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Based on observation, staff and patient interviews, medical record and document reviews, the hospital failed to effectively govern the activities and conduct of the hospital staff to provide safe and quality care to all patients as evidenced by:

A. The hospital failed to provide surgical services that were well organized and in accordance with acceptable standards of practice in order to ensure safe and high quality surgical care to all patients (cross reference A 940).

B. The hospital failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. The hospital's infection control program and policies were not in accordance with nationally recognized infection control standards to effectively prevent, control, and minimize cross-contamination and risks for infections and communicable diseases (cross reference A 0747).

C. The hospital failed to ensure that anesthesia services were well-organized and administered by qualified personnel in accordance with acceptable standards of practice for all locations where anesthesia services were delivered (cross reference A 1000).

The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Governing Body Services.

Findings:

A review on 5/17/11 of the 3/25/11 Governing Body Bylaws under Preamble documented that the Governing Board was responsible for "the evaluation and supervision of the conduct of the Hospital, including the care and treatment of patients." The patient population served with medical/surgical treatment was described as "individuals primarily needing long term, acute care and subacute care who suffer from medically complex or catastrophic illnesses." Article 1 required the hospital to organize an effective governing body which was legally responsible for the conduct of the hospital as an institution, to ensure hospital patients received quality care, and to furnish and maintain facilities for the proper care and safety of all patients, physicians, and employees.

In a telephone interview on 5/19/11 at 1 p.m. with the President of the Medical Staff, also a member of the Governing Board, the President acknowledged that the Governing Board was responsible for the total operations of the hospital to ensure high quality care and safety for all patients. The President indicated he was not aware that the operating room nurse supervisor was not qualified to oversee surgical operations, and the Medical Director of Surgical Services (those were the people responsible for the service) may not be fully knowledgeable about sterile processing and other surgical/infection control operations for which regulatory violations were identified during the survey. The President indicated he was not aware that members of the medical staff had not documented evidence of skill and competence for the privileges requested and approved by the Governing Board.

Review on 5/17/11 of the 3/25/11 Governing Body Bylaws under Section 7.09 documented a requirement for the Medical Staff and Governing Board to consider a practitioner's education, training, experience, current competence, references, and peer appraisal before granting clinical privileges to the practitioner.

Based on observation, interview, and medical record reviews the facility failed to provide an environment to avoid sources and transmissions of infection and communicable diseases as evidenced by:

A. The hospital failed to ensure personnel were consistently screened for infectious diseases
according to acceptable standards of practice (cross reference 0749, item 1).

B. The hospital failed to ensure environmental conditions (such as air exchange measurements) were monitored in accordance with nationally recognized standards (cross reference 0749, item 2).

C. Hospital personnel failed to wear personal protective equipment in the surgery suite(s) in accordance with nationally recognized standards of practice (cross reference 0749, item 3).

D. The hospital failed to ensure appropriate personal protective equipment (PPE) was worn when reprocessing an endoscope in the sterile reprocessing room (cross reference 0749, item 4).

E. Surgical personnel failed to decontaminate and reprocess endoscope equipment that had not been used for more than five days in accordance with nationally recognized standards of practice (cross reference 0749. item 5a).

F. Surgical personnel failed to dry endoscope equipment in accordance with nationally recognized standards of practice (cross reference 0749. item 5b).

G. Surgical instruments were not processed according to nationally recognized standards of practice (cross reference 0749, item 6).

H. Preoperative surgery site hair removal from patients is done in accordance with nationally recognized standards of practice (cross referece 0749, item 7).

I. Traffic patterns in the operating room suite did not conform to nationally recognized standards of practice (cross reference 0749, item 8).

J. Physician documentation of medical necessity for patient central lines did not conform to the hospital's protocol (cross refernce 0749, item 9).

The cumulative effects of these systemic problems resulted in the facility's inability to provide infection control services and care in a safe and effective manner in accordance with the statutorily-mandated Condition for Coverage for Infection Control Services.

Based on observation, staff and patient interviews, medical record and document reviews, the hospital failed to provide surgical services that were well organized and in accordance with nationally recognized standards of practice in order ensure safe and high quality surgical care to all patients as evidenced by:

1. Traffic patterns in the operating room suite did not conform to nationally recognized surgical/infection control standards of practice to minimize environmental cross-contamination (cross reference A 747).

2. Surgical personnel failed to adhere to surgical attire policies and infection control standards when entering the semi-restricted and restricted zones of the surgical suite (cross reference A 747).

3. The hospital failed to monitor environmental conditions (such as air exchange measurements) in accordance with nationally recognized standards in order to prevent cross contamination and surgical site infections (cross reference A 747).

4. Surgical personnel failed to wear personal protective equipment in accordance with nationally recognized surgical/infection control standards of practice (cross reference Q 747).

5. Surgical personnel failed to decontaminate and reprocess endoscope equipment that had not been used for more than 5 days in accordance with nationally recognized surgical/infection control standards of practice (cross reference A 747).

6. Surgical instruments were not processed in accordance with nationally recognized surgical/infection control standards (cross reference A 747).

7. Surgical services were not organized to ensure that surgical personnel reported to qualified surgical managers with knowledge and expertise in surgical service operations, and to ensure that all surgical equipment was maintained in accordance with policy (cross reference A 941).

8. The hospital failed to ensure that a qualified registered nurse or doctor of medicine/osteopathy with knowledge and expertise in sterile processing, staffing, scope of practice, and infection control effectively supervised the operating rooms and surgical operations (cross reference A 942).

9. The hospital failed to arrange supervision of licensed practical nurses and operating room technicians by a registered nurse in accordance with acceptable standards of practice and scope of practice (cross reference A 943).

10. The hospital failed to arrange for qualified registered nurses to perform circulating duties in the operating room in accordance with state law and acceptable standards of practice to ensure immediate availability of nursing interventions for patient safety (cross reference A 944).

11. The hospital failed to ensure that surgical tasks were performed by qualified, competent and privileged practitioners in accordance with scope of practice, state law, and nationally recognized standards of practice (cross reference A 945).

12. The hospital failed to ensure surgical services met the needs of its patients to ensure safe and high-quality care when surgical policies did not conform to nationally recognized standards of practice and care (cross reference A 951).

13. The hospital failed to ensure that an accurate updated examination and assessment of the patient's condition was documented prior to surgery for all procedures requiring anesthesia services (cross reference A 952).

14. The hospital failed to ensure the ready availability of a tracheotomy set for all surgical procedures (cross reference A 956).

15. The hospital failed to ensure the safety of all surgical patients by providing adequate post-operative assessments and monitoring, which resulted in the potential for serious harm from a fall in one sampled patient (Patient 16) (cross reference A 957).

16. The hospital failed to ensure the operating room register was complete and accurate for all surgical procedures (cross reference A 958).

The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Surgical Services.

Based on staff interview and document review, the hospital failed to ensure that anesthesia services were well-organized and administered by qualified personnel in accordance with acceptable standards of practice for all locations where anesthesia services were delivered as evidenced by:

A. The hospital failed to ensure that the Medical Director of Anesthesia Services actively participated in the development, maintenance, and oversight of moderate sedation (the administration of drugs to render a minimally depressed level of consciousness that allows a surgical patient to retain the ability to independently and continuously maintain a patent airway and respond appropriately to verbal commands and physical stimulation, also known as moderate sedation/analgesia, conscious sedation and intravenous sedation) practices that conformed to current standards of practice for anesthesia care.

B. The hospital failed to ensure that the Medical Director of Anesthesia Services actively participated in the development and maintenance of moderate sedation policies that conformed to current standards of practice for anesthesia care (cross reference A 0951).

C. The hospital leadership approved deep sedation privileges for 2 of 8 medical staff files reviewed (Physicians 3 and 4) without verifying the practitioners were qualified and competent to perform deep sedation (a drug-induced depression in consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation; independent ventilatory function may be impaired) in accordance with acceptable standards of practice (cross reference A 1001).

The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Anesthesia Services.

Findings:

A. Oversight of moderate sedation practices

In an interview with the Director of Quality Management (DQM) on 5/19/11 at 1:45 p.m., the DQM acknowledged that many hospital patients who had surgeries with moderate sedation by non-anesthesiologists were medically fragile with many co-existing medical problems that required a high level of medical support. The surgeries were performed either in the operating room or at the bedside. The patients often had compromised airways with artificial devices to maintain the airways. The devices could dislodge and require highly skilled interventions. Such sick patients may be more sensitive to the effects of medications. However, surgical procedures were routinely performed without requesting the presence of an anesthesiology provider who possessed the training and skill to anticipate and recognize when such patients may experience adverse events or complications from surgery or sedation.

In an interview on 5/18/11 at 3:45 p.m. with the Medical Director of Anesthesia Services, the Director indicated that the hospital had a contract with her anesthesia provider group to attend surgical procedures when requested. However, the Director had not been requested to provide anesthesia services for over a year. The Director indicated that she was designated to oversee anesthesia services, including local/moderate/deep sedation/analgesia, for all locations of the hospital. Although the Director regularly attended Quality Committee and Medical Executive Committee meetings, she did not directly observe and evaluate the physician or nursing staff who performed sedation/analgesia care. The Director did not routinely audit the medical records of patients who received sedation/analgesia care. The Director expected all sedation/analgesia practitioners to follow the standards and guidelines of the American Society of Anesthesiology (ASA), including the formal education, training, and annual demonstrated competence requirements outlined in the 2006 ASA Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who Are Not Anesthesia Professionals. If surgeons wished to administer deep sedation, the Director expected the surgeons to request the services of an anesthesia professional to participate in the procedure or to be immediately available. The Director acknowledged that non-anesthesiologists were routinely performing surgery on frail, elderly patients with multiple fragile co-existing conditions without requesting the presence of an anesthesia professional and stated, "but I think we have not had any bad outcomes."

In a review on 5/17/11 at 9:45 of medical staff files with the medical staff coordinator, 5 of 8 files reviewed (Physicians 1, 2, 3, 4, and 6) indicated that moderate sedation privileges were requested without documented evidence of formal and current education, training, experience, and demonstrated competence to ensure the physicians were currently knowledgeable, experienced, and competent to use/supervise sedation/analgesia treatments, including the rescue from unintended over-sedation or heart and lung instabilities that can occur with sedation/analgesia treatments.

Review on 5/18/11 of nursing personnel files indicated no documented evidence of current and updated knowledge of sedation/analgesia practices, and no return demonstration validation of sedation/analgesia administration and monitoring practices by a qualified anesthesia professional.

The hospital presented no outcomes data focused on sedation/analgesia care from a qualified source (review by an anesthesia professional) to show that sedation/analgesia care was conducted safely in accordance with ASA standards. No policies and procedures were presented to specify sedation/analgesia care be conducted in accordance with current ASA standards.

Review on 5/19/11 of the Anesthesiology Services Agreement, effective 7/1/10, referred to in the anesthesia services director's interview above, listed the duties of the Medical Director of Anesthesia Services to include:

a. Consult with and advise other Hospital departments and medical staff appointees regarding appropriate patient care and other clinical issues affecting the Department.
b. Conduct in-service education for Hospital personnel as may be required ...
c. Consult with Hospital medical staff physicians in formulating and/or reviewing patient care plans.
f. Participate full in Hospital's quality improvement program (quality improvement, peer review).
j. Maintain the policies of Hospital as they relate to the purpose of this Agreement.
k. Develop and monitor compliance with regulations, safety rules, policies and procedures for the Department ...

Review on 5/20/11 of the 2011 Association of peri-Operative Registered Nurses standards and practices documented in item IX of the Recommended Practices for Managing the Patient Receiving Moderate Sedation/Analgesia, the competency of the perioperative registered nurse to administer moderate sedation/analgesia should be assessed, demonstrated, documented, and maintained.

Based on interview, clinical record and document review, the facility failed to obtain an order when restraints were used for Patient 12.

Findings:

On 5/18/11 at 4:16 p.m., the clinical record for Patient 12 was reviewed. Review of Patient 12's clinical record revealed the following 4/25/11 nurse's note in part: "... Pt (patient) was beginning to swing at RT (Respiratory Therapist) and RN (Registered Nurse) when attempting to hold O2 (oxygen) near trach (tracheotomy - incision through the neck into the wind pipe to assist breathing), and beginning to pull at trach... Soft wrist restraints were placed at 0320 (3:20 a.m.) and pt placed back on c-pap (continuous positive airway pressure) by RT with resulting O2 sats (saturations - amount of oxygen absorbed in the blood) of 96-98%. Pt still trying to argue through c-pap and fighting and testing restraints."

Further review of Patient 12's clinical record revealed the "24 Hour Restraint Order and Flow Sheet Documentation." This document with an original date of 4/25/11 indicated the type of restraint used, physician order and nursing assessment. The section "Physician Assessment of patient need for restraint" contained the physician's signature dated 4/28/11 at 1521 (3:21 p.m.) with the following notation checked: "I have completed a comprehensive individual assessment on this patient including the potential medical problems that may be contributing to the patient's present behavior. I have determined that the restraints are medically necessary for a limited period of time."

This document was signed by the physician three days after the restraint was placed on Patient 12 (4/25/11 at 3:20 p.m.). Patient 12's clinical record review did not produce any documentation of the physician's order prior to 4/28/11.

On 5/19/11 at 1:45 p.m., an interview was conducted with the NM(Nurse Manager). After reviewing Patient 12's clinical record the NM stated she could not locate any documentation of the physician's order prior to the one written on 4/28/11.

Review of the facility's 11/09 policy "Use of Physical or Chemical Restraints" contained the following: "3. Restraint use requires an order by a physician or licensed independent practitioner (LIP) responsible for the patient's care and authorized to order restraint use. B. Medical Staff and Qualified ... (LIPs): 1. The physician must examine the patient as soon as possible when notified that restraint use is indicated, but no later than 24 hours after the initiation of non-emergent restraint use. For patients with violent or self-destructive behavior, a face-to-face examination must be made within one hour from the time the restraint was initiated."

Based on interview, clinical record and document review, the facility failed to follow their policy and procedure when orders for restraints were PRN (as needed) for Patient 2.

Findings:

On 5/19/11 at 2 p.m., the clinical record for Patient 2 was reviewed which revealed a physician's order dated 12/29/10 at 8 p.m. as follows: "May restrain PRN severe agitation/restlessness."

During a concurrent interview with the Clinical Coordinator concerning this order, she stated it was "not an acceptable order."

Review of the facility's 11/09 policy "Use of Physical or Chemical Restraints" stipulated the following: "3. Restraint use requires an order by a physician or licensed independent practitioner (LIP) responsible for the patient's care and authorized to order restraint use. They may never be ordered as a standing or PRN (as needed) order."

Based on interviews and review of facility documents, the facility failed to ensure that all patient falls were being tracked as part of the Quality Improvement Program. Two medical records for Patients' 17 and 21 did not contain information related to, their reported falls, any implemented interventions and the patients' responses to those activities.

Findings:

On 5/17/11 at 11:30 a.m., the facility's, "Event Reporting" binder was reviewed. The documentation read that Patient 17 had two reported falls without injury on 4/15/11 and 4/22/11. Further documentation also read that Patient 21 had a fall without injury on 5/13/11. An interview was conducted with the Director of Quality Management (DQM) on 5/17/11 at 1:00 p.m. and she stated that all patient falls were reviewed as part of the facility's "Quality Improvement Program." The DQM stated that a unit would call her to alert her that a fall had occurred and they would also send her a, "Fall Investigation Sheet" in order for her to investigate any fall.

On 5/18/11 at 1:30 p.m., a clinical record review was conducted on Patient 17 and Patient 21's medical record. Upon review of the medical record for both patients, there was no documented evidence that a fall had occurred. There was no mention of the fall in the care plan or nurses' notes, nothing in the physicians' notes and no documented interventions regarding the falls.

An interview with the medical-surgical unit Nursing Manager (MN) was conducted on 5/19/11 at 10:00 a.m. The MN was asked to access the electronic medical record (EMR) and retrieve the documented fall information for Patient 17 and 21 from the EMR. The MN was unable to find any documentation related to the falls before, during or after, the reported date in the EMR. The MN was asked if the falls were not documented because there was no injury and she stated that all falls are to be documented in the chart. The MN also stated that the care plan should have been revised to reflect the fall and any interventions that were implemented. In addition, the patients should have been evaluated to see if the current fall risk score was appropriate, post-fall.

On 5/19/11 at 10:30 a.m., the DQM was interviewed about Patient 17 and 21's fall documentation. On interview, the DQM stated that a staff member will usually call her about a fall and follow that up by sending her a fall worksheet. The DQM stated that she would then talk with the involved nurse, physician and pharmacist to ascertain a possible reason for the fall and any other information that she could gather. The DQM stated that she did not have any written documentation of these interviews, or what the outcomes were. The DQM stated that all the falls were called into her department, however upon further review, she did not receive fall worksheets for 2 of the 3 falls.

The DQM stated that the nurse who called her on Patient A's first fall and sent a fall worksheet was on-duty and she contacted her (LN 1) on the unit via telephone. LN 1 stated that she was the charge nurse for that unit and that she had probably called the DQM and sent the form on behalf of the nurse who was assigned to Patient A. LN 1 was asked if she, after notifying the DQM, checked to see if the involved nurse had appropriately charted on the incident and she stated, "We always should, but I must not have followed-up on this fall." The DQM was asked if this current process accurately captured the needed fall information and she stated, "No, that the current system did not always capture or show all the information needed to effectively investigate a fall in the facility."

Based on staff interview and document review, the medical staff failed to ensure that privileges were granted to practitioners in accordance with the procedures outlined in the medical staff bylaws for 6 of 8 medical staff files reviewed (Physicians 1, 2, 3, 4, 6 and 8) to ensure practitioners were qualified and competent, and subsequently to ensure safe and high quality patient care.

Findings:

In a review on 5/17/11 at 9:45 a.m. of medical staff files with the medical staff coordinator, 2 of 8 files reviewed (Physician 3, a lung specialist, and Physician 4, a general surgeon) indicated that deep sedation privileges were approved without documented evidence of formal and current education, training, experience, and demonstrated competence to ensure the physicians were currently knowledgeable, experienced, and competent to use/supervise deep sedation/analgesia treatments, including the rescue from unintended over-sedation or heart and lung instabilities that can occur with deep sedation/analgesia treatments.

Review on 5/20/11 of the 2010 American Society of Anesthesiology (ASA) Statement on Granting Privileges for Deep Sedation to Non-Anesthesiologist Sedation Practitioners documented that only physicians and other practitioners specifically permitted by the Center for Medicare and Medi-caid Services (i.e., a qualified anesthesiologist, a doctor of medicine or osteopathy, a dentist/oral surgeon/podiatrist qualified to administer anesthesia under State law, a certified registered nurse anesthetist, or an anesthesiologist's assistant) may administer or supervise the administration of deep sedation. The practitioner must complete a formal training program, demonstrate current knowledge of the complex practice, possess experience and demonstrate skill in airway assessment and ventilation of patients in a state of anesthesia, of capnography, and of heart rhythm disorders.

In an interview on 5/18/11 at 3:45 p.m. with the Medical Director of Anesthesia Services, the Director indicated that she expected all sedation/analgesia practitioners to follow the standards and guidelines of the ASA, including the formal education, training, and periodic demonstrated competence requirements outlined in the 2010 ASA Statement on Granting Privileges for Administration of Deep Sedation to Non-Anesthesiologist Sedation Practitioners. The Director stated that she had not directly observed (proctored) the performance of moderate, deep, or any other anesthesia care performed by medical staff who had approved privileges for such care. The Director also stated that she had not routinely audited the medical records of patients receiving anesthesia care in order to evaluate the performance of the medical staff in that area of care.

In a review on 5/17/11 at 9:45 a.m. of medical staff files with the medical staff coordinator, 5 of 8 files reviewed (Physicians 1, 2, 3, 4, and 6, all non-anesthesiologists) indicated that moderate sedation privileges were approved without documented evidence of formal and current education, training, experience, and demonstrated competence to ensure the physicians were currently knowledgeable, experienced, and competent to use/supervise moderate sedation/analgesia treatments, including the rescue from unintended over-sedation or heart and lung instabilities that can occur with moderate sedation/analgesia treatments. The coordinator stated that the qualifications for sedation privileges were not documented in medical staff privileging policies or rules.

On 5/19/11 at 10:30 a.m. a review was conducted with the Medical Staff Coordinator on the medical staff file for Physician 8 which indicated that a new privilege for endotracheal intubation (the insertion of a tube through the mouth into the lung airways) was requested and approved in the most recent reappointment cycle on 4/30/11. However, no evidence of recent training, experience or competency in endotracheal intubation skills were documented. The coordinator indicated that neither she or the medical staff leadership noticed that the privilege was a new request and had not sought evidence of performance before approving the privilege request.

Review on 5/17/11 of the 3/25/11 Medical Staff Bylaws, under section 5.1.2 documented that the basis for granting clinical privileges to medical staff members shall include medical education, medical training, experience, ability to perform the requested privileges, and current competence.

Based on staff interview, medical record and document review, the hospital failed to ensure that all medication and treatment orders were clarified by the staff receiving the order (for pre-operative antibiotic) and were documented in accordance with medical staff rules, policies and/or acceptable standards of practice (for intraoperative medications) for 3 of 3 medical records reviewed (Patients 7, 16, and 30).

Findings:

1. In a collaborative medical record review on 5/19/11 at 3:45 p.m. with Nurse Manager (NM), NM was asked about a physician medication order for a surgical patient (Patient 16) which was documented as a verbal order on 4/21/11 at 7:25 p.m. NM indicated that the order was very specific to administer an antibiotic (cefazolin) at a very precise time (4:30 p.m.) but no date or indication (pre-op) was stated for the order. NM stated that a nurse would interpret the order to intend the medicine to be given the next day at 4:30 p.m. The progress notes indicated that a surgical procedure was planned for the same date as the administration of the antibiotic was to occur, but the surgery time was not specified by the recorded notes. NM acknowledged that there may have been a relationship between the purpose of ordering the antibiotic and the surgery, but the nurse who noted the order did not document that she did not clarify the antibiotic order to ensure that it was administered within a time frame prior to surgery to be effective as an infection-preventing treatment. Administration of the ordered antibiotic was documented on 4/22/11 at 5 p.m., 3 hours prior to the start of surgery and not consistent with guidelines for pre-operative antibiotic administration.

Review on 5/20/11 of the 2011 Association for peri-Operative Registered Nurses (AORN) Perioperative Standards and Practices Guidance Statement related to Preoperative Patient Care in the Ambulatory Surgery Setting (which applied to settings where invasive procedures were performed) documented, "Depending on the type of prophylactic medication used, administration should occur between 30 minutes and one hour before incision."

2. Review on 5/18/11 at 4 p.m. of the surgical records for Patient 30 with the Director of Quality Management (DQM) indicated that Patient 30 had bowel surgery in an operating room (as a planned procedure and different level of care, not in his unit room as an emergency) on 2/24/11. Moderate sedation (the administration of drugs to render a minimally depressed level of consciousness that allows a surgical patient to retain the ability to independently and continuously maintain a patent airway and respond appropriately to verbal commands and physical stimulation, also known as moderate sedation/analgesia, conscious sedation and intravenous sedation) medications were administered by a registered nurse (RN) at varying intervals over a 45 minute period, and documented on a form titled Invasive Procedures with Moderate Sedation. Additional medications administered included intravenous fluids and oxygen administration with several changes in concentration documented. No specific surgical admission/discharge orders were documented. DQM stated that the surgeon directed the nurse to administer each medication entry verbally. DQM acknowledged that each entry was not specifically documented as a verbal order with read back verification. Instead a single physician signature (untimed) on page 3 of the form was intended to globally authorize all physician orders for medications, supplies, and specimens used in the procedure. In addition, treatment orders for return to the patient care unit following surgery were not clearly documented.

The same types of documentation issues for medication administrations and patient care activities were identified in the medical records for Patient 7 (who had bowel surgery on 2/9/11) and for Patient 16 (who had bowel surgery on 4/22/11). Patients 7, 16 and 30 each had special airway management treatments but no perioperative orders were documented by the practitioner responsible for managing those treatments throughout the surgical experience (orders for ventilator settings, positive pressure device settings, suctioning, etc).

Review on 5/17/11 of the hosptial policy, dated 07-002, titled "General Documentation Guidelines", presented as current, required under item 14 for verbal orders to be read back by the person receiving the order (and documented), and authenticated by the responsible practitioner within 48 hours.

Review on 5/17/11 of the 3/25/11 Medical Staff Rules item B-7 documented, "All clinical entries in the patient's medical record shall be accurately dated, timed, and authenticated." Item C-2 noted, "All verbal orders shall be transcribed in the medical record and shall be countersigned by the practitioner (within 48 hours)." Item C-3 documented, "Orders must be reviewed and rewritten/reentered, as appropriate, by the responsible practitioner when patients are transferred to or from ICU (Intensive Care Unit) and following surgery."

Of note, item E of the 3/25/11 Medical Staff Rules documented that the level of care provided to patients who had been administered anesthesia in areas outside the operating room was comparable to that provided in the operating room.

Based on observation and staff interview, the hospital failed to ensure that adequate personnel were employed to ensure prompt completion, assembly, and filing of records.

Findings:
A tour of the Health Information Management (HIM) department was made with the supervisor beginning at 12:40 PM on 5/17/11. A moveable cart containing records was noted. The supervisor stated that these were records of recently discharged patients which were waiting to be processed. There were a total of 12 records, with the oldest discharge date of 5/4/11. She further stated that her goal is to complete these records within 72 hours of the patient's discharge. Also observed were 3-4 rows of records in a section of the files. The supervisor stated that these were records which needed to have additional processing done prior to being filed as "complete." She estimated these records dated back to discharges from December 2010. A count of these records done on 5/20/11 revealed a total of 117 records awaiting this final processing step.

During further interviews with the HIM supervisor on 5/19/11, she stated that there were no other employees to assist her (she is the only employee in the HIM department). When asked who covers for her when she is absent or on vacation, she stated that she has not taken more than a few days off at a time during her 2 plus years of employment at the hospital.

The Chief Financial Officer was interviewed on 5/19/11 at approximately 3:00 p.m. He confirmed that there were no additional staff to assist the HIM supervisor with the workload or any staff who were trained to cover during her absences.

Based on interviews and review of facility documents, the facility failed to ensure that the medical records of two patients (17,21) contained information related to, their reported falls, any implemented interventions and the patients' responses to those activities.

Findings:

On 5/17/11 at 11:30 a.m., the facility's, "Event Reporting" binder was reviewed. The documentation read that Patient 17 had two reported falls without injury on 4/15/11 and 4/22/11. Further documentation also read that Patient 21 had a fall without injury on 5/13/11. An interview was conducted with the Director of Quality Management (DQM) on 5/17/11 at 1:00 p.m. and she stated that all patient falls were reviewed as part of the facility's, Quality Improvement Program." The DQM stated that a unit would call her to alert her that a fall had occurred and they would also send her a, "Fall Investigation Sheet" in order for her to investigate any fall.

On 5/18/11 at 1:30 p.m., a clinical record review was conducted on Patient 17 and Patient 21's medical record. Upon review of the medical record for both patients, there was no documented evidence that a fall had occurred. There was no mention of the fall in the care plan or nurses' notes, nothing in the physicians' notes and no documented interventions regarding the falls.

An interview with the medical-surgical unit Nursing Manager (Mgr.) was conducted on 5/19/11 at 10:00 a.m. The Mgr. was asked to access the electronic medical record (EMR) and retrieve the documented fall information for Patient 17 and 21 from the EMR. The Mgr. was unable to find any documentation related to the falls before, during or after, the reported date in the EMR. The Mgr. was asked if the falls were not documented because there was no injury and she stated that all falls are to be documented in the chart. The Mgr. also stated that the care plan should have been revised to reflect the fall and any interventions that were implemented. In addition, the patients should have been evaluated to see if the current fall risk score was appropriate, post-fall.

On 5/19/11 at 10:30 a.m., the DQM was interviewed about Patient 17 and 21's fall documentation. On interview, the DQM stated that a staff member will usually call her about a fall and follow that up by sending her a fall worksheet. The DQM stated that she would then talk with the involved nurse, physician and pharmacist to ascertain a possible reason for the fall and any other information that she could gather. The DQM stated that she did not have any written documentation of these interviews, or what the outcomes were. The DQM stated that all the falls were called into her department, however upon further review, she did not receive any fall worksheets for 2 of the 3 falls.

The DQM stated that the nurse who called her on Patient A's first fall and sent a fall worksheet was on-duty and she contacted her (LN 1) on the unit via telephone. LN 1 stated that she was the charge nurse for that unit and that she had probably called the DQM and sent the form on behalf of the nurse who was assigned to Patient A. LN 1 was asked if she, after notifying the DQM, checked to see if the involved nurse had appropriately charted on the incident and she stated, "We always should, but I must not have followed-up on this fall." The DQM was asked if this current process accurately captured the needed fall information and she stated, "No, that the current system did not always capture or show all the information needed to effectively investigate a fall in the facility."

Based on interview, clinical record and document review, the facility failed to ensure telephone orders were signed by the physician within 48 hours for Patients 9 and 27.

Findings:

On 5/17/11 at 1:17 p.m., the clinical record for Patient 9 was reviewed. Review of the clincal record revealed a telephone order dated 5/6/11 for clarification of a diet order. The telephone order was co-signed by the physician on 5/11/11, 5 days after the telephone order was obtained.

On 5/17/11 at 2:18 p.m., an interview was conducted with LN 7. When questioned about telephone orders and when they should be co-signed by the physician, LN 7 stated it should be done "as soon as possible or the next day."

On 5/19/11 at 3:42 p.m., the clinical record for Patient 27 was reviewed. Review of the clinical record revealed two telephone orders both dated as received on 5/2/11. The telephone orders were co-signed by the physician on 5/7/11, 5 days after the orders were obtained.

Review of the facility's policy "Verbal, Telephone and Hazardous Orders", revised 1/2009 by the Medical Staff Administration stipulated the following: "C. Medication and other orders will be authenticated within 48 hours."

Based on interview and document review, the facility failed to implement their radiology procedures to ensure personnel were free from hazards when the film badges were not monitored monthly for radiation exposure.

Findings:

On 5/17/11 at 12:20 p.m., examination of the Radiology Department was conducted with the Radiology Supervisor (RS). The RS provided documentation of file badge monitoring. According the document "Radiation Dosimetry (instrument for measuring the amount of radiation absorbed) Report" the monitoring for the film badges were done for the periods of 01/10/11 to 03/09/11, 11/10/10 to 01/09/11 and 09/10/10 to 11/09/10. The RS stated the film badges were being monitored and changed every 2 months.

Review of the facility's 3/94 policy "Radiation Protection - Exposure to Staff'" stipulated the following: "2. Each person is responsible for his own film badge/ring. This includes the responsibility for exchanging the badge/ring at the beginning of each month and returing the old one. C. Radiation exposure is monitored monthly by the Radiation Detection Company and records are maintained on file by the Radiology Director."

Based on observation, interview, and document review, the hospital failed to ensure the dietetic services department was organized to ensure foods were stored using safe and sanitary methods as evidenced by outdated foods that were available for patient food preparation, bread was stored at temperatures that maximize staleness, and prepared foods were not discarded following hospital policies.

Findings:

On 5/17/11 between 8:30 a.m.-10:00 a.m. during the initial tour of the kitchen, the following was observed:

In the walk-in refrigerator there was:
a. A plastic covered container of Jalapenos labeled "Use by 5/7", a plastic covered container of lemon jello and another container of strawberry jello, labeled "Use by 5/16."
b. 10 loaves of white bread, hot dog buns, wheat bread. Information from the food vendor specified "never refrigerate bread, freeze or store at room temperature."

In the walk-in freezer there was
a. Two bags of Hushpuppy meatballs, one labeled "Use by 4/11", and the other labeled "Use by 3/11."
b. Undated, prepared products, all out of the original packaging, including: pancakes, French toast, pound cake, and Philadelphia cheese beef. Hospital policy specified all food taken out of the original packaging be labeled and dated. Dietary Staff B stated she was unable to state how long the products had been there, nor how long the manufacturer claimed they were safe to use.

In the ICU nourishment room there were three "Thick and Easy" individual juices, two had expiration dates 4/27/11 and one had expiration 3/27/11.

On 4/18/11 during an interview at 10:30 a.m., Dietary Staff B acknowledged foods needed to be discarded by the "use-by" dates, bread should never be stored in the refrigerator, and foods taken out of the original packaging must have a "use by" date based on manufacturer's specifications, to ensure it is safe to use. During a concurrent interview, Dietary Management Staff A stated the policies and procedures needed some editing to ensure food safety.

Based on observation, interview, and medical record reviews the facility failed to develop systems for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel as evidenced by:

1. The hospital failed to ensure personnel were consistently screened for infectious diseases according to acceptable standards of practice.

2. The hospital failed to ensure environmental conditions (such as air exchange measurements) were monitored in accordance with nationally recognized standards.

3. Hospital personnel failed to wear personal protective equipment in the surgery suite(s) in accordance with nationally recognized standards of practice.

4. The hospital failed to ensure appropriate personal protective equipment (PPE) was worn when reprocessing an endoscope in the sterile reprocessing room in accordance with nationally recognized standards of practice.

5. Surgical personnel failed to decontaminate and reprocess endoscope equipment in accordance with nationally recognized standards of practice when:
a. The hospital failed to reprocess endoscopes if they went unused for more than five days.
b. Endoscopes were taken from the sterile reprocessing area to the post anesthesia care unit (PACU) to be dried.

6. Surgical instruments were not processed according to nationally recognized standards of practice.

7. Preoperative surgery site hair removal from patients is done in accordance with nationally recognized standards of practice.

8. Traffic patterns in the operating room suite did not conform to nationally recognized standards of practice.

9. The hospital failed to ensure the physician consistently documented the ongoing medical neccesity of need for central line(s) for Patient's 6 and 18.

Findings:

1. During an interview on 5/18/11 at 8:45 a.m. with the Human Resources/Medical Staff Coordinator (HR/MED ST Cord), she indicated the medical staff 's tuberculosis status was evaluated every two years at the time of their reappointment. HR/MED ST Cord indicated the hospital follows CDC guidelines for Tuberculosis screening and acknowledged that the medical staff should have been screened annually for tuberculosis along with the other facility healthcare workers.

During an interview on 5/19/11 at 12:30 p.m. with the Nusrising Manager, she acknowledged some of the healthcare workers records needed to be updated for evidence of immunity or vaccination to MMR, varicella, and influenza.

A review of ten facility healthcare worker and physician provider medical files was conducted on 5/18/11 at 2:00 p.m. Seven of the ten files reviewed, (RN 4, RN 6, RN 7, and Physician's 1,2,3,4, and 5) did not contain evidence of the employee's immune status or vaccination for one or more of the following communicable diseases: influenza, measles, mumps, rubella, hepatitis b and/or varicella. The review confirmed the facility was screening the majority of medical providers every two years for tuberculosis.

According to the Centers for Communicable Diseases (CDC) Guidelines for Preventing the Transmission of Mycobacterium tuberculosis (a in Health-Care Setting, 2005, page 10, "the classification of medium risk should be applied to settings in which the risk assessment has determined that health care workers (HCW) will or will possibly be exposed to persons with TB disease or to clinical specimens that might contain M. tuberculosis. The recommendations for medium risk included, "All HCWs should receive baseline TB screening (checked to identify presence of the disease) upon hire, using two-step TST (skin test) or a single BAMT (alternate test) to test for infection," and "After baseline testing for infection, HCWs should receive TB screening annually."

Review on 5/19/11 at 8 p.m. of the 7/30/09 Association for Professionals in Infection Control and Epidemiology (APIC) Position Paper: Safe Injection, Infusion and Medication Vial Practices in Healthcare indicated that healthcare workers whose activities involved contact with blood or body fluids be offered hepatitis B vaccination. The national guideline also recommended that compliance with safe injection practices be periodically assessed "by observing and evaluating personnel performing these procedures."

Review on 5/19/11 at 2 p.m. of the CDC Morbidity and Mortality World Report (MMWR Volume 46, Number RR-18, December 26, 1997) documented on page 24: Persons who work within medical facilities should be immune to measles and rubella. Immunity to mumps is highly desirable for all HCWs. Because any HCW (i.e., medical or nonmedical, paid or volunteer, full time or part time, student or nonstudent, with or without patient-care responsibilities) who is susceptible can, if exposed, contract and transmit measles or rubella, all medical institutions (e.g., inpatient and outpatient, public and private) should ensure that those who work within their facilities* are immune to measles and rubella. Likewise, HCWs have a responsibility to avoid causing harm to patients by preventing transmission of these diseases. On page 25, the MMWR documented: All HCWs should ensure that they are immune to varicella.

Review on 5/19/11 at 2 p.m. of the CDC MMWR Early Release Volume 55, dated February 9, 2006, recommended annual vaccination for influenza for all health care workers.

Review on 5/19/11 at 2 p.m. of the 2011 Association for peri-Operative Registered Nurses Recommended Practices for Prevention of Transmissible Infections in the Perioperative Practice Setting (page 295), Recommendation VIII.1. addressed the immunization and/or screening of health care workers for hepatitis B virus. Recommendation VIII.2. read, "Health care workers should be immunized against other communicable and infectious agents," with a footnote reference to the CDC MMWRs above.

Review on 5/19/11 at 2 p.m. of a revised California Department of Public Health (CDPH) All Facilities Letter to general acute care hospitals (AFL 10-29), dated 9/16/10, indicated that licensed hospitals were required to report to CDPH the status of influenza vaccination of all health care workers annually (each influenza season). The hospital presented no evidence of the influenza vaccination status for the 200+ medical staff members discussed with the medical staff coordinator.

A review of the facility policy and procedure titled Employee Immunizations, dated 11/2010, provided the following direction, " Individuals who lack proof of immunization to measles, mumps, rubella (MMR), and varicella will be tested for immunity and offered the vaccine if found to be susceptible. The facility will comply with the ACIP and CDC guidelines for the administration of vaccines."Physicians were included among the types of employees the hospital screened under this policy.

2. During an interview with the maintenance supervisor (Maint) on 5/17/11 at 1:20 p.m., he was unable to produce any evidence of the air exchange rates in the perioperative areas. Maint produced the facility building plans and indicated the facility had been built to specifications which included calculated air exchange rates by minute in the perioperative areas. He asserted because the facility was new it must meet the plan building specifications.

Review of the facility's policy and procedure titled "Operating Room General Safety", reviewed 3/10, included under 1iii) Environmental Control in the Operating Room: "Air exchanges are maintained at 15 per hour."

According to AORN Perioperative Standards and Recommended Practices 2011 Edition, under Recommendation V.d. the following direction was provided: "The air exchange rate in the perioperative area should be carefully controlled. The number of air exchanges per hour is based upon the need to remove microbiological or chemical contaminants from the environment." Addition direction was provided under V.d..1., "The minimum rate of total air exchanges per hour should be maintained at a constant level as follows: Operating Room: minimum of 15 exchanges per hour with a recommended range of 20-25 air exchanges; Post Anesthesia Care Unit: six air exchanges per hour; Sterile storage area: four exchanges per hour.
3.From 5/17/11 through 5/19/11 the Chief Clinical Officer (CCO) and Maint were observed in the operating rooms in their regular work clothes.

The CMS guidelines use the following definition of surgery, developed by the American College of Surgeons, to determine whether or not a procedure constitutes surgery and is subject to surgical services Condition of Participation: " Surgery is performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. Surgery also is the diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of live human tissue which include lasers, ultrasound, ionizing radiation, scalpels, probes, and needles. The tissue can be cut, burned, vaporized, frozen, sutured, probed, or manipulated by closed reductions for major dislocations or fractures, or otherwise altered by mechanical, thermal, light-based, electromagnetic, or chemical means. Injection of diagnostic or therapeutic substances into body cavities, internal organs, joints, sensory organs, and the central nervous system also is considered to be surgery (this does not include the administration by nursing personnel of some injections, subcutaneous, intramuscular, and intravenous, when ordered by a physician)."

The definition of surgery, according to the American College of Surgeons, was reviewed on 5/19/11 at 10:50 a.m. with the Infection Contol Nurse (ICN), and during a concurrent interview, she acknowledged the procedures being done in the hospital operating rooms were surgeries. The ICN acknowledged hospital staff members should wear surgical attire when they entered the operating rooms.

On 5/19/11 at 1:50 p.m., review of the facility's policy and procedure titled "Operating Room General Safety", dated last reviewed 3/10, included under 11 a. i) "Any person in the operating room must wear correct attire: scrub suit, cap, mask, and shoe covers."

On 5/19/11 at 2 p.m., the 2011, Perioperative Standards and Recommended Practices, published by AORN were reviewed. On page 61, under Recommendation III, direction was given that, "All individuals who enter the semi-restricted and restricted areas should wear freshly laundered surgical attire that is laundered at a healthcare-accredited laundry facility or disposable surgical attire provided by the facility and intended for use within the perioperative setting.

On page 96, under Recommendation 1, direction was given that " Persons entering the semirestricted or restricted areas of the surgical suite for a brief time for a specific purpose (eg, biomedical engineers) should cover all head and facial hair and may don either freshly laundered surgical attire or a single use coverall suit (eg, jumpsuit) designed to totally cover outside apparel.

4. On 5/18/11 between 8:30 a.m. and 8:50 a.m., the RespiratoryTherapist (RT) Sup was observed decontaminating and reprocessing a bronchial endoscope. The RT Sup wore her work uniform and she donned only gloves at the beginning of the procedure. While decontaminating the scope, the RT Sup pointed out the blood and mucous that was being removed from the scope.

During an interview with RT Sup on 5/19/11 at 11:35 a.m., she acknowledged she should have worn personal protective equipment when cleaning and disinfecting the endoscope.

The hospital policy and procedure titled "Endoscope (Flexible, Fibroptic) Cleaning and Disinfection", dated last revised 7/09, was reviewed on 5/18/11 at 1 p.m. On page one under Policy D., direction was given that "Personal protective equipment (PPE) is to be worn during cleaning and disinfecting procedures. On page one under Policy C. direction was given that " Personnel must practice universal precautions when handling and processing FEE's accessories, and related equipment to reduce the risk of exposure to blood, body fluids, and other fluids that may contain bloodborne pathogens. On page two under 4 A. " Equipment to Have Readily Available included: "gloves, goggles, mask, and a personal protective gown." On page two under IV B 5. Direction is again given to: "Wear PPE during cleaning and disinfecting procedure."

On 5/19/11 at 2:30 p.m., the 2011, the Perioperative Standards and Recommended Practices, published by AORN were reviewed. On page 423, under Recommendation XII.a., "Personnel Handling Contaminated Endoscopic Equipment Must Wear Appropriate PPE " direction was given that "Personal protective equipment consistent with the anticipated exposure must be worn. The appropriate PPE for these types of exposures includes, but is not limited to, a fluid resistant gown, disposable chemical resistant glove, a mask, and face protection. Splashes, splatters, and skin contact can be reasonably anticipated when handling contaminated flexible endoscopes."

5.a On 5/18/11 at 4 p.m., the hospital's Endoscope Cleaning Log was reviewed for the dates 1/5/11 through 4/711. The cleaning schedules documented the cleaning schedules for four endocopes numberd as 665, 093, 309, and 053. All four endscopes were documented as having had one or more periods of going unused 6 to 43 days before being reprocessed. Documentation indicated endocscope 665 was reproccessed on 1/26/11 and was not documented as used or reprocessed again until 43 days later on 3/16/11.

During an interview with Licensed Nurse 3 (LN 3) on 5/19/11 at 9:45 a.m., he responded endoscopes were reprocessed if they went unused for more than 30 days.

The hospital policy and procedure titled "Endoscope (Flexible, Fibroptic) Cleaning and Disinfection", dated revised 7/09, was reviewed on 5/18/11 at 1p.m.and found to not contain guidelines for the frequency of cleaning the endoscopes.

The 2011 perioperative standards and recommended practices published by the Association of periOperative Registered Nurses (AORN) on page 421 Recommendation IX.b. indicated: "Flexible endoscopes should be reprocessed before use if unused more than five days."

5b. On 5/18/11 at 9:50 a.m., an endoscope, having just been disinfected , was observed being carried by the Respiratory Therapist (RT) Sup in a clean towel from the sterilization room, where it had been reprocessed, and laid upon a sheeted gurney in the post anesthesia care unit (PACU). The endoscope was then dried using compressed air in the PACU.

During an interview with Infection Control Nurse (ICN) on 5/19/11 at 10:20 a.m., she acknowledged the endoscope should not have been taken from the sterilization room to the PACU for drying. The infection control nurse (ICN) acknowledged moving the endoscope to PACU placed it at risk for cross contamination as the cleanliness or the gurney and the sheet on top of it was unknown. Additionally, the ICN acknowledged the scope was moved from a semi-restricted area (the sterilzation room) to a non restriced area (PACU).

The hospital's policy and procedure titled "Endoscope (Flexible, Fibroptic) Cleaning and Disinfection," dated revised 7/09, was reviewed on 5/18/11 at 1p.m. The hospital's policy/procedure indicated the endoscope should be brought to the "Sterilization Room" for disinfection and drying.

6. On 5/17/11 at 9 a.m., two pairs of scissors, in the closed position, were observed in sealed peel pouches in the second drawer of a cart located in operating room one.

During an interview with the Licensed Nurse 3 (LN3) on 5/19/11 at 9:30 a.m., he acknowledged he had sterilized scissors in the closed position. He stated this occurred when he "mass sterilized surgical supplies"

During an interview with the Infection Control Nurse (ICN) on 5/19/11 at 10:30 a.m., she agreed surgical instruments should be placed in the peel pack pouch in the open position, and she acknowledged their may be a need for more ICN oversight/monitoring of the surgical supply sterilization processes.

On 5/3/11 at 4 p.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN was reviewed. On page 430, direction was given that, "Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces and instruments with hinges should be opened..." On page 431, direction was given that, "Instruments should be kept in the open and unlocked position using instrument stringers, racks, or instrument pegs designed to contain instruments."

7. On 5/18/11 two razors were observed in the first drawer of a cart located in the operating room.

During an interview with the Infection Control Nurse (ICN) on 5/19/11 at 10:40 a.m., she acknowledged hospital staff were using razors to remove hair preoperatively. The ICN also acknowledgd the standard of practice was to use clippers, not razors, when patients require hair removal prior to a procedure.

On 5/19/11 at 12 p.m. the hospital policy and procedure titled "Skin Preparation of Patients", dated 2/10, was reviewed. On page one under IV A.3. direction was provided that, "A razor shave may be used when an electric clipper is not available or when a physician orders a razor shave."

On 5/19/11 at 3:30 p.m., the 2011, Perioperative Standards and Recommended Practices, published by AORN was reviewed. On page 367, under Recommendation IV.b., direction was provided that "Hair at the surgical site should not be removed with a razor. Shaving increases the risk of surgical site infection." Under IV.b.2, direction is provided that " Hair removal should be performed the day of surgery, in a location outside of the operating or procedure room. Only hair interfering with surgery should be removed. Hair should be clipped using a single-use electric or battery operated clipper, or a clipper with a reusable head that can be disinfected between patients."

8. On 5/17/11 at 9 a.m., during the initial tour, no signage or floor marking were observed in the perioperative area denoting the location of the semirestricted areas

During an interview with the Licensed Nurse (LN) 3 on 5/19/11 at 9:40 a.m., he indicated that he did not know why the decontamination and sterile processing areas located in the perioperative area were not behind the red line (referring to a line that indicated entrance into semirestricted/restricted areas of the perioperative area). He acknowledged the deconatamination and sterile processing areas should be included in the semirestricted zone of the perioperative area as well as the portion of the hallways leading to the surgical suites.

During an interview with ICN on 5/19/11 at 10:40 a.m., she acknowledged the perioperative area did not have accurate signage and floor markings to indicate the semi-restricted areas.

On 5/19/11 at 8 a.m. a review of the hospital policy and procedure titled "Traffic Patterns in the Surgical Suite", dated 3/10, indicated under its scope the policy requires all hospital personnel, surgeons, anesthesiologists, observers, surgical patients, and visitors to observe traffic flow patterns in the hospital 's surgical department. Included under section V. B. direction is provided that, "The semi-restricted zone serves as an intermediate access between the OR and restricted corridors. Included are the decontamination rooms, storage rooms, workrooms, scrub sinks, and corridors leading to the restricted areas of the surgical suite. Traffic is limited to authorized personnel and patients. Personnel are to wear surgical attire, hair, and shoe coverings as appropriate. The restricted zone includes the operating rooms, procedure rooms, areas where unwrapped supplies are sterilized or packaged. Personnel are to wear surgical attire, masks, hair, and shoe coverings as appropriate."

9. Patient 7, an 84 year old, was admitted to the hospital on 2/4/11 with diagnoses that included acute respiratory failure.

Patient 7 was admitted to the hospital with a peripherally inserted central catheter (PICC). A PICC is a long, slender, small, flexible tube that is inserted into a peripheral vein, typically in the upper arm, and advanced until the catheter tip terminates in a large vein in the chest near the heart to obtain intravenous access.

A review of Patient 7's medical record was conducted on 5/18/11 at 10:10 a.m. Record documentation revealed there was no documentation of the medical necessity of Patient 7's PICC line for seven of the eight days Patient 7 resided at the hospital.

Patient 18, a 61 year old, was admitted to the hospital on 3/23/11 with diagnoses including respiratory failure and end-stage renal failure.

A review of patient 18's medical record was conducted on 5/18/11 at 10 a.m. Record documentation revealed from 3/28/11 through 5/18/11, for 20 days, there was no daily physician documentation for the medical necessity of Patient 18's central line. It was also noted the hemodialysis summary stamp was placed over and partially occluded the "Central Line Daily Necessity Assessment" stamp located on the Physicians Progress Notes for the dates 4/11/11 through 4/18/11.

A review of the hospital's "Central Line Daily Necessity Assessment" stamp included the following attestation statement: "I attest the Central Line is necessary for the following reasons: Hemodialysis, Limited Vascular Access; Volume Presssure Managment; Long Term Drug Treatment; Frequent Blood Draws; Infusates with PH <5 or > than 9; or Continuous Vesicant. The stamp was located on the lower right corner of the "Physician's Progress Note" forms.

During an inteview with the Infection Control Nurse (ICN) on 5/19/11 at 11:10 a.m., she acknowledged there had been difficulty in obtaining consistent physician documentation on the Central Line Daily Necessity Assessment in accordance with the hospital's protocol for reduction of central line infections. The ICN admitted she was not aware that sometimes the Hemodialysis Summary sticker was placed over and partially occluded the Central Line Assessment stamp.

Based on an interview along with clinical record review and facility document review, the facility failed to implement the procedure to identify discharge planning needs for Patient 22 within 2 business days of admission.

Findings:

Patient 22 was admitted on 5/13/11 with a diagnosis of acute respiratory failure. The Department reviewed Patient 22's chart on 5/19/11 via the electronic medical record and there was no indication that the discharge planning process had been initiated.

On 5/19/11 at 10:45 a.m., the case manager in charge of Patient 22 was interviewed about the discharge planning process. The case manager stated that "It had not been started yet, I haven't had a chance". Later the case manager provided a print out identifying that the initial discharge planning process started on 5/18/11, which still exceeds the 2 business days.

A review of the facility document titled Discharge Planning, Policy number H-ML-10-013, under Procedure, item 1; Within 2 business days of admission, the Case Manager will identify discharge planning needs... .

Based on interview, clinical record and document review, the facility failed to implement written protocols for organ donation for Patients 8, 9 and 10.

Findings:

On 5/17/11 at 8:37 a.m., the clinical records for Patients 8, 9, and 10 were reviewed. Review of the Patients' clinical records revealed a document "Anatomical Gift by a Living Donor." Each document was signed by the patients but left blank in the section to mark for the appropriate choices to indicate the patient's desires. This document was incomplete with no indication to alert the Organ Procurement Organization to the patients' wishes.

On 5/19/11 at 2:04 p.m., an interview was conducted with the HIM. The HIM was questioned about the "Anatomical Gift by a Living Donor" document and she stated the form was not filled out completely. The "Admissions Clerk is responsible for assisting the patients with filling out this form." stated the HIM and this was not done.

According to the facility's 11/10 policy "Organ and Tissue Donation" the following procedure was to be conducted on admission: "B. The patient/family ' s donation preference will be documented in the section of the medical record as determined by the hospital."

Based on observation, staff interviews, medical record and document reviews, the hospital failed to ensure that the scope of surgical services was clearly (by documentation) organized to ensure that surgical personnel reported to qualified surgical managers with knowledge and expertise in surgical service operations.

Findings:

1. In an interview with Nurse Manager (NM) 1 on 5/17/11 at 8:45 a.m., NM 1 stated that surgical procedures were performed in the hospital. The procedures were performed either in the operating room or at the bedside utilizing a consistent surgical crew that included one registered nurse (RN 4), one operating room technician (ORT) , and one licensed vocational nurse (LVN 3) regardless of which surgeon was performing the procedure. Review with NM 1 of the surgical records for Patient 16 who underwent a stomach surgery on 4/22/11 confirmed the signatures of the surgical crew members mentioned by NM 1.

Review on 5/18/11 of the hospital's "Current Employee List" for May 2011, presented as the department roster for surgical and other services, documented three names under the section titled "Operating Room." The three names corresponded to RN 4, ORT, and the RN Operating Room Supervisor. The listing did not note the job titles for these persons, nor the reporting relationships among the persons. LVN 3 was listed under the intensive care department, and not the operating room department.

In an interview with the medical staff coordinator on 5/18/11 at 9:45 a.m., the coordinator indicated that Physician 4 (a general surgeon) held a leadership position titled "Medical Director of Surgery." Review of the medical staff file for Physician 4 did not contain a duty statement or evidence that Physician 4 performed oversight of operating room procedures or personnel. Neither did leadership committee meeting minutes for 2010-2011 show that Physician 4 performed any management or oversight of operating room services.

Review on 5/19/11 of operating room administrative policy 1.5 titled Medical Director of Surgical Services documented that a Board-certified (with the American Board of Surgery) member of the medical staff would assure that all patients having surgical procedures would receive quality care. Various consulting duties were described. However, no direct authority over personnel, or responsibility for operations, were included in the duties listed.

Among the organization charts and staff rosters presented by hospital leadership during the survey, there was no documented evidence of the chain of command for surgical services, from the front line nursing and technical staff up to the managers and supervisors who evaluated the provision of care, in order to document who was responsible and accountable for the duties rendered at each level.

No job description or policy and procedure was presented that specified the qualifications and surgical oversight duties of a Operating Room Nurse Manager/Supervisor.
In an interview with the Director of Quality Management on 5/17/11, the DQM indicated that LN 6 was the designated Operating Room Nurse Supervisor.





28991

Based on staff interviews, and document reviews, the hospital failed to ensure that a qualified registered nurse or doctor of medicine/osteopathy with knowledge and expertise in sterile processing, staffing, scope of practice, and infection control effectively supervised the operating rooms and surgical operations in order to ensure safety and minimize infections for all patients.

Findings:

1. In an interview with the medical staff coordinator on 5/18/11 at 9:45 a.m., the coordinator indicated that Physician 4 (a Board-certified general surgeon) held a leadership position titled "Medical Director of Surgery." Review of the medical staff file for Physician 4 did not contain a duty statement or evidence that Physician 4 performed oversight of operating room procedures or personnel. The coordinator indicated that Physician 4 had low clinical activity for 2010, performing only 2 procedures and 5 consults.

Review on 5/19/11 of operating room administrative policy 1.5 titled "Medical Director of Surgical Services" documented that a Board-certified (with the American Board of Surgery) member of the medical staff would assure that all patients having surgical procedures would receive quality care. Various consulting duties were described. However, no qualifications for knowledge and experience in sterile processing, staffing of nursing and technical personnel in accordance with state laws, scope of practice, and nationally recognized standards of operating room staffing and procedures, or infection control training and expertise were included in the requirements for this position.

Review of the hospital leadership minutes for 2010-2011 did not show active participation in the way of reports or recommendations from Physician 4 related to surgical operations and policies.

In a telephone interview on 5/19/11 at 1 p.m. with the President of the medical staff, the President indicated that Physician 4 held the position of Medical Director of Surgical Services. The President was not certain whether Physician 4 had directed the hospital to function in accordance with any particular surgical standards of practice for managing the operating rooms and practices. The President was not aware that operating room technicians and non-RN assistants were manipulating surgical instruments outside of their scope of practice. The President was not aware that instruments were not being processed correctly. The President was not aware that the RN operating room manager was not certified with documented training in sterile processing and operating room practices. The President acknowledged that although Physician 4 was a general surgeon, he may not possess the knowledge and expertise in managing sterile processing, staffing, personnel training, and infection control direction to achieve surgical care practices that conform to nationally recognized standards, such as those noted by the Association of peri-Operative Nurses (AORN).

2. During an interview with LN 6 on 5/17/11 at 9 a.m., she confirmed she was the facility operating room supervisor. LN 6 stated she also worked full-time at a local nursing convalescent hospital. The convalescent hosptial did not perform surgery.

Review of LN 6's personnel file on 5/18/11 at 1p.m. included no evidence of recent experience and formal professional education in the delivery and supervision of surgical services. LN 6's last experience working in an operating room was in 1994.

Review of LN 6's Annual Performance Appraisal Form, dated 11/29/10 stated "LN 6 works per diem and is working to make sure the OR is ready when we start doing procedures." The appraisal form also documented LN 6 required more training in performing conscious sedation.

Review of the Operating Room Supervisor Job Description included under "Summary of Major Essential Functions" the following: "Overseas the OR and Special Procedure Area. Circulates and /or scrubs for cases in the OR/at the bedside. Competent in the adminstration of IV sedation under the direction of a physician privliged in IV sedation. Performs audits and assists in the monitoring of performance improvement for both the OR and for nursing. Supports nursing department as a supervisor by assisting with staffing, scheduling, completing staff evaluations, and coaching staff. Attends meetings as required."

Based on staff interview, medical record and document review, the hospital failed to arrange and implement supervision in accordance with acceptable standards of practice and scope of practice by a registered nurse (RN) of licensed practical nurses (LPN) and operating room technicians (ORT) during surgical procedures for 2 of 2 LPN/ORT personnel reviewed (LVN 3 and ORT 1).

Findings:

In an interview on 5/19/11 at 9:15 a.m. with licensed vocational nurse (LVN) 3, LVN 3 indicated that he and operating room technician (ORT) 1 routinely performed surgical technician duties for surgical procedures both in the operating room and at the bedside. Many of the planned procedures were performed in the evening hours when the bowel surgeon was most available. Usually there would be a dedicated sedation RN to monitor the patient and a surgeon who was performing the procedure. LVN 3 or ORT 1 would set up the surgical equipment and supplies, hand items to the surgeon, and assist in manipulating certain surgical instruments when requested by the surgeon (grasping, clamping, and clipping/cutting tissue for biopsy). If both LVN 3 and ORT 1 were staffed for the procedure, one would function as a "circulator" to position the patient, retrieve drugs and supplies, tend to equipment malfunctions, particularly if the other "scrub" was in sterile attire assisting the surgeon. No circulating RN was usually present for the procedures. If an emergency occurred, the team would push a "code blue" button for staff from the ICU to respond (rapid response team). The rapid response team members would need to leave their patient assignments in order to respond.

Review of the medical records for Patients 7, 16 and 30 indicated that the signatures on surgical records included those for a sedation RN, a scrub/assist, and for Patient 30 an additional non-RN staff. No supervising RN or circulating RN signatures were documented.

Review on 5/19/11 of the job description for LVN 3 titled License Vocational Nurse: Operating Room, presented as current, indicated a requirement for a RN license, which LVN 3 did not possess. In addition to sterile processing and scrub technician duties, the LVN was responsible to ensure the scrub technician was competent in surgical procedures, instrument set up, and counts of instruments (as though the LVN supervised the scrub tech). Duties also included, "Functions in circulating nurse position during surgery. Coordinates anesthesia management during the intr operative period." The LVN also functioned as a "scrub" when another OR nurse was circulating.

Review on 5/19/11 of the job description for Registered Nurse: Operating Room, presented as current, was identical to License Vocational Nurse: Operating Room.

Review on 5/19/11 of the job description for the sedation RN titled OR/Special Procedures Nurse, presented as current, documented duties which included oversight of the OR/Procedures area, schedule coordination, circulating and/or scrub duties, administration and monitoring of moderate sedation, evaluating and coaching staff (not specified which staff), and sterile processing skills.

Review on 5/19/11 of the job description for ORT 1 titled OR Technician/Special Procedures Assistant, presented as current, documented various surgical technician and sterile processing duties, but no circulating nurse or surgical assist (grasp, clamp, cut tissue) to physician duties. ORT 1 reported to a person with the job description of the sedation RN, or a nursing supervisor.

Review on 5/19/11 of the job description for Nurse Supervisor indicated no circulating nurse or perioperative RN duties or specific supervision of OR personnel.

Review of the 2011 Association of peri-Operative Registered Nurses (AORN) Position Statement on Allied Health Care Providers and Support Personnel in the Perioperative Practice Setting preamble documented that a perioperative registered nurse was responsible for the supervision of delegated nursing tasks to allied health providers and support personnel, including sterile processing technicians, endoscopy technicians, and surgical technologists.

Review of the 2011 AORN Guidance Statement on Perioperative Staffing documented as minimum intraoperative requirements: One RN per patient per OR in the role of the circulating nurse. One scrub person per patient per room (RN, LPN, or surgical technologist); in some circumstances a scrub person may not be required. One dedicated RN to manage moderate sedation different from the dedicated RN circulator.

Review of the 2011 AORN Position Statement on One Perioperative Registered Nurse Circulator Dedicated to Every Patient Undergoing a Surgical Or Other Invasive Procedure documented echoed the minimum requirement for one perioperative registered nurse circulator to be dedicated to each patient undergoing a surgical/invasive procedure, physically present during the patient's entire intraoperative experience, to permit access to the unique clinical knowledge, judgment, and critical-thinking skills possessed by the perioperative RN.

Review of the California Code of Regulations Title 22, a state standard for general acute care hospitals, under Chapter 1, section 70217(a)(2) documented, "The surgical service operating room shall have at least one registered nurse assigned to the duties of the circulating nurse and a minimum of one additional person serving as scrub assistant for each patient-occupied operating room.

Review on 5/20/11 of a position statement from the California Board of Registered Nurses (BRN) effective January 2011 documented,"The Board of Registered Nursing interprets any individual not licensed to practice professional nursing who performs scrub nursing functions may do so only as an assigned technical function under the direct supervision of a perioperative registered nurse."

To further address the responsibility of a RN who supervises licensed vocational nurses and unlicensed personnel, the BRN addressed some aspects in a position statement effective January 2011: "While it is true that LVNs practice on their own licenses, RNs must recognize that by law LVNs practice under the direction of registered nurses (or physicians)."

Based on staff interview, medical record and document review, the hospital failed to arrange for qualified registered nurses to perform circulating duties in the operating room in accordance with state law and acceptable standards of practice to ensure immediate availability of nursing interventions for patient safety.

Findings:

In an interview on 5/19/11 at 9:15 a.m. with licensed vocational nurse (LVN) 3, LVN 3 indicated that he and operating room technician (ORT) 1 routinely performed surgical technician duties for surgical procedures both in the operating room and at the bedside. Many of the planned procedures were performed in the evening hours when the bowel surgeon was most available. Usually there would be a dedicated sedation RN to monitor the patient and a surgeon who was performing the procedure. LVN 3 or ORT 1 would set up the surgical equipment and supplies, hand items to the surgeon, and assist in manipulating certain surgical instruments when requested by the surgeon (grasping, clamping, and clipping/cutting tissue for biopsy). If both LVN 3 and ORT 1 were staffed for the procedure, one would function as a "circulator" to position the patient, retrieve drugs and supplies, tend to equipment malfunctions, particularly if the other "scrub" was in sterile attire assisting the surgeon. No circulating RN was usually present for the procedures. If an emergency occurred, the team would push a "code blue" button for staff from the ICU to respond (rapid response team). The rapid response team members would need to leave their patient assignments in order to respond.

Review of the medical records for Patients 7, 16 and 30 indicated that the signatures on surgical records included those for a sedation RN, a scrub/assist, and for Patient 30 an additional non-RN staff. No circulating RN signatures were documented.

Review on 5/18/11 of policy H-PC 04-001 titled Documentation Requirements for Invasive Procedures with and Without Sedation (Universal Protocol), presented as current, defined the members of a Surgical Team to include "surgeon, anesthesia provider, circulating Registered Nurse, Scrub Tech, X-ray Technician, Respiratory Therapist or any other healthcare team member providing care to the patient in the Operating Room." The policy, however, did not specify that a circulating RN was to be dedicated to circulating duties and not coincidentally acting as other team member roles.

Review of the 2011 Association of peri-Operative Registered Nurses (AORN) Position Statement on Allied Health Care Providers and Support Personnel in the Perioperative Practice Setting preamble documented that a perioperative registered nurse was responsible for the supervision of delegated nursing tasks to allied health providers and support personnel, including sterile processing technicians, endoscopy technicians, and surgical technologists.

Review of the 2011 AORN Guidance Statement on Perioperative Staffing documented as minimum intraoperative requirements: 1 RN per patient per OR in the role of the circulating nurse. 1 scrub person per patient per room (RN, LPN, or surgical technologist); in some circumstances a scrub person may not be required. 1 dedicated RN to manage moderate sedation different from the dedicated RN circulator.

Review of the 2011 AORN Position Statement on One Perioperative Registered Nurse Circulator Dedicated to Every Patient Undergoing a Surgical Or Other Invasive Procedure documented echoed the minimum requirement for one perioperative registered nurse circulator to be dedicated to each patient undergoing a surgical/invasive procedure, physically present during the patient's entire intraoperative experience, to permit access to the unique clinical knowledge, judgment, and critical-thinking skills possessed by the perioperative RN.

Review of the California Code of Regulations Title 22, a state standard for general acute care hospitals, under Chapter 1, section 70217(a)(2) documented, "The surgical service operating room shall have at least one registered nurse assigned to the duties of the circulating nurse and a minimum of one additional person serving as scrub assistant for each patient-occupied operating room.

Review on 5/20/11 of a position statement from the California Board of Registered Nurses (BRN) effective January 2011 documented,"The Board of Registered Nursing interprets any individual not licensed to practice professional nursing who performs scrub nursing functions may do so only as an assigned technical function under the direct supervision of a perioperative registered nurse."

To further address the responsibility of a RN who supervises licensed vocational nurses and unlicensed personnel, the BRN addressed some aspects in a position statement effective January 2011: While it is true that LVNs practice on their own licenses, RNs must recognize that by law LVNs practice under the direction of registered nurses (or physicians).

Based on staff interview and document review, the hospital assigned surgical tasks and duties to physicians, nurses and technicians without verifying the qualifications and competencies of those individuals, and for some, without delineating the authority to perform the duties through a formal privileging process in order to ensure safe and high quality care, as evidenced by:

1. The hospital assigned moderate sedation (the administration of drugs to render a minimally depressed level of consciousness that allows a surgical patient to retain the ability to independently and continuously maintain a patent airway and respond appropriately to verbal commands and physical stimulation, also known as moderate sedation/analgesia, conscious sedation and intravenous sedation) administration and monitoring duties to 5 of 5 registered nurses (RNs) reviewed (Director of Quality Management (DQM), Chief Clinical Officer (CCO), Nurse Manager (NM) 1, RN 4 and RN 7) without ensuring that their demonstration of competency was evaluated by a qualified individual, in accordance with hospital policy and acceptable standards of practice.

2. The hospital permitted surgical assist tasks to be performed by unlicensed staff and licensed nurses during upper and lower bowel surgery (GI, endoscopy) procedures without assigning clinical privileges or evaluating qualifications, competency, and authority to practice medicine, in accordance with hospital policy, standards of practice and scope of practice state laws for 3 of 3 surgical technicians (ORT 1, LVN 3, RN 5) reviewed.

3. The hospital leadership approved moderate sedation clinical privileges for 5 of 8 medical staff files reviewed (Physicians 1, 2, 3, 4, and 6) without documented evidence of current knowledge and demonstrated proficiency in performing moderate sedation in accordance with acceptable standards of care.

Findings:

1. Registered Nurses who performed conscious sedation were not evaluated by a qualified individual and documented to be qualified.

In an interview with Nurse Manager (NM) on 5/17/11 at 8:45 a.m., NM indicated that the majority of surgical procedures that utilized moderate sedation were performed in the operating room or at the bedside. A standard crew usually attended the procedures, which included RN 4 as the sedation RN.

Review of the medical records for Patients 16 and 30 on 5/19/11 documented the signature of RN 4 as the sedation RN for surgical procedures performed at the hospital during each patient's stay (4/22/11 for Patient 16, 2/24/11 for Patient 30).

In an interview on 5/18/11 at 1 p.m. with the Chief Clinical Officer (CCO), who was a registered nurse, the CCO indicated that both she and the DQM (also a registered nurse) were authorized to perform moderate sedation administration and monitoring for surgical procedures. The required qualifications included reading a study module and passing a 20 question test. Neither the CCO or the DQM evaluated the competency of sedation RNs (including NM, RN 4, and RN 7) for this skill, which exceeded the general scope of practice for a registered nurse. However, no formal proctoring or evaluations of performance by an anesthesiologist or qualified physician had been in place as a process for determining moderate sedation competencies. The RNs did not have medical staff privileges to perform moderate sedation. Neither CCO or DQM had been proctored (evaluated by direct observation) by an anesthesia professional.

Review of the personnel files for NM, RN 4, and RN 7 on 5/18/11 indicated competencies for moderate sedation were checked off but no evidence of formal up-to-date training was documented. The competencies for sedation consisted of a written test after reading a 2001 training module. No return demonstration of skills was documented. No proctoring or evaluation by a medical staff member who was qualified to perform sedation/analgesia was documented.

Review on 5/19/11 of the "MD and ACLS RN Self Study Competency Review Module for IV Sedation" dated 6/2001 documented as references "JCAHO (The Joint Commission, no date) Standards, and "Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists" from 1996. Nothing in the module emphasized the need for the sedation RN to be dedicated to continuously monitor the patient, to assess the airway for difficulty of rescue purposes and provide positioning maneuvers to optimize ventilation, to demonstrate competency on an annual basis, to review current anesthesia standards of practice, to be granted clinical privileges, or to participate in the hospital's peer review and quality measures processes.

In an interview on 5/18/11 at 3:45 p.m., the Medical Director of Anesthesia Services (an anesthesiologist) indicated that she provided oversight of all hospital anesthesia care for the medical staff and governing body. The Medical Director indicated that she generally subscribed to the standards of the American Society for Anesthesiologists (ASA), including the standards for moderate sedation/analgesia provided by non-anesthesiologists. The Medical Director expected the hospital's policies and protocols to reflect ASA standards. The Medical Director was aware that RNs administered and monitored moderate sedation/analgesia for surgical procedures in the operating room or at the bedside. Some procedures required placement of a "scope" to inspect and surgically obtain tissue samples of the bowel or lung systems under the supervision of a non-anesthesiologist physician who was performing the surgery. Other procedures required skin incisions for placement of devices into the stomach. However, neither the Medical Director nor other anesthesiology providers had provided formal sedation training to the RN staff. No direct observations or proctoring of RN sedation performance had been conducted. The Medical Director did not conduct patient chart audits to evaluate the performance of sedation RNs. No reports of RN sedation performance had been presented to the medical staff.

Review on 5/17/11 of the medical staff bylaws, rules, regulations and hospital policies showed no specific provision for the medical staff to evaluate the performance of RNs who performed specialized tasks beyond general nursing duties, unless the RN was categorized as an "allied health professional" who would be subject to medical staff credentialing and privileging requirements. No policies were presented that documented the education, training, or current demonstrated competency qualifications for a sedation RN that were in accordance with sedation standards of care.

Definitions and standards of sedation/analgesia, procedural sedation, moderate sedation and conscious sedation have been addressed by a number of nationally recognized organizations including the American Society of Anesthesiologists (ASA), the Association for peri-Operative Nursing (AORN), and the California Board of Registered Nursing (BRN). The organizations have agreed that professionals who administer, or supervise the administration of, moderate sedation, as well as the "supervised sedation professionals," should have specialized and formal education, training, and current demonstrated competency for the knowledge related to respiratory physiology, cardiac rhythms, medication pharmacology, airway management, and rescue from unintended oversedation or complications. (Refer to the ASA Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who Are Not Anesthesia Professionals, 10/18/06) The ASA recommended privileging all practitioners given this patient care authority (including registered nurses) with ongoing performance improvement oversight by the facility governing body. The BRN 9/95 position statement titled "Conscious Sedation" directed agencies that utilize registered nurses to administer conscious sedation to consult with national guidelines in establishing agency policies and procedures. The BRN statement further directed "the institution should have in place a process for evaluating and documenting the RNs demonstration of the knowledge, skills, and abilities for the management of clients receiving agents to render conscious sedation."

Review of medical staff files with the medical staff coordinator on 5/18/11 indicated that no RNs were granted privileges to administer and monitor moderate sedation/analgesia.

In an interview with the DQM on 5/19/11 at 1:45 p.m., the DQM indicated that no peer review reports from patient care chart audits addressed the performance of RNs who administered and monitored conscious sedation. The Anesthesia Director was not conducting chart audits of anesthesia care. Objective data for the outcomes of patients undergoing moderate sedation by a RN were not documented.

2. Surgical technicians performing surgical tasks were not qualified or privileged.

Review on 5/19/11 of Operating Room Administrative Policy 1.4 titled Authorized Surgical and Invasive Procedures, presented as current, documented, "only physicians privileged by the credentialing function of the Medical Staff with final approval by the Governing Board may perform the surgical and invasive procedures listed below." The procedures list included scope and stomach surgeries.

In an interview on 5/18/11 at 9:45 a.m. with the medical staff coordinator, the coordinator indicated that the hospital utilized no allied health practitioners or surgical assistants to perform surgery. No surgical technicians or surgical first assistants were granted privileges to perform surgical tasks, such as cutting, clamping, grasping, or suctioning tissue. Only physicians (MD/DO) were credentialed and granted surgical privileges to perform the procedures on the policy list.

Review on 5/17/11 of the 3/25/11 Medical Staff Bylaws, under section 5.1.1, documented that "every practitioner who practices in the hospital must request and be granted specific delineated privileges ... and may exercise only those privileges that have been expressly granted." The section added, "any Practitioner who performs professional services in the Hospital that are outside the scope of his/her delineated privileges will be subject to corrective action."

Review on 5/17/11 of the 3/25/11 Medical Staff Rules, under item E-4 related to operative and invasive procedures, documented, "The physician performing the procedure shall have a qualified assistant in attendance at all surgeries in accordance with current medical Staff policies and procedures."

In an interview on 5/19/11 at 9:15 a.m. with LVN 3, LVN 3 indicated that he routinely assisted surgeons during scope surgery procedures. His duties included manipulating the scope controls in order to grasp, clamp and cut tissue specimens in the upper or lower bowel. LVN 3 indicated that he received training for his surgical technician and surgical assisting tasks from an operating room technician (ORT) at another hospital, and from equipment sales representatives. LVN 3 was not a licensed physician or advanced practice nurse. LVN 3 had no formal surgical certifications to perform surgical assistant functions. LVN 3 indicated that ORT 1 also performed comparable scope surgery tasks for upper and lower bowel surgeries.

Review on 5/19/11 of the medical record for Patient 30 indicated that Patient 30 had upper and lower bowel surgery procedures with tissue biopsy performed on 2/24/11. Page 1 of a form titled Invasive Procedures with Moderate Sedation documented RN 5 as the "Scrub/Asst."

Review on 5/17/11 of the job description for LVN 3 titled "License Vocational Nurse:Operating Room" documented as an essential function, "The Registered Nurse (referring to the LVN employee) is responsible for the care of the peri-operative patient in the Operating Room or Procedure Room." Education and Experience requirements included "Graduate of an approved Operating Room certificate program," and "1+ years clinical experience in operating room." Licensure requirements included "RN in state of practice." Job duties and responsibilities included "functions in circulating nurse position during surgery. Coordinates anesthesia management during the intra operative period," and "demonstrates ability to function in Scrub position in surgery as needed and when another OR nurse is circulating." The job description did not specify that the LVN would perform surgical grasping, clamping, or cutting of tissue during surgical procedures.

Review on 5/17/11 of the job description for RN 5 was identical to the features documented for LVN 3. The job description did not specify that the RN would perform surgical grasping, clamping, or cutting of tissue during surgical procedures.

Review of Operating Room Policies and Procedures (P&Ps) #(III.32a) titled Colonoscopy (lower bowel scope surgery), presented as current, documented under item I.F.6. that the nurse (not surgical technician) was responsible for assisting the physician with biopsy cytology. Item I.G.4, documented, "The snare or hot biopsy forcep is passed down the biopsy channel. The nurse will open and close at the physician's direction. The physician will advise that electrosurgical current setting is to be used. The nurse verbally verifies the current setting."

Review of Operating Room P&Ps #(III.30) titled Gastroscopy (scope inspection of the stomach), presented as current, documented under item III.A., "a physician will perform the procedure with the assistance from OR Nursing personnel."

No other policies were presented to define the qualifications (education, training, experience, demonstrated competence) of practitioners who performed the surgical assistant duties described by LVN 3. The hospital presented no documented evidence that LVN 3, ORT 1, or any of the RNs were certified in perioperative surgical assist skills. ORT 1 was not a licensed professional. No standardized procedures (as defined by the State of California Business and Professions Code Section 2725) were presented to show that licensed RNs were authorized in collaboration with the physician staff, nursing and hospital administration, to perform surgical assist duties under the supervision of the licensed physician.

In a telephone interview on 5/19/11 at 1 p.m. with the President of the Medical Staff, the President indicated he was not aware that unlicensed staff and LVN staff were manipulating the scope controls to grasp, clamp, and cut tissue during surgical procedures. The President acknowledged that those staff were not granted surgical privileges, and did not possess the formal education, training and licensure comparable to that of physicians and advanced practitioners to perform surgical tasks. The President acknowledged that the performance of the unprivileged staff was not captured in the performance improvement measures and peer review system in place to evaluate the medical staff.

The Center for Medicare and Medicaid Services, in the current State Operations Manual Appendix A, under CFR 482.51 defined "surgery" in accordance with the American College of Surgeons at www.facs.org/fellow_info/statements/st-11.html. "Surgery is performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. Surgery also is the diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of live human tissue ... can be cut, burned, vaporized, frozen, sutured, probed, ..."

The California Business and Professions Code (B&P) Section 2052, retrieved 5/20/11, defined the scope of practice for a physician as "treating the sick or afflicted in this state, or who diagnoses, treats, operates for, or prescribes for any ailment, blemish, deformity, disease, disfigurement, disorder, injury or other physical or mental condition" under the authority of a certificate (state license). The only other health practitioner categories given this authority within the B&P were licensed podiatrists, licensed dentists, and licensed mid-level practitioners with advanced education and training (such as physician assistants, nurse practitioners, midwives, etc.)

Referenced in the previously cited current Appendix A CMS regulation CFR 482.51(a)(4) was a requirement for the hospital to specify surgical privileges for each practitioner who performed surgical tasks. However, the hospital did permit unlicensed staff to perform surgical tasks without subjecting them to the privileging process. The hospital permitted surgical technicians to perform various aspects of the surgical procedure involving alteration of tissue (clamping and cutting) for which they had no evidence of competence and no legal authority.

Review on 5/20/11 of the American College of Surgeons Statements on Principles for G. Surgical Assistants, retrieved from , documented that it may be necessary to utilize nonphysicians as first assistants. Assistants with additional surgical training should meet national standards and be credentialed by the appropriate local authority.

Review of the current California Code of Regulations Title 22 for general acute care hospitals, under Division 5, Chapter 1, item 70217(m), indicated that unlicensed personnel were limited to assist with simple nursing procedures, tasks that did not require licensure as a registered or vocational nurse. The current California Business and Professions Code Section 2725.3 documented that in a licensed general acute care hospital, unlicensed personnel shall not be assigned to perform nursing functions in lieu of a RN, and may not be allowed to perform functions under the direct clinical supervision of a RN that require a substantial amount of scientific knowledge and technical skills (such as invasive procedures and tracheal suctioning). The current B&P Division 2, Chapter 6.5, Section 2518.5 documented the scope of vocational nursing practice for LVNs and it did not include surgical tasks as direct patient care activities.

3. The hospital did not verify current knowledge and demonstrated competency for moderate and deep sedation privileges of medical staff members.

In a review on 5/18/11 at 9:45 a.m. of medical staff files with the medical staff coordinator, the following was identified:

Physician 1 (a lung specialist) was first appointed to the medical staff on 12/23/93 and granted moderate sedation privileges after completing a 20 question knowledge test in 2002. No direct observations of sedation care were documented but an anesthesiologist documented three chart reviews of sedation performance in 2001. No subsequent sedation reviews by anesthesiology experts or physicians with sedation privileges to assess whether Physician 1 performed sedation in accordance with current ASA standards were documented. No current Advanced Cardiac Life Support Certification (ACLS) was documented. Yet, moderate sedation privileges were renewed at the most recent reappointment cycle on 2/26/11.

Physician 2 (a lung specialist) was appointed to the medical staff on 3/30/09. No documented evidence of experience or competence for moderate sedation was in the file. The privilege list indicated moderate sedation privileges were not approved until Physician 2 successfully passed a knowledge test (after which they would be approved without additional verifications). No ACLS certification was documented. Physician 2 generated very little patient care activity with hospital patients. Proctoring verification for one of the 22 surgical privileges requested was obtained from a local hospital but the proctoring did not specify that it was by direct observation or included sedation. No other current evidence of Physician 2's ability to perform sedation or other surgical privileges were documented; yet, Physician 2 was granted the requested privileges at a renewal cycle on 3/31/10.

Physician 3 (a lung specialist) was initially appointed to the medical staff in 1997. Chart review performance evaluations for surgical privileges including moderate sedation were documented between 1999 and 2001. Completion of a 20 question sedation knowledge test was documented in 2001. No ACLS or specialized training in anesthesia, moderate or deep sedation were documented. Physician 3 also had low patient care volume with no documented evidence of current knowledge, experience, or observed performance for most of the surgical privileges requested, including deep and moderate sedation. However, at the most recent privilege renewal cycle on 9/30/09, both deep and moderate sedation privileges were granted.

Physician 4 (a general surgeon) was initially appointed to the medical staff on 2/1/10 and granted 27 privileges at a renewal cycle on 2/1/11. The privileges granted included moderate and deep sedation. Completion of a 20 question moderate sedation knowledge test was dated 12/7/09. However, no ACLS, formal anesthesia or sedation education and training, or direct observations of performance for deep and moderate sedation were documented.

Physician 6 (a gastroenterology specialist) was initially appointed to the medical staff on 2/1/10. Chart review evaluations from a local hospital for surgery and moderate sedation performance were dated 5/09 to 6/09. Completion of a 20 question moderate sedation test was dated 4/1/10. No ACLS or current demonstrated competency of airway assessment, airway management, or rescue of airway compromise were documented. Yet, renewal of surgical and moderate sedation privileges were granted by the hospital on 2/1/11.

The medical staff coordinator indicated that the qualifications for moderate and deep sedation were not defined in policy or medical staff bylaws and rules. The coordinator was not required to seek evidence of ACLS training, periodic completion of a sedation knowledge test after one was complete regardless of how long ago that occurred, or evidence of recent experience performing sedation with measures of the practitioner's outcomes.

In a telephone interview on 5/18/11 at 3:45 p.m. with the Medical Director of Anesthesia Services, the Director indicated that non-anesthesiology practitioners were expected to follow the guidelines of the American Society of Anesthesiolgists for all anesthesia services throughout the hospital (including local, moderate and deep anesthesia).The Director expected these practitioners to maintain ACLS certification. The Director was not aware that some non-anesthesiologists were granted deep sedation privileges and expected that surgeons would be requesting the services of an anesthesiologist when deep sedation was necessary, or when the fragile clinical condition of a patient raised the risk for undergoing the surgery and withstanding the anesthesia care. The Director expected the sedation providers to be performing pre-operative airway assessments to judge the ease or difficulty of rescuing the airway (Mallampati scoring system) for all sedation patients. The Director had not been onsite at the hospital to deliver clinical care or directly observe the performance of sedation practitioners for over a year. Neither the Director (nor any other anesthesiologist) had periodically audited the surgical patient charts under the care of non-anesthesiologists for adherence to ASA standards.

Definitions and standards of sedation/analgesia, procedural sedation, moderate sedation and conscious sedation have been addressed by a number of nationally recognized organizations including the American Society of Anesthesiologists (ASA), the Association for peri-Operative Nursing (AORN), and the California Board of Registered Nursing (BRN). The organizations have agreed that professionals who administer, or supervise the administration of, moderate sedation, as well as the "supervised sedation professionals," should have specialized and formal education, training, and current demonstrated competency for the knowledge related to respiratory physiology, cardiac rhythms, medication pharmacology, airway management, and rescue from unintended oversedation or complications. (Refer to the ASA Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who Are Not Anesthesia Professionals, 10/18/06) The ASA recommended privileging all practitioners given this patient care authority with ongoing performance improvement oversight by the facility governing body.

Review on 5/20/11 of ACS standard ST-46 titled "Statement on patient safety principles for office-based surgery utilizing moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia" documented under Core Principle #10, "Physicians administering or supervising moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia should have appropriate education and training."

Based on staff interviews, medical record and document reviews, the hospital failed to ensure surgical services met the needs of its patients to ensure safe and high-quality care when surgical policies and procedures (P&Ps) did not conform to acceptable standards of practice and care for all surgical practices relevant to the hospital's scope of surgical care.

Findings:

In an interview on 5/19/11 at 1 p.m. with the President of the Medical Staff, the President acknowledged that surgical processes may not be managed by qualified or knowledgeable directors for all areas of surgical services, and policies and practices may reflect the lack of organization and oversight in accordance with current surgical standards of practice. The President stated, "We don't do surgery. Only procedures."

During reviews of operating room and infection control policies throughout the survey, no specific surgical organizational standards were referenced for most policies. A number of inconsistencies between policies, and practices that violated established surgical organizational standards were also noted. These included:

1. No P&P was presented to guide nursing staff about the use of pre-operative antibiotics to effectively prevent surgical site infections.

In an collaborative medical record review on 5/19/11 at 3:45 p.m. with Nurse Manager (NM) , NM was asked about a physician medication order for a surgical patient (Patient 16) which was documented as a verbal order on 4/21/11 at 7:25 p.m. NM indicated that the order was very specific to administer an antibiotic (cefazolin) at a very precise time (4:30 p.m.) but no date or indication (preop) was stated for the order. NM stated that a nurse would interpret the order to intend the medicine to be given the next day at 4:30 p.m. The progress notes indicated that a surgical procedure was anticipated to occur on the same date as the administration of the antibiotic was to occur, but the surgery time was not specified by the recorded notes. NM acknowledged that there may have been a relationship between the purpose of ordering the antibiotic and the surgery, but the nurse who noted the order did not document clarifying the intent of the antibiotic order in order to ensure it was administered within a time frame prior to surgery to be effective as an infection-preventing treatment. NM indicated that she knew of no policy on the timeframes for administering prophylactic pre-operative antibiotics. NM stated that if a physician wanted a pre-operative antibiotic given at a particular time, regardless of when the surgery started, the nurse was expected to follow the order as issued.

Further review of Patient 16's record indicated that the ordered pre-operative antibiotic was actually administered at 5 p.m. on 4/22/11. No other antibiotics were administered on 4/22/11. The operative records indicated that a bowel surgery procedure was started on 4/22/11 at 8 p.m., and completed at 8:45 p.m. An operative report for the 4/22/11 bowel surgery dictated by the surgeon documented that a prophylactic antibiotic was administered within 90 minutes of surgery, which was not accurate and not consistent with guidelines for prophylactic pre-operative antibiotic administration.

Review on 5/20/11 of the 2011 Association for peri-Operative Registered Nurses (AORN) Perioperative Standards and Practices Guidance Statement related to Preoperative Patient Care in the Ambulatory Surgery Setting (which applied to settings where invasive procedures were performed) documented that written P&Ps should be developed for the prevention of postoperative infections. Prophylactic antibiotics should be considered and used according to published guidelines that identify the types of procedures, types of medications, timing of administering medications, route of administration, and personnel responsible for procuring preparing and administering the medication. "Depending on the type of prophylactic medication used, administration should occur between 30 minutes and one hour before incision."

2. No P&Ps were presented that clearly instructed operating room staff how to prepare each operating room (OR) for surgical procedures that included maintaining a complete emergency stock of drugs and supplies dedicated to the OR and stored in an accessible location known to all OR personnel. Setting up the OR with a reliable source of oxygen and suction capability prior to all surgical procedures was not documented in P&P. OR preparation policies did not address the location where the malignant hyperthermia (MH, a life-threatening reaction to anesthesia medications) supplies were stored; the MH supplies were not in close proximity to the ORs.

In an interview on 5/19/11 at 9:45 a.m. with LVN 3 who routinely worked in the OR as a surgical technician, LVN 3 indicated that he set up the OR by bringing a crash cart from the closest patient care unit, the intensive care unit (ICU) prior to transporting a patient into the OR. The ICU crash carts were checked daily by ICU staff and assumed to be fully stocked and appropriate for OR needs. Portable oxygen tanks often accompanied the patient's gurney and/or the crash cart; tubing to the reliable piped oxygen supply in the OR wall or ceiling was not hooked up routinely. Portable suction was brought in from the ICU on the crash cart also; tubing to the more reliable wall suction was not hooked up routinely. The MH kit was stored in a locked medication storage room on the med-surg patient care unit, some distance from the OR.

Review on 5/23/11 of policy H-MM 20-008 titled Emergency Medications, presented as current, noted that the contents of the emergency cart (crash cart) should follow current ACLS (Advanced Cardiac Life Support) guidelines. Inclusion of anesthesia and sedation rescue medications was not documented on this policy (not considered ACLS medications).

An un-numbered policy titled Crash Cart, revised 5-11, contained an inventory checklist that did not document that a rescue drug to reverse the effects of sedation medications (called Romazicon) was stocked, nor was a tracheotomy kit stocked.

Inspection of two crash carts in ICU and two crash carts on the med-surg patient unit on 5/18/11 at 1:20 p.m. discovered that no cart contained a complete tracheotomy set. No cart contained Romazicon. Three of the four carts lacked complete sets for chest tube insertion, cut-down catheter insertion, and pneumothorax tray. All items were listed on the crash cart inventory stock list for each cart and to be checked daily by unit staff.

In an interview with Nurse Manager (NM) on 5/19/11 at 3:45 p.m., NM indicated that on the day of a planned surgical procedure (typically done in the evening), the surgeon spoke with a unit nurse and directed the nurse to check out an estimated amount of sedation and narcotic pain medications from the pharmacy before it closed for the day. The nurse brought the medications to the night medication storage locker, where the sedation RN later checked them out and brought them to the OR prior to surgery. This procedure to arrange for OR medications did not routinely include rescue medications such as Romazicon. No medication administration order accompanied the directive for the nurse to check out the meds from the pharmacy, as the medications were not given for many hours after the pharmacy closed.

Review on 5/20/11 of the 2003 American Society for Anesthesiologists (ASA) Guidelines for NonOperating Room Anesthetizing Locations (also referred to by the 2003 ASA Guidelines for Ambulatory Anesthesia and Surgery) indicated there should be in each location a reliable source of oxygen. Oxygen piped from a central source was strongly encouraged. There should be in each location an adequate and reliable source of suction. There should be in each location an emergency cart with emergency drugs and other adequate equipment.

Review on 5/20/11 of the 2011 AORN Recommended Practices for Managing the Patient Receiving Moderate Sedation/Analgesia, documented under Recommendation VI that properly working equipment should be present and immediately available in the room where the procedure is performed. Equipment should include suction, airway management devices, blood pressure monitoring device, pulse oximetry, electrocardiograph, and sedative and analgesic antagonists (reversal drugs). An emergency resuscitation cart should also be immediately available in every location in which moderate sedation was administered.

3. No P&Ps to guide other critical aspects of safe sedation care were presented.

Review of the few sedation P&Ps presented by hospital leadership indicated that the sedation self-study training module was outdated from 2001. The module referred to an emergency plan as using an ACLS-equipped crash cart and pulling a Code Blue button to activate a Rapid Response Team, call 911 and transfer an unstable patient to another hospital. The policies did not emphasize carefully assessing the typical fragile patients of the hospital who had co-existing conditions to seek consultation with an anesthesia professional before performing surgeries using moderate sedation. The policies did not emphasize that a sedation RN should be dedicated to monitoring sedation and ventilation needs with no interruptions to circulate or assist the surgeon. The policies did not emphasize the need to have a circulating RN present and immediately available for all procedures. The policies did not emphasize which drugs had boxed warnings or interactions with recommendations for dosage adjustments. The policies did not direct how to arrange for surgery to be performed elsewhere. The policies did not direct staff to provide individualized monitoring upon return from surgery to a patient care unit.

Review on 5/20/11 of the AORN Recommended Practices for Managing the Patient Receiving Moderate Sedation/Analgesia, documented under Recommendation XI noted that P&Ps for managing sedation patients should include:

a. patient selection criteria;
b. personnel requirements;
c. staffing requirements;
d. monitoring;
e. risk assessment and criteria for consultation (e.g. anesthesia);
f. specific medication dosage guidelines (with adjustments for age and co-existing conditions);
g. recovery and discharge criteria;
h. documentation;
i. emergency procedures;
j. alternative care arrangements when the patient's acuity and/or level of care required is outside the capabilities and scope of practice of the perioperative registered nurse.

In an interview on 5/18/11 at 3:45 p.m. with the Medical Director of Anesthesia Services, the Director acknowledged that hospital sedation policies may be outdated or incomplete to meet the current ASA and AORN standards of practice.

Review of Operating Room Administrative policy 1.5 titled Medical Director of Anesthesia Services, presented as current, documented a duty to develop and monitor compliance with regulations, safety rules, policies and procedures for the Anesthesia Department and appropriate P&Ps and guidelines for patient care.

Based on staff interview, medical record and document review, the hospital failed to ensure that an accurate updated examination and assessment of the patient, performed by the operating surgeon, was documented prior to surgery in accordance with acceptable standards of practice and state laws in order to arrange for a safe surgery and anesthesia plan for 3 of 3 patient records reviewed (Patients 7, 16, and 30).

Findings:

Review on 5/19/11 at 3:45 p.m. of the medical record for Patient 16 with the Nurse Manager (NM) indicated by an admission history and physical exam (H&P) report dated 4/13/11 that Patient 16 (age 79) had survived a heart attack, heart bypass surgery, heart and kidney failure, lung failure and infections, other skin and urinary infections, and lengthy hospitalization elsewhere when he was transferred to the hospital on 4/13/11. He had a tube placed through the skin in his neck into his windpipe to breath (tracheotomy) with an air pressure device (CPAP) attached to the tube to keep his lungs inflated and oxygenated. He was fed by a tube through the nose to the stomach and was not able to speak, eat normally or swallow. A plan to surgically place a tube through the skin into his stomach after his general condition was further stabilized was documented in physician progress notes. In the first week, treatment centered on blood pressure instability, kidney failure and blood salt imbalances. An attending physician documented these issues in daily assessments. On 4/22/11 a brief consultation note from an intestinal specialist (Physician 6) documented "Asked to place [stomach tube]. Chart reviewed. Pt examined. No contraindications. Informed consent obtained."

On a form titled Invasive Procedures with Moderate Sedation signed and dated 4/22/11 at 7:50 p.m. by the operating surgeon, a section for Physician Patient Assessment Prior to Procedure Plan documented "Airway Assessment completed" and "Patient appropriate for procedure - Yes." The American Society of Anesthesiologists Physical Status level 3 classification was checked. Level 3 refers to severe systemic disease that is not a constant threat to life, but a higher level than mild systemic disease. No specific findings were documented by the surgeon of the condition of the neck airway tube, the lung sounds, the CPAP settings, the head and neck exam, heart exam, oxygen saturation (the nursing pre-operative oxygen level was not documented with the other vital signs on 4/22/11 at 1:44 p.m.), or the most recent blood salt levels which had not normalized in the latest daily progress note. The patient's routine medications with times of recent doses were not documented on the operative records. No consideration of enlisting the attendance of an anesthesiologist for a patient with critical co-existing conditions that had not been consistently stabilized in the recent days was documented by the surgeon. No respiratory therapist attendance during the surgery was documented or ordered by the surgeon. The doses of sedation medications administered to Patient 16were not adjusted for his advanced age. Patient 16 experienced residual effects of the sedation medications postoperatively and took a fall with potential for serious injury.

Review of the hospital's 6/2001 training manual for moderate sedation titled "MD and ACLS RN Self Study Competency Review Module for IV Sedation" documented that a thorough pre-procedure evaluation should be completed and documented by the MD performing the procedure. The sedation drugs "must be used conservatively, especially in light of the debilitated condition of most of our hospitalized patients in this facility. The dosages should be reduced for patients with congestive heart failure, chronic and acute renal failure ... hypoventilation (insufficient breathing) may still be a serious consequence of drug administration (in a patient with a tracheotomy). The Respiratory Staff are available to assist in adjusting ventilator settings or helping to maintain the airway of a patient without a secure airway." The module further documented that the sedative and narcotic medication doses may need to be decreased by as much as 70% and the peak effect may take longer to achieve in chronically ill patients.

In an interview with the Director of Quality Management (DQM) on 5/19/11 at 1:45 p.m., the DQM acknowledged that patients like Patient 16 were medically fragile with many co-existing medical problems that required a high level of medical support. They often had compromised airways with artificial devices to maintain the airways. The devices could dislodge and require highly skilled rescue interventions. Such sick patients may be more sensitive to the effects of medications. However, surgical procedures were routinely performed without requesting the presence of an anesthesiology provider who possessed the training and skill to anticipate and recognize when such patients may experience adverse events or complications from surgery or sedation.

Review on 5/20/11 of the 2004 American Society for Anesthesiologists (ASA) statement "Distinguishing Monitored Anesthesia Care (MAC) from Moderate Sedation/Analgesia" indicated that even using similar sedation medications and target levels of sedation/analgesia, the presence of an anesthesia professional can benefit high risk patients. Given that the surgeon is concentrating on the technical operative tasks, and a registered nurse is dedicated to monitoring the patient's airway and response to surgery and medications, an anesthesia professional possesses superior training and skills to manage a high risk patient: "An essential component of MAC is the anesthesia assessment and management of a patient's actual or anticipated physiological derangements or medical problems that may occur during a diagnostic or therapeutic procedure ... In some patients who may require only minimal sedation, MAC is often indicated because even small doses of these medications could precipitate adverse physiologic responses that would necessitate acute clinical interventions and resuscitation." The ASA statement emphasized that "in situations where the procedure is more invasive or when the patient is especially fragile, optimizing sedation level is necessary to achieve ideal procedural conditions."

Review on 5/20/11 of the 2011 AORN standards and practices related to managing the patient receiving moderate sedation/analgesia indicated that consultation with an anesthesia provider should be obtained if a patient presented with a known history of respiratory or hemodynamic instability, airway related issues such as breathing difficulties during sleep, one or more significant co-existing health conditions, inability to communicate, multiple medications with potential for drug interaction with sedative analgesics, and unstable systemic conditions requiring constant medical support (such as patients requiring assisted ventilation).

Review of the surgical records for Patient 7 with the Health Information Manager on 5/18/11 indicated that Patient 7, age 84, had a upper bowel and stomach surgery on 2/9/11. Patient 7's medical record lacked documentation to show a current and complete pre-surgical assessment/update by the operating surgeon. During surgery, Patient 7's blood pressure and blood oxygen levels were lowered and additional oxygen was required. The dictated operative report documented that the oxygen was increased as Patient 7 "was very sensitive to the Versed (sedation drug)."

Further review of medical records with DQM on 5/19/11 indicated that Patient 30, age 59, had co-existing conditions of diabetes, high blood pressure, recent stroke, blood clots, heart rhythm abnormality, pneumonia and respiratory failure. Surgical procedures of the stomach and bowel were performed on 2/24/11. The pre-operative vital signs documented on 2/24/11 at 1:14 p.m. recorded an abnormally low body temperature of 95.6 degrees Fahrenheit, and his blood sugar was elevated at 186. No repeat body temperatures or blood sugar measurements were documented prior to surgery, during surgery or in the recovery period.

The Physician Patient Assessment Prior to Procedure Plan portion of the Invasive Procedures with Moderate Sedation form signed and dated by the operating surgeon on 2/24/11 at 6:50 p.m. documented "tracheotomy on Vent, airway assessment complete," with no specific findings of the condition of the neck airway tube, the lung sounds, the ventilator settings, the head and neck exam, heart exam, abdomen exam, recent laboratory values in light of the low body temperature, or determination whether the patient was changed or unchanged from the admission H&P. The patient's routine medications with times of recent doses were not documented on the operative records. No consideration of enlisting the attendance of an anesthesiologist for a patient with critical co-morbid conditions that had not been consistently stabilized in the recent days was documented by the surgeon. No respiratory therapist attendance during the surgery was documented or ordered by the surgeon.

According to the 2011 Association of peri-Operative Registered Nurses standards and practices chapter relating to the prevention of unplanned perioperative hypothermia (low body temperature less than 98.6 degrees F), patients with low body temperatures experience higher rates of post-surgical infections, heart rhythm problems, blood loss, and altered medication metabolism. The risks are greater for frail or elderly patients.

In a telephone interview on 5/18/11 at 3:45 p.m. with the Medical Director of Anesthesia Services, the Director indicated that the hospital had a contract with her anesthesia provider group to attend surgical procedures when requested. However, the Director had not been requested to provide anesthesia services for over a year. The Director was aware that non-anesthesiologists were performing surgical procedures using moderate sedation administered by registered nurses. The Director expected the surgeons to adhere to the guidelines and standards published by the American Society of Anesthesiologists. The Director expected the sedation professionals to fully assess and document the head and neck exam, airway, heart and lung function prior to all moderate sedation procedures. If patients were frail and high risk, the Director expected the surgeons to request the presence of an anesthesia professional to perform Monitored Anesthesia Care (MAC). However, no written policy was currently in place to guide the surgeons on the conditions and situations in which to strongly consider such requests.

Review on 5/20/11 of standard ST-25 from the American College of Surgeons (ACS) titled "ACS Statement on Principles Underlying Perioperative Responsibility," retrieved from , under item 4 that the surgeon was responsible for the proper preoperative preparation of the patient. Minimizing the risk of operation, while providing maximal opportunity for a satisfactory outcome, required full appreciation by the surgeon of the patient's condition. Item 5 noted that the surgeon was responsible for the safe and competent performance of the operation. Part of this responsibility included planning for the operation with the anesthesiologist in order to ensure anesthesia that was best for the patient.

Review on 5/20/11 of the National Integrated Accreditation for Healthcare Organization (NIAHO) standards for assessments prior to anesthesia services indicated that a pre-anesthesia or pre-sedation evaluation must be performed and documented, by an individual qualified and privileged to administer anesthesia/sedation, not more than 48 hours prior to surgery or procedure requiring anesthesia services. This evaluation must include airway assessment, anesthesia risk assessment and anesthesia drug and allergy history.

Review on 5/17/11 of the 3/25/11 Medical Staff Bylaws under Section 2.6.8 documented that medical staff members were responsible for accurately documenting a history and physical examination within 30 days prior to admission or within 24 hours after admission but prior to surgery. In addition an updated medical record entry documenting an examination for any changes must be completed within 24 hours if the H&P was completed within 30 days prior to admission.

Review on 5/17/11 of the 3/25/11 Medical Staff Rules and Regulations under section B.2.c. documented, "Before surgery, the patient's physical examination and medical history, and indicated diagnostic tests and a preoperative diagnosis must be completed and recorded in the patient's medical record." Section 2.a. documented, "a physical examination which at a minimum would include assessment of the head, neck, heart, abdomen, respiratory, cardiovascular and other systems relevant to the diagnosis, diagnostic information, impression and plan of treatment."

Review of the California Code of Regulations Title 22, a state standard for general acute care hospitals, under Chapter 1, section 70223(d)(1) documented that prior to commencing surgery the person responsible for administering anesthesia, or the surgeon if a general anesthetic is not to be administered, shall verify ... and ascertain that a record of an interval medical history and physical examination performed and recorded within the previous 24 hours appeared in the patient's medical record.

In addition, the 2011 AORN standards and practices related to preoperative care in the ambulatory surgery setting (directed to procedural surgeries including bowel scope surgeries) directed that a medical history and physical examination should be conducted and documented before a surgical or invasive procedure, reviewed immediately before surgery, and any changes to the patient's condition then documented. AORN also recommended that a pre-anesthesia evaluation and assessment be conducted and documented for patients receiving any type or level of anesthesia to determine whether the patient was an appropriate candidate for moderate or deep sedation or anesthesia, particularly for patients with significant co-existing conditions.

Based on observation, interview, and medical record review the facility failed to have an effective system in place to ensure emergency medical equipment (tracheotomy kit) was available in the operating room.

Findings:

During the initial tour, on 5/17/11 9 at a.m., no tracheotomy kits were observed in the two operating room suites. Two facility crash carts were observed located against the wall opposite the nursing station on the facility's Medical Surgical Unit. The other two facility crash carts were located in the Intensive Care Unit; one cart was located closer to the entry door and the other cart was closest to the back door of the ICU.

Review of the inventory list for the crash cart closet to the back door of the ICU included the statement " Trach tray not available."

On 5/18/11 between 1:15 p.m. and 1:30 p.m. the four crash carts were opened and only one of the four carts, the ICU cart located closest to the entry door in the ICU, contained a tracheotomy kit. The tracheotomy kit was not complete as it did not contain an inner trach cannula.

During an interview with LN 3 on 5/19/11 at 9:55 a.m., he stated they took the crash cart closest to the back door of ICU to surgery when performing procedures in surgery. This was a cart observed to not contain a tracheotomy kit.

During an interview with the Pharmacy Director (Pharm Dir) on 5/18/11 at 9:30 a.m., he indicated a crash cart was taken from ICU to surgery so that emergency equipment, such as a tracheotomy kit, was available in the OR during surgical procedures.

During an interview with LN 5 on 5/18/11 at 9:40 a.m., she stated "The two crash carts are always in the ICU. I don't think they ever leave the unit."

During an interview with ICN on 5/19/11 at 11 a.m., she acknowledged that all the crash carts should contain a tracheotomy kit for emergency use and she stated "I learned from this experience we need to check the crash carts every day."

Review of the hospital's policy and procedure titled "Authorized Surgical and Invasive Procedures", dated 5/10, included tracheotomy among the facility procedures that were potentially done on an "emergent" basis.

Review of the hospital's policy and procedure, titled "Operating Room General Safety", dated 3/10, contained the following direction: "The crash cart and malignant hyperthermia drugs shall be available in immediate area."

Based on patient/family and staff interviews, medical record and document reviews, the hospital failed to ensure that adequate provisions for immediate post-operative care and monitoring were directed in policy in order to meet the needs of all patients and to ensure the safe recovery from moderate sedation for 1 of 3 surgical patient records reviewed (Patient 16). Patient 16 was disoriented and fell out of his bed a few hours after surgery, experienced abdominal pain at the surgical site for several days, and had potential for very serious injury from the fall related to sedation drug effects.

Findings:

In an interview with Patient 16, his wife and daughter in Room 106 on 5/19/11 at 12:15 p.m., Patient 16 was lying awake, semi-reclined in a hospital bed, with a breathing device inserted into the front of his neck and unable to speak. His family members explained and he nodded that he had a stomach surgery on the evening of 4/22/11. The family stayed with him in his room until 10:30 p.m. that day. Nursing staff called them the next morning to report that he had fallen during the night. He did not remember the events of 4/22/11. The daughter stated, "He was disoriented and still under the effects of the surgery when he tried to get out of bed and fell." The family further stated that Patient 16 was moved to a room closer to the nursing station the next day, and had no further episodes of disorientation and falling. A mattress that was placed on the floor beside his bed the day after the fall now was set against a wall and no longer used.

Review of the medical record on 5/19/11 at 3:45 p.m. with the Nurse Manager (NM) indicated by an admission history and physical exam (H&P) report dated 4/13/11 that Patient 16 (age 79) had survived a heart attack, heart bypass surgery, heart and kidney failure, lung failure and infections, other skin and urinary infections, and lengthy hospitalization elsewhere when he was transferred to the hospital on 4/13/11. He had a tube placed in his neck to breath with an air pressure device attached to keep his lungs inflated and oxygenated (CPAP). He was fed by a tube through the nose to the stomach and was not able to speak, eat normally, or swallow. A plan to surgically place a tube through the skin into his stomach after his general condition was further stabilized after admission was documented in physician progress notes. The surgery was performed on 4/22/11 by an intestinal specialist with a registered nurse administering and monitoring the moderate sedation treatments to reduce pain and anxiety of surgery. The RN documented administration of 8 milligrams of Versed (sedation drug) and 50 micrograms of Fentanyl (narcotic pain drug) between 8 p.m. and 8:40 p.m. Although Patient 16 cannot speak, the nursing notes indicated a light level of sedation with monitoring extended for 1 hour after the last Versed dose. Patient 16 was handed off from the sedation nurse to the unit nurse at 9:45 p.m., presumably back to his hospital room where routine care resumed. Physician orders following transfer were not documented. No nursing assessments upon return to the unit were documented, until close to midnight when an electronic entry noted a change in condition because the patient was found on the floor as a result of an altered mental state and disorientation. A physician was notified and nursing notes documented neurologic status intermittently through the night. Other than the change in condition entry, no fall assessments, medication analysis, or update of the nursing care plan were documented.

NM indicated that when postoperative patients return to the unit, the previous care orders were resumed unless specific orders were issued by the surgeon (rarely done, no transfer orders were documented for Patient 16). No policies directed unit staff to monitor postoperative patients differently for bleeding, pain, or delayed medication reactions, even if the patient was elderly with co-existing and fragile conditions. No policies directed respiratory staff to periodically assess patients with compromised airways in the hours while sedation and pain medications were still in effect. A physician was not routinely present in the hospital during the night hours. The NM acknowledged that fragile patients such as Patient 16 can experience prolonged effects from the sedation and pain medications used during surgery. The NM indicated that the receiving unit nurse should have documented an assessment of Patient 16 upon return to the unit, which may have identified the fall potential.

Review on 5/17/11 of the 3/25/11 Medical Staff Rules and Regulations under item C.3. documented, "Orders must be reviewed and rewritten/reentered, as appropriate, by the responsible practitioner when patients are transferred to or from the ICU (intensive care unit) and following surgery."

No policies were presented to specifically address the monitoring responsibilities of unit staff for the prolonged effects of sedation/analgesia treatments or post-surgical complications when postoperative patients were transferred back from the surgical recovery unit.

Review of the hospital's 6/2001 training manual for moderate sedation titled "MD and ACLS RN Self Study Competency Review Module for IV Sedation" documented that the sedation drugs "must be used conservatively, especially in light of the debilitated condition of most of our hospitalized patients in this facility. The dosages should be reduced for patients with congestive heart failure, chronic and acute renal failure ... hypoventilation (insufficient breathing) may still be a serious consequence of drug administration (in a patient with a tracheotomy)". The module further documented that the sedative and narcotic medication doses may need to be decreased by as much as 70% and the peak effect may take longer to achieve in chronically ill patients

Based on staff interview, surgical log and medical record reviews, the hospital failed to ensure the operating room register was complete and accurate for all surgical procedures.

Findings:

In an interview on 5/17/11 at 8: 45 a.m. with Nurse Manager (NM) 1, NM 1 indicated that most surgical procedures were performed in the operating room or at the bedside utilizing moderate sedation () administered by registered nurses (RNs) rather than general anesthesia administered by anesthesiologists. A standard crew consisting of a sedation RN, surgical technician, LVN scrub assistant, and the surgeon were generally the personnel participating in the procedures. A circulating nurse was not specifically assigned for each procedure.
In an interview on 5/19/11 at 9:15 a.m. with licensed vocational nurse (LVN) 3, LVN 3 indicated that he provided technical assistance to set up and process surgical equipment, and to assist the surgeons for upper and lower intestinal biopsy procedures (surgical assist). A sedation RN provided continuous sedation care. No RN was assigned to circulate but LVN 3 often functioned as a circulating nurse to bring drugs and supplies or deliver specimens or adjust equipment or position a patient.

Review on 5/17/11 of the surgical log indicated that the names of sedation nurses were listed under the circulating nurse column, and no names were entered under anesthesia or anesthetist columns for sedation procedures. The ages of patients were not consistently documented. The entry for Patient 30 who had intestinal surgery on 2/24/11 documented RN 4 as the circulating nurse but the medical record for Patient 30 listed RN 4 as the sedation nurse. The log documented LVN 3 as the Assistant but the medical record listed LVN 3 as "other team members." The log documented RN 5 as scrub nurse but the medical record listed RN 5 as scrub/assistant. Total time (duration) of the procedures were not documented for all patients.

Based on staff interview and document review, the hospital failed to ensure that anesthesia (deep sedation) would be administered only by qualified practitioners in order to ensure safe and high quality anesthesia care, when the hospital leadership granted clinical privileges to 2 of 8 medical staff members (Physicians 3 and 4) who were non-anesthesiology physicians and had not documented evidence of formal education, training, experience, or competence to perform deep sedation in accordance with acceptable standards of practice and medical staff bylaws.

Findings:

In a review on 5/17/11, at 9:45 a.m., of medical staff files with the medical staff coordinator, 2 of 8 files reviewed (Physician 3, a lung specialist, and Physician 4, a general surgeon) indicated that deep sedation privileges were approved without documented evidence of formal and current education, training, experience, and demonstrated competence to ensure the physicians were currently knowledgeable, experienced, and competent to use/supervise deep sedation/analgesia treatments, including the rescue from unintended over-sedation or heart and lung instabilities that can occur with deep sedation/analgesia treatments.

In an interview on 5/18/11 at 3:45 p.m. with the Medical Director of Anesthesia Services, the Director indicated that she was designated to oversee anesthesia services, including local/moderate/deep sedation/analgesia, for all locations of the hospital. Although the Director regularly attended Quality Committee and Medical Executive Committee meetings, she did not directly observe and evaluate the physician staff who performed sedation/analgesia care. The Director did not routinely audit the medical records of patients who received sedation/analgesia care. The Director expected all sedation/analgesia practitioners to follow the standards and guidelines of the American Society of Anesthesiology (ASA), including the formal education, training, and periodic demonstrated competence requirements outlined in the 2010 ASA Statement on Granting Privileges for Administration of Deep Sedation to Non-Anesthesiologist Sedation Practitioners. If surgeons wished to administer deep sedation, the Director expected the surgeons to request the services of an anesthesia professional, to participate in the procedure or to be immediately available. However, no guidelines for medical staff members to consult with an anesthesia professional were documented in policy.

Review on 5/20/11 of the 2010 ASA Statement on Granting Privileges for Deep Sedation to Non-Anesthesiologist Sedation Practitioners documented that only physicians and other practitioners specifically permitted by the Center for Medicare and Medi-caid Services (i.e., a qualified anesthesiologist, a doctor of medicine or osteopathy, a dentist/oral surgeon/podiatrist qualified to administer anesthesia under State law, a certified registered nurse anesthetist, or an anesthesiologist's assistant) may administer or supervise the administration of deep sedation. The practitioner must complete a formal training program, demonstrate current knowledge of the complex practice, possess experience and demonstrate skill in airway assessment and ventilation of patients in a state of anesthesia, monitoring of blood gases and of heart rhythm disorders.

Review on 5/17/11 of the 3/25/11 Medical Staff Bylaws, under section 5.1.2 documented that the basis for granting clinical privileges to medical staff members shall include medical education, medical training, experience, ability to perform the requested privileges, and current competence.

Based on observation, interviews and review of facility documents, the facility failed to utilize their collected data to identify opportunities for improvement and change related to the reduction of their medication errors (ME). The facility's Medication Error Reduction Program (MERP), for 2009, 2010, 2011, advocated the same reduction measures even though data showed the errors continued to increase.

Findings:

On 5/18/11 at 1:00 p.m., the Director of Quality Management (DQM) was interviewed about the medication error data. The DQM stated that the Pharmacy Manager reported the data to the Medication Safety Committee (MSC) and also sent the data to the Quality Committee. The medication error data for 2004 to 2011 was reviewed with the DQM. The data showed several categories related to medication errors. A review of the category titled, "Transcription", showed the following error rates: 2005 (2), 2006 (5), 2007 (4), 2008 (2), 2009 (33), 2010 (36), 2011 (January to present-16). The DQM stated that the majority of transcription errors were related to nursing not inputting all administered medications into the electronic medical record (EMR). The difference with narcotic charting is that a nurse must sign it out on the narcotic sheet and input the medication into the EMR. Per the DQM, if the medication is not documented in the EMR, another nurse could mistakenly give a double dose of a medication because it was not on the EMR as being given.

The DQM was asked what the Quality Improvement Committee (QIC) analysis results were as to why these errors increased beginning in 2009 and she stated that the QIC believed it to be a nursing error issue. The DQM was asked if the QIC had changed their action plan since 2009 and she said, "No." The DQM was asked if the QIC looked at the data and brain-stormed (to come up with fresh ideas from a different perspective) the possible reasons as to why this error was not only still present, but also increasing and she stated that it was an educational issue for the nurses who made the error. The involved nurses were in-serviced and, "counseled" when an error occurred. The DQM was asked if this action was successful and she stated that the facility aggressively continues to re-educate the nurses and the unit manager continues to counsel any nurse who is involved. The DQM was asked to provide any evidence of the committee's review of data and development/review of the action plan and she stated, "It is not in writing."

The DQM was asked how the committee gauged the effectiveness of their plan and she stated that the Pharmacy Supervisor tracked the data and submitted it monthly. The DQM was asked how the committee analyzed the data and developed action plans and she stated that it was the committee's view that the increase was due to the lack of nursing inputting the medication into the system. The DQM was asked if the lack of computer input was due to a new program and she stated that the current EMR had been in place for several years. The DQM was asked if the computer system could be revised with additional helps or prompts to help the nurse and she stated she wasn't sure. The DQM was asked if any staff nurses were on this committee and she stated, "No." When asked if the staff nurses were interviewed to see why they were making errors, she stated, "I'm not sure." The DQM was reminded that the errors were increasing and she stated that they were trying to educate nursing about the importance of not making errors. The DQM was asked if she felt the current plan was working and she stated, "Not that well." The DQM was asked to have the Pharmacist join the interview.

The Pharmacist joined the interview at 1:20 p.m. and stated that they had been looking at this data and that the QIC had attributed the marked increase in the last couple of years to the nursing staff not adhering to the facility's practice for documenting the administration of medication. The Pharmacist stated that he reports the ME data monthly and gives the involved staff names to the Nursing Unit Manager at the QIC for follow-up. The Pharmacist was asked that given the current ME data for 2009 to present, did he feel that the current action plan was working and he stated, "Not really." The Pharmacist was asked if the lack of documentation was a patient safety issue and he stated, "Yes, but we are trying to decrease the errors." The Pharmacist was asked if a patient could receive a double dose of medication now, even with their current action plan in place and he stated, "Yes." The Pharmacist was asked if the QIC, or Medication Safety Committee was currently working on a new strategy to ensure that the current process would not endanger patient safety and he stated that there was no new plan. The Pharmacist did say that the QIC had discussed the possibility of a medication bar code that could be swiped prior to administering the medication which would in turn generate an online patient medication record. However, the Pharmacist stated that he thought that, "wasn't going to happen." The Pharmacist did state that one of the newest processes they have implemented this year was to bring the ME information to the nursing staff so they would be able to see what errors are being tracked and why. The Pharmacist was asked to provide any examples of patients (within the last 6 months), who had received a double dose of medication due to an inputting error.

On 5/19/11 at 1:40 p.m., the Pharmacist produced documents related to an ME that occurred to Patient 18 on 4/9/11 due to the computer input omission of medication administration. Per the Pharmacist, the on-duty nurse had given Patient 18 his morning medications, received a personal phone call and abruptly left the unit without documenting what medications had been given. The replacement nurse that came on did not know that the patient had received any medications and repeated the morning medications. A review of a copy of the nursing notes titled, "Additional note, 4/9/11", indicated that Patient 18 was being monitored for double dosage of antihypertensive medications.
A review of the Pharmacy on-line audit showed that the event was reported and reviewed by Pharmacy on 4/12/11. There was no specific documentation of what medications had been administered and the Pharmacist was asked what medications Patient 18 received and he said he wasn't sure, he would have to, "research it," but that Patient 18 had, "No ill effects from it."

A list of the 9:00 a.m. medications (double dose) that were given to Patient 18 was provided by the DQM, they were:
Amlodipine 5mg (for high blood pressure) via tube feed
Aspirin 81mg
Carvedilol 25mg (for congestive heart failure).
Cholecalciferol 1000 units (Vitamin D)
Famotidine 20mg (decreases acid in the stomach).
Heparin 5,000 units (blood thinner)
Kepra 1000mg (anti-epileptic).
Losartan 100mg (for high blood pressure)
Digoxin 0.0125mg (helps the heart beat stronger).

A written review by the charge nurse indicated that the off-going nurse did not mention that she had given any medications before she left. The Pharmacist stated that he had not interviewed the involved staff member to ascertain whether an action plan needed to be developed to ensure patient safety. The Pharmacist stated that the reason this event occurred was because Patient 18 had an extra 3-day supply in his medication cabinet, so it looked like he had not had any medication given.

The Pharmacist stated that the locked medication cabinet in each room is stocked by his department. The medications for Tuesday through Friday are stocked daily and the medications for Saturday through Monday are brought up on Friday morning. The Pharmacist stated that his staff are busy making solutions and other duties during the weekend, so they bring up the 3 day supply on Friday to expedite the process. The Pharmacist stated that this event happened on a Saturday. The Pharmacist stated that a nurse would have been able to identify whether or not the morning medications had been given if the additional 3-day stock had not been in the cabinet. The Pharmacist was asked if there was any changes made to the 3-day supply process in order for this event not to happen again and he stated that the nursing staff member had been "counseled" about the error.

On 5/19/11 at 1:50 p.m., a random observation was made of room 108's medication cabinet with the Pharmacist. Inside the cabinet was a blue storage tray filled with medications, some in plastic bags, some loose in the tray and one of the bags was labeled, "PRN Medications" (as needed). The Pharmacist was asked if this display of medications was conducive to safe administration of medications and he stated it could be a problem. The Pharmacist was asked how the 3-day supply is packaged when put in the cabinet and he stated, "usually" it is in a plastic bag." The Pharmacist was asked if the 3-day supply was packaged in a manner that would allow staff to easily recognize it and he stated, "No, but that's a good idea."

A review of the facility's annual MERP plan reported in January, 2010, indicated that reported errors had increased in 2009. Analysis and actions read that during the annual nursing competency review, safe medication practices were to be reviewed, with an emphasis on administering and documenting of medications. One of the goals for 2010 read that the facility would continue to review all systems that impact the safety of medication use. One error reduction measure was to perform a medication pass audit on 20 staff members per month, to ensure that medications are administered correctly, timely and that charting is done accurately.

A review of the Medication Safety Committee minutes for 9/21/10 and 10/26/10, showed that narcotics were still not charted and that individuals were counseled and the nursing manager was to oversee and counsel the staff.

A review of the facility's annual MERP plan reported in February, 2011, indicated that the transcription errors were due to lack of charting of narcotics. The staff was signing the narcotic out on the control sheet, but not inputting it into the EMR. Analysis with actions centered on educating staff about the proper EMR charting. The facility also continued to perform a medication pass on 20 staff per month to once again, verify that medications are administered correctly, timely and that charting is done accurately.

A review of the Medication Safety Committee minutes for 1/25/11 and 3/22/11 showed that there were still errors related to documentation and that, "responsible persons are counseled or reeducated if needed." The medication pass audits showed that they were being returned late but that the staff were very capable, "when watched." Under the actions for 1/25/11 it read, "Continue to perform audit although useful data not obtained." Under the actions for 3/22/11 it read that, "staff very capable when watched, deficiencies noted when staff do not realize being watch (ed)." The actions indicated that the audits would continue so that staff would not be aware that they were being audited. A review of the ME audit showed that from January to April, 2011, there were currently 16 transcription errors.

Based on interviews, record review and review of the facility's accepted standards of practice, the facility failed to ensure that patient (23) had verbal orders countersigned by the prescribing physician within 48 hours.

Findings:

Patient 23 was admitted with diagnoses including respiratory failure. On 5/3/11 at 1:05 p.m. a nurse accepted a telephone order from Patient 23's physician. The order was to discontinue IV (intravenous) fluid, NS (normal saline), KVO (keep vein open). The prescribing physician countersigned this order on 5/6/11, time is illegible.

Also on 5/3/11, at 4:55 p.m., a nurse accepted a telephone order from the same prescribing physician for Nystatin 5 ml, (a mouth rinse) swish and swallow once every 6 hours. The physician countersigned the order on 5/6/11, time is illegible. On 5/17/11 at 11 a.m. an interview was conducted with a Licensed Nurse (LN 2) and the Director of Quality. Both confirmed that telephone orders should be countersigned within 48 hours by the prescribing physician.

A Policy titled Verbal, Telephone and Hazardous Orders, revised 1/2009 by the Medical Staff Administration was reviewed on 5/18/11 by the Department. This Policy identified under item C; Medication and other orders will be authenticated within 48 hours. Also under item D; Verbal or telephone orders should be managed in the following manner: 2. In the case of medication orders they must be signed within 48 hours.

Review of the Medical Staff Rules and Regulations, revised 6/2007, under c. General Conduct of Care: 2. In California, the countersignature for drug and biological orders must be obtained within 48 hours.