addition, under section (c), titled, "MANUAL CLEANING", it stipulated, " ... Most instrument manufacturers recommend ultrasonic cleaning as the best and most effective way to clean surgical instruments, particularly those with hinges, locks and other moving parts ... " (Ultrasonic cleaning machine is a machine that uses ultrasonic energy to pull off debris from the surface of an instrument to help clean an instrument prior to sterilization (autoclaving).
2. On December 12, 2012, at approximately 1:45 PM, the following sterilized surgical trays/packs were unwrapped, opened and inspected of its contents:

a. Basic Laparotomy Cholecystectomy Tray.
b. Chest Tube Insertion Tray.
c. Rigid Bronchoscope Tray.
d. Tracheostomy Tray.
e. Obstetrical Tray.

All surgical trays/packs inspected contained hinged instruments (greater than 50 %) with their instrument (i.e. clamps, forceps, scissors, needle holders, etc.) blades/tips found to be a closed and in a locked position and not in the open position as recommended by Nationally Recognized Infection Control Organizational (Industry) standards and according to the manufacturer's recommended instructions in order for thorough sterilization to take place.

According to the Healthcare Infection Control Practice Advisory Committee (HICPAC), under the heading, " GUIDELINES FOR DISINFECTION AND STERILIZATION IN HEALTHCARE FACILITIES " , dated 2008, " ...Sterilization is defined as a process that destroys all microorganisms and spores on the surface of an article or instrument to prevent disease transmission associated with the use of that item. Proper sterilization includes all instruments to be in an open position, as opposed to being in a closed position, in order for direct steam to reach those surface areas. Multiple pieced instruments must first be disassembled prior to being sterilized."

According to the AORN (Association of Preoperative Registered Nurses), under the title, " Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment", dated 2011, it recommended the following:

a. Section 1(a) (1): "The manufacturer's written instructions should identify requirements related to cleaning equipment and processing methods."
b. Section V (d): " When instruments are composed of more than one piece, they should be opened, disassembled, and arranged in an orderly fashion. Disassembling and opening of instruments minimizes the risk of instrument displacement and improves the efficiency of reprocessing."
c. Section V (d) (2): " Instrument box locks should be fully open and the instruments secured to prevent closing by using stringers (apparatus to prevent instruments from closing while keeping instruments in an open position during sterilization or autoclaving)."

According to the Hospital's Sterile Processing Department's resource manual/catalog (Miltex Surgical Instruments-Manufacturer's guide), used to identify various surgical instruments in surgery, titled, "CLEANING, STERILIZATION AND MAINTENANCE OF SURGICAL INSTRUMENTS", copy right date 1996, it stipulated, " ...Unlock all instruments and sterilize then in an open position. NEVER LOCK AN INSTRUMENT DURING AUTOCLAVING. It will not be sterile as steam cannot reach the metal to metal surfaces. The instrument will develop cracks in hinge areas because of heat expansion during the sterilization cycle ... "

3. During an observation on December 12, 2012, at approximately 2:30 PM, of the sterile processing department's practice and procedure during normal sterilization of instruments by Sterile Supply Technician B, it was observed after manual decontamination of instruments of bioburden material (old blood, plasma and tissue left on the instrument) through soaking with a disinfectant solution and spraying with pressurized water; all instruments after soaking and spraying were flash sterilized (sterilization of unwrapped instruments in an autoclave) for approximately 4 to 5 minutes. All instruments then were wrapped in peel packs or in multi-instrument trays and placed into the steam autoclave machine set for 50 to 60 minutes to complete the sterilization process.

According to the AORN (Association of Preoperative Registered Nurses), titled, "Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment", dated 2011, it recommended the following:

a. Section X (c): "Mechanical cleaning of surgical instruments should be accomplished by ultrasonic cleaners, washer decontaminators/disinfectors, or washer sterilizers. Mechanical cleaning is preferred because it removes soil efficiently and provides consistent washing and rinsing parameter during the process." (Ultrasonic cleaning machines are machines that uses ultrasonic energy that peels off debris off instruments, on hard-to-reach areas and crevices of an instrument. This process facilitates cleaning the instrument in preparation for autoclaving or sterilizing the instrument).
b. Section X (c) (1): "Ultrasonic cleaners should be used according to the manufacturer's operating recommendations and instructions. Ultrasonic cleaners use a process called 'cavitation' that facilitates removal of small particles and debris from instrument joints, crevices, and hard to reach places. The ultrasonic energy is passed through a water bath, creating bubbles that implode. This process of implosion creates a suction action that pulls debris away from instrument surfaces."

There was no evidence that a mechanical ultrasound cleaning machine was utilized to ensure decontamination of bioburden debris off instruments prior to being steamed sterilized as a preferred recommendation by AORN guidelines during the decontamination and cleaning observation on December 12, 2012.

There was no evidence that a mechanical Ultrasound Cleaning Machine was available for use in the Sterile Processing Department, at the time of the inspection, on December 12, 2012, at approximately 2:45 PM.

During an interview with the nurse in charge of the Sterile Processing Department, when asked if the department utilized an ultrasonic cleaning machine to remove bioburden debris on instruments, he stated, "No, we never had a machine like that in the department. In its place, we routinely flash sterilize the instruments for 4 to 5 minutes for an added precaution, at 270 degrees Fahrenheit, before transferring the instruments into the autoclave machine for an additional 50 to 60 minutes to complete the process."

According to the AORN (Association of Preoperative Registered Nurses), titled, "Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment", dated 2011, it recommended the following:

a. Section Vl (e): "Removal of organic material from instruments becomes more difficult after the debris has dried. Blood and body fluids that have dried on the instruments (i.e. after flash sterilization) are hard to remove, can cause continuing surface corrosion damage, pitting over time, and can inhibit sterilization."

According to the Healthcare Infection Control Practice Advisory Committee (HICPAC), under the heading: " GUIDELINES FOR DISINFECTION AND STERILIZATION IN HEALTHCARE FACILITIES " , dated 2008, it stipulated, " ...Flash sterilization should not be used for reasons of convenience, as an alternative to purchasing instrumentation sets, or to save time. It is not recommended as a routine sterilization method because of the lack of time and pressure and the possibility of contamination of processed items during transfer ... "

The was no documented evidence in the facility's Sterile Processing Department's policy and procedure manual, adopting and promulgating the AORN's preferred recommendation to "utilize a mechanical ultrasound cleaning machine" prior to autoclaving instruments to ensure that complete and thorough decontamination has taken place prior to sterilization.

There was no documented evidence in the AORN recommended guidelines directing healthcare facilities to utilize a "flash sterilization" method for 4 to 5 minutes in lieu of utilizing a mechanical ultrasound cleaning machine prior to steam autoclaving of instruments.

According to the AORN (Association of Preoperative Registered Nurses), titled, "Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment", dated 2011, it recommended the following:

a. Section Vll (b): "Automated cleaning and decontamination of equipment is recommended because it provides a high level of cleaning that is difficult to consistently replicate using manual methods. Compressed air is needed to clear lumens after cleaning."

The hospital failed to adhere to nationally recognized infection prevention and control precautions, such as accepted "AORN Guidelines and Recommendations", for infections/communicable diseases and methods to reduce transmission in the sterile processing department of the hospital.

During an interview with the Hospital's Director of Quality Assurance and Performance Improvement Department, on December 18, 2912, at approximately 4:00 PM, when asked if quality indicators or performance improvement indicators were being monitored, tracked and trended with collectable data and then analyzed for possible development of improvement activities in the sterile processing department of the hospital, he stated, "No, we have not, because our Surgical Site Infection Rate (SSI) for the last few quarters was zero percent (0%)".

When asked further what quality review methodology was used to calculate Surgical Site Infection Rates (SSI) in post-surgical patients, he stated, "We mail out a standard questioner survey letter to our physicians after the patient is discharged, and when it's mailed back, we tabulate the results". When asked what was the physicians questioner's mail-back response rate, he stated, "I don't know exactly, I'll have to check on that."

When asked, out of 100 or more surgical cases performed by the Hospital throughout the last two quarters, would a response rate of 25% (1 in 4) be an appropriate response rate for data collection of surgical site infection rates of surgical patients; there was no response from the Director of Quality Assurance and Performance Improvement.

There was no documented evidence that the Quality Assurance and Performance Improvement Department had accurately tracked and trended quality indicators for Surgical Site Infection rates of post-surgical patients for the last two quarters. (Capturing data for all (100%) patients that underwent a surgical procedures at the facility, and not relying only on mail-out and mail-back questioner letters to tabulate SSI rates).

According to the AORN (Association of Preoperative Registered Nurses), titled, "Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment", dated 2011, it recommended the following:

a. Section XXll: "The hospital's Quality Management program should evaluate the care of instruments to improve patient safety. A Quality management program should be in place to test mechanical cleaning equipment. When investigating surgical infections, documentation of the cleaning process of instruments should be reviewed."

During an interview with the Hospital's Interim Director on Infection Control and Prevention of Diseases, on December 18, 2012, at approximately 3:15 PM, when asked if active surveillance of the sterile processing department was being conducted regarding the practice and procedures of decontamination, cleaning, processing, packaging and sterilization of all surgical and medical instruments and equipment in the hospital, she stated, "No".

The Hospital failed to conduct active surveillance on a hospital-wide basis, especially, in the sterile processing department, in order to identify infectious risks or communicable disease problems.

The Hospital failed to document its surveillance activities in the sterile processing department, including the measures selected for monitoring, and collection and analysis methods. There was no documented evidence provided that active infection control surveillance was being conducted in accordance with recognized infection control surveillance practices, such as, for example, those utilized by the CDC's National Healthcare Safety Network (NHSN).

By not conducting active surveillance in the Sterile Processing Department, the Hospital missed an opportunity to develop and implement appropriate infection control interventions to address issues identified through its detection activities (missed opportunity) and then monitor the effectiveness of interventions through further data collection and analysis.

During an interview with Sterile Processing Technician A (Senior Processing Technician), on December 12, 2012, at approximately 2:00 PM, when asked if he received any formal in-service training by the Hospital in areas of sterile processing or infection control measures, he stated, "Not really, I was trained by the Operating Room Charge Nurse on how to do things."

During an interview with Sterile Processing Technician B (Technician demonstrating procedure for cleaning and sterilizing of surgical instruments), on December 12, 2012, at approximately 2:15 PM, when asked if she received any formal training by the Hospital in the areas of cleaning and sterile processing and infection control measures, she stated, "No, I was taught everything I know by Sterile Processing Technician A on a one-to-one basis. We really don't have a department process on how to sterilize instruments from beginning to end. I also use the departments' catalog manual (Miltex Surgical Instrument Book) to reference various surgical instruments for proper arrangement in surgical trays prior to sterilization."

On December 12, 2012, a review was conducted of Sterile Processing Technician A's (Senior Technician) annual reorientation training records, dated July 26, 2012, documentation revealed no evidence of a "Skill Evaluation" assessment in the section titled: "INFECTION CONTROL" . The infection control section of the evaluation sheet was found incomplete, blank and not filled out by the evaluating supervisor (Director of Surgical Services).

On December 12, 2012, a review was conducted of Sterile Processing Technician B's reorientation training records dated July 26, 2012, it revealed under the heading: "Skill Evaluation: Decontamination Process; ULTRASONIC CLEANING", the section was marked "YES" (meaning the employee received training in how to demonstrate proficiency in operating an Ultrasound Cleaning Machine and had pass the skills test). However, there was no evidence that the hospital had an ultrasound cleaning machine available for the department as of December 12, 2012.

The Hospital failed to ensure proper education to staff was being conducted appropriately regarding infections, and methods to reduce transmission in the sterile processing department during procedures of sterilizing instruments.

According to the AORN (Association of Preoperative Registered Nurses), titled, "Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment", dated 2011, recommended the following:

a. Section XlX (b): "Personnel should receive education on new instruments and equipment, new cleaning agents and methods, and new procedures."

b. Section XlX (c): "Administrative personnel should validate the competencies of personnel participating in decontamination of surgical instruments. The validation of competencies should include all types of instruments that the individual is authorized to reprocess. Validation of competencies provides an indication that personnel are able to appropriately perform decontamination procedures."

There was no documented evidence that the Hospital developed a multidisciplinary process or approach in place to review the hospital's sterile processing department.

There was no documented evidence there was a system in place to identify potential infection control issues related to the sterile processing procedure.

During an interview with the Interim Infection Control Preventionist, on December 12, 2012, at approximately 3:30 PM, she confirmed that her department had not conducted active surveillance and had not monitored, tracked, trended or provided oversight of the Sterile Processing Department in the areas of quality control or infection control as it pertains to sterilization of instruments.



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4. During an observation on December 10, 2012 at 11:05 AM, accompanied by multiple staff members present on the Intensive Care Unit (ICU), a bleach based disinfectant cleaner was not available to the ICU staff.

During an interview on December 10, 2012 at 11:05 AM with RN 15, she stated that the disinfectant cleaner available to the ICU staff was "CaviWipes ", a pre-moistened alcohol based disinfectant towelette. RN 15 stated that the CaviWipes were used to clean the surface area of items when a patient is placed in a room with contact isolation precautions (infection control precaution measures designed to prevent the spread of infection from one person to another). Per RN 15, the CaviWipes do not contain bleach and she was not certain if the disinfectant product should be used when a patient has C-Diff (Clostridium difficile; a bacteria that causes severe diarrhea and other intestinal disease)

A record review, on December 10, 2012 at 11:15 AM, of Patient 27's medical record noted that on December 10, 2012 at 9:40 AM a stool culture was collected and sent to the laboratory to determine if the patient had a C-Diff infection.

During an observation on December 10, 2012 at 11:20 AM, Patient 27 was in a private hospital room with contact isolation precautions (an isolation precaution system to prevent the spread of infections to patients, visitors and healthcare staff, where a bacteria or virus can be acquired by either directly touching the infected site or body fluid or by touching equipment that may be contaminated with infectious material) with a sign posted at the doorway to the room. No bleach based disinfectant was available to the staff and visitors entering or exiting the patient's room. RN 14 confirmed that the only disinfectant available on the ICU was CaviWipes.

During an interview on December 10, 2012 at 11:25 AM with RN 14, she stated that it is the hospital's practice to consider a patient to be positive (infected) with C-Diff when a stool culture (a test to find organisms in the feces) test is collected and sent to the laboratory, the test takes about three days for the results. Per RN 14, while waiting for the test results, the patient is placed in contact isolation precautions and a bleach based cleaning products are used to clean items in the patient's room. RN 14 confirmed that there was not a bleach based cleaning products available to the staff and visitors on the ICU unit. RN 14 made a phone call to the environmental services (EVS) department (Housekeeping) and requested a bleach based cleaning product for the ICU unit.

During a subsequent observation on December 11, 2012 at 3:00 PM, the ICU did not have a bleach based disinfectant cleaner available to the staff and visitors.

During a subsequent interview with RN 14 on December 11, 2012 at about 3:00 PM, she confirmed that the ICU did not have a bleach based disinfectant cleaner available to the staff and visitors. She further confirmed that Patient 27 remained in a private hospital room with contact isolation precautions and no bleach based disinfectant cleaner was available for use in the patient's room.

During an observation on December 11, 2012 at 3:00 PM, with RN 16 present, Unsampled Patient F was in a private hospital room, on the on the Medical/Surgical Unit, with a contact isolation precautions sign posted at the doorway to the room. No bleach based disinfectant were available to the staff and visitors entering or exiting the patient's room.

During an interview on December 11, 2012 at 3:10 PM with RN 16, he confirmed that he was unable to locate a bleach based disinfectant product available on the Medical/Surgical Unit. RN 16 stated that Unsampled Patient F was under contact isolation precautions due to a positive C-Diff test results.

A record review of Unsampled Patient F medical record noted that the 12/6/12 test results indicated that the patient was positive for C-Diff.

An interview was conducted on December 11, 2012 at 3:25 PM, with EVS Worker 1, who worked full-time during the day shift for the 2nd Floor of the hospital (where the ICU and the Medical/Surgical units are located), with the Infection Control Preventionist and the EVS Manager present. The EVS Worker 1 stated that when a patient is suspected of a C-Diff infection, the EVS staff will be notified by the nursing staff. The EVS staff will then arrange for the bleach based disinfectant solution to be available for the staff and for visitors. EVS Worker 1 stated that none of nursing staff from the ICU unit or from the Medical/Surgical unit informed her that Patient 27 and Unsampled Patient F needed a bleach based disinfectant solution product while these patients were in a contact isolation precautions room for C-Diff.

Record review on December 13, 2012, of the hospital ' s Policy and Procedure titled "Clostridium Difficile - Associated Disease (CDAD): Special Infection Control Precautions", dated August 2009, noted "...1) Patients with confirmed CDAD will be placed in Contact Precautions until diarrhea ceases. 2) Dedicated equipment, reusable or disposable, will be used on all patients in Contact Precautions (i.e. temperature, blood pressure, scale). 3) If equipment is unable to be dedicated, it must be cleaned with a hospital approved disinfectant ... " . The Policy further noted that "it is the responsibility of the nursing staff to make all other employees who come in contact with patient aware of the presence of CDAD or colonization with, and of, the precautions used " .

Record review on December 13, 2012, of the hospital's EVS Material Safety Data Sheet (MSDS) index, not dated, noted a list of cleaning products used in the hospital. Three bleach based cleaning products were noted to be listed.



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5a) On December 11, 2012, starting at 8:30 AM, during an inspection of the food service operation, the following was noted:

In the walk-in refrigerator, a pan containing two five-pound pieces of uncooked meatloaf was noted to be stored on a sheet pan on the top of a storage rack. Stored directly underneath the meatloaf were containers of ready to eat pickles and lettuce. Also noted in the facility's outside refrigerator, three fifteen-pound cases of raw bacon were stored adjacent to cases of cooked sausage and directly above two cases of cooked turkey ham. In a concurrent interview with the Director of Food and Nutrition Services (DFNS), present at the time of the observations, he confirmed that the raw meat products should not have been stored directly above ready to eat food products.

On December 11, 2012, at 3:30 PM, review of the facility policy titled, "Purchasing, Receiving and Storage - approved 6/11", indicated: "When storing raw foods the following top-to-bottom order will be used:

a. Cooked and ready-to-eat foods (top shelf)
b. Raw fish
c. Raw ground beef
d. Raw pork, ham, bacon and sausage
e. Raw ground beef and pork
f. Raw chicken (bottom shelf)"

5b) On December 11, 2012, at 9:00 AM, during an inspection of the main kitchen, a red pail containing a cleaning cloth immersed in a liquid was noted in the cold food preparation area. In an interview with Food service Worker 1 (FSW 1), she stated that the liquid in the pail was a sanitizer solution (Quaternary Ammonia) obtained from a dispenser in the dishroom, and the cleaning cloth was used to wipe down the food preparation area when food production was complete. FSW 1 was unsure what the sanitizer concentration should be, and stated that she had never utilized a chemical test strip to check the sanitizer concentration. Upon testing the chemical sanitizer, the test strip registered 50 parts per million.

Review of the facility policy titled, "General Cleaning/Sanitizing of Dietary Equipment /Surfaces - Reviews 6/11", showed, "All area surfaces will be

Based on observation, interview and record review, the Hospital's Surgical Services failed to ensure that surgical care and services acheived the highest standards of medical practice and patient care by failing to ensure the following:

1a. Ensure that all individually packaged sterile instruments (peel pouches/packs) stored on inventory shelves, that the instrument blades were sterilized in an open position to enhance sterilization and not in a closed position per the facility's policy and procedure and the manufacturere's recommended instructions. This was observed for 8 of 10 sampled sterile peel pouches that were inspected.

1b. Ensure that all stored individually packaged sterile instruments of multiple pieced units, were disassembled to enhance sterilization prior to autoclaving (sterilization) per the facility's policy and procedure and the manufacturere's recommended instructions.

2. Ensure that all surgical hinged instruments (i.e. clamps, forceps, scissors, needle holders, etc.) arranged in sterilized wrapped surgical trays, that the instrument blades were opened to enhance sterilization and not closed per the facility's policy and procedure and the manufacturere's recommended instructions for those instruments found in 5 of 5 sterile surgical trays inspected.

3. Ensure that the hospital's sterile processing procedures/practices were consistent with the facility's policy and procedure and the manufacturere's recommended instructions. The hospital failed to provide and maintain an ultrasonic decontamination cleaning machine as part of the departments' decontamination and cleaning process of all critical equipment used for surgical or medical care of all patients treated at the hospital.

4. Ensure that the Neonatal Emergency Crash Cart was equiped with a Pediatric/Neonatal cardiac monitor and defebrillator in Operating Room 1 prior to scheduling a surgical Cesarian Section (C-Section) procedure.

The cumulative effect of these deficient practices had the potential to affect the health and safety of patients requiring surgical interventions in the hospital.

Findings:

During record review, the review of the facility's policy and procedure entitled, "PROCESSING CONTAMINATED INSTRUMENTS & EQUIPMENT FOR STERILIZATION", with an effective date of November 2011, showed that under the "Procedure" section:

A. The care and handling of surgical instruments and powered equipment should follow the recommendations of the manufacturers.

11. Hinged instruments should be opened and instruments with more than one part should be disassembled as they are placed in the instrument pan or tray.

13. All instruments opened for a procedure, whether soiled or not, may be cleaned using an ultrasonic cleaner, washer/decontaminator, and washer/sterilizer following the manufacturer's instructions for operation.

During record review, the review of the facility Sterile Processing Department's resource manual, Miltex Surgical Instruments (Manufacturer's Guide), that was used to identify various surgical instruments in surgery, titled, "CLEANING, STERILIZATION AND MAINTENANCE OF SURGICAL INSTRUMENTS", copyright 1996, it stipulated, "...Unlock all instruments and sterilize them in an open position. NEVER LOCK AN INSTRUMENT DURING AUTOCLAVING. It will not be sterile as steam cannot reach the metal to metal surfaces. The instrument will develop cracks in hinge areas because of heat expansion during the sterilization cycle..."

In addition, under section (c), titled, "MANUAL CLEANING", it stipulated, "...recommend ultrasonic cleaning as the best and most effective way to clean surgical instruments, particularly those with hinges, locks and other moving parts..."
1(a) (b). During an observation on December 12, 2012, at approximately 10:30 AM, at the hospital's Sterile Processing Department and storage area, an inspection of 8 of 10 individually packaged sterile instruments (packaged in transparent peel packs) and multi-pieced units, stored in plastic containers on multiple inventory shelves, showed that the instrument blades/tips were found to be in a closed and locked position, as opposed to be in an open position and they were not disassembled.

During an interview with the nurse in charge of the Sterile Processing Department and Central Service Technician A, on December 12, 2012, at approximately 11:45 AM, when asked what position should hinged surgical instrument blades be in for optimal sterilization to take place, they both stated, "It does not matter what position the instrument blades should be in, as long as it passes through the autoclave machine".

2. On December 12, 2012, at approximately 1:45 PM, the following five (5) sterilized surgical trays/packs were unwrapped, opened and inspected of its contents:

a. Basic Laparotomy Cholecystectomy Tray.
b. Chest Tube Insertion Tray.
c. Rigid Bronchoscope Tray.
d. Tracheostomy Tray.
e. Obstetrical Tray.

All surgical trays inspected contained hinged instruments (i.e. clamps, forceps, scissors, needle holders, etc.) with their blades found to be in a closed and locked position and not in the open position per the facility's policy and procedure and according to the manufacturer's recommended instructions in order for thorough sterilization to take place.

3. During an observation on December 12, 2012, at approximately 2:30 PM, of the sterile processing department's practice and procedure for sterilizing instruments, it was observed after manual decontamination of instruments of bioburden (old blood, plasma and tissue) material, through disinfection soaking and spraying, all instruments after soaking were flash sterilized for approximately 4 to 5 minutes in the prevacumed sterilizer. All instruments then were transferred and placed into the steam autoclave machine set for 50 to 60 minutes to complete the sterilization process.

There was no evidence that a mechanical ultrasound cleaning machine was utilized per the facility's policy and procedure and the manufacturer's recommended instructions during the decontamination and cleaning observation on December 12, 2012.

There was no evidence that a mechanical Ultrasound Cleaning Machine was available for use in the Sterile Processing Department, at the time of the inspection, on December 12, 2012, at approximately 2:45 PM.

During an interview with the nurse in charge of the Sterile Processing Department, when asked if the department utilized an ultrasonic cleaning machine to remove bioburden debris on instruments, he stated, "No, we never had a machine like that in the department. In its place, we routinely flash sterilize the instruments for 4 to 5 minutes, at 270 degrees Fahrenheit, before transferring the instruments into the sterile autoclave for an additional 50 to 60 minutes to complete the process."

The hospital failed to adhere to it's policy and procedure, to reduce the risk of transmission of infections/communicable diseases in the sterile processing department of the hospital.

During an interview with the Hospital's Director of Quality Assurance and Performance Improvement Department, on December 18, 2012, at approximately 4:00 PM, when asked if quality indicators or performance improvement indicators were being monitored, tracked and trended with collectable data and then analyzed for possible development of improvement activities in the Sterile Processing Department of the hospital, he stated, "No, we have not because our Surgical Site Infection Rate (SSI) for the last few quarters was zero (0)".

During an interview with the Hospital's Interim Director on Infection Control and Prevention of Diseases, on December 18, 2012, at approximately 3:15 PM, when asked if active surveillance of the sterile processing department was being conducted regarding the practice and procedures of decontamination, cleaning, processing, packaging and sterilization of all surgical and medical instruments and equipment in the hospital, she stated, "No".

The Hospital failed to conduct active surveillance on a hospital-wide basis, especially, in the sterile processing department, in order to identify infectious risks or communicable disease problems.

The Hospital failed to document its surveillance activities in the sterile processing department, including the measures selected for monitoring, and collection and analysis methods. There was no documented evidence provided that active infection control surveillance was being conducted in accordance with recognized infection control surveillance practices, such as, for example, those utilized by the Centers for Disease Control and Prevention's (CDC) National Healthcare Safety Network (NHSN).

By not conducting active surveillance in the Sterile Processing Department, the Hospital missed an opportunity to develop and implement appropriate infection control interventions to address issues identified through its detection activities (missed opportunity) and then monitor the effectiveness of interventions through further data collection and analysis.

During an interview with Sterile Processing Technician A (Senior Processing Technician), on December 12, 2012, at approximately 2:00 PM, when asked if he received any formal in-service training by the Hospital in areas of sterile processing or infection control measures, he stated, "Not really, I was trained by the Operating Room Charge Nurse on how to do things".

During an interview with Sterile Processing Technician B (Technician demonstrating procedure for cleaning and sterilizing of surgical instruments), on December 12, 2012, at approximately 2:15 PM, when asked if she received any formal training by the Hospital in the areas of cleaning and sterile processing and infection control measures, she stated, "No, I was taught everything I know by Sterile Processing Technician A on a one-to-one basis. We really don't have a department process on how to sterilize instruments from beginning to end. I also use the departments' catalog manual (Miltex Surgical Instrument Book) to reference various surgical instruments for proper arrangement in surgical trays prior to sterilization".

On December 12, 2012, a review was conducted of Sterile Processing Technician A's (Senior Technician) annual reorientation training records, dated July 26, 2012, documentation revealed no evidence of a "Skill Evaluation" assessment in the section titled: "INFECTION CONTROL". The infection control section of the evaluation sheet was found incomplete, blank and not filled out by the evaluating supervisor (Director of Surgical Services).

On December 12, 2012, a review was conducted of Sterile Processing Technician B's reorientation training records dated July 26, 2012, it revealed under the heading: "Skill Evaluation: Decontamination Process; ULTRASONIC CLEANING", the section was marked "YES" (meaning the employee received training in how to demonstrate proficiency in operating an Ultrasound Cleaning Machine and had pass the skills test). However, there was no evidence that the hospital had purchased an ultrasound cleaning machine for the department as of December 12, 2012.

The Hospital failed to ensure proper education to staff was being conducted regarding infections, and methods to reduce transmission in the sterile processing department during procedures of sterilizing instruments.

According to the AORN (Association of Preoperative Registered Nurses), titled, "Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment", dated 2011, recommended the following:

a. Section XlX (b): "Personnel should receive education on new instruments and equipment, new cleaning agents and methods, and new procedures".

b. Section XlX (c): "Administrative personnel should validate the competencies of personnel participating in decontamination of surgical instruments. The validation of competencies should include all types of instruments that the individual is authorized to reprocess. Validation of competencies provides an indication that personnel are able to appropriately perform decontamination procedures".

There was no documented evidence that the Hospital developed a multidisciplinary process or approach in place to review the hospital's sterile processing department.

There was no documented evidence that there was a system in place to identify potential infection control issues related to the sterile processing procedure.

During an interview with the Interim Infection Control Preventionist, on December 12, 2012, at approximately 3:30 PM, she confirmed that her department did not conduct active surveillance and was not monitoring, tracking, trending or providing oversight of the Sterile Processing Department in the areas of quality control or infection control as it pertains to sterilization of instruments.

4. During an inspection tour of the Hospital's Surgery Department on December 12, 2012, at approximately 10:45 AM, it was observed in OR 1, that the Neonatal Emergency Crash Cart did not have the following equipment:

a. Neonatal cardiac monitor with appropriate electrocardiac pads and leads.
b. Neonatal Defibrillator with appropriate neonatal defibrillator paddles
c. Neonatal Cardiopulmonry (CPR) flow sheet for documentation of an emergecy event in the Operating Room.

During an interview with the Intrim Director of the Neonatal Intensive Care Unit, on Decemeber 12, 2012, at approximately 11:00 AM, she confirmed the finding and stated, "I did not know we had an Neonatal Emergency Crash Cart in this room (Operating Room 1), I guess we don't have a cardiac monitor and defibrillator on this cart."

Based on observation, interview and record review, the Hospital failed to ensure that anesthesia services and resources were consistent with recognized standards for anesthesia care and that the provided services met the needs of a universe of 51 patients. The facility failed to ensure that the Surgery Department's Malignant Hyperthermia (a condition where a patient receiving general anesthesia experiences a marked increase in body temperature and uncontrolled muscle contractions) Emergency Cart contained all the drugs and items recommended by the Malignant Hyperthermia Association of the United States (MHAUS) to be readily accessible in an emergency situation. This deficient finding had the potential to affect the health and safety of patients experiencing a Malignant Hyperthermia crisis.

Findings:

According to the MHAUS, dated January 2001, "Malignant Hyperthermia is a chain reaction (a syndrome) event triggered in susceptible individuals by commonly used general anesthetics. Syndrome must be identified and treated early in its course in order for there to be a successful outcome. Therefore, preparedness is essential to prevent death from Malignant Hyperthermia crisis. Treatment is predicated upon preparation for a rare event."

During a tour of the Hospital's Surgery Department, on December 12, 2012, it was observed that the department's Malignant Hyperthermia Emergency cart did not contain the following items.

a. A total of 2160 ml. (milliliters) of sterile water. There was 800 ml were readily available.

b. Two (2) 1000 ml. bags of normal saline.

c. One (1) vial of Regular Insulin (100 units/ml).

d. Two (2) boxes of Procainamide (500 mg/ml, 10-ml vials).

According to the MHAUS, dated January 2001, the following recommended checklist of drugs and equipment should be readily available:

a. Dantrolene sodium intravenous medication. 36 vials (each diluted with 60 ml of sterile water).

b. Sterile water for injection without bacteriostatic agent to reconstitute Dantrolene. 1000 ml times 2 bags.

c. Sodium bicarbonate (8.4%). 50 ml times 5 doses.

d. Mannitol (20%). 500 ml times 2 doses.

e. Furosemide (Lasix) 40 milligrams/amp times 4 ampules.

f. D50 (50 % Dextrose). 50 ml vials time 2 doses.

g. Calcium chloride (10%) times 2 doses.

h. Regular Insulin 100 units/ml time 1 dose refrigerated.

i. Lidocaine Hydrochloride (2%) 1 dose.

j. Procainamide 500 mg/ml. 10 ml vial times 2 doses.

k. Hypothermia blanket, ice machine to manufacture ice, and at least 3000 ml of cold saline solution.

l. Anesthesia machine, EKG monitor, pulse oximeter and capnometer (device that measures exhaled carbon dioxide levels of a patient).

m. A machine to measure End-Tidal carbon dioxide and core body temperature measurement by electronic probe.

During an interview with the Director of Surgical Services, on December 12, 2012, at approximately 10:30 AM, she confirmed the finding.

Based on staff interview and document review, the hospital failed to have an ongoing quality appraisal and performance improvement program that included tracking and trending of findings, and integrated interdisciplinary efforts to address deficient practice and effectively implement change to improve patient quality of care.

Findings:

On December 13, 2012, at 9:55 AM, a review of the Performance Improvement quality assurance data was conducted with the Director of Food and Nutrition Services (DFNS) and the Registered Dietitian (RD).

One of the established performance indicators for clinical nutrition services was, "A copy of computer generated request in the actual chart." The RD explained the indicator reflected nutritional consults that were actually generated by nursing services and forwarded to the RD for follow-up. The desired threshold for compliance was 95%. Review of the documented compliance percentage from May 2012 to November 2012, showed a range from 68% to 85%.

The RD comments in June and July 2012, indicated she provided education to nursing staff through "bed huddles" and 1:1. In October 2012, the RD documented, "Still working with nursing", and in November 2012, the RD documented, "Appeared due to registry staff. Discussed with charge nurses."

The second performance indicator reviewed was, "Patient consumption of breakfast, lunch, dinner, supplements/snacks will be entered in patient charts daily by nursing staff." The RD explained that she relied on this information when assessing/reassessing patients and implementing nutritional recommendations. The desired threshold for compliance was 95%. Review of the documented compliance percentage from May 2012 to November 2012, showed a range from 62% to 90% with two months at 100%.

The RD comments in June, July, September and October 2012, indicated she provided education to nursing staff through "bed huddles" and 1:1. In October 2012, the RD documented, "Mostly dinner misses. Day nursing needs to pass to night nursing."

In a discussion with the RD regarding the performance improvement data, it was noted that there was no detailed analysis documented on the forms submitted to the quality assurance committee delineating the nursing units, days of the week or nursing shifts most often implicated with deficient practice, in order to better determine intervention processes to improve performance. The RD stated she was not sure it was her role to track and trend data that represented nursing deficient practice. She stated that she had discussed her concerns with previous Chief Nursing Officers (CNO), but not the current CNO as she had shortly assumed her position. She stated that intervention by prior CNOs consisted of the CNO being present while the RD provided inservices to nursing staff, which "seemed to help."

In a discussion with the DFNS, he confirmed that the RD did not attend the quality assurance (QA) committee meetings and it was his responsibility to present the performance improvement data to the committee. He stated that committee members would ask, "Why are the numbers low?", but no formal action plans were generated or recommended by QA committee members. He stated suggestions such as possibly including some training related to identified deficient nursing practice in the nursing orientation process were made, but have not been implemented.

On December 13, 2012, at 11:43 AM, in an interview with the Director of Quality and Risk Management, he confirmed that the quarterly QA committee minutes did not include suggestions for improvement or departmental action plans. He stated that in addition to the QA committee, department heads also attend a quality subcommittee, where more detailed discussion of departmental performance is included and suggestions for improvement are provided. Minutes provided were for the "Environment of Care" (EOC) committee meetings. Review of the minutes for November 14, 2012, showed the following action plan for nutritional services, "___(department head) to continue to monitor and report data to the EOC Committee to ensure quality patient care. There was no evidence of integrated interdisciplinary efforts, to address deficient practice as identified by performance improvement data, to ensure improved patient quality of care.



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2. On December 18, 2012, at 3:50 PM, a review of the Performance Improvement quality assurance data was conducted with the Director of Quality and Risk Management (DQRM).

One of the established performance indicators for Surgical Site Infection (SSI) rates was the, "SSI Rate Report". The DQRM explained the indicator reflected the number of surgical site infections that were actually self -reported by the physicians and forwarded to the QA for follow-up. Review of the documented SSI percentage rate from January 2012 to July 2012 showed a rate of 0% (no reported surgical site infections).

The DQRM stated that a letters were mailed to all the physicians who completed surgeries listed as Orthopedics, Obstetrics and General surgery. The letter had asked the physicians to respond with information regarding patient's that have acquired a surgical site infection. The SSI Rate Report noted several hundreds of surgeries conducted for each month from January 2012 to July 2012 and the SSI rate was noted to be 0% for each of the months. The DQRM stated that "We do not feel there is a need for surveillance of the Central Sterilization Department (the area in the hospital that sterilizes the surgical instruments). We go by our Surgical Site Infection rates and our rates are near 0%. We feel this is not an issue".

In a discussion with the DQRM regarding the information gathered to develop the SSI Rate Report and to provide tracking and trending of the SSI results to monitor the quality of the originations, the DQRM confirmed that the number of letters mailed out to the physicians each month, compared to the number of completed responses were not listed on the SSI report. The information regarding letters mailed to the physicians were not tracked and were not trended. The DQRM further stated that a "Quality Sub-Committee" is responsible for tracking and treading the physician's responses to the letters mailed out. The DQRM stated that the Quality Sub-Committee last met together on May 17, 2012. There was no Quality Sub-Committee meeting in September 2012 and no meeting in October 2012. The information reported by the Quality Sub-Committee used to develop a November 2012 report that calculated the 0% surgical site infection rate for the hospital was not available. The DQRM was unable to locate the Quality Sub-Committee ' s November 2012 report for the Survey Team to review.

Based on observation, interview and record review, the facility failed to:

1. Provide nursing services that were supervised and evaluated by a Registered Nurse (RN) when the facility failed to ensure that 1 of 32 sampled patients (Patient 43) had nursing assessments that accurately assessed and documented the full scope of the patient's condition when the fetal (unborn baby) monitoring indicated that the baby was in distress. This failure had the potential to result in a dangerous condition for the baby.

2. Ensure that 1 of 32 sampled patients (Patient 25) was monitored according to the patient's level of care needs. This failure had the potential to result in the staff not responding quickly to a patient emergency.

3. Ensure that nursing staff:

a. Accurately completed the nutrition screen portion of the admission assessment for one patient (Patient 13).

b. Documented daily weights in accordance with physician orders for one patient (Patient 11).

c. Followed-up on significant weight gain for one patient (Patient 22).

d. Developed a policy to accurately implement fluid restriction orders for patients.

Failure to accurately complete nutrition screening, and to complete daily weights could result in a lack of referral of high nutritional risk patients to the dietitian, delayed nutritional intervention and compromised nutritional status of the patients. Failure to develop a fluid restriction policy could result in fluid restriction orders not implemented correctly with possible negative patient outcome.

Findings:

1. A review of Patient 43's record on December 17, 2012 showed that the patient was admitted to the hospital's labor and delivery unit on May 31, 2012 at 1:03 AM with a diagnosis of pregnancy and abdominal pain.

A review of the physician history and physical with a revision date of August 15, 2012 showed that the patient was pregnant at 35 weeks and that an ultrasound done at 33 weeks was abnormal (indicating that the baby may have had a defect). Patient 43 was having some contractions, the baby was moving, but the baby had irregular heart beats. The physician's plan for Patient 43 was that, "she is going to have a cesarean section."

In an interview and review of Patient 43's record with RN 3 regarding Patient 43 on December 18, 2012 at 10:40 AM, RN 3 stated that the patient's initial monitor strips (documentation of monitoring the baby's heart and the mother's contractions) showed that the mother was having some contractions and that the baby's heart rate was about 150 beats per minute (normal). RN 3 stated that the monitor started showing the baby's heart beat rate decreasing for a few seconds at the end of the mother's contraction at 1:50 AM that could indicate that the baby was having some distress. RN 3 stated that the monitoring strips showed increasing episodes of distress as time went on. RN 3 stated that the physician should have been notified of the monitor showing the distress. The patient's nurse called the physician at 3:00 AM to notify the physician of urinalysis (urine lab test) results and non stress test (NST - the test involves attaching one belt to the mother's abdomen to measure fetal heart rate and another belt to measure contractions. Movement, heart rate and "reactivity" of heart rate to movement is measured for 20-30 minutes). There was no documentation of the NST results. (The nurse did not inform the physician of the baby's distress and the physician did not come to examine the patient at this time.) The patient's nurse documented that the physician was called at 6:17 AM to report the result of the biophysical exam of 6/8 (an abnormal result) and the result of the NST showed no accelerations (heart rate increases), the nurse did not inform the physician of the baby's distress noted on the monitor. (The physician did not come to examine the patient at this time.) When asked why the patient was not transferred to a hospital with a Neonatal Intensive Care Unit (NICU) as the Cesarean section (C-section - the surgical removal of a baby from the mother's body) was 12 hours after the patient's hospital admission, RN 3 stated that she wasn't a physician, but as a nurse she would have discussed with the physician that the baby was only 35 weeks and had a previous abnormal ultrasound test and that maybe the physician would want to transfer the patient to a hospital with a NICU.

A review of the operative report dated May 31, 2012 showed the following: "Through a low transverse cesarean section, we delivered a live baby; however, the heartbeat went down to 60 right after I clamped the cord and the baby deceased (died) within 5 minutes and was declared dead by the emergency room physician."

2. A review on December 11, 2012 of Patient 25's record showed that the patient was admitted to the facility on December 4, 2012 with a diagnosis of exacerbation of Chronic Obstructive Pulmonary Disease (COPD - a flare-up of emphysema or a chronic lung disease that causes difficulty breathing). The physician ordered that the patient be transferred to the intensive care unit (ICU) on December 10, 2012 at 7:55 PM. The patient was placed on bi-pap (a machine to deliver oxygen under pressure with a special mask.)

During a tour of the second floor medical-surgical unit on December 11, 2012 at 9:30 AM it was observed that there was a patient (Patient 25) in a room with bi-pap (a machine to deliver oxygen under pressure with a special mask.) on and a nurse in the room.

In an interview with the nurse (RN 7) on December 11, 2012 at 10:15 AM, RN 7 stated that the patient was on ICU status since the previous night but that there were no beds available in the ICU, so the patient was being cared for on the medical-surgical unit with a nurse assigned exclusively to the patient. RN 7 stated that Patient 25's vital signs (temperature, pulse and respirations) were to be checked every one hour. RN 7 stated that she was not able to visually monitor what the patient's heart rhythm displayed on the cardiac monitor because there was no bedside monitor like the patient would have had in the ICU.

In an interview with RN 8 on December 11, 2012 at 9:45 AM, RN 8 stated that she was told that the physician gave orders to transfer the patient to the ICU but that there were no beds available and the facility did not have available nurses to open up the other ICU unit so the physician gave orders to make the patient a "2 to 1" and put the patient on a telemetry monitor. The patient was on ICU status not on telemetry status (a classification that the patient requires remote heart monitoring and the nurse can have up to 4 patients. When a patient is on ICU status, the nurse can have the responsibility of only 2 of these patients for closer monitoring).

A review on December 18, 2012 of the hospital's ICU "Scope of Care" showed the following: "The ICU is set up to provide hemodynamic (the observation of
hemodynamic parameters over time, such as blood pressure and heart rate) and intensive patient monitoring and to respond to emergency situations within short time frames."




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3a. On December 12, 2012, at 10:30 AM, review of the medical record for Patient 13 showed that he was admitted on December 4, 2012, with diagnoses that included diabetes and renal (kidney) disease requiring dialysis (a mechanical process for removing waste and excess water from the blood). A review of the Adult Multidisciplinary Initial Assessment, Nutritional Status Section, completed by the nursing staff, showed that the patient had no swallowing or chewing difficulties and a 20 pound weight loss noted as "intentional". No skin breakdown was noted and no Registered Dietitian (RD) referral was made.

On December 10, 2012, six days after admission, the RD completed a nutritional assessment and documented that the patient had unintentional significant weight loss secondary to renal disease, poor dentition and the inability to chew. The patient also had a wound and an albumin (measure of protein stores) of 1.4 grams per deciliter (g/dl) (normal range 3.4-5.4 g/dl).

A review of the facility policy titled, "Nutrition Screening and Assessment - Approved 6/11", sh

Based on interview and record review, the facility failed to ensure that the nursing staff
developed and kept current a nursing care plan for 5 (Patients 5, 22, 24, 25 and 30) of 32 sampled patients, in a universe of 51, based upon nursing care needs, ongoing nursing assessments, and responses to interventions. These failures had the potential to affect health outcomes and quality of care for Patients 22, 24 and 30.

Findings:

1. A review of Patient 5's medical record was conducted on December 10, 2012. Patient 5 was admitted to the Hospital on December 3, 2012 with an admitting diagnosis of respiratory failure due to experiencing shortness of breath two days prior to admission. Patient 5 was admitted to the Intensive Care Unit (ICU) on December 3, 2012 and was placed on a ventilator for respiratory support.
A review of Patient 5's Physicians' Order sheet, dated December 4, 2012, revealed an order for Naso-gastric tube feedings (NGT-a plastic tube placed through the nose, leading into the stomach, for liquid feeding purposes) and to start Jevity 1.2 feedings continuously at 52 milliliters per hour.

A review of Patient 5's "MULTIDISCIPLINARY PATIENT PLAN OF CARE" forms, dated December 4, 2012 through December 9, 2012, revealed no documented evidence of a nursing care plan addressing Patient 5's nutritional needs of receiving Jevity 1.2 feedings continuously at 52 milliliters per hour through the naso-gastric tube as ordered by the physician on December 4, 2012.

In addition, on page 4 of 8, of Patient 5's multidisciplinary care plan, under the section titled: "NUTRITION/METABOLISM/HYDRATION", the section was found to be incomplete, not filled out and left blank.

There was no documented evidence in Patient 5's medical record or from other hospital sources that the nursing staff had developed a nursing care plan to address Patient 5's nutritional feedings as ordered by the physician on December 4, 2012.

Nursing care plans should be comprehensive and individualized to reflect the condition and needs of the patient. Nursing care plans should be developed with identifiable problems, measurable goals and interventions, and should be time-limited.

A review on December 10, 2012, of the Hospital's policy and procedure titled: "MULTIDISCIPLINARY PLAN OF CARE", dated November 2011, stipulated, "...Each patient will have a comprehensive, integrated multidisciplinary plan of care, which is developed from the initial assessment. The care plan shall include, at minimum, physician and nursing components. The care plan and discharge plan will be initiated within 24 hours of admission. Each discipline is responsible for being knowledgeable and coordinating with the plan (s) of other disciplines in respect to each individual patient..."


During an interview with the Director of the Intensive Care Unit, on December 10, 2012, she confirmed the finding that Patient 5's multidisciplinary plan of care did not address Patient 5's nutritional feedings of receiving Jevity 1.2 feedings via the nasogastric tube continuously.


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2. A record review, on December 10, 2012 at 3 PM, of Patient 22, revealed that the patient was admitted on December 2, 2012 with the diagnosis of "New onset diarrhea."

A record review, on December 10, 2012 at 3 PM, of Patient 22's physician orders dated December 2, 2012, documented the following: "Seizure/DT (due to)/Fall/Head injury precautions" the orders also included to provide a sitter if needed.

A record review of Patient 22's medical record and a concurrent interview with RN 9 were conducted on December 10, 2012 at 3 PM. RN 3 stated that Patient 22 required a sitter because the patient was delusional (a false belief or opinion) and had attempted to pull out a foley catheter (a catheter inserted into the bladder to allow drainage of urine). RN 3 also stated that Patient 22's care plans did not include information related to the sitter and that the care plan should have been revised to include the medical necessity for the sitter because the patient was delusional.

3. A record review of Patient 30 was conducted on December 11, 2012 at 2:15 PM and revealed that the patient (pediatric) was admitted on December 9, 2012 with the diagnosis of exacerbation of asthma (an asthma attack which can cause a sudden constriction of the airways and causes extreme shortness of breath or difficulty breathing). Patient 30's physician documented that the patient had "Obvious respiratory distress and hypoxia with wheezes" (signs and symptoms due to asthma which cause respiratory distress). The physician's plan of care and orders for Patient 30 included steroids (a medication to help the inflammation which could be caused by the asthma), breathing treatments and chest percussions therapy after every breathing treatment (a treatment to help patients breathe more freely and to get more oxygen into the body).

A review of Patient 30's care plan on December 11, 2012 at 2:15 PM, revealed no documented evidence of the plan of care that the physician ordered for Patient 30.

An record review of Patient 30's care plan and a concurrent interview with RN 6 was conducted on December 11, 2012 at 2:30 PM. RN 6 stated that the care plan in Patient 30's medical record was a generic care plan and was not reflective of the patient ' s treatment plan that the physician ordered. Additionally, RN 6 stated that the care plan should have been revised to be more specific to Patient 30.

A record review on December 11, 2012 at 3 PM, of the hospital policy titled "Multidisciplinary Plan of Care, revised on 11/11," indicated the following: "It is the policy of (Name of hospital) to provide comprehensive care to all patients. It is also the policy of (Name of hospital) to describe the mechanism whereby the patient's treatment/care planning is provided and to describe how nursing diagnoses, patient care needs, and standards of care will guide the provision of care for all disciplines through the development and maintenance of the multidisciplinary care plan and discharge planning process ...Each patient will have a comprehensive, integrated multidisciplinary plan of care, which is developed from the initial patient assessment. The care plan shall include, at a minimum, physician and nursing components. The delivery of patient specific care, treatment and rehabilitation requires planning ...Because of the patient ' s unique needs, including those that are dictated by the patient ' s age, expectation and characteristics, the care/treatment planning process is designed to identify, prioritize and incorporate such needs into a multidisciplinary, individualized and appropriate plan of care/treatment ..."




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4. A review of Patient 24's record on December 10, 2012 showed that the patient was admitted to the facility on November 27, 2012 with a diagnosis of altered level of consciousness.

A review of the patient care plan showed that there was no care plan developed to reflect the patient's altered level of consciousness and to identify the patient's care needs.

In an interview on December 10, 2012 at 4:00 PM with RN 1, RN 1 acknowledged that there was no care plan for Patient 24 for altered level of consciousness and that there should have been a care plan for the patient's altered level of consciousness.

A record review on December 11, 2012 at 3 PM, of the hospital policy titled "Multidisciplinary Plan of Care, revised on 11/11," indicated the following: "It is the policy of (Name of hospital) to provide comprehensive care to all patients. It is also the policy of (Name of hospital) to describe the mechanism whereby the patient's treatment/care planning is provided and to describe how nursing diagnoses, patient care needs, and standards of care will guide the provision of care for all disciplines through the development and maintenance of the multidisciplinary care plan and discharge planning process ...Each patient will have a comprehensive, integrated multidisciplinary plan of care, which is developed from the initial patient assessment. The care plan shall include, at a minimum, physician and nursing components. The delivery of

Based on staff interview and facility record review, the facility failed to ensure that all continuous intravenous Versed medication drips (medication used to induce sedation when on a ventilator) and all Levophed vasopressor medication drips (medication used to treat low blood pressure) in the Intensive Care Unit were initiated/started and titrated according to the practitioners specific orders or according to approved hospital-wide titration protocol for 2 of 32 sampled patients (Patient 5 and 27).
1. For Patient 5, ICU Registered Nurses started/initiated Versed Drips without a physicians' order and were interpreting and making judgment decisions when to initiate start rates from a prescribed protocol range.
2. For patient 27, ICU Registered Nurses started/initiated Versed Drips and Levophed Drips without a physicians' order and were interpreting and making judgment decisions when to initiate start rates from a prescribed protocol range.

These deficient practices had the potential for unsafe dosages being administered affecting the health and safety of those patients in the Intensive Care Unit.

Findings:

1. A review of Patient 5's medical record was conducted on December 10, 2012. Patient 5 was admitted on December 3, 2012 with an admitting diagnosis of respiratory failure due to experiencing shortness of breath 2 days prior to admission. Patient 5 was admitted to the Intensive Care Unit (ICU) on December 3, 2012 and was placed on a ventilator for respiratory support.
On December 10, 2012, a review of Patient 5's ICU Physician Order sheet, dated December 4, 2012, documented the following orders by the practitioner:
a. At 11:30 PM: Versed drip to maximum 10 mg/min (mg-milligrams per minute). Titrate as per sedation.
b. At 11:45 PM: Versed drip 3 mg-10 mg, titrate for agitation.

A review of Patient 5's ICU Flow Sheet Record, dated December 4, 2012, indicated that RN 1 started/initiated the Versed Intravenous Continuous Medication drip at 4 mg/min.

There was no documented evidence in Patient's 5 medical record (Physician Order Sheet) that the practitioner had specifically ordered RN 1 to start Patient 5's Versed drip at at 4 mg/min.

On December 10, 2012, a review was conducted of the Hospital's policy and procedure titled: "MEDICATION ADMINISTRATION", dated October 2011, it stipulated in section A (1), " All orders for drugs and biological, must be documented and signed by a practitioner who is authorized by hospital policy and in accordance with State Law, and who is responsible for the care of that patient".

In addition, in section 7 (b): "Medication orders must have the following elements:
a. Exact strength and/or concentration.
b. Exact dose, frequency and route.
c. Quantity and duration.
d. Specific instructions for use".

A review of the Hospital's policy and procedure, titled: "INTRAVENOUS MEDICATION POLICY", dated September 2012, it documented the following information for the medication Versed:
a. " Initial dose: 1-5 mg Intravenous Push at 1 mg/min. "
b. " Usual Loading Dose: 2-8 mg Intravenous Push. "
c. " Usual Maintenance Dose: 2-10 mg/hr. "
d. " One or more loading doses may be required. "
e. " Sedation Goal: The sedative bolus or infusion dose is generally titrated to subjective and objective criteria. Using target criteria improves communication about the goals of sedation among caregivers " .

There was no documented evidence in Patient 5's medical record or from other hospital sources that RN 1 had administered Versed Intravenous Continuous drip at 4 mg./min according to hospital approved guidelines for agitation (i.e. Ramsay Sedation Scale) or at a specific targeted level to achieve a desired sedation level while the Patient was on the ventilator.

There was no documented evidence that Patient 5's practitioner had written specific orders for titrating the Versed Drip according to specific agitation-sedation guideline or according to his specific instructions and direction (parameters), including specific time based assessment frequencies with accompanying dosing rates.

There was no documented evidence in the medical record that RN 1 had implemented a hospital-wide ICU flow sheet addressing Patient 5's agitation level according to the " Ramsay Sedation Scale " .

A review on December 10, 2012, of the Hospital's policy and procedure, titled: "RAMSAY SEDATION SCALE", dated April 2012, it documented the following sedation levels of a patients' condition:
a. Level 1: Anxious, agitated, restless.
b. Level 2: Cooperative, oriented, tranquil.
c. Level 3: Drowsy and responds only to commands.
d. Level 4: Brisk response to glabellar tap (Blinking of the eyes when the forehead just above the bridge of the nose is tapped. If blinking of the eyes does not stop with continued tapping, brain disease is suspected) or loud auditory stimuli.
e. Level 5: Asleep with sluggish response to stimuli.
f. Level 6: No response to firm nail bed pressure or other noxious stimuli.

During an interview with the ICU Charge Nurse, on December 10, 2012, at approximately 11:40 AM, when asked if Patient 5's Versed order was ambiguous regarding the starting dosage rate, its titration directions, and whether RN 1 had a direct order by the practitioner specifically start the Versed rate at 4 mg/hr, she stated, " Yes, I would have called the physician to clarify the order for a set starting dosage rate and sedation level. Our protocols have ranges, so we (nurses) have to decide at what starting rate and titration levels we have to keep the patient at. "

During an interview with the Director of the Intensive Care Unit, on December 10, 2012, at approximately 11:45 AM, she confirmed the finding and stated, " Nurses are starting and titrating Versed drips without a physicians order and leaving it up to the individual nurse to decide. "

2a. A review of Patient 27's medical record was conducted on December 10, 2012. Patient 27 was admitted on December 4, 2012 with an admitting diagnosis of pneumonia and was placed on a ventilator on December 6, 2012 due to respiratory failure. Patient 27 was admitted to the Intensive Care Unit (ICU) on December 5, 2012.
On December 10, 2012, a review of Patient 27's ICU Physician Order sheet, dated December 5, 2012, and timed at 12:06 AM, documented the following orders by the practitioner:
a. Versed drip 2-8 mg/hr. PRN (as necessary).
b. If blood pressure doesn't tolerate, start Propofol drip.
c. Maintain drips at Ramsey Scale 4-5.
d. Versed drip PRN sedation for Systolic Blood Pressure less than 100 millimeters of Mercury.

A review of Patient 27's ICU Flow Sheet Record, dated December 6, 2012, indicated that the ICU Registered Nurse started/initiated the Versed Intravenous Continuous Medication drip at 4 mg/min. at 2:30 AM, and increased the rate to 8 mg/hr. at 3:30 AM.

There was no documented evidence in Patient 27's medical record (Physician Order Sheet) that the practitioner had specifically ordered the ICU Registered Nurse to start Patient 27's Versed drip at at 4 mg/min. at 2:30 AM and titrate up to 8 mg/min at 3:30 AM, on December 6, 2012.

On December 10, 2012, a review was conducted of the Hospital's policy and procedure titled: "MEDICATION ADMINISTRATION", dated October 2011, it stipulated in section A (1), " All orders for drugs and biological, must be documented and signed by a practitioner who is authorized by hospital policy and in accordance with State Law, and who is responsible for the care of that patient. "

In addition, in section 7 (b): " Medication orders must have the following elements:
a. Exact strength and/or concentration.
b. Exact dose, frequency and route.
c. Quantity and duration.
d. Specific instructions for use. "

A review of the Hospital's policy and procedure, titled: "INTRAVENOUS MEDICATION POLICY", dated September 2012, it documented the following information for the medication Versed:
a. "Initial dose: 1-5 mg Intravenous Push at 1 mg/min. "
b. "Usual Loading Dose: 2-8 mg Intravenous Push. "
c. "Usual Maintenance Dose: 2-10 mg/hr. "
d. "One or more loading doses may be required "
e. "Sedation Goal:

Based on interview and record review, the hospital failed to ensure that 3 of 32 sampled patients (Patients 22, 24 and 41), in a universe of 51, had all of their physician orders authenticated (with the name, date and time) of the ordering practitioner, within 48 hours. This failure had the potential for errors in transcription and the potential to affect patient treatment and safety.

Findings:

1. A record review, on December 10, 2012 at 3 PM, of Patient 22, revealed that the patient was admitted on December 2, 2012 with the diagnosis of "New onset diarrhea." A physician telephone order obtained by a Register Nurse (RN), dated December 2, 2012 at 6:40 PM for oxygen 2 liters to keep saturations at greater than 92%, was not authenticated by the physician who ordered the oxygen. Another telephone order obtained by an RN dated December 5, 2012 at 9:20 PM, for Ativan (A medication used for anxiety) 1 milligram intravenous every 4 hours as needed, was not authenticated by the physician who ordered the medication.

An interview, on December 10, 2012 at 3 PM, with RN 9 was conducted. RN 9 stated that the orders were not signed by the physician and that all telephone orders were supposed to be signed within 48 hours.

2. A record review, on December 17, 2012 at 4 PM, of Patient 41, revealed that the patient was admitted on November 23, 2012 with the diagnosis of pregnancy contractions. Patient 41 was discharged from the hospital on November 26, 2012. Several physician orders dated November 23, 2012 at 6:05 PM, 8:15 PM, 8:25 PM and 10:40 PM (all which included several medication orders, IV fluid orders, diagnostic tests, laboratory tests and a cesarean section [c-section] order), were not authenticated by the ordering physician.

An interview, on December 17, 2012 at 4:15 PM, with RN 4 was conducted. RN 4 stated that there was no physician signatures on any of the telephone orders for Patient 41 and that it was the hospital's policy per the physician rules and regulations to sign every order within 48 hours.

A record review, on December 18, 2012 at 8:30 AM, of the hospital's document, titled "General Rules & Regulations of the Medical Staff, revised on 12/6/11." The rules and regulations indicated the following, "...Verbal orders for medications must be dated and timed by licensed personnel lawfully authorized to receive the order and authenticated, dated and timed by the ordering or attending physician within 48 hours..."


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3. A review of Patient 24's record on December 10, 2012 showed that the patient was admitted to the facility on November 27, 2012 with a diagnosis of altered level of consciousness.

A review of a physician order, dated December 6, 2012, showed a telephone order written by a nurse. The order was as follows: "Keep NPO (nothing by mouth) after midnight for EGD (esophagogastroduodenoscopy - a procedure where the physician puts a tube down the throat and into the stomach of the patient to visualize the structure of the stomach and small intestine for any abnormalities) tomorrow, obtain consent." The order had not been authenticated (signed as ordered by the physician) as of December 10, 2012, 96 hours after the order had been given,

In an interview on December 10, 2012 at 4:00 PM with RN 1, RN 1 stated that the physician orders should have been signed within 48 hours.

A record review was conducted on December 18, 2012 at 8:30 AM, of the hospital's document, titled "General Rules & Regulations of the Medical Staff, revised on 12/6/11." The rules and regulations indicated that, "...Verbal orders for medications must be dated and timed by licensed personnel lawfully authorized to receive the order and authenticated, dated and timed by the ordering or attending physician within 48 hours..."

Based on interview, record review, and policy and procedure review the facility failed to (a) restrict its Pharmacy Technician's duties to that of non-discretionary tasks. The facility failed to ensure that pharmacy technician staff was assigned duties to be in compliance with state regulations to assure quality pharmaceutical services, (b) ensure that Patient 1's own medication Lyrica that was brought to the hospital was verified before administration, c.the facility failed to ensure that Patient 4's allergy profile was correctly identified, and (d) ensure that an unapproved abbreviation was not included in Patient 5's medical record, that medication orders were complete for pain to include the intensity of pain treated for patient 4, and lack of clear communication to staff when to administer specific pain medications to Patient 7, and clear communication and guidance for the administration of sliding scale insulin to Patient 3.
.

Findings:

a. On 12/12/12 at approximately 11:30 during a tour of the surgery department, the distribution of drugs to malignant hyperthermia (MH) crash cart and (ADC) automated dispensing cabinet was reviewed. It was noted during the review that drugs necessary for immediate use during the code were not stored in the cart, but in the ADC adjacent to the cart. During the inventory check, it was noted that only one opened vial of regular insulin was available. The ADC report indicated that two vials should be available. Sufficient inventory should be available for routine use and unusual events such as a MH code.

The lead pharmacy technician was asked if a pharmacist inspected thus evaluated the use of drugs in the department. She stated that the pharmacy technicians checked for outdates monthly and that the Director of Pharmacy (DOP) stated that the pharmacist inspects the drugs on the units and the pharmacy technicians checks for outdates. Review of the facility ' s policy and procedure titled, ' Medication Area Monthly Inspections ' a pharmacist inspects on a monthly basis.


On 12/13/12 at approximately 1:30 PM, the Director of Pharmacy (DOP) was interviewed regarding drug distribution and inspection of medications stored on patient care units and departments. The DOP reported that designated pharmacists were assigned specific patient care areas, however, medications stored on the nursing units and other areas of the hospital were checked by a pharmacy technician on a monthly basis, after which the pharmacist signs the inspection sheet.

Review of the facility's policy and procedure titled, 'Medication Area Monthly Inspections' a pharmacist inspect on a monthly basis.

Current regulation stipulates as follows, " Drugs maintained on the nursing unit shall be inspected at least monthly by a pharmacist" . And " the supply shall be inspected by a pharmacist at periodic intervals specified in written policies. Such inspections shall occur no less frequently than every 30 days. Records of such inspections shall be kept for at least three years. "

The Board of Pharmacy (BOP) delineated the scope of practice for a Pharmacy Technician to that of non-discretionary tasks. Hence, the facility failed to assure that pharmacy staff assigned duties to be in compliance with state regulations. Such inspections shall occur no less frequently than every 30 days. Records of such inspections shall be kept for at least three years. "

The Board of Pharmacy (BOP) delineated the scope of practice for a Pharmacy Technician to that of non-discretionary tasks. Hence, the facility failed to assure that pharmacy staff assigned duties to be in compliance with state regulations.

b. During the medication observation pass conducted on 12/11/12 at 9:25 AM, RN 16 obtained a bottle containing Lyrica tablets for Patient 1 from the medication room. Inspection of the bottle with the RN revealed that Patient 1 ' s patient label covered the drug name, and strength.

When asked how the pharmacy verifies medications brought to the hospital, RN 16 stated that the medication is taken to the pharmacy and the pharmacist lets the RN know if it can be used. Further inspection of the bottle revealed that it lacked a pharmacy verification label or initials. The RN was unable to explain the lack of the verification label or pharmacist ' s initials.

A review of the medical record on 12/11/12 at 3:02 PM revealed a physician's order on 12/6/12 at 9:05 AM , that stated 'Pt (patient) to bring Lyrica from home. Lyrica 75 mg - continue.

A review of the facility's policy and procedure titled, "Patients Own Medication(s)" documents that the pharmacist attaches the label to the medication container with the patient's name, room number, and a pharmacist's initials. "

Interview with the CNO on 12/11/12 at approximately 9:59 AM confirmed the finding.
Interview with the Director Of Pharmacy (DOP) on 12/13/12 at approximately 12:30 PM, he acknowledged that the verification of medications brought to the hospital must occur before administration.

c. Patient 4 received medications during the medication pass observation conducted on 12/11/12 at approximately 9 AM. Patient 4's medical chart was reviewed on 12/11/12 at 2:50 PM. Documentation on the medication reconciliation form dated 12/7/12 at 10:50 PM documented that Patient 4 was allergic to Geodon " Bactrim " . Geodon and Bactrim have different indications for use.

Geodon is a medication indicated for psychotic illnesses such as schizophrenia, bipolar (manic/depressive) states, and may cause negative cardiac effects. Bactrim is a combination sulfonamide antibiotic (sulfamethoxazole and trimethoprim). Bactrim has a sulfa component which may illicit allergic reactions. Subsequent medication orders dated 12/7/12 at 10:50 PM listed only Bactrim as Patient 4 ' s allergy.

In an interview with the Director of Emergency Department on 12/11/12 at 3:10 PM he acknowledged that an allergy profile should be accurately documented in the medical record.

d. Patient 5 was admitted to the facility via the Emergency Department on 12/3/12 with diagnoses that included chronic obstructive pulmonary disease (COPD), (a lung disease), respiratory failure and was intubated.
A review of Patient 5's medical record on 12/10/12 at approximately 2:35 PM revealed respiratory care orders for Xopenex (levobuterol) 0.63 mg (milligram) via MedNeb (medical nebulizer) q4h (every 4 hours) RTC (around the clock), a medication used to treat the narrowing of airways, and Do not Substitute, Atrovent 0.5 mg via via neb(nebulizer) q4h RTC, Pulmocort 1 mg neb qh, Solu Medrol 100 mg IV q6h. During the transcription of orders Pulmocort was ordered as 1.0 mg which is an unacceptable abbreviation according to the facility's policy and procedure titled, "Unapproved Abbreviations."

Patient 4 received medications during the medication pass observation conducted on 12/11/12 at approximately 9 AM. Patient 4 ' s chart was reviewed on 12/11/12 at 2:50 PM. The review revealed a medication order dated 12/8/12 at 10:50 PM for Dilaudid 1 mg (milligram) IV(intravenous) Q3 (every 3 hours) PRN (as needed) pain, Toradol 30 mg IVP (intravenous push) Q6 PRN pain. These orders as written do not delineate the intensity of pain (mild, moderate, or severe) being treated. The nurse will have to decide which drug to administer to Patient 4 as the physician failed to clearly state when either medication should be administered.

A review of the facility ' s policy and procedure titled, 'Medication Administration' documents that medication orders to include all elements of an order, PRN to include indications.

An interview with the Emergency Department Director on 12/11/12 at 3:10 PM confirmed the finding that medication orders for pain should be complete so that physicians ' orders are not subject to interpretation.


A review of Physician A's standing order titled, "Post-Operative Orders for Dr. A" and dated 12/9/12 (no time) for Patient 7 on 12/12/12 at approximately 12 PM revealed variance order sets for Demerol 50 mg IV Q6h PRN for mild and moderate pai

Based on observations, interviews and document review, the facility failed to ensure that the Director of Food and Nutrition Services (DFNS):
1) Monitored written procedures/manufacturer recommendations for food service operational processes relating to food safety.

2) Ensured the integrity of disaster food supplies for all patients and staff, and the appropriateness of disaster foods for all therapeutic diets.

3) Ensured that data reported as part of the Quality Assurance Performance Improvement (QAPI) program was tracked and trended for analysis purposes with effective action plans for improved provision of care.

These failures may result in patients being exposed to foodborne illness and cross contamination which may further compromise medical status, inadequate food supplies in the case of a disaster, and lack of intervention in response to quality assurance measures not meeting established thresholds.

Findings:

1) On December 11, 2012, starting at 8:30 AM, during an inspection of the food service operation, the following was noted:

A. In the walk-in refrigerator, a pan containing two five-pound pieces of uncooked meatloaf was noted to be stored on a sheet pan on the top of a storage rack. Stored directly underneath the meatloaf were containers of ready to eat pickles and lettuce. Also noted in the facility's outside refrigerator, three fifteen-pound cases of raw bacon were stored adjacent to cases of cooked sausage and directly above two cases of cooked turkey ham. In a concurrent interview with the Director of Food and Nutrition Services (DFNS), present at the time of the observations, he confirmed that the raw meat products should not have been stored directly above ready to eat food products.

On December 11, 2012, at 3:30 PM, review of the facility policy titled, "Purchasing, Receiving and Storage - approved 6/11", indicated: "When storing raw foods the following top-to-bottom order will be used:

a. Cooked and ready-to-eat foods (top shelf)
b. Raw fish
c. Raw ground beef
d. Raw pork, ham, bacon and sausage
e. Raw ground beef and pork
f. Raw chicken (bottom shelf)"

B. In the main kitchen, a red pail containing a cleaning cloth immersed in a liquid was noted in the cold food preparation area. In an interview with Food Service Worker 1 (FSW 1), she stated that the liquid in the pail was a sanitizer solution (Quaternary Ammonia) obtained from a dispenser in the dishroom, and the cleaning cloth was used to wipe down the food preparation area when food production was complete. FSW 1 was unsure what the sanitizer concentration should be, and stated that she had never utilized a chemical test strip to check the sanitizer concentration. Upon testing the chemical sanitizer, the test strip registered 50 parts per million.

Review of the facility policy titled, "General Cleaning/Sanitizing of Dietary Equipment /Surfaces - Reviews 6/11", showed, "All area surfaces will be cleaned with an approved multi-quat sanitizing solution after each meal." There was no indication of what the concentration of the sanitizer should be. Review of the manufacturer recommendations posted in the dishwashing are, showed that the recommended concentration for the quaternary ammonia sanitizer was 150 to 400 parts per million.

C. Inspection of the ice-machine showed a log indicating that the ice-machine was cleaned/sanitized on a weekly basis by food service staff. The DFNS stated food service staff utilized a quaternary ammonia solution to sanitize the ice machine. This was confirmed in an interview with Food service Worker 2 (FSW 2) on December 12, 2012, at 3:10 PM.

On December 12, 2012, at 3:30 PM, the manufacturer recommendations for sanitizing of the ice machine were provided by facility staff. The recommended chemical was noted to be sodium hypochlorite, a chlorine based chemical. The DFNS acknowledged the discrepancy in the ammonia based chemical currently used to sanitize the ice machine compared to the chlorine based sanitizer recommended by the manufacturer.

D. On December 12, 2012, at 3:20 PM, in an interview with the DFNS, he stated that the facility utilized a "Cooling Log", to monitor potentially hazardous food (PHF) items, such as hot cooked ground beef and turkey, as they were cooled for future use. Review of the facility policy titled, "Hazard Analysis Critical Control Points Program (HACCP) - Approved 06/11", showed, "Hot food must be cooled from 135 degrees F (Fahrenheit) to 70 degrees F within 2 hours and from 70 degrees F to 41 degrees F within 4 hours. Corrective action must be taken if this process is not achieved. Reheating is required to 165 degrees F for at least 15 seconds in 2 hours."

Review of the "Cooling Log" showed an entry on October 6, 2012, for "Turkey". The temperature documented after the initial 2 hours was 90 degrees F. On October 27, 2012, another entry for "Turkey" was noted, with the temperature documented after the initial 2 hours as 79.5 degrees F. There was no documented corrective action noted on the "Cooling Log" or an area for corrective action to be documented. The DFNS acknowledged the lack of documented intervention as related to the PHF items not reaching the recommended temperature of 70 degrees F after the initial 2 hours of cooling.

2) On December 11, 2012, at 8:40 AM, in the outside refrigerator, disaster menu food supplies were noted. Inspection of the disaster foods showed:

A. One case of Cup-A-Soup with an imprinted "Best By" date of November 17, 2007.
Two cases of bulk Cornflakes cereal were imprinted with a manufacturer "Best Buy" date of September 9, 2006.
One case of Tapioca pudding was imprinted with a "Use By" date of December 5, 2012.
Five cases of individual packets of Quaker Oats oatmeal were imprinted with a manufacturing date of November 2006, and two cases of cream of wheat were imprinted with a manufacturing date December 2006.

In a concurrent interview with the DFNS, he stated he was not sure of the shelf life of those products. On December 12, 2012, at 7:15 AM, in a telephone interview with a representative from Quaker Oats, she stated that the "Best Before" date imprinted on oatmeal products was designed for optimal nutritional value, taste and freshness of the product. The representative stated that the recommended storage time for the product was 18 months from manufacturing, however, the product may be kept longer but needs to be monitored for off coloring, off-flavor and changes in texture and odor based on prolonged storage. She further stated that the recommended storage location for the product was the pantry or freezer versus the refrigerator, as the moisture/humidity in the refrigerator may cause the product to clump. This information was discussed with the DFNS on December 12, 2012, at 1:42 PM. The DFNS acknowledged that the facility did not have an established system to monitor the oatmeal beyond the recommended 18 month manufacturer storage date to ensure optimal freshness for use.

Two cases containing four one-pound bags of Cream of Wheat were imprinted with manufacturing dates of November 3, 2006, and November 10, 2006, respectively. In a concurrent interview with the DFNS, he was not sure how long the product can be kept.

Two cases pureed carrots were also noted. The product was imprinted with a manufacturer code that the DFNS could not discern. On December 12, 2012, at 1:42 PM, in an interview with the DFNS, he stated that, upon contacting the manufacturer, he determined the imprinted code as a manufacturing date of November 24, 2009. He stated the manufacturer recommendation for retention of the product was two years from manufacturing date, in this case, November 24, 2011.

Three cases of pureed beef were similarly imprinted with manufacturer codes that the DFNS could not discern. The cases were labeled as having been delivered to the facility on September 15, 2008. The DFNS did not know how long the product could be kept. As of the date of the survey exit, there was no additional information obtained from the manufacturer of the puree beef.

Six cases of one-half ounce individual servings of peanut butter were noted with a manufacturing date o

Based on observation, interview and record review, the facility failed to provide and maintain a sanitary environment to avoid transmission of infections and communicable diseases in the Sterile Processing Department. The Hospital failed to ensure that all surgical instruments or articles requiring sterilization were sterilized thoroughly according to Nationally Recognized Infection Control and Prevention Recommendations and manufacturers' instructions. The facility failed to ensure the following:

1a. Ensure that all individually packaged sterile instruments (peel pouches/packs) stored on top of inventory shelves, that the instrument blades were sterilized in an open position and not in a closed position as recommended by Nationally Recognized Infection Control Organizational (Industry) standards and according to the manufacturer's recommended instructions. This condition existed for 8 of 10 sampled sterile peel pouches inspected.

1b. Ensure that all stored individually packaged sterile instruments of multiple pieced units, were disassembled prior to sterilization as recommended by Nationally Recognized Infection Control Organizational (Industry) standards and according to the manufacturer's recommended instructions.

2. Ensure that all surgical hinged instruments (i.e. clamps, forceps, scissors, needle holders, etc.) arranged in sterilized wrapped surgical trays, that the instrument blades were opened and not closed as recommended by Nationally Recognized Infection Control Organizational (Industry) standards and according to the manufacturer's recommended instructions for those instruments found in 5 of 5 sterile surgical trays inspected.

3. Ensure that the hospital's sterile processing procedures/practices were consistent with recommendations by Nationally Recognized Infection Control Organizations (Industry) standards and guidelines. The hospital failed to provide and maintain an ultrasonic decontamination cleaning machine as part of the departments' decontamination and cleaning process of all critical equipment used for surgical or medical care of all patients treated at the hospital.
These deficient practices resulted in an "Immediate Jeopardy" situation being declared (called) against the Hospital on December 12, 2012, at approximately 6:05 PM, and was abated on December 13, 2012, at 4:07 PM. The facility's plan of correction included revised policy and procedures for sterilization of the hinged surgical instruments in the open position, the use of an ultrasonic washer and staff education regarding the changes made to sterilization process.

4. Ensure that Hospital-Wide Infection Control precautions for the care of patients with Clostridium Difficile infection (antibiotic associated infections) were being followed and implemented for 2 patients (Patient 27 and Unsampled Patient F) who were on special contact infection control precautions. These failures had the potential to jeopardize the health of patients and contributed to an unsanitary hospital environment.

5. Ensure that the infection control officer provided effective infection control oversight into food services when the dietary staff:

5a. Failed to ensure that raw food items were not stored above ready to eat foods

5b. Failed to ensure that food service surface cleaning surfaces were cleaned with a sanitizer maintained at the correct concentration.

5c. Failed to ensure that the ice machine in the dietary department was cleaned using the manufacturer recommended sanitizer solution.

5d. Failed to ensure that the cooling process for potentially hazardous foods (PHF) reflected appropriate processes.

5e. Failed to ensure that disaster food items were not kept past manufacturer suggested "Best By" dates.

These processes have the potential of promoting food-borne illness if not appropriately implemented/monitored.

6. Ensure that (a) the respiratory care practitioner assigned to Patient 2 observed infection control precautions during the course of administering treatment, and (b) the registered nurse RN who administered medication to Patient 3 observe infection control precautions during the course of administering medications.

Findings:

According to the Healthcare Infection Control Practice Advisory Committee (HICPAC), under the heading, "GUIDELINES FOR DISINFECTION AND STERILIZATION IN HEALTHCARE FACILITIES", dated 2008, "...The aim of Central Processing of medical and surgical instruments are to protect patient from infections while minimizing risks to staff. Ensuring consistency of sterilization practices requires a comprehensive program that ensures operator competency and proper methods of cleaning and wrapping instruments and monitoring of the entire process ..."

During an interview with the Director of Surgical Services and the nurse in charge of the hospital's sterile processing department, on December 12, 2012, at approximately 3:00 PM, when asked what Nationally Recognized Infection Control Organizational standard of practice that was promulgated or was being implemented by the hospital's sterile processing department, they stated concurrently, "The AORN (Association of peri-operative Registered Nurses) standards."

1 (a) (b). During an observation on December 12, 2012, at approximately 10:30 AM, at the hospital's Sterile Processing Department and storage area, inspection of 8 of 10 individually packaged sterile instruments (packaged in transparent peel packs) and multi-pieced units, stored in plastic containers on multiple inventory shelves, the instrument blades/tips were found to be in a closed and locked position, as opposed to be in an open position and not disassembled, as recommended by Nationally Recognized Infection Control Organization guidelines and manufacturer's instructions in order for thorough sterilization to occur.

During an interview with the nurse in charge of the Sterile Processing Department and Central Service Technician A, on December 12, 2012, at approximately 11:45 AM, when asked what position should hinged surgical instrument blades be in for optimal sterilization to take place, they both stated, " It does not matter what position the instrument blades should be in, as long as it passes through the autoclave machine."

According to the Healthcare Infection Control Practice Advisory Committee (HICPAC), under the heading, "GUIDELINES FOR DISINFECTION AND STERILIZATION IN HEALTHCARE FACILITIES", dated 2008, "...Sterilization is defined as a process that destroys all microorganisms and spores on the surface of an article or instrument to prevent disease transmission associated with the use of that item. Proper sterilization includes all instruments to be in an open position, as opposed to being in a closed position, in order for direct steam to reach those surface areas. Multiple pieced instruments must first be disassembled prior to being sterilized."

According to the AORN (Association of Preoperative Registered Nurses), under the title, "Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment", dated 2011, it recommended the following:

a. Section 1(a) (1): "The manufacturer's written instructions should identify requirements related to cleaning equipment and processing methods."
b. Section V (d): "When instruments are composed of more than one piece, they should be opened, disassembled, and arranged in an orderly fashion. Disassembling and opening of instruments minimizes the risk of instrument displacement and improves the efficiency of reprocessing."
c. Section V (d) (2): "Instrument box locks should be fully open and the instruments secured to prevent closing by using stringers (apparatus to prevent instruments from closing)."

According to the Hospital's Sterile Processing Department's resource manual (Miltex Surgical Instruments-Manufacturer's guide), used to identify various surgical instruments in surgery, titled, "CLEANING, STERILIZATION AND MAINTENANCE OF SURGICAL INSTRUMENTS", copy right date 1996, it stipulated, "...Unlock all instruments and sterilize then in an open position. NEVER LOCK AN INSTRUMENT DURING AUTOCLAVING. It will not be s

Based on observation, interview and record review, the Hospital's Surgical Services failed to ensure that surgical care and services acheived the highest standards of medical practice and patient care by failing to ensure the following:

1a. Ensure that all individually packaged sterile instruments (peel pouches/packs) stored on inventory shelves, that the instrument blades were sterilized in an open position to enhance sterilization and not in a closed position per the facility's policy and procedure and the manufacturere's recommended instructions. This was observed for 8 of 10 sampled sterile peel pouches that were inspected.

1b. Ensure that all stored individually packaged sterile instruments of multiple pieced units, were disassembled to enhance sterilization prior to autoclaving (sterilization) per the facility's policy and procedure and the manufacturere's recommended instructions.

2. Ensure that all surgical hinged instruments (i.e. clamps, forceps, scissors, needle holders, etc.) arranged in sterilized wrapped surgical trays, that the instrument blades were opened to enhance sterilization and not closed per the facility's policy and procedure and the manufacturere's recommended instructions for those instruments found in 5 of 5 sterile surgical trays inspected.

3. Ensure that the hospital's sterile processing procedures/practices were consistent with the facility's policy and procedure and the manufacturere's recommended instructions. The hospital failed to provide and maintain an ultrasonic decontamination cleaning machine as part of the departments' decontamination and cleaning process of all critical equipment used for surgical or medical care of all patients treated at the hospital.

4. Ensure that the Neonatal Emergency Crash Cart was equiped with a Pediatric/Neonatal cardiac monitor and defebrillator in Operating Room 1 prior to scheduling a surgical Cesarian Section (C-Section) procedure.

The cumulative effect of these deficient practices had the potential to affect the health and safety of patients requiring surgical interventions in the hospital.

Findings:

During record review, the review of the facility's policy and procedure entitled, "PROCESSING CONTAMINATED INSTRUMENTS & EQUIPMENT FOR STERILIZATION", with an effective date of November 2011, showed that under the "Procedure" section:

A. The care and handling of surgical instruments and powered equipment should follow the recommendations of the manufacturers.

11. Hinged instruments should be opened and instruments with more than one part should be disassembled as they are placed in the instrument pan or tray.

13. All instruments opened for a procedure, whether soiled or not, may be cleaned using an ultrasonic cleaner, washer/decontaminator, and washer/sterilizer following the manufacturer's instructions for operation.

During record review, the review of the facility Sterile Processing Department's resource manual, Miltex Surgical Instruments (Manufacturer's Guide), that was used to identify various surgical instruments in surgery, titled, "CLEANING, STERILIZATION AND MAINTENANCE OF SURGICAL INSTRUMENTS", copyright 1996, it stipulated, "...Unlock all instruments and sterilize them in an open position. NEVER LOCK AN INSTRUMENT DURING AUTOCLAVING. It will not be sterile as steam cannot reach the metal to metal surfaces. The instrument will develop cracks in hinge areas because of heat expansion during the sterilization cycle..."

In addition, under section (c), titled, "MANUAL CLEANING", it stipulated, "...recommend ultrasonic cleaning as the best and most effective way to clean surgical instruments, particularly those with hinges, locks and other moving parts..."
1(a) (b). During an observation on December 12, 2012, at approximately 10:30 AM, at the hospital's Sterile Processing Department and storage area, an inspection of 8 of 10 individually packaged sterile instruments (packaged in transparent peel packs) and multi-pieced units, stored in plastic containers on multiple inventory shelves, showed that the instrument blades/tips were found to be in a closed and locked position, as opposed to be in an open position and they were not disassembled.

During an interview with the nurse in charge of the Sterile Processing Department and Central Service Technician A, on December 12, 2012, at approximately 11:45 AM, when asked what position should hinged surgical instrument blades be in for optimal sterilization to take place, they both stated, "It does not matter what position the instrument blades should be in, as long as it passes through the autoclave machine".

2. On December 12, 2012, at approximately 1:45 PM, the following five (5) sterilized surgical trays/packs were unwrapped, opened and inspected of its contents:

a. Basic Laparotomy Cholecystectomy Tray.
b. Chest Tube Insertion Tray.
c. Rigid Bronchoscope Tray.
d. Tracheostomy Tray.
e. Obstetrical Tray.

All surgical trays inspected contained hinged instruments (i.e. clamps, forceps, scissors, needle holders, etc.) with their blades found to be in a closed and locked position and not in the open position per the facility's policy and procedure and according to the manufacturer's recommended instructions in order for thorough sterilization to take place.

3. During an observation on December 12, 2012, at approximately 2:30 PM, of the sterile processing department's practice and procedure for sterilizing instruments, it was observed after manual decontamination of instruments of bioburden (old blood, plasma and tissue) material, through disinfection soaking and spraying, all instruments after soaking were flash sterilized for approximately 4 to 5 minutes in the prevacumed sterilizer. All instruments then were transferred and placed into the steam autoclave machine set for 50 to 60 minutes to complete the sterilization process.

There was no evidence that a mechanical ultrasound cleaning machine was utilized per the facility's policy and procedure and the manufacturer's recommended instructions during the decontamination and cleaning observation on December 12, 2012.

There was no evidence that a mechanical Ultrasound Cleaning Machine was available for use in the Sterile Processing Department, at the time of the inspection, on December 12, 2012, at approximately 2:45 PM.

During an interview with the nurse in charge of the Sterile Processing Department, when asked if the department utilized an ultrasonic cleaning machine to remove bioburden debris on instruments, he stated, "No, we never had a machine like that in the department. In its place, we routinely flash sterilize the instruments for 4 to 5 minutes, at 270 degrees Fahrenheit, before transferring the instruments into the sterile autoclave for an additional 50 to 60 minutes to complete the process."

The hospital failed to adhere to it's policy and procedure, to reduce the risk of transmission of infections/communicable diseases in the sterile processing department of the hospital.

During an interview with the Hospital's Director of Quality Assurance and Performance Improvement Department, on December 18, 2012, at approximately 4:00 PM, when asked if quality indicators or performance improvement indicators were being monitored, tracked and trended with collectable data and then analyzed for possible development of improvement activities in the Sterile Processing Department of the hospital, he stated, "No, we have not because our Surgical Site Infection Rate (SSI) for the last few quarters was zero (0)".

During an interview with the Hospital's Interim Director on Infection Control and Prevention of Diseases, on December 18, 2012, at approximately 3:15 PM, when asked if active surveillance of the sterile processing department was being conducted regarding the practice and procedures of decontamination, cleaning, processing, packaging and sterilization of all surgical and medical instruments and equipment in the hospital, she stated, "No".

The Hospital failed to conduct active surveillance on a hospital-wide basis, especially, in the sterile processing department, in order to identify infectious risks or communicable disease pr