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Based on interview and record review, the facility failed to ensure compliance with the California Code of Regulations as evidenced by:

1. Policies for patient care were not approved by medical staff;

2. Policies were not reviewed and approved every 3 years by the hospital administration and governing body;

3. Failure to have adequate office space for the Food Service Manager (FSM) at both facility campuses; and

4. Failure to track and report inflenza vaccination rates to the Department of Public Health.

Findings:

1. The California Code of Regulations, Title 22, Division 5, Chapter 1, Section 70213(a)(1) requires, "Written policies and procedures for patient care shall be developed, maintained and implemented by the nursing service. Policies and procedures which involve the medical staff shall be reviewed and approved by the medical staff prior to implementation."

During the survey, from 4/23 to 4/30/12, the following policies did not contain evidence of medical staff approval, prior to implementation:

Orders, Transcription and Requisition - Nursing, dated 4/4/12;
Adult Admission Assessment/Screen for Multidisciplinary Needs Form - Nursing, dated 9/10;
Consents - Hospitalwide, dated 7/08; and
Blood Glucose Monitoring, Meter Maintenance and Quality Control ..., dated 8/10.

On 4/26/12 at 8:11 am, the Vice President of Quality Management confirmed that the above policies were not approved by the medical staff.

2. The California Code of Regulations, Title 22, Division 5, Chapter 1, Section 70213(a)(4) requires, "Written policies and procedures for patient care shall be developed, maintained and implemented by the nursing service. The hospital administration and the governing body shall review and approve all policies and procedures that relate to the nursing service every three years or more often, if necessary."

During the survey, from 4/23 to 4/30/12, the following policies did not contain evidence of review and approval every three years:

Consents - Hospitalwide, dated 7/08; and
Restraints - Hospitalwide, dated 2/06.

On 4/26/12 at 8:11 am, the Vice President of Quality Management confirmed that the above policies were not reviewed and approved every three years.

3. The California Code of Regulations, Title 22, Division 5, Chapter 1, Section 70279(f) requires, "Office or other suitable space shall be provided for the dietitian or dietetic service supervisor for privacy in interviewing personnel, conducting other business related to dietetic service and for the preparation and maintenance of menus and other necessary reports and records."

During initial tour and concurrent interview on 4/23/12 beginning at 9:30 am, the FSM was introduced as the person hired by the contracted food service as responsible for dietetic services at both the Rideout and Fremont campuses. Within the dietetic services space at the Rideout campus, there were two offices, one of which was occupied by the Chef and the remaining one was occupied by the diet clerks. The FSM confirmed that there was no privately designated space for the director of the department to conduct the day to day operations of the department, rather, the directors' office was across the street in the hospitals' medical office building.




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4. Review of a revised California Department of Public Health (CDPH) All Facilities Letter (AFL) 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 tracking and reporting inflenza vaccination rates/status for the medical staff members discussed with the medical staff coordinator.

Based on interview and document review, the hospital failed to ensure compliance with the California Code of Regulations as evidenced by:

1. Failure for dietary staff to possess required certifications;
2. Failure to maintain dietary staffing in accordance with regulatory requirements on each campus;
3. Failure to have formal infection control training for the chairperson of the facility Infection Control Committee; and
4. Failure to have infection control training for 342 of 342 medical staff members.

These failures may affect the quality of dietetic services provided by the hospital, further compromising the medical status of inpatients and result in the spread of infection.

Findings:

1a. California Code of Regulations, Title 22, Division 5, Chapter 1, Section 70271 defines Dietetic service as providing safe, satisfying and nutritionally adequate food for patients with appropriate staff, space, equipment and supplies.

California Code of Regulations, Title 22, Division 5, Chapter 1, Section 70275(a)(b) also describes the requirements for dietetic services staffing. It requires that within dietetic services a registered dietitian shall be employed on a full-time, part-time or consulting basis and if a registered dietitian is not employed full-time, a full-time person who has completed an approved dietetic supervisor's training program shall be required. California Health and Safety Code, Section 1265.4 describes the required qualifications for this certification.

The dietetic services supervisor shall have completed at least one of the following educational requirements:
(1) A baccalaureate degree with major studies in food and nutrition, dietetics, or food management and has one year of experience in the dietetic service of a licensed health facility.
(2) A graduate of a dietetic technician training program approved
by the American Dietetic Association, accredited by the Commission on
Accreditation for Dietetics Education, or currently registered by the Commission on Dietetic Registration.
(3) A graduate of a dietetic assistant training program approved by the American Dietetic Association.
(4) Is a graduate of a dietetic services training program approved
by the Dietary Managers Association and is a certified dietary manager credentialed by the Certifying Board of the Dietary Managers Association, maintains this certification, and has received at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility.
(5) Is a graduate of a college degree program with major studies in food and nutrition, dietetics, food management, culinary arts, or hotel and restaurant management and is a certified dietary manager credentialed by the Certifying Board of the Dietary Managers Association, maintains this certification, and has received at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility.
(6) A graduate of a state approved program that provides 90 or more hours of classroom instruction in dietetic service supervision, or 90 hours or more of combined classroom instruction and instructor led interactive Web-based instruction in dietetic service supervision.
(7) Received training experience in food service supervision and management in the military equivalent in content to paragraph (2), (3), or (6).

b. During initial tour on 4/23/12 beginning at 9:30 am, the FSM was introduced as the person hired by the contracted food service as responsible for dietetic services at both the Rideout and Fremont campuses. Review on 4/26/12 at 10 am of the FSM's personnel file revealed that he did not possess the necessary state certifications for this position. Concurrent review of the hospitals organization chart, dated 3/19/12, noted that the unqualified FSM was not full time at either of the organizations campuses, rather split his time between the two.

In an interview on 4/26/12 at 10:30 am, the Food Service Manager (FSM) stated that he was the person responsible for the development of the organizational structure for food and nutrition services. He acknowledged that as of 4/26/12, he did not possess the necessary qualifications for the position, that he split his time between the two hospital campuses, and that at the Fremont campus there was not a full time supervisor that had the required State regulatory certifications.

In an interview on 4/26/12 at 2 pm with Administrator 1, he was asked how the hospital ensured that contracted employees possessed required state certifications, prior to being placed at the hospital. He stated that until several months ago he was unaware that the FSM did not have the required certifications. Review of an undated hospital document titled, "Annual Contract Service Review for 2011," revealed that that the hospital determined that the performance measure "1. Adheres to regulatory ...standards" was met. There was no indication that the hospital identified that the FSM or the organizational structure did not meet regulatory requirements. The contracted service position description, revised 8/5/04, titled, "General Manager 4, Food," failed to note the certification requirements; rather noted "none" in the section titled, "Certification Requirements," in the minimum requirements for the position.

2. The California Code of Regulations Title 22, Division 5, Chapter 1, Section 70275(a) reads, "A registered dietitian shall be employed on a full-time, part-time or consulting basis. Part-time or consultant services shall be provided on the premises at appropriate times on a regularly scheduled basis and of sufficient duration and frequency to provide continuing liaison with medical and nursing staffs, advice to the administrator, patient counseling, guidance to the supervisor and staff of the dietetic service, approval of all menus and participation in development or revision of dietetic policies and procedures and in planning and conducting in-service education programs."

On 4/25/12 beginning at 4 pm, the unsigned organizational chart, dated 3/19/12, for food and nutrition services was reviewed. It was noted that the Food and Nutrition Services Director, who was not a Registered Dietitian (RD), was the position responsible for all aspects of the department, including supervision of the Clinical Nutrition Manager (CNM), the RD. It was also noted that the evaluation of the CNM, provided by the contracted food services vendor, did not reflect responsibilities for foodservice oversight, rather was limited to clinical nutrition care activities in addition to activities such as increasing profitability, implementation of cost services program, increase in patient satisfaction results, and creation of trayline standards. The competency of the RD was assessed by the Director of Food and Nutrition Services who was not qualified by education or experience to evaluate the competency of the RD.

In an interview on 4/26/12 10:30 am, the FSM stated that he was the person responsible for the development of the organizational structure for food and nutrition services and was unaware of the necessity for the RD to be empowered to provide guidance and oversight of dietetic services.



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3. In a collaborative review on 4/30/12 at 1:20 pm of the medical staff file for the designated Chair of the Infection Control Committee, MD 3, the MSC presented no documented evidence of formal infection control training for MD 3.

Review of California Health and Safety law 1288.95 documented, "a physician designated as a hospital epidemiologist or infection surveillance, prevention and control committee chairperson shall participate in a continuing medical education (CME) training program offered by the federal Centers for Disease Control and Prevention and the Society for Healthcare Epidemiologists of America, or other recognized professional organization. The CME program shall be specific to infection surveillance, prevention, and control. Documentation of attendance shall be placed in the physician's credentialing file."

4. Infection control training and competency was not documented for all health care workers (for five of 27 environmental services workers blood borne pathogen training, for 342 of 342 medical staff members for any training);

Review on 4/25/12 at 1:50 pm of 27 training records for the EVS personnel with the EVS Manager were reviewed. Five of 27 EVS had no documented bloodborne pathogen training and one of 27 had no job orientation (EVS 1). Review of a summary of competencies, dated 9/15/11, for EVS 1 showed completion for biohazardous waste disposal procedures, but not for bloodborne pathogens (often present in medical waste). No EVS workers had documented job descriptions.

Review of medical staff files on 4/30/12 at 1:20 pm with the Medical Staff Coordinator (MSC) indicated that annual training for infection control was not documented for 342 of 342 medical staff members. The MSC indicated that annual infection control training was not required for medical staff members, not addressed in policy, and not tracked.

In an interview on 4/26/12 at 10 am with the Infection Control Coordinator (ICC), the ICC indicated that he maintained no system for training or evaluating infection control practices and compliance for all medical staff members.

Review of California Health and Safety law 1288.95 indicated that all staff (including physicians and independent licensed contractors) shall be trained in methods to prevent transmission of health care associated infections, including multiply-resistant Staphylococcus aureus (type of bacteria) and Clostridium difficile (bacteria) infection. All employees and contractural staff shall also be trained in hospital-specific infection prevention and control policies, isolation procedures, patient hygiene, and environmental sanitation procedures, on an annual basis. Environmental services staff shall be trained upon hire and annually thereafter, and observed for compliance with hospital sanitation measures.

Review 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 periodically assessed for compliance with safe injection practices "by observing and evaluating personnel performing these procedures." The national guideline also recommended that facilities should implement an education and competency evaluation program for staff, and consider audits for adherence to the facility's safe injection practices policy/procedure.

Review of materials published by MCN Healthcare, a national repository of accreditation standards, retrieved from , documented the Staffing Management standards for the National Integrated Accreditation for Healthcare Organizations (NIAHO). The NIAHO standards required hospitals to conduct staff performance/competency evaluations to measure the ability of staff to perform all job duties, as outlined in his/her job description.

Based on observation, staff and patient interviews, and 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 ensure an effective system for monitoring and evaluating the services performed under a contract, in order to verify the services were safe and effective. Refer to A84.

B. The hospital failed to ensure that written policies and procedures for the appraisal of emergencies and referral were in effect for all off-campus departments. Refer to A94.

C. The hospital failed to protect and promote patient rights. Refer to A115.

D. The hospital failed to ensure that an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program was developed, implemented and maintained for high risk patient care activities throughout the hospital. Refer to A263.

E. The hospital failed to ensure that nursing services were furnished or supervised by a registered nurse and consistent with nationally accepted standards of practice A385

F. The hospital failed to ensure that pharmaceutical services met the needs of all patients. Refer to A490.

G. 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. Refer to A747.

H. 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. Refer to A940.

I. 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. Refer to A1000.

J. The hospital failed to ensure that rehabilitation services were well-organized, administered by qualified personnel, and integrated into the hospitalwide Quality Assessment and Performance Improvement program (QAPI). Refer to A1123.

These failures (described in detail in Conditions of Participation A115, A263, A385, A490, A747, A940, A1000, A1123) resulted in a potential for increased infections and adverse events for all patients. The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Governing Body.

Findings:

Review of the 5/11 Medical Staff Bylaws documented under section 6.9 for Hospital Board Oversight Responsibilities, "The Medical Staff acknowledges that the Board must act to protect the quality of medical care provided and to ensure the competency of the Medical Staff and the responsible governance of the Hospital in the event that the Medical Staff fails in any of its duties and responsibilities."

In a meeting on 4/26/12 at 10:45 a.m., with governing board members and hospital leaders (CEO, CFO, CIO, CMO, CNO, ADM 1, MD 5, and GB 1), all present agreed that patient care and quality was top priority and the Board was responsible to be informed about, and provide resources to correct, matters that threatened the safety of hospital patients.

Review of governing board Resolution No. 2012-1, dated 1/26/12, documented that its bylaws section related to Board Responsibility be amended to say, "The Board is the legal body responsible for establishing, maintaining, supporting, and exercising oversight of an on-going, quality assessment/performance improvement and risk program that includes specific and effective review, evaluation and monitoring mechanisms to assess, preserve and improve the overall quality and efficiency of patient care in the hospital."

Based on staff interview and document review, the governing body failed to ensure that contracted services were performed in a safe and effective manner when an effective quality oversight system to objectively measure and evaluate the performance of contracted vendors, on a periodic basis, was not documented in a plan or policy to hold the governing body responsible to ensure that vendor services were continuously safe and effective. This failure put patients at risk for unsafe or ineffective care and services.

Findings:

In an interview on 4/26/12 at 9:30 a.m. with the Vice President of Quality Management (VPQM), VPQM indicated that the hospital administration had published an evaluation of 9 contract vendors since being cited for not evaluating vendors in a previous Center for Medicare and Medicaid Services complaint validation survey in October of 2011. However, the hospital maintained contracts with as many as 50 to 100 patient care-related service vendors, and the remaining vendors had not been evaluated. When asked whether the evaluations were based on objective performance measures produced through the quality program, VPQM stated there was no data to support the findings of the 9 vendor evaluations and they were largely based on consensus or subjective opinion.

Review of the Annual Contract Service Review for 2011 showed 9 vendors listed with descriptions of performance measures, but no actual measurements. For example, a performance measure for the nutrition services was "timely and appropriate clinical nutrition services for all referrals" - met. No numerical value was attached to show from an audit or log what percentage of referrals was timely and appropriate. Timely and appropriate were not defined. Therefore, the determination that the vendor performed safely and effectively was not meaningful.

Despite being previously cited for not having a defined system to measure and evaluate contracted services, the hospital presented no revisions to the quality program, governing board bylaws, or other policies that specified the procedures to track, measure, and analyze the vendor services, and to report the performance outcomes periodically to the governing board, in order to ensure the services were safe, effective, and in accordance with the terms of the contract.

Based on interview and record review, the facility failed to ensure that the list of contracted services contained all contracted services. This failure had the potential for services to not be evaluated regularly and negatively impact patient outcomes.

Findings:

On 4/23/12, the list of contracted services was reviewed. The contracts for the clinical engineering services, the environmental services, and clinical nutrition/food services were not present on the list of contracted services.

On 4/24/12 at 10:49 am, the Vice President of Quality Management reviewed the the list of contracted services and confirmed that the above contracted services were not present on the list.

Based on observation, interview, and policy review, the hospital failed to ensure that its policies were revised to reflect current practices for treatment of anyone in need of emergency treatment at off-campus outpatient sites. This had the potential to result in a delay in providing appropriate emergency treatment.

Findings:

During a tour of the outpatient urgent care center on 4/24/12 at 11:15 am, Registered Nurse (RN) 56 stated that for emergencies they would call 9 to get an outside line then 911 and begin CPR. RN 56 also said they had an automatic external defibrillator (AED) available, as well as an emergency medication box stocked by the facility pharmacist.

During a tour of the outpatient cardiac rehab on 4/25/12 at 11:30 am, Exercise Physiologist (EP) 1 stated that, for emergencies, they would call 911 and begin CPR. EP 1 said they also had oxygen available, as well as an (AED) for use during emergencies.

During a tour of the outpatient cancer center on 4/24/12 at 8:45 am, Registered Nurse (RN) 57 stated that for emergencies they would call 911 and start CPR. They also had oxygen available for use.

The facility policy titled, "Emergency Conditions & Basic Staff Response - Safety/Security," dated 2/10, was reviewed. It instructed off-campus facilities to call 911 for unresponsive patients. There were no further instructions to direct staff on the use of other available equipment or medications.

During an interview on 4/25/12 at 10:30 am, the Vice President of Quality Management confirmed that the facility did not have specific policies regarding emergency conditions for all of their outpatient areas.

Based on observation, staff interview, and record and policy review, the facility failed to protect and promote patient rights as evidenced by:

1. Failure to ensure that two patients (Patients 74 and 75) were free from restraints when both patients were administered Haldol, an antipsychotic mediation, for agitation with no documented evidence justifying such use, or evidence that less restrictive measures were attempted before use of restraints (Refer to A154);

2. Failure to ensure that one of 83 sampled patients (Patient 1) had a physician's order for the use of restraints (Refer to A168);

3. Failure to monitor two of six sampled patients, who were restrained (Patients 1 and 72)(Refer to A175);

4. Failure to ensure that two of six sampled patients, who were restrained (Patients 1 and 72), had documentation that included a description of the behavior that warranted the use of restraints, the alternative approaches that were used, and efforts to release or discontinue restraints (Refer to A185).

These failures impacted the patients rights to be free from restraints, and may result in harm to patients from the medication side effects, entrapment, or death.

The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation: Patient Rights.

Based on staff interview and record review, the facility failed to ensure that two Patients (Patients 74 and 75) were free from restraints when both patients were administered Haldol, an antipsychotic mediation, for agitation with no documented evidence justifying such use, or evidence that less restrictive measures were attempted before use or restraints. The facility had orders to restrain Patient 75, but the order did not include the type of restraint or the reason for use. These failures impacted the patients rights to be free from restraints and may result in harm to patients from the medication side effects, entrapment, or death.

Findings:
1. On 4/25/12 at 11 a.m., Patient 74's record was reviewed with ADM1 and the Director of Pharmacy (DP). The record revealed an order, on 4/22/12, for Haldol (an antipsychotic medication) to be given by injection through the veins (IV). The order specified that Haldol 5 milligrams (mg) to be given IV every 8 hours as needed for agitation. Patient 74 was given a dose of Haldol at 15:44 (3:44 p.m.) on 4/22/12. Review of the record for Patient 74 revealed no documented evidence of the rationale for Haldol use. There were no progress notes explaining what happened that might necessitate the use of chemical restraint. A Nurse's note documented at 17:46 (5:46 p.m.) indicated that the patient was medicated "with Haldol 5 mg IV, repositioned and reassured." The documentation was two hours after Haldol was removed from the automated dispensing cabinet for administration.

On 4/26/12 at 10:40 a.m., ADM1 stated that there was no documentation of using other measures before use of the Haldol. On 4/26/12 at 2:55 p.m., RN 54 said during an interview that Patient 74 was trying to climb out of bed. That while she was taking care of another patient, she heard one staff nurse calling the patient to stay in bed. She added that one of the doctors had to talk to the patient. The medical record for Patient 74 did not include documentation of what happened, if Haldol use was justified to control Patient 74's behavior, or if less invasive measures were tried before resorting to use of the medication.

2. Patient 75's record was reviewed with the Director of Quality Management on 4/26/12 at 12:30 p.m. Patient 75 had an order, dated 3/27/12, for Haldol 5mg IM (injection into the muscle) to be given "now," then every six hours for agitation. The automated dispensing machine documented removal of Haldol twice on 3/27/12 at 17:15 (5:15 p.m.) and on 3/28/12 at 3:03 a.m.

Review of the nurses notes for that time revealed no documented evidence of any events that would justify the use of Haldol. The notes documented that at 17:20 and 17:25, as needed medications were given for "anxiety." There was no documented evidence that less restrictive measures were tried before Haldol was given.

Review of the facility's policy titled, "Restraints- Hospitalwide," approved on 2/2006, directed that the purpose of the policy was "To assure that restraints use is limited to those medically necessary, clinically justified situations in which alternative or less restrictive measure have failed." The facility's philosophy as included in the policy was "to support patient's right to ...be free of physical and chemical restraints: by using alternatives whenever possible so as to limit the use of physical and chemical restraints." The policy also included that "Assessment of patient behaviors, non-restraint interventions, alternatives and less restrictive devices attempted and the reason restraint needed to be applied."

3. On 4/25/12 at approximately 11 a.m., Patient 74's record was reviewed with ADM1 and DP. Patient 74 had a physician's order for "NON- BEHAVIORAL RESTRAINT." The order was dated, timed, and signed by the physician, however, the order did not include the type of restraint or the reason for use. Review of the facility's policy titled, "Restraints- Hospitalwide," approved on 2/6, directed, "Orders must include the type of restraints and rationale for use ..."

Based on observation, interview, and record review, the facility failed to ensure that one of 83 sampled patients had a physician's order for the use of restraints (Patient 1). This failure had the potential for patients to be restrained unnecessarily and suffer untoward effects from that restraint.

Findings:

On 4/23/12 at 9:10 am and 4/24/12 at 7:50 am, Patient 1 was observed in bed with bulky mitts on both hands, limiting the patient's ability to use both hands.

On 4/25/12, Patient 1's record was reviewed. Patient 1 was admitted on 4/17/12 with diagnoses that included pneumonia and a urinary tract infection. Patient 1's record indicated he had mitts placed on 4/21/12 at 2203 (10:03 pm) and these mitts continued to be in place through 4/25/12. A physician's order for restraints was not obtained until 4/23/12 at 1300 (1pm) that directed lower side rails be elevated.

On 4/23/12, the facility's policy titled, "Restraints - Hospitalwide," dated 2/06, listed mitts without ties under alternatives to restraints.

On 4/24/12 at 8 am, Nurse Managers (NM) 2 and 3 stated that mitts were not restraints so they did not need a physician's order.

The Code of Federal Regulations (CFR) §482.13(e)(1)(i)(C) (Tag A-0161) includes discussion on what is and is not considered a restraint. This section reads, "Many types of hand mitts would not be considered restraint. However, pinning or otherwise attaching those same mitts to bedding or using a wrist restraint in conjunction with the hand mitts would meet the definition of restraint and the requirements would apply. In addition, if the mitts are applied so tightly that the patient's hand or fingers are immobilized, this would be considered restraint and the requirements would apply. Likewise, if the mitts are so bulky that the patient's ability to use their hands is significantly reduced, this would be considered restraint and the requirements would apply."

On 4/24/12 at 10:49 am, the Vice President of Quality Management (VPQM) acknowledged that the facility policy was not consistent with the CFR regarding the use of mitts as a restraint. The VPQM acknowledged that Patient 1 did not have a physician's order for bulky mitt restraints from 4/21 at 10:03 pm until 4/23/12 at 1 pm because it was believed they were not restraints.

Based on interview and record review, the facility failed to ensure that two of six sampled patients, who were restrained, were monitored every two hours as outlined in the facility policy (Patients 1 and 72). This failure had the potential for patients needs not to be met and possibly injury while in restraints.

Findings:

On 4/24/12, the facility's policy titled, "Restraints," dated 2/06, indicated that "Patients in restraints are assessed every 2 hours to assure their physical and emotional well being and to assure that their rights, dignity, and safety are maintained. Assure that the patient's personal needs are met (verify that the patient is warm enough, offer food/fluids/toilet)."

1. On 4/25/12, Patient 1's record was reviewed. Patient 1 was admitted on 4/17/12 with diagnoses that included pneumonia and a urinary tract infection. Patient 1's record indicated he had mitts placed on 4/21/12 at 2203 (10:03 pm) and these mitts continued to be in place through 4/25/12. Patient 1's record contained documentation that nursing assessment did not occur every two hours between 4/23 at 10:29 pm and 4/24/12 at 2:38 pm (4+ hours).

On 4/24/12 at 8 am, Nurse Manager (NM) 2 acknowledged that Patient 1's record did not demonstrate the patient was assessed by the registered nurse every 2 hours.

2. On 4/30/12, Patient 72's record was reviewed. Patient 72 was admitted with a diagnosis of pneumonia. Patient 72's record indicated he was placed in soft wrist restraints on 4/22/12 at 12 pm which continued through 4/25/12 at 6:15 pm. Patient 72's record contained documentation that nursing assessment did not occur every two hours between 4/23 at 4:15 pm and 4/23/12 at 8:15 pm (4 hours).

On 4/24/12 at 8 am, NM 5 acknowledged that Patient 72's record did not demonstrate the patient was assessed by the registered nurse every 2 hours.

Based on interview and record review, the facility failed to ensure that two of six sampled patients, who were restrained, had documentation that included a description of the behavior, the alternative approaches that were used that warranted the use of restraints, and efforts to release or discontinue restraints (Patients 1 and 72). This failure had the potential for patients to be unnecessarily restrained.

Findings:

1. On 4/25/12, Patient 1's record was reviewed. Patient 1 was admitted on 4/17/12 with diagnoses that included pneumonia and a urinary tract infection. Patient 1's record indicated he had mitts placed on 4/21/12 at 2203 (10:03 pm) and these mitts continued to be in place through 4/25/12. A physician's order for restraints was obtained on 4/23/12 at 1300 (1 pm) that directed lower side rails be elevated. Patient 1's record did not contain a description of Patient 1's behaviors which resulted in the additional restraint of the lower side rails or the use of alternatives that were implemented.

On 4/23/12, the facility's policy titled, "Restraints - Hospitalwide," dated 2/06, indicated, "Each episode of restraint use shall be documented in the patient's record along with the clinical justification for its use, the duration of use, the ongoing assessment of the patient while in restraints, including efforts to release or discontinue restraint use."

On 4/24/12 at 8 am, Nurse Manager (NM) 2 acknowledged that Patient 1's record did not include a description of behaviors which resulted in the additional restraint of the lower side rails or the use of alternatives that were implemented.

2. On 4/30/12, Patient 72's record was reviewed. Patient 72 was admitted with a diagnosis of pneumonia. Patient 72's record indicated he was placed in soft wrist restraints on 4/22/12 at 12 pm which continued through 4/25/12 at 6:15 pm. Patient 72's record did not contain a description of the behavior, the alternative approaches that were used that warranted the use of restraints, efforts to release or discontinue restraints, or why restraints were discontinued.

On 4/24/12 at 8 am, NM 5 acknowledged that Patient 72's record did not include a description of the behavior, the alternative approaches that were used that warranted the use of restraints, efforts to release or discontinue restraints, or why restraints were discontinued.

Based on observation, staff interview, medical record and document review, the hospital failed to ensure an active, effective, ongoing data-driven surveillance of patient care practices, i.e. practices that carried high risk to patient safety, through its Quality Assessment and Performance Improvement program, reflecting the complexity of the hospital's organization and services, in all locations, in order to minimize those risks to all patients as evidenced by:

The facility failed to provide documented evidence to show the following care processes were effectively evaluated when continued evidence of regulatory violations were identified:

1a. Adequacy of pre-surgical assessments by nursing and physician staff to address each surgical patient's risks (co-existing conditions) for surgery. Refer to A952

b. Compliance with post-operative monitoring to be consistent hospitalwide and in accordance with surgical standards. Refer to A957 and A392

c. Surveillance of high risk medications used in surgical and sedation care to verify safe and standard dosages, safe frequency of administration, and safe monitoring of the effects of administration to avoid potential adverse events. Refer to A404 and A405.

d. Availability of nursing staff to all locations where surgical procedures were performed in order to prevent sedation care from being interrupted and to attend to the needs of patients during procedures. Refer to A944 and A941.

e. Consistency of hand-hygiene, cleaning, and disinfecting practices throughout the hospital, including observations of all staff. Refer to A748 and A749.

2. The facility failed to gather data and analyze their performance related to the safety of patients in restraints. Refer to A168, A175, and A185.

3. The facility failed to integrate all quality indicators into the QAPI program and failed to regularly collect patient care data, analyze data and develop action plans to improve performance. Refer to A267.

4. The hospital failed to have an ongoing quality appraisal and performance improvement program that addressed the complexity and scope of Food and Dietetic Services. Departmental staff failed to recognize inadequacies in clinical nutrition care services, menu planning and development that could lead to unmet patient nutritional needs. Refer to A 265.

5. The hospital failed to ensure that rehabilitation services were well-organized, administered by qualified personnel, and integrated into the hospitalwide Quality Assessment and Performance Improvement program (QAPI). Refer to A1123.

These failures put patients at risk for substandard care, adverse events, infections, poor patient safety, compromised nutritional status, and foodborne illness. The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Quality Assessment and Performance Improvement.

Findings:

Review of the Governing Board Bylaws, approved 3/23/06, documented a number of responsibilities of board members. Specific patient care oversight by the Board was documented on page 6 which directed the Board to institute procedures to establish and monitor an effective medical and hospital care performance improvement program. Section 9.1 on page 31 read, "The Board shall establish, maintain, support and exercise oversight of an ongoing quality assessment/performance improvement and risk program that includes specific and effective review, evaluation and monitoring mechanisms to assess, preserve and improve the overall quality and efficiency of patient care in the hospital."

Review of the 5/11 Medical Staff Bylaws documented under section 6.9 for Hospital Board Oversight Responsibilities, "The Medical Staff acknowledges that the Board must act to protect the quality of medical care provided and to ensure the competency of the Medical Staff and the responsible governance of the Hospital in the event that the Medical Staff fails in any of its duties and responsibilities."

In a meeting on 4/26/12 at 10:45 a.m. with governing board members and hospital leaders (CEO, ADM 1, CNO, CFO, CIO, CMO, MD 5, and GB 1), all present agreed that patient care and quality was top priority and the Board was responsible to be informed about, and provide resources to correct matters that threatened the safety of hospital patients.

Based on administrative and dietary staff interview and dietary department document review, the hospital failed to have an ongoing quality appraisal and performance improvement program that addressed the complexity and scope of Food and Dietetic Services which resulted in failure to identify issues in safe food handling practices and food storage, all of which could result in foodborne illness. Departmental staff failed to recognize inadequacies in clinical nutrition care services and menu planning and development that could lead to unmet patient nutritional needs. Failure to identify opportunities for improvement in operational processes may compromise the nutritional status of inpatients.

Findings:

During the survey process specific issues related to food services and clinical nutrition care were identified (Refer to A620, A628, A629, A630, A631 and A749).

On 4/26/12 at 10 am, an interview with the Food Service Manager (FSM) and review of performance indicators beginning in 5/2011 revealed that the dietary department was completing 1) monthly food safety audits; 2) plant safety audits and 3) weekly patient tray assessments. It was also noted that with the exception of two outliers with respect to the monthly food safety audits, the department reached the expected threshold of greater than 90%. The FSM, an employee of the contracted food service, stated that he reviewed the information on a monthly basis and would provide the information to the contracted food service, however, the information was not provided to the hospitals' performance improvement committee.

In an interview on 4/26/12 at 10:45 am, with the hospitals' governing body and hospital leaders (CEO, CFO, CIO, CMO, ADM 1, CNO, and GB 1), that included members of the hospitals' performance improvement committee, they stated that it was the Boards' responsibility to ensure the quality of services provided as well as patient safety.

In an interview on 4/26/12 at 1 pm, the Vice President of Quality Management (VPQM) was asked if the contracted service representing food and nutrition services submitted performance improvement activities to the performance improvement committee. She stated that they had not. On 4/26/12 at 4 pm, for the Condition of Participation for Dietetic Services, the VPQM recalled that nursing staff implemented a corrective action plan in relationship to the timing of meals for diabetic patients. The VPQM stated that the information would be provided. As of 4/30/12, no additional information demonstrating integration of dietetic services into the hospital wide plan was provided.

Review of hospital document titled, "Retail Gold Check Audit," dated 1/30/12 and completed by the FSM, revealed that the evaluation included the evaluation of "proper temperatures." It was also noted that safe food handling standards were not fully met, however, there was no description of the area that was deficient, nor was there an action plan to mitigate the deficient practice.

Similarly, review of clinical nutrition documentation, dated 1/19 to 2/13/09, revealed that the department completed audits titled, "diet prescription processing audit" and "nutrition screening process audit." While the audit was completed there was no assessment of the data gathered, rather described characteristics of the sample such as the percentage of patients that had nutrition risk factors, the number of incomplete nutrition assessments, the number of patients that had nutrition risks identified by nursing staff and whether or not the patients were referred to the RD.

Review of hospital document titled, "Performance Improvement-FNS," dated 9/12/11, revealed that the departmental procedure was to "work with other disciplines ...to design, measure, assess and improve nutrition related processes and outcomes. While the hospital completed various monthly audits, there was no indication that this information was provided to the hospitals' performance improvement committee nor was evaluated by the hospital wide committee. Hospital document titled, "Organizational Performance Improvement & Patient Safety Plan 2012-2013" revealed that it was the scope of the performance improvement plan to include ..."all clinical and operational areas throughout the organization ..." It was also noted that there was an appendix to the document that outlined "Quality Reporting Recommendations." While it was noted that the nutrition department was listed; there was no indication that the recommendations were implemented. Additionally, there was no indication that the hospital or the department identified that the information submitted by Food and Nutrition Services did not systematically identify opportunities for improvement, rather reflected monitoring of elements that demonstrated a satisfactory levels of performance.

Based on observation, staff interview, medical record and document review, the hospital failed to:

1. Ensure that processes of care and operations, including several previously cited as deficient practices, were measured, analyzed and tracked as quality indicators to demonstrate implementation of corrective actions and sustaining safe care practices. Documented evidence was lacking to show the following care processes were effectively evaluated when continued evidence of regulatory violations were identified:

a. Adequacy of pre-surgical assessments by nursing and physician staff to address each surgical patient's risks (co-existing conditions) for surgery. Refer to A952.

b. Compliance with post-operative monitoring to be consistent hospital-wide and in accordance with surgical standards. Refer to A957.

c. Surveillance of high risk medications used in surgical and sedation care to verify safe and standard dosages, safe frequency of administration, and safe monitoring of the effects of administration to avoid potential adverse events. Refer to A405.

d. Availability of nursing staff to all locations where surgical procedures were performed in order to prevent sedation care from being interrupted and to attend to the needs of patients during procedures. Refer to A944.

e. Consistency of hand-hygiene, cleaning and disinfecting practices throughout the hospital, including observations of all staff. Refer to A749, A756.

2. The hospital failed to ensure that care processes are measured and analyzed and integrated into the hospital quality assurance and performance improvement (QAPI) program and the Restraint Committee failed to collect data on the safe care of patients in restraints and integrate into the QAPI program. As a result, the facility was unable to identify non-compliant practices which placed patients in restraints at risk of injury.

3. The hospital failed to ensure that the Rehabilitation Department quality program documented analysis and actions taken to improve performance and integrated into the hospital QAPI program.

4. The hospital failed to ensure that the hospital committees that provide oversight to the QAPI program routinely received data, analyzed data, and developed and implemented action plans to improve performance.

Findings:

1. In an interview on 4/25/12 at 4:15 p.m. with the Vice President of Quality Management (VPQM), VPQM indicated that the quality program had not collected and analyzed data to accurately measure the appropriateness of pre-surgical assessments by physicians or nurses. Monthly audits of the presence or absence of a pre-surgical history and physical examination (H&P) document for surgical patients were conducted by the health information management (HIM, medical records) staff. However, VPQM acknowledged that the HIM staff was not clinically qualified to determine if a H&P contained the expected elements of an H&P to direct for safe planning of a surgical procedure. VPQM also stated that clinical audits of other care practices that were cited in a previous Center for Medicare and Medicaid Services (CMS) survey of October 2011 (available for public view) had not been conducted to validate compliance with corrective actions to those deficiencies. The deficiencies included pre and post-surgical assessments, safe use of high risk medications, safe sedation care without interruption, availability of nursing staff to meet surgical needs of patients, and a number of infection control breaches that posed risks for cross contamination of equipment, supplies and patients.

In an interview on 4/26/12 at 1:45 p.m. with MD 4, the Director of Anesthesia Services, MD 4 stated that the Anesthesia Department conducted selected clinical reviews of anesthesia care triggered by adverse events, incident reports, and the use of "reversal drugs" to rescue patients from oversedation. The Anesthesia Department (nor other qualified individuals) did not, however, perform direct observations of moderate or deep sedation care performed by non-anesthesia professionals. The Anesthesia Department did not perform random retrospective chart audits to evaluate the drugs selected, dose, frequency, or effect on patients, near miss situations, patient risk profiles, accuracy of machine monitor devices, or sedation monitoring staff leaving their monitoring duties to perform other tasks (as occurred during an observation of Patient 22 on 4/24/12 beginning at 8:20 a.m. in the heart studies laboratory).

In an interview with VPQM on 4/30/12 at 3 p.m., VPQM indicated that the governing board was first formally notified of compliance with previously cited deficiencies (identified in October 2011) at a meeting following a presentation to the Quality Council on 3/13/12. At these meetings, a dashboard summary of the compliance data showed that for 8 care practices, compliance ranged from 85 to 100%. However, the areas studied did not (as described above) effectively represent many patient safety practices, such as pre and post-surgical assessments, safe use of high risk medications, safe sedation care without interruption, availability of nursing staff to meet surgical needs of patients, and a number of infection control breaches that posed risks for cross contamination of equipment, supplies and patients that continued to be identified as deficient on the current survey.

Review of the 5/11 Medical Staff Bylaws indicated that the Medical Executive Committee bore responsibility to develop policies related to patient care and to evaluate the medical care provided to hospital patients, with reporting of the findings to the governing board. A Medical Review Committee was responsible to develop policies and procedures for the ongoing monitoring of the quality of medical care provided. A Surgical Review Committee was responsible to review the quality of care rendered to patients undergoing surgery and other invasive procedures.

In an interview with VPQM on 4/30/12 at 3 p.m., VPQM indicated that the Surgery Review Committee was no longer active, largely absorbed by the Quality Oversight and Patient Safety Committee. Review of the existing committee minutes between October 2011 and March 2012 did not identify reports and analysis of objective measures for performance and compliance with the care practices listed in items 1-5 above.

Review of the Governing Board Bylaws, approved 3/23/06, documented a number of responsibilities of board members. Specific patient care oversight by the Board was documented on page 6 which directed the Board to institute procedures to establish and monitor an effective medical and hospital care performance improvement program. Section 9.1 on page 31 read, "The Board shall establish, maintain, support and exercise oversight of an ongoing quality assessment/performance improvement and risk program that includes specific and effective review, evaluation and monitoring mechanisms to assess, preserve and improve the overall quality and efficiency of patient care in the hospital."



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2. During the survey, from 4/23 to 4/30/12, patients with restraints were observed and their records reviewed. Deficient practices related to the care of patients in restraints were identified. Refer to A168, A175, and A185.

On 4/24/12 at 8:40 pm, Nurse Managers (NM) 2 and 3 were asked about the monitoring that occurs to assure safe care of patients in restraints. NM 2 and 3 stated there was a Restraint Committee and that they had been working on a new restraint policy and developing a computerized report to collect data to monitor their performance with restraints.

On 4/24/12, the minutes of the Restraint Committee were reviewed. The committee met three times since 7/28/11. No data regarding the use of restraints was reviewed during these meetings. The minutes revealed the facility was aware that the restraint policy was outdated (2/06) and that they had non-compliant practices. The work of the committee was centered around developing a report that would collect data and discussing how the restraint policy should be changed.

On 4/24/12 at 10:49 am, the Vice President of Quality Management (VPQM) confirmed that the only restraint data that was collected and reported in the QAPI program included a count of the number of patients in restraints on a specific day of the month. The VPQM further confirmed that the facility policy on restraints was not current, and permitted non-compliant practices such classifying the use of bulky hand mitts as an alternative to a restraint versus a restraint.

3. On 4/30/12 at 11:15 am, the Rehabilitation Manager (PTM) 1 presented data collected as part of the quality indicators for the rehabilitation services. The report presented did not include evidence of data analysis or the actions taken to improve performance.

In a concurrent interview, PTM 1 acknowledged that there was no evidence of data analysis or actions taken to improve performance. PTM stated that he forwarded the data to the Quality Management Department who reported to the appropriate committees.

On 4/30/12 at 12:15 pm, the VPQM and the Director of Quality Management stated the rehabilitation quality indicators had not been reported to any quality committee and were not part of the hospital's QAPI program.

4. During the survey, from 4/23 to 4/30/12, the minutes of the Medical Staff Quality Oversight Committee and the Quality Council were reviewed. The attachments to the minutes revealed numerous data collection efforts as part of the QAPI program. Most of these quality indicators did not include data analysis or action plans to improve performance.

On 4/24/12 at 10:49 am and 4/30/12 at 12:15 pm, VPQM acknowledged that the hospital's QAPI program did not contain many examples of data analysis and action plans to improve performance.

Based on staff interview, medical record review, and facility document and policy review, the facility failed to focus performance improvement activities on high-risk or problem-prone areas as evidenced by:

1. Orders for medications with cumulative side effects were processed with no intervention to ensure safety of patients. (Patients 72, 75, and 77). Refer to A500.

2. Lack of tracking and accountabilities for controlled substances to ensure patient safety. (Patients 78, 79, and 83). Refer to A508.

3. Lack of meaningful monitoring for pain medications. (Patient 77). Refer to A500.

Findings:

1a. On 4/25/12 at 11 a.m., the record for Patient 72 was reviewed with the Director of Pharmacy (DP) and Pharmacy Distribution Manager (PDM). The 71-year-old patient had, prior to admission, a fentanyl patch 25 micrograms. Fentanyl is a potent opioid medication that is applied to the skin and provides continuous delivery of medication. On 4/20/12, Patient 72 had an order for Norco 10/325 for pain. Norco is a combination medication of 10 milligrams of hydrocodone (opioid) and 325 milligrams (mg) of acetaminophen (also known as Tylenol). On 4/21/12 at 4:40 p.m., Patient 72 had an order for Dilaudid 2 mg every 6 hours, as needed for severe pain. Dilaudid is a potent pain medication similar to, but about six times more potent than morphine. On 4/21/12 at 2:00 p.m., an order for 2mg of Dilaudid was ordered to be given now.

Review of the medication administration records for 4/21/12 revealed that the same nurse administered both medications to Patient 72, Norco at 13:54 and Dilaudid at 14:21, within 27 minutes.


b. On 4/25/12 at 3:00 p.m., the record for Patient 77 was reviewed with DP and ADM1. Patient 77 had an order for Norco 10/325, 2 tablets to be given every 6 hours for pain. Patient 77 also had an order for Demerol 75mg intravenously every 3 hours, as needed for pain. Demerol is an opioid pain medication, also known as meperidine.

The orders did not have any specific parameters for when to use Demerol by intravenous injections or Norco by mouth and there was no evidence that nurses that administered the medications clarified the indications. Review of the medication removal from the automated dispensing cabinets and the medication administration record showed that both medications were given concurrently.

c. The medical record for Patient 75 was reviewed with the Director of Quality Management (DQM) on 4/26/12 at 12:30 p.m. Patient 75 had an order, dated 3/27/12, for Haldol 5 mg IM (injection into the muscle) to be given "now," then every six hours for agitation. There was an order for 5 mg of Valium, (a sedative hypnotic) to be given by mouth every six hours, as needed for agitation. Both were verbal orders, and there was no clarification or specific directions when to use the oral and when to use the injection.

The DP and PDM confirmed that there was no documented evidence of any interventions by pharmacists processing the orders regarding the duplication of therapy, fentanyl, Dilaudid and Norco. All these medications are in the same class and have similar side effects that are dose dependent and cumulative. There was no documented evidence that pharmacy questioned the duplicate therapy or clarified the specific indications for when to give which medications.

The DQM confirmed that there was no documented evidence that the pharmacy staff clarified these orders to specify when to give which medications. Both medications have central nervous system (CNS) side effects, which include sedation. The medication administration electronic record revealed that both the Haldol and Valium were given within 7 minutes, regardless of their additive effects.

2. On 4/23/12, the DP provided information about a situation of controlled substance loss/abuse that was identified by a nurse manager more than a year ago. However, on 4/26/12 at approximately 3 p.m., the DP confirmed that the facility did not have a system for surveillance to detect any potential misuse, abuse, or theft of controlled substance timely and prevent similar occurrences.

On 4/26/12 at 3 p.m., the DP stated that the hospital did not have a system in place to track or trend activities, such as returned controlled substance, frequent users, frequent errors, or discrepancy rate. They were not evaluating frequencies of restocking the automated dispensing cabinets with controlled substance or the disposition of these medications. There was no system in place to validate use, or randomly verify use of high doses or high frequencies. The DP said that they only look at non-reconciled discrepancies. Non-reconciled discrepancies are potentially nonexistent because nursing staff are expected to resolve discrepancies by the end of their shift, according to the policy titled, "Controlled substance-Hospitalwide," dated 2/20/2012.

a. The pharmacy department did not evaluate how these discrepancies were resolved or look for any pattern or trends. Evaluation of the discrepancy report for 24 hours (4/29/12 at 6:00 until 4/30/12 at 6:00) revealed 12 events of discrepancies. The resolution comments for seven out of the 12 times were "Error in counting, no discrepancy." There was no evidence that these situations were remedied or the medications were accounted for. It was not clear, for instance, how a discrepancy for Ativan (a sedative hypnotic) was resolved if the count was supposed to be 15, but the user found zero. The count remained at zero. The comment under resolution was "Error in counting, no discrepancy" and the comment for this event under "Discrepancy Resolution" was "COMPLETED."

b. On 4/26/11 at 3 p.m., during reconciliation of the controlled substance distributed to practitioners, the record for medication use from box 13 revealed that two patients were administered fentanyl, but no fentanyl was signed out to them. Pharmacy Tech 2, responsible for reconciling the controlled substance in the anesthesia boxes, explained the discrepancy as follows: fentanyl 5 milliliters ampule was removed for Patient 83, who was given 1 milliliter, then Patient 78 was given 2 milliliters (ml), and Patient 79 was given 2 ml, which would account for all 5 ml. And that would be validated as accurate account. There was no evidence that pharmacy evaluated the practice of MD 15 or if there were other practitioners using single dose vial for multiple patients. Such practice of preparing syringes ahead of procedure is associated with multiple risks including but not limited to medication errors, loss, or misuse of the medications.

3. Evaluation of the effectiveness of pain medication was not meaningful, as the evaluation was not completed in a timely manner to reflect the effect of the medications given. Record review revealed that Patient 77 was given Demerol on 4/1/12 at 8:22, 11:17, 14:42, and 18:03. The reassessment for pain for all these times was documented as 22:04 and with zero pain score and "acceptable." These assessments were done at 4 hours, 8 hours, 10 hours, and approximately 13.5 hours after the medication was administered. Similarly, on 3/31/12, the Demerol was administered at 21:37, 00:50, and 4:50 a.m. The pain reassessment was documented at 6:00 a.m. with zero pain scale and "acceptable" for all of them. These assessments were done at about one, five, and eight hours after the medication was administered.
Monitoring pain therapy is essential to evaluate efficacy and prevent drug toxicity. The assessment of pain medications did not reflect the condition of the patient.

Review of the pain re-assessment documentation for Patient 77 revealed that the pain assessment was not completed within 60 minutes, the time for re-assessment ranged from 15 minutes to 13.5 hours after the medication was administered. On 4/26/12, these findings were discussed with the DP, but there was no justification or explanation provided for such documentation.

Facility staff did not follow the pain assessment policy for reassessing pain after pain medication administration. According to the facility policy titled, "Pain Management-Hospitalwide," approved on 9/10, "The patient's pain will be re-assessed within 60 minutes of administration of a PRN medication."

Based on staff interview, medical record review, and hospital document and policy review, the facility failed to ensure that adverse reactions and medical errors were tracked as evidenced by:
1. Not reporting Patient 72's adverse drug reaction (respiratory depression/failure) resulting from concomitant administration of opioid medications (fentanyl, Dilaudid, and hydrocodone). Patient 72 had to be given Narcan, a reversal agent, oxygen, and required breathing support from a BiPAP (Bi-level positive airway pressure) machine.
2. The facility did not have a working system for reporting adverse drug events. Even though they had a policy to evaluate use for reversal agents, such as Narcan and Romazicon, the case of Patient 72 was not identified by that system. The facility had a very small number of events reported, 0.008 %, per doses dispensed.

Findings:

1. On 4/25/12 at 11 a.m., the record for Patient 72 was reviewed. The 71-year-old patient was admitted on 4/19/12. His medication reconciliation showed that he had a fentanyl patch 25 microgram. Fentanyl is a potent opioid medication that is applied to the skin to provide continuous delivery of medications. On 4/20/12, Patient 72 had an order for Norco 10/325 for pain. Norco is a combination medication of 10 milligrams (mg) of hydrocodone (opioid) and 325mg of acetaminophen (also known as Tylenol). On 4/21/12 at 4:40 p.m., Patient 72 had an order for Dilaudid 2mg every 6 hours, as needed for severe pain. Dilaudid is a potent pain medication similar to, but about six times more potent than, morphine. On 4/21/12 at 2:00 p.m., an order for 2mg of Dilaudid was ordered to be given now.

Review of the medication administration records and the electronic tracking system for medication removal for 4/21/12 revealed that the same nurse removed both medications from the automated medication dispensing cabinets, Norco at 13:58 and Dilaudid at 14:22. The same nurse administered both medications to Patient 72, Norco at 13:54 and Dilaudid at 14:21, within 27 minutes.

About 2 hours after the medication was administered, on 4/21/12 at 16:33, the physician was notified that Patient 72 was "...lethargic, and [had] labored breathing." The Patient was put on BiPAP which is a breathing apparatus that helps gets air into the lungs and is used for critically ill patients in hospital with respiratory failure. Patient 72 was transferred to the intensive care unit.
Narcan, a reversal agent for opiate/opioid type medication that reverses sedation and respiratory depression, was ordered to be given to Patient 72, and was given two times, once at 17:34 and again at 20:31.

On 4/30/12 at 11:10 a.m., the Pharmacy Distribution Manager (PDM) was asked specifically for the instance related to Patient 72, Narcan use, it was said that the incident was not reported. On 4/30/12 at 1:50 p.m., the Director of Quality Management (DQM) confirmed that the incident for Patient 72 was not reported.

2. The facility's policy titled, "Adverse Drug Reaction Program- Hospitalwide," approved 6/9, was reviewed. The policy directed, "Vigilanz will screen for trigger drugs, certain specific lab values, or combination of drugs and lab values ... The Vigilanz report will be reviewed by the pharmacist for reporting and tracking adverse drug reactions on periodic basis..."

During interview on 4/30/12 at 9 a.m. with the DP and PDM, it was stated that triggered agents (such as Narcan, Romazicon) were evaluated, however, the report for these medications was not available for evaluation. At that time, a report of use of these medications was requested, but the surveyor was informed that such a list could not be generated. That same morning at 11 a.m., the DP stated that the report of Narcan and Romazicon could be generated only per patient.

3. On 4/30/12 at 9 a.m., during an interview with the DP and PDM regarding the facility system for adverse drug reaction (ADR) reporting, it was stated that the percentage of adverse drug events reported in the facility was about 0.0008 per doses dispensed (eight for each 10,000 doses dispensed). In one quarter, the facility had reported only 12 cases: three adverse effects in October, three in November, and six in December of 2011. There was no evidence that the pharmacy was evaluating all potential ADRs consistent with facility policy.

Based on staff interviews and document reviews, the process used by the medical staff to evaluate and approve surgical/sedation privileges failed to ensure documented experience and competence for all privileges requested and renewed for 261 of 261 medical staff members (MDs 1-261) and 42 of 42 allied health professionals (AHPs 1-42) reviewed, in accordance with medical staff bylaws and policies. This failure put patients at risk for unsafe care by unqualified providers.

Findings:

Review of the lists of medical staff members and AHP members indicated there were 261 medical staff members (MDs 1-261) who were granted clinical privileges to deliver patient care tasks directly at the hospital, and 42 (AHPs 1-42) allied health professionals similarly authorized.

In a review of medical staff and allied health professional files on 4/30/12 at 1:20 p.m. with the medical staff coordinator (MSC), MSC indicated that the files for the 261 medical staff members and the 42 AHPs contained documented evidence of education, training, references, and reportable outcomes for all providers. However, when each provider requested renewal of the clinical privileges, the evidence of experience relied on a volume report of billing codes for the previous 1-2 year period. The billing codes did not typically match or align with all the requested privileges. The hospital had no method to determine if certain privileges had not been performed for an extended period of time, which might require additional evaluation of the provider's skills and ability to remain currently competent. In addition, the patient outcomes data set was limited to a small number of selected patient events that did not reflect a provider's skills and competence for all the requested privileges. The Credentials Committee, who maintained the files and made recommendations to the hospital leadership about whether to renew privileges or not, did not receive and review the results of ongoing performance evaluations conducted by each department on the members of its staff members.

Review with MSC of the files for MDs 1, 2, 3, 8, 9, 10, and 11 on 4/30/12 at 1:20 p.m. confirmed what MSC described: Lists of insurance codes did not match the specific privileges approved by the hospital leadership. In addition, the privilege lists for MDs 8 and 9 did not include approval to perform pre-surgical history and physical examinations (H&Ps), tasks which were routinely performed by MDs 8 and 9.

MSC indicated that the performance of the AHPs was not captured in the event-driven quality data relating to patient outcomes. Therefore, the AHP files did not contain summaries of the patient outcomes relevant to their privileges.

MSC confirmed that the file for AHP 3 indicated that privileges for core acute care as a physician assistant were approved 2/16/12, and still not signed by the Governing Board. The file contained proctoring reports (verifications of competence by direct observation) of emergency department (ED) care from many years ago when AHP 3 possessed ED privileges. However, no proctoring reports for the current acute care privileges were documented. The current privilege documents noted that all practice was to be performed under the supervision of a supervising physician in accordance with written policies and protocols developed and approved by the relevant clinical department or service, nursing and administrative representatives. Also included in the privileging documents was a Core Procedure List, which included surgical removal of damaged skin and tissue (debridement), care of chest tubes, draining abscesses, ordering tests, and "direct care as specified by medical staff approved protocols." However, no documented evidence of these policies and protocols was present in the file, or presented by hospital staff.

MSC confirmed that the file for AHP 1 contained core ED privileges that were approved 2/23/12. The privileges included sedation, analgesia, and regional block anesthesia (specialized tasks that require demonstration of specific education, training, and competence separate from AHP certification and not documented in the file). The privileges included tendon repairs, wound surgery, eye pressure measurement, removal of a device from a patient's uterus, drainage of fluid from joints, manipulating a dislocated joint back into place, and "direct care as specified by medical staff approved protocols." Such protocols and procedures were not specifically documented. Instead, a "Delegation of Services" agreement between AHP 1 and her supervising physicians listed a number of medical textbooks and other literature sources prefaced by this statement: "As outlined in Section 1399.545 of the Physician Assistant Regulations, California Emergency Physicians has adopted the following as the protocols and clinical practice guidelines for PA practice of medicine." However, at the bottom of this page was also documented, "These are intended as reference resources only and do not necessarily constitute approval of all procedures therein." No further documents clearly directed which care practices and procedures within the literature references were approved for AHP 1 to perform without direct supervision (physical presence of a physician). The references covered the medical management of a broad array of diseases, such as how to bore holes into the skull to relieve pressure on the brain, how to inject dye into a vein to study the blood supply to the heart, and how to inject medicines into the spine to treat cancer, all very specialized management practices which exceed the scope of practice for a physician assistant.

In an interview on 4/23/12 at 9:20 a.m., AHP 1 stated that her training program included 12 weeks of experience in the ED and additional time in surgical care. AHP 1 stated that she was authorized to perform any type of emergency treatment based on her judgment of whether she was capable or whether she should refer the patient to an ED physician. AHP 1 stated that no formal protocols were provided to guide her to decide which care practices required a physician. For example, AHP 1 stated that she could perform a procedure to drain fluid or air from the chest and could reposition a dislocated shoulder, without direct supervision or referring to practice protocols for these types of procedures.

In an interview on 4/26/12 beginning at 1:45 p.m. with MD 4, who served as the Director of Anesthesia Services, MD 4 stated that none of the AHPs were privileged to perform/supervise sedation care for procedures. MD 4 did not expect an AHP to be performing surgical procedures and other physician practices without documented evidence of education, training, experience, and competence, plus proctoring and procedure-specific protocols in place.

Review of the 5/11 Medical Staff Bylaws indicated in Section 2.7 that members may exercise those clinical privileges granted to them by the governing board. Article XI defined the organizational documents that supplemented the Bylaws, which included the Credentialing Manual, Organizational Manual, Rules and Regulations, and Allied Health Professionals manual.

Review of the 5/11 Medical Staff Credentialing Manual indicated in Section 2.1 that a practitioner shall be entitled to exercise only those Clinical Privileges or specified services specifically granted by the governing board. Section 2.2-2 documented that privilege determinations shall be made in connection with observed clinical performance, demonstrated ability and judgment, proctoring and the results of peer review, and the documented results of patient care audit and other quality review and evaluation activities conducted by the hospital. The information shall be added to and maintained in the medical staff file.

Review of the 5/11 Medical Staff Rules and Regulations indicated in Section A-4 and Section F-4 that a pre-surgical H&P was required for surgical patients.

Review of the 5/11 AHP Manual documented in Section 1.8 that privileges shall be granted in accordance with the Credentialing Manual, but in all cases must be within the scope of the AHP's licensure.

Based on observation, interview, record and policy review, the facility failed to ensure that nursing services were furnished or supervised by a registered nurse and consistent with nationally accepted standards of practice evidenced by:

1. Failure to provide nursing care during conscious sedation in a manner consistent with nationally accepted standards of practice for four of four conscious sedation patients reviewed (Patients 22, 23, 24, and 27). Refer to A392;

2. Failure to follow physicians orders for repositioning and application of barrier cream for one of 89 sampled patients. Refer to A396;

3. Failure to provide safe administration of medication in accordance with physician orders, facility policy, and nationally accepted standards of practice for 10 of 83 sampled patients (Patients 11, 14, 15, 16, 17, 18, 22, 71, 73, and 77). Refer to A404;

4. Failure to provide deep sedation for one of nine surgical patients reviewed, in accordance with nationally accepted standards of practice (Patient 17). Refer to A405.

These failures resulted in potential for delays in recognition of patient complications, and treatment of adverse outcomes such as excessive medication, pressure ulcers, cross contamination, spread of infection, and medical errors.

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

Based on observation, interview, and record review, the hospital failed to ensure that two nurses (a medication nurse, sedating and monitoring patients, and a circulator nurse, in charge of the room and supervision of the technician) were available during a conscious sedation (lighter level of sedation than general anesthesia where the patient maintains a good airway and responds to stimuli) procedure, the documentation of intraprocedure (during the procedure) and post procedure monitoring for moderated conscious sedation, according to policy and standards of practice, and to verify pre procedure lab results, prior to a radiology procedure, for 4 of 4 patients (Patients 22, 23, 24, and 27). The failure to not have adequate nursing staff and lack of monitoring intra and post procedure care may result in not identifying potential and current complications for patients.

Findings:

1. On 1/5/12, Patient 27 had a bronchoscopy (visualization of the airway to the lungs) procedure and received moderate conscious sedation. The conscious sedation medication was documented given at 2:40 pm and the procedure ended at 3:05 pm. After the medication was given, vital signs were taken 8 minutes later at 2:48 pm, 2 minutes at 2:50 pm, and last set 9 minutes at 2:49 pm. There was documentation that a circulator nurse and technician were in the room during the procedure, however, there was no additional documentation that the conscious sedation nurse was different than the circulator nurse.

In an interview on 4/30/12 at 10:30 am, the Director of Quality Management stated that there was no evidence that there had been two registered nurses in the room during the procedure and intraoperative and postoperative monitoring were not done, per hospital policy.

According to AORN (Association of periOperative Nurses) Perioperative Standards and Recommended Practices, Edition 2012, Recommended Practices for Managing the Patient Receiving Moderate Sedation/Analgesia, Recommendation IV reads, "The perioperative registered nurse monitoring the patient receiving moderate sedation/analgesia should have no other responsibilities that would require leaving the patient unattended or would compromise continuous monitoring during the procedure...IV.a. A designated perioperative registered nurse should continually monitor the patient during administration of moderate sedation/analgesia. IV.b. An additional perioperative registered nurse should be assigned to the circulating role during the administration of moderate sedation."

According to AORN Perioperative Standards and Recommended Practices, Edition 2012, Recommended Practices for Managing the Patient Receiving Moderate Sedation/Analgesia, Recommendation VI reads, "The perioperative registered nurse should continuously monitor the patient throughout the procedure...VI.d. Vital signs should be monitored before the start of the procedure, after administration of sedative or analgesic medications, and at least every five minutes during the procedure based on the patient's condition, type and amount of medication administered, and length of procedure...Recommendation VII The perioperative registered nurse should monitor the patient who receives moderate sedation/analgesia postoperatively...VII.a. The same monitoring parameters used during the procedure should be used during the recovery phase...VII.a.2. Postoperative monitoring should include, but is not limited to, heart rate and rhythm, LOC (level of consciousness), blood pressure, cardiac monitoring, oxygenation monitored by pulse oximetry with an audible pulse rate and alarms; and ventilation monitored by direct observation and/or auscultation."

2. On 4/24/12, Patient 22 was observed in the cardiac cath lab for pacemaker (controls the heart rhythm of contraction and relaxation) replacement with the capacity of defibrillation (ability to produce a brief electroshock to the heart, allowing the heart's pacemaker to regain control and regulation of the heart rate and rhythm). There were 3 RNs in the procedure room, RNs 60, 61 and 63. At 7:45 am, RN 61 stated that she was the circulator nurse (RN who assumed responsibility and accountability for patients undergoing a procedure) and greeted Patient 22 upon entering the procedure room. At 8 am, RN 61 was observed to be wearing a cap, mask, and a sterile gown. RN 61 then proceeded to set up a sterile field and took on the role of Cath Lab Cardiovascular Technician assisting the physician during the procedure.

At 8:20 am, RN 63 was observed administering 2 mg (milligrams) of Versed (sedation) and then 2 mg Morphine (narcotic). RN 60 was sitting across the room, away from the patient, documenting the procedure on the computer. Five minutes after sedation was administered, at 8:25 am, RN 63 left the procedure room to get additional sedation (Versed) while having the responsibility of conscious sedation nurse. There was no circulator nurse available during the procedure to leave the room to gather supplies. At 9 am, 2 mg of Versed was administered. Then at 9:10 am, RN 63 left the room to get additional Versed for the anticipation of sedating for a test shock of the defibrillator. RN 60 was not observed interacting with Patient 22 and did not make herself available to assist during the procedure while RN 63 left the procedure room twice leaving Patient 22 bedside.

In an interview on 4/25/12 at 3:30 pm, the Quality Manager (QM) stated that she observed the procedure the previous day (4/24/12) and stated that RN 63 left the room twice while monitoring the patient receiving moderate sedation. RN 60 was positioned across the room. RN 61 was positioned in the role of technician and assisting the physician.

According to AORN Perioperative Standards and Recommended Practices, Edition 2012, Recommended Practices for Managing the Patient Receiving Moderate Sedation/Analgesia, Recommendation IV reads, "The perioperative registered nurse monitoring the patient receiving moderate sedation/analgesia should have no other responsibilities that would require leaving the patient unattended or would compromise continuous monitoring during the procedure...IV.a. A designated perioperative registered nurse should continually monitor the patient during administration of moderate sedation/analgesia. IV.b. An additional perioperative registered nurse should be assigned to the circulating role during the administration of moderate sedation."

3. On 4/24/12, Patient 23 had an upper endoscopy (scope visualization of the throat, stomach, and entrance of the small intestine) procedure and received moderate conscious sedation. The procedure was conducted in the patient's room, beginning at 10:37 am and ending at 10:44 am. The vital signs prior to sedation at 10:30 am, were Blood Pressure (BP) 123/72, Heart Rate (HR) 82, Respirations (R) 27, and Oxygen Saturation (SaO2) 99. Last set of vital signs taken at 10:50 am, were BP 92/53, HR 74, R 18, and SaO2 97. The next set of vital signs followed the physician's orders and "Monitoring Post-Return to Sending Unit" policy when vital signs were documented every 15 minutes twice, and then every 30 minutes twice. The documented disposition (placement) after the procedure was PACU, however Patient 23 remained in his room after the procedure. PACU would have monitored the patient as per "Immediate Post-procedure Monitoring." This step (monitoring every 5 min for 20 minutes) in the process post procedure was not done per hospital policy for conscious sedation.

The policy for "Procedural Anesthesia/Analgesia - Adult-Hospitalwide," dated 1/27/12, directed staff immediately after the conscious sedation procedure, O. Immediate Post-procedure Monitoring: Post-procedure monitoring for both inpatient and outpatient will include vital signs (including SaO2, pain and sedation scale) will be assessed and documented every 5 minutes for 20 minutes either in the procedure area or PACU (Post Anesthesia Care Unit) or Critical Care Unit (prior to transport to the sending unit)...P. Monitoring Post-Return to Sending Unit: For inpatients - upon return to the sending unit, HR, BP, R, pain and sedation scale will be monitored every 15 minutes twice, then every 30 minutes twice.

In an interview on 4/25/12 at 3:30 pm, the QM stated that Patient 23 did not have the immediate post-procedure monitoring after the upper endoscopy as per hospital policy. QM stated that she observed the procedure in Patient 23's room and he was not transferred to PACU as per documentation.

4. On 4/24/12, Patient 24 had a procedure to declot (remove or dissolve blood clots for passage of blood flow) his hemodialysis (abnormal tubelike passage between an artery and a vein) vascular access for kidney dialysis (exchange of fluid and certain electrolytes) and received conscious sedation. The procedure ended at 5:30 pm and he was transferred to his room at 5:50 pm. There was an order to monitor vital signs every 15 minutes times 4, followed by every 30 minutes twice. There was no documented post procedure vital signs in Patient 24's record.

On 4/26/12 at 11:20 am, the QM stated that there was no documented post procedure vital signs in Patient 24's record, even though there was a physician's order and hospital policy to monitor post procedure vital signs.

5. On 4/24/12, Patient 24 had a procedure to declot his hemodialysis vascular access. The physician had ordered blood test to check his complete blood count, electrolytes (Potassium, Glucose, Chloride, etc), and bleeding times. There was no documented verification that the blood test results were available prior to the procedure as ordered.

In an interview on 4/26/12 at 9:30 am, QM stated that there was no documentation to verify that the blood test results for Patient 24 were available prior to procedure.

Based on observation, interview, and record review, the facility failed to ensure that the skin care plan including physician's orders was implemented for one patient admitted to the facility with a pressure ulcer (bedsore). The facility did not turn the patient side to side, as ordered and did not apply barrier cream to the skin at least every six hours, as ordered. This had the potential to result in a worsening of the pressure ulcer. (Patient 10).

Findings:

On 4/30/12, a review of Patient 10's record disclosed he was admitted to the facility on 4/26/12 with diagnoses that included pneumonia and lung disease. He was admitted with a Stage II (partial thickness loss of the skin) pressure ulcer on the coccyx (tailbone) area.

A physician's order, dated 4/28/12 and timed 8:45 am, read, "turn and reposition patient from side to side at least every 1-2 hours" and "apply thick layer barrier ointment to affected area every six hours and prn (as needed) incontinence." The care plan which had been initiated on 4/26/12, included, "reposition every two hours." It had not been updated to specify side to side at least every 1-2 hours and did not include the physician's order for barrier cream.

A review of the turning schedule following the physician's order, showed that Patient 10 was turned onto his back on 4/28/12 at 12 pm and 6 pm. On 4/29/12, there was no documented turning at 4 am and Patient 10 was turned onto his back at 6 am, 10 am, 2 pm, and 10 pm. On 4/30/12, Patient 10 was turned onto his back at 2 am. Patient 10 was observed to be on his back at 10:35 am.

During an interview and record review on 4/30/12 at 1 pm, Nurse Manager (NM) 2, confirmed the above findings regarding the time Patient 10 stayed on his back. NM 2 said it appeared that the skin barrier cream had not been applied at least every six hours, as ordered.

During an interview and record review on 4/30/12 at 1:25 pm., Registered Nurse (RN) 53 stated that the barrier cream had been applied three times on 4/28/12, at 7:30 am, 8 pm, and 10 pm. On 4/29/12, it had been applied at 12 am, 3:40 am, and 5:44 am. It was not applied again until 4:08 am on 4/30/12.

Based on observation, staff interview, record review, and document and policy review, the hospital failed to:

Ensure that mediations were given, as ordered by the physician, for three Patients (71, 73, and 77): 1) Patient 73's Epogen (a medication to treat anemia) was administered late 3 out of 4 days (75% of the time) and was not given in 1 out of 4 days (25% of the time); 2) Patient 77 was administered Demerol (a potent pain medication) every 2.5 hours instead of every three hours as ordered; 3) Patient 71's blood sugar monitoring and subsequent insulin administration was done only two times instead of four times per day.

Ensure safe administration and monitoring of medications in accordance with physician orders, hospital policy, and/or acceptable standards of practice (e.g. manufacturers' Specifications, organizational standards) for 7 of 9 surgical patient records reviewed (Patients 11, 14, 15, 16, 17, 18 and 20): 1) Intravenous fluids (IVF, solutions administered through a plastic tube inserted into a vein) were not administered in accordance with physicians orders for 4 of 9 surgical patients (Patients 11, 15, 16, and 20); 2) Verbal orders were not documented as read-back, per hospital policy, for 5 of 9 surgical patients (Patients 11, 14, 16, 17, and 18); 3) Administration of local anesthetics by the physician were not documented, in accordance with standards of practice, for 3 of 9 surgical patients (Patients 11, 15, and 16).

Ensure that medication from a carpuject (medication container that can be used directly with a special holder to administer medication) was administered in accordance with the manufacturer's recommendations for 1 of 2 patients observed during conscious sedation procedures (Patient 22).

These failures placed patients at risk for treatment failures, adverse outcomes related to excessive medication administration, inadequate blood sugar monitoring and treatment, cross contamination and the spread of infection, and medication administration errors.


Findings:

1. On 4/24/12 at 8:45 a.m., Patient 73 was observed receiving morning medications. During the preparation of the medication, Registered Nurse (RN) 59 checked the refrigerator and stated that he needed to call the pharmacy to get the Epogen for Patient 73. Later the same morning at 11 a.m., RN 59 stated that Patient 73's Epogen had not been administered.

On 4/26/12, review of the electronic medication administration record and medication dispensing record with the Director of Pharmacy (DP) for administration of Epogen on 4/12, 4/22, 4/23 and 4/24, revealed that the medication was administered late (more than 60 minutes after the specified time) on 4/21, 4/22, and 4/24, and it was not given on 4/22/12.

Review of the policy titled, "Medication Administration-Bedside Barcode Scanning and Non-Bedside Barcode Scanning" version 2, approved 2/28/12, read, "Medication must be administered within 60 minutes prior to, or 60 minutes after the designated schedule time unless otherwise defined..."

2. On 4/25/12 at 3:00 p.m., the record for Patient 77 was reviewed with the DP and Chief Clinical Officer (ADM1). Patient 77 had an admission order, Norco 10/325 two tablets to be given every 6 hours, as needed for pain. Norco is a combination medication of 10 milligrams (mg) of hydrocodone (opioid) and 325mg of acetaminophen (also known as Tylenol). Patient 77 also had an order for Demerol 75mg intravenously every 3 hours, as needed for pain. Demerol is an opioid pain medication, also known as meperidine.

Review of the medication removal from the automated dispensing cabinets and the medication administration record showed that both medications were given concurrently. On 3/30/12, Patient 77 was given Demerol at 15:00 and another dose of Demerol at 17:31. On 3/31/12 Patient 77 was given Demerol at 18:03 and another dose of Demerol at 20:44. On 3/30 and 3/31, Demerol was administered within 2.5 hour and 2.3 hours, not every three hours, as ordered by the physician.

3. On 4/23/12 at 3 p.m., accompanied with ADM1 and the DP, the record for Patient 71 was reviewed. Patient 71 had a physician's order for blood sugar checks four times every day, before meals and at bedtime, and based on the blood sugar level, Patient 71 was to receive insulin, per sliding scale. Review of the mediation record for 4/20/12 through 4/21/12, revealed that Patient 71's blood sugar was checked only twice, not four times, as ordered by the physician. There was no documented justification for not implementing the order.


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4. In a collaborative review of the medical record for Patient 11 on 4/23/12 at 12:45 p.m. with Registered Nurse (RN) 58 who cared for Patient 11 during a liver biopsy procedure earlier that day, RN 58 indicated that the physician order for IVF was to be administered at a rate of "to keep open" which would usually amount to only a few teaspoons of fluid per hour. Yet, the surgical records documented the administration of over 3 ounces of fluid in 45 minutes. No order change or clarification was documented to explain the different rates.

In a collaborative review of the medical records for Patients 15, 16 and 20 on 4/26/12 at 10 a.m. with Nurse Manager (NM) 12 who managed a procedural nursing unit, NM 12 confirmed that the physician orders for Patients 15, 16 and 20 directed a rate of a few teaspoons of fluid per hour. However, 3 to 6 ounces of fluid per hour were actually administered during surgery without additional orders or clarifications documented.

Review of a policy titled, "Orders, Transcription and Requisition-Nursing," last reviewed 4/4/12, documented under item III that all patients shall have specific, written orders for diagnostic and therapeutic care written/directed by a provider who possessed the authority (hospital privileges). Medication orders shall be written on a physician order sheet and shall include the name of the medication, route of administration, specific dosage and frequency (rate) for administration.

Review of a hospital-wide policy titled "Medication Administration - Non-IntelliDOT and IntelliDOT System," last approved 10/10, documented, "Medication may be given only upon the specific written order of the physician ... All orders must specify the name of the drug, the amount to be given, the frequency to be given ..."

Review of the 2012 AORN Guidance Statement: Preoperative Patient Care in the Ambulatory Surgery Setting, intended for care performed in settings where invasive procedures were performed, documented that a pre-operative nursing assessment should verify that prescribed surgical preparations were administered prior to surgery.

5. Collaborative reviews of medical records for Patients 11, 14, 16, 17, and 18 with RN 58 and NM 12 as described above indicated that oxygen, sedation and pain medications were administered by RNs during surgical procedures for these patients. The medications were verbally ordered but not noted in the medical record as verbal orders. However, the RNs who documented which drugs were given and when, did not note that the orders were verbal with "read-back" to the physician who issued the orders.

Review of a policy titled "Orders, Transcription and Requisition - Nursing," last reviewed 4/4/12, documented under item IV-J that orders taken verbally should be written by the person taking them as "VO/RB" to indicate the order was read back (and clear) to the issuer.

Review of a hospital-wide policy titled "Medication Administration - Non-IntelliDOT and IntelliDOT System," last approved 10/10, documented under Item III(A)(2), "Each verbal/telephone order should be read back to the provider to assure accuracy."

Review of the 2012 AORN Guidance Statement: Safe Medication Practices in Perioperative Settings Across the Life Span directed RNs to perform a "read-back" of each verbal order to confirm the accuracy of the order.

6. Collaborative reviews of medical records for Patients 11, 15, and 16 with RN 58 and NM 12 as described above indicated from the operative reports that the surgeons administered topical anesthetic medications (lidocaine) to the surgical sites during the surgeries, but the medication administrations were not documented on the intraoperative records to note the dose, time, and person responsible in the continuum of care.

Review of the 2012 AORN Guidance Statement: Safe Medication Practices in Perioperative Settings Across the Life Span directed RNs to verbally and visually confirm with the scrub person or licensed professional performing the surgical procedure all medications delivered to the sterile field, including medication name, strength, dosage, and expiration date. AORN further guided that an accurate and complete accounting of all medications administered throughout a procedure be documented, to address medication-related issues that may arise during all phases of perioperative care.

Review of the 5/11 Medical Staff Rules and Regulations documented under item C-1 that an accurate medical record shall be kept for every patient receiving care in the hospital.



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7. On 4/24/12 at 9:02 am, RN 63 was observed transferring medication from a carpuject into another syringe and then administered the medication into Patient 22's intravenous line. A tubex (special holder which attaches to the barrel and needle for linking directly to intravenous tubing line or injection) was observed on the counter where RN 63 was handling the medication. In a concurrent interview, RN 63 stated that he transferred the medication from the carpuject into another syringe, because he thought it was faster to use the syringe, the carpuject was relatively new to him, and he had the habit of using the syringe. This practice posed a risk for cross-contamination.

According to the manufacturer, Carpuject Syringe System was a system of prefilled cartridges that are loaded into a syringe holder to create a drug delivery system. The reusable, full-length plastic holder was designed to provide both stability during injection and easy, safe disposal of the glass cartridge unit after use.

Based on staff interview and medical record and document review, the hospital failed to
ensure the safe administration and monitoring/supervision of administration and monitoring of general anesthetic agents in accordance with accepted standards of practice and federal laws (United States Health and Human Services Food and Drug Administration, FDA) and regulations when it permitted (both in practice and policy) unqualified staff to perform the administration and monitoring of the effects of ketamine (a general anesthetic agent) sedation for 1 of 9 surgical patients reviewed (Patient 17). This failure put patients at risk for delays to recognize and treat adverse medication effects.

Findings:

Review of the medical record for Patient 17 on 4/30/12 at 12:15 p.m. with the Director of Perioperative Services (DPS) indicated that Patient 17, age 2, had reduction of fractures in the right arm performed under deep sedation on 4/8/12 in the emergency room. [Deep sedation is the administration of drugs to reduce pain and awareness during a surgical procedure; the intended depth of sedation makes a patient not easily aroused but can respond purposefully to repeated or painful stimulation; the drive to breathe may be impaired.] Nursing notes indicated that a general anesthetic agent (ketamine 22 milligrams) was administered through a plastic tube into Patient 17's vein (IV, intravenous) by a registered nurse (RN) at 6:31 p.m. At 6:32 p.m. the child's breathing rate rose to 50 breaths per minute (normal is 21-29) and heart rate was 120 beats per minute (normal is 80-140). The fracture reduction was performed by a physician at 6:33 p.m. Starting at 6:34 p.m., the child's heart rate rose from 141 to 162, the breathing rate rose to 65, and the Patient 17 was intermittently described as sleeping, though no sedation score was recorded. Patient 17 continued to "sleep" with no movement besides eyelids documented until 7:30 p.m., when he was drinking juice and the heart rate finally fell back to 122. The breathing rate, however, remained 47 to 62 until discharge at 8:50 p.m. No monitoring of expired carbon dioxide was documented. All the monitoring was documented by an RN. The physician made entries 2 hours after the procedure at 8:30 p.m. (procedure note, tolerated well, no complications), and a discharge note at 8:32 p.m. (patient symptoms improving, no symptoms or objective findings that are life or limb threatening, stable for disposition from the emergency room), without reconciling the persistently elevated breathing rate at the time of discharge.

Review of the FDA labeling approvals to manufacturers that were posted on an online reference (Lexi-Comp Online, ) indicated that Ketamine was categorized as general anesthetic with labeled indications for induction and maintenance of general anesthesia, with investigational use in analgesia and sedation. The warnings section read, "Experienced physician: should be administered under the supervision of a physician experienced in administrating general anesthetics." Adverse effects included increased secretions from the airway and mouth, abnormal heart rhythms including fast heart rate, release of blood chemicals that stimulate heart rate and nervous system (catecholamines such as adrenalin), spasm or abnormal movement of the vocal cords, airway obstruction, depression of the nervous system, and psychosis. Use of a sedation score to monitor the nervous system effects was recommended.

In an interview with MD 6, an emergency room (ED) physician, on 4/24/12 at 10:30 a.m., MD 6 stated that he and other physicians routinely utilized deep sedation to perform procedures on patients in the emergency room, especially children. MD 6 stated that ketamine produced a state of immobility and unresponsiveness that was ideal for children and patients who were likely to move about and make the procedure difficult. The depth of sedation with ketamine was difficult to determine because of this particular effect, and must be considered deep. MD 6 confirmed that the hospital policy permitted injections of ketamine into a muscle to be administered by a registered nurse. MD 6 did not think the policy permitted administration of ketamine into a vein (IV) by a RN, though he acknowledged that the drug was classified no differently whether it was administered into a vein or into a muscle. Subsequent monitoring (after administration) of the effects of ketamine and other general anesthetic agents in the ED was permitted in policy to be performed by a RN. After the procedure was completed, MD 6 indicated he would not typically remain with the patient as the RN was responsible to further monitor the persistent/extended effects of the deep sedation. MD 6 stated that he did not expect a RN to possess the comparable airway management skills as those of a physician or anesthesia professional to recognize the early signs of a patient drifting from deep sedation further into a state of general anesthesia, nor the early signs of complications in order to provide rescue interventions of the airway or circulation before they progressed to a dangerous state.

In an interview on 4/24/12 at 10:15 a.m. with RN 51, who routinely worked in the ED, RN 51 stated that she completed a training for moderate and deep sedation in February 2012. She learned from the training that RNs could administer ketamine IM, and perform the monitoring portion of all deep sedation care involving other general anesthetic agents such as propofol and etomidate. RN 51 indicated that the hospital RNs were not certified registered nurse anesthetists.

In a 9/95 position statement titled, "Conscious Sedation" from the California Board of Registered Nursing (BRN) retrieved at www.rn.ca.gov, the right and obligation of the RN caring for a sedation patient was documented as "to act as the client's advocate by refusing to administer or continue to administer any medication not in the client's best interest; this includes medications which would render the client's level of sedation to deep sedation and/or loss of consciousness."

Review of a policy titled, "Procedural Anesthesia/Analgesia-Adult-Hospitalwide," last reviewed 1/27/12, documented under item IV-E-1 that RNs MAY NOT administer Propofol, Etomidate, Precedex or Ketamine IV (general anesthetic agents) for the purpose of deep sedation; however the RN may administer IM Ketamine. [Ketamine IM is the same drug as Ketamine IV.] Item IV-F listed, among equipment requirements, continuous expired carbon dioxide monitor with the term "preferred" underlined for Deep Sedation, suggesting it was optional. The references for this policy included the 10/20/10 American Society of Anesthesiologists (ASA) Statement [sic for Advisory] on Granting Privileges for Deep Sedation to Non-Anesthesiologist Sedation Practitioners. Review of the hospital's training slides for Procedural Sedation 2012 gave similar direction for RNs to administer IM ketamine and monitor other general anesthetic agents.

Review of the 10/20/10 American Society of Anesthesiologists (ASA) Advisory on Granting Privileges for Deep Sedation to Non-Anesthesiologist Sedation Practitioners reminded the reader of the risk for deeply sedated patients to slip into a state of general anesthesia. "Any professional who administers and monitors deep sedation must be dedicated to that task," i.e. different from the individual performing the diagnostic or therapeutic procedure. The ASA Advisory recognized that non-anesthesiologist practitioners, if qualified, may perform the deep sedation care, or supervise deep sedation care performed by certified registered nurse anesthetists (CRNAs) or others named by the Centers for Medicare and Medicaid Services (CMS, a federal regulatory body) per the Code of Federal Regulations at 42 CFR 482.52(a). Those parties named by CMS did not include registered nurses, other than CRNAs. The ASA Advisory described the various skills and qualifications to perform deep sedation care, which encompassed administration and monitoring, and not administration separate from monitoring. The qualifications included skills and experience in airway management, ventilating patients whose breathing drive was depressed by drugs, as well as patients whose airways become obstructed, skills for use of expired carbon dioxide monitors, skills to insert a variety of airways (oral, nasopharyngeal, laryngeal mask airway, intubation), skills to recognize heart rhythm abnormalities, and advanced cardiac life support certification (ACLS, or similar training for children). The hospital presented no evidence that RNs possessed all such skills and were qualified anesthesia providers.

In an interview on 4/26/12 at 1:45 p.m. with MD 4, the Director of Anesthesia Services, MD 4 agreed that the administration and monitoring of deep sedation drugs was considered deep sedation care, and the skills to perform administration were not distinct from the skills to perform monitoring. In other words, whoever was responsible for administering deep sedation was also responsible for monitoring the effects of the care; it was considered a single care task with high risks and the need for an advanced skill set. MD 4 acknowledged that the hospital policy permitted RNs who were not qualified anesthesia providers to perform deep sedation care.

Based on observation, interview, and record review, the hospital failed to ensure that records were accurate and complete for three of 83 patient records reviewed (Patients 1, 2, and 23). The failure for not having accurate and complete records may result in not identifying potential and current problems which may adversely effect patient care and outcomes.

Findings:

1. On 4/24/12 at 10:30 am, Patient 23 was observed in a patient care room undergoing a bedside procedure. The patient was noted to have continuous cardiac monitoring (tracing of electrical activity of the heart), oxygen delivered through nasal cannula (tubing that fits into the nostrils of the nose for delivery of oxygen therapy), and was administered Cetacaine spray (local anesthesia of throat), prior to an endoscopy scope (scope visualization of the throat, stomach, and entrance of the small intestine) being placed in his mouth, down his throat. Patient 23 remained in his room after the procedure. The record did not have documentation that Cetacaine spray was administered, time oxygen was initiated, heart rhythm interpretation from the continuous cardiac monitoring, and date and time consent was signed by Patient 23. The record was inaccurate when the disposition (placement) after the procedure was documented that Patient 23 went to PACU (post anesthesia care unit) for recovery.

In an interview on 4/25/12 at 3:30 pm, the Quality Manager (QM) stated that she observed the procedure and the document was incomplete in the record: not documenting the administration of the Cetacaine spray, time oxygen was initiated, heart rhythm interpretation from the continuous cardiac monitoring, and date and time consent was signed by Patient 23. The QM stated that Patient 23 was recovered in his room and was not transferred to PACU, as documented.


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2. On 4/23/12, Patient 2's record was reviewed. Patient 2 was admitted to the facility on 4/23/12 with diagnoses that included gastrointestinal bleeding and dementia. Patient 2's record contained a nurses note, dated 4/24/12 and timed 2300 (11 pm), which was a date and time that had not yet occurred.

On 4/25/12 at 9:55 am, Nurse Manager (NM) 6 stated she had spoken with Registered Nurse (RN) 52 regarding the above nursing note as she was the author. NM 6 stated the RN 52 had intended the note to be a late entry (out of time order) and had recorded the entry after midnight resulting in the entry appearing to be in the future. NM 6 confirmed that the date had not been changed in the computer documentation by RN 52 to reflect an accurate recording of time for the events for Patient 2.

3. On 4/24/12, the facility policy titled, "Foley Catheter Protocol - Hospitalwide," dated 10/26/11, read, "The prolonged use of indwelling urinary (Foley) catheters in the hospital setting can lead to many complications...Foley catheters should be promptly removed as soon as they are no longer necessary." The policy further indicated that nurses were to assess patients with catheters daily for the continued need for the catheter, using established criteria.

On 4/24/12, Patient 1's record was reviewed. Patient 1 was admitted on 4/17/12 with diagnoses that included pneumonia. Patient 1's record indicated he had a Foley catheter (be sure defined in based on statement). Patient 1's record had documentation that from 4/19 to 4/23/12 daily assessments indicated that Patient 1's catheter was necessary because he met the criteria "incontinent with skin breakdown." Patient 1's record contained no evidence that he had skin breakdown on the above dates.

On 4/24/12 at 8:40 am, NM 2 and 3 reviewed Patient 1's record and confirmed that Patient 1 did not have skin breakdown documented. NM 2 and 3 acknowledged that Patient 1's record did not accurately record the reasons why Patient 1's Foley catheter was continued.

Based on staff interview and document and medical record review, the facility failed to ensure that medical record entries were legible, complete, dated, and timed in 8 of 10 patient records reviewed. (Patients 24, 61, 62, 63, 65, 66, 67, and 69).

Findings:

1. The facility policy titled, "Abbreviations-Hospitalwide," last approved 3/09, was reviewed on 4/23/12. It stated that an on-line reference book is used as the acceptable standard for abbreviations. However, on 4/26/12 at 1:50 PM, the Director of Quality Management (DQM) stated that the only hospital staff who had access to this reference were the transcriptionist's. This policy did not state what steps staff were to take when the meaning of an abbreviation is not clear because the on-line reference lists all the possible meanings.

The following records were reviewed on 4/25/12 and 4/26/12. The findings noted were reviewed and confirmed with the DQM on 4/26/12 at 4:20 PM:

a. In the pre-anesthesia evaluation, the choice of anesthesia planned to be administered was not completed (Records 61 and 62).

b. In a post-anesthesia care unit physician's order, the liter flow for oxygen was not written in the space provided on the form (Record 63).

c. The electronically-generated radiology reports did not print a date and time when the physician actually reviewed and authenticated the document (Records 65 and 66).

d. The physician's order for non-behavioral restraint on 3/10/12 was not timed in the space provided on the form (Record 66).

e. The consent for labor epidural did not have the physician's name entered in the space provided on the form (Record 62). The consent to surgery or procedure was not timed (Record 63).

f. The consent to surgery or procedure form has a section authorizing release of the social security number which was to be checked (Yes or No) and initialed by the patient, but this was left blank (Record 67).

g. The interval history and physical has a section for the physician to indicate the "ASA Physical Status Class." It had not been completed. (Record 61).

h. The patient was evaluated by two physicians and the ASA Status Class assigned by each physician was different, Class 2 and Class 3. (Record 67).

i. Transcribed reports did not include the name of the hospital and there were two dates typed at the bottom of the reports without any further explanation as to what those dates meant (Records 61, 62, 63, 66, and 69).


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2. On 4/26/12 at 9:45 am, Patient 24's record was reviewed. On 4/24/12, two pages of physician's orders were written and not legible. In a concurrent interview, the Quality Manager stated that Physician (MD) 3 was known to have poor handwriting and was unable to interpret over 50 percent of the orders, as documented by MD 3.

Based on interview and record review, the facility failed to ensure that one of 83 sampled patients (Patient 2) had a properly executed patient consent. This failure had the potential for the patient 's right to be informed of and consent to medical procedures not being honored.

Findings:

On 4/24/12, Patient 2's record was reviewed. Patient 2 was admitted on 4/23/12 with diagnoses that included gastrointestinal bleeding and dementia. Patient 2's record contained a consent for blood transfusion which was signed by Patient 2 on 4/23/12 at 2100 (9 pm). A corresponding nurses entry by Registered Nurse (RN) 52 in Patient 2's record indicated the consent was signed by the patient and the patient was confused.

Patient 2's record contained a form, titled, "Crossmatch/Transfusion Order Form," signed on 4/23/12 at 2045 (8:45 pm) that indicated that the patient had been provided suitable information concerning the risk and benefits of blood transfusions, and of alternative therapies and their risks and benefits. This form did not indicate who had received the information regarding the risks and benefits.

Patient 2's record contained Physician (MD) 13's consultation, dated 4/24/12, which indicated that he spoke at length to Patient 2's family member, who was the representative responsible for Patient 2's healthcare decisions. This consult indicated that Patient 2's family member had consented to the blood transfusion. The consult did not contain any reference as to when this consent was obtained nor the time the report was dictated.

On 4/24/12, the facility's policy, titled, "Consents - Hospitalwide," dated 7/08, read, "Competent adults must sign their own consents. Competent adults are those persons who:.....Have the ability to understand the nature and consequences of that which they are asked to sign." The policy further indicated that in an emergency situation where the patient cannot legally sign the informed consent, the attending physician must inform the patient's legal representative of the nature of the treatment, its risks and benefits... Witnessed by a responsible hospital employee and exact time and nature of consent must be documented; (and) two witnesses were necessary for a telephone consent."

On 4/25/12 at 9:55 am, Nurse Manager 6 reviewed Patient 2's consent documentation and stated the consent form documented by RN 52 was not properly executed when she had Patient 2, who was confused and had a history of dementia, sign her own consent.

Based on observation, staff interview, and record and policy review, the facility failed to ensure the development and implementation of policies and procedures to provide safe and effective use of drugs and the safe administration and monitoring/supervision of administration and monitoring of general anesthetic agents, to ensure that pharmaceutical services met the needs of patients evidenced by:

1. Medications were not controlled, distributed, administered, and monitored in a manner that ensures patient safety. Refer to A500.

2. Adverse drug reactions and medication errors were not reported immediately. Refer to A508.

3. Controlled substances were not evaluated for appropriate use, to ensure patient safety and prevent or detect timely abuse of diversion. Refer to A494.

4. Medications were not administered in accordance with policy, acceptable standards of practice, or the order of the physician. Refer to A404.

5. The hospital permitted (both in practice and policy) unqualified staff to perform the administration and monitoring of the effects of ketamine (a general anesthetic agent) sedation for 1 of 9 surgical patients reviewed (Patient 17). Refer to A500.

The cumulative effect of these systemic problems resulted in the hospitals inability to ensure the provision of quality pharmaceutical services safely and effectively.

Based on staff interview and medical record and policy review, the facility failed to ensure accurate accountability of all controlled substances when they failed to evaluate frequent use or high doses of medication. The facility failed to have a surveillance process to detect timely and identify potential controlled substance misuse, abuse, or theft. There were no evaluations of situations, such as frequent discrepancies, or tracking and trending these occurrences. Lack of accountability posed a risk for misuse or abuse of controlled substances, and subsequently put patients at risk of harm by being cared for by an intoxicated person, or suffer pain if the medications intended to treat them are diverted.
Findings:

1. On 4/26/12 at 3 p.m., the Director of Pharmacy (DP) stated, relating to controlled substance accountability, that there was no system in place to trend or track activities such are returned controlled substance, frequent users, or discrepancy rate. She said that they only look at non-reconciled discrepancies. Non-reconciled discrepancies is potentially nonexistent because nursing staff are expected to resolve discrepancies by the end of their shift, according to the policy titled, "Controlled substance-Hospitalwide," dated 2/20/12.
The pharmacy department does not evaluate how these discrepancies were resolved or look for any pattern or trends. Evaluation of the discrepancy report for 24 hours (4/29/12 at 6:00 until 4/30/12 at 6:00) revealed 12 events of discrepancies. The resolution comments for seven out of the 12 times were "Error in counting, no discrepancy." There was no evidence that these situations were remedied or that the medications were accounted for. It was not clear, for instance, how a discrepancy for Ativan (a sedative hypnotics) was resolved if the count was supposed to be 15, but the user found zero. The count remained at zero. The comment under resolution was "Error in counting, no discrepancy" and the comment for this event under "Discrepancy Resolution" was "COMPLETED."

2. There was no documented evidence that the pharmacy department was evaluating the frequencies of restocking the automated dispensing cabinets with controlled substances or the disposition of these medications. There was no system in place to validate use of controlled substances in high doses or high frequencies to verify that these medications were administered to the intended patients, or that there were physician orders for such medications. On 4/23/12, the DP provided information about a situation of controlled substance loss/abuse that was identified by a nurse manager more than a year ago. However, on 4/26/12 at 3 p.m., the DP confirmed that the facility did not have a system for surveillance to detect any potential misuse, abuse, or theft of controlled substance timely and prevent similar occurrences.

Based on observation, staff interview, and clinical record and document review, the facility failed to ensure patient safety when medications were not administered in a safe and effective manner:

Medications that had similar or additive side effects were ordered and administered with no evidence or interventions for three of 83 sampled patients (Patients 72, 77, and 75).

Monitoring of medications to evaluate efficacy and prevent toxicity was not completed, when pain assessment for one of 83 sampled patients (Patient 77) was not performed in accordance with facility's policy or standards of practice.

A general anesthesia agent (ketamine) was not distributed, administered, and monitored in accordance with applicable standards of practice and federal laws (United States Health and Human Services Food and Drug Administration, FDA), by qualified staff. (Patient 17).

Control solutions and chem strips for checking patients' blood sugar levels were not kept within the time frame to be safely and effectively used, according with the facility's policy.

These failures put patients at risk ineffective treatment, adverse medication reactions and outcomes, unreliable blood sugar level test results, and delayed recognition and treatment for adverse effects from general anesthesia administration by unqualified persons.


Findings:


1. On 4/25/12 at 11 a.m., the record for Patient 72 was reviewed. The 71-year-old patient was admitted on 4/19/12. His medication reconciliation showed that he had a fentanyl patch, 25 micrograms. Fentanyl is a potent opioid medication that is applied to the skin and provides continuous delivery of the medication. On 4/20/12, Patient 72 had an order for Norco 10/325 for pain. Norco is a combination medication of 10 milligrams (mg) of hydrocodone (opioid) and 325mg of acetaminophen (also known as Tylenol). On 4/21/12 at 4:40 p.m., Patient 72 had an order for Dilaudid 2mg every 6 hours, as needed for severe pain. Dilaudid is a potent pain medication similar to, but about six times more potent than, morphine. On 4/21/12 at 2:00 p.m., an order for 2mg of Dilaudid was ordered to be given now.

On 4/26/12, during a collaborative interview, the Director of Pharmacy (DP) and Pharmacy Distribution Manager (PDM), confirmed that there was no documented evidence of any interventions by pharmacists processing the orders regarding the duplication of therapy, fentanyl, Dilaudid, and Norco. All these medications are in the same class and have similar side effects that are dose dependent and cumulative. This is significant because Patient 72 was 71 year old and, as it related to opioid drug use, the elderly may be particularly susceptible to the central nervous system depressant action. Adverse reactions including acute airway obstruction, apnea, dyspnea, respiratory depression are dose related.

Review of the medication administration records and the electronic tracking system, for medication removal from the automated dispensing cabinet for 4/21/12, revealed that the same nurse removed both medications from the automated medication dispensing cabinets, Norco at 13:58 and Dilaudid at 14:22. The same nurse administered both medications to Patient 72, Norco at 13:54 and Dilaudid at 14:21.

According to the electronic record, and about 2 hours after the medication was administered, on 4/21/12 at 16:33, the physician was notified that Patient 72 was " ...lethargic, and [had] labored breathing. " And that the Patient was put on BiPAP, (Bi-level positive airway pressure), which is a breathing apparatus that helps gets air into the lungs and is used for critically ill patients with respiratory failure. Patient 72 was transferred to the intensive care unit. Narcan, a reversal agent for opiate/opioid type medication that reverses sedation and respiratory depression, was ordered to be given to Patient 72. It was given two times, once at 17:34 and again at 20:31.

It is not clear if hospital staff that were taking care of Patient 72, physician, nurse or the pharmacist, knew if Patient 72 had the fentanyl patch when he came to the hospital. The medical record did not have any documentation of the presence or the absence of the patch. On 4/25/12, the emergency department record was reviewed. There were no notes about the fentanyl patch.

2. On 4/25/12 at 3:00 p.m., the record for Patient 77 was reviewed with the DP and ADM1. Patient 77 had an admission order for Norco 10/325, 2 tablets to be given every 6 hours for pain. Norco is a combination medication of 10mg of hydrocodone (opioid) and 325mg of acetaminophen (also known as Tylenol). Patient 77 also had an order for Demerol 75mg intravenously every 3 hours, as needed for pain. Demerol is an opioid pain medication, also known as meperidine.

There was no documented evidence that pharmacy staff questioned the duplicate therapy or clarified the specific indications for when to give which medication.
According to the drug information, Meperidine hydrochloride generally should be limited to short-term use (a few days) because of the risk of accumulation of the toxic normeperidine metabolite with repeated or large doses. Toxicities associated with Demerol use include CNS (central nervous system) stimulation (e.g., seizures, agitation, irritability, nervousness, tremors, twitches, and myoclonus) and have been attributed to accumulation of this metabolite.

The orders did not have any specific parameters for when to use Demerol by intravenous injections or Norco by mouth. There was no evidence that nurses administered the medications or clarified the indications for use.

Review of the medication removal from the automated dispensing cabinets and the medication administration record showed that both medications were given concurrently. For example, the record showed that Patient 77 was given both medications as follows:

On 3/29/12, 2 tablets of Norco at 15:45 and Demerol at 16:26 (within 41 minutes);
On 3/30/12, 2 tablets of Norco at 23:52 and Demerol at 00:44 (within 52 minutes);
On 3/30/12, Demerol at 15:00, 2 tablets of Norco at 16:06, and another dose of Demerol at 17:31;
On 3/31/12 Demerol at 18:03, 2 tablets of Norco at 19:56, and another dose of Demerol at 20:44;
On 3/29/12, Demerol at 3:11, 2 tablets of Norco at 5:18, and another dose of Demerol at 6:24.

3. The medical record for Patient 75 was reviewed with the Director of Quality Management (DQM) on 4/26/12 at 12:30 p.m. Patient 75 had an order, dated 3/27/12, for Haldol 5 mg IM (injection into the muscle) to be given "now," then every six hours for agitation. The record also had an order for 5 mg of Valium, (a sedative hypnotic) to be given by mouth every six hours, as needed for agitation. Both were verbal orders and there was no clarification or specific directions for when to use the oral and when to use the injection. There was no documented evidence that the pharmacy staff clarified these orders to specify when to give which medication.
The medication administration electronic record revealed that Haldol, an antipsychotic medication was administered at 17:17 (5:17 p.m.), and Valium (a sedative hypnotic) 5mg was administered at 17:25 (5:25), both medications have sedative properties. Both medications were given within 7 minutes, regardless of their additive effects.

4. On 4/25/12 at 3:00 p.m., the record for Patient 77 was reviewed with the DP and ADM1. Further review of the medication administration record revealed inconsistent data that did not represent Patient 77's condition. The pain score documented when the medication was given and on re-evaluation was erroneous and confusing. It did not represent Patient 77's true assessments.

For example, on 3/26/12 at 9 a.m., Demerol was administered. At 10:38 a.m., about 1.5 hours after administering Demerol, the assessment of pain on a scale of 0-10 was documented as zero. However, at 10:32 a.m., at which time Norco was administered, the pain scale was documented as seven. According to Drugs.com, the onset of action for Norco is 1.3 hours. Therefore, it would take 1.3 hours to take effect and It would be highly unlikely for Norco to be dissolved, absorbed, and to give its intended effect, so the pain scale is reduced from seven to zero (no pain) within six minutes.

On 3/26/12, two hours after administering Demerol, at 5:21 a.m., the assessment of pain was documented as zero. However, at 5:15 a.m., when Norco was administered, the pain scale was documented as seven. That is also 6 minutes, and is too short a time period for Norco to be dissolved, absorbed, and to give its intended effect, in order for the pain scale is reduced from seven to zero.

Similarly, on 3/30/12 at 5:08 a.m., the pain scale was documented as zero, but, on 3/30/12 at 5:06 a.m., when Demerol was given, the pain scale was documented as seven. Demerol is a potent pain medication, however, it is unlikely that it would affect the pain that quickly so that the pain scale is dropped from seven to zero within 2 minutes. According to Drugs.com, when given IV, Demerol takes 2-10 minutes to take effect.

According to the Board of Registered Nursing for Pain Management, proper management of patient's pain is a nursing function. Pain management includes assessing pain and evaluating response to pain management interventions; Documenting pain assessment, intervention, and evaluation activities in a clear and concise manner; and intervening to minimize drug side effects.

a. Evaluation of the effectiveness of pain medication was not meaningful, as the evaluation was not completed in a timely manner to reflect the effect of the medication given. Review of the records, revealed that Patient 77 was given Demerol on 4/1/12 at 8:22, 11:17, 14:42, and 18:03; the reassessment for pain for all these times was documented as 22:04 and with zero pain score and "acceptable." These assessments were done at 4 hours, 8 hours, 10 hours, and approximately 13.5 hours after the medication was administered. Similarly, on 3/31/12, the Demerol was administered at 21:37, 00:50, and 4:50 a.m.; the pain reassessment was documented at 6:00 a.m. with zero pain scale and "acceptable" for all of them. These assessments were done at about one, five, and eight hours after the medication was administered. Monitoring therapy is essential to evaluate efficacy and prevent toxicity. The assessment of pain medications did not reflect the condition of the patient.

b. Review of the pain re-assessment documentation for Patient 77 revealed that the pain assessment was not completed within 60 minutes, the time for re-assessment ranged from 15 minutes to 13.5 hours after the medication was administered. For example, Patient 77 was given Demerol on 4/1/12 at 8:22, 11:17, 14:42, and 18:03, the reassessment for pain for all these times was documented as 22:04. These assessments were done at 4 hours, 8 hours, 10 hours, and approximately 13.5 hours after the medication was administered. Similarly, on 3/31/12, the Demerol was administered at 21:37, 00:50, and 4:50 a.m.; the pain reassessment was documented at 6:00 a.m. These assessments were done at about one, five, and eight hours after the medication was administered. On 4/26/12, these findings where discussed with the DP, but there was no justification or explanation provided for such documentation.

The facility staff did not follow the pain assessment policy for reassessing pain after pain medications. According to the facility policy titled, "Pain Management-Hospitalwide," approved on 9/10, "The patient's pain will be re-assessed within 60 minutes of administration of a PRN medication."


22710

5. Review of the 5/11 Medical Staff Rules and Regulations under item B-7 documented that all drugs and medication administered to patients shall be those listed in the hospital formulary, United States Pharmacopoeia, National Formulary, and New and Non-official Drugs, with the exception of investigational drugs.

Review of the medical record for Patient 17 on 4/30/12 at 12:15 p.m. with the Director of Perioperative Services (DPS) indicated that Patient 17, age 2, had reduction of fractures in the right arm performed under deep sedation on 4/8/12 in the emergency room. [Deep sedation is the administration of drugs to reduce pain and awareness during a surgical procedure; the intended depth of sedation makes a patient not easily aroused but can respond purposefully to repeated or painful stimulation; the drive to breathe may be impaired.] The record indicated that a general anesthetic drug (ketamine) was administered and monitored by a registered nurse (RN), who was not a qualified anesthesia professional.

Review of the federal Center for Medicare and Medicaid Services (CMS) Code of Federal Regulations 42 CFR 482.52(a) limited the administration of anesthetics (included deep sedation care) to a qualified anesthesia professional as defined by a qualified anesthesiologist, a doctor of medicine or osteopathy, a dentist, oral surgeon or podiatrist who was qualified to administer anesthesia, a certified registered nurse anesthetist, or an anesthesiologist's assistant.

Review of the FDA labeling approvals to manufacturers (on which the National Formulary was based) that were posted on an online reference (Lexi-Comp Online, ) indicated that Ketamine was categorized as a general anesthetic with labeled indications for induction and maintenance of general anesthesia, with investigational use in analgesia and sedation. The warnings section read, "Experienced physician: should be administered under the supervision of a physician experienced in administrating general anesthetics." Adverse effects included increased secretions from the airway and mouth, abnormal heart rhythms including fast heart rate, release of blood chemicals that stimulate heart rate and nervous system (catecholamines such as adrenalin), spasm or abnormal movement of the vocal cords, airway obstruction, depression of the nervous system, and psychosis. Use of a sedation score to monitor the nervous system effects was recommended.

In interviews on 4/24/12 beginning at 10:15 a.m. with RN 51 and MD 6, who routinely worked in the emergency department (ED), RN 51 and MD 6 indicated that general anesthetic agents (such as ketamine and propofol) were routinely administered to ED patients during procedures without dedicating an anesthesia professional to perform the deep sedation administration and monitoring care desired. For example, a qualified physician might administer propofol, then perform a procedure on the affected patient while a RN performed the monitoring of the effects of the propofol. The same was true for ketamine, which was more commonly used in children and had longer lasting effects than propofol.

Review of a policy titled "Procedural Anesthesia/Analgesia - Adult - Hospitalwide," last reviewed 1/27/12, documented under item IV-E-1 that RNs MAY NOT administer Propofol, Etomidate, Precedex or Ketamine (general anesthetic agents) through a plastic tube that was inserted into a vein (intravenous, IV) for the purpose of deep sedation; however the RN may administer ketamine by injection into a muscle (intramuscular, IM). [Ketamine IM is the same drug as Ketamine IV.] Item IV-F listed, among equipment requirements, continuous expired carbon dioxide monitor with the term "preferred" underlined for Deep Sedation, suggesting it was optional. The references for this policy included the 10/20/10 American Society of Anesthesiologists (ASA) Statement [sic for Advisory] on Granting Privileges for Deep Sedation to Non-Anesthesiologist Sedation Practitioners.

Review of the 10/20/10 ASA Advisory on Granting Privileges for Deep Sedation to Non-Anesthesiologist Sedation Practitioners clearly warned under item 2-Advisory that any professional who administered and monitored deep sedation must be dedicated to that task. The non-anesthesiologist sedation practitioner who administered and monitored deep sedation must be different from the individual performing the diagnostic or therapeutic procedure, similar to the guidelines for moderate sedation care. Deep sedation practitioners must be qualified with skills and experience in airway management, ventilating patients whose breathing drive was depressed by drugs, as well as patients whose airways become obstructed, skills for use of expired carbon dioxide monitors, skills to insert a variety of airways (oral, nasopharyngeal, laryngeal mask airway, intubation), skills to recognize heart rhythm abnormalities, and advanced cardiac life support certification (ACLS, or similar training for children). The hospital presented no evidence that RNs possessed all such skills and were qualified anesthesia providers.

In an interview on 4/26/12 at 1:45 p.m. with MD 4, the Director of Anesthesia Services, MD 4 agreed that the administration and monitoring of deep sedation drugs was considered deep sedation care, and the skills to perform administration were not distinct from the skills to perform monitoring. In other words, whoever was responsible for administering deep sedation was also responsible for monitoring the effects of the care; it was considered a single care task with high risks and the need for an advanced skill set. MD 4 acknowledged that the hospital policy permitted RNs to perform deep sedation care who were not qualified anesthesia providers.

MD 4 further stated that there was no system in place to proactively review the use and safety of deep sedation medications and practices, other than when reversal drugs were utilized to rescue patients from a deeper than intended level of sedation, or when an incident report or adverse outcome related to such care was identified. Neither MD 4 nor administrative quality staff presented data or analyses to show safe and consistent use of general anesthetic agents for deep sedation that conformed with nationally recognized organizational standards or the FDA (i.e., use of expired carbon dioxide monitoring, sedation scores, medication dosage or contraindications, reconciling abnormal swings in heart rate, breathing, blood oxygen, or other measures of safe tolerance of the medications, or administration and monitoring by qualified persons who were not also performing the procedure).

Based on staff interview and record review, the facility failed to ensure that adverse drug reactions were immediately reported to the hospital-wide quality assurance program. Patient 72's adverse drug reaction (respiratory depression/failure) resulting from concomitant administration of opioid medications (Fentanyl, Dilaudid, and hydrocodone), necessitating the use or reversal agents, oxygen and respiratory equipment to support him, was not reported. The facility did not have a working system for reporting adverse drug events.

Findings:

1. On 4/25/12 at 11 a.m., the record for Patient 72 was reviewed. The 71-year-old patient was admitted on 4/19/12. His medication reconciliation showed that he had a fentanyl patch 25 microgram. Fentanyl is a potent opioid medication that is applied to the skin to provide continuous delivery of medications. On 4/20/12, Patient 72 had an order for Norco 10/325 for pain. Norco is a combination medication of 10 milligrams (mg) of hydrocodone (opioid) and 325mg of acetaminophen (also known as Tylenol). On 4/21/12 at 4:40 p.m., Patient 72 had an order for Dilaudid 2mg every 6 hours, as needed for severe pain. Dilaudid is a potent pain medication similar to, but about six times more potent than, morphine. On 4/21/12 at 2:00 p.m., an order for 2mg of Dilaudid was ordered to be given now.

Review of the medication administration records and the electronic tracking system for medication removal for 4/21/12 revealed that the same nurse removed both medications from the automated medication dispensing cabinets, Norco at 13:58 and Dilaudid at 14:22. The same nurse administered both medications to Patient 72, Norco at 13:54 and Dilaudid at 14:21, within 27 minutes.

About 2 hours after the medication was administered, on 4/21/12 at 16:33, the physician was notified that Patient 72 was "...lethargic, and [had] labored breathing." And that the Patient was put on BiPAP (Bi-level positive airway pressure) which is a breathing apparatus that helps gets air into the lungs and is used for critically ill patients in hospital with respiratory failure. Patient 72 was transferred to the intensive care unit. Narcan, a reversal agent for opiate/opioid type medication that reverses sedation and respiratory depression was ordered to be given to Patient 72. It was given two times, once at 17:34 and again at 20:31.

On 4/30/12 at 11:10 a.m., the Pharmacy Distribution Manager (PDM) was asked specifically about the incident related to Patient 72 and Narcan use. The PDM said that the incident was not reported. Later, at 1:50 p.m., the Director of Quality Management (DQM) confirmed that the incident for Patient 72 was not reported.

2. On 4/30/12 at 9 a.m., during interview with the DP and PDM regarding the facility's system for adverse drug reaction (ADR) reporting, it was stated that the percentage of adverse drug events reported in the facility was about 0.0008 per doses dispensed (eight for each 10,000 doses dispensed). In one quarter, the facility had reported only 12 cases: three adverse effects in October, three in November, and six in December of 2011. There was no evidence that the pharmacy was evaluating all potential ADRs consistent with policy.

Review of the facility's policy for "Adverse Drug Reaction Program-Hospitalwide" approved 6/9, included: "Vigilanz will screen for trigger drugs, certain specific lab values, or combination of drugs and lab values...The Vigilanz report will be reviewed by the pharmacist for reporting and Tracking adverse drug reaction on periodic basis..."

During an interview on 4/30/12 at 9 a.m., the DP and PDM, stated that triggered agents (such as Narcan, Romazicon) are evaluated, however, the report for these medications was not available for evaluation. At that time, a report of use of these medications was requested, but the surveyor was informed that such a list could not be generated. Later that same morning at 11 a.m., the DP stated that the report of Narcan and Romazicon could be generated only per patient.

Based on observation, interview, and document review, the hospital failed to ensure that dietary services met the needs of all patients as evidenced by failure to:
1. Ensure the implementation of dietetic services in an effective and organized manner. Refer to A619, A620.
2. Develop performance improvement activities that accurately reflected the scope and nature of the services. Refer to A265.
3. Ensure safe and effective food storage/production practices. Refer to A749.
4. Develop comprehensive organizational structure to ensure the nutritional needs of patients were met. Refer to A628, A629, A630, A631.
5. Ensure maintenance of equipment per manufacturers' instructions. Refer to A701.
6. Ensure staffing of dietetic services in accordance with State regulatory requirements. Refer to A23.

The cumulative effect of these systemic problems resulted in the inability of the hospitals' food and nutrition services to direct and staff in such a manner to ensure that the nutritional needs of the patients' were met in accordance with practitioners' orders and acceptable standards of practice.

Based on dietary staff interview and dietary document review, the hospital failed to ensure that the organizational structure of dietetic services met State regulatory requirements as evidenced by the sharing of one Food Service Manager (FSM) for two separate hospitals.

Findings:

A review of the organizational structure of dietetic services beginning on 4/23/12 at 9:30 am, revealed that the department was not organized in a manner consistent with State regulatory requirements (Refer to A23).

During initial tour on 4/23/12 beginning at 9:30 am, the FSM was introduced as the person hired by the contracted food service as responsible for dietetic services at both the Fremont and Rideout campuses. Concurrent review of the hospitals organization chart, dated 3/19/12, noted that the FSM was not full time at either of the organizations' campuses, rather split his time between the two.

In an interview on 4/26/12 at 10:30 am, the FSM stated that he was the person responsible for the development of the organizational structure for food and nutrition services, and acknowledged that he split his time between the two hospital campuses.

Based on dietetic services observations, dietary staff interview, and departmental document review, the hospital failed to ensure development of the departmental structure to ensure comprehensive oversight as evidenced by: 1) food storage practices that promoted the retention of expired food items and storage of food items inconsistent with manufacturers' guidance; and 2) lack of development of a departmental wide quality appraisal and performance improvement program for the complexity and scope of the Food Service and Nutrition Department. 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. During initial tour on 4/23/12 beginning at 9:15 am, the following was noted:

a. In the walk in refrigerator, there were three boxes of nutritional supplements dated 4/12. The manufacturers' instructions printed on the outside of the boxes guided staff to "keep frozen." In a concurrent interview with the Food Service Manager (FSM), he stated that the date was reflective of when the item was delivered and placed in the freezer. The surveyor asked the FSM to describe the system for dating the items once they were placed in the refrigerator. He stated that each of the individual 4-ounce cartons should have been dated. Hospital policy titled, "Food Storage and Storage Times," dated 1/09, guided staff that the health shakes "will be given a 5-day expiration date."

b. In the walk-in refrigerator, there was an opened jar of coleslaw dressing with a ship date of 5/2/11 and an open date of 3/2/12. In a concurrent interview with the FSM, he was asked to describe how he ensured that food items were used in a timely manner. He stated he was unsure why the item was still in stock 11 months after delivery. He also stated that foods would be held according to the facility's storage policy. Hospital policy titled, "Food Storage and Storage Times," dated 1/09, revealed that while there were guidelines for unopened shelf staple items, such as soy sauces and salad dressings, it was noted that storage timeframes for these items ranged from 2 years to indefinitely. While the hospital developed the policy, there was no standard of practice reference for these lengthy timeframes.

c. In refrigerator #39, there were two cases of muffins with manufacturers' instructions to "keep frozen ...do not refrigerate." In a concurrent interview with the FSM, he was unable to explain why the items were not stored per the manufacturers' guidance and stated that they always stored the items in the refrigerator. Similarly in the walk-in refrigerator, there were three cases of polish sausage and hot dogs, both of which were thawed. The manufacturers' guidance printed on the outside of the boxes was to "keep frozen." It was noted that the hot dogs were pulled from the freezer on 4/18/12, 6 days prior.

d. In the area adjacent to the walk-in freezer there was a box of sweet potatoes, four of which were covered with a grey fuzzy material resembling mold. It was noted that the outside of the box had storage guidance to "store at 55-65°F." In a concurrent interview with the FSM, he acknowledged that the ambient temperature in the kitchen was likely greater than 65°F. It was also noted that there was a case of russet potatoes with manufacturers' guidance to store at 45-50°F.

2. On 4/26/12 at 10 am, the FSM was asked about the Department's quality appraisal and performance approval program. The FSM stated that his quality assurance consisted of monthly monitoring checks, of which the majority of the audits demonstrated substantial compliance with the hospital developed thresholds (Refer to A265).

Review of the Food Service Managers' job description showed no job duties that included developing or monitoring department quality performance programs. The Clinical Nutrition Mangers' position description did include a statement that this person was responsible for compliance with all federal, state and local regulations such as quality assurance, as well the implementation of quality improvements.

Based on staff interviews and review of dietary documents, the hospital failed to ensure the menus were analyzed for the nutritional components to meet the current national standards including the RDA (Recommended Dietary Allowances) and the DRI (Dietary Reference Intake) of the Food and Nutrition Board of the National Research Council. This has the potential for the patients in the hospital to receive inadequate nutrition.

Findings:

On 3/25/12 at 4:00 p.m., the hospital's nutrient analysis for the regular and therapeutic diet menus were reviewed. The analysis provided was limited to one day and showed no analysis for Vitamins D, E, pantothenic acid, biotin and choline or elements magnesium, selenium, molybdenum, manganese, fluoride, iron, copper, cobalt, and chromium, as are specified in the RDA or DRI.

Review of the Dietary Reference Intakes (DRIs): Recommended Dietary Allowances and Adequate Intakes for Elements indicated recommended daily intake ranges for Vitamin D as 10-20 micrograms; Vitamin E 6-19 mg; Vitamin K 30-120 micrograms; pantothenic acid-2-7 mg; biotin-8-35 micrograms; and choline 200-550 mg. Similarly, the recommended daily intake ranges for magnesium-80-420 mg; selenium-20-70 micrograms; molybdenum-17-50 micrograms; manganese 1.2-2.6 mg; fluoride-2-4 mg; iron 7-27 mg; copper-440-1300 mg and chromium 15-45 micrograms per day. All RDA's/DRI's are age and gender specific. Since the hospital menus were not evaluated for these vitamins/elements there was no way to ensure the menus served met the RDAs or RDIs. It was noted that the fiber content of the menus ranged from 6-13 grams of fiber.

Review of the DRI for Macronutrients, dated 2002/2005, indicated total fiber for males nine through 13 years of age is 31 g; 14 through 50 years of age is 38 g; and 50 years through greater than 70 years of age is 30 g; females nine through 18 years of age is 26 g; 19 through 50 years of age is 25 g; 50 through greater than 70 years of age is 21 g. The hospital menus were inadequate in Fiber depending on the age and gender.

In an interview on 4/25/12 beginning at 8:30 am with the Chief Nutritional Manager (CNM), she stated that the menus have been in place for greater than 10 years with little to no modifications. She also stated that she believed that previous CNM's reviewed the menus for nutritional adequacy. She also stated she had not reviewed and/or compared them to current RDA's/DRI's. In a follow up interview on 4/26/12 at 9:00 am, the CNM was interviewed regarding the nutrition analysis of the regular and therapeutic menus. The CNM stated that the analysis provided was all that was available and acknowledged that since the analysis was limited to 1 day, it would not be possible to accurately assess whether or not the menu met the RDA's/DRIs. It was noted that the hospital policy titled, "Menu Specifications," dated 3/08, listed the availability of an obstetrics as well as a pediatric menu. There was no nutritional analysis for either of these menus.

Review of hospital policy titled, "Nutritional Standards of Menus-FNS," dated 9/12/11,noted, "The Fremont Rideout Health Group Menu Program meets the Dietary Reference Intake (DRI) adopted by the Food and Nutrition Board, Institute of Medicine-National Academy of Sciences."

Review of the policy titled, "Nutritional considerations in menu planning revised 10/11, stated, "The provisions of the Dietary Reference Intakes, which include the Recommended Dietary Allowances (RDA ' s) Adequate intake, and Acceptable Macronutrient distribution Range, developed by the Food and Nutrition Board under the aegis of the Institute of Medicine are used to evaluate nutritional adequacy of patient/resident menus. The menus used were not evaluated for the complete array of macro and micro nutrients specified by the RDA. Review of undated hospital document titled, "Chef Select Gold Check # Sample Audit" failed to note that the hospital did not have a nutritional analysis, rather noted that a nutritional analysis for the current house diet was present.

Based on medical record review and nursing and clinical nutrition manager interview, the hospital failed to ensure diets were ordered by the physician as evidenced by: 1) interpretation of physician ordered diets by nursing and/or dietary staff; and 2) the use of diet as tolerated as a physician ordered diet for 2 of 6 patients reviewed for nutrition care (Patients 54 and 55). Failure to follow and/or clarify physician ordered diets may compromise the nutritional and medical status of patients.

Findings:

Fremont Campus

1. Patient 51 was admitted to the Fremont campus on 4/20/12 for labor and delivery, via cesarean delivery. Patient 51 had a diagnosis of gestational diabetes. Medical record review was conducted on 4/23/12 beginning at 3 pm. A hospital document titled, "Postpartum standing orders," dated 4/20/12, noted a physician's order for diet as tolerated. Review of the hospital requisition order #2124027, dated 4/21/12, noted an order for a general diabetic (Standard Consistent Carbohydrate) diet.

In an interview on 4/23/12 at 3:10 pm with Food Service Worker (FSW) 6 and a concurrent document review of Patient 51's dietary Cardex (an individual description of patients' diets) file, revealed that the kitchen noted the patient was to receive a 2000 calorie ADA diet. FSW 6 stated that when nursing staff input for an obstetrics patient into the electronic diet ordering system, the kitchen would translate it into a 2000 calorie diet. FSW 6 also demonstrated that she utilized a pre-defined meal pattern titled, "2000 calorie ADA: Gestational," that listed the number of servings at each meal and snack. In an interview on 4/23/12 at 4 pm, with Registered Nurse (RN) 21, she demonstrated the order entry system. She stated that since the physician ordered diet was listed as a diet as tolerated, nursing staff would choose the diet that they felt was most appropriate, in this case a diabetic diet as the patine was on insulin therapy.

Hospital policy titled, "Advancement of Diet as Tolerate-FNS." dated 8/30/11, guided staff that for a diet as tolerated for post-partum patients, the patient will receive either a regular diet or a clear liquid diet. If the patient received a clear liquid diet, the diet would be advanced to a regular diet based on the presence of positive bowel sounds and absence of nausea and vomiting, per nursing assessment.

Rideout Campus

2. Patient 54 was admitted with right foot cellulitis (an inflammation of tissue), sepsis (presence of bacteria in the blood) and diabetes. Medical record review was conducted on 4/25/12 beginning at 9:30 am. A physicians' admission order, dated 4/12/12, was for an 1800 calorie diet. A follow up order, dated 4/13/12, was for a 2000 calorie ADA (American Diabetes Association) diet. Review of the hospitals' diet list, dated 4/25/12, revealed that the dietary department was delivering a high consistent carbohydrate diet.

Calorie controlled diets, such as an 1800 calorie diet, limits the amount of calories consumed within a 24 hour period. In contrast, a consistent carbohydrate diet (CCHO), indicated as part of a treatment for diabetes diagnosis, generally would not limit the number of calories consumed rather limits the amount of carbohydrate per meal. The number of carbohydrates would be consistent between breakfast, lunch and dinner each day (American Diabetes Association). Review of the hospitals' document titled, "Crosswalk to Convert ADA Diets to Consistent Carbohydrate Diets," dated 4/18/12, noted that a standard CCHO would equal 1500-2000 calories and a high CCHO diet would be greater than 2000 calories. It would not be within the scope of professional practice for registered nursing staff to independently order patient diets (California Business and Professions Code, 2012). Review of undated hospital document titled, "Chef Select Gold Check # Sample Audit," failed to note that the hospital did not have "an effective and accurate communication system ...for diet orders..." rather indicated that an effective system was in place.

3. Patient 55 was admitted with diagnoses including right hip fracture and diabetes. Admission diet order, dated 4/14/12, was NPO (nothing by mouth) except medications. A follow up order, dated 4/15/12, noted a physicians' order for diet as tolerated. Review of the hospital diet list, dated 4/25/12, noted that nursing staff entered the order as a general diabetic consistent carbohydrate diet.

In a concurrent interview with the CNM she stated that on 4/18/11, the hospital changed the method of ordering diets for patients with a diagnosis of diabetes. She stated that if a physician ordered a specific calorie level that the dietary department would convert the order into a consistent carbohydrate diet based on the hospitals' crosswalk. She also stated that if the diet was entered into the electronic diet order system dietary staff would convert the diet into the CCHO diet based on the crosswalk and would not request clarification of the order by either nursing staff or the Registered Dietitian. The CNM acknowledged that the diet was not implemented, as ordered by the physician.

It would not be within the scope of professional practice for registered nursing staff to independently order patient diets (California Business and Professions Code, 2012). Diet as tolerated is not a recognized physician ordered diet. It would be the expectation that the physician determines the patients diet based on medical status. While it was noted that the hospital had a policy titled, "Advancement of Diet as Tolerated-FNS," dated 8/30/11, which noted that for patients other than obstetrics patients, physician ordered diet as tolerated would be translated into a regular diet. While the policy was developed the existence of this policy would not allow for individualization of diets based on medical need.

Based on clinical nutrition care review, clinical nutrition manager interview and dietary department document review, the hospital failed to ensure an effective system, based on standards of practice, for evaluation of medical nutrition therapy interventions for 1 of 6 patients reviewed for nutrition care (Patient 52). Failure to implement timely and effective systems for evaluation of medical nutrition therapy may result in further compromising nutritional and medical status for at risk patients.

Findings:

Rideout Campus

Patient 52 was admitted with a history of heart disease and anemia. Medical record review was conducted on 4/25/12 beginning at 10:15 am. Admission diet order was noted as a low sodium vegetarian diet. A nursing admission assessment, dated 4/19/12, noted that the patient had an unstagable pressure ulcer (localized area of tissue damage). The standard of practice for an unstagable pressure ulcer would be to classify it as a Stage 4. Hospital policy titled, "Adult Nutrition Risk Level Criteria," dated 4/20/12, noted that patients with Stage 3 and 4 pressure ulcers would be considered to be at high nutritional risk.

A comprehensive nutrition assessment, dated 4/20/12, noted that the patient was 5 feet 6 inches and weighed 106 pounds. The Registered Dietitian (RD) noted the patients' desirable body weight was 130 pounds. It was also noted that the patients' body mass index was 17. Patients whose body mass index is less than 18.5 are considered to be underweight (National Institutes of Health, 2012) and may be at greater nutritional risk. The RD estimated Patient 52's nutritional needs to be 1446-1687 calories and 48-58 grams of protein. The RD recommended the implementation of a health shake, three times/day with meals, as well as a magic cup supplement twice daily. The nutritional goal for Patient 52 was documented as a dietary intake of greater than 75% for wound healing and weight gain. It was also noted that the only recorded meal intake at the time of assessment was 25%. The RD classified the patient as being at moderate nutritional risk and would re-evaluated at 4-6 days. Review of documented dietary intake beginning on 4/19/12 revealed that of 16 meals nursing recorded the intake for 4 meals. It was also noted that the 2 most recent meals were an average intake of 40%.

In an interview on 4/25/12 beginning at 11 am with Patient 52, she acknowledged that she was receiving a vegetarian diet, as well as nutritional supplements. She also stated that she was not eating very much because she was receiving "Indian" foods that were too spicy for her. She also stated she did not like the health shakes and was not consuming them. She also stated she was scheduled to be returning home later in the day.

In an interview on 4/25/11 beginning at 11:15 am, with the Chief Nutrition Manager (CNM), she was asked to describe the reference and/or the standard of practice on how the hospital determined the amount of time between assessments by the RD. She stated that she was unsure if a standard of practice was used to develop the policy, but did recall that the previous CNM contacted other local hospitals and modeled their policy based on the responses. The CNM also stated that the RD would likely not be aware that the nutritional interventions that were recommended were ineffective for the patient until the ensuing visit, which in this case could be as late as 4/26/12, at which time the patient would have already been discharged. Review of hospital policy titled, "Adult Nutrition Risk Level Criteria," dated 4/20/12, noted that patients with Stage 3 and 4 pressure ulcers would be considered to be at high nutritional risk and would receive re-assessment every 1-4 days. Patient 52 was not classified at high nutritional risk nor was there a timely evaluation of the effectiveness of implemented medical nutritional therapy. It would be the standard of practice for nutrition practitioners to assess and evaluate the effectiveness of nutrition care according to each person's individual medical condition and needs (Academy of Nutrition and Dietetics, 2010).

Based on trayline observations, dietary staff interview, and dietary document review, the hospital failed to: 1) have a therapeutic diet manual that accurately reflected physician ordered diets and current standards of practice; and 2) ensure the diet manual was consistently utilized to develop the hospitals' diets. Lack of a current and comprehensive diet manual that reflected hospital developed diets may result in inaccurate guidance to dietary and hospital staff when following physician ordered diets and meeting the nutritional needs of patients, further compromising medical status.

Findings:

1. During trayline observation on 4/23/12 beginning at 11:15 am, it was noted that random patients (Patients 58, 59, 60) had tray tickets labeled as consistent carbohydrate diets. It was also noted that there were variations in the number of carbohydrates listed as either 3 or 4. A consistent carbohydrate diet (CCHO), indicated as part of the treatment for diabetes diagnosis, generally would not limit the number of calories consumed rather limits the amount of carbohydrate per meal. The number of carbohydrates would be consistent between breakfast, lunch and dinner each day (American Diabetes Association).

In an interview with Food Service Worker (FSW) 3 on 4/23/12 at 10:30 am, who was responsible for completing patient tray tickets, the surveyor asked her to describe the use of the CCHO diet. She stated that physicians would order either the CCHO diet or a specific calorie level. She also stated that if the physician ordered a calorie level she would use the hospitals' CCHO guideline and convert it to the specified number of carbohydrates per meal.

In an interview on 4/25/12 beginning at 8:30 am, with the Chief Nutrition Manager (CNM), she stated that several years ago the hospital replaced its diet manual with the American Dietetic Association Nutrition Care Manual, as well as the hospital developed document titled, "Consistent Carbohydrate Diets Replace ADA Diets" on Monday April 18, 2011. It was noted that the guide had 5 different levels of the CCHO diet ranging from very low carbohydrates to a level for pregnant women. It was also noted that each of these diets had an associated calorie range from less than 1500 calories to 2400 calories. The surveyor asked the CNM to describe the mechanism for combining diets with two distinct, unrelated parameters such as carbohydrates and calories. She stated that they grouped together several calorie levels of diets to form the carbohydrate consistent diet.

Comparison of the nutrition care manual on 4/27/12 at 9 am, with the hospitals' crosswalk for the CCHO, revealed that the Nutrition Care Manual was a conceptual description of diets rather than a diet manual. A diet manual would ensure that the diets offered met the current standards of practice, included a comprehensive description of the therapeutic diets offered by including the purpose of the diet, indications of the diet, nutritional adequacy, sample meal plans consistent with the hospitals' menu and standard of practice references for the diets. With the exception of the CCHO crosswalk, there was no other guidance specific to the hospitals' menus that provided guidance for physicians ordering the diets, nurses who facilitated implementation of the diets, and dietary staff who prepared the diets. Not all elements were present for each routinely ordered hospital diets that would allow for hospital and/or dietary staff to use the document as a comprehensive resource to order and/or prepare patient diets.

Hospital document titled, "Menu Specifications," dated 3/08, revealed that the hospital standard diets were listed as a regular/4 gram diet, soft/low-residue, 2 gram sodium, calculated, cardiac and renal diet. There was no listing for a CCHO diet.

2. During review of the hospitals' menu on 4/26/12 at 9 am with the CNM, it was noted that the therapeutic spreadsheet combined 2 distinctly different diets; a low residue-soft and a mechanical soft diet onto one column on the spreadsheet. In a concurrent interview, the CNM she stated that these diets were combined, however, when a low residue diet was ordered, dietary staff was guided to place the food with the lower fiber content on the meal tray.

The undated hospital document titled, "Low-Fiber Nutrition Therapy," guided staff that the purpose of the low fiber diet was to lessen gastrointestinal irritation, as well as reduce the frequency and volume of stools. Review of an undated hospital document titled, "Nutrition Therapy for Soft Foods" revealed that the purpose of the mechanical soft diet was to alter the texture of foods to ensure that they were easy to chew and swallow. The mechanical soft diet guided staff to ensure that foods were ½" or smaller. There was no indication that the intent of the mechanical soft diet was to alter the fiber content of the diet and there was no quantitative indication of amount of fiber that would be in the low residue diet.

Review of the hospitals' weekly menu cycle revealed that there was no guidance to staff to alter the size of foods on the mechanical soft diet. The vegetable for the evening meal on Mondays' was yellow squash. Review of the evening meal on Tuesday revealed inconsistencies as zucchini was noted for both the low residue and mechanical soft diet. Review of the guidance for vegetables revealed that the sample meal plan was to avoid those with skins or seeds. Similarly, the menu offered both puffed rice cereal and cream of wheat for breakfast. However, there was no indication which of these cereals would be appropriate for the low residue diet and there was no specific guidance for staff to alter the texture of items, such as meats. The menu was inconsistent with the hospitals' diet descriptions and did not provide adequate information to ensure that dietary staff followed the physicians' orders.

Based on dietetic services and physical plant observations, staff interviews, and document review, the hospital failed to ensure: 1) kitchen equipment was maintained in a safe manner, as evidenced by the buildup of ice in the walk in freezers; 2) ensure availability of disaster food supplies on the hospital site at the Rideout campus; and 3) patient showers were maintained in a sanitary manner to ensure the health and safety of patients. These failures had the potential to result in insufficient food supply and unmet patient nutritional needs during a disaster, spoiled foods, foodborne illness, and infection.

Findings:

1. During initial tour of the Rideout campus kitchen on 4/23/12 beginning at 9:15 am, it was noted there was a build-up of ice on the floor at the walk-in freezer door entrance measuring 24-36 inches in length, 4 inches wide and ½ inch deep. It was also noted that the air-curtain had missing and torn plastic panels. In a concurrent interview with the Food Service Manager (FSM), he acknowledged he had not identified that these items were in disrepair. Ice build-up on walk-in freezers may be indicative of uncontrolled temperature changes within the unit, resulting in condensation and freezing of the condensate (UScooler, 2012). Review of dietary department maintenance logs beginning 3/28/12 revealed there was no work order submitted for the freezer.

During initial tour of the Fremont campus kitchen on 4/23/12 beginning at 2:40 pm, it was noted that there was a build-up of ice on the blower and shelf below the blower. The ice deposited in 2 separate mounds, hanging from the bottom of the blower, measuring approximately 4 inches deep, a total of 10-12 inches in length and 4 inches wide. In a concurrent interview with the FSM, there was no indication that he identified that the unit was not functioning properly. Ice build-up on walk-in freezers may be indicative of uncontrolled temperature changes within the unit, resulting in condensation and freezing of the condensate (UScooler, 2012). Review of dietary department maintenance logs beginning 3/28/12 revealed there were no work orders submitted for either of the freezers.

Review on 4/26/12 of contracted vendor documents titled, "Chef Select Gold Check # Sample Audit" one, dated 1/11/12, and a second one that was undated, revealed that while the contractor had implemented an audit tool, the tool did not evaluate the functionality of the equipment. Hospital policy titled, "Maintenance Repair Requests," dated 1/09, guided staff that in order to receive maintenance on an item an "individual must submit an on-line maintenance repair request ..."

2. On 4/23/12 beginning at 1:50 pm, document review revealed that while the hospital developed a disaster feeding plan, the supplies were not stored within the hospital, rather were stored in a building several blocks away. In a concurrent interview with the FSM, he stated that storage space within the hospital was problematic which resulted in the food supplies stored away from the general acute care hospital.



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3. During the initial tour on 4/23/12 at 10:35 am, in the 1 West unit, two patient shower rooms were observed to have black mold-like substance with pink-orange substance along the grout on the floor and sides of the showers and a wet washcloth was lying on the shelf of one of the bathrooms. These findings were confirmed during a concurrent interview with the Director of Risk Management.

During a repeat observation of the 1 West shower rooms on 4/25/12 at 2:20 pm, the stains in both showers remained as described above during the 4/23/12 observation. During a concurrent interview, Environmental Service Staff (EVS) 4, stated that the shower stains have been there since she started working at the facility four years ago. EVS 4 took a Clorox wipe and wiped the grout along the floor of one of the showers, and although the stain remained, the wipe had a dark brown substance on it.

Based on observation, interview, and record review, the facility failed to ensure that equipment and supplies were maintained in manner to assure an acceptable level of safety when:

Expired patient care supplies and broken equipment were available for use;

A sequential compression device (SCD - a device used to prevent blood clots to the legs following surgery) had not had timely preventative maintenance;

Rental infusion pumps had not had preventative maintenance;

An electrical cord was a safety hazard.

A faucet in a dirty utility room at the Fremont campus was leaking.

These failures had the potential for patient, staff and visitors to experience accidents, and other unintended consequences of malfunctioning equipment and expired supplies.

Findings:

1. On 4/23/12 at 9:45 am, during the initial tour, the CVICU unit the following was observed:

a. Tracheostomy tubes that had expiration dates of 3/10 and 4/11 and were available for use;
b. Two Doppler machines (used to measure blood flow) and a peripheral nerve stimulator that had cracked housings and no preventative maintenance tags were available for use;
c. A SCD that had an expired preventive maintenance sticker, dated 3/12; and
d. An infusion pump with a sticker that did not clearly indicate when preventative maintenance was due.

In concurrent interviews, Nurse Managers (NM) 7 and 8 acknowledged that expired supplies and broken equipment should not be available on the unit for use with patients.

On 4/23/12 at 10:29 am, Biomedical Technician 1 reviewed the SCD and acknowledged that it was past it's due date for preventative maintenance. He reviewed the sticker for the infusion pump and stated that his department did not provide preventative maintenance for the infusion pumps, as they were rentals. He further acknowledged that he could not tell from the sticker when preventative maintenance was due.

On 4/30/12 at 10 am, the Director of Risk Management stated that the clinical equipment preventative maintenance was routinely monitored in the Safety Committee, but that the rental infusion pump preventative maintenance had not been reported to Safety Committee.

2. The facility's policy titled, "Blood Glucose Monitoring, Meter Maintenance and Quality Control with Nova StatStrip Glucose Meter - Hospitalwide," last approved on 8/10, was reviewed and read, "StatStrip Glucose Control Solutions and Test Strips will be labeled when opened with discard date (28 days from date opened)."

During the initial tour of the Emergency Department on 4/23/12 at 8:30 am, an opened bottle of Glucose Test Strips was observed to be undated in the medication room. During a concurrent interview, the Director of Risk Management confirmed that the bottle was opened but undated. Because the bottle was undated, there was no way to determine if it had been opened longer than 28 days.

3. On 4/23/12 at 9:10 am, during initial tour on the 3 West unit, an electrical cord was observed looped out of Room 306 entry into the hallway, presenting a tripping hazard. In a concurrent interview, the Director of Quality Management acknowledged that the above findings was a safety hazard.

4. On 4/23/12 at 10:29 am, during the initial tour on the 3 West unit, glucometer control solutions with an expiration of 2/1/12 were observed to be available for use. During concurrent interviews, the Director of Pharmacy and the Vice President of Nursing Services confirmed the glucometer control solutions were expired.



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5. On 4/24/12, during inspection of the CVICU, it was observed that there were opened bottles of blood glucose strips with an expiration date on them of 7/22/12. The expiration date was 3 months from the date that the bottles were opened.

On 4/24/12, during inspection of the medical ICU, it was observed that the blood glucose strips had an expiration date on them of 5/27/12, which was three months from the date they were opened.

On 4/23/12 at 2:30 p.m., during inspection of 2 Central, the glucose control solutions were given 3 month expiration dates.

According to the policy "Blood Glucose Monitoring, Meter Maintenance and Quality Control ..." approved 8/10, "StatStrip Glucose Control Solutions and Test Strips will be discarded after 28 days."

6. On 4/23/12 at 10:35 am, the faucet attached to the hopper, a large open toilet for disposing wastes, in the dirty utility near the ultrasound department in the Fremont building was observed to be leaking water. In a concurrent interview, the Quality Manager stated that the faucet was leaking and needed to be repaired.

Based on interview and document review, the hospital failed to monitor air exchanges, ventilation, humidity, and temperature for the Post Anesthesia Care Unit (PACU, recovery room), operating rooms for obstetrics, compressed-gas storage areas, and sterile storage areas, and document corrective action when ventilation, humidity, and temperatures were out of range in operating/procedure rooms. These failures increased the risk to patients and personnel for hospital-acquired infections.

Findings:

1. On 4/26/12 at 8:40 am, Nursing Manager (NM) 11 stated that monitoring the temperature and humidity was not done for the PACU.

According to AORN (Association for periOperative Nurses) Perioperative Standards and Recommended Practices, 2012 Edition, under Recommended Practices for a Safe Environment of Care, reads, "Recommendation V Potential hazards associated with HVAC (Heating, Ventilation, and Air Conditioning) systems in the practice setting should be identified, and safe practices should be established...V.b. Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas. Low humidity increases the risk of electrostatic charges, which pose a fire hazard in an oxygen-enriched environment or when flammable agents are in use and increases the potential for dust. High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed... V.b.2. Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC system. V.c. Temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC system. V.c.1. Temperature should be maintained between 68 degree Farenheit (F) to 73 degree F within the operating room suite and general work areas in sterile processing... V.c.3. A temperature of 70 degree F to 75 degree F should be maintained in recovery areas and cardiac catheterization rooms. V.d. The air-exchange rate in the perioperative area should be carefully controlled...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 air exchanges per hour with a recommended range of 20 to 25 air exchanges. Cardiac catheterization rooms: 15 air exchanges per hour. Postanesthesia care unit: six air exchanges per hour. Compressed-gas storage area: eight air exchanges per hour. Sterile storage area: four air exchanges per hour.

2. On 4/25/12, a request for evidence of air exchanges monitored within the hospital was made to the Engineering department. Air exchange monitoring documentation revealed that for operating rooms (ORs) 1 through 6, which included endoscopy procedures and cardiac cath lab, the bronchoscopy room, and the operating rooms at an ambulatory surgery center (ASC), there was no documentation of air exchanges for the ORs for obstetrics, postanesthesia care unit, compressed-gas storage areas, and sterile storage areas.

3. On 4/26/12, temperature and humidity logs were reviewed. The logs for OR 5 and 6, Radiology, and the ASC did not have the normal temperatures and humidity ranges posted for when to notify the Engineering department.

For the Labor and Delivery ORs, Room 1, documentation revealed that three times (one each in the months of 2/12, 3/12, and 4/12) humidity levels were above 60%. Engineering had not been notified of two of the three occurrences. OR Room 2 had documentation that seven times during 3/12, temperatures were below 68 degrees F. There was no documentation that Engineering had been notified, or action taken.

The log for OR Room 1 for the months of 1/12, 2/12, and 3/12, revealed that for 20 of 84 days, humidity was less than 30% humidity. The log for OR Room 3 for the months of 1/12, 2/12, and 3/12, revealed that for 13 of 82 days humidity was less than 30% . There was a period of 6 of 8 days in 1/12 that documented less than 30% humidity. There was no documentation that Engineering had been notified, or that action was taken.

On 4/26/12 at 10:35 am, the temperature and humidity logs were reviewed with the Infection Control Coordinator (ICC). The logs for Radiology beginning 2/22/12 showed that for 6 of 7 days, temperature was less than 68 degree F.

The logs for the ASC did not include the month of 4/12. The logs provided were for 10/11 through 3/12. More than half of the documented temperatures were below 68 degrees F in OR 1:

3/12: 9 of 12 documented temperatures were below 68 degrees F;
2/12: 10 of 10 documented temperatures were below 68 degrees F;
1/12: 8 of 8 documented temperatures were below 68 degrees F:
12/11: 7 of 11 documented temperatures were below 68 degrees F;
11/11: 8 out of 8 documented temperatures were below 68 degrees F; and
10/11: 8 out of 10 documented temperatures were below 68 degrees F.

There was no documentation that Engineering was contacted or that any action was taken. In a concurrent interview, the ICC confirmed the above findings.

Based on observation, interview, and document review, the hospital failed to ensure an infection control system that conformed effectively with nationally recognized infection control standards and facility policy to provide a sanitary environment and minimize sources and transmission of infections evidenced by:

Failure to document evidence that the hospital's infection control committee chair was qualified, in accordance with state standards. Failure to ensure a competent Infection Control Coordinator provided oversight to the infection control program. Failure to ensure an ongoing, effective infection control program was developed to identify noncompliance of infection control practices. Refer to A748.

Failure of staff handling biohazardous materials that potentially contained leaking body fluids without wearing and changing appropriate protective equipment and without implementing measures to minimize exposure and cross contamination in public and patient care areas of the hospital. Refer to A749.

Failure to ensure health care workers were consistently screened for infectious diseases, in accordance with acceptable standards of practice, for 342 of 342 medical staff members. Health screening of medical staff members was not integrated into the hospital-wide infection control program. Refer to A749.

Failure to document Infection control training and competency for health care workers (for five of 27 environmental services workers blood borne pathogen training and for 342 of 342 medical staff members for any training). Refer to A23.

Failure to have Safety information related to chemical hazards and precautions readily available to staff in all unit locations. Refer to A749.

Failure to ensure surgical supply storage and other surgical work areas were maintained (temperature, humidity, air exchanges), in accordance with nationally recognized standards and to clean and disinfect storage areas of nursing supplies and medications to minimize cross-contamination. Refer to A726, A749.

Failure to scrub hands, prior to a surgical procedure, ensure a sanitary surgical site prep, and ensure hand hygiene and glove use was in accordance with facility policy and nationally accepted standards of practice. Refer to A749.

Failure to process sterile scissors and clamps to ensure that they remained in the open position to be effectively sterilized. Refer to A749.

Failure to handle patient care equipment and supplies properly and ensure outdated supplies were not available for use. Refer to A749.

Failure to ensure that fentanyl (narcotic for severe pain) and albuterol (bronchodilator) medications were not used for multiple patients. Refer to A749.

Failure to ensure safe food handling practices by holding potentially hazardous foods at temperatures capable of supporting bacterial growth associated with foodborne illness. Failure to ensure safe food handling practices by cross contamination of patient meal trays and the retention of expired food items. Failure to ensure safe food handling practices by lack of an air gap in food production and 3-compartment sinks. Refer to A749.

Failure to assess and determine whether the continued use of a Central Venous Catheter was medically necessary for one of 83 sampled patients (Patient 9). Refer to A749.

Failure to provide MRSA (methicillin resistant staphylococcus aureus - a bacteria that is resistant to most antibiotics and can result in life threatening infections) screening for two patients (Patients 2 and 7), as required by policy. Refer to A749.

These failures put patients at risk for substandard care, adverse events, infections, poor patient safety, compromised nutritional status, and foodborne illness. The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Infection Control.

Based on observation, interview, and document review, the hospital failed to have an infection control officer who effectively, competently monitored hospitalwide infection prevention practices. These failures increased the risk to patients and personnel for hospital-acquired infections.

Findings:

In an interview on 4/24/12 at 7:35 am, the Infection Control Coordinator (ICC) stated that he makes rounds to each of the departments daily, checked areas for general cleanliness, confirm necessary supplies available to implement recognized infection control practices, checked the sharps container so that it is not full, and checked for outdates on supplies. The ICC stated that he would go into the Cardiac Cath Lab (invasive heart procedures) approximately twice a month and observe staff practices in the procedure rooms from the control room (room in between the two Cardiac Cath Lab rooms).

The job description for "Infection Prevention/Control Assistant," dated 8/07, signed 11/21/11 by ICC, A. Infection Prevention/Surveillance...2. Supports the Infection Control Coordinator to implement surveillance throughout the facilities to identify outbreaks, potential infection hazards, track hospital-acquired infections, and communicable disease exposures. Completes regular rounds to assigned units for the purposes of staff observation and data collection."

On 4/24/12, beginning at 7:45 am, several breaks in infection control practices were identified while observing a pacemaker (controls the heart rhythm of contraction and relaxation) insertion in the Cardiac Cath Lab. The blinds were closed so that the room could not be viewed from the control room. The area for placement of the pacemaker (left upper chest area) was prepped using an applicator stick with chlorhexide gluconate (preoperative skin preparation for reducing risk of postoperative wound infections). Nurse Manager 13 was observed using the chlorhexide gluconate to the surgical site without gloves, bare handed. Physician (MD) 12 entered the Cardiac Cath Procedure Room was observed to use 3M Avagard Foam (antiseptic) to wash his hands and then dried his hands with a towel. RN 63 was observed removing medication from a carpujet (medication container that can be used directly with a tubex to administer medication), placing the medication into another syringe and which was then administered to the patient.

In an interview on 4/24/12 at 10:49 am, the Vice President Quality Management stated the ICC did not have a comprehensive program to address the full scope of the facilities services.

On 4/26/12, a review of the ICCs personnel record was conducted. The last documented evaluation was signed by Director of Quality Management (DQM) on 8/26/10. The evaluation documented "below standard" for general job performances and did not include specific job responsibilities. A letter, dated 10/18/11, identified concerns in the Infection Control Program and detailed corrective action to be implemented.

Based on observation, staff interview, and document review, the hospital failed to maintain a sanitary environment, and ensure an infection control system that effectively conformed with nationally recognized infection control standards to identify, report, investigate and control infections and communicable diseases of patients and personnel when:

1. Staff handled biohazardous materials that potentially contained leaking body fluids without wearing and changing appropriate protective equipment and without implementing measures to minimize exposure and cross contamination in public and patient care areas of the hospital;

2. Facility healthcare staff were not consistently screened for infectious diseases, in accordance with acceptable standards of practice for 342 of 342 medical staff members. Health screening of medical staff members was not integrated into the hospital-wide infection control program;

3. Safety information related to chemical hazards and precautions was not readily available to staff in all unit locations;

4. Surgical supply storage and other surgical work areas were not maintained (temperature and humidity) in accordance with nationally recognized standards;

5. Surgical hand scrub procedures were not performed, prior to a surgical procedure, in accordance with manufacturer recommendations;

6. Hand hygiene and glove use was not performed in accordance with hospital policy and nationally recognized standards;

7. Surgical site preparation was not performed in accordance with hospital policy and nationally recognized standards;

8. Cleaning the surface of equipment was not done in accordance with manufacturer recommendations;

9. Sterilization procedures for surgical equipment, scissors, clamps, and hemostats were not conducted in accordance with nationally recognized standards;

10. Intravenous solutions were not handled or stored in a manner to prevent contamination, in accordance with nationally recognized infection control practices;

11. Outdated/expired patient care supplies were available for patient use;

12. Patient care items were contaminated when allowed to fall onto the floor between patient uses;

13. Single use Betadine (antiseptic) was available for use on multiple patients;

14. Single dose ampules of fentanyl (a potent narcotic used to relieve severe pain) were used for multiple patients;

15. An unsealed Metered Dose Inhaler (MDI) of albuterol (medication used to dilate the airways) was available for other patients use in the operating room;

16. Potentially hazardous foods were held at temperatures capable of supporting bacterial growth associated with foodborne illness;

17. Patient meal trays were handled in a manner that failed to prevent cross contamination;

18. Expired food items were available for use which could be served to patients;

19. There was no air gap in the food production and 3-compartment sinks in the kitchen;

20. Daily assessments to evaluate the continued need for use of a central venous catheter (CVC) were not performed;

21. Expired Vacutainers (holds blood for lab tests), sterile gloves, and guaze were available for patient use;

22. Intravenous line tubing was opened and and not labeled or dated; and

23. The 1W, 2W, 3W, 4M, and the CVICU nursing unit environments were not maintained under sanitary conditions.

24. Hand hygiene was not performed during a medication pass;

25. MRSA screening was not performed for 2 of 83 sampled patients (Patients 2 and 7);

These failures may result in patients, staff, and visitors acquiring infections, communicable diseases, and foodborne illnesses.

Findings:

1. During observations on 4/24/12 beginning at 9:45 am in the hospital laboratory, housekeeping staff (EVS 1) entered the unit dressed in street clothes with a thin plastic apron covering his front from mid-chest to knees and leaving his head, arms, lower legs, and feet exposed, and wearing blue gloves on his hands. EVS 1 proceeded to replace, from large receptacles, partly filled red plastic bags with empty clean bags. The partly filled bags contained biohazardous waste materials that posed a risk to spread disease if not handled properly. As EVS 1 removed each filled bag, he tied the top and carried it out of the unit. EVS 1 placed each filled bag into a large, gray, dinged and scratched, metal cart with drop down doors that was parked in the hall outside the laboratory. As the upper door dropped down, the cart contents were stacked to about five feet in height. A white towel was set on the floor below the center of the cart, where dark yellow-green fluid was dripping slowly through cracks in the bottom of the cart onto the towel. The cart remained parked in the hall, a public space, for approximately five minutes while EVS 1 retrieved several red bags to load onto the cart. When finished, EVS 1 closed the drop-down door, picked up the soiled towel and placed it on top of the cart. He then pushed the cart through public hallways leading to the emergency room. Along the way, he pressed metal automated door openers and door handles with the same gloves used to handle the soiled towel (did not change gloves).

EVS 1 pushed the gray cart through halls of the emergency room along which patients were stationed in beds, until arriving near the ambulance entrance to the emergency room. The cart was then parked in the middle of that entry while EVS 1 similarly changed out red biohazardous bags from a soiled utility closet nearby. At this time, the dark yellow-green fluid continued to drip from the bottom of the cart directly onto the floor to form a small puddle. When EVS 1 finished changing out the red bags, EVS 1 took the same soiled towel from the top of the cart and mopped up the fluid on the floor, put the towel back on the top of the cart, and pushed the cart outside through the ambulance doors. From there, he pushed the cart down the sidewalk for 2-3 blocks, crossed the street, continued into a driveway that eventually led to an outdoor waste collection site. Along the route, he passed by an area behind a trash dumpster where five metal gurneys with mattresses and sheets were set, and other discarded equipment. EVS 1 then unloaded the contents of the cart into rubber bins stored in the out-building. When he lifted a bag near the bottom of the cart, matted dark yellow-green material could be seen smeared inside the bag, with fluid leaking out the bottom. EVS 1 swung the bag out from the cart and into a rubber bin. The bag beneath the dripping one was also wet and similarly transferred into a bin. Then EVS 1 placed the soiled towel onto a large pool of fluid on the bottom of the cart, closed the drop-down doors, and pushed the cart back into the hospital.

In a concurrent interview, EVS 1 stated that the red hazardous waste bags were picked up twice daily from throughout the hospital. He recognized that a bag was leaking this day, but did not know which bag from the pile inside the cart was the one leaking. He stated that he considered the collection of red bags to be one task not to be interrupted until completed, after which he would bring the cart to be cleaned on the second floor of the hospital, because the outdoor area where he wanted to hose it out was now filled with the discarded equipment described above.

Review of the facility policy, titled, "Infections Waste Policy," reviewed 10/2011, documented that all infectious materials and waste must be handled to ensure the safety of patients, employees, visitors and the community environment. The policy required employees to receive training on the procedures. Body fluids in liquid and semiliquid form sufficient to be flowing were subject to the procedures. Infectious waste spills were to be cleaned up immediately using paper towels initially, followed by a cleansing agent. Protective gloves were required to handle infectious waste. Additional gowns, masks, goggles may be necessary as determined by each department ' s policies and procedures (no approved policies were presented for the circumstances experienced by EVS 1). Collection of infectious waste was to occur at a time and location that will minimize the exposure of others to the waste. Each cart shall be washed in the Sani-Wash washing unit, rinsed, and dried after the contents in the cart are emptied.

In a review of proposed environmental policies (not yet approved but no other Environmental Services (EVS) policies were currently in place) with the EVS Manager on 4/25/12 at 1:50 pm, the policy, titled, "Infectious Waste Handling," directed that hazardous waste was stored in a leak-proof container. Personal protective equipment when handling the waste containers was required and may include protective gowns, goggles, and gloves (did not specify how much of the body to cover). Hand Washing procedures directed staff to apply protective gloves after washing hands for the duration of "each different phase of your work assignment." The policies did not address how to contain the leakage experienced by EVS 1, to wash hands and change gloves after handling soiled materials before touching additional surfaces, and to interrupt a work assignment when such instances occurred, rather than continuing with the one phase until completed.

In an interview on 4/25/12 at 10:30 am, the EVS Manager indicated that EVS 1 should have cleaned up the spill promptly to prevent further contamination of other hospital locations before completing his task. The EVS Manager also indicated that the gray cart was not adequately designed and maintained to contain leakage of waste material.

2. In a review of medical staff files on 4/30/12 at 1:20 pm with the Medical Staff Coordinator (MSC) indicated that documentation of health screening for communicable diseases (e.g. annual tuberculosis, measles, mumps, rubella, varicella, hepatitis B, influenza) that can be unknowingly transmitted in a health care setting to produce harm to patients or health care workers was lacking for 342 of 342 medical staff members reviewed. MSC indicated there was no policy to require screening or tracking of medical staff members, despite their routine exposure to potentially contaminated blood and sick patients.

In an interview on 4/26/12 at 10 am with the Infection Control Coordinator (ICC), the ICC stated that he knew of no policy that addressed health screening requirements for medical staff. However, employee health policies did include screening for communicable diseases upon hire and tracking of annual influenza vaccination offerings; but those policies applied only to hospital employees and not to medical staff.

According to the Centers for Communicable Diseases (CDC) Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in a 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, included physicians) 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 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.

Review 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 of the CDC MMWR Early Release Volume 55, dated February 9, 2006, recommended annual vaccination for influenza for all health care workers.

3. In an interview on 4/25/12 at 10:15 am, the EVS Manager stated that EVS staff were taught and directed to use the computer to look up information about chemical hazards and toxicities, known as the materials safety data sheets (MSDSs). However, some staff members were not proficient at using a computer and had not acquired such skills. The EVS Manager stated that printed MSDS literature was not available to each unit where staff worked.

In an interview on 4/25/12 at 10:30 am with EVS 2, who routinely cleaned the patient unit known as 2-West, EVS 2 indicated that if a cleaning chemical spilled onto her body, she would remove her clothing and wash her skin with water. If she experienced pain, burning or other health symptoms, she would seek help in the emergency room. EVS 2 was not familiar with accessing information about the chemical toxicities on the computer. EVS 2 showed this surveyor a binder stored near the EVS staff break room where she thought printed information about chemical hazards was located. The binder contained hospital policies dated 1999, but no hazardous literature.

Review of materials published by MCN Healthcare, a national repository of accreditation standards, retrieved from , addressed the federal standards for the Occupational Safety and Health Administration Hazard Communication Standard that required MSDSs to be "readily accessible during each work shift to employees when they are in their work area(s)." If safety information was stored in a computer database, the employee would need to have access to a computer in his work area and know how to search for the MSDSs needed. If the MSDSs were accessible only out of the employee's work area, the employer would be out of compliance with the standard.

4. During tour of the clean utility storage room in the emergency department on 4/23/12 at 9:30 am, the room was noticeably warm and contained a blanket warmer, ice machine, and several automated storage units containing sterile supplies that generated heat. A covered cart containing clean linen was also stationed in the middle of the room. Two oxygen canisters in cradles were parked near the blanket warmer. No temperature or humidity gauges were identified in the space. The findings were confirmed by administrative staff who had joined the tour.

Review of the 2012 AORN Perioperative Standards and Recommended Practices, under Recommended Practices for a Safe Environment of Care, Recommendation V documented the guidelines for maintaining heating and air ventilation systems to avoid potential infection and safety hazards. "V.b.2. Humidity should be monitored and recorded daily...V.c. Temperature should be monitored and recorded daily...V.d.2. Air exchanges per hour should be monitored per the organization's policy." Daily monitoring of temperature and humidity in specific surgical care areas was recommended to ensure the levels were maintained in a safe range.

The AORN recommended temperature within the operating room suite and work areas in sterile processing "should be maintained between 68 to 73 degrees Fahrenheit (F)." In the July 2011 issue of AORN Journal, Volume 94, No. 1, page 104, reads, "The Facility Guidelines Institute and the Association for the Advancement of Medical Instrumentation recommend storing sterile packages under environmentally controlled conditions that include a temperature of approximately 75 degrees F, a maximum relative humidity of 70%, a positive air flow pressure in relation to adjacent areas, and a minimum of four air exchanges per hour."

AORN also recommended, "V.b. Relative humidity should be maintained between 30% and 60 % within the perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas. Low humidity increases the risk of electrostatic charges, which pose a fire hazard in an oxygen-enriched environment or when flammable agents are in use and increases the potential for dust. High humidity increases the risk for microbial growth in areas where sterile supplies are stored or procedures are performed."



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5. On 4/24/12 at 8:15 am, Physician (MD) 12 was observed to enter the Cardiac (Heart) Cath Lab procedure room, dispense one time 3M Avagard Foam Instant Hand Antiseptic into his hand, rub thoroughly onto both hands, and while wet, grab a blue sterile towel that was handed to him by Registered Nurse (RN) 61, and wipe his hands dry before putting on a sterile gown for the surgical procedure.

The manufacturer's directions for 3M Avagard Foam Instant Hand Antiseptic were to "allow the hands to dry," prior to touching any sterile item, such as a blue sterile towel.

On 4/26/12 at 8:25 am, RN 61 stated that MD 12 insisted that the blue sterile towel was available for him to dry his hands, prior to all surgical procedures.

The policy, "Surgical - Surgical Hand Scrub," dated 8/10, under procedure read, "b. Alcohol-Based Hand Rubs...After an initial hand wash of the subungual, fingers, hands, and arms at a minimum of 30 seconds then dried completely: Dispense half a palm full of FDA (approved antibacterial Hand Rub and submerge the opposite hand's fingertips in the product. Work the product into the cuticle and nails. Repeat on the opposite side. Dispense additional Hand Rub and work the product over the fingers, hand, 2/3 of the arms. Dispense additional Hand Rub paying particular attention to fingers, cuticles, and interdigital spaces. Following application, rub hands until dry.

6. On 4/24/12 at 11:45 am, MD 2 was observed to enter the Endoscopy Suite procedure room, shuffle paperwork at the desk, cough into his right hand, continue to review Patient 25's record, scratch his neck and then scratch his face with his right hand, then typed on the computer, wiped his glasses with his scrub top, stood up and walked toward Patient 25 and yawned with his right hand covering his mouth. MD 2 then put on gloves and a gown for Patient 25's procedure.

In an interview on 4/24/12 at 2:35 pm, MD 2 stated that he recalled washing his hands in the dressing room, prior to entering the Endoscopy Suite procedure room. MD 2 stated he should have coughed into his elbow.

The facility policy, "Hand Hygiene - Infection Control," dated 7/11, Policy, "The recommended times for hand hygiene are: A. With alcohol based hand rub or soap and water...2. Before and after direct patient contact...4. Before putting on gloves and after removing gloves...7. Before and after invasive procedures...9. After contact with your face or mouth, i.e., blowing or wiping nose, coughing or sneezing."

In an interview on 4/30/12 at 10:35 am, the Infection Control Coordinator (ICC) stated that there had been no monitoring of washing hands and surgical scrub for staff in the Surgery Department, Endoscopy Procedures, and Cardiac Cath Lab.

7. On 4/24/12 at 7:55 am, Nursing Manager (NM) 13 was observed prepping a surgical site for a pacemaker insertion on the left upper chest area. NM 13 was using an applicator stick with chlorhexide gluconate (preoperative skin preparation for reducing risk of postoperative wound infections) bare handed, without gloves. NM 13's bare hand was observed over the surgical site during the prep.

In an interview on 4/26/12 at 8:55 am, NM 13 stated that on 4/24/12, during the surgical site prep, he was not wearing gloves.

According to AORN (Association of periOperative Registered Nurses) Perioperative Standards and Recommended Practices, 2012 Edition, the Recommended Practices for Preoperative Patient Skin Antisepsis, reads, "Recommendation VII: The antiseptic agent should be applied to the skin over the surgical site and surrounding area in a manner to minimize contamination, preserve skin integrity, and prevent tissue damage...VII.c.1. Sterile gloves should be worn unless the antiseptic prep applicator is of sufficient length to prevent the antiseptic and patient's skin from contact with the unsterile glove."

8. On 4/24/12 at 10:50 am, NM 1 and Endo Tech (ET) were observed wiping down endoscopy equipment in Patient 23's room after a procedure. The surface of the equipment was observed to remain wet for one minute. ET was observed wiping down the surface of equipment and used the same cloth on a second surface of equipment, without wearing gloves.

In an interview on 4/24/12 at 10:55 am, the ICC stated that he observed the cleaning of the equipment and that the equipment was not wiped down on the side of the equipment, surfaces remained wet for only 45 seconds, the same cloth was used on two pieces of equipment, and ET did not wear gloves.

According to the manufacturer's recommendation, cleansed surfaces were to remain wet for 2 minutes for effective disinfecting of surfaces.

9a. During a tour on 4/23/12 at 9:30 am of the clean utility storage room in the emergency department, on the wall adjacent to the entrance were multiple pegs jutting out. On each peg were hung various types of sterile surgical instruments in sealed peel-pouches and available for use. Inspection of peel-pouches containing scissors and clamps showed that the tips of three instruments were in the closed position.

In an interview on 4/23/12 at 9:30 am with a sterile processing technician supervisor (STPS 1), STPS 1 stated that from the appearance of the closed tipped instruments one could not determine if the instruments were open when they were sterilized. STPS 1 acknowledged that sterilization may be inadequate if the tips were closed and touching while processed. STPS 1 stated that the hospital did not routinely utilize any method to prevent the tips from touching or closing during sterilization (such as tip protectors).

In a review of the 2012 AORN Perioperative Standards and Recommended Practices, Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, Recommendation XII, 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..." Recommendation XII-c-1 further directed that, "Instruments should be kept in the open and unlocked position using instrument stringers, racks, or instrument pegs designed to contain instruments."

9b. On 4/23/12 at 11:35 am, several packages of scissors and hemostats were observed in sterile packages with closed hinges in the cabinet of the nursery area.

In a concurrent interview, the Quality Manager (QM) confirmed the sterile instruments in the nursery area were packaged with closed hinges and should have been in the open position for sterilization.

Centers for Disease Control and Prevention Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, under packaging, "hinged instruments should be opened; items with removable parts should be disassembled unless the device manufacturer or researchers provide specific instructions or test data to the contrary...The packaging material must allow penetration of the sterilant, provide protection against contact contamination during handling, provide an effective barrier to microbial penetration, and maintain the sterility of the processed item after sterilization."

10. On 4/23/12 at 11 am, Pharmacy Tech (PT) was observed sitting on the floor going through supplies and had four bags of intravenous (IV) fluids on the floor next to her. PT then placed the bags inside the cabinet to be used by staff. In a concurrent interview, the QM stated that the IV bags should not be on the floor.

11. On 4/23/12 at 10:40 am, 18 Starswab II culture tubes with a experiation date of 3/30/12 and two Povidone Iodine scrub large winged sponges, with an expiration date of 3/12, were observed in a cabinet in the Obstetrics Department. In a concurrent interview, NM 14 stated that these items should be removed from the patient care area ad not used.

12. On 4/24/12 at 2:25 pm, electrocardiogram leads (long thin wires used in recording electrical activity of the heart) were observed on the floor in the area of Bed 3, in the Post Anesthesia Care Unit.

In an interview on 4/24/12 at 2:40 pm, the ICC stated that the leads were left on the floor which was not a good infection control practice.

13. On 4/24/12 at 2:55 am, an opened and used bottle of "single use" Betadine solution was observed in a cabinet in the x-ray procedure room. In a concurrent interview, the QM stated that the Betadine solution should not be available for use on another patient.


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14. On 4/26/11 at 3 pm, inspection of controlled substances distributed to practitioners in the operation room was evaluated. Reconciliation of the medications in box 13, revealed that two patients were administered fentanyl, but no fentanyl was signed out to them. Pharmacy Tech 2, responsible for reconciling the controlled substance in the anesthesia boxes, explained the discrepancy as follows: Fentanyl 5 milliliters (ml) ampule was removed for Patient 83, who was given 1 ml , then Patient 78 was given 2 ml, and Patient 79 was given 2 ml, which would account for all 5 ml. And that would be validated as an accurate account. Fentanyl comes in glass ampules, which is a single dose. In concurrent interviews, the Chief Clinical Officer (ADM 1) and the Director of Pharmacy (DP) were asked about the facility's policy for using same syringes on multiple patients. They said, "don't do it."

On 4/30/12 at 1 pm, MD 15 said on interview that based on the scheduled cases, he anticipated how much fentanyl he needed to use for each patient. Therefore, when he breaks the ampule, he pulls 1, 2, or 3 ml in different syringes, based on what each case requires.

Review of the policy, titled, "Medication Administration-Bedside Barcode Scanning and Non-Bedside Barcode Scanning," version 2, approved on 2/28/12, 16-d under "Administration Precautions and Procedures for Medications of all Routes" stated, "All ampules or single dose vials shall be discarded immediately after first use."

15. On 4/25/12, during inspection of the medication cart in Operation Room 2, accompanied by Nurse Manager (NM) 11 and ADM 1, a Proventil MDI medication, also known as albuterol, given by inhalation to dilate the airways for treatment or prevention of obstructive airway disease, was not in the sealed box that it comes in. When asked about the integrity of the MDI, NM 11 said that the MDI was not used, but she could not confirm that, as there was no seal. The cover of the mouthpiece can be removed and put back on with no evidence of usage. Leaving unsealed medication available for use, put patients at risk for infections.


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16. Potentially Hazardous Foods (PHF's) are those foods susceptible for supporting growth of bacteria associated with foodborne illness. PHF's require time/temperature monitoring to ensure food safety. PHF's include protein based items such as meat and dairy as well as cut raw vegetables such as tomatoes (Food Code, 2009). Hospital policy titled "Food Storage and Storage Times" dated 1/09 guided staff that refrigerated storage should be 41 degrees or lower to hold potentially hazardous foods."

During initial tour of the café area at the Rideout campus on 4/23/12 beginning at 10:10 am, it was noted that Food Service Worker (FSW) 5 completed the set-up of the deli bar. It was noted that the deli bar contained PHF's which required time/temperature control for food safety. In a concurrent interview, she stated that the area was set up each morning between 9 and 9:30 am. She further stated that the items would be used throughout the day. She further stated that if items were unused they would be labeled/dated, put in the refrigerator overnight and would be set up again on the following day.

In an observation 4/25/12 at 3:25 pm, the following temperatures were taken: tomatoes-43°F; ham-46 °F; tuna-50°F; egg salad-48°F and cottage cheese-44°F. In a concurrent interview with the Food Service Manager (FSM) he was asked to describe the system for ensuring that PHF's were held within a safe range. The FSM stated that there was a log to monitor temperatures. He also stated that the Chef completed daily rounds that included temperature monitoring; however did not record when those rounds were completed or the resulting temperatures. In a concurrent interview and review of the log titled "Daily Temperature Log" dated 4/23/12, with FSW 5 she stated that the temperatures of the items on the salad bar should be taken every 2 hours. She also stated that she had not had an opportunity to take the temperatures at 1 pm or 3 pm.

In a follow up observation on 4/26/12 beginning at 3 pm, additional temperatures were taken of PHF's using the surveyors' thermometer. The temperatures were as follows: tomatoes-45°F; tuna-47°F; egg salad-47°F; roast beef-43°F and turkey-47°F. The surveyor also completed calibration of the thermometer in the presence of the FSM and the Clinical Nutrition Manager (CNM) which was noted to be accurate. Concurrent review of the daily temperature log noted that temperatures were recorded on 4/26/12 ad 3 pm, and ranged from 38-40°F. Additional logs dated 4/23 and 4/14/12 also noted that all temperatures ranged from 38-40°F. In a concurrent interview with the FSM, he was unable to explain the differences in observed and recorded temperatures.

17. On 4/23/12 beginning at 12 pm, food distribution was observed noting opportunities of cross contamination of patient food.

a. It was noted that dietary staff would transport the meals to the floors in a closed cart. Once the cart was transported to the unit dietary staff would take individual tray into patient rooms. It was also observed that dietary staff would place the cart in a single location and would walk through the entire length of the unit with uncovered food items, potentially contaminating these items.

b. In a study conducted by the University of Iowa, released 9/26/11, revealed that the privacy curtains used in hospital rooms were frequently contaminated with potentially harmful bacteria. The study found that there was significant contamination of the privacy curtains and included bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and Enterococci, including specific vancomycin-resistant strains. The study also noted that "the hospital environment plays an important role in the transmission of infections."

On 4/23/12 beginning at 12 pm, dietary staff was observed delivering a meal to Room 202. In the room were two patients, RN 20, Food Service Worker (FSW) 4 and Patient Transporter (PT) 1. It was noted that the patient in the bed nearest the door advised FSW 4 she was nauseous and did not want to eat. It was also noted that while FSW 4 was holding the tray as PT 1 pulled the privacy curtain across the patients' tray touching the items. FSW 4 was then observed placing the tray back in the cart with remaining unserved meal trays.

In an interview on 4/23/12 with RN 20 in the presence of the FSM she was asked to describe how she provided oversight to meal delivery performed by dietary staff. She stated that as the nurse it was her responsibility to ensure that the diet was correct. The surveyor described the observed cross contamination; RN 20 replied that she did not notice the incident. The surveyor waited several minutes to ascertain if RN 20 or the FSM would remove the tray from the cart. There was no intervention by either staff member despite discussion of the observed cross contamination.

18. During review on 4/23/12 beginning at 10:10 am, it was noted that in the walk-in refrigerator there were 4 packages of deli style roast bee

Based on observation, staff 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 to ensure safe and high quality surgical care to all patients evidenced by:

A. The hospital failed to ensure that the organization of surgical services was appropriate to the scope of services offered evidenced by inconsistent perioperative practices (e.g. pre-operative screening and assessments, post-operative nursing care, cleaning/disinfecting practices and ventilation monitoring) among various locations where surgical procedures were performed with fragmented oversight to provide clear direction of care, in accordance with acceptable standards of practice. Refer to A941.

B. The hospital failed to ensure that unlicensed surgical technologists (Techs) who functioned in the scrub nurse role for surgical procedures: (1) performed within the scope of practice for unlicensed personnel, and (2) were supervised by a registered nurse who was not assigned to other dedicated duties, in accordance with acceptable standards of practice, in all surgical locations of the hospital. Refer to A943.

C. The hospital failed to arrange for qualified registered nurses (RNs) to perform circulating duties in the operating room for all operating room locations, in accordance with state regulations and acceptable standards of practice. Refer to A944.

D. The hospital assigned surgical tasks and duties to physicians, allied health professionals (AHPs, non-physicians with advanced medical practice skills), registered nurses (RNs) and cardiovascular technicians (CVTs) without verifying the qualifications and current competencies of those individuals, and for some, without delineating the authority to perform the duties through a formal privileging process, in accordance with acceptable standards of practice, hospital policies, and medical staff policies/bylaws. Refer to A945.

E. The hospital failed to ensure that surgical services consistently met the unique needs of each patient by developing and/or implementing surgical care policies and procedures designed to assure the achievement and maintenance of high standards of medical practice and patient care. Refer to A951.

F. The hospital failed to ensure that a complete and accurate examination and assessment of the patient, performed by a qualified individual and updated by the operating surgeon, to reflect the current condition of the patient was documented prior to surgery, in accordance with hospital policies and acceptable standards of practice. Refer to A952.

G. The hospital failed to ensure that the risks, benefits, and alternatives to surgery were documented by the surgeon, in accordance with hospital policy. Refer to A955.

H. The hospital failed to ensure that each operating room was equipped with a tracheotomy kit that was immediately available to ensure preparedness and timely emergency response for all surgical patients. Refer to A956.

I. The hospital failed to ensure adequate immediate post-operative care was provided, in accordance with physician orders, hospital policy, and acceptable standards of care. Refer to A957.

J. The hospital failed to maintain a sanitary environment, and ensure an infection control system that effectively conformed with nationally recognized infection control standards to identify, report, investigate and control infections and communicable diseases of patients and personnel. Refer to A749.

K. The hospital failed to monitor air exchanges, ventilation, humidity, and temperature for the Post Anesthesia Care Unit (PACU, recovery room), operating rooms for obstetrics, compressed-gas storage areas, and sterile storage areas. Refer to A726

These failures put patients at risk for adverse surgical outcomes or infections. 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 observation, interview, and document review, the hospital failed to ensure patients received conscious sedation during a surgical procedure, in accordance with acceptable standards of practice, for 1 of 2 patients (Patient 22) observed receiving conscious sedation.

The hospital failed to ensure that the organization of surgical services was appropriate to the scope of services offered as evidenced by inconsistent perioperative practices (e.g. pre-operative screening and assessments, post-operative nursing care, cleaning/disinfecting practices and ventilation monitoring) among various locations where surgical procedures were performed with fragmented oversight to provide clear direction of care in accordance with acceptable standards of practice.

These failures put patients at risk for medical errors or adverse surgical outcomes from poorly understood surgical care direction and a risk to patient safety by not affording immediate availability of nursing interventions for emergencies and other patient needs.

Findings:

1. On 4/24/12, Patient 22 was observed in the cardiac cath lab for replacement of his pacemaker (controls the heart rhythm of contraction and relaxation) with the capacity of defibrillation (ability to produce a brief electroshock to the heart, allowing the heart's pacemaker to regain control and regulation of the heart rate and rhythm). At 7:45 am, Registered Nurse (RN) 61 stated that she was the circulator nurse (RN who assumed responsibility and accountability for patients undergoing a procedure) and greeted Patient 22 upon entering the procedure room. At 8 am, RN 61 was observed wearing a cap, mask, and a sterile gown. RN 61 proceeded to set up a sterile field and took on the role of Cath Lab Cardiovascular Technician, assisting the physician during the procedure. At 8:20 am RN 59 was observed administering medication and RN 60 was sitting across the room documenting the procedure. There was no circulator nurse available during the procedure to leave the room to gather supplies. At 8:25 am and at 9:10 am, RN 63 left the procedure room to gather supplies while having the responsibility of conscious sedation nurse. At 8:50 am, RN 63 positioned his back to the patient while documenting. The documented circulation nurse was RN 60 who was observed sitting across the room, away from the patient watching a monitor while documenting on the computer. RN 60 was not observed interacting with Patient 22 and did not make herself available to assist during the procedure while RN 60 left the procedure room twice.

The "Cardiac Cath Lab RN Job Description," dated 4/00, read, responsibilities include "1. The registered nurse in the cardiac cath lab will be responsible for overseeing all patient care during the procedure...2. Assists with patient care in the cardiac cath lab in the role of scrub, circulator, and monitor person by: Identify and greet the patient. Assess educational needs. Prepare the patient as needed for the procedure; Initiate IV's and pre-procedural medications as needed; Prepare table using sterile technique; Scrub during the procedure as needed, including patient preparation, percutaneous vascular access and sheath insertion, catheter and guidewire manipulation, and coronary artery injection; Assess and monitor the patient before, during, and after the procedure and manage peri-procedural complications of procedures, including adverse drug reactions; Circulate during the procedure as needed, assessing and monitoring the patient's status and response to intervention; Document assessment and re-assessment findings, interventions, and response to interventions; Operate the physiological monitoring system and obtain necessary hemodynamic parameters during the procedure, run waveforms, and procedural report...3. Set-ups and operates the intra-aortic balloon pump, temporary pacemaker generator, and Medrad power injector."

The policy "Cardiac Cath-Structure Standards for the Cardiac Catheterization Lab," dated 4/4/11, read, "VIII Governing Rules of the Area, P. Staffing: 1...A minimum of three staff, one of whom must be a registered nurse, is present during each procedure."

AORN (Association of periOperative Nurses) Recommended Practices for Managing the Patient Receiving Moderate Sedation/Analgesia, 2012 Edition, Recommendation IV The perioperative registered nurse monitoring the patient receiving moderate sedation/analgesia should have no other responsibilities that would require leaving the patient unattended or would compromise continuous monitoring during the procedure.

AORN Position Statement: One Perioperative Registered Nurse Circulator Dedicated to Every Patient Undergoing A Surgical or Other Invasive Procedure.


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2. Review of a facility policy titled, "Plan for Providing Patient Care - Hospitalwide," dated 12/13/11, documented under item V-1, "the same standard of care will be provided for all patients who have similar needs regardless of the setting in which the care is provided." Item V-15 directed that patients had the right to receive treatments safely and in accordance with approved policies and procedures.

a. Pre-operative screening and assessments varied by surgical location.

During a tour on 4/23/12 at 11:30 a.m. of the central operating room pre and post-operative (PACU) units with NM 11, who managed the units, NM 11 indicated that interventional radiology (IR) surgeries were performed in a distant location, but IR patients received pre-operative (pre-op) and post-operative care (i.e. patients were admitted and discharged) in this unit. NM 11 indicated that Patient 11 was admitted to the pre-operative unit earlier on 4/23/12 where a registered nurse (RN) assessed him and documented on a checklist. Then Patient 11 was brought to the distant IR location where surgery was performed. Following the surgery, Patient 11 was brought back to the PACU for post-operative monitoring until discharge home.

Review of the medical record for Patient 11, confirmed by NM 11 and RN 50 who admitted Patient 11 to the pre-op area in a telephone interview on 4/25/12 at 4:10 p.m., indicated that Patient 11 had a liver biopsy performed in the IR unit under moderate sedation on 4/23/12. Brief entries by RN 50, written next to vital sign measurements on a pre-op checklist, noted examination findings of heart, lungs, and skin. No other descriptions of the patient's mental or emotional state, airway, neuromuscular condition, or co-existing health conditions were documented. NM 11 indicated that most same-day elective outpatient surgery patients were screened, prior to the day of surgery, to identify health conditions that might affect the planned surgery or increase the surgical risk, to reconcile medications, to order pre-op testing or consultation, or to provide clear direction to prepare for surgery (e.g. to take or hold routine medications). However, the IR patients did not participate in that pre-op screening process. RN 50 indicated that typically the only information available about the IR patients was derived from a physician history and physical examination (H&P) presented with the records on the day of surgery, however, often the H&Ps were incomplete. RN 50 typically reviewed what was available, but did not pursue questioning the IR patients extensively about their health history or past surgical history, or document such. RN 50 documented a blood sugar result on the pre-op checklist, but did not document the medical reason the test was performed (history of diabetes, insulin medication, etc). RN 50 acknowledged that Patient 11's H&P did not document a history of diabetes or other health conditions, accurate medication history, allergy history, or baseline heart and breathing rate or weight (facts relevant to the surgical risk).

Review on 4/30/12 at 10 a.m. of the medical record for Patient 15 with NM 12, who managed the IR nursing unit, indicated that Patient 15 had an elective outpatient liver biopsy performed in the IR unit on 4/10/12. The H&P did not document that Patient 12 took a medication for high blood pressure (BP) or whether Patient 12 had complications from the disease. The H&P and admission pre-op checklist documented elevated blood pressure measurements. However, on arrival to the IR unit, the sedation RN obtained a significantly higher measurement (168/112, normal BP is 120/80) and noted that Patient 15 did not take her routine blood pressure medications that day. Patient 15's blood pressure remained significantly elevated throughout the surgery, which increased her risks for bleeding. Not until after surgery was treatment for high blood pressure ordered (without great effect).

In an interview with NM 11 on 4/25/12 at 4:15 p.m., NM 11 stated that nursing staff in the central operating room unit and one of the off-campus ambulatory surgery centers were receiving training on surgical nursing standards and competencies directed by a national surgical nursing organization (ASPAN). However, the nursing staff in the intensive and critical care units, IR, emergency room, or other surgical locations were not included in the standardized surgical nursing training, even though those units routinely cared for surgical patients. NM 11 indicated that policies to guide staff in those locations that would consistently reflect ASPAN or the Association for peri-Operative Registered Nurses (AORN) standards were not fully developed.

Review of the 2012 AORN Guidance Statement on Preoperative Patient Care in the Ambulatory Surgery Setting urged the perioperative services to be organized to address the special needs of their patients. Admission criteria with written guidelines for preadmission should be developed. A preadmission nursing assessment should include at least an appropriate baseline physical assessment, allergies, emotional assessment, pain assessment medication history, anesthetic history, results of testing, identification of physical alterations that require additional equipment or supplies. Special screening may be needed for high-risk patients with certain conditions (e.g., cardiac disease, obesity, sleep apnea). Findings from the history, physical examination, and designated studies must be documented in the record before surgery/anesthesia care is performed. A review of the preadmission information and a baseline admission physical assessment should also be documented on the day of surgery.

b. Post-operative nursing care not consistent in all hospital locations.

Review of policies titled, "Perioperative Post Anesthesia Care of the Post Procedure Patient - Hospitalwide," last reviewed April 2012, "Care of the Patient Undergoing Cardiac Catheterization - Hospitalwide," last reviewed 7/10, and "Procedural Anesthesia/Analgesia - Adult - Hospitalwide," last reviewed 1/27/12, gave direction to nursing staff for the features and intervals of monitoring various aspects of a patient's post-surgical condition. Some inconsistencies were identified among the policies for time intervals (5 minutes vs 15 minutes) and inconsistencies related to assessment features and methods (direct assessment vs machine-driven measurements). However, all policies expected fairly frequent post-operative nursing assessments to be documented in the first 1-2 hours following surgical procedures when complications were most likely to occur.

In a collaborative record review on 4/24/12 at 2:05 p.m. of the care of Patient 12 with a perioperative nurse manager, NM 10, indicated that Patient 12 had surgery in the heart studies unit (cardiac cath lab) under moderate sedation on 3/9/12. Immediately following the procedure, Patient 12 was brought to the intensive care unit (ICU). ICU Nursing notes did not document Patient 12's post-surgical condition (pulses and circulation, heart exam, lung sounds and depth of breathing, activity (muscle strength and movement), pain, level of consciousness, skin condition), sedation and pain scale, or Aldrete score at the frequency intervals directed by policies or physician orders.

Review on 4/30/12 of the medical record for Patient 13 indicated that Patient 13 had an urgent surgical procedure in the endoscopy operating room (OR) on 4/25/12 for low blood pressure and a bleeding stomach ulcer. He was transferred from the emergency room to the endoscopy OR at 8:30 a.m. with a blood transfusion in progress. Moderate sedation treatments were administered, and surgical treatments to stop the bleeding sites were also administered. Following surgery, Patient 13 was brought back to the emergency room to await the availability of a bed in a critical care unit. Monitoring documentation in the emergency room between 9:34 a.m. and his arrival to a critical care unit at 2:25 p.m. did not conform to the policy-directed assessment features or Aldrete documentation required of a PACU, critical care unit, or sending unit (sedation and pain scale, skin, circulation, quality and depth of breathing, etc).

In an interview on 4/24/12 at 2:05 p.m., NM 10 stated that post-surgical nursing care performed in the recovery room (post-anesthesia care unit, PACU) of the central operating room unit did adhere to the policies named above and surgical nursing standards (Association for peri-Operative Registered Nurses). NM 10 indicated that for patients who were transferred to a critical care unit or other nursing unit directly following a surgical procedure, the same post-anesthesia and post-surgical assessment and monitoring standards as were used in the PACU applied (but were not performed for Patients 12 and 13) in those locations as well, until the patient was determined adequately recovered from the surgical, and anesthesia, care.

In an interview on 4/30/12 at 10 a.m. with NM 12 who managed the interventional radiology (IR) nursing unit, NM 12 indicated that she was not familiar with surgical care policies related to pre and post-operative monitoring that applied to the IR unit. (none were presented)

In an interview on 4/30/12 at 12:15 p.m. with the Director of Perioperative Services (DPS), DPS indicated that some surgical units (interventional radiology, heart studies laboratory, emergency department) still maintained certain distinct and separate policies and standards for surgical care, though many policies such as those described above were intended to apply hospital-wide. DPS was not directly responsible for surgical care in the separate units. DPS indicated that attempts to coordinate processes for consistency in surgical care were still under development.

In an interview on 4/25/12 at 4:15 p.m. with the Vice President of Quality Management (VPQM), VPQM indicated that audits of consistency in care (e.g. content of H&Ps, airway assessment feature documentation, nursing monitoring) for the various surgical locations had not been conducted, and care consistency had not been analyzed, despite a previous deficiency on the matter cited in a federal Centers for Medicare and Medicaid Services (CMS) survey conducted in October of 2011.

Based on staff interview, medical record and document review, the hospital failed to ensure that unlicensed surgical technologists (Techs) who functioned in the scrub nurse role for surgical procedures: (1) performed within the scope of practice for unlicensed personnel, and (2) were supervised by a registered nurse who was not assigned to other dedicated duties, in accordance with acceptable standards of practice, in all surgical locations of the hospital for 1 of 9 surgical records reviewed (Patient 12).

Findings:

In a previous Centers for Medicare and Medicaid Services (CMS) survey of October 2011, available for public view, the hospital was cited for permitting unlicensed technologists/technicians to perform patient care that exceeded their scope of practice and without supervision by registered nurses who were not already assigned to perform tasks that could not be interrupted (sedation care). Policies of the heart studies laboratory (cardiac cath lab) indeed permitted these practices to occur by virtue of their staffing directives and procedures delegated to cardiac cath technicians. Review of current cardiac cath lab policies indicated no change in these practices:

a. Review of a policy titled, "Cardiac Cath-Structure Standards for the Cardiac Catheterization Lab," last approved 4/4/11, documented the responsibilities that RNs and cardiovascular technicians (CVTs) were authorized to perform. In the policy, CVTs specifically were authorized "to remove arterial and venous sheath and apply compression device/manual pressure."

b. Review of a policy titled, "Cardiac Cath - Intravascular Sheath Removal," last reviewed 4/20/12, documented that under a physician order to remove an arterial catheter, a RN or CVT may apply manual or mechanical arterial compression and remove a catheter. The policy listed several serious complications that can occur while performing this care. The risks included fainting, bleeding if blood pressure was elevated, compromise to circulation beyond the blood vessel location, and collections of blood around the catheter insertion (large bruise) that can damage neighboring structures. The procedure required patient assessment and monitoring, generally skills assigned to licensed nurses and not to technicians. The specific methods outlined in the procedure were highly technical. For example, "Place index finger of left hand over artery and left middle finger just above it. With a slow and steady movement, remove the sheath with the right hand. Allow one second of bleeding, then apply consistent pressure in a downward manner with the left hand. Bleeding allows the release of any thrombi (clots). Continue with firm pressure over the artery for 20-30 minutes." The procedures were based on textbooks for critical care nursing, not on literature from CVT certification programs.

c. Review of a policy titled, "Cardiac Cath - Addendum O - Staffing," last approved 4/4/11, documented that the staffing team for procedures was comprised of three members, one of whom must be a registered nurse and one of whom must be a cardiovascular technician. In that the third person may also be a CVT, and cath lab patients typically undergo some type of sedation/analgesia care requiring the services of one RN uninterrupted and not available to perform sheath care, a CVT would be eligible to perform the care.

Despite the policies permitting a CVT to perform catheter sheath care, a review of the job description for Cath Lab CVT did not list catheter sheath removal with compression of the artery or vein as one of the scrub functions or equipment duties that a CVT performs.

Review on 4/24/12 at 2:05 p.m. of the medical record for Patient 12 with perioperative nurse manager (NM) 10 indicated that Patient 2 was admitted to the hospital on 3/9/12 for an acute heart attack that required emergent heart catheterization with placement of a stent in the cath lab (operating room where plastic tubes were placed into deep blood vessels leading to the heart to perform studies and surgery). Three minutes before the surgeon "scrubbed out" of the procedure, the final steps of the surgical procedure noted that the arterial catheter sheath was pulled and exchanged for another catheter, and a pressure device was applied. The record did not specify which staff member (doctor, nurse, technician) performed the catheter sheath care. NM 10 acknowledged that handling arterial catheters and removing them from deep blood vessels in patients experiencing a heart attack required specialized education and technical training beyond that of basic nursing school. NM 10 was not sure if a standardized procedure for registered nurses was in place for this type of care.

Review of a policy titled, "Cardiac Cath - Addendum F - Delivery of Care Methodology," last approved 6/22/11, directed the RN to carry out all aspects of the nursing process, including assessment, problem identification, goal setting and care planning. The RN was responsible for the implementation of those tasks that cannot be delegated to non-registered nursing staff and the evaluation of effectiveness of nursing interventions. The RN (and not CVT) was responsible for assessment and re-assessment.

Review of the 2012 Association of peri-Operative Registered Nurses (AORN) Recommended Practices for Managing the Patient Receiving Moderate Sedation/Analgesia documented under Recommendation IV that the RN monitoring the patient receiving moderate sedation/analgesia should have no other responsibilities that would require leaving the patient unattended or would compromise continuous monitoring during the procedure.

The position statement titled, "Conscious Sedation from the California Board of Registered Nursing (BRN)," last revised 7/97, retrieved at www.rn.ca.gov on 10/11/11, in part indicated: "... National guidelines for administering conscious sedation should be consulted in establishing agency (facility) policies and procedures ... RNs managing the care of patients receiving conscious sedation shall not leave the patient unattended or engage in tasks that would compromise continuous monitoring of the patient by the registered nurse. Registered nurse functions as described in this policy may not be assigned to unlicensed assistive personnel... "

Review of the 2012 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 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." Therefore, when non-RN staff were performing nursing functions, continuous supervision by a RN (other than the sedation RN) must be arranged. Typically, that role was filled by a circulating RN.

Based on staff interview medical record and document review, the hospital failed to arrange for qualified registered nurses (RNs) to perform circulating duties in the operating room for all operating room locations, in accordance with state regulations and acceptable standards of practice. This failure posed a risk to patient safety by not affording immediate availability of nursing interventions for emergencies and other patient needs.

Findings:

During observation of surgery for Patient 22 on 4/25/12 at 8:25 am and 9:10 am in the heart studies unit, the sedation RN was observed to leave the room and unable to continuously view Patient 22's ventilation and condition on two occasions to fetch medications needed for the procedure.

Review of the records for Patient 11 with NM 11 on 4/25/12 at 3:30 p.m., for Patients 14, 15, and 16 with NM 12 on 4/30/12 at 10 a.m., and for Patient 17 with the Director of Perioperative Services (DPS) on 4/30/12 at 12:15 p.m. indicated that only one RN participated in care and no other RN was designated to perform circulating duties. The records for Patients 11, 15 and 16 lacked documentation of the physician administering local anesthetic for the surgery, a task typically managed by a circulating RN.

In an interview on 4/30/12 at 10 a.m. with NM 12, who managed the IR nursing unit, NM 12 confirmed that only one RN was typically assigned to cover a number of duties during IR procedures. IR procedures included liver and other organ/tissue biopsies, manipulation of blood vessels and devices attached to blood vessels, placement of tubes into the stomach, and other surgeries that carried significant risk for bleeding or injury to the surgical site. If items were needed or the surgeon needed assistance, the sedation RN or a technician would provide the assistance, or an emergency response team from elsewhere in the hospital would be summoned.

Review of a hospital-wide policy titled, "Procedural Anesthesia/Analgesia-Adult," last reviewed 1/27/12, the policy documented under item IV-E, for surgical procedures involving moderate or deep sedation, "in addition to the procedure physician, at a minimum there will be one registered nurse who has validated competency and required training present for the procedure to administer medications upon direct order of the credentialed physician who is supervising the sedation. The RN is responsible for continuously monitoring physiologic parameters, pain and sedation level throughout the procedure in accordance with this policy, assisting with the procedure, and recovering the patient post-procedure." The policy did not require additional staff be assigned to function in the circulating role to assist the surgeon, position the patient if needed, obtain medications and supplies as necessary, supervise technical staff, or provide nursing assistance to meet the emergency needs of the patient. The policy did not emphasize that the person responsible for moderate or deep sedation monitoring should not interrupt monitoring to perform tasks such as assisting in the surgery, etc. Other staffing policies (e.g. Cardiac Cath lab) required a minimum of one RN for a sedation procedure with no additional RN staffing for these other nursing duties. The policy listed no nationally recognized surgical nursing organization in its references.

In an interview on 4/24/12 at 3:30 p.m. with NM 10, a nurse manager for perioperative services, NM 10 stated that a circulating nurse was assigned to each case performed in the central operating room suite, except for cardiac catheterization procedures. NM 10 was not familiar with the staffing arrangements for procedures performed elsewhere in the hospital. NM 10 indicated that the hospital ' s surgical nursing practices were based on the Association of peri-Operative Registered Nurses (AORN) standards and recommendations, which did recommend assignment of a circulating RN to each surgical procedure, regardless of location. NM 10 stated that tasks performed by circulating RNs included supervising scrub and unlicensed assistants, documenting tasks and medications administered by the surgeon, assisting the surgeon with patient positioning, equipment and supplies needed throughout the surgery, arranging for emergency items such as blood products and specialized medications or other necessary staff, and labeling specimens.

The position statement titled, Conscious Sedation from the California Board of Registered Nursing (BRN), last revised 7/97, retrieved at www.rn.ca.gov, in part indicated: "... National guidelines for administering conscious sedation should be consulted in establishing agency (facility) policies and procedures ... RNs managing the care of patients receiving conscious sedation shall not leave the patient unattended or engage in tasks that would compromise continuous monitoring of the patient by the registered nurse. Registered nurse functions as described in this policy may not be assigned to unlicensed assistive personnel ... "

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 completing a surgical procedure).

Review of the 2012 AORN Guidance Statement on Perioperative Staffing documented as minimum intraoperative requirements: One RN per patient per operating room in the role of the circulating nurse. One scrub person per patient per room (RN, licensed practical nurse, 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 2012 AORN Position Statement on One Perioperative Registered Nurse Circulator Dedicated to Every Patient Undergoing a Surgical Or Other Invasive Procedure 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 Division 5, 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 of the 2012 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 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." Therefore, when non-RN staff were performing nursing functions, continuous supervision by a RN (other than the sedation RN) must be arranged. Typically, that role was filled by a circulating RN.

Based on staff interview and document review, the hospital assigned surgical tasks and duties to physicians, allied health professionals (AHPs, non-physicians with advanced medical practice skills), registered nurses (RNs) and surgical technologists (Techs) without verifying the qualifications and current competencies of those individuals, and for some, without delineating the authority to perform the duties through a formal privileging process, in accordance with acceptable standards of practice, hospital policies, and medical staff policies, evidenced by:

1. The hospital leadership permitted medical staff members to perform history and physical examinations (H&P, a type of comprehensive physician assessment) on pre-surgical patients, without designating the authority (by approved clinical privileges) to conduct H&Ps for 2 of 2 medical staff members reviewed (MD 8 and MD 9).

2. The hospital leadership approved surgical privileges for 114 of 114 medical staff members with incomplete documented evidence of privilege-specific experience and performance.

3. The hospital leadership approved moderate sedation [Moderate sedation is a type of anesthesia service and treatment utilizing medications to reduce a patient's awareness and pain during surgical procedures, but still respond to both verbal and light physical stimulation] clinical privileges for 45 of 71 physician files reviewed without documented evidence of demonstrated proficiency in performing airway management or rescue skills in accordance with medical staff policy and organizational standards of care.

4. The hospital leadership approved surgical assist clinical privileges for 12 of 12 AHPs with no documented evidence of the privilege-specific experience and performance for various surgical skills reflected by the privileges.

5. The hospital leadership permitted surgical assist tasks to be performed by unlicensed staff and licensed nurses during heart surgery procedures without assigning clinical privileges or evaluating qualifications, in accordance with hospital policies and state standards of practice for 1 of 1 heart surgery patient reviewed (Patient 2).

These failures put patients at risk to have surgery performed by unqualified persons.

Findings:

Review of the 5/11 Medical Staff Credentialing Manual under item 2.2-2 documented that clinical privileges shall be evaluated on the basis of the practitioner's education, training, and experience. The basis for ongoing privilege determinations shall be made in connection with observed clinical performance demonstrated ability and judgment, proctoring, the results of peer review, and the documented results of patient care audit/quality activities.

Review of the 5/11 Medical Staff Credentialing Manual under item 2.1 documented that a practitioner shall be entitled to exercise only those clinical privileges or specified services specifically granted by the governing board.

In a collaborative interview and document review on 4/30/12 at 1:20 p.m. of medical staff files with the medical staff coordinator (MSC), the following was identified:

1. Physicians were performing H&Ps without approved privileges.

a. MD 8 was a radiologist who did not routinely evaluate health conditions for patients admitted to the hospital. However, MD 8 did routinely perform selected invasive procedures on both inpatients and outpatients, which require the surgeon to perform an H&P or update to a recent H&P. Many of the procedures appeared on privilege request forms dated 1/1/12, 1/16/12, none of which were signed by the hospital leadership. In addition, no currently approved privileges to perform H&Ps were documented.

b. MD 9 was also a radiologist who functioned similar to MD 8. MSC stated that MD 9's request for radiology privileges was approved at a hospital leadership meeting in January, but the documents were not in his file presently. MSC confirmed that privileges for H&Ps were not approved for either MD 8 or MD 9.

2. The hospital leadership approved surgical privileges for 114 of 114 medical staff members with incomplete documented evidence of privilege-specific experience and performance.

A list of physicians granted moderate sedation privileges for surgical procedures identified 71 members of the medical staff. [Moderate sedation is a type of anesthesia service and treatment utilizing medications to reduce a patient's awareness and pain during surgical procedures, but still respond to both verbal and light physical stimulation; also known as moderate sedation/analgesia, IV (intravenous, medications injected directly into a vein) sedation, or conscious sedation.] A medical staff roster identified an additional 43 physicians who were granted surgical privileges for care relating to bones, eye, ear, female reproduction, and general surgery. MSC indicated that the files for all such members (114) would not contain documentation of the volume of cases (experience) and competencies (performance outcomes) for the specific approved surgical privileges contained in the files. MSC also stated that the data collected for physician specific audits (from the ongoing performance evaluations) was not routinely submitted to the Credentials Committee (the group who made recommendations to the hospital leadership for approval/disapproval of care privileges) as evidence of physician competence.

3. The hospital leadership approved moderate sedation clinical privileges for 45 of 71 physicians without documented evidence of demonstrated proficiency in performing airway management or rescue skills.

MSC presented the requirements for moderate sedation privileges (for non-anesthesiologists) as documented on a privileging affidavit. The requirements included an attestation of prior training or experience, knowledge and skill to manage the airway and effects of moderate sedation, review of the related hospital policies, viewing a training video and scoring 80% on a pot-test, and documenting care on a hospital form. The requirements did not include maintaining Advanced Cardiac Life Support Certification (ACLS, which includes hands-on training and experience with abnormal heart rhythm interpretation and rescue of patients who are not breathing or circulating blood). The requirements did not include any other formal demonstration of ventilating and managing the airways of patients under the effects of a deeper than intended level of sedation (i.e. deep sedation).

In an interview on 4/26/12 beginning at 1:45 p.m. with MD 4, who served as the Director of Anesthesia Services, MD 4 stated that the hospital-wide anesthesia services (including privileging for moderate sedation) were based on the standards of the American Society for Anesthesiology. MD 4 described the privileging requirements for moderate sedation, similar to MSC above. However, physicians who maintained Board-certification in emergency medicine and critical care medicine automatically qualified due to the Boards requiring current hands-on demonstration of airway management skills and heart rhythm interpretation and rescue from deep sedation.

MD 4 confirmed that ACLS certification was no longer required for moderate or deep sedation privileges (a change from previous privileging options). MD 4 indicated that he did not proctor airway management skills, or routinely review the moderate sedation care performed by non-anesthesiologists, unless a case triggered from an incident-driven quality system. Therefore, no system to verify each non-anesthesiologist's moderate sedation performance and ongoing competence was in place.

MD 4 confirmed that airway assessment skills were not emphasized in the sedation education materials available to the non-anesthesiologists. MD 4 acknowledged that physicians were not documenting airway assessments as part of the sedation care, despite the ASA standard to do so.

Review of a list of 71 physicians granted moderate sedation privileges for surgical procedures with MD 4 identified 45 physicians who were granted moderate sedation privileges with no evidence of current demonstrated competence for airway management or rescue from a deeper than intended level of sedation, including cardiac arrest.

Review of the ASA Statement on Granting Privileges for Administration of Moderate Sedation to Practitioners Who Are Not Anesthesia Professionals, issued on 10/18/06, documented that professionals who administer, or supervise the administration of, moderate sedation, should have specialized and formal education, training, and current demonstrated competency for the knowledge and skills related to respiratory physiology, cardiac rhythms, medication pharmacology, airway management, and rescue from unintended oversedation or complications. "Skills for obtaining the patient's medical history and performing a physical examination to assess risks and co-morbidities, including assessment of the airway for anatomic and mobility characteristics suggestive of potentially difficulty airway management " should be included in education and training. "Proficiency of airway management with facemask and positive pressure ventilation" should be supervised or instructed on an airway simulator, or both. Mastery of heart rhythms and signs of oxygen lack should be demonstrated. The ASA recommended privileging all practitioners given this patient care authority with ongoing performance improvement oversight by the facility governing body.

Review on 10/12/11 of American College of Surgeons 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."

Review 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 (included moderate sedation). This evaluation must include airway assessment, anesthesia risk assessment and anesthesia drug and allergy history.

4. AHPs were granted surgical assist clinical privileges with no documented evidence of privilege-specific experience and performance for various surgical skills reflected by the privileges.

Review of the AHP staff roster indicated there were 12 physician assistants (PA, type of AHP) classified under surgical departments and eligible for surgical assist privileges. MSC indicated that the files for the AHPs would not contain documentation of the specific volume of surgical cases (experience) and competencies (performance outcomes) for the approved surgical privileges contained in the files. MSC also stated that ongoing performance evaluations based on patient-specific care for AHPs were not routinely submitted to the Credentials Committee (the group who made recommendations to the hospital leadership for approval/disapproval of care privileges) as evidence of AHP competence.

5. The hospital leadership permitted surgical assist tasks to be performed by unlicensed staff and licensed nurses during heart surgery procedures without assigning clinical privileges or evaluating qualifications.

Review on 4/24/12 at 2:05 p.m. of the medical record for Patient 12 with perioperative nurse manager (NM) 10 indicated that Patient 2 was admitted to the hospital on 3/9/12 for an acute heart attack that required emergent heart catheterization with placement of a stent in the cath lab (operating room where plastic tubes were placed into deep blood vessels leading to the heart to perform studies and surgery). NM 10 indicated that the documentation of care showed that 2 RNs made entries and provided direct care throughout the surgery. The RNs clearly documented the activities of the participating physician. Other staff members including another RN and cardiovascular technician were listed as participating. Three minutes before the surgeon "scrubbed out" of the procedure, the final steps of the surgical procedure noted that the arterial catheter sheath was pulled and exchanged for another catheter, and a pressure device was applied. The record did not specify which staff member performed the catheter sheath care. NM 10 acknowledged that handling arterial catheters and removing them from deep blood vessels in patients experiencing a heart attack required specialized education and technical training beyond that of basic nursing school. NM 10 was not sure if a standardized procedure for registered nurses was in place for this type of care.

Review of a policy titled, "Cardiac Cath - Structure Standards for the Cardiac Catheterization Lab," last approved 4/4/11, documented the responsibilities that RNs and cardiovascular technicians (CVTs) were authorized to perform. In the policy, CVTs specifically were authorized "to remove arterial and venous sheath and apply compression device/manual pressure."

Review of a policy titled, "Cardiac Cath - Intravascular Sheath Removal," last reviewed 4/20/12, documented that under a physician order to remove an arterial catheter, a RN or CVT may apply manual or mechanical arterial compression and remove a catheter. The policy listed several serious complications that can occur while performing this care. The risks included fainting, bleeding if blood pressure was elevated, compromise to circulation beyond the blood vessel location, and collections of blood around the catheter insertion (large bruise) that can damage neighboring structures. The procedure required patient assessment and monitoring, generally skills assigned to licensed nurses and not to technicians. The specific methods outlined in the procedure were highly technical. For example, "Place index finger of left hand over artery and left middle finger just above it. With a slow and steady movement, remove the sheath with the right hand. Allow one second of bleeding, then apply consistent pressure in a downward manner with the left hand. Bleeding allows the release of any thrombi (clots). Continue with firm pressure over the artery for 20-30 minutes." The procedures were based on textbooks for critical care nursing, not on literature from CVT certification programs.

Review of a policy titled "Cardiac Cath - Addendum O - Staffing," last approved 4/4/11, documented that the staffing team for procedures was comprised of three members, one of whom must be a registered nurse and one of whom must be a cardiovascular technician. In that the third person may also be a CVT, and cath lab patients typically undergo some type of sedation/analgesia care requiring the services of one RN uninterrupted and not available to perform sheath care, a CVT would be eligible to perform the care.

However, a conflicting policy titled, "Cardiac Cath - Addendum F - Delivery of Care Methodology," last approved 6/22/11, directed the RN to carry out all aspects of the nursing process, including assessment, problem identification, goal setting and care planning. The RN was responsible for the implementation of those tasks that cannot be delegated to non-registered nursing staff and the evaluation of effectiveness of nursing interventions. The RN (and not CVT) was responsible for assessment and re-assessment.

In an interview with MSC on 4/30/12 at 1:20 p.m., MSC indicated that the hospital leadership had not granted clinical privileges for catheter sheath removal to cath lab RNs or CVTs.

Review of the job description for Cath Lab CVT did not list catheter sheath removal with compression of the artery or vein as one of the scrub functions or equipment duties that a CVT performs.

In an interview on 10/10/11 at 10 a.m. with the Director of the Cath Lab (DCL) during a previous Center for Medicare and Medicaid Services complaint validation survey (October 2011, available for public view) of the same surgical care, DCL indicated that CVTs routinely pulled the catheter sheaths from blood vessels and applied compression as described in the policies above. The survey cited this as a practice performed by unqualified persons. This and other findings cited as deficient practices spurred this current full validation survey to determine compliance with the Surgical Services Condition of Participation. The survey process directed the hospital to make corrections to the deficient practice. The hospital presented no evidence of correcting the sheath care to be performed only by licensed and qualified staff, as previously cited.

Based on observation, staff interview, medical record and document review, the hospital failed to ensure that surgical services consistently met the unique needs of each patient by developing and/or implementing surgical care policies and procedures designed to assure the achievement and maintenance of high standards of medical practice and patient care when:

1. Intraoperative monitoring of the effects of sedation/analgesia care and surgery relied on unreliable machine printouts, rather than direct verification by the person responsible for monitoring the condition of the patient for 5 of 9 surgical patient records reviewed (Patients 11, 14, 15, 16, and 17).

2. The licensed practitioner responsible to monitor sedation/analgesia patients was assigned simultaneous responsibilities (supervising unlicensed staff, circulating, assisting surgeon) which interrupted the monitoring duties for 6 of 9 surgical patients reviewed (Patients 11, 14, 15, 16, 17, and 22).

3. Documentation of pre-operative nursing assessments was incomplete for 5 of 9 surgical patient records reviewed (Patients 11, 14, 15, 16, and 20).

4. The licensed practitioner performing surgery simultaneously performed or supervised the monitoring of deep sedation for 1 of 9 surgical patient records reviewed (Patient 17).

5. Sterile instruments were not processed in accordance with acceptable standards of practice.

6. Documentation of air exchanges, ventilation, humidity, and temperature for the Post Anesthesia Care Unit (PACU, recovery room), operating rooms for obstetrics, compressed-gas storage areas, and sterile storage areas, was not monitored or incomplete.

These failures put patients at increased risk to develop surgical and other infections or adverse outcomes from a surgical experience.

Findings:

1. Inaccurate and unsafe intraoperative monitoring was identified.

In a collaborative review of Patient 11's care with NM 11, who managed pre and post-operative nursing, on 4/25/12 at 3:30 p.m., NM 11 acknowledged that during Patient 11's liver biopsy on 4/23/12 the registered nurse (RN) responsible for monitoring and documenting Patient 11's condition while under the effects of moderate sedation (the administration of drugs to reduce pain and awareness during a surgical procedure) did not record the vital sign (VS) measurements of heart rate, breathing rate, blood oxygen level, and blood pressure. Instead, a machine-generated strip of stamped measurements was pasted into the medical record. NM 11 stated that the machines were unreliable, were often not accurately calibrated with the correct time, and unpredictably skipped recording various measurements. NM 11 indicated that in some surgical units, the RN assigned to monitor a moderate sedation patient was also responsible to assist the surgeon, supervise the technician or unlicensed staff, fetch medications and supplies, and other tasks that interrupted the continuous monitoring of the patient's airway and condition. Therefore, there was no time to verify the machine measurements by directly assessing the condition of the patient and recording the measurements as validated, or measuring in an alternative way (like counting respirations, feeling a pulse, listening to blood pressure sounds manually when the machine numbers did not match the appearance or condition of the patient).

NM 11 also indicated that a form titled, "Frequent Vital Signs" was routinely completed manually for moderate sedation patients treated in the central operative room locations. The form listed blocks to manually record blood pressure, heart rate, breathing rate, blood oxygen level, pain scale, sedation scale, Aldrete score, and other aspects of a patient's condition. However, the form was utilized only to record pain scale and sedation scale for Patient 11. NM 11 agreed that the time stamps on the pasted machine strips for Patient 11's VS did not match the procedure times noted on the Moderate Sedation Procedure Record (were off by nearly one hour). The machine recordings did show a period of significantly low blood pressures for 10 minutes but no nursing notes provided clarity or explanation for the alteration from Patient 11's baseline blood pressure.

In an interview on 4/23/12 at 12:45 p.m. with RN 58, the nurse who cared for Patient 11, RN 58 indicated that she was frustrated with the inaccuracy of the VS machines but was not permitted to calibrate them. RN 58 stated that she was concerned about Patient 11's low blood pressure, tried verifying the reading with a different device, checked his fluid intake, but did not document any additional assessments or interventions.

Review on 4/30/12 at 10 a.m. of additional surgical records with NM 12 indicated the following:

Patient 14 (age 77 with high risk conditions of kidney failure, lung disease, diabetes) had a dye study of blood vessels attached to his kidney dialysis access device on 4/10/12 in the interventional radiology (IR) unit. Moderate sedation in frequent administrations over 10 minutes resulted in a fall in blood oxygen level and mentation, requiring administration of a narcotic reversal drug. The sedation RN did not document VS but pasted a VS machine print-out into the chart. The print-out times did not match the surgical care times, but did record abnormal breathing rates throughout the procedure that were not verified or commented on by the RN.

Patient 15 had a liver biopsy in the IR unit on 4/10/12. No sedation was administered. There was no documented evidence of monitoring throughout the procedure as VS were recorded on arrival at 8:30 a.m. and at transfer at 9:15 a.m., but not between.

Patient 16 had a liver biopsy in the IR unit on 4/11/12 with moderate sedation. The print-out VS strip showed incomplete entries at 8:10, 8:23, and 8:29, none of which corresponded to the surgical times of 9:18, 9:20, and 9:35. The RN did not document VS entries at 5 minute intervals.

Patient 17 had reduction of an arm fracture in the emergency room on 4/8/12 under deep sedation. The intraoperative record did not document sedation level at 5 minute intervals. The breathing rate was significantly elevated (50-65 breaths per minute when normal is 21-29 breaths per minute), as well as the heart rate (122-162 when normal is 80-140) from the time of ketamine administration until discharge, a 2 hour period, without clearly addressing why. Measurements of expired carbon dioxide as a more accurate reflection of the effects of ketamine were not documented.

Review of a policy titled, "Procedural Anesthesia/Analgesia - Adult - Hospitalwide," last reviewed 1/27/12, documented under item VIII-M that VS, pain and sedation levels were to be recorded every 2-5 minutes throughout the procedure and "it is acceptable to use a print-out from the monitor as long as this is posted in the chart." The policy did not require the print-out measurements to be accurate and verified as consistent with the patient's actual condition. The policy recommended the use of a device to measure expired carbon dioxide for deep sedation patients.

In an interview on 4/24/12 at 2:05 p.m. with NM 10, an experienced perioperative nurse manager, NM 10 agreed that the use of machine print-outs for intraoperative assessments was not standard in any operative setting. NM 10 expected that the person responsible for continuously assessing and monitoring a patient during surgery and moderate or deep sedation care would directly document the results of their care, and verify machine measurements rather than rely on them.

In an interview on 4/26/12 at 1:45 p.m. with MD 4, the Director of Anesthesia Services, MD 4 indicated that the standard in all surgical locations for documenting the condition of a patient during surgery and moderate or deep sedation was for the person responsible to directly record the assessments at 5 minute intervals (at least) and not interrupt continuous monitoring. MD 4 stated that when he performed such care he never printed and pasted a machine print-out in lieu of his own entries.

2. Continuous monitoring of moderate sedation patients was not ensured.

During observation of surgery for Patient 22 on 4/25/12 at 8:25 am and 9:10 am in the heart studies unit, the sedation RN 59 was observed to leave the room and unable to continuously view Patient 22's ventilation and condition on two occasions to fetch medications needed for the procedure.

Review of the records with hospital managers throughout the survey for Patients 11, 14, 15, 16, and 17 indicated that only one RN was documented to participate in care and no other RN was designated to perform circulating duties. The records for Patients 11, 15 and 16 lacked documentation of the physician administering local anesthetic for the surgery, a task typically managed by a circulating RN.

As described in the interview on 4/25/12 at 3:30 p.m. with NM 11, in some surgical units such as interventional radiology (IR) where Patient 11 was treated, the RN assigned to monitor a moderate sedation patient was also responsible to assist the surgeon, supervise the technician or unlicensed staff, fetch medications and supplies, and other tasks that interrupted the continuous monitoring of the patient's airway and condition.

In the interview with RN 58 on 4/23/12 at 12:45 p.m., RN 58 indicated that only one RN was present throughout Patient 11's liver biopsy under moderate sedation on 4/23/12. Additional circulating tasks were performed by either the sedation RN and/or the technician.

In an interview on 4/30/12 at 10 a.m. with NM 12, who managed the IR nursing unit, NM 12 confirmed that only one RN was typically assigned to cover a number of duties during IR procedures. IR procedures included liver and other organ/tissue biopsies, manipulation of blood vessels and devices attached to blood vessels, placement of tubes into the stomach, and other surgeries that carried significant risk for bleeding or injury to the surgical site. If items were needed or the surgeon needed assistance, the sedation RN or a technician would provide the assistance, or an emergency response team from elsewhere in the hospital would be summoned.

Review of a policy titled, "Procedural Anesthesia/Analgesia - Adult - Hospitalwide," last reviewed 1/27/12, documented under item VI-E that a minimum of one qualified RN would be present to continuously monitor physiologic parameters, pain and sedation level throughout the procedure, and to assist with the procedure. The policy did not emphasize that the person responsible for moderate or deep sedation monitoring should not interrupt monitoring to perform tasks such as assisting in the surgery, etc. Other staffing policies (e.g. Cardiac Cath lab) required a minimum of one RN for a sedation procedure with no additional RN staffing for these other nursing duties.

Review of the 2012 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 (licensed nurse 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.

3. Pre-operative nursing assessments were incomplete.

Review of Patient 11's preoperative records with NM 11 on 4/25/12 at 3:30 p.m. indicated that the preoperative nursing assessment was documented on a form titled "Pre-Procedure Checklist" and not on a a form titled "Ambulatory Surgi-Service Pre-op Record," which was available to staff. The Checklist was not designed to enter specific assessment findings so the RN squeezed in brief notes about Patient 11's heart, lungs and skin beside the VS and blood sugar measurements.

Similarly for Patients 14, 15, 16, and 20 who had outpatient surgeries under moderate or no sedation, the pre-operative nursing assessment was squeezed on to the Checklist. Additional aspects of a pre-operative assessment, such as co-existing health conditions that raise the patient's surgical risks, were not documented. Patient 15, for example, had not taken her blood pressure medication on the day of surgery. The admission blood pressure was elevated. No one documented whether Patient 15 had symptoms of high blood pressure (headache, dizziness, nausea, weakness) before proceeding with surgery. Patient 15's blood pressure remained high throughout surgery, which increased the risk for bleeding from her liver biopsy.

In a telephone interview on 4/25/12 at 4:10 p.m. with RN 50, who admitted Patient 11 for his liver biopsy on 4/23/12, RN 50 stated that she routinely documented the pre-operative nursing assessment on the Checklist. RN 50 stated that the assessment included a brief entry about the Patient's heart, lungs and skin. She did not routinely inquire about or document the patient's health conditions.

In an interview on 4/25/12 at 3:30 p.m. with NM 11 stated that most of the outpatient surgery patients were evaluated through a pre-operative anesthesia screening process, except for the IR patients. The screening was performed prior to the day of surgery and identified co-existing health conditions, medications, allergies, past surgical and anesthesia experiences, and high risk aspects (obesity, sleep apnea, etc) in order to prepare the patient for surgery. The IR patients, however, did not benefit by the pre-operative planning system.

Review of the 2012 AORN Guidance Statement on Preoperative Patient Care in the Ambulatory Surgery Setting urged the perioperative services to "be organized to address the special needs of their patients. Admission criteria with written guidelines for preadmission should be developed. A preadmission nursing assessment should include at least an appropriate baseline physical assessment, allergies, emotional assessment, pain assessment medication history, anesthetic history, results of testing, identification of physical alterations that require additional equipment or supplies. Special screening may be needed for high-risk patients with certain conditions (e.g., cardiac disease, obesity, sleep apnea). Findings from the history, physical examination, and designated studies must be documented in the record before surgery/anesthesia care is performed. A review of the preadmission information and a baseline admission physical assessment should also be documented on the day of surgery."

4. Deep sedation care was performed unsafely by unqualified persons.

Review of the medical record for Patient 17 on 4/30/12 at 12:15 p.m. with the Director of Perioperative Services (DPS) indicated that Patient 17, age 2, had reduction of fractures in the right arm performed under deep sedation on 4/8/12 in the emergency room. [Deep sedation is the administration of drugs to reduce pain and awareness during a surgical procedure; the intended depth of sedation makes a patient not easily aroused but can respond purposefully to repeated or painful stimulation; the drive to breathe may be impaired.] Nursing notes indicated that a general anesthetic agent (ketamine 22 milligrams) was administered through a plastic tube into Patient 17's vein (IV, intravenous) by a RN at 6:31 p.m. At 6:32 p.m. the breathing rate rose to 50 breaths per minute (normal is 21-29) and heart rate was 120 beats per minute (normal is 80-140). The fracture reduction was performed by a physician at 6:33 p.m. Starting at 6:34 p.m., the heart rate rose from 141 to 162, the breathing rate rose to 65, and the patient was intermittently described as sleeping, though no sedation score was recorded. Patient 17 continued to "sleep" until 7:30 p.m. when he was drinking juice and the heart rate finally fell back to 122. The breathing rate, however remained 47 to 62 until discharge at 8:50 p.m. No monitoring of expired carbon dioxide was documented. All the monitoring was documented by an RN. The physician made entries after the procedure at 8:30 p.m. (procedure note, tolerated well, no complications) and a discharge note at 8:32 p.m. (patient symptoms improving, no symptoms or objective findings that are life or limb threatening, stable for disposition from the emergency room).

According to Lexi-comp (http://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/7135), ketamine has significant effects on body systems lasting up to 2.5 hours. The drug effects continue and persist for up to 2.5 hours after administration and require close monitoring and support for life-threatening effects.

In an interview with MD 6, an emergency room (ED) physician, on 4/24/12 at 10:30 a.m., MD 6 stated that he and other physicians routinely utilized deep sedation to perform procedures on patients in the emergency room, especially children. If a general anesthetic drug was selected to be administered IV, the treating physician would administer the drug, observe the patient briefly, then proceed to perform the procedure while a RN documented the effects of the drug and the surgery (monitoring) on the patient. The physician generally did not document any monitoring. If the general anesthetic drug was selected to be administered by an injection into the muscle (IM), the RN could administer it and also perform the monitoring. There was no requirement to request the presence of an additional qualified anesthesia provider to participate in the deep sedation care. MD 6 stated that ketamine produced a state of immobility and unresponsiveness that was ideal for children and patients who were likely to move about and make the procedure difficult. The depth of sedation with ketamine was difficult to determine because of this particular effect, and must be considered deep. Because no other qualified anesthesia professional was routinely present during such procedures, if a patient decompensated or required airway management interventions, MD 6 would need to interrupt the surgical procedure to tend to the patient. He would not expect an RN to possess the necessary skills to recognize spasm of the vocal cords, muscle rigidity, and ventilation alterations that can occur with deep sedation early enough to avoid a fall in blood oxygen levels or worse. Monitoring of carbon dioxide with a special airway device was not routinely performed in the ED. MD 6 stated that he was responsible for both the surgery and the deep sedation monitoring. To achieve those goals simultaneously, he kept his peripheral vision on the machines that measured the patient ' s vital signs, but was not always able to view the patient's skin color, ventilation effectiveness, or depth of sedation. After the procedure was completed, MD 6 indicated he would not remain with the patient to further monitor the extended effects of the deep sedation, but expected the RN to do that and call for help if needed.

In an interview on 4/24/12 at 10:15 a.m. with RN 51, who routinely worked in the ED, RN 51 stated that she completed a training for moderate and deep sedation in February 2012. She learned from the training that RNs could administer ketamine IM, and perform the monitoring portion of all deep sedation care. RN 51 indicated that the hospital RNs were not certified registered nurse anesthetists.

Review of a policy titled, "Procedural Anesthesia/Analgesia - Adult - Hospitalwide," last reviewed 1/27/12, documented under item IV-E-1 that RNs MAY NOT administer Propofol, Etomidate, Precedex or Ketamine IV (general anesthetic agents) for the purpose of deep sedation; however the RN may administer IM Ketamine. [Ketamine IM is the same drug as Ketamine IV.] Item IV-F listed among equipment requirements continuous expired carbon dioxide monitor with the term "preferred" underlined for Deep Sedation, suggesting it was optional. The references for this policy included the 10/20/10 American Society of Anesthesiologists (ASA) Statement on Granting Privileges for Deep Sedation to Non-Anesthesiologist Sedation Practitioners.

Review of the 10/20/10 ASA Statement on Granting Privileges for Deep Sedation to Non-Anesthesiologist Sedation Practitioners clearly warned under item 2-Advisory that "any professional who administered and monitored deep sedation must be dedicated to that task. The non-anesthesiologist sedation practitioner who administered and monitored deep sedation must be different from the individual performing the diagnostic or therapeutic procedure, similar to the guidelines for moderate sedation care. Deep sedation practitioners must be qualified with skills and experience in airway management, ventilating patients whose breathing drive was depressed by drugs, as well as patients whose airways become obstructed, skills for use of expired carbon dioxide monitors, skills to insert a variety of airways (oral, nasopharyngeal, laryngeal mask airway, intubation), skills to recognize heart rhythm abnormalities, and advanced cardiac life support certification (ACLS, or similar training for children)." The hospital presented no evidence that RNs possessed all such skills or were qualified anesthesia providers.



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5. On 4/23/12 at 11:35 am, several packages of scissors and hemostats were observed in sterile packages with closed hinges in the cabinet of the nursery area. In a concurrent interview the Quality Manager (QM) confirmed the sterile instruments in the nursery area were packaged with closed hinges and should have been in the open position for sterilization.

According to Disease Control prevention Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008, under packaging, "hinged instruments should be opened; items with removable parts should be disassembled unless the device manufacturer or researchers provide specific instructions or test data to the contrary... The packaging material must allow penetration of the sterilant, provide protection against contact contamination during handling, provide an effective barrier to microbial penetration, and maintain there sterility of the processed item after sterilization."

On 4/26/12 at 8:40 am, Nursing Manager (NM) 11 stated that monitoring the temperature and humidity was not done for the PACU.

According to AORN (Association for periOperative Nurses) Perioperative Standards and Recommended Practices, 2012 Edition, under Recommended Practices for a Safe Environment of Care, reads, "Recommendation V Potential hazards associated with HVAC (Heating, Ventilation, and Air Conditioning) systems in the practice setting should be identified, and safe practices should be established...V.b. Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas. Low humidity increases the risk of electrostatic charges, which pose a fire hazard in an oxygen-enriched environment or when flammable agents are in use and increases the potential for dust. High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures are performed... V.b.2. Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC system. V.c. Temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC system. V.c.1. Temperature should be maintained between 68 degree Farenheit (F) to 73 degree F within the operating room suite and general work areas in sterile processing... V.c.3. A temperature of 70 degree F to 75 degree F should be maintained in recovery areas and cardiac catheterization rooms. V.d. The air-exchange rate in the perioperative area should be carefully controlled...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 air exchanges per hour with a recommended range of 20 to 25 air exchanges. Cardiac catheterization rooms: 15 air exchanges per hour. Postanesthesia care unit: six air exchanges per hour. Compressed-gas storage area: eight air exchanges per hour. Sterile storage area: four air exchanges per hour.

On 4/25/12, a request for evidence of air exchanges monitored within the hospital was made to the Engineering department. Air exchange monitoring documentation revealed that for operating rooms (ORs) 1 through 6, which included endoscopy procedures and cardiac cath lab, the bronchoscopy room, and the operating rooms at an ambulatory surgery center (ASC), there was no documentation of air exchanges for the ORs for postanesthesia care unit, compressed-gas storage areas, and sterile storage areas.

On 4/26/12, temperature and humidity logs were reviewed. The logs for OR 5 and 6, Radiology, and the ASC did not have the normal temperatures and humidity ranges posted for when to notify the Engineering department.

The log for OR Room 1 for the months of 1/12, 2/12, and 3/12, revealed that for 20 of 84 days, humidity was less than 30% humidity. The log for OR Room 3 for the months of 1/12, 2/12, and 3/12, revealed that for 13 of 82 days humidity was less than 30% . There was a period of 6 of 8 days in 1/12 that documented less than 30% humidity. There was no documentation that Engineering had been notified, or that action was taken.

On 4/26/12 at 10:35 am, the temperature and humidity logs were reviewed with the Infection Control Coordinator (ICC). The logs for Radiology beginning 2/22/12 showed that for 6 of 7 days, temperature was less than 68 degree F.

The logs for the ASC did not include the month of 4/12. The logs provided were for 10/11 through 3/12. More than half of the documented temperatures were below 68 degrees F in OR 1:

3/12: 9 of 12 documented temperatures were below 68 degrees F;
2/12: 10 of 10 documented temperatures were below 68 degrees F;
1/12: 8 of 8 documented temperatures were below 68 degrees F:
12/11: 7 of 11 documented temperatures were below 68 degrees F;
11/11: 8 out of 8 documented temperatures were below 68 degrees F; and
10/11: 8 out of 10 documented temperatures were below 68 degrees F.

There was no documentation that Engineering was contacted or that any action was taken. In a concurrent interview, the ICC confirmed the above findings.

Based on staff interview, medical record and document review, the hospital failed to ensure that a complete and accurate examination and assessment of the patient, performed by a qualified individual and updated by the operating surgeon, to reflect the current condition of the patient was documented, prior to surgery in accordance with hospital policies and acceptable standards of practice for 6 of 9 surgical patient records reviewed (Patients 11, 14, 15, 16, 17, and 20). This failure resulted in the potential to not recognize the need (1) for additional intraoperative support, treatments, or consultation, in order to arrange for a safe surgery and anesthesia plan, and (2) to minimize the risk for adverse outcomes for all surgical patients.

Findings:

Review of the May 2011 Medical Staff Rules and Regulations documented under item A-4 that a history and physical examination (H&P) was required for all patients undergoing surgical procedures. The H&P must contain (1) history of present illness; (2) medical and surgical history, medications and allergies; (3) physical exam; (4) impression; and (5) plan. The H&P should be sufficient in information to allow appropriate medical care of the patient by other Practitioners in an emergency. Item F-4 further clarified that elective surgical procedures performed anywhere in the Hospital must have a preoperative history and physical as defined in Section A.

Review on 4/25/12 at 3:30 p.m. of the medical record for Patient 11 with a nurse manager for the pre and post-operative nursing service, NM 11, indicated the following:

Patient 11 had an elective outpatient surgical procedure (liver biopsy) under moderate sedation performed on 4/23/12 by a radiologist, MD 8. [Moderate sedation is a type of anesthesia service and treatment utilizing medications to reduce a patient's awareness and pain during surgical procedures, but still respond to both verbal and light physical stimulation; also known as moderate sedation/analgesia, IV (intravenous, medications injected directly into a vein) sedation, or conscious sedation.] A brief "Progress Note" authored by MD 3 and dated 4/4/12 was presented as the pre-surgical physician history and physical examination (H&P) assessment. The H&P lacked important patient information, such as weight or obesity, heart rate, allergies, medications, past medical history and co-existing health conditions. On admission for surgery, no nursing assessment was clearly documented. Instead, a form titled "Pre-Procedure Checklist" noted selected assessment data, including measurements of vital signs, height, weight, blood sugar measurement, allergies, and findings of heart, lungs, and skin per the admitting nurse (RN 50). A form titled "Moderate Sedation Plan (Adult) and Post-Procedure Note," signed by MD 8, checked a box to indicate that MD 8 "examined the patient and there is no significant change from my previous examination." No previous examination by MD 8 was documented. No allergy history was documented by MD 8. The specific features of an airway assessment (e.g. mouth opening, neck shape and motion, heart sounds and rhythm, lung sounds) were not documented by MD 8, nor entirely by MD 3 in his report. A box was checked to designate "ASA Class I." (ASA Class is a surgical risk classification system originally developed by the American Society of Anesthesiologists [ASA]. ASA Class I means a normal healthy patient with no co-existing health conditions.) Nursing entries documented inconsistent information about medication allergies. One entry noted no allergies, another noted allergy to sulfa medication.

In a telephone interview with RN 50 on 4/25/12 at 4:10 p.m., RN 50 indicated that for patients undergoing interventional radiology procedures, such as Patient 11, H&Ps were routinely limited in content by some referral doctors (such as MD 3). Nursing staff was expected to verify the presence of an H&P, which meant that a physician had documented some entry about the patient's heart and lungs within 30 days. RN 50 stated that the elements of a pre-surgical nursing assessment included examination of heart, lungs and skin, plus the vital signs found on the Pre-Procedure Checklist, but not a specific review of the patient ' s past and other health conditions. RN 50 stated that Patient 11 told her something to lead her to believe he may be diabetic, and for that reason obtained a blood sugar measurement, even though it was not ordered. She recalled that Patient 11 said he had high blood pressure but could not remember the name of the medication he took for that condition.

In an interview on 4/23/12 at 12:45 p.m. with RN 58, who performed moderate sedation care for Patient 11 throughout the surgery on 4/23/12, RN 58 stated that MD 8 spoke with Patient 11 to obtain an informed consent prior to the surgery, but did not directly examine him or his airway, though MD 8 checked the form to indicate an examination was done.

In an interview on 4/26/12 at 1:30 p.m. with the MD 4, who served as the Chief of the Anesthesia Service, MD 4 indicated that the policies and expectations for moderate and deep sedation care had been recently adjusted to be based on the recommendations of the ASA. MD 4 acknowledged that ASA recommended that physicians performing or supervising the care of patients receiving sedation were expected to perform and document an examination of the airway features that are known to pose a risk for sedation complications (such as obesity, short neck, large tongue, incomplete opening of the mouth, limited neck motion, lung congestion, and heart rhythm disorders, in order to recognize any special needs or difficulties to support or rescue the airway. MD 4 agreed that all surgical patients were to have a physician H&P assessment (consistent with the medical staff rules and regulations) performed within 30 days of the surgery, and updated by the person performing the surgery before proceeding with the surgery. MD 4 stated that H&Ps should document at least the patient's allergies, medications, obesity, and past medical history, particularly for conditions that raise one's surgical risks.

Review of hospital policies and trainings related to sedation care did not define the elements of an airway assessment. The policies did not require a physician to document the actual current examination (specific features of the airway) findings prior to surgery and sedation. The policies did require compliance with the medical staff rules and regulations.

Further medical record reviews on 4/30/12 at 10 a.m. with NM 12 indicated the following:

Patient 15 had an elective liver biopsy (no sedation or anesthesia administered) performed by MD 9 on 4/10/12. An H&P dated 3/21/12 from a referral physician failed to document allergies or treatment for high blood pressure, despite an elevated blood pressure measurement of 147/99 (normal is 120/80) in the report. Nor did the H&P update by MD 9 document allergies or an assessment of high blood pressure, despite an elevated blood pressure measurement noted by the admitting nurse. The admitting nurse also noted a height of 5 feet and weight of 208 pounds, which increased Patient 15's risk for surgery and sedation, had sedation been administered as indicated on the consent form that was signed by Patient 15. (Patient 15 declined narcotic medications for pain after surgery due to recovery from addiction. Addiction was not documented in the physician assessment related to the decisions and plan for sedation care.) Nursing notes documented that Patient 15 usually took a medication for high blood pressure, but did not take it on the day of surgery. Patient 15's blood pressure before surgery was 168/112 after surgery blood pressure was 169/105, a medication for high blood pressure was ordered and administered after that, but blood pressure remained nearly as high through the recovery observation for about 2 hours, despite pain levels of zero (pain can also elevate blood pressure but did not appear to be relevant in this case). Patient 15's persistently elevated blood pressure measurements increased the risk for bleeding from the surgical site.

Patient 14, age 77 with end stage kidney failure, diabetes, chronic lung disease, and wheelchair-bound, had an x-ray procedure (insertion of tubes and dye into a dialysis vein graft of the arm to study the blood flow) with moderate sedation on 4/10/12 by MD 9. Patient 14's admission blood oxygen level and lung exam noted by a nurse were abnormal. However, specific features of an airway assessment, or measures to minimize Patient 14's risk for airway compromise, prior to surgery and sedation were not documented as part of the sedation plan by MD 9. Multiple administrations of sedation and pain medications were given over 10 minutes during the procedure, resulting in altered mentation and lowered blood oxygen levels that required administration of increased oxygen and a rescue drug to reverse the pain medication effects.

Patient 16 had an elective liver biopsy with moderate sedation performed by MD 9 on 4/11/12. An H&P, dated 4/3/12, noted surgical risk factors of obesity, chronic lung disease, and high blood pressure. The H&P update, however, noted "no history of difficult airway or obstructive sleep apnea," without documenting the specific features of an airway assessment prior to surgery and sedation.

Patient 20, age 87 with mild asthma, heart murmurs, and other minor conditions documented on a comprehensive H&P dated 4/3/12, had an outpatient elective scope procedure of her airways (bronchoscopy) with biopsies performed on 4/11/12. The updated H&P signed by the same physician who documented the 4/3/12 H&P (which did include an airway assessment) noted he had examined Patient 20 and there were no changes. However, he assigned an ASA class level of 5, which meant Patient 20 was near death and not expected to survive without the procedure. ASA 5 clearly contradicted the description of Patient 20 as alert, attentive, well developed, well nourished, and in no distress, that was documented in the H&P.

Patient 17, age 2, had an orthopedic procedure (reduction of arm fractures) in the emergency room under the effects of a general anesthetic agent (ketamine for deep sedation) on 4/8/12. The physician assessment did not document a full airway examination to include the mouth and heart. (This record was reviewed with the Director of Perioperative Nursing on 4/30/12 at 12:15 p.m.)

Review of a policy titled, "Patient Care-Patient Monitoring During Invasive Procedures without the use of Conscious Sedation," last reviewed May 2008, noted, "Patient will need a recent History and Physical evaluation at time of Imaging procedure from the referring physician. If the patient has not had a recent History & Physical that would be pertinent to the procedure, then a short form history and physical will need to be completed upon arrival to the Imaging Department and prior to the procedure."

Review on 10/12/11 of a chapter from the online Merck Manual for Professionals (a nationally recognized reference for medical practice) titled Preoperative Evaluation retrieved at documented that a preoperative evaluation was intended to minimize surgical risk by identifying correctable abnormalities and by determining whether additional monitoring was needed or whether a procedure should be delayed so to better control an underlying disorder. The preoperative physical examination should include not only the areas affected by the surgical procedure but also the cardiopulmonary system and a search for any signs of ongoing infection (e.g. lungs, skin). Surgical risk factors were identified to include age greater than 70 years, heart attack within 6 months, poorly controlled heart failure, other heart diseases, co-existing infections, poor gas exchange in the lungs, low blood potassium level, and low blood protein level.

Review 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 (included moderate sedation). This evaluation must include airway assessment, anesthesia risk assessment and anesthesia drug and allergy history.

Review of standard ST-25 from the American College of Surgeons (ACS) titled, "ACS Statement on Principles Underlying Perioperative Responsibility," retrieved from , under item 4 documented 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, if indicated, in order to ensure anesthesia care that was best for the patient.

Based on staff interview and policy and medical record review, the hospital failed to ensure that the risks, benefits, and alternatives to surgery were documented by the surgeon for 2 of 9 surgical records reviewed (Patients 11 and 17), in accordance with hospital policy. This failure posed a threat that surgery could proceed against a patient's wishes.

Findings:

Review on 4/24/12 at 3:30 p.m. of the medical record for Patient 11 with administrative quality management staff (VPQM), the VPQM indicated that physicians were responsible to directly speak with surgical patients to obtain an informed consent that clearly explained the risks, benefits and alternatives prior to the planned procedure. A form (Moderate Sedation Plan Adult and Post-Procedure Note) was developed where physicians could document that task, unless they chose to document it in some other way. For Patient 11, the surgeon checked a box on the form that stated, "The risks benefits and alternatives to procedure and to moderate sedation were discussed with patient/legal representative, including the risks of:" and the remaining portion was blank. A box was checked, "See Dictation." A dictated procedure report by the surgeon documented that the procedure and potential complications were explained to the patient and informed consent obtained. However, the risks, benefits, and alternatives to the procedure were not named.

Review on 4/30/12 at 12:15 p.m. of the medical record for Patient 17 with the Director of Perioperative Services (DPS), the DPS confirmed that Patient 17 had an orthopedic surgery procedure (reduction of a forearm fracture) under deep sedation in the emergency room on 4/8/12. The consent verification form documented the name of the procedure to be performed under conscious sedation. (Conscious sedation, also known as moderate sedation, involves the use of drugs to reduce pain and awareness of the procedure but still preserve the ability to respond to light stimulation. Deep sedation involves the use of drugs to reduce pain and awareness to a deeper level with limited movement or responses to stimulation. Risks for each level of sedation differ in severity.) The physician did not check boxes related to informed consent on the The Moderate (nor the Deep) Sedation Plan Adult and Post-Procedure Note. In the physician generated electronic notes entered after the procedure, the physician documented that the procedure and possible complications were discussed with the patient's representative, who consented. The specific complications, however, were not described. No other documentation verified the specific risks, benefits, and alternatives prior to administering to Patient 17 the procedures that required consent.

Review of a policy titled, "Consents - Hospitalwide," last approved 7/08, documented under item III.G, "An Informed Consent (verification) Form shall be signed by the patient before initiation of a surgical, diagnostic or therapeutic procedure which involves known risk of bodily harm. The physician is responsible for obtaining the informed consent, including discussing and documenting risks, benefits, and alternatives." Item IV.C documented that the purpose of informed consent was to indicate that the patient/representative was aware that he/she had the right to consent to or refuse a procedure.

Based on observation, staff interview, and document review, the hospital failed to ensure that each operating room was equipped with a tracheotomy kit that was immediately available, to ensure preparedness and timely emergency response for all surgical patients.

Findings:

During a tour of the Interventional Radiology (IR) surgical unit (a location where blood vessel procedures, organ and tissue biopsies, and stomach tube insertions were routinely performed) on 4/30/12 at 11:40 a.m. with the Radiology Manager (RM), the emergency supply (crash cart) was inspected. Among the items stored in the cart, no tracheotomy kit (surgical tools used to provide direct access to the large lower airway when the airway above was obstructed) was identified.

Review of the Crash Cart Inventory Sheet for the IR unit did not list a tracheotomy kit. The RM confirmed that a tracheotomy kit was not immediately available to the IR unit for patients whose airways could not be supported with other equipment during a serious surgical crisis.

Based on staff interview and medical record and document review, the hospital failed to ensure adequate immediate post-operative care was provided in accordance with physician orders, hospital policy, and acceptable standards of care for two of nine surgical patient records reviewed (Patients 12 and 13). This failure in post-surgical monitoring put patients at risk for potential injury and adverse events from non-recognition of the need for timely critical care interventions.

Findings:

Review of a policy titled, "Surgery - Perioperative Services Structure Standards," last approved 12/08, indicated that the Association for peri-Operative Registered Nurses standards were utilized for perioperative services that included the heart studies unit (cardiac cath lab, CVOR).

Review of the 2012 AORN Standards and Recommended Practices, under Recommended Practices for Managing the Patient Receiving Moderate Sedation/Analgesia, documented for item VII (a) that the same monitoring parameters (safe boundaries of specified patient characteristics) used during the procedure (e.g. vital sign measurements every 5 minutes for sedation/analgesia) should be used during the recovery phase. Postoperative care and monitoring should be consistent for all patients, should include wounds, dressings, drains, pain, heart rate and rhythm, level of consciousness, blood pressure, heart monitoring, oxygen level, and breathing assessment by direct observation and/or listening to the lungs. Item VIII (b) (discharge readiness) directed that patients who received sedation/analgesia should remain awake for at least 20 minutes without stimulation before they were considered ready for discharge. Use of a sedation scale in combination with a modified wakefulness test may ensure a more objective discharge criterion, compared to using the caregiver's judgment alone. Item VIII(d)(1) documented that written discharge criteria should include an evaluation of the patient for nausea, vomiting, pain, chills, shivering, the surgical site condition, bleeding, emotional status, fluid and urinary status, cognitive abilities, peripheral circulation, and temperature before being discharged to home. The criteria should include a numeric scoring system to evaluate the patient's condition.

In an interview on 4/26/12 at 1:45 p.m. with MD 4, who served as the Director of Anesthesia Services, MD 4 indicated that moderate/deep sedation and anesthesia care was based on the standards and recommendations of the American Society of Anesthesiologists (ASA).

Review of the American Society of Anesthesiologists committee standard titled "Standards for Postanesthesia Care," last amended 10/21/09, indicated that all patients who have received general anesthesia, regional anesthesia or monitored anesthesia care (MAC) shall receive appropriate postanesthesia management (as addressed in the statement). Standard IV specified that a patient's condition shall be evaluated continually in the PACU. Particular attention should be given to monitoring oxygenation, ventilation, circulation, level of consciousness and temperature. Use of an appropriate PACU scoring system is encouraged for each patient on admission, at appropriate intervals prior to discharge and at the time of discharge.

Review of hospital policies during the survey indicated the following:

Review of a policy titled, "Perioperative Post Anesthesia Care of the Post Procedure Patient - Hospitalwide," last reviewed April 2012, was intended to provide care guidelines for post-surgical, post interventional radiology, endoscopy and post cardiac cath lab patients and any other patients requiring conscious sedation. [Conscious or moderate sedation is a type of anesthesia service and treatment utilizing medications to reduce a patient's awareness and pain during surgical procedures, but still respond to both verbal and light physical stimulation.] Item II-A under Guidelines read, "all vital signs will be taken every five minutes for the first twenty and then every fifteen minutes until the first hour is complete, then every thirty minutes for one hour, then every hour until discharge criteria have been met." Item II-H noted, "The Aldrete scoring system will be performed and documented on patient arrival and discharge from the post anesthetic recovery phase. It evaluates the patient's ability to move, respiration, circulation, consciousness and oxygen saturation." Items III through X explained how to assess for effective breathing, blood circulation, skin color, and pain by direct examination, not relying only on machine measurements.

Another policy titled, "Care of the Patient Undergoing Cardiac Catheterization - Hospitalwide," last reviewed 7/10, gave somewhat different direction for post-procedure and recovery care, item VIII. The receiving nurse would obtain vital sign measurements, assess and document level of consciousness, pain, blood vessel access site, strength of pulses on admission, reassess every 15 minutes x 4, every 30 minutes x 4, every hour x 4, then per unit routine. The policy did not require use of the Aldrete scoring system.

Another policy titled, "Procedural Anesthesia/Analgesia - Adult - Hospitalwide," last reviewed 1/27/12, under item VII-O of the procedure for Immediate Post-procedure Monitoring directed for staff to assess and document vital sign measurements every 5 minutes x 20 minutes either in the procedure area or post-anesthesia recovery unit (PACU) or Critical Care Unit, and to continue to record Aldrete scores every 15 minutes until 8 or greater. Patients in critical care will have at least one Aldrete score recorded upon receipt of the patient from the procedure area. Before releasing a post-surgical patient to a sending unit, specific criteria were outlined, after which "monitoring may go to every 15 minutes until ready to leave the procedure area and Aldrete Score of 8 or above is reached." Item VIII-S further noted that for inpatients returning to a sending unit, vital sign measurements, pain, and sedation scale will be monitored every 15 minutes x 2, then every 30 minutes x 2. Item IX directed for documentation of heart rate, blood pressure, respiratory rate, sedation and pain scale, oxygen saturation every 5 minutes x 20 minutes during the immediate post-procedure recovery period.

In a collaborative record review on 4/24/12 at 2:05 p.m. of the care of Patient 12 with a perioperative nurse manager, NM 10, the following was identified:

Patient 12 had surgery in the heart studies unit (cardiac cath lab) under moderate sedation [Moderate sedation is a type of anesthesia service and treatment utilizing medications to reduce a patient's awareness and pain during surgical procedures, but still respond to both verbal and light physical stimulation] on 3/9/12. The procedure ended at 1:49 p.m., the patient left the cath lab at 2:02 p.m., and arrived in the intensive care unit (ICU), a critical care nursing unit, at 2:05 p.m. Post-operative orders directed critical care staff to "assess & document vital signs including distal pulse and arterial access site every 15 minutes x 4, every 30 minutes x 4, every hour x 4, then per unit routine." On arrival to the ICU a nursing assessment was documented that included pulses and circulation, heart exam, lung sounds and depth of breathing, activity (muscle strength and movement), pain, level of consciousness, skin condition, intravenous catheter condition, and vital sign measurements (VS, measures of oxygen, heart rate, breathing rate, blood pressure). However, other than VS every 15 minutes which were recorded from a machine into the electronic medical record, and occasional pain scores, the assessments of Patient 12's post-surgical condition by the same features described above, or by an Aldrete score, were not specifically documented at 15 minute intervals thereafter, per policy, or even by the direction of the physician orders. Sedation and pain scale measurements were not documented every 5 minutes x 20 minutes, followed by every 15 minutes x 2, then every 30 minutes x 2. At 4 p.m., an entry noted "assessment unchanged Observe Per Policy," but the specific details of the assessment were also not documented then (2 hours after surgery).

NM 10 indicated that for patients who were transferred to a critical care unit or other nursing unit directly following a surgical procedure, the same post-anesthesia and post-surgical assessment and monitoring standards as were used in the PACU applied in those locations, until the patient was determined adequately recovered from the surgical, and anesthesia, care.

Review on 4/30/12 of the medical record for Patient 13 indicated that Patient 13 had an urgent surgical procedure in the endoscopy operating room (OR) on 4/25/12 for low blood pressure and a bleeding stomach ulcer. He was transferred from the emergency room to the endoscopy OR at 8:30 a.m. Moderate sedation treatments were administered, and surgical treatments to stop the bleeding sites were also administered. Blood transfusion was in progress as the surgery was begun. The surgery ended at 9:14 a.m. Monitoring of VS, pain, sedation level, every 5 minutes x 20 minutes was documented until 9:34 a.m., when Patient 13 was returned to the emergency room. However, subsequent monitoring in the emergency room between 9:34 a.m. and his arrival to a critical care unit at 2:25 p.m. did not conform to the policy-directed assessment features or Aldrete documentation required of a PACU, critical care unit, or sending unit (sedation and pain scale, skin, circulation, quality and depth of breathing, etc).

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 evidenced by:

A. The hospital failed to ensure that anesthesia services were organized when a general anesthetic agent was administered (and monitored) by an unqualified person (not a qualified anesthesiologist, a doctor of medicine or osteopathy, a dentist, oral surgeon or podiatrist who was qualified to administer anesthesia, a certified registered nurse anesthetist, or an anesthesiologist's assistant). Refer to A1001.

B. The hospital failed to ensure a complete pre-anesthesia evaluation was documented by the qualified anesthesia provider, prior to a deep sedation procedure. Refer to A1003.

C. The hospital failed to ensure that policies provided for a complete and accurate intraoperative anesthesia record be documented. Refer to A1004.

D. The hospital failed to ensure that a post-anesthesia evaluation was completed and documented by a qualified anesthesia provider, in accordance with hospital policy. Refer to A1005.

These failures put patients at risk for unsafe anesthesia care by persons lacking the skills to manage the effects of deep sedation, and for delays in recognition and rescue interventions for adverse effects of anesthesia treatments.

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

Based on staff interview, medical record, and document review, the hospital failed to ensure that anesthesia services were appropriately organized when a general anesthetic agent was administered (and monitored) by an unqualified person (not a qualified anesthesiologist, a doctor of medicine or osteopathy, a dentist, oral surgeon or podiatrist who was qualified to administer anesthesia, a certified registered nurse anesthetist, or an anesthesiologist's assistant) for one of one deep sedation records reviewed (Patient 17). This failure put patients at risk for unsafe anesthesia care by persons lacking the skills to manage the effects of deep sedation.

Findings:

Review of the medical record for Patient 17 on 4/30/12 at 12:15 p.m. with the Director of Perioperative Services (DPS) indicated that Patient 17, age 2, had reduction of fractures in the right arm performed under deep sedation on 4/8/12 in the emergency room. [Deep sedation is the administration of drugs to reduce pain and awareness during a surgical procedure; the intended depth of sedation makes a patient not easily aroused but can respond purposefully to repeated or painful stimulation; the drive to breathe may be impaired.] Nursing notes indicated that a general anesthetic agent (ketamine 22 milligrams) was administered through a plastic tube into Patient 17's vein (IV, intravenous) by a RN at 6:31 p.m. At 6:32 p.m. the breathing rate rose to 50 breaths per minute (normal is 21-29) and heart rate was 120 beats per minute (normal is 80-140). The fracture reduction was performed by a physician at 6:33 p.m. (before much of the ketamine took effect). Starting at 6:34 p.m., the heart rate rose from 141 to 162, the breathing rate rose to 65, and the patient was intermittently described as sleeping, though no sedation score was recorded. Patient 17 continued to "sleep" until 7:30 p.m. when he was drinking juice and the heart rate finally fell back to 122. The breathing rate, however remained 47 to 62 until discharge at 8:50 p.m. No monitoring of expired carbon dioxide was documented. All the monitoring was documented by an RN. The physician made entries after the procedure at 8:30 p.m. (procedure note, tolerated well, no complications) and a discharge note at 8:32 p.m. (patient symptoms improving, no symptoms or objective findings that are life or limb threatening, stable for disposition from the emergency room), despite the persistently elevated heart and breathing rates.

In an interview with MD 6, an emergency room (ED) physician, on 4/24/12 at 10:30 a.m., MD 6 stated that he and other physicians routinely utilized deep sedation to perform procedures on patients in the emergency room, especially children. If a general anesthetic drug was selected to be administered IV, the treating physician would administer the drug, observe the patient briefly, then proceed to perform the procedure while a RN documented the effects of the drug and the surgery (monitoring) on the patient. The physician generally did not document any monitoring. If the general anesthetic drug was selected to be administered by an injection into the muscle (IM), the RN could administer it and also perform the monitoring. There was no requirement to request the presence of an additional qualified anesthesia provider to participate in the deep sedation care. MD 6 stated that ketamine produced a state of immobility and unresponsiveness that was ideal for children and patients who were likely to move about and make the procedure difficult. The depth of sedation with ketamine was difficult to determine because of this particular effect, and must be considered deep. Because no other qualified anesthesia professional was routinely present during such procedures, if a patient decompensated or required airway management interventions, MD 6 would need to interrupt the surgical procedure to tend to the patient. He would not expect an RN to possess the necessary skills to recognize spasm of the vocal cords, muscle rigidity, and ventilation alterations that can occur with deep sedation early enough to avoid a fall in blood oxygen levels or worse. Monitoring of carbon dioxide with a special airway device was not routinely performed in the ED. MD 6 stated that he was responsible for both the surgery and the deep sedation monitoring. To achieve those goals simultaneously, he kept his peripheral vision on the machines that measured the patient's vital signs, but was not always able to view the patient's skin color, ventilation effectiveness, or depth of sedation. After the procedure was completed, MD 6 indicated he would not remain with the patient to further monitor the extended effects of the deep sedation, but expected the RN to do that and call for help if needed.

In an interview on 4/24/12 at 10:15 a.m. with RN 51, who routinely worked in the ED, RN 51 stated that she completed a training for moderate and deep sedation in February 2012. She learned from the training that RNs could administer ketamine IM, and perform the monitoring portion of all deep sedation care. RN 51 indicated that the hospital RNs were not certified registered nurse anesthetists.

Review of a policy titled "Procedural Anesthesia/Analgesia - Adult - Hospitalwide," last reviewed 1/27/12, documented under item IV-E-1 that RNs MAY NOT administer Propofol, Etomidate, Precedex or Ketamine IV (general anesthetic agents) for the purpose of deep sedation; however the RN may administer IM Ketamine. [Ketamine IM is the same drug as Ketamine IV.] Item IV-F listed, among equipment requirements, continuous expired carbon dioxide monitor with the term "preferred" underlined for Deep Sedation, suggesting it was optional. The references for this policy included the 10/20/10 American Society of Anesthesiologists (ASA) Statement [sic for Advisory] on Granting Privileges for Deep Sedation to Non-Anesthesiologist Sedation Practitioners. Review of the hospital's training slides for Procedural Sedation 2012 gave similar direction for RNs to administer IM ketamine and monitor other general anesthetic agents.

Review of the 10/20/10 ASA Advisory on Granting Privileges for Deep Sedation to Non-Anesthesiologist Sedation Practitioners clearly warned under item 2-Advisory that any professional who administered and monitored deep sedation must be dedicated to that task. The non-anesthesiologist sedation practitioner who administered and monitored deep sedation must be different from the individual performing the diagnostic or therapeutic procedure, similar to the guidelines for moderate sedation care. Deep sedation practitioners must be qualified with skills and experience in airway management, ventilating patients whose breathing drive was depressed by drugs, as well as patients whose airways become obstructed, skills for use of expired carbon dioxide monitors, skills to insert a variety of airways (oral, nasopharyngeal, laryngeal mask airway, intubation), skills to recognize heart rhythm abnormalities, and advanced cardiac life support certification (ACLS, or similar training for children). The hospital presented no evidence that RNs possessed all such skills or were qualified anesthesia providers.

In an interview on 4/26/12 at 1:45 p.m. with MD 4, the Director of Anesthesia Services, MD 4 agreed that the administration and monitoring of deep sedation drugs was considered deep sedation care, and the skills to perform administration were not distinct from the skills to perform monitoring. In other words, whoever was responsible for administering deep sedation was also responsible for monitoring the effects of the care; it was considered a single care task with high risks and the need for an advanced skill set. MD 4 acknowledged that the hospital RNs were not qualified anesthesia providers but were permitted in policy to perform deep sedation care.

Based on staff interview, medical record, and document review, the hospital failed to ensure a complete pre-anesthesia evaluation was documented by the qualified anesthesia provider prior to a deep sedation procedure for one of one deep sedation records reviewed (Patient 17), in accordance with acceptable standards of practice. This failure put patients at unnecessary risk for treatments without safe preparation.

Findings:

Review of the medical record for Patient 17 on 4/30/12 at 12:15 p.m. with the Director of Perioperative Services (DPS) indicated that Patient 17, age 2, had reduction of fractures in the right arm performed under deep sedation on 4/8/12 in the emergency room. [Deep sedation is the administration of drugs to reduce pain and awareness during a surgical procedure; the intended depth of sedation makes a patient not easily aroused but can respond purposefully to repeated or painful stimulation; the drive to breathe may be impaired.] An entry by the physician who performed the procedure was documented as a medical screening examination prior to the procedure. The physician examination did not describe Patient 17's mouth or heart. The consent verification form signed by the patient's representative noted the fracture reduction would be performed under "conscious sedation," not deep sedation. [Conscious sedation, also known as moderate sedation, is the administration of drugs to reduce pain and awareness during a surgical procedure but differs from deep sedation in that the patient remains easily aroused by light touch or verbal stimulation.] Nursing notes documented that Patient 17 was continuously sleeping throughout the procedure, did not waken or move limbs for approximately 2 hours, and sustained rapid rates of breathing and heart rate throughout.

In an interview on 4/26/12 at 1:45 p.m. with MD 4, who served as the Director of Anesthesia Services, MD 4 stated that a pre-anesthesia/sedation assessment included examination and documentation of the mouth, neck, heart, lungs, size (overweight), or other features of a difficult airway or complex rescue. Discussing risks, benefits and alternatives to the specific type of anesthesia service planned was also part of the pre-anesthesia evaluation.

Review of a policy titled, "Procedural Anesthesia/Analgesia - Adult - Hospitalwide," last reviewed 1/27/12, documented under item V that a pre-anesthesia evaluation must be completed and documented prior to the first dose of medication for deep sedation. Minimum elements of the evaluation were listed. They did include identification and documentation of potential anesthesia problems (e.g. limited IV access or difficult airway), and informing the patient/representative of the risks and benefits including alternatives to anesthesia/deep sedation. The policy, however, did not specify examination of the mouth, neck, heart, lungs, size, or airway features be performed by the sedation professional.

Review 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 (included moderate sedation). This evaluation must include airway assessment, anesthesia risk assessment and anesthesia drug and allergy history.

Based on staff interview, medical record, and document review, the hospital failed to ensure that policies provided for a complete and accurate intraoperative anesthesia record be documented for one of one deep sedation patients reviewed (Patient 17), in accordance with acceptable standards of care to meet the needs of anesthesia patients. This failure put patients at risk for a delay to rescue a patient from a deeper than intended level of sedation and adverse outcome.

Findings:

Review of the medical record for Patient 17 on 4/30/12 at 12:15 p.m. with the Director of Perioperative Services (DPS) indicated that Patient 17, age 2, had reduction of fractures in the right arm performed under deep sedation on 4/8/12 in the emergency room. [Deep sedation is the administration of drugs to reduce pain and awareness during a surgical procedure; the intended depth of sedation makes a patient not easily aroused but can respond purposefully to repeated or painful stimulation; the drive to breathe may be impaired.] Nursing notes indicated that a general anesthetic agent (ketamine 22 milligrams) was administered through a plastic tube into Patient 17's vein (IV, intravenous) by a RN at 6:31 p.m. At 6:32 p.m. the breathing rate rose to 50 breaths per minute (normal is 21-29) and heart rate was 120 beats per minute (normal is 80-140). The fracture reduction was performed by a physician at 6:33 p.m. (before much of the ketamine took effect). Starting at 6:34 p.m., the heart rate rose from 141 to 162, the breathing rate rose to 65, and the patient was intermittently described as sleeping, though no sedation score was recorded. Patient 17 continued to "sleep" until 7:30 p.m. when he was drinking juice and the heart rate finally fell back to 122. The breathing rate, however remained 47 to 62 until discharge at 8:50 p.m. No monitoring of expired carbon dioxide was documented. Sedation scale values were not documented. All the monitoring was documented by an RN. The physician made entries after the procedure at 8:30 p.m., but never addressed Patient 17's abnormal breathing and heart rate levels.

In an interview with MD 6, an emergency room (ED) physician, on 4/24/12 at 10:30 a.m., MD 6 stated that he and other physicians routinely utilized deep sedation to perform procedures on patients in the emergency room, especially children. Generally, a RN rather than a physician, performed and documented the deep sedation monitoring. Monitoring of expired carbon dioxide with a special airway device was not routinely performed in the ED. MD 6 still considered himself responsible to keep an eye on the machines attached to the patient in his peripheral vision while he was performing the procedure. MD 6 stated that he was not always able to view the patient's skin color, ventilation effectiveness, or depth of sedation. After the procedure was completed, MD 6 indicated he would not remain with the patient to further monitor the extended effects of the deep sedation, but expected the RN to do that and call for help if needed.

Review of the American Society of Anesthesiologists (ASA) Standards for Basic Anesthetic Monitoring, effective 7/1/11, directed under item I that anesthesia care monitoring be performed and documented by qualified anesthesia personnel, present in the room throughout the conduct of the care. Item 2.2 emphasized continuous assessment of color and oxygen level. Item 3.2.4 read, "During moderate or deep sedation the adequacy of ventilation shall be evaluated by continual observation of qualitative clinical signs and monitoring for the presence of exhaled carbon dioxide." A time-based documentation (every 5 minutes) of vital signs and assessments was standard. The standard did not permit substituting direct assessment of the patient with machine print-outs of vital sign measurements.

Review of the 10/20/10 ASA Advisory on Granting Privileges for Deep Sedation to Non-Anesthesiologist Sedation Practitioners also recommended the use of a monitoring device to measure exhaled carbon dioxide in the care of deep sedation.

Review of a policy titled, "Procedural Anesthesia/Analgesia - Adult - Hospitalwide," last reviewed 1/27/12, documented under item IV-F listed, among equipment requirements, continuous expired carbon dioxide monitor with the term "preferred" underlined for Deep Sedation, suggesting it was optional.

Based on staff interview, medical record, and document review, the hospital failed to ensure that a post-anesthesia evaluation was completed and documented by a qualified anesthesia provider in accordance with hospital policy for one of one deep sedation patient record reviewed (Patient 17). This failure put patients at risk for adverse health conditions to be unrecognized or delayed.

Findings:

Review of the medical record for Patient 17 on 4/30/12 at 12:15 p.m. with the Director of Perioperative Services (DPS) indicated that Patient 17, age 2, had reduction of fractures in the right arm performed under deep sedation on 4/8/12 in the emergency room. [Deep sedation is the administration of drugs to reduce pain and awareness during a surgical procedure; the intended depth of sedation makes a patient not easily aroused but can respond purposefully to repeated or painful stimulation; the drive to breathe may be impaired.] Nursing notes documented that Patient 17 was continuously sleeping throughout the procedure, did not waken or move for approximately 2 hours, and sustained rapid rates of breathing and heart rate throughout. At the time of discharge, the physician who performed the procedure (a qualified anesthesia provider) documented that the child was alert, drinking juice and "looks good." However, the nursing notes at that time recorded an elevated breathing rate of 62 breaths per minute (normal is 21-29) and heart rate was at the upper limits of normal after a period of significant elevation. No measurements of expired carbon dioxide levels were documented. The physician did not document an examination of heart and lungs, or provide a rationale for the persistently abnormal breathing rate (such as lung congestion or airway spasm from the general anesthetic drug).

In an interview on 4/26/12 at 1:45 p.m. with MD 4, who served as the Director of Anesthesia Services, MD 4, stated that a post-anesthesia/sedation assessment was expected to be documented by the anesthesia provider for deep sedation cases. The assessment should demonstrate recovery from the effects of the treatment in order to be safely released from monitoring.

Review of a policy titled, "Procedural Anesthesia/Analgesia - Adult - Hospitalwide," last reviewed 1/27/12, documented under item V-D that the post-anesthesia evaluation must be performed and documented by a qualified anesthesia provider only at a time when the patient was sufficiently recovered from the acute effects of the deep sedation. At a minimum, the evaluation included respiratory function (rate, airway patency and oxygen level), heart function (pulse, blood pressure), mental status, temperature, pain, nausea/vomiting, and hydration. Complications should be addressed.

Based on observation, interview, and document review, the hospital failed to ensure that its policies were revised to reflect current practices for treatment of anyone in need of emergency treatment at off-campus outpatient sites. This had the potential to result in a delay in providing appropriate emergency treatment.

The facility was also unable to demonstrate that all emergency equipment was checked in accordance with its policy. This had the potential to result in all equipment not being ready at all times in case of an emergency.

Findings:

1. During a tour of the outpatient urgent care center on 4/24/12 at 11:15 am, Registered Nurse (RN) 56 stated that for emergencies they would call 9 to get an outside line then 911 and begin CPR. RN 56 said they had an automatic external defibrillator (AED) available as well as an emergency medication box stocked by the facility pharmacist.

During a tour of the outpatient cardiac rehab on 4/25/12 at 11:30 am, Exercise Physiologist (EP) 1, stated that for emergencies they would call 911 and begin CPR. EP 1 said they had oxygen available as well as an (AED) for use during emergencies.

During a tour of the outpatient cancer center on 4/24/12 at 8:45 am, RN 57 stated that for emergencies they would call 911 and start CPR. They also had oxygen available for use.

The facility policy titled, "Emergency Conditions & Basic Staff Response - Safety/Security," last reviewed on 2/10, was reviewed. It instructed off-campus facilities to call 911 for unresponsive patients. There were no further instructions to direct staff on the use of other available equipment or medications.

During an interview on 4/25/12 at 10:30 am, Vice President of Quality Management, confirmed that the facility did not have specific policies regarding emergency conditions for all of their outpatient areas.

2. A tour of the outpatient Magnetic Resonance Imaging (MRI) department was conducted on 4/24/12 at 8:10 am. The MRI Tech demonstrated how he checks the crash cart (a cart with available medication and equipment for emergencies). He stated that he signs off the log when he checks the crash cart. The log ws reviewed and there were some blanks on days when the department was opened. There was one signature missing for the month of March and two from 4/1 - 4/22/12. The MRI Tech stated he did not know why the crash cart log was not signed as being checked.

The facility policy titled, "Crash Cart Care, Locking, Emergency Medications, Supplies and Exchange - Hospitalwide", last approved 8/10, was reviewed. It required staff to check the crash carts daily and sign the crash cart record.

Based on interview and record review, the facility failed to ensure that two of its Emergency Department (ED) policies were reviewed for relevancy and accuracy. This had the potential to result in confusion regarding the performance requirements of ED staff.

Findings:

1a. A policy titled, "Standards for Assessment and Reassessment - Hospitalwide", last approved 5/09, was reviewed. For ED patient reassessments it required a Level 1 patient to be reassessed upon discharge if in the department more than one hour. It required a Level 5 patient to be reassessed every 15 minutes.

According to the facility's ED-Clinical Intake policy as well as accepted standards in the community, Level 1 patients have conditions that pose a threat to limb or life requiring aggressive interventions. Level 5 patients have conditions that do not appear to pose an acute threat to their health.

During an interview on 4/26/12 at 9:40 am, Nurse Manager (NM) 9 stated that the acuity levels were switched and Level 1 should be reassessed every 15 minutes and Level 5 should be reassessed upon discharge if in the department more than one hour.

1b. A policy titled, "Patients Leaving Against Medical Advise - Hospitalwide", last approved 11/09, was reviewed. The policy read, "In the event the patient leaves prior to an evaluation by the physician or without notifying a staff member, the Registered Nurse shall attempt to locate the patient, notify the physician, the Administrative House Supervisor and security, and document the elopement in the nurse's notes and complete an incident report.

During an interview on 4/26/12 at 10:20 am, NM 9 stated that ED staff do not notify the House Supervisor and security or complete an incident report for patients who elope. NM 9 stated this is a hospital wide policy that should be revised to refect their specific patient population in the ED.

Based on interview and record review of eight Emergency Department (ED) records, the facility failed to ensure the implementation of its written policies by failing to perform a Medical Screening Exam (MSE, process to determine if an emergency medical condition exists) or document the reasons for departure before receiving a MSE for two patients. This had the potential to result in a deterioration in the conditions of these patients. (Patients 33 and 39).

Findings:

1a. A review of Patient 33's record disclosed that he presented to the ED with a complaint of cough on 1/2/12 at 4:31 pm. No discharge time was noted. Following a triage assessment (short assessment performed by licensed staff to determine the order MSEs will occur) Patient 33 was assigned a Level 3 (conditions that could pose a potential threat to life, limb, requiring early emergency intervention and would benefit from evaluation and/or treatment) status. There was no further documentation in the record.

A facility policy titled, "Emergency Medical Treatment and Labor Act (EMTALA)" dated 9/10, read as follows: "A MSE will be offered to any individual who comes to the ED. The MSE will be provided within the capabilities of the Dedicated ED, including ancillary services routinely available to the ED. . . . If an individual leaves the hospital before receiving an MSE, either with or without notice to staff of his/her departure, staff should document the circumstances and reasons (if known) for the individual's departure and the time of departure."

During a record review and interview on 4/24/12 at 2:15 pm, Nurse Manager (NM) 6 confirmed that an initial assessment by the intake Registered Nurse (RN) had been done, but a MSE had not been done. NM 6 stated that there was no way to know how long Patient 33 had been in the ED. NM 6 stated that the nurse who called the patient to come back to a bed, should have documented what time the patient had been called and that the patient had left without telling anyone.

1b. A review of Patient 39's record disclosed that she presented to the ED with a complaint of an abscess on her leg on 1/2/12 at 4:30 pm. No discharge time was noted. Following a triage assessment, Patient 39 was assigned a Level 4 (conditions that may pose a foreseeable threat to the patient's health and would benefit from timely evaluation and/or treatment) status. There was no further documentation in the record.

During a record review and interview on 4/26/12 at 9:15 am, NM 9 stated that he thought this patient left without telling staff and was taken off their board in the ED by staff who failed to chart the disposition in the record. NM 9 stated staff should have documented the time they called this patient and that she left without notifying staff.

Based on staff interview and document review, the hospital failed to ensure that rehabilitation services were well-organized, administered by qualified personnel, and integrated into the hospitalwide Quality Assessment and Performance Improvement program (QAPI) evidenced by:

1. Rehabilitation QAPI activities were not integrated into the hospitalwide program;

2. Rehabilitation policies and procedures were not developed for the therapy modalities (methods used by therapists to ease pain and improve movement such as the use of ultrasound and electrical stimulation) provided and the medical staff were not involved in the review and approval of patient rehabilitation policies governing patient care and medication use. (Refer to A1124);

3. Rehabilitation staff did not have evidence of competency assessment for iontophoresis (a technique using a small electric charge to deliver a medicine or other chemical through the skin). (Refer to A1134).

These failures put patients at risk for unsafe rehabilitation care by failing to have medical staff oversight for patient care activities and medication administration.

The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation: Rehabilitation Services.

Findings:

1. On 4/30/12 at 11:15 am, the Rehabilitation Manager (PTM) 1 presented data collected as part of the quality indicators for the rehabilitation services. The reports presented did not include evidence of data analysis or the actions taken to improve performance.

In a concurrent interview, PTM 1 acknowledged that there was no evidence of data analysis or actions taken to improve performance. PTM stated that he forwarded the data to the Quality Management Department who reported to the appropriate committees.

On 4/30/12 at 12:15 pm, the VPQM and the Director of Quality Management stated the rehabilitation quality indicators had not been reported to any quality committee and were not part of the hospital's QAPI program.

Based on interview, the facility failed to ensure that policies and procedures were developed to govern patient care and medications for the therapy modalities (methods used by therapists to ease pain and improve movement such as the use of ultrasound and electrical stimulation) provided and that the medical staff were involved in the review and approval of patient rehabilitation policies. This failure had the potential for therapy to be provided to patients in a manner inconsistent with the accepted standards of care.

Findings:

On 4/30/12 at 11:15 am, Rehabilitation Manager (PTM) 1 stated his therapist provided a full range of therapy modalities including ultrasound, electrical stimulation, and iontophoresis (a technique using a small electric charge to deliver a medicine or other chemical through the skin.) PTM 1 was asked to provide the policies that guided staff for the therapy modalities provided by his staff. PTM 1 stated he did not have policies for the specific therapy modalities.

PTM 1 was asked how he ensured that therapists understand the standard of practice for each of the therapy modalities, he stated that they receive this as part of their therapy education. PTM 1 stated he observed staff in practice and that they had skills reviews. PTM 1 stated medical staff was not involved in the review and approval of patient care policies for the rehabilitation department.

On 4/30/12 at 12:30 pm, the Vice President of Quality Management (VPQM) confirmed that the rehabilitation policies were not reviewed or approved by the medical staff. The VPQM stated that the medical staff was responsible for all patient care and medications administered in the facility.

Based on interview and record review, the facility failed to ensure that physical therapists were assessed on their competence to perform iontophoresis (technique using a small electric charge to deliver a medicine or other chemical through the skin.) This failure had the potential for patients to experience harm due to improper iontophoresis technique.

Findings:

On 4/30/12 at 11:15 am, the Rehabilitation Manager (PTM) 1 shared the competency evaluations of therapists. When asked about iontophoresis competency, PTM 1 showed me that electrical stimulating therapies were covered in the competency evaluations. When asked if this competency specifically covered iontophoresis, he stated it had not. PTM 1 confirmed that the therapists' competency with iontophoresis had not been evaluated.