The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ST LOUISE REGIONAL HOSPITAL 9400 NO NAME UNO GILROY, CA 95020 June 14, 2012
VIOLATION: LICENSURE OF PERSONNEL Tag No: A0023
Based on staff interview and document review, the hospital failed to employ a registered dietitian who provided guidance to the dietetic supervisor and staff approved of all menus, and participated in developing and revising dietetic policies and procedures. A Registered Dietitian as specified in the California Code of Regulations, Title 22, Division 5, Chapter 1, Section (a) and California Health and Safety Code 1265.4, specify a registered dietitian shall be employed full-time, or part time, provide guidance to the supervisor and staff of the dietetic service, approve all menus, and participate and revise dietetic policies and procedures. This failure placed patients at risk of food-borne illness and compromised care. Findings:

During the validation survey from 6/4/12 to 6/6/12 the organization of the Nutrition Services reflected the director of food and nutrition services was a dietary service supervisor (DSS) qualified as a (diet technician) per the Section DTR.

On 6/4/12 at 2:20 p.m., the hospital Food Services organization chart, Director of Food and Nutrition Services' job description, and her personnel file were reviewed. The job description of Director of Food and Nutrition revealed she was responsible for the management of the food service operation and was a full time employee. The Director of Food and Nutrition was equivalent to a Dietary Service Supervisor (DSS) as described in the California Code of Regulations. The organizational chart outlined that the DSS reported directly to the VP/Chief Operating Officer. The organizational chart had the staff Registered Dietitians (RD) report directly to the Director of Food and Nutrition.

On 6/4/12 at 2:20 p.m., the Director of Food and Nutrition's personnel file confirmed she had a certificate from a community college for Dietetic Technician Program and was a Registered Diet Technician with the Commission on Dietetic Registration for the American Dietetic Association.

The RD stated on 6/4/12 at 1:25 p.m., that she was a full time employee and there were four registered dietitians on staff. The dietitian's responsibilities were clinical and she participated in some patient tray evaluations and menu review. She stated they did not provide guidance to the Director of the Food and Nutrition Department or food service staff, or develop or revise the policies and procedures for the food service department.

Review of the Clinical Dietitian's job description on 6/4/12 at 1:25 p.m., listed only clinical nutrition care responsibilities. The job description did not have provision for the oversight and guidance to the Director of Food and Nutrition Services.

In an interview with the Chief Operating Officer (COO) on 6/4/12 at 1:25 p.m., confirmed the staff RDs should report to her and one of the RDs was designated to provide guidance to the Food and Nutrition Department.
VIOLATION: GOVERNING BODY Tag No: A0043
Based on document review and interview, the hospital governing body failed to ensure that contracted services were provided in a safe and effective manner . In addition, they failed to implement a plan of correction for the same deficient practice regarding contracts cited in a survey on 1/18/12 (cross-reference A084). The governing body failed to provide nursing service oversight to ensure patient care competencies were validated for nursing services provided by registry nurses, and failed to ensure safe medication administration (cross reference A084, A385, and A392). The governing body failed to provide oversight of the hospital nutritional services (cross-reference A618, A620, A622, A749 and A267).
Findings:

1. The governing body failed to implement a plan of correction regarding oversight of contracted services cited on 1/18/12 that stated, "Chief Nurse executive identified managers who have agency staff reporting to them who have competencies outside the manager's scope of practice. Established an evaluation process for each of these areas, identifying who (contracted service manager or peer) will perform evaluations of specialized clinical competencies. Documentation of competencies and evaluations will be forward to responsible Department Director and be maintained in agency personnel file" (cross-reference A084).

2. The governing body failed to provide oversight of the nursing services to ensure safe medication administration. Nursing staff from temporary nursing agencies did not have patient care competencies validated by the hospital to provide care in a manner that was safe and consistent with hospital policy (cross-reference A084, A385 and A392).

3. The Chief Operating Officer (COO) allowed the Director of Food and Nutrition who was a registered diet technician to manage the entire hospital food service without guidance from the registered dietitian with findings of improper infection control and lack of quality program for food service (cross-reference A749), and failed to have an organized dietary service (cross-reference A618, A620, A622 and A267).

The cumulative effect of these systemic problems, and repeat violation, resulted in the hospital's failure to deliver quality healthcare in a safe environment.
VIOLATION: CHIEF EXECUTIVE OFFICER Tag No: A0057
Based on staff interview and administrative document review, the governing body failed to ensure there was safe and effective implementation of the patient food service when the Chief Operating Officer (COO) allowed the Director of Food and Nutrition who was a registered diet technician to manage to entire hospital food service without guidance from the registered dietitian with findings of 1) improper infection control (cross-reference A749), lack of quality program for food service (cross-reference A749), 3) failure to have organized dietary service (cross-reference A618, A619, and A620, A622 and A27).

Findings:

In an interview with the COO on 6/4/12 at 2:20 p.m., she agreed there were serious and substantial issues regarding the Food and Dietetic Services. The COO stated she did not know there were problems that required addressing when the organizational structure of the department did not include the registered dietitian providing guidance to the Department Director. The COO stated she was the individual in administration who was responsible for the Food and Dietetic Department.
VIOLATION: CONTRACTED SERVICES Tag No: A0084
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on documentation, the hospital governing body failed to ensure that contracted temporary nursing agencies performed services in a manner that was safe and consistent with hospital policy. A registery nurse administered a medication incorrectly. The hospital had not validated her skills in providing care to patients in the Intensive Care Unit or a procedure requiring conscious sedation.

An Immediate Jeopardy situation was identified on 6/13/12 at 3:00 p.m. Hospital administrative staff were informed of the Immediate Jeopardy during a conference and a plan of correction was requested. An acceptable plan of correction was received on 6/14/12 at 10:20 a.m. The hospital's immediate correction included the discontinuation of temporary nurse agencies at the hospital (See A084).

Findings:

The hospital utilized temporary nursing agencies to provide additional nursing staff to assist with patient care. The hospital received a report from the agency with the temporary nurses' individual skills check list. This document was completed by the temporary nurse with no verification that she could perform the documented task.

The hospital policy for competency (Education Service Manual - 10/06) was reviewed on 6/13/12. The policy stated the initial and ongoing competency process includes assessment, planning, implementation, evaluation, and documentation for all personnel and persons contracted to provide services to patients and families. In addition, Section C of the policy indicated the department manager was responsible and accountable for developing the department competency based assessment, assuring that each individual was assessed, and that work assignments were consistent with the individuals' competency level.

In a patient chart review, conducted on 6/6/12 and 6/12/12 it was noted that Patient 19 was admitted on [DATE] for shortness of breath and subsequently transferred to a medical unit for care.

Due to the patient's condition, on 5/15/12, she was transferred to the hospital's intensive care unit (ICU). Physician documentation indicated on 5/16/12 at 2:35 p.m. Patient 19's physician gave a verbal order to Nurse S that read, "Versed (central nervous system depressant) 4 mg. IV now and Fentanyl (opiate analgesic to block pain) 200 mcg., IV now."

The physician was preparing the patient for a conscious sedation treatment (a combination of medicines to help you relax and to block pain during a medical procedure) that required intubation (placing a tube through the patients mouth to aid in breathing). Nurse H (registry nurse) obtained the medication at 2:50 p.m. and immediately administered the medication through the patient's intravenous line (IV). The time of administration could not be identified as Nurse H failed to document this process.

Based on documentation in the physicians note, Nurse H administered the medication prior to the procedure and the patient became apneic (having difficulty breathing) and an emergent intubation evolved. An emergency medical code (code blue) was initiated at 3:05 p.m. The patient expired at 4:14 p.m.

In an interview with Nurse S on 6/12/12 she stated she was the charge nurse when she received the physician's order for Versed and Fentanyl. She forward the order to the pharmacy and put it into the computer system, thus allowing the pyxis machine (medication dispensing machine) to allow removal. Nurses S and Nurse H cosigned the medication removal. Nurse H then went to Patient 19's room. After a few minutes, Nurse S returned to Patient 19's room and noted Nurse H "flushing" the line (process to clear the tubing normally done after medication administration). She then asked Nurse H if she gave the medication. Nurse H stated "yes" she gave it all. Nurse S stated the medication should have been given in small increments with a 5 minute delay between the doses.

According to the Director of Critical Care Services and Interim Chief Nursing Executive who were interviewed on 6/13/12, Nurse H administered the medication incorrectly. Although she read the order to give the medication now, the medication was supposed to be given prior to intubation (process of placing a tube in the patient's trachea to aid in breathing) and in small increments. Instead, the nurse gave the medications all at once without notifying the healthcare team, who were preparing for the procedure.

On 6/12/12 the competency file of Nurse H was reviewed. The file revealed a list of skills from the contracted nursing agency in which she had experience. There was no evidence the hospital or agency had validated her skills in providing care to patients in the ICU or the procedure requiring conscious sedation.

On 6/13/12 the competencies and skills evaluation for 9 nurses (including Nurse H) from 8 different contracted nursing agencies were reviewed. Nine of 9 of the staff did not have validated hospital patient care competencies. All agencies provided a skill list which the applicant completes but there was no evidence validating these skills (see A385).
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to honor a patient's right to an informed consent before a surgical procedure for one of nine patients sampled. Findings:

Patient 1 was admitted to the facility on [DATE] with respiratory problems. The patient had a surgical procedure on 5/9/12 to insert a tracheostomy (an incision made in the neck to insert a tube to provide oxygen to the lungs) tube and did not have capacity to provide a consent. On 5/8/12 at 7 p.m. the registered nurse obtained via telephone, consent from a family member not authorized to provide consent for the tracheostomy procedure.

The hospital policy for verbal/telephone consents reviewed on 6/5/12 indicated when verbal/telephone consent was necessary, a registered nurse and other authorized licensed personnel may witness the verbal/telephone consent by the patient, the patient's authorized legal representative, and the signature of the physician or licensed independent practitioner obtaining the consent.

The acting Chief Nursing Officer (CNO) acknowledged during the review the consent was not obtained according to their procedure.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on staff interview and administrative document review, the hospital failed to ensure they measured, analyzed and tracked the services provided by Food and Nutrition Services Department to address, 1) ) infection control for handwashing and proper cool down (cross-reference A749), and 2) organized dietary service (cross reference A618, A620 and A622).

The failure to measure, analyze and track the deficient practices and develop an integrated quality program for Food and Nutrition Services allows potential failures to continue, not develop new quality programs.
Findings:

On 6/6/12 at 1:30 p.m., a nurse educator described the hospital-wide quality program which included the Care Council and system-wide monitoring of sepsis, and the patient experience including all hospital departments. She stated the quality appraisal and performance program did not have any quality or performance improvement plans for the Food and Nutrition Department except for being included in the patient experience data. She confirmed there were no quality or performance related plans for the food service to measure, analyze and track aspects of food service sanitation, infection control, specific monitoring to prevent essential food-borne illness such as proper cool down or effective handwashing techniques, equipment cleaning and staff competencies.

There was no quality program in place in Food and Nutrition Services and there was no documentation reflecting food safety concerns for the past 12 months.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on staff interview and administrative document review, the hospital failed to ensure they measured, analyzed and tracked the services provided by Food and Nutrition Services Department to address, 1) ) infection control for handwashing and proper cool down (cross-reference A749), and 2) organized dietary service (cross reference A618, A620 and A622).

The failure to measure, analyze and track the deficient practices and develop an integrated quality program for Food and Nutrition Services allows potential failures to continue, not develop new quality programs.
Findings:

On 6/6/12 at 1:30 p.m., a nurse educator described the hospital-wide quality program which included the Care Council and system-wide monitoring of sepsis, and the patient experience including all hospital departments. She stated the quality appraisal and performance program did not have any quality or performance improvement plans for the Food and Nutrition Department except for being included in the patient experience data. She confirmed there were no quality or performance related plans for the food service to measure, analyze and track aspects of food service sanitation, infection control, specific monitoring to prevent essential food-borne illness such as proper cool down or effective handwashing techniques, equipment cleaning and staff competencies.

There was no quality program in place in Food and Nutrition Services and there was no documentation reflecting food safety concerns for the past 12 months.
VIOLATION: MEDICAL STAFF PERIODIC APPRAISALS Tag No: A0340
Based on interview and record review, the hospital failed to consider procedure-specific experience at the time of medical staff reappointments in 3 of 8 sampled credentials files (Practitioners 1, 2 and 4). The deficient practice eliminated a mechanism by which the hospital could ensure its medical staff had current competencies to perform each of the privileges requested and granted.

Findings:

1. Review of Practitioner 1's credentials file indicated he was an anesthesiologist reappointed to the hospital's medical staff effective 9/1/11. The credentials file indicated how many patient encounters Practitioner 1 had, but did not indicate how often he had performed each of the procedures for which he had requested and been granted privileges.

2. Review of Practitioner 2's credentials file indicated he was a radiologist reappointed to the hospital's medical staff effective 11/1/10. The credentials file indicated the number of studies Practitioner 2 had interpreted for the hospital and overall, but did not indicate how often he had interpreted each of the various types of studies for which he had requested and been granted privileges.

3. Review of Practitioner 4's credentials file indicated he was a pulmonologist (lung doctor) reappointed to the hospital's medical staff effective 8/1/10. The credentials file indicated how many patient encounters Practitioner 4 had, but did not indicate how often he had performed each of the procedures for which he had requested and been granted privileges.

In an interview on 6/6/12 at 12:27 p.m., Staff D shook her head "no" when asked if the credential file for Practitioner 1 contained information regarding how many of which procedures Practitioner 1 had done. Staff C stated that Practitioner 1's file did not have a breakdown of patient volume by procedure. Staff C stated Practitioner 2's file contained the total number of studies he had performed and that the hospital was working with the teleradiology (sending electronic imaging for a radiologist to interpret) contractor to obtain information regarding experience by procedure. In an interview on 6/6/12 at 1:03 p.m., Staff C stated the data in Practitioner 4's file did not address how many of which procedures he had done. Staff D stated the hospital was working on obtaining such data.
VIOLATION: MEDICAL STAFF BYLAWS Tag No: A0353
Based on interview and record review, the hospital failed to follow its medical staff bylaws when 2 of 8 sampled credentials files (Practitioners 1 and 2) did not contain the department chair's recommendations regarding reappointment and clinical privileges. The deficient practice diminished the role of department chairs as agreed in the medical staff bylaws.

Findings:

Review of the hospital's medical staff bylaws (revised 5/3/12) section on department chairs indicated, "Each chair shall have the following authority, duties and responsibilities, and the vice-chair, in the absence of the chair, shall assume all of them and shall otherwise perform such duties as may be assigned: ...transmit to the Medical Executive Committee the department's recommendations concerning practitioner appointment and classification, reappointment, criteria for clinical privileges, monitoring of specified services, and corrective action with respect to persons with clinical privileges in the department.."

1. Review of Practitioner 1's credentials file indicated he was reappointed to the hospital's medical staff effective 9/1/11. Comparison of Practitioner 1's file to the hospital's roster of department chairs and vice chairs (dated 7/11 to 6/13) indicated the departmental recommendations concerning Practitioner 1's reappointment were signed by a person other than the department chair or vice chair.

In an interview on 6/6/12 at 9:19 a.m., Staff D stated the hospital usually had someone on the credentials committee sign the departmental recommendations instead of the department chair. In an interview on 6/6/12 at 12:27 p.m., Staff C stated the person who signed Practitioner 1's departmental recommendation was the department's representative to the credentials committee and not the department chair.

2. Review of Practitioner 2's credentials file indicated he was reappointed to the hospital's medical staff effective 11/1/10. Comparison of Practitioner 2's file to the hospital's roster of department chairs and vice chairs (dated 7/11 to 6/13) indicated the departmental recommendations concerning Practitioner 2's reappointment were signed by a person other than the department chair or vice chair.

In an interview on 6/6/12 at 12:27 p.m., Staff C stated the person who signed Practitioner 2's departmental recommendation was the department's representative to the credentials committee and not the department chair.
VIOLATION: MEDICAL RECORD SERVICES Tag No: A0450
Based on interview and record review, the hospital failed to ensure medical record entries were legible for one sampled patient (Patient 34) when a handwritten history and physical (H&P) contained illegible entries regarding the patient's social history, family history, and diagnosis. (Refer to A952).
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
Based on observation and interview, the hospital failed to perform preventive maintenance before the due date on two patient warming devices. The deficient practice had the potential to allow the malfunction of equipment that can cause burns.

Findings:

In an observation and interview on 6/4/12 at approximately 11:30 a.m., the operating room (OR) suite contained two patient warming devices with labels indicating they were due for preventive maintenance in 5/2012. Staff A agreed the preventive maintenance labels appeared to indicate both devices were overdue for maintenance.

In an interview on 6/5/12 at 10:58 a.m., Staff A stated the patient warming devices had been temporarily used and should have been removed from service before the next preventive maintenance was due.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on observation, interview and record review, the hospital failed to follow its own policies when an opened set of sterile instruments was covered with a drape and left unattended. The hospital also failed to follow national guidelines when endoscopes were stored with their tips covered and in contact with a soiled towel at the bottom of the storage cabinet such that the ends of the scopes were curved, and a sterile package of endoscopic biopsy forceps was opened and retained for future use. The deficient practices had the potential to allow health care associated infections.

Findings:

1. In an observation and interview on 6/4/12 at 11:06 a.m., the obstetrics OR contained a cart covered with a blue drape. Staff A stated the cart contained opened instruments and she thought it was a vaginal delivery set which had just been set up and pushed into the operating room OR. Staff A asked two staff in the OR whether the cart was a vaginal delivery set and one replied yes. In an observation on 6/4/12 at approximately 1:00 p.m., the cart was still in the obstetrics OR and was unattended by facility staff.

In an interview on 6/4/12 at approximately 4:40 p.m., Staff B stated the vaginal delivery instruments were opened ahead of an impending delivery and were normally stored in the hall. She stated opening the instruments in the room where the delivery was occurring would provoke anxiety in the mother. She stated the hospital did try to maintain a sterile field for vaginal deliveries and that the doctors wore sterile gowns, sterile gloves, caps, and masks for vaginal deliveries. She stated she would get the hospital's policy regarding setting up the instruments.

In an interview on 6/5/12 at 9:33 a.m., Staff A gave the surveyor a policy, "Basic Aseptic Technique" and stated was the policy the surveyor had requested from Staff B.

Review of the hospital's policy "Basic Aseptic Technique" (revised 7/09) indicated, "Sterile Drapes will be used to establish a sterile field... Sterile fields should be maintained and monitored constantly... The sterile field should be prepared in a location in which it will be used... Sterile fields should be prepared as close as possible to the time of use... An open sterile field requires continuous observation... Sterile fields should not be covered."

2. In an observation and interview on 6/4/12 at approximately 12:45 p.m., a cabinet in the special procedures room contained endoscopes hanging from the wall. Several endoscopes had their tips covered in red rubber sleeves. The sleeves were touching a black speckled white towel at the bottom of the cabinet. The endoscopes for which the sleeve-covered tips were in contact with the bottom of the cabinet, were curved to allow the length of the scopes to fit in the cabinet. Staff A stated that the towel at the bottom of the scope closet needed to be changed.

In an interview on 6/5/12 at 1:43 p.m., Staff A stated the hospital followed the AORN (Association of periOperative Registered Nurses) guideline, that she interpreted it as allowing the scope protector if the endoscope channels were dry, and that the hospital staff did dry the endoscope channels prior to storing the scopes in the cabinet.

Review of the AORN "Recommended Practices for Cleaning and Processing Flexible Endoscopes and Endoscope Accessories" indicated, "Flexible endoscopes should be stored... in a closed cabinet with... adequate height to allow flexible endoscopes to hang without touching the bottom of the cabinet, and... with scope protectors applied if the protector does not interfere with the flexible endoscope hanging straight or restrict the air movement around channel openings... When flexible endoscopes are hung in the vertical position, coiling or kinking is prevented, allowing any remaining moisture to drain out of the endoscope and decreasing the potential development of an environment conducive to microbial growth in the endoscope. Proper storage facilitates drying and decreases potential for contamination... The scope protector may create an environment favorable for microbial growth if the flexible endoscope is not dry and cannot hang straight... Flexible endoscopes should be reprocessed before use if evidence of improper drying exists (e.g.,evidence of discoloration, wet spots, or stains, or soil in the storage cabinet) when the scope is removed from storage... Evidence of improper drying may include wet spots or stains on the bottom of the cabinet where the flexible endoscopes have been hanging. Improper drying creates an environment conducive to growth of microorganisms... Storage cabinets should be cleaned and disinfected with an Environmental Protection Agency (EPA)-registered disinfectant when visibly soiled and on a weekly or monthly schedule... Cleaning and disinfecting storage cabinets periodically will decrease dust and soil build up."

3. In an observation and interview on 6/4/12 at approximately 12:45 p.m., the special procedures room was not in use but contained an opened peel pack with endoscopic biopsy forceps still inside. Staff A agreed the peel pack had been opened and stated that it should not be used and would be discarded.

Review of the hospital's policy "Association of Operating Room Nurses (AORN) Standards" (revised 3/12) indicated, "The Nursing Staff... shall strive to achieve the highest standards of their profession by following the current published AORN standards. Policies and procedures... will reflect variations in practice settings and/or clinical situations that determine the degree to which the recommended practices can be fulfilled."

In an interview on 6/5/12 at 9:33 a.m., Staff A stated the hospital's usual practice was not to keep opened peel packs. In an interview on 6/5/12 at 1:43 p.m., Staff A stated the hospital followed AORN guidelines in the surgical suite.

Review of the AORN "Recommended Practices for Cleaning and Processing Flexible Endoscopes and Endoscope Accessories" indicated, "Endoscopic accessories (e.g., biopsy forceps, cytology brushes) that enter sterile tissue or the vascular system should be cleaned and sterilized between use... These devices enter sterile tissue and, if contaminated, increase the risk of patient infection."
VIOLATION: HISTORY AND PHYSICAL Tag No: A0952
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure one sampled patient (Patient 34) had a complete medical history and physical examination (H&P) within 30 days prior to surgery. The deficient practice had the potential to allow changes in the patient's health since the last H&P to go unnoticed.

Findings:

Review of Patient 34's medical record indicated he had a hernia repair at the hospital on [DATE]. A typed "PRE-OP HISTORY AND PHYSICAL" indicated the date of admission was 6/4/12, but the document indicated it had been dictated and transcribed on 4/30/12, over 30 days prior to surgery.

A handwritten "History & Physical" dated 6/4/12 was also present in Patient 34's record. The history of present illness stated, "NON INCARCERATED 0 [zero] PRIOR see DICTATION", but did not state how or when the patient developed his hernia. The past medical history had a minus sign written over lines labeled "Surgery's" and "Current Medications", even though the 4/30/12 dictation stated Patient 34 had previously had surgery. The field labeled "SOCIAL/FAMILY HISTORY" had an illegible entry. The H&P stated "ROS - [review of systems negative] see DICTATION" but did not state what issues had been reviewed. The "PHYSICAL EXAMINATION" stated, "+ RIH [right inguinal hernia] non-incarcerated", but did not include vital signs or an examination of other parts of Patient 34's body. The "IMPRESSION" contained an illegible entry.

In an interview on 6/4/12 at approximately 4:30 p.m., Staff A stated she did not know what the entries meant for social/family history or impression on Patient 34's handwritten H&P. She agreed that the handwritten H&P was not comprehensive. In an interview on 6/5/12 at 10:58 a.m., Staff A stated there was no newer dictated H&P for Patient 34 than the one dated 4/30/12 and that the comments to "see dictation" on the 6/4/12 handwritten H&P were referring to the H&P dictated on 4/30/12.

Review of the facility's medical staff rules and regulations dated 2/4/10 indicated a complete H&P was required prior to surgery and "A complete History and Physical shall include: a. Chief Complaint; b. History of present illness, medications and allergies; c. Past medical history; d. Past surgical history; e. Past psycho-social and family history; f. Review of systems; f. [sic] Physical examination; g. Diagnosis; h. Treatment plan."
VIOLATION: NURSING SERVICES Tag No: A0385
Based on interview and record review, the hospital failed to ensure that temporary nursing staff had verified competencies to care for patients.

Findings:

1. A nurse from a temporary nursing agency working in the intensive care unit (ICU) failed to safely administer medications in a manner consistent with hospital policy and the same nurse did not have hospital verified competencies to provide patient care in the ICU (cross-reference A084).

2. In addition, the hospital failed to ensure staff from 8 contracted nursing agencies were competent to perform their duties in accordance with hospital policy and in a safe manner (cross-reference A397).

The cumulative effect of these systemic problems resulted in the hospital's failure to provide safe nursing care to patients.
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, the hospital failed to ensure that temporary nursing personnel were assigned to patient care duties in which they were competent. Failing to verify a nurse's competency with a non-routine procedure does not ensure that patient care needs will be met.

Findings:

In a patient chart review, conducted on 6/6/12 and 6/12/12 it was noted that Patient 19 was admitted on [DATE] for shortness of breath and subsequently transferred to a medical unit for care. Due to the patient's condition, on 5/15/12 she was transferred to the hospital's intensive care unit (ICU). Physician documentation indicated on 5/16/12 at 2:35 p.m. Patient 19's physician gave a verbal order to Nurse S that read, "Versed (central nervous system depressant) 4 mg. IV now and Fentanyl (opiate analgesic to block pain) 200 mcg., IV now." The physician was preparing the patient for a conscious sedation treatment (a combination of medicines to help you relax and to block pain during a medical procedure) that required intubation (placing a tube through the patient's mouth to aid in breathing).

Nurse H (registry nurse) obtained the medication at 2:50 p.m. and immediately administered the medication through the patient's intravenous line (IV). The time of administration could not be identified as Nurse H failed to document this process. Based on documentation in the physicians note, Nurse H administered the medication prior to the procedure and the patient became apneic (having difficulty breathing) and an emergent intubation evolved. An emergency medical code (code blue) was initiated at 3:05 p.m.

In an interview with Nurse S on 6/12/12 revealed she was the charge nurse on 5/16/12 and received a verbal order from the physician for the medications Versed and Fentanyl. She forwarded the order to the pharmacy and put it into the computer system, thus allowing the pyxis machine (medication dispensing machine) to allow removal.

Nurse S and Nurse H cosigned the medications' removal and Nurse H, who was assigned to Patient 19 went to the patient's room with the medications. After a few minutes, Nurse S returned to Patient 19's room and noted Nurse H "flushing" the IV line (process to clear the tubing normally done after medication administration). She then asked Nurse H if she gave the medications. Nurse H stated "yes" she gave it all. Nurse S stated the medications should have been given in small increments with a 5 minute delay between doses. When asked about staff assignments, Nurse S stated she assigned patient care to other nurses during her shift. Nurse S stated at the change of shift, a report by the night charge nurse indicated Nurse H could take care of Patient 19. Nurse S did not verify the competency of the nursing staff but depended on the individual nurse to inform her of their competencies. When asked, Nurse H stated she could care for Patient 19.

On 6/12/12 the competency file of Nurse H was reviewed. The file revealed a list of procedures in which she self-attested to being proficient. There was no evidence the hospital had validated her competency in providing care to patients in the ICU including conscious sedation procedures.
VIOLATION: PATIENT CARE ASSIGMENTS Tag No: A0397
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on documentation and interview, nursing staff were assigned to patient care without having validated competencies to provide care as defined by the hospital's standards of staff performance.

Findings:

On 6/13/12 a review of the hospital policy regarding nursing competencies (Education Services Manual) indicated, "The Patient Care Team at Saint Louise Regional Hospital will remain knowledgeable and competent in performance of care for all patients. This will be accomplished through a planned program of competency assessment." The Policy Interpretation indicated, under subsection C: "The department manager is responsible and accountable for developing the department competency based assessment, assuring that each individual is assessed, and that work assignments are consistent with the individuals competency level."

Based on a patient chart review, conducted on 6/6/12 and 6/12/12 it was noted that Patient 19 was admitted on [DATE] for shortness of breath and subsequently transferred to a medical unit for care. Due to the patient's condition, on 5/15/12, she was transferred to the hospital's intensive care unit (ICU). Physician documentation indicated on 5/16/12 at 2:35 p.m. Patient 19's physician gave a verbal order to Nurse S that read, "Versed (central nervous system depressant) 4 mg. IV now and Fentanyl (opiate analgesic to block pain) 200 mcg., IV now."

The physician was preparing the patient for a conscious sedation treatment (a combination of medicines to help you relax and to block pain during a medical procedure) that required intubation (placing a tube through the patient's mouth to aid in breathing).

Nurse H (registry nurse) obtained the medication at 2:50 p.m. and immediately administered the medication through the patient's intravenous line (IV). The time of administration could not be identified as Nurse H failed to document this process. Based on documentation in the physician's note, Nurse H administered the medication prior to the procedure and the patient became apneic (having difficulty breathing) and an emergent intubation evolved. An emergency medical code (code blue) was initiated at 3:05 p.m. and the patient expired at 4:14 p.m.

On 6/12/12 during an interview with Nurse S revealed she was the charge nurse on 5/16/12 and received a verbal order from the physician for the medications Versed and Fentanyl. She forwarded the order to the pharmacy and put it into the computer system, thus allowing the pyxis machine (medication dispensing machine) to allow removal of the medications. Nurse S and Nurse H cosigned the removal of medications and Nurse H, who was assigned to Patient 19, went to the patient's room with the medication. After a few minutes, Nurse S returned to Patient 19's room and noted Nurse H "flushing" the IV line (process to clear the tubing normally done after medication administration). She then asked Nurse H if she gave the medication. Nurse H stated "yes" she gave it all. Nurse S, who has a hospital ICU competency in providing care for conscious sedation patients, stated the medication should have been given in small increments with a 5 minute delay between doses.

The hospital standard for conscious sedation was reviewed on 6/12/12 and indicated for the medication fentanyl, it recommended titrating small increments of the medication with a 5 minute delay between doses.

On 6/12/12 Nurse H's competency file was reviewed. The file revealed a list of procedures in which she self-attested to being proficient. There was no evidence the hospital had validated her competency in providing care to patients in the ICU including conscious sedation procedures.

In an interview with the interim Chief Nursing Executive on 6/13/12 stated registered nurses from temporary nursing agencies were not subject to the same patient care competency standards as registered nurses who are employees of the hospital. She further stated temporary nursing agencies submit the competencies in which the nurse is proficient. Patient care assignments were based on the temporary nursing agencies competencies.

On 6/14/12 a review of 9 nurses (including Nurse H) from 8 temporary nurse registries indicated the patient care competency standards for each agency was not the same as the hospital. Further review of the nurse agencies competencies revealed that all 8 agencies relied on the individual nurse stating what they were competent in performing. This self-attestation does not ensure the nurse can in fact perform procedures in a safe manner. In addition, this process does not follow the hospital policy on nursing competencies.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on review of one of one patient record (Patient 18) of patients who were currently in the hospital and who had received propofol (a general anesthetic used to treat agitation in mechanically ventilated patients) during their current admission, document review and staff interview, the hospital failed to ensure that an accurate weight was used to program the smart intravenous (IV) pump used by nursing staff to administer the propofol to Patient 18 based on a weight based dosing regimen measured in micrograms (mcg)/kilogram (kg)/minute (min). Patient 18's recorded weights of 126 to 137.5 kg was 48.5 to 60 kg less than the 186 kg weight entered by staff onto Patient 18's preprinted order set for propofol which would result in an error of 35% to 47% in the rate of infusion. The hospital also failed to ensure staff carried out the preprinted order to obtain a triglyceride level (a component of fat) on the first day of propofol administration. Propofol is delivered in an emulsion of lipids (fat) and triglyceride levels are monitored to ensure the patient is not becoming overloaded on fats.

Findings:

1. On 6/6/12 a review of Patient 18' s clinical record indicated that Patient 18 received propofol as an IV infusion between 11:45 a.m. on 5/31/12 through 8 a.m. on 6/2/12. He received this because he was on a ventilator and propofol was used to prevent agitation of the patient while he was intubated.

The propofol was ordered on a preprinted form, "SEDATION AND ANALGESIA ORDER FOR MECHANICALLY VENTILATED PATIENTS". It had a section of preprinted orders for propofol that included an order to weigh the patient if a recent weight was not available and a space in the order set for staff to write in the weight in kilograms (kg). A staff member had filled "186" in this space documenting Patient 18 weighed 186 kg (409 lbs). The order set directed staff to start the drip at 10 mcg/kg/min and to increase the rate by 5 mcg/kg/min every five minutes until the sedation level ordered by the physician was reached. The order set directed staff to check the patient's triglyceride levels on Day 1 and then every 72 hours while on propofol.

A review of the electronic section of the medical record indicated that it contained two weights for Patient 18: 126.099 kg (278 lbs) taken on 5/23/12 and 137.5 kg (303 lbs) taken on 6/2/12.

A review of the CRITICAL CARE FLOWSHEET dated 5/31/12 indicated the rate of administration was 20 mcg/kg/min at 11 a.m. and 12 noon, 30 mcg/kg/min at 1 p.m. and 2 p.m., 20 mcg/kg/min at 4 p.m., 5 p.m., 6 p.m., 7 p.m. and 8 p.m. and 25 mcg/kg/hr each hour on 6/1/21 starting at 1 a.m. through 6 a.m. There were no other CRITICAL CARE FLOWSHEETs in the clinical record. The INTAKE & OUTPUT RECORD dated 6/1/12 documented propofol was given at 30 mcg/kg/min at 8 a.m. and 1 p.m. and 40 mcg/kg/min at 4 p.m. on 6/1/12. The INTAKE & OUTPUT RECORD dated 6/2/12 documented that propofol was off at 8 a.m. on that date and no other entries for propofol appeared on that document.

On 6/6/12 a review of an All Station Events report generated from the Pyxis database for Patient 18 with respect to propofol indicated it documented that fourteen 100 ml bottles of propofol had been removed from the Intensive Care Unit (ICU) Pyxis MedStation (an automated dispensing device) for Patient 18 between 11:15 a.m. on 5/31/12 and 4:38 a.m. on 6/2/12. Bottle fifteen was removed at 6:16 a.m. on 6/2/12. Hence Patient 18 used 1,400 ml of propofol 10 mg/ml between 11:15 a.m. on 5/31/12 and 6:16 a.m. on 6/2/12 (a 43 hour period) for a total of 14,000 mg or 14,000,000 mcg. Dividing 14,000,000 mcg by 43 hours yields and average rate of 1 mcg/hr. Dividing this number by 60 minutes yields an average rate 5426 mcg/min. Dividing this number by 186 kg (the weight recorded on the printed order set) results in an average rate of 29 mcg/kg/min, which is in agreement with the various recorded infusion rates recorded in Patient 18's clinical record. This was verified with the Pharmacist-In-Charge (PIC) at that time.

During an interview of the PIC on 6/6/12 at 3:47 p.m. he stated the hospital smart IV pumps did not have information that could be downloaded as to what a specific patient received. He stated that staff would have entered the patient's weight into the smart pump data base followed by the desired infusion rate in mcg/kg/min and combined with information regarding the concentration of propofol, the pump would automatically deliver the propofol at a given rate in ml/hr based on the patient's weight, drug concentration, and rate of drug administration in mcg/kg/min.

Thus the rate of use of propofol based on the amount removed from the Pyxis MedStation in the ICU supports the fact that a weight of 186 kg, as documented on the printed order set, was used in the smart pump which was not in agreement with two weights of 126 kg and 137.5 kg recorded in Patient 18's clinical record. Hence Patient 18 did not receive propofol as ordered by the physician.

Further review of Patient 18's clinical record indicated that staff did not order a triglyceride level on Day 1 of the propofol drip as ordered by the physician via the preprinted order set.
VIOLATION: PHARMACY DRUG RECORDS Tag No: A0494
Based on inspection of the supply of outdated controlled substances (medications subject to abuse such as morphine) stored in the hospital controlled medication cabinet, review of the "Outdated Narcotics" log, and staff interview, the staff failed to keep accurate records of the disposition of controlled substances on this log. Two entries (Fiorinal #3, nine tablets, and hydromorphone for injection 20 milliliters [ml]) out of twenty-one entries of the current expired controlled medication supply listed on this log did not match the contents found in the expired medication supply. The supply contained Fiorinal not Fiorinal #3 and it contained 17.5 ml of hydromorphone, not 20 ml. Fiorinal is used to treat migraine headaches and hydromorphone is a narcotic pain reliever. Fiorinal #3 contains codeine in addition to other ingredients found in Fiorinal (aspirin, butalbital (a barbiturate), and caffeine).

Findings:

1. On 6/4/12 a review of the "Outdated Narcotics" log (a log used to record and account for those controlled substances that had been removed from active stock until they could be transferred to a reverse distributor for destruction) followed by inventory of the expired controlled substances awaiting destruction indicated the following discrepancies:

a. The log indicated the expired supply contained nine Fiorinal #3 tablets. The expired supply contained nine generic Fiorinal tablets (without any codeine in them). The plain generic Fiorinal did not appear anywhere on the "Outdated Narcotics" log.

b. The log indicated the expired supply contained 20 ml of hydromorphone for injection. The expired supply contained a 20 ml vial of hydromorphone for injection with a dispensing pin (a device that would accommodate a syringe to withdraw a measured amount of hydromorphone solution) inserted through the vial rubber diaphragm. Measurement of the contents of the vial by the Pharmacist-In-Charge (PIC) at that time indicated it only contained 17.5 ml of hydromorphone solution for injection.

On 6/4/12 at 4:01 p.m. during an interview of the PIC he stated that Pharmacist A had told him Pharmacist A felt the symbol "C III" (schedule III of the controlled substance act) on the generic Fiorinal label made him think it was Fiorinal #3 (with codeine) when he logged it in. The PIC stated that Pharmacy Tech B had told him the hydromorphone vial came back to the pharmacy with a dispensing pin and that the contents were not measured when it was logged onto the "Outdated Narcotics" log.
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, record review, and staff interview:

a. The hospital failed to ensure that staff carried out the hospital policy and procedures that stipulated designated pharmacy staff logged each DEA 222 form (required by law to order Schedule II controlled substances which are drugs, such as morphine, with a high potential for abuse), the date of receipt of Schedule II controlled substances, and the identity of the receiving staff member onto a hospital approved log. Recording of these forms on a log would enable the Pharmacist-In-Charge (PIC) to track them and would make diversion of the forms more difficult. Recording the date of receipt and the identity of the receiving staff member would make tracking of the receipt of Schedule II controlled substances into the pharmacy inventory easier.

b. The hospital failed to maintain monthly controlled substance (drugs subject to abuse) summaries as stipulated by the hospital policy and procedures. Such a list could be used to check entries made on the controlled substance perpetual inventory maintained by this pharmacy (as verified by inspection of these records on 6/4/12) to ensure that all medications brought into the pharmacy in any given month had been entered accurately into the perpetual inventory.

c. The hospital failed to put a procedure into place to ensure that Xopenex (a medication used to dilate airways in patients with reversible obstructive airway disease such as asthma and a drug which has a shortened shelf life when the protective foil package housing individual dosage units is opened) was accurately dated when staff opened the protective foil package enclosing the dosage units and/or when staff removed the dosage units from the foil pouch. Such dating would be used as a tool by staff to remove expired Xopenex from active stock supplies available for patient use.

d. The hospital failed to ensure the Pharmacy and Surveillance Committee (identified by the Medical Staff Bylaws as the committee responsible for the hospital pharmaceutical services) established and approved the contents of the "Intubation Kit" (contained drugs to facilitate placement of an airway in a patient who could not breathe), and failed to ensure this committee provided procedures for use of this emergency supply as well as procedures for restocking and sealing this emergency supply. The hospital also failed to ensure staff stocked three 12 ml syringes in the kit as listed on the content list and which would be needed to administer the medications in the kit.

e. The hospital failed to establish an approved list of medication contents of anesthesia trays (a specialized form of floor stock made available to anesthesiologists for use during surgical procedures) as recommended by the American Society of Health System Pharmacists (ASHP: a nationally recognized organization that sets standards of practice for hospital pharmacies) and the Medical Staff Bylaws.

Findings:

1. The American Society of Health System Pharmacists (ASHP) is a nationally recognized organization that sets standards of practice for hospital pharmacies. This organization has published ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals in which it documents that "An operations manual governing pharmacy functions shall exist ...Appropriate mechanisms to ensure compliance with the policies and procedures should be established."

Schedule II controlled substances are ordered from the wholesalers by pharmacy staff via a DEA 222 form. This is a triplicate form issued by the Drug Enforcement Agency and each form has a unique identifying number. These forms are ordered by pharmacy staff from the DEA and are issued in envelopes containing a group of DEA 222 forms in numerical sequence. After ordering Schedule II controlled substances using this form, the pharmacy sends copy of the triplicate to the DEA while the wholesaler that supplies the Schedule II drugs keeps a second copy for their records. The pharmacy keeps a third copy for its records. The DEA uses these forms to keep track of what pharmacies order from the wholesalers and to audit the pharmacies.

On 6/5/12 a review of the policy and procedure entitled CONTROLLED SUBSTANCE MONITORING (Original Date: 10/00; Revised 07/07, Reviewed 8/09) indicated that it stipulated "Upon receipt of DEA 222 forms from the Drug Enforcement Agency, the Pharmacy Director or designee shall record each DEA 222 from number onto a control log to document all forms received into the facility." Logging in these forms onto the "222 FORM LOG SHEET" would make it more difficult to divert these forms or lose track of them. It also identified who ordered Schedule II controlled drugs and who received Schedule II controlled drugs and when this occurred.

On 6/5/12 an inspection of the "222 FORM LOG SHEET" indicated that it had columns with title prompts for "Date", "Ordered By", "DEA order No.", "Date Received", and "Received By". During an interview of the PIC at 9:01 a.m. on 6/5/12 he stated these were the dates designated staff ordered Schedule II controlled substances, which staff member did the ordering, the DEA form number, the date the order was received by the pharmacy, and the initials of the staff member who received the order.

The log appeared to have a gap in the data entry as there were no entries between form number 1990 logged in on 1/13/12 until form number 4302 logged in on 5/30/12. This gap in data entry was verified when the surveyor found DEA forms with dates from 1/25/12 through 5/23/12 on file in the pharmacy which had not been logged onto the "222 FORM LOG SHEET". There were 14 such forms and two more forms were missing (ascertained by noting gaps in the sequence of unrecorded forms) which were subsequently located by the pharmacy staff and (MDS) dated [DATE] at 9:17 a.m. Therefore, a total of 16 forms had not been logged onto the form.

Furthermore, four entries for form numbers "11X 8, 1989, 1990, and 1992" did not have dates received or the names/initials of the persons receiving the controlled substances ordered via these particular forms recorded on the "222 FORM LOG SHEET". The surveyor located forms 1989, 1990, and 1992 which had the information (date and identity of receiving staff member) that staff had failed to enter on the "222 FORM LOG SHEET". Form "11X 8" was missing but the PIC presented it on 6/5/12 at 5:16 p.m. and it too had the information that staff had failed to enter on the "222 FORM LOG SHEET".

In summary, the hospital failed to ensure that staff carried out the hospital policy and procedures that stipulated designated pharmacy staff logged each DEA 222 form, the date of receipt of Schedule II controlled substances, and the identity of the receiving staff member onto a hospital approved log.

2. The American Society of Health System Pharmacists has published ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals in which it documents that "An operations manual governing pharmacy functions shall exist ...Appropriate mechanisms to ensure compliance with the policies and procedures should be established."

On 6/5/12 a review of the policy and procedure entitled CONTROLLED SUBSTANCE MONITORING (original date: 10/00; revised 07/07, reviewed 8/09) indicated that it stipulated that: "The Pharmacy Director shall maintain the 'Monthly Record of Controlled Substances' purchasing summary available from drug wholesalers, or a written history of all controlled drug purchases made by the facility for the month, sorted by date."

On 6/5/12 an inspection of the controlled substance records maintained by the pharmacy indicated that monthly summaries for [DATE], March 2012, and May 2012 had been maintained in the pharmacy controlled substance records. During an interview of the PIC on this date at 11:14 a.m. he agreed to try and locate additional monthly summaries. By the end of the survey, the PIC had not supplied any additional monthly summaries.

3. The American Society of Health System Pharmacists has published ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals in which it documents that "An operations manual governing pharmacy functions shall exist ...Appropriate mechanisms to ensure compliance with the policies and procedures should be established." Under the standard for "Medication Distribution and Control" it stipulates that: "Medications shall be stored ...under proper conditions of ...temperature, (and) light ...to ensure medication integrity ..."

Xopenex is a solution that can be nebulized into a fine mist using appropriate respiratory equipment and is used to dilate constricted airways in patients with reversible obstructive airway disease such as asthma. The Food and Drug Administration (FDA) approved product labeling for Xopenex documents that the unit dose 3 ml vials are to remain stored in the foil package and to protect the product from light. The product labeling documents that once the pouch is opened, the vials have a two week shelf life if stored in the open foil pouch. It documents that vials removed from the foil pouch should be protected from light and used within one week.

On 6/4/12 at 2:28 p.m. during an inspection of the pharmacy medication supplies, the surveyor found an open box containing 12 vials of Xopenex stored in a clear plastic bag along with two unopened foil pouches. There was no indication on the clear plastic bag or on the vials to indicate when they had been removed from their foil pouch. During an interview of Pharmacy Technician B at that time she stated the shelf life of the vials in the clear plastic bag was two weeks (not one week as documented in the product labeling and on labeling that appeared on the foil pouches in the same box as the vials stored in the plastic bag).

On 6/5/12 an inspection of two out of six Pyxis MedStations (Med Surg 1 and Med Surg 2: automated dispensing devices) that currently contained Xopenex as documented on a Pyxis report for the current Pyxis MedStation inventory of Xopenex on the nursing units indicated the following:

a. At 11:36 a.m. an inspection of the Med Surg 2 MedStation indicated it contained seven vials outside of any foil pouch and which had individual labels applied to each of them with the date "6/10/2012".

b. At 11:51 a.m. an inspection of the Med Surg 1 MedStation indicated it contained twelve Xopenex vials stored in two sealed clear plastic packages of six vials. A staff member had applied a label on each pack with the date 6/11/12.

On 6/6/12 at 9:58 a.m. during an interview of the PIC he stated there was no formal hospital procedure directing staff how to assign an expiration date to Xopenex vials. He stated there was no way to tell when a given Xopenex dosage unit was put into a Pyxis MedStation and that there was no way to tell how long the vials not in the foil wrap had been in a Pyxis MedStation. He said he felt the dates on the Xopenex vials in the Pyxis MedStation the surveyor had inspected were 14 day expiration dates. He stated he could not say with 100% certainty that all the assigned expiration dates had been assigned accurately. He stated that until the survey, not all of his staff had been aware that expiration date was 7 days outside of the foil pouch. He stated that at the present time he had no method to ensure the accuracy of the expiration dates placed on the Xopenex vials (stored in the Pyxis MedStations).

4. The American Society of Health System Pharmacists has published the ASHP Technical Assistance Bulletin on Hospital Drug Distribution and Control (revised November 1981). This bulletin documents: "The effectiveness of the drug control system depends on adherence to polices ...and ...procedures. Under "Emergency Supplies" this bulletin documents: "A policy to supply emergency drugs when ...there is insufficient time to get to the pharmacy should exist ...The P&T Committee should specify the drugs and supplies to be included in emergency stocks".

On 6/6/12 a review of the MEDICAL STAFF BYLAWS (amended 5/3/12) indicated it established a "Pharmacy and Surveillance Committee" that included representatives from the medical, pharmacy, nursing, and administrative department. The bylaws stipulated that one of the "duties" of this committee was: "assisting in the formulation of professional practices and policies regarding the ...use, safety procedures, and all other matters relating to drugs in the hospital ...."

On 6/5/12 at 4:53 p.m. an inspection of an "Intubation Kit" stored in the refrigerator in an Emergency Department (ED) Medication Room indicated it contained medications used to facilitate the placement of an airway in patients who could no longer breathe for themselves. The medications were in a sealed plastic bag and the content list was completely visible through the bag. All medications that appeared on this content list were present in the "Intubation Kit".

On 6/5/12 at 5:16 p.m. during an interview of the PIC, he stated he could find no policy that established the contents of this emergency supply, provided procedures for use of this emergency supply, and procedures for restocking and sealing this emergency supply.

5. On 6/5/12 at 4:53 p.m. an inspection of an "Intubation Kit" stored in the refrigerator in an ED Medication Room indicated the content list was completely visible through the bag. All medications that appeared on this content list were present in the "Intubation Kit". However the content list indicated the supply contained three 12 ml syringes and inspection of the kit contents indicated it did not contain three empty 12 ml syringes. Such syringes would be needed to administer the drugs to patients.

6. The American Society of Health System Pharmacists has published the ASHP Technical Assistance Bulletin on Hospital Drug Distribution and Control (revised November 1981). This bulletin documents: "The effectiveness of the drug control system depends on adherence to polices ...and ...procedures." Under "Drug Control in Operating and Recovery Rooms" it documents: "The institution's drug control system must extend to its operating room complex. The pharmacist should ensure that all drugs used within this area are properly ordered, stored, prepared, and accounted for."

On 6/6/12 a review of the MEDICAL STAFF BYLAWS (amended 5/3/12) indicated it established a "Pharmacy and Surveillance Committee" that included representatives from the medical, pharmacy, nursing, and administrative department. The bylaws stipulated that one of the "duties" of this committee was: "assisting in the formulation of professional practices and policies regarding the ...use, safety procedures, and all other matters relating to drugs in the hospital ...." The bylaws also stipulated that one of the "duties" of this committee was: "making recommendations concerning drugs to be stocked on the nursing unit floors and by other services."

On 6/6/12 at 10:41 a.m. inspection of two of three anesthesia trays (contained medications used by anesthesiologist during surgical procedures and stored in an anesthesia cart in a given operating room for use by the anesthesiologist) indicated they had individual pockets for individual drug products. Most but not all of the pockets had labels with drug names. Most but not all of the pockets had label prompts establishing the number of dosage units (par levels) to be stored in a given pocket.

On 6/6/12 at 10:31 a.m. during an interview of Pharmacist C, she stated there were no quantities for these anesthesia trays. She stated she had never checked these trays although pharmacists did check the trays before they were sent to the anesthesia carts (contain medications and equipment utilized by anesthesiologists in a given operating room).

On 6/6/12 at 11:53 a.m. during an interview of Pharmacist D, she said she rarely checked anesthesia trays. She stated she checked the drug name and the expiration dates but not the quantities sent out with the tray.

On 6/6/12 at 11:56 a.m. during an interview of Pharmacist E he stated he had never checked the anesthesia trays before they were sent out.

On 6/6/12 at 11:59 a.m. during an interview of Pharmacist A, he stated he had checked and/or filled the anesthesia trays before they were sent out. He stated he checked for the correct drug and the expiration dates but not the amounts. He stated he was not aware of established par levels.

On 6/6/12 at 11:15 a.m. during an interview of the PIC he stated there was no hospital approved list that he was aware of that established the type of drugs and quantities to be put in the anesthesia trays. He did provide a fill diagram entitled "OR Tray" that he had located in his computer. There were no dates on this sheet that documented when it was approved and/or reviewed and revised. It did provide a diagram of the pockets along with the names of the drugs to be stored in each pocket and the par level for each pocket. During a second interview at 11:50 a.m. the PIC state he did not know if the "OR Tray" form was a hospital approved form and he was not aware of hospital approved procedures to restock these anesthesia trays.
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
Based on inspection of one of one "Intubation Kits" (contained medications used to facilitate the placement of an airway in patients who could no longer breathe for themselves) stored in the Emergency Department (ED) refrigerator, document review, and staff interview, the hospital failed to store medications under conditions specified by the manufacturer and was unable to provide any data to support this practice for the vial of etomidate (used for the induction and maintenance of general anesthesia) and the vial of vecuronium (used to paralyze muscles and facilitate placement of an airway in patients who cannot breathe) found in this kit. As the stability of these drugs under refrigeration was not known, these medications would be considered unusable for patients in the hospital.

Findings:

1. On 6/5/12 at 4:53 p.m. an inspection of an "Intubation Kit" stored in the refrigerator in an ED Medication Room indicated the medications were in a sealed plastic bag and the content list was completely visible through the bag. All medications that appeared on this content list were present in the "Intubation Kit" . The kit contained succinylcholine, rocuronium, etomidate, and vecuronium. The vecuronium was not in the carton provided by the manufacturer. The manufacturers of succinylcholine and rocuronium document these drugs are to be stored under refrigeration.

On 6/6/12 a review of the product labeling (supplied by the pharmacy staff) for etomidate and vecuronium indicated the manufacturer's document that these drugs are to be stored at controlled room temperature (68 - 77 deg F). The product labeling for vecuronium documented that the vial was to be retained in the carton until the time of use.

On 6/6/12 at 10:26 a.m. during an interview of the PIC he stated he had no data to support the storage of etomidate or vecuronium under refrigeration. He said he had no data to support the storage of vecuronium outside of its carton.
VIOLATION: FOOD AND DIETETIC SERVICES Tag No: A0618
services was directed and staffed by qualified personnel that met the needs of all patients, as evidenced by failing to:

1. Ensure the implementation of dietetic services in an effective and organized manner that included a) staff in-services and competencies, b) safe and effective food production, c)dietary staff handwashing, d) food storage and inventory management, and e) comprehensive disaster plan (cross-reference A620).

2. Develop performance improvement activities that accurately reflect the scope and nature of the dietary services (cross-reference A267).

3. Ensure infection control oversight of food service as evidenced by failure to appropriately cool foods to prevent food-borne illness and ensure proper handwashing practices (cross-reference A749).

4. Ensure food service staff were competent in assigned duties (cross-reference A622).

The cumulative effect of these systemic problems resulted in the inability of the hospital's food and nutrition services to direct and manage staff in such a manner to ensure the nutritional needs of the patients were met in accordance with practitioner orders and acceptable standards of practice.
VIOLATION: ORGANIZATION Tag No: A0619
Based on staff interview and document review, the hospital failed to ensure the food service department was organized when there was no oversight by the Registered Dietitian (RD) of the food service operation. This failure includes the potential that patients would not receive safe food nor meet nutritional needs.

Findings:

On 6/4/12 starting at 2:30 p.m., the organizational of the Food and Nutrition Services was reviewed with the Chief Operating Officer (COO) and RD. The organizational chart documented the Director of Food and Nutrition Services as the DTR (Diet Technician Registered) and had the responsibility of the direction of the department. The RD stated on 6/4/12 at 2:30 p.m., she performed clinical nutritional functions with review of the patient menu and menu development. She stated she did not provide any guidance to the Director of the Food and Nutrition Services or food service staff on food safety or sanitation practices or provide in services.

The COO acknowledged on 6/4/12 at 2:30 p.m. that the food service department should be organized with a qualified RD. They should provide guidance to the Director of Food and Nutrition Department to meet regulatory requirements, ensure the safe production of food and implement policies and procedures to ensure competent and safe food production.
VIOLATION: DIRECTOR OF DIETARY SERVICES Tag No: A0620
Based on observation, staff interview and document review, the hospital failed to employ a Director of Food and Nutrition Services responsible for the daily management of the department who 1) ensured food service staff was knowledgeable in food safety practices including cool-down procedures and that there was a system to ensure staff competencies, 2) developed a detailed disaster food plan including directions for reconstituting dehydrated food items including therapeutic diets, 3) maintained food service area in a clean and sanitary manner and 4) ensured safe storage and inventory control for frozen foods and enteral products. Failure to evaluate the comprehensive scope of operational processes may result in patient exposure to unsafe food handling practices and/or food production systems that may not meet the nutritional needs of patients compromising medical status.

Findings:

1. On 6/4/12 at 9:15 a.m. through 6/6/12 review of the "Food and Nutritional Services HACCP (Hazard analysis critical control point program) Food Cooling Log" revealed it did not include documentation of the cooling of potentially hazardous foods cooked the day before serving the food. The log did not include roast beef cooked on 5/24/12 and served on 5/25/12. The lead cook could not verify the roast beef met industry food cool-down timeline standards to prevent growth of pathogenic bacteria and prevent foodborne illness (from 135 to 70 Fahrenheit (F) degrees within two hours and from 70 to 41 degrees F within four additional hours) as documented by the staff. During an interview on 6/6/12 at 2:00 p.m., the food service associate (FSA1) and the lead cook confirmed leftover foods from tray line service were the only items recorded on the log.

The FSA1 stated on 6/4/12 at 4:00 p.m., she only logged the leftover food from 135 degrees F to 70 degrees F for the first 2 hours and was unaware of the requirement to monitor the food temperatures from 70 degrees to 41 degrees F for an additional 4 hours.

The lead cook stated on 6/4/12 at 4:00 p.m. that he did not supervise or review of the Cool Down log and was unaware of the requirement to monitor the temperatures of cooling foods from 70 degrees F to 41 degrees F. In addition, FSA1 stated she could not monitor and log the dinner trayline leftovers because she went home at 7 p.m. and the tray line ended at around 6 p.m. She stated she would not have the required 6 hours to monitor the food temperatures to ensure proper cool down.

2. On 6/5/12 at 3:00 p.m., the hospital's full disaster plan provide for 300 patient, staff and visitor meals for three days consisting of dehydrated food entree products, and other food items. The directions on the dehydrated food containers stated to prepare with boiling water. On 6/5/12 at 3:00 p.m., the lead cook stated the water could be heated on a barbecue grill but they had not tried to heat this quantity of water using this method. In addition, review of the plan did not direct staff on how to prepare the dehydrated disaster entrees with boiling water including the source of the heat or time required to heat. The COO acknowledged on 6/5/12 at 3:00 p.m., that the disaster plan did not include all of the preparation information for the dehydrated entree food to be successfully reconstituted..

In addition, the Scenario Two full disaster menu did not address therapeutic diets and whether the dehydrated product would be appropriate to use for diabetic, renal or sodium restricted diets.

The disaster menu plan stated the Full Disaster Menu (Scenario Two) was designed to accommodate a 96 hour requirement (4 days) and 300 people per meal. The sample menu for Scenario Two only specified Day 1 to Day 3. There were no directions for Day 4.

3. On 6/4/12 at 9:15 a.m., the following items were noted during the kitchen inspection:

a. The tabletop can opener blade and surrounding area were covered with a thick black matter. The lead cook stated the can opener was cleaned after each use but acknowledged the can opener looked like it had not been cleaned in a while.

b. The table mounted can opener had shiny metal flakes in the gears indicating metal shavings from a dull blade opening the can. The lead cook stated he did not have a system to monitor the blade and change it when it became dull and produced metal shavings that would cross-contaminate patient food.

The policy, "Infection Control" indicated the manual can openers were to be cleaned between use and at the end of each shift. There was no policy to address changing the dull can opener blade.

c. The open 6x6x6 inch floor drains in the kitchen and dish room were observed to be dirty with black matter. On 6/4/12 at 9:15 a.m., the lead cook acknowledged the drains appeared to be dirty and thought housekeeping was to clean them.

The Infection Control policy stated the drains were cleaned by FSA (food service associates) in the dish room nightly, and the other drains monthly.

d. The ice machine bin cover had black stains across the entire interior surface. The lead cook stated on 6/4/12 at 9:15 a.m., the engineering staff was responsible for cleaning the ice machine. He stated he did not inspect the ice machine and was not aware of the black substance on the interior of the bin door.

4. On 6/4/12 at 9:17 a.m. during the initial tour of the kitchen, an inspection of the walk-in freezer revealed it was overcrowded, and seven cases of food were stored on the floor. There was no shelf space available within the freezer to store the seven cases. The overcrowded, disorganized conditions in the freezer prevented adequate cold air circulation. The industry standard from the United States Department of Agriculture Food and Drug Administration's Federal Food Code (Section 3-305.11 Food Storage) recommends storing food items at least six inches above the floor. The Food and Nutritional Services Manual NS Policy No. 3404 "Hazard Analysis Critical Control Points (HACCP)" A. Perishable Food Storage 9. stated "Items are arranged in the refrigerators and freezers to allow the cold air to circulate freely."

On 6/5/12, a review of the freezer inventory records "US Foods Shopping List" revealed staff did not consistently conduct a physical inventory of freezer contents prior to ordering supplies. There was no par level included on the inventory/order form to guide the ordering process and help prevent over ordering. Over ordering of frozen food contributed to the overcrowded freezer condition.

5. An inspection on 6/5/12 at 10:20 a.m. of the "night refrigerator" used by nursing staff when the kitchen is closed revealed:

a. A thermometer reading 30 degrees Fahrenheit

b. No temperature logs

c. Four packages of enteral feeding "Nestle' HN Fibersource" with manufacturer instructions to store at room temperature (59 - 86 degrees Fahrenheit) and a "do not freeze" warning on the label

d. One package of enteral feeding "Nestle' Peptamen" with an expiration date of 5/19/12

e. One box of nutritional supplement "Nestle' Renal Novasource" with an expiration date of 2/14/12

f. Two thawed frozen juice cartons with no "use by date" labels. The frozen juice cartons included instructions to use within 14 days of thawing. An interview with the chef revealed the food service department did not have a method to document when the juice cartons were removed from the freezer or how long each juice carton was stored in the refrigerator

g. One sandwich with a "use by 6/4/12" label.

The COO stated on 6/5/12 at 10:20 a.m., that they were unaware of the temperature in the refrigerator or the storage requirement for the enteral formula. She acknowledged the outdated products. The lead cook stated on 6/5/12 at 10:20 a.m., that he was aware the thawed juice was to be used in 14 days but they did not have a system to ensure the product was labeled to use within 14 days.

Enteral product held below the manufacturer's recommended temperature or used after expiration date can alter the product and compromise the delivery of nutrition compromising patient care.

Review of the Infection Control policy addressing basic food service procedures did not address the storage of food or enteral products in the "night refrigerator." The policy did not address the system to ensure the thawed juice was labeled per manufacturer's directions.
VIOLATION: COMPETENT DIETARY STAFF Tag No: A0622
Based on observation, staff interview, and document review, the hospital failed to ensure food service staff were competent in their respective duties as evidenced by no ongoing department-wide in service program and failure of staff to demonstrate knowledge of cool down practices and handwashing practices. The potential outcome is food-borne illnesses.

Findings:

During the survey starting on 6/4/12, food service staff were observed not following handwashing practice and not following the policy for cool down of food prepared ahead of serving (cross-reference A620).

1. On 6/4/12 at 2:20 p.m. the food service department in-service records for the last 12 months were reviewed. The Chief Operating Officer (COO) stated during the review the food service employees all attended the annual hospital in-service which included basic fire safety review, infection control, and review of hospital values. There were no in-services specific to the job duties of the food service staff including safe food preparation techniques, handwashing with return demonstration or other procedures to ensure staff competencies. The COO further stated that the Director of Food and Nutrition Services monitored the handwashing but there was no documentation of the monitoring of handwashing or other specific food safety practices of the staff.

2. On 6/4/12 at 2:20 p.m., the personnel records of Cooks 1, 2, 3, lead cook, and food service associate 1 were reviewed. Their files included a generalized annual performance appraisal document that evaluated the general quality of work but did not evaluate specific competencies of the assigned work tasks. One aspect stated "Observes infection control at all times." There was no specific documentation regarding the staff knowledge of specific infection control practices including handwashing techniques or safe food handling of products.

On 6/4/12 at 2:20 p.m. the COO confirmed during an interview that food service staff evaluations did not evaluate the specific competencies of the assigned work of the cooks, lead cook or the food service associates.

Review of the Infection Control Policy Education section dated 8/09, stated annual mandatory education should include at least the following: correct handwashing procedures, source of foodborne illness, techniques to minimize sanitation hazards during handling, storage, preparation, and serving of food, care and storage of supplies.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

3. During a medication administration observation on 6/5/12 at 11 am. registered nurse A (RN A) was observed administering six oral and one intravenous (IV) medication to Patient 8. RN A brought the medication administration records (MAR), taken from the patient medical record, to the patient's room and placed it on the bare overbed table.

RN A was observed licking her fingers as she turned the pages of the MAR and recorded the oral medications given to Patient 8. RN A then failed to perform hand hygiene prior to handling the IV lines and attaching the schedule IV antibiotic to Patient 8. The RN also programmed the infusion pump for the IV antibiotic. During the interview after the medication observation, RN A stated she always "gels in and gels out".

The hospital policy for handwashing and hand antisepsis (dated 4/09) was reviewed on 6/6/12. It indicated nursing staff will comply with CDC (Centers for Disease Control) guidelines on hand hygiene in the following situations: "...before and after using the bathroom, blowing your nose, covering a sneeze or cough, etc, ...before and after preparing and administering medications."

The observation was discussed with the acting chief nursing officer and the nursing supervisor. The nursing supervisor acknowledged hand hygiene would be required before handling any medications.

4. On 6/5/2012 at 11:15 a.m. a staff nurse was observed checking Patient 6's blood sugar before lunch with a glucometer (a device measuring blood sugar). After the procedure, the nurse handed the glucometer to registered nurse C to use it for another patient. RN C did not clean and sanitize this device before taking the device into Patient 4's room. Patient 4 was admitted with complaints of cough and the sputum tested positive for yeast and staphylococcus (a bacteria) according to the nursing unit report on 6/6/12.

RN C placed the glucometer device on Patient 4's bare over bed table. RN C was interviewed on 6/5/12 at 1:50 p.m. She stated she did not remember getting trained to sanitize the device after use. The nurse supervisor observed the exchange and acknowledged this was a breach in infection control.

The hospital guidelines for "handwashing and hand antisepsis", "use of the accu-check (glucometer) inform hospital blood glucose monitoring system" and the "infection prevention and control plan" reviewed on 6/6/12, did not specifically require the glucometer be cleaned and sanitized between patients as recommended by the CDC to prevent patient-to-patient transmission of blood borne pathogens.

5. During the medication administration one of four nurses was observed removing supplies from her pocket. She pulled out a package with a bluecap for capping off the intravenous lines, alcohol swabs and a pen.

6. During a tour of the hospital on [DATE] the evaluator was allowed to enter the labor and delivery (L&D) operating corridor where C-sections (surgical procedure to deliver a baby)were performed, wearing street clothes. This corridor was an access point to the operating room scrub sinks and was considered a semi restricted area. When asked about the need to "gown up" the L&D nurse stated street clothes would be okay, as long as there were no operations in progress.

According to the Association of Perioperative Registered Nurses (AORN), Perioperative Standards and Recommended Practices, 2011 Edition, personnel were required to wear surgical attire (gown up), and cover all head and facial hair, while in a semi-restricted area. A semi-restricted area includes the peripheral support areas of the surgical suite. It includes storage areas for clean and sterile supplies, work areas for storage and processing of instruments, scrub sink areas, and corridors leading to the restricted areas of the surgical suite.

The process of allowing visitors into a semi-restricted area of a surgical suite increased the risk of patient infection as street clothes may not necessarily be clean and free of bacteria. The industry standard as referenced in the above AORN publication does not allow this practice.






Based on observation, staff interview and document review, the hospital failed to ensure the infection control officer developed a system for identifying potential food-borne illness in the Food and Dietary Department when 1) Food Service staff did not demonstrate correct handwashing technique 2) Infection control prevention including policy review and safe food handling practices was not implemented hospital-wide including in the Food and Dietary Department. In addition, infection control practices were not implemented by nursing staff when caring for patients. It was also noted, the labor and delivery operating suite was not maintained in a safe and sanitary manner consistent with industry standards.

Findings:

1. On 6/4/12 10:15 a.m., cook 2 was observed washing her hands after handling dirty dishware. She applied soap and rubbed her hands together under the running water. She was asked to about the handwashing practice observed and she stated that she soaped and rinsed her hands. The lead cook was asked if this was appropriate handwashing procedure. He stated and demonstrated the proper handwashing was to wet hands and apply soap and scrub the hands for 15 to 20 seconds and then rinse off the soap.

The Infection Control Policy (8/09) reviewed on 6/4/12 stated, "Food service is an important factor within the health care facility...Unsanitary food service can play a significant role in disease transmission." The policy stated the handwashing technique was to wet hands and lather soap with a scrub for 15-20 seconds.

2. An interview was conducted on 6/6/12 at 1:30 p.m. with the director of infection prevention. She stated her role in infection prevention included environmental rounds of departments and planning and monitoring hospital infections. She stated neither she nor the infection control committee reviewed the Food and Dietary Department infection control policies. She stated she was not familiar with the FDA (Food and Drug Administration) Food Code 2009 guide that established practical, science based guidance and enforceable provisions for mitigating risk factor to known causes of foodborne illness. She stated she was not familiar with the HACCP principles developed to ensure the monitoring of food preparation including cooling of cooked food that is the basis for implementing safe food practices.

Review of the Infection Prevention and Control Plan (revision date 1/10) stated, "This is an organization wide program. Unless otherwise noted herein, additional policy and procedure may be developed to address specific infection control and prevention issues on an organization-wide and/or department basis".

The infection control and prevention hospital wide program must be included in the review of department infection control policies to ensure they are in line with industry standards and ensure the staff is following critical food safety practices.