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Based on observation, staff interview, clinical record and administrative document review, the hospital failed to have an effective governing body when:

1. Medical Staff Bylaws were not enforced in regards to incomplete records and the lack of disciplinary actions taken to correct the problem. (refer to A276 finding 1, A353, A468, & A469).

2. The quality of health care services in the hospital were negatively affected by the lack and/or delay of nutritional screenings, nutritional assessments and nutritional follow-up assessments on patients in the hospital. (refer to A276 finding 2, & A621)

3. The lack of a comprehensive Infection Control program negatively affected the quality of healthcare in the hospital. (refer to A276 finding 3, A749, & A951)

4. Patient rights were not protected in regards to restraint use. Restraint use in the hospital did not follow hospital policy and procedure. (refer to A276 finding 4, & A164)

5. The lack of action to improve medication errors as reported in the pharmacy discrepancy data could negatively affect the quality of health care delivery in all patients in the hospital. (refer to A276 finding 5, & A500 finding 2)

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

Based on observation, staff interview, clinical record and administrative document review, the hospital failed to ensure restraints may only be used when less restrictive interventions has been determined to be ineffective to protect the patient. The facility failed to attempt to use less restrictive interventions in three of three patients (Patients 72, 86, & 87). These failures resulted in the loss of patient rights to be free of restraints.
Findings:
1. On 1/11/12, Patient 72's clinical record was reviewed. There was no documented evidence of an attempt to use less restrictive interventions. The facility was not able to provide evidence of documentation that less restrictive interventions had been attempted.
On 1/12/12 at 10:25 a.m., during an observation on 2 Intensive Care Unit (ICU) Campus 1, Patient 72 was observed to be intubated with eyes closed and calm demeanor. The patient was restrained with bilateral soft wrist restraints.
On 1/12/12 at 10:39 a.m., during an interview, Staff 87 (Respiratory Therapist) stated while she was in Patient 72's room, she did not observe the patient with any agitation or behavioral issues. Staff 87 stated that she was familiar with Patient 72 and cared for her routinely.
On 1/12/12 at 10:41 a.m., during an interview, Staff 111 (Registered Nurse) stated the rationale for restraints for Patient 72 was because she was intubated. Staff 111 stated Patient 72 was known to immediately try to extubate (take breathing tube out of throat) herself when released from restraints.
On 1/12/12 at 10:45 a.m., during a concurrent interview and observation, Staff 111 was in Patient 72's room and released the patient's right wrist restraint. Patient 72's hand remained on the bed and the patient did not attempt to move her arm. Staff 111 stated, "she is not reaching for her tube right now."
On 1/12/12 at 11:30 a.m., during an interview, Staff 111 (Registered Nurse), when asked when would be the earliest possible time to discontinue Patient 72's restraints, she stated when Patient 72 was extubated.
2. On 1/9/12 at 1 p.m., during an observation on 3 (Intensive Care Unit) ICU Campus 1, Patient 86 was noted to be restrained with bilateral soft wrist restraints. Patient 86 was intubated. Patient 86 had her eyes closed and was not moving or displaying signs of agitation.
On 1/11/12 at 10:03 a.m., during an interview, Staff 108 (Registered Nurse) stated she did not know if any less restrictive interventions were tried prior to the placement of restraints on Patient 86. Staff 108 stated Patient 86 was able to follow commands but was still on sedation. Staff 108 stated she had not observed Patient 86 demonstrating any behaviors such as pulling on intravenous (IV) lines.
On 1/10/12, during Patient 86's clinical record review for the period of 1/1/12 to 1/10/12, the documentation indicated restraints were used routinely as a precaution. The form "Restraint/Seclusion Monitoring" was used to document the rationale and behaviors for restraint use. Nursing notes dated 1/7/12 at 4 p.m., 1/9/12 at 8 p.m., and 1/10/12 at 8 a.m. indicated the rationale for continued use of restraints was "Medically approved mechanical ventilation protocol", and the patient behavior was noted as "Affect/Behavior: Calm, Cooperative, Forgetful, Other: sedated." On the following dates: 1/2/12, 1/3/12, and 1/4/12, the reason for the restraint was left blank.
3. On 1/9/12 at 1 p.m., during an observation on 3 (Intensive Care Unit) ICU Campus 1, Patient 87 was noted to be restrained with bilateral soft wrist restraints. Patient 87 was intubated. Patient 87 had her eyes closed and appeared calm and did not display signs of agitation.
On 1/10/12, during Patient 87's clinical record review for the period of 1/1/12 to 1/10/12, the documentation indicated restraints were used routinely as a precaution. There was no documented evidence the facility attempted less restrictive interventions prior to the use of soft wrist restraints.
On 1/10/12 at 9:25 a.m., during an interview, Staff 112 stated restraints were used as a precautionary measure to prevent patient extubation. Staff 112 was not aware of the hospital's policy requirement to determine less restrictive interventions ineffective prior to the use of restraints.
On 1/18/12 at 10:35 a.m., during an interview, Staff 125 (pulmonology physician) stated he was not aware of the routine practice of utilizing restraints as a precautionary measure since the rationale for restraints should be based on patient behaviors. Staff 125 stated it made no sense that a sedated intubated patient be restrained. Staff 125 stated he would be opposed to the routine use of restraints with the rationale as "Mechanical ventilator protocol." Staff 125 routinely cared for patients in the ICU.
On 1/18/12 at 2:30 p.m., during an interview, Staff 119 (Vice President of Quality and Patient Care Services) stated, "There are not enough sitters (staff used for one-on-one observation) so MD's (medical doctors) order soft restraints. We need to increase the education on restraints." This comment was in response as to why the hospital restraint policy was not being followed.
On 1/11/12, the facility policy and procedure reviewed and titled " RESTRAINT POLICY " dated 12/22/2010, indicated ... " The least restrictive type of restraint will be used based on the patient's behavior exhibited... 4. Restraints will be used only when clinically appropriate, after an individualized patient assessment, and in situations in which less restrictive alternative measures have been employed and proven ineffective..."

Based on staff interview, clinical record and administrative document review, the hospital failed to ensure the use of restraints were in accordance with the order of a physician when the use of restraints was administered to Patient 52 without a physician order. This failure resulted in Patient 52's patient rights not being protected and could possibly lead to harm or injury.

Findings:

On 1/10/12 at 10:40 a.m., during clinical record review, Patient 52 was admitted to the hospital on 12/14/11 with a history of falls and a diagnosis of multifocal cardiovascular events (strokes).
On 1/10/12 at 10:45 a.m., during a concurrent interview and record review, Staff 105 (Registered Nurse in-charge) stated a physician's order could not be located for restraints for Patient 52 for 1/9/12. The clinical record review for Patient 52 indicated a physician's order for restraints was obtained on 1/8/12 and on 1/10/12. A physician's order could not be located for 1/9/12. Patient 52's "Nursing Restraint Monitoring" notes were recorded every two hours from 1/9/12 at 2:00 p.m. until 1/10/12 at 6:00 a.m. and indicated restraints were applied on the patient.
The facility policy and procedure titled "RESTRAINT POLICY" dated 12/22/10 indicated "G. Physician Orders ... 1. Restraints will only be used on the order of a physician. 2. Restraints can be initiated by a nurse without a physician ' s order if a delay will cause additional risk to patient safety. The physician must be contacted during or immediately following the application of restraints AND an order must be obtained ... NOTE: A new order to be obtained daily".

Based on observation, staff interview clinical record and administrative document review, the hospital failed to maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program when:

1. Census Reports (list of patients in the hospital with admission dates, diet orders, and admitting diagnosis) were not tracked and trended for missed due dates regarding nutritional screening, nutritional assessments, and nutritional follow-up assessments. (refer to A276 finding 1, & A621)

2. Incomplete medical records data was not utilized to identify methods or projects to reduce incomplete medical records. (refer to A276 finding 2, A353, A468, & A469)

3. Infection control data was not tracked and trended for all areas of both campuses of the hospital. The hospital failed to have an effective quality management and performance improvement program in place to ensure infection control issues were identified and resolved. (refer to A276 finding 3, A749, & A951)

4. The use of restraints was not tracked in order to document whether or not restraint use followed accepted standards of practice, followed hospital policy and protected patient rights. (refer to A276 finding 4, & A164)

5. Medication error data and pharmacy reports on discrepancies involving Automated Dispensing Cabinets (ADCs) were not utilized to identify projects to reduce medication errors. A discrepancy occurred when the number of doses of a particular medication in the ADC was discovered to be different from the number of doses listed in the computer attached to the ADC. (refer to A276 finding 5, & A500, finding 2).

The cumulative effect of this systemic problem resulted in the hospital's failure to meet compliance with a hospital-wide Quality Assessment and Performance Improvement Program.

Based on staff interview, clinical record and administrative document review, the hospital failed to utilize, collect and track data in order to identify opportunities to improve quality health care when:

1. Census Reports were not tracked and trended for missed due dates regarding nutritional screening, nutritional assessments, and nutritional follow-up assessments. This failure resulted in the potential for patients not receiving nutritional services pertinent to the health care for which the patients were hospitalized.

2. Incomplete medical records data was not utilized to identify methods or projects to reduce incomplete medical records. This failure resulted in a backlog (to the year 2009) of incomplete medical records and possibly affecting continuity of hospital care for all patients.

3. Infection control data was not tracked and trended for all areas of both campuses of the hospital. The hospital failed to have an effective quality management and performance improvement program in place to ensure infection control issues were identified and resolved. These failures had the potential for obstructing the infection control and prevention process and put patients and hospital personnel at risk for exposure to blood-borne pathogens and transmission of communicable diseases. (cross reference A749)

4. The use of restraints was not tracked in order to document whether or not restraint use followed accepted standards of practice, followed hospital policy and protected patient rights. This failure resulted in the potential loss of patient rights regarding restraint use.

5. Medication error data and pharmacy data on discrepancies were not utilized to identify projects for improvements. This failure resulted in missed opportunities to improve medication errors and possibly affecting the safety and quality of health of all patients.

Findings:
1. Review of the policy No. 4000.14.06 titled Nutrition Services: Interventions For Patients At Nutrition Risk indicated patients at low risk would be screened by the clinical nutritional staff within 4 days from admission. The patient would be further evaluated by clinical nutrition staff depending upon the acuity of the patient as determined by diagnosis, laboratory review, anthropometrical (skin fold) measurements, nutritional status and route of nutrition delivery.

On 1/10/12 the Campus 1 Census Report for 1/10/12 was reviewed. The Census Report listed current patients in the hospital with admission dates, diet orders and admitting diagnosis. Twelve patients (Patients 26, 38, 40, 41, 43, 44, 45, 49, 51, 52, 53, 54) were admitted between the dates of 12/28/11 and 1/7/12; none of the twelve patients had received a nutrition screening or nutritional assessment. For example, the clinical record for Patient 41 indicated the patient was admitted on 12/28/11 and had not been assessed for a total of 12 days and was listed to have a therapeutic diet of carbohydrate control, high protein, sodium and potassium restricted diet.

The Campus 1 Census Report listed 18 patients (Patients 29, 30, 31, 32, 33, 34, 35, 36, 37, 39, 42, 46, 47, 48, 50, 56, 98, 99) with late RD (Registered Dietician) follow-up assessments. The due dates for the RD follow-up assessments for these 18 patients ranged between 1/6/12 to 1/9/12.

The Campus 2 Census Report for 1/10/12 showed 8 patients (Patients 22, 23, 24, 25, 26, 27, 28, and 29) who had admission dates from 12/29/11 to 1/4/12 that had not had a nutrition screening or nutrition assessment. One patient (Patient 93) had a follow-up nutrition assessment that was 6 days late.

On 1/10/12 at 10 a.m., during an interview, Staff 133 (registered dietitian) stated the RDs reviewed the Census Report each morning. The purpose of the daily Census Report review was to prioritize the work load. Patients with nutrition consults and those patients with high nutrition risk were prioritized first. Staff 133 stated many of the patients on the census list were not triggered for a nutrition consult. Staff 133 acknowledged the policy stated that patients newly admitted to the hospital would be seen for screening or assessment within 4 days of admission. She stated that when they had a heavy work load some of the patients were not seen but the RD would ask the nurse if there were any nutrition concerns. Staff 133 acknowledged nutrition assessments would be delayed even if it was overdue per the policy.

On 1/11/12 at 10:00 a.m., the quality team was interviewed. The members included the VPs (Vice Presidents) of Quality and Patient Safety. They addressed some potential upcoming clinical issues regarding diabetes taskforce that could include the RD. The team was not able to describe how the Nutrition Department was integrated into the hospital quality program and how the Nutrition Department measured, analyzed and tracked program elements like patient food safety standards and clinical nutrition standards. The quality team stated they did not have a mechanism for Nutrition department to develop quality and performance improvement plans through the quality committee. They stated the nutrition department quality only went to the Pharmacy and Therapeutics committee.

On 1/11/12 at 11:00 a.m., Staff 132 (Director of Nutritional Services) was interviewed regarding the RD staffing and coverage of nutrition assignments at both Campus 1 and Campus 2. Staff 132 acknowledged that many nutritional assessments for new admissions were overdue and delayed. Staff 132 acknowledged that a full-time RD position had been left vacant for several months. Staff 132 stated that she had discussed the RD staffing needed to meet the patient nutrition care with the Associate Vice President of Support Services (AVPSS) but there was no interim RD staffing approved. The AVPSS reported to Quality Improvement Committee and to the Governing Body.

On 1/11/12 at 11:40 a.m., during an interview, Staff 132 stated regarding the quality and performance improvement program for the department that she reported the quarterly reports to the Pharmacy and Therapeutics Committee. When asked, Staff 132 stated only when there was an issue identified would she be involved in the Quality Committee.
Review of the organization chart showed Staff 132 reported to the Associate Vice President of Support Services.

On 1/11/12 at 12:20 p.m., the Senior Vice President of Network Operations was interviewed regarding the nutrition care of patients and the number of nutrition assessments that were late. The Senior Vice President of Network Operations stated that Staff 132 reported to the VP of Support Services who was currently on vacation. The Senior Vice President stated that he was not aware of the late nutrition assessments and the staffing issues. He stated that he would work with Staff 132 to ensure the patients received the nutrition care.

On 1/11/12 at 11:40 a.m. an interview was conducted with Staff 132 regarding the quality and performance improvement program for the department. Staff 132 stated she reported the quarterly reports to the Pharmacy and Therapeutics Committee. When asked, Staff 132 stated only when there was an issue identified would she be involved in the Quality Committee. Staff 132 acknowledged that monitoring for quality was not necessarily for performance improvement activities in the department.

The quality program was reviewed on 1/11/12. The policy titled Organizational Performance Improvement plan stated the purpose of the Organizational Performance Improvement Plan was to ensure the Governing Body, Medical Staff, clinical and professional services staff endeavor to deliver care. The policy did not specify this quality program was a hospital wide quality program.

The plan included key elements including clinical care delivery and scope of activities including patient safety and environment of care. There was no specific direction for the nutrition services integration into these generalized elements or scope of activities. There was no direction for the Nutrition Department to develop a quality program to track trend and analyze the department ' s food safety functions, clinical nutrition functions integrated into the hospital quality program.

2. On 1/12/12 at 3:45 p.m., during administrative document review, the Missing Dictation Report compiled by Staff 146 (Health Information Manager) indicated the following delinquent reports (incomplete more than 14 days following discharge) that needed to be completed by physicians: 214 Operation/Procedure reports, 732 Discharge Summaries, 126 Emergency Department Physician Notes, and 151 History and Physicals. The oldest reports were for patients who were discharged in 2009.

On 1/12/12 at 4:15 p.m., the Hospital Medical Record Statistics Form report for December 2011 was reviewed with Staff 146. Staff 146 stated the Monthly Delinquency Total was listed as 1162 records, and that a more recent count as of 1/12/12 was 1174 total delinquent records.

The Medical Staff Bylaws, Rules and Regulations, approved 11/11, stated that members of the medical staff were required to complete medical records within the time outlined (14 days following the patient's discharge). If a record was not completed within 14 days, practitioners shall incur temporary suspension of his/her clinical privileges until the delinquent medical records were completed (Bylaws Section 8.4-4; Rules and Regulations Section II. O).

On 1/10/11 at 10 a.m., during an interview, Staff 145 (Health Information Analyst) stated medical staff members had not been suspended since at least 2009, or possibly since 2008.

No documented evidence was provided showing the data of incomplete medical records was utilized to identify and formulate opportunities for improvement.

3. On 1/13/11 at 9:30 a.m., during an interview, Staff 1 (Director of Infection Control) stated that increased infection control audits were needed in every area of both hospital campuses and follow-up was needed to ensure identified deficient practices remained resolved. Staff 1 stated she provided consultation to program directors and staff related to identification and resolution of deficient infection control practices and regulations, but it was necessary for directors and staff to also assume responsibility to correct and monitor for deficient infection control practices.

On 1/13/12 at 12:05 p.m., during an interview, Staff 66 stated the hospital did not have a culture that would maintain and sustain what is taught when deficient practices are identified. Staff 66 stated " We (referring to the Quality Management/Performance Improvement Committee) haven't established a sustainment plan." Staff 66 stated a plan and system to identify and ensure deficient practices were addressed and remained resolved was needed now.

Examples of problems validated during the survey from 1/10/12 through 1/13/12 were (cross reference A749, A951):

a. Traffic pattern in the endoscopy suite did not conform to nationally recognized infection control standard of practice.

b. The hospital failed to have an effective system to ensure personnel wore appropriate attire in the operating and endoscopy suites.

c. The hospital failed to have an effective system to ensure environmental cleaning was performed in accordance with nationally accepted standards, the manufacturer's specifications, and the hospital's policy and procedure.

d. The hospital failed to have an effective system to ensure endoscopes were cleaned and stored in accordance with nationally accepted standards.

f. The hospital failed to ensure staff cleaned and disinfected the equipment effectively between patient use.

g. The hospital failed to ensure the MSDS (Materials Safety Data Sheet) was readily available in various units of the hospital.

h. The hospital failed to ensure staff processed surgical instruments in accordance with nationally recognized infection control guidelines and/or the manufacturer's specifications and/or the hospital's policy and procedure.

i. The hospital failed to ensure staff used the single-use items in accordance with manufacturer's specifications and nationally recognized infection control guidelines.

j. The hospital failed to have an effective system to ensure the physician performed and documented daily assessment of central line (a tube that healthcare providers place in a large vein in the neck, chest, or arm to give fluids, blood, or medications or to do certain medical tests quickly) necessity for all patients with central lines.

k. The hospital failed to ensure the clean linen and/or the surgical suits were transported, distributed and stored in accordance with the nationally recognized infection control guidelines and the hospital's policies and procedures.

l. The hospital failed to ensure the clean and soiled supplies were stored separately in accordance with nationally recognized infection control guidelines.

m. The hospital failed to have an effective system to ensure personnel were consistently screened for infectious diseases in accordance with nationally accepted standards.

n. The hospital failed to have an effective system to monitor and maintain the relative humidity, the temperature, and air exchanges in the perioperative (surgical procedure), areas including operating rooms, endoscopy rooms, decontamination room, sterile processing areas, sterile storage and post anesthesia care units, in accordance with nationally recognized infection control guidelines.

4. On 1/10/12 at 9:25 a.m., during an interview, Staff 112 (Registered Nurse in the Intensive Care Unit Campus 1) stated restraints were used as a precautionary measure to prevent patient extubation. Staff 112 was not aware of the hospital policy requirement that prior the use restraints less restrictive measures needed to be determined ineffective.
On 1/18/12 at 10:35 a.m., during an interview, Staff 125 (pulmonology physician) stated he was not aware of the routine practice of utilizing restraint use as a precautionary measure and would be opposed to such a protocol since the rationale for restraints should be based on patient behaviors. Staff 125 stated it made no sense that a sedated intubated patient be restrained. Staff 125 stated he would be opposed to the routine use of restraints with the rationale as "Mechanical ventilator protocol."
On 1/18/12 at 2:30 p.m., during an interview, Staff 119 (Vice President of Quality and Patient Care Services) stated, "There are not enough sitters (staff used for one-on-one observation) so MD's (medical doctors) order soft restraints. We need to increase the education on restraints." This comment was in response as to why the hospital restraint policy was not being followed.
On 1/11/12, the facility policy and procedure reviewed and titled "RESTRAINT POLICY " dated 12/22/2010, indicated ... " The least restrictive type of restraint will be used based on the patient 's behavior exhibited... 4. Restraints will be used only when clinically appropriate, after an individualized patient assessment, and in situations in which less restrictive alternative measures have been employed and proven ineffective..."

No documented evidence was provided to show trends of restraint use in patients. No improvement project was identified to track whether or not the hospital policy was being followed.

5. On 1/18/12 at 2:00 p.m., during an interview the Vice President of Quality and Patient Safety (VPQPS) stated she had worked for the hospital for about one year and "Was not aware of all of the issues." The VPQPS stated it had been unclear who had ownership in monitoring and measuring goals." The Regional Network Director (RND) gave an example of this. She stated, before the hospital moved they got new Omnicells (medication dispensers) and educated staff. When the hospital moved they did not re-educate staff and medication errors resulted from this.

On 1/18/12 at 2:10 p.m., during an interview, the RND stated it was the process for medication errors to go to Pharmacy and Therapeutics (P&T) Committee and Medical Staff and Governing Board. She stated there were sub- committees where frontline staff took one area at a time. The RND stated the process and structure affected outcomes and "Medical Staff did not bring in as deficient enough." The RND stated information was collected by the incident process and word of mouth. The incident tracking was not automated and was an antiquated system. The system was not able to sort information frequency by physician. "We have to collect it manually." "The Pharmacy Director collects rates of medication error types but they "Do not get trends over time."

On 1/18/12 at 2:20 p.m., during an interview the VPQPS indicated she did not hear about discrepancies.

On 1/18/12 at 2:22 p.m., during an interview, the Director of Regulatory Compliance & Accreditation (DRCA) stated "The process takes too long to define and to process information up to the Governing Board and make sure critical elements are addressed quickly."

On 1/18/12 at 2:30 p.m., during an interview, the VPQPS stated we were not looking at critical-high-risk policies and procedures. We had policies imbedded in other policies and procedures. An example was no distinct PCA (patient controlled administration of medication device) parameters.

On 1/18/12 at 2:35 p.m., during an interview the DRCA indicated there were "Fewer policies and procedures that were packed full of different pieces, leaving too much to interpretation."

On 1/18/12 at 2:40 p.m., during an interview the VPQPS indicated "I want the Board to have more detail. Issues were falling through the cracks. We did not have enough structure to apply processes. There was not enough detail and we were not monitoring and following through. Hundreds and hundreds of of issues needed to be tracked, but we do not have a formal tracking system now."

On 1/18/12 the hospital policy titled "Organizational Performance Improvement (PI) Plan" dated 7/28/2010 indicated under "Quality Reporting: A. The Performance Improvement (PI) Plan includes the tracking and trending key quality indicators. These measures will be objective, measurable based on current knowledge and experience and are structured to produce statistically valid, data driven, performance measures. As appropriate, measures will be tracked over time to provide for evaluation of improvements and the sustainability of the improvement.

Based on staff interview and administrative document review, the hospital failed to ensure Medical Staff Bylaws were enforced when the suspension of member's privileges was not done for failure to complete medical records within the required time period. The December 2011 Hospital Medical Record Form showed 1162 delinquent medical records (not completed within 14 days of patient discharge). This failure had the potential to result in lack of medical information needed for continuity of care and could lead to patients not receiving quality health care.

Findings:

On 1/10/11 at 10 a.m. the December 2011 Hospital Medical Record Statistics Form was reviewed concurrently with Staff 145 (Health Information Manager). This form represented the total cumulative number of incomplete medical records that were delinquent. Delinquency was defined as 14 days after patient discharge. There were 1162 medical records that were delinquent and incomplete.

The Medical Staff Bylaws, Rules and Regulations, approved 11/11, stated that members of the medical staff were required to complete medical records within the time outlined (14 days following the patient's discharge). If a record was not completed within 14 days, practitioners shall incur temporary suspension of his/her clinical privileges until the delinquent medical records were completed (Bylaws Section 8.4-4; Rules and Regulations Section II. O).

On 1/10/11 at 10 a.m., during an interview, Staff 145 stated medical staff members had not been suspended since at least 2009, or possibly since 2008.

Based on staff interview, clinical record, and administrative document review, the hospital failed to ensure a medical record service that had administrative responsibility for medical records when:

1. Hospital Policies and Procedures were not current and approved every three years as required; and employee performance was not evaluated annually. (refer to A432)

2. Medical record entries were not accurately written. (refer to A438)

3. Medical record entries were not completed, timed, and authenticated, as required by Medical Staff Rules and Regulations. (refer to A450)

4. All verbal orders were not authenticated within 48 hours, as required by Hospital Policy and Procedure. (refer to A457)

5. Conditions of Registration consents were not obtained, properly executed, or complete. (refer to A466)

6. All medical records did not contain documentation of a discharge summary, as required by Medical Staff Rules and Regulations. (refer to A468)

7. All medical records were not completed within 14 days following discharge, as required by Medical Staff Rules and Regulations. (refer to A469)

8. Medical staff did not enforce Medical Staff Bylaws regarding the suspension of member's privileges for failure to complete medical records. (refer to A353)

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

Based on staff interview and administrative document review, the hospital failed to ensure four of seven staff (Staff 127, 128, 129, 130) had a current performance evaluation and that department policies and procedures had been reviewed every three years as per hospital policy. Theses failures had the potential of staff not being qualified to perform their duties and hospital policy and procedures to not be updated and reflect current standards of practice.

Findings:

On 1/11/12, the Facility Policy No. 2000.03.03, "Criteria-Based Performance Evaluations," last reviewed 8/19/09, indicated each department director was responsible for ensuring their employees were evaluated in a timely manner.

On 1/11/12 at 1 p.m., during a concurrent interview and review of four employee files (Staff 127, 128, 129, 130) Staff 145 (Human Resource Director) and Staff 146 (Human Resource Analyst), stated employees should have annual evaluations. Three of the employee files (Staff 127, 128, 129) did not have a performance evaluation done since 2009 and one employee's (Staff 130) latest evaluation was 2008. These findings were confirmed concurrently with Staff 145 and Staff 146.

On 1/11/12, the Facility policy no. 1000.16.15, "Policy/Procedure Development, Review and Approval...for Facility Specific Policies," last reviewed 12/1/2010, indicated in "Section C. 1. ... all policies will be reviewed every 3 years or as required by regulatory agency guidelines." A sample of the Health Information Management policies revealed 9 of 12 policies were not reviewed within the past three (3) years; the oldest one, Chart Analysis #8700.03.22, was last reviewed in 12/2003.

Based on staff interview and administrative document review, the hospital failed to ensure medical records were accurately written when there was no approved abbreviation list to explain the meaning of abbreviations, as required by facility policy. This failure resulted in the potential to increase medical record error and possibly affect patient health and safety.

Findings:

On 1/9/12 at 12:00 p.m., during an interview, Staff 145 (Director of Human Resources) and Staff 146 (Human Resources Analyst) stated the hospital no longer had a list of approved abbreviations.

On 1/11/12 at 1:00 p.m., during an interview, Staff 149 (Registered Nurse), stated there was a reference book of abbreviations which was used on the nursing units to help staff interpret abbreviations used in the medical record.

On 1/11/12, The Medical Staff Rules and Regulations, approved 11/11, Section II. I indicated: "Only approved symbols and abbreviations may be used in the medical record. An official record of approved and non-approved symbols and abbreviations will be kept on file in the medical record department and on the nursing units. (Reference Policy #1000.01.06)" This policy, last reviewed/revised 2/2/11, indicated the intent was to define the abbreviations which are not allowed to be used in the medical record. There was nothing in the policy to address the abbreviations which were allowed.

Based on staff interview, clinical record, and administrative document review, the hospital failed to ensure all medical record entries were complete, timed, and authenticated in six of 11 patients' (Patient 11, 12, 13, 14, 15, and 16) clinical record. This failure resulted in the potential to increase medical record error and possibly affect patient health and safety.

Findings:

On 1/11/12 and 1/12/12, closed clinical records for Patients 11, 12,13, 14,15, and 16 were reviewed. The following types of entries were not timed: post-anesthesia notes for Patients 11 and 16; physician progress notes for Patients 13 and 15; moderate sedation form and physicians' orders for Patient 12. The Authorization for and Consent to do Surgery forms did not indicate the type of anesthesia to be administered to Patients 11, 12, 14, 15, and 16. Patient 15's Non-Acute Transfer Form had not been authenticated and there was no identification of the author.

On 1/12/12, at 9:30 a.m., during document review, Medical Staff Rules and Regulations, last approved 11/11, Section II. B. indicated: "....All clinical entries in the patient's medical record shall be accurately dated, timed, and authenticated...."

On 1/12/12, at 9:35 a.m.,during concurrent interview and record review,the above findings were confirmed by Staff 148 (Registered Nurse), and Staff 147 (Health Information Management).

Based on staff interview, clinical record and administrative document review, the facility failed to ensure physician's verbal and telephone orders were authenticated (electronic or written signature) within 48 hours for seven of 16 patients (Patients 13, 14, 52, 68, 72, 75, and 86 ). This failure had the potential for an order to be transcribed in error resulting in a risk to patient health and safety.
Findings:
On 1/10/12 at 11:45 a.m., during an interview, Staff 46 (Registered Nurse) stated, for telephone orders, the physicians were supposed to sign the order when they came into the unit. There was no other system in place and electronic signatures were not used.
On 1/11/12 at 3:30 p.m., during an interview, Staff 143 (Director of Medical Staff) stated there was currently no process in place to track verbal/telephone orders to ensure they were being signed by the physicians.
On 1/12/12 at 1:55 p.m., during an interview, Staff 110 (Registered Nurse Intensive Care Unit 2, Campus 1) stated she was never told or trained to follow up with the physicians regarding the signing of verbal orders. She stated she didn't know what the process was for obtaining physician signatures on verbal/telephone orders.
On 1/12/12, at 2:05 p.m., during concurrent closed clinical record review, Patients 13 and 14 contained a total of 13 verbal orders that were not signed within 48 hours. All these orders had been electronically signed after the patients had been discharged. The findings were confirmed by Staff 147 (Health Information Analyst).
On 1/12/12, at 2:15 p.m., during clinical record review, Patient 75's medical record contained 10 telephone orders and one verbal order that were unsigned for the following dates: 12/8/11,12/11/11, 12/12/11,12/19/11, 12/27 (year unidentified), 12/27 (year unidentified), 12/31/11, 12/31 (year unidentified), 1/2/12, 1/4/12, and 1/5/12.
On 1/12/12, at 2:25 p.m., during clinical record review, Patient 72's medical record contained five telephone orders and one verbal order unsigned for the following dates: 12/31/11, 12/31/11, 12/31/11, 1/1/12, 1/1/12, and 1/2/12.
On 1/12/12, at 2:35 p.m., during clinical record review for Patients 68, 86, and 52, telephone orders were not signed on various dates.

On 1/12/12, Medical Staff Rules and Regulations, last approved 11/11, Section II. H. indicated: "....All verbal orders for medication must be signed, dated and timed by the practitioner ordering the medication or the covering practitioner within 48 hours."

On 1/12/12, the facility policy and procedure titled "PHYSICIAN'S ORDERS: GIVING / RECEIVING / AUTHENTICATING / VERBAL AND TELEPHONE ORDERS" dated 10/20/2010, indicated "C. 1. Verbal and telephone orders shall be signed, dated and timed by the prescribing physician within 48 hours."

Based on staff interview and clinical record review, the hospital failed to ensure that the Conditions of Registration (CoR) consent forms were obtained, properly executed, and complete in four of 12 patient records (Patients 11, 13, 15, and 17). This failure resulted in the potential for the hospital to treat patients without documentation of the patient/responsible party's consent.

Findings:

On 1/11/12 at 1:15 p.m., during closed record review, Patient 17's (newborn infant) medical record, contained an unsigned CoR form. Staff 146 (Health Information Analyst) stated the mother's signature on her form covers the baby born in the hospital. Staff 146 obtained the mother's record and the CoR form was not signed. The CoR form for Patient 11 (mother of infant) was incomplete (not initialed by the patient in the space provided or timed.

On 1/12/12 at 3:05 p.m., during closed record review, Patient 13's medical record had no CoR form. Patient 13 had a 10-day stay, before expiring. Patient 17 had a sheet scanned into the electronic record after discharge, to indicate the CoR form was missing. Staff 146 was unable to locate these forms. The CoR form for Patient 15 was signed by a family member, but the family member signed the patient's name, rather than her own signature.

All findings were confirmed by Staff 147 (Health Information Analyst).

Based on staff interview and clinical record review, the hospital failed to ensure medical records documented information necessary to monitor patient condition when Patient 93's weight was not recorded. This failure resulted in the potential risk for Patient 93 not receiving quality health care.

Findings:

On 1/10/12 at 11:30 a.m., during clinical record review, Patient 93 was admitted on 11/22/11 with diagnosis of interventricular bleed (bleeding into the spaces of the brain). Admission weight was 80.0 kilograms. Patient 93 was hospitalized for 49 days with moderate to low nutrition risk and weight was not monitored on a regular basis. Patient 93 had a weight loss of 10.6 kilograms during his stay and this was not assessed.

Review of Patient 93's medical record showed weights on 1/4/12 of 74.1 kilograms. Weight recorded on 1/9/12 was 70.3 kilograms.

The RD (Registered Dietician) assessment note dated 11/23/11 did not contain a current weight. The nutrition note dated 12/6/11 did not contain a current weight but did recommend daily weights. The nutrition note dated 1/6/12 did not contain the current weight.

On 1/10/12 at 11:30 a.m., during an interview, Staff 133 (Registered Dietician) stated weights were not regularly obtained on the units (patient care areas), but RDs would request as needed. Staff 133 confirmed the current weights and the weight loss had not been assessed for Patient 93.

Staff 133 stated the patient's weight was an essential element for complete nutrition assessment. Staff 133 stated monitoring Patient 93's weight would be necessary considering the length of stay and the patient's medical condition.

On 1/10/12 at 11:40 a.m., during an interview, Staff 150 (Registered Nurse) stated the hospital did not have a policy specifying when to weigh patients if the patient was hospitalized for a long time.

On 1/10/12 during clinical record review, no documentation of the physician being notified of Patient 93's weight loss was found.

Staff 133 verified there was no system to ensure that all staff including RDs and physicians, had complete information to accurately assess patient nutrition status and plan nutrition and medical care.

Based on staff interview, clinical record and administrative document review, the hospital failed to ensure medical records documented a discharge summary for 934 patients. This failure had the potential to result in lack of information needed for patient health and continuity of care.

Findings:

The Medical Staff Rules and Regulations, last approved 11/11, stated in Section II. K.: "The attending physician is responsible for completing and signing the discharge summary within 14 days of discharge...."

On 1/11/12 at 1:35 p.m., during closed clinical record review, outpatient surgery records for Patient 11 and Patient 12 were lacking a discharge summary or final physician progress note including the outcome of the procedure/surgery, disposition of the case, and provisions for follow-up care. These findings were confirmed with Staff 146 (Health Information Manager). Staff 146 stated during the post-discharge analysis of records, the staff did not check outpatient surgery records for these elements.

On 1/12/12 at 2:10 p.m., during closed record review, the dictated/transcribed discharge summary for Patient 15 had a blank space where the date of discharge was to be documented. Patient 15's operation (repair of a hip fracture) was not mentioned; and the summary of the patient's seven-day stay was a short paragraph of three sentences. The finding was confirmed with Staff 147 (Health Information Manager).

On 1/12/12 at 3:45 p.m., during administrative record review, the Missing Dictation Report indicated there were 732 delinquent discharge summaries (incomplete more than 14 days after patient's discharge). The oldest missing dictation was from 2009 and there were 214 missing discharge summaries from patient's discharged in 2010.

Based on staff interview and administrative document review, the hospital failed to ensure that records were completed within 14 days following discharge, as required by the Medical Staff Rules and Regulations. This failure had the potential to result in records lacking vital information for continuity of care for patients during their hospital stay and after discharge.

Findings:

On 1/12/12 at 3:45 p.m., during administrative document review, the Missing Dictation Report compiled by Staff 146 (Health Information Manager) indicated the following delinquent reports (incomplete more than 14 days following discharge) that needed to be completed by physicians: 214 Operation/Procedure reports, 732 Discharge Summaries, 126 Emergency Department Physician Notes, and 151 History and Physicals. The oldest reports were for patients who were discharged in 2009.

Medical Staff Rules and Regulations, last approved 11/11, Section II. O. indicated: "All medical records must be completed within 14 days following the patient's discharge...."

On 1/12/12 at 4:15 p.m., the Hospital Medical Record Statistics Form report for December 2011 was reviewed with Staff 146. Staff 146 stated the Monthly Delinquency Total was listed as 1162 records, and that a more recent count as of 1/12/12 was 1174 total delinquent records.

Based on observations, staff interviews, clinical record and administrative document review, the hospital failed to ensure:

1. That all newly ordered medications for patients in the Emergency Department, the Post Anesthesia Recovery Unit, and the Radiology Department received a pharmacists review before administration. Pharmacists reviewed new medication orders for safety and efficacy (effective drug for disease/disorder) reasons. The absence of a pharmacist's review before administration increased the potential for a medication error and an adverse outcome. (refer to A500, finding 1)

2. The safe use of medications with the occurrence of large numbers (approximately 948 over 22 days) of drug discrepancies in their automated drug dispensing cabinets (ADCs). The hospital failed to follow-up to determine the actual disposition (what happened to them) of discrepancies involving many dangerous drugs. These discrepancies could have resulted in medication errors and the hospital's policy and procedures classified them as such (that is, medication errors). Medical errors could result in adverse outcomes for patients. (refer to A500, finding 2)

3. All registered nurses could quickly and accurately draw up into syringes doses of emergency medications for administration to patients. Two of four registered nurses (Staff 139, Staff 140) who were tested (three of twelve opportunities) made at least one error in drawing up the correct dose. This failure potentially placed patients at increased risk for adverse outcomes, including death, during a medical emergency. (refer to A500, finding 3)

4. All patients administered fentanyl transdermal systems were opioid tolerant prior to administration. One of four patients (Patient 2) whose medical records were reviewed was not opioid tolerant before being administered fentanyl transdermal systems (opioid - narcotic type analgesic for pain relief). The US Food and Drug Administration (FDA) has mandated a boxed warning accompany each package of the medication which defines opioid tolerance. The FDA warning requires that patients are opioid tolerant before being administered fentanyl transdermal systems. This failure could result in respiratory (breathing) failure and death. (refer to A500, finding 4)

5. All patients administered intravenous insulin received correct doses. Two of five patients (Patient 5, Patient 7) whose medical records were reviewed received incorrect doses of intravenously (IV) administered insulin. The hospital did not have a protocol or policies and procedures which promoted the safe administration of continuously administered IV insulin. This failure could result in patients developing hyperglycemia (high blood sugar) or hypoglycemia (low blood sugar). Either condition could result in adverse outcomes for patients up to and including death. (refer to A500, finding 5)

6. The drug storage areas were administered according to the hospital's policies and procedures and California State law. This occurred when pharmacists did not conduct unit (patient care area) inspections every month as required by hospital policy. These failures potentially increased patients' exposure to outdated, mislabeled or otherwise unusable medications which could be detrimental to their health. (refer to A491)

7. The elimination of outdated medications from patient care areas. Manufacturers of medications do not ensure the potency and integrity of medications beyond their expiration dates. Lack of medication potency and/or integrity could have an adverse effect on patients' health. (refer to A500, finding 6)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of safe and effective drugs to meet the needs of the hospital's patients.

Based on observation, staff interview and administrative document review, the hospital failed to administer the drug storage areas according to the hospital's policies and procedures and California State law when unit area inspections were not conducted every month as per hospital policy. These failures potentially increased patients' exposure to outdated, mislabeled or otherwise unusable medications which could be detrimental to their health.

Findings:

On 1/10/12 at 10:05 a.m., the DOP (Director of Pharmacy) said pharmacists did not conduct unit (patient care areas) inspections in the hospital every month. She said they only inspected pharmacy areas to remove outdated, mislabeled, or otherwise unusable drugs. At 10:10 a.m., the DOP provided copies of all of the unit inspections for 2011. These records demonstrated that unit inspections were not conducted for the first nine months of the year (January through September).

On 1/12/12 at 2:00 p.m., five containers of rocuronium (a muscle paralyzing agent), 10 milligrams/milliliter (ml), 5 ml, were observed in an anesthesia cart located in Operating Room 1 on Campus 1. The five containers were not refrigerated. The containers were labeled by the manufacturer to be used within 60 days upon removal from refrigeration. The containers were not labeled regarding when they were removed from refrigeration.

The hospital's policy and procedures regarding unit inspections ("Unit Inspection, 7710.21.01") read: "All drug storage areas within the hospital will be inspected at least every 30 days by the pharmacist or a designee (technician)." Drugs shall not be kept in stock after the expiration date on the label and no contaminated or deteriorated drugs shall be available for use." The California Code of Regulations, Title 22, 70263(q)(9) and (10) read, "Drugs shall not be kept in stock after the expiration date on the label and no contaminated or deteriorated drugs shall be available for use. Drugs maintained on the nursing unit (patient care areas) shall be inspected monthly by a pharmacist."

Based on observations, staff interviews, clinical record and administrative document review, the hospital failed to ensure:

1. That all newly ordered medications for patients in the Emergency Department, the Post Anesthesia Recovery Unit, and the Radiology Department received a pharmacists review before administration. Pharmacists reviewed new medication orders for safety and efficacy (effective drug for disease/disorder) reasons. The absence of a pharmacist's review before administration increased the potential for a medication error and an adverse outcome.

2. The safe use of medications with the occurrence of large numbers (approximately 948 over 22 days) of drug discrepancies in their automated drug dispensing cabinets (ADCs). The hospital failed to follow-up to determine the actual disposition (what happened to them) of discrepancies involving many dangerous drugs. These discrepancies could have resulted in medication errors and the hospital's policy and procedures classified them as such (that is, medication errors).

3. All registered nurses could quickly and accurately draw up into syringes doses of emergency medications for administration to patients. Two of four registered nurses (Staff 139, Staff 140) who were tested (three of twelve opportunities) made at least one error in drawing up the correct dose. This failure potentially placed patients at increased risk for adverse outcomes, including death, during a medical emergency.

4. All patients administered fentanyl transdermal systems were opioid tolerant prior to administration. One of four patients (Patient 2) whose medical records were reviewed was not opioid tolerant before being administered fentanyl transdermal systems (opioid - narcotic type analgesic for pain relief). The US Food and Drug Administration (FDA) has mandated a boxed warning accompany each package of the medication which defines opioid tolerance. The FDA warning requires that patients are opioid tolerant before being administered fentanyl transdermal systems. This failure could result in respiratory (breathing) failure and death.

5. All patients administered intravenous insulin received correct doses. Two of five patients (Patient 5, Patient 7) whose medical records were reviewed received incorrect doses of intravenously (IV) administered insulin. The hospital did not have a protocol or policies and procedures which promoted the safe administration of continuously administered IV insulin. This failure could result in patients developing hyperglycemia (high blood sugar) or hypoglycemia (low blood sugar). Either condition could result in adverse outcomes for patients up to and including death.

6. The elimination of outdated medications from all patient care areas. Manufacturers of medications do not ensure the potency and integrity of medications beyond their expiration dates. Lack of medication potency and/or integrity could have an adverse effect on patient's health.

Findings:

1. On 1/9/12 at 3:15 p.m., during an interview, the DOP (Director of Pharmacy) said the ADCs (automated drug dispensing cabinets) in the ED (Emergency Department) and in the PACU (Post Anesthesia Care Unit) were not profiled. The DOP stated nurses removed medications from ADCs when they were ready to administer them to patients. "Profiled" ADCs were those which required a pharmacist to review prescribers' new medication orders before a nurse could remove the ordered medication from the ADC. Prescribers' orders were delivered to the pharmacy where a pharmacist reviewed them. Medications obtained from ADCs which were not profiled did not require a pharmacist to review the new medication orders before removal. Pharmacists communicated their approval of the order with the pharmacy computer which had an electronic connection to the computer in the ADC. This electronic approval subsequently allowed the nurse to remove the medication. Pharmacists reviewed new medication orders for several safety and efficacy (effectiveness of the drug for the disease or disorder) reasons which included: ensuring the correct medication and dose was ordered and to avoid unwanted drug interactions, adverse drug effects (side effects), drug allergies, and medication errors. Medications removed for patients from ADCs which were not profiled did not benefit from these safety and efficacy checks. Nurses obtained medications from ADCs which were not profiled without having a pharmacist review the prescriber's order before removal from the ADC. On 1/12/12 at 8:05 a.m., the DOP agreed that the ADCs in the ED and PACU needed to be profiled to improve patient safety and efficacy. Hospital policy and procedures ("Automated Dispensing System: Medication Administration; Narcotic Policy; Medication Supply Pharmacy Access") read, "When a patient is admitted to the hospital, the orders for medications are faxed to pharmacy for review by a pharmacist. The pharmacist enters the order onto the patient medication profile ...".

On 1/9/12 at 3:15 p.m., the DOP said Radiology needed a small ("tabletop") ADC because it did not have one. Radiology ordered their medications (contrast media) from pharmacy and stored them there. The DOP indicated that Radiology personnel could administer medications before a pharmacist had reviewed the new order because it did not have an ADC.

On 1/12/12 at 8:05 a.m. the DOP said the hospital needed to change the process in Radiology to ensure a pharmacist reviewed new medication orders before administration.

The American Society of Health-Systems Pharmacists (ASHP) has established the standards of practice for ADCs ("ASHP Guidelines on the Safe Use of Automated Medication Storage and Distribution Devices: Am J Health-Syst Pharm. 1998; 55:1403-07"). The ASHP guidelines indicated that the automated system or device should ... "Provide for prospective, timely review of medication orders by a pharmacist at all appropriate decision points in the medication-use process, especially before administration of the first dose and provide for the independent interpretation of the medication order by a pharmacist and a nurse." The ASHP standard also required that "Clearly stated organizational policies should be developed that limit access to medications before orders have been reviewed and approved by a pharmacist. " ASHP also had indicated "The pharmacist (except in emergency situations) must receive the physician's original order or a direct copy of the order before the drug is dispensed. This permits the pharmacist to resolve questions or problems with drug orders before the drug is dispensed and administered. (ASHP Technical Assistance Bulletin on Hospital Drug Distribution and Control. Am J Hosp Pharm. 1980;37:1097-103).

2. On 1/10/12 at 9:10 a.m., the DOP provided ADC discrepancy reports for the period from 12/19/11 through 1/10/12. This time period was chosen because the hospital instituted a "blind" count on 12/19/11 which required the nurse who removed a medication from the ADC to list the number of doses of that medication remaining in the ADC. The reports occupied 237 pages with approximately four discrepancies/page or approximately 948 discrepancies for the 22 day period (approximately 43 per day or potentially 15,728 per year at that rate). A discrepancy occurred when the number of doses of a particular medication in the ADC was discovered to be different from the number of doses listed in the computer attached to the ADC. The numbers of doses placed in the ADC were listed in the computer attached to the ADC when the medication drawer or pocket in the ADC was filled. For example, discrepancies could occur when a nurse indicated in the computer that he/she removed one dose but actually removed two or more. Also, a discrepancy could occur if a nurse listed in the computer that he/she removed one dose but changed his/her mind and did not remove it. Discrepancies could indicate either too many or too few doses were in the ADC. Potential problems attributable to discrepancies included drug diversion (employee taking medication for own use), administration of too many or too few doses, and other medication errors such as giving a medication to the wrong patient.

Some of the reasons listed on the discrepancy reports for the period from 12/19/11 through 1/10/12 included: "unexplainable loss", "error in count", "error in previous countback quantity", "pharmacy to resolve", "need to count drawer", "technician error", "counted wrong item", "counted wrong bin", and "incorrect use of ADC". On 1/10/12 at 9:10 a.m., the DOP said pharmacy did not follow-up to determine the actual reasons for discrepancies and the explanations listed on the reports did not necessarily reflect the actual reasons for the discrepancies. She said some of the "resolved" discrepancies (which listed reasons) were not a real reason for the discrepancies and she did not know if they were correct. The DOP said nurses reviewed the discrepancies and listed the reasons. The discrepancies included many potentially dangerous and high risk drugs. Examples included antibiotics (levofloxacin), drugs to lower blood pressure (clonidine), sedatives (lorazepam), muscle paralyzing drugs (rocuronium), drugs for mental illness (olanzapine), drugs to decrease/prevent blood coagulation (heparin 25,000 units), opioids (narcotics, fentanyl 2500 micrograms), drugs to raise blood pressure (norepinephrine), drugs to decrease irregular heart rhythms (digoxin), antidepressants (doxepin), and vaccines (influenza).

The Hospital's policy and procedures regarding ADC discrepancies ("Automated Dispensing System: Medication Administration; Narcotic Policy; Medication Supply Pharmacy Access, 4000.16.19") read, "Unresolved discrepancies will be treated as medication errors if inconsistencies are discovered in the cabinet activity MAR's (medication administration record) records, or if a nurse resolves a discrepancy that remains unclear."

3. On 1/11/12 at 3:25 p.m., Staff 139 (Registered Nurse) (who worked on 3 North Campus 1) was asked to draw up into syringes doses of three different emergency medications for a theoretical pediatric patient. PSD (Patient Safety Director) observed. Staff 139 accurately drew up epinephrine (raises blood pressure, increases heart rate) and sodium bicarbonate (decreases acid in the blood). However, she incorrectly drew up 0.26 ml (milliliters) of atropine (increases heart rate) when the correct dose was 2.6 ml or 0.26 mg (milligrams). The concentration of atropine was 1.0 mg/10 ml. Staff 139 required more than 20 minutes to draw up the three medications.

On 1/12/12 at 8:30 a.m., PSD said it was "disappointing" that Staff 139 did not correctly draw up into syringes all of the emergency medications. She said the nurse did not appear to be familiar with the drugs.

On 1/12/12 at 3:00 p.m., Staff 140 in the ED (Campus 2) was asked to draw up into syringes three medications for a theoretical pediatric patient. She correctly calculated doses for all three medications. She drew up into a syringe the correct dose of atropine. However, she drew up 2.6 ml of epinephrine, 1 mg/10 ml, when the correct dose was 1.3 ml. She also did not correctly draw up sodium bicarbonate; she drew up 8 mEq (milliequivalents) when the correct dose was 13 mEq. The error with sodium bicarbonate occurred because she used two different strengths of sodium bicarbonate (4.2 % and 8.4 %) and neglected to note the difference in strengths.

The hospital's policy regarding emergency medications ("Code Blue/Code White") did not address nurses' functions/responsibilities during a medical emergency.

4. On 1/11/12 at 9:00 a.m., the medical records for four patients (Patient 1, Patient 2, Patient 3, Patient 4) who had received fentanyl transdermal systems from November 2011 through January 2012 were arbitrarily chosen for review. Fentanyl transdermal systems, also known as fentanyl patches, are opioid (narcotic type) analgesics (relieve pain). Fentanyl patches had an FDA (U.S. Food and Drug Administration) required boxed warning which read that they "should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose of at least equivalent to fentanyl transdermal system 25 mcg (micrograms)/hour. Patients who are considered opioid tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine [narcotic analgesic] daily, or at least 30 mg of oral oxycodone [narcotic analgesic] daily or at least 8 mg of oral hydromorphone [narcotic analgesic] daily or an equianalgesic [equal in pain relief activity] dose of another opioid." Boxed warnings are the strongest warnings the FDA requires for medications. This boxed warning was intended to prevent the administration of fentanyl patches to patients who were not opioid tolerant because they can cause fatal respiratory (breathing) depression in such patients.

The medical records were reviewed electronically via computer by DPRR (Director Patient Relations and Risk Management). The medical records for Patient 2 did not demonstrate that the patient was opioid tolerant. Patient 2 was admitted on 11/17/11 and received a fentanyl patch on 11/22/11. The patient's "Home Medication Review and Order Sheet" (history of medications patient was taking before admission) did not indicate that the patient was taking opioids before admission to the hospital. Therefore, the records indicated that Patient 2 had not received the equivalent of 60 mg. of oral morphine for seven days (no opioids on 11/15/11 and 11/16/11) before receiving the fentanyl patch on 11/22/11.

Hospital policy and procedures ("Fentanyl Transdermal Patch Administration", 7710.06.04) read, "Since the use of transdermal fentanyl in non-opioid tolerant patients may lead to fatal respiratory depression, this drug should only be used in patients who already are receiving opioid therapy and who have demonstrated opioid tolerance." Also, "Prior to dispensing a non-renewal fentanyl transdermal patch, the dispensing pharmacist shall independently ascertain the opioid-tolerance of the patient ...". The required "Fentanyl Transdermal Patch Orders" which must be completed by the prescriber read, "Patient is opioid TOLERANT (e.g. [for example], having received 60 mg morphine, 30 mg oral oxycodone, or 8 mg hydromorphone daily or equianalgesic opioid dose ONE WEEK or LONGER. Must be substantiated by home medication history.")

5. On 1/11/12 between 9:50 a.m. and 10:55 a.m., the medical records for five patients (Patient 5, Patient 6, Patient 7, Patient 8, Patient 9) who had received IV (intravenous) infusions (continuous IV administration) of insulin (lowers blood sugar) were arbitrarily chosen for review. They were reviewed by the DOP in order to determine whether the changes in insulin doses were correct, that is, if they were made according to the prescribers' orders. The medical records demonstrated that the insulin infusions were administered to these patients between 10/29/11 and 12/11/11. No errors were found in the records for Patient 6, Patient 8 and Patient 9. However, errors in insulin doses were found in the medical records for Patient 5 and Patient 7.

On 11/5/11 at 11:15 a.m., the insulin dose for Patient 5 was 14.2 units/hr (hour) but should have been 16.6 units/hr; at 2:15 p.m. the dose was 6.4 units/hr but should have been 4.6 units/hr; at 4:00 p.m., the dose was 6.4 units/hr but should have been 5.3 units/hr.

On 11/14/11 at 5:51 p.m., the insulin dose for Patient 7 was 10.88 units/hr but should have been 10.14 units/hr; at 6:05 p.m., the insulin dose was 10 units/hr but should have been 9.0 units/hr.

Administering incorrect doses of insulin can lead to life threatening hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar). The DOP said the hospital had not implemented a policy and procedures or an IV insulin infusion protocol during the times the five patients described above received insulin infusions. A protocol had been developed ("Hyperglycemia Order Set") but was never implemented because the PSD (Patient Safety Director) said the hospital believed it was too complicated. She said prescribers were writing IV insulin infusion orders without using a protocol.

6. On 1/10/12 at 10:05 a.m., the DOP (Director of Pharmacy) said pharmacists did not conduct unit (patient care areas) inspections in the hospital every month. She said they only inspected pharmacy areas to remove outdated, mislabeled, or otherwise unusable drugs. At 10:10 a.m., the DOP provided copies of all of the unit inspections for 2011. These records demonstrated that unit inspections were not conducted for the first nine months of the year (January through September).

On 1/10/12 at 11:35 a.m., expired medications were observed with DPRR (Director Patient Relations and Risk Management) in the medication room on 2 West Intensive Care Unit Campus 1. The following were observed: One 50 ml (milliliter) container of normal saline (salt solution) with an expiration date of December, 2011 and one 500 ml container of 3% saline with an expiration date of November, 2011.

On 1/12/12 at 11:40 a.m. four containers of expired diazepam injection (sedative), 10 mg (milligrams)/2 ml, were found in a "Cardiology Tee Kit" in the pharmacy at Campus 2. The expiration date on the diazepam was 1/1/12.

On 1/12/12 at 2:00 p.m., five containers of rocuronium (causes muscle paralysis), 10 mg/ml, were found in Operating Room 1 Campus 2. The rocuronium was located in the anesthesia cart, were not refrigerated, and were not dated regarding when they were removed from refrigeration. The containers were labeled with the caution that they be used within 60 days upon removal from refrigeration.

The hospital's policy and procedures regarding unit inspections ("Unit Inspection, 7710.21.01") read: "All drug storage areas within the hospital will be inspected at least every 30 days by the pharmacist or a designee (technician)." Also, Drugs shall not be kept in stock after the expiration date on the label and no contaminated or deteriorated drugs shall be available for use." The California Code of Regulations, Title 22, 70263(q)(9) and (10) read, "Drugs shall not be kept in stock after the expiration date on the label and no contaminated or deteriorated drugs shall be available for use. Drugs maintained on the nursing unit (patient care areas) shall be inspected monthly by a pharmacist."

Based on observation, staff interview, clinical record and administrative document review, the hospital failed to ensure the dietary services met the needs of all patients when:

1. The Dietetic Service did not use national standards for dietary practice. The daily average in the hospital menu was inadequate for Calcium, Zinc and Fiber. (refer to A630).

2. Nutritional screening, nutritional assessments and nutritional follow-up assessments were not done timely and did not follow hospital policy.
(refer to A621).

3. Hospital standard menus did not meet the minimum daily requirement for certain elements (Calcium and Zinc) and macronutrients (Fiber) and the hospital menu did not follow current national standards for dietary practice. (refer to A630)

3. Ensure safe and effective food production practices. (refer to A724)

4. Did not develop performance improvement activities that reflected the scope and nature of patient needs for dietary and nutritional services. (refer to A276 & A621)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of food and dietetic services to meet the needs of the hospital's patients.

Based on staff interview and administrative document review, the hospital failed to ensure the Director of Nutritional Services was responsible for the daily management of dietary services when she failed to adequately supervise the emergency menu to include puree diet. This failure had the potential to result in not meeting patient specific dietary pureed requirements and possible choking episodes for these patients in the event of an emergency.

Findings:

On 1/10/12 at 2:20 p.m., the emergency food plan for Campus 1 was reviewed with Staff 135 (a Registered Dietitian).

Review of the emergency menu showed there was a four-day menu in place for patients on a regular diet. The hospital policy titled Disaster Procedures for Emergency Menus indicated patients requiring texture-modified diets would receive mechanically altered general diets with purees of those items.

On 1/10/12 at 2:30 p.m., during an interview, Staff 135 stated the hospital usually had around five to ten patients who received puree food items. Staff 135 acknowledged the emergency menus did not include puree diets.

On 1/11/12 at 12:00 p.m., during an interview, Staff 132 (Director of Nutritional Services) acknowledged there was no emergency menu for the patients on a puree diet.

Based on staff interview, clinical record and administrative document review, the hospital failed to ensure a qualified dietitian was available to oversee the nutritional needs of patients when 30 patients at Campus 1 (Patients 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 56, 98, 99, 100) and 9 patients at Campus 2 (Patients 73, 22, 23, 24, 25, 26, 27, 28, and 93) did not receive a timely nutritional screening or a timely nutritional assessment or a timely nutritional follow-up assessment as per hospital policy. These failures resulted in placing patients at risk of not having their nutritional needs assessed and met and possibly extending hospitals stays and not receiving quality health care.
Findings:
Review of the policy No. 4000.14.06 titled Nutrition Services: Interventions For Patients At Nutrition Risk indicated patients at low risk would be screened by the clinical nutritional staff within 4 days from admission. The patient would be further evaluated by clinical nutrition staff depending upon the acuity of the patient as determined by diagnosis, laboratory review, anthropometrical (skin fold) measurements, nutritional status and route of nutrition delivery.

On 1/10/12 the Campus 1 Census Report for 1/10/12 was reviewed. The Census Report listed current patients in the hospital with admission dates, diet orders and admitting diagnosis. Twelve patients (Patients 26, 38, 40, 41, 43, 44, 45, 49, 51, 52, 53, 54) were admitted between the dates of 12/28/11 and 1/7/12; none of the twelve patients had received a nutrition screening or nutritional assessment. For example, the clinical record for Patient 41 indicated the patient was admitted on 12/28/11 and had not been assessed for a total of 12 days and was listed to have a therapeutic diet of carbohydrate control, high protein, sodium and potassium restricted diet.

The Campus 1 Census Report listed 18 patients (Patients 29, 30, 31, 32, 33, 34, 35, 36, 37, 39, 42, 46, 47, 48, 50, 56, 98, 99) with late RD (Registered Dietician) follow-up assessments. The due dates for the RD follow-up assessments for these 18 patients ranged between 1/6/12 to 1/9/12.

The Campus 2 Census Report for 1/10/12 showed 8 patients (Patients 22, 23, 24, 25, 26, 27, 28, and 29) who had admission dates from 12/29/11 to 1/4/12 that had not had a nutrition screening or nutrition assessment. One patient (Patient 93) had a follow-up nutrition assessment that was 6 days late.

The following clinical records were reviewed as examples of delayed nutrition screening and/or assessment:

Patient 100 was admitted 12/16/11 with diagnosis of thrombocytopenia (low platelet count which may lead to internal bleeding) and the medical record was reviewed on 1/9/12 at 2:30 p.m. The RD note was dated 1/3/12 and assessed the patient at low nutritional risk. Patient 100 was not seen for the initial nutrition screen until 18 days after admission.

Patient 24 was admitted 12/31/11 with diagnosis of a serious wound infection to the right foot and the medical history documented the patient as a new onset diabetes mellitus (high blood sugar). There were no nutrition assessments documented.

On 1/10/12 at 11 a.m., during an interview, Staff 134 (an RD) stated regarding Patient 24 that the admission nursing screen from 12/31/11 which was completed in the electronic medical record documented a Certified Diabetic Educator (CDE) consultation request. Staff 134 stated that the hospital does not have a CDE. Staff 134 did not know why the consult was not sent to the RD who would have conducted the nutritional assessment. The Staff 134 stated Patient 24 was an example of a patient that would have been assessed at high nutrition risk. Staff 134 acknowledged Patient 24 did not receive a timely nutritional assessment.

Patient 93 was admitted 11/22/11 with diagnosis of interventricular bleed (bleeding into the spaces of the brain) and the medical record documented the admission weight as 80.0 kilograms (178 pounds). Review of the medical record showed RD nutrition reports dated 11/23/11 and the patient was assessed at moderate nutrition risk. Patient 93 was to have a nutritional follow-up for moderate nutritional risk in 6 days (11/29/11). His follow up was 7 days late. RD note was dated 12/6/11 and Patient 93 was assigned low nutritional risk. The follow-up was to be within 8 days for patient assessed at low nutritional risk. His follow-up that was due on 12/14/11 was 23 days late.

Staff 133 (an RD) stated on 1/9/12 at 2:30 p.m., that they were short staffed and they do the best they can.

On 1/10/12 at 10 a.m., during an interview, Staff 133 stated the RDs reviewed the Census Report each morning. The purpose of the daily Census Report review was to prioritize the work load. Patients with nutrition consults and those patients with high nutrition risk were prioritized first. Staff 133 stated many of the patients on the census list were not triggered for a nutrition consult. Staff 133 acknowledged the policy stated that patients newly admitted to the hospital would be seen for screening or assessment within 4 days of admission. She stated that when they had a heavy work load some of the patients were not seen but the RD would ask the nurse if there were any nutrition concerns. Staff 133 acknowledged nutrition assessments would be delayed even if it was overdue per the policy.

On 1/11/12 at 11:00 a.m., Staff 132 (Director of Nutritional Services) was interviewed regarding the RD staffing and coverage of nutrition assignments at both Campus 1 and Campus 2. Staff 132 acknowledged that many nutritional assessments for new admissions were overdue and delayed. Staff 132 acknowledged that a full-time RD position had been left vacant for several months. Staff 132 stated that she had discussed the RD staffing needed to meet the patient nutrition care with the Associate Vice President of Support Services (AVPSS) but there was no interim RD staffing approved. The AVPSS reported to Quality Improvement Committee and to the Governing Body.
On 1/11/12 at 11:40 a.m., during an interview, Staff 132 stated regarding the quality and performance improvement program for the department that she reported the quarterly reports to the Pharmacy and Therapeutics Committee. When asked, Staff 132 stated only when there was an issue identified would she be involved in the Quality Committee.
Review of the organization chart showed Staff 132 reported to the Associate Vice President of Support Services.

On 1/11/12 at 12:20 p.m., the Senior Vice President of Network Operations was interviewed regarding the nutrition care of patients and the number of nutrition assessments that were late. The Senior Vice President of Network Operations stated that Staff 132 reported to the VP of Support Services who was currently on vacation. The Senior Vice President stated that he was not aware of the late nutrition assessments and the staffing issues. He stated that he would work with Staff 132 to ensure the patients received the nutrition care.

Based on staff interviews and review of administrative documents, the hospital failed to ensure standard menus met the current national standards for dietary practice when the daily average menu content for Calcium, Zinc and Fiber were inadequate. This failure had the potential for the patients in the hospital to not receive adequate nutrition and to meet the estimated recommended dietary allowances for Calcium, Zinc and Fiber.

Findings:

The hospital's nutrient analysis for the regular menu indicated the daily average for the seven day menu was 1098 milligrams (mg) of Calcium, 9 mg of Zinc and 13 grams (g) of Fiber.

The Dietary Reference Intakes (DRIs): Recommended Dietary Allowances and Adequate Intakes for Elements was reviewed for Calcium and Zinc and for Macronutrients. The DRIs for Calcium were dated 1997. The DRIs for Zinc were dated 2001. The DRIs for Macronutrients were dated 2002/2005.

For Calcium, the recommended standard daily average intake for males and females between the ages of 9 and 18 years was 1,300 mg; females between the ages of 51 through 70 years was 1,200 mg; and females and males greater than 70 years was 1,200 mg.

The hospital menu was inadequate in Calcium content (depending on the age and gender) between 102 and 202 mg.

For Zinc, the recommended daily average intake for males and females between 14 and greater than 70 years of age was 11 mg. The hospital menu was inadequate for Zinc content (depending on the age and gender) between 2 and 5 mg.

The recommended daily average intake for Fiber for males nine through 13 years of age was 31 g; 14 through 50 years of age was 38 g; and 50 through greater than 70 years of age was 30 g; females nine through 18 years of age was 26 g; 19 through 50 years of age was 25 g; 50 through greater than 70 years of age was 21 g.

The hospital menu was inadequate in Fiber depending on the age and gender between 8 and 25 g.

On 1/11/12 at 11:52 a.m. an interview was conducted with Staff 132 regarding the hospital menu and nutrition analysis of the menu. Staff 132 stated the menu was originally developed using the food groups. Staff 132 stated she was not able to make sure the menu met the DRIs. Staff 132 stated she was currently in the process of building a new menu and would make sure the new menu would be adequate.

Based on observation, staff interview and administrative document review, the hospital failed to maintain equipment to ensure an acceptable level of safety and quality when the walk-in refrigerator located at Campus 2 was not free from pealing and flaking paint and the condenser vent was not clean. This failure resulted in the potential risk of cross contamination of food stored in the refrigerator and possibly affecting the health and safety of hospital staff and patients.

Findings:

On 1/10/12 at 8:30 a.m. the produce walk-in refrigerator located in the kitchen area of Campus 2 was observed. White flaking paint and black substance was observed on areas of the ceiling. The condenser vents were covered with black flaking substance.

On 1/10/12 at 9 a.m., during an interview, the Nutrition Manager for Campus 1 stated they had washed the ceiling a year ago but had not had the ceiling refinished. The Nutrition Manager acknowledged the flaking paint presented a risk of cross contamination to the fresh produce stored in this refrigerator.

No documented evidence was provided for the cleaning schedule for the condenser vents located in the walk-in refrigerator. The Nutrition Manager could not give an estimated date as to when the last maintenance was done.

Based on observations, staff interviews, and document review, the hospital failed to provide and maintain a sanitary and safe environment for the patients and employees to avoid sources and transmission of infections and communicable diseases as evidenced by:

1. Traffic pattern in the endoscopy suite did not conform to nationally recognized infection control standard of practice. (refer to A749, finding 1)

2. The hospital failed to have an effective system to ensure personnel wore appropriate attire in the operating and endoscopy suites. (refer to A749, finding 2)

3. The hospital failed to have an effective system to ensure environmental cleaning was performed in accordance with nationally accepted standards, the manufacturer's specifications, and the hospital's policy and procedure. (refer to A749, finding 3)

4. The hospital failed to have an effective system to ensure endoscopes were cleaned and stored in accordance with nationally accepted standards. (refer to A749, finding 4)

5. The hospital failed to ensure staff cleaned and disinfected the equipment effectively between patient use. (refer to A749, finding 5)

6. The hospital failed to ensure the MSDS (Materials Safety Data Sheet) was readily available in various units of the hospital. (refer to A749, finding 6)

7. The hospital failed to ensure staff processed surgical instruments in accordance with nationally recognized infection control guidelines and/or the manufacturer's specifications and/or the hospital's policy and procedure. (refer to A749, finding 7)

8. The hospital failed to ensure staff used the single-use items in accordance with manufacturer's specifications and nationally recognized infection control guidelines. (refer to A749, finding 8)

9. The hospital failed to have an effective system to ensure the physician performed and documented daily assessment of central line (a tube that healthcare providers place in a large vein in the neck, chest, or arm to give fluids, blood, or medications or to do certain medical tests quickly) necessity for all patients with central lines. (refer to A749, finding 9)

10. The hospital failed to ensure the clean linen and/or the surgical suits were transported, distributed and stored in accordance with the nationally recognized infection control guidelines and the hospital's policies and procedures. (refer to A749, finding 10)

11. The hospital failed to ensure the clean and soiled supplies were stored separately in accordance with nationally recognized infection control guidelines. (refer to A749, finding 11)

12. The hospital failed to have an effective system to ensure personnel were consistently screened for infectious diseases in accordance with nationally accepted standards. (refer to A749, finding 12)

13. The hospital failed to have an effective system to monitor and maintain the relative humidity, the temperature, and air exchanges in the perioperative (surgical procedure), areas including operating rooms, endoscopy rooms, decontamination room, sterile processing areas, sterile storage and post anesthesia care units, in accordance with nationally recognized infection control guidelines. (refer to A749 finding 13 & A951)

14. The hospital failed to have an effective system to ensure quality assurance performance improvement related to infection control in accordance with nationally acceptable infection control guidelines. (refer to A749, finding 14)

The cumulative effect of these systemic problems resulted in the hospital's inability to comply with the statutorily-mandated condition for coverage for infection control.

Based on observations, staff interviews, clinical record and administrative document review, the hospital failed to have an active, hospital-wide infection control program reflecting the infection control practitioner's responsibilities for measures to identify, investigate, report, prevent and control infections and communicable diseases when:

1. Traffic patterns in the endoscopy suite at Campus 2 did not conform to nationally recognized infection control standards of practice;

2. The hospital failed to have an effective system to ensure personnel wore appropriate attire in the perioperative areas (operating rooms, endoscopy rooms or suites [the room for procedures in which an instrument is passed into the body for the purpose of visual examining the interior of a bodily canal or a hollow organ such as the esophagus, bronchus, colon, bladder, stomach or intestine], decontamination room, sterile processing areas, sterile storage and post anesthesia care unit). Examples that validated a system-wide failure were:

a. The OR (operating room) Technician did not cover her upper arms when open sterile supplies were located in the OR 2 on Campus 2;

b. Three of three staff members (Staff 6, Staff 44, and Staff 45) did not cover the hair completely when working in the restricted areas (operating rooms, procedure rooms, and the clean core area) and semi-restricted areas (the storage areas for clean and sterile supplies, work areas for storage and processing of instruments, scrub sink areas, and corridors leading to the surgical suites);

c. One staff member (Staff 4) did not secure the mask with the bottom ties when handling the soiled instruments in the decontamination room;

d. Three staff members (Staff 3, Staff 188, and Staff 19) were in a semi-restricted zone of the perioperative area on Campus 1 without covering their respective beards and or mustaches.

e. On Campus 2, in the endoscopy area, Staff 55 cleaned the endoscopy procedure room while wearing street attire, no hair covering, and a pair of gloves.

3. The hospital failed to have a system to ensure staff performed effective environmental cleaning in accordance with nationally accepted standards, the manufacturer's specifications, and the hospital's policies and procedures. Examples that validated a system-wide failure were:

a. Two staff members (Staff 29 and Staff 21) cleaned multiple surfaces with one cleaning cloth/wipe and did not allow adequate wet contact time with the disinfectant;

b. Staff 48 returned the used cleaning mop to the cleaning solution container during the between surgeries cleaning procedure in the OR 2 of Campus 2;

c. The hospital did not have a system to ensure regular cleaning and disinfecting of the aerators on the faucets of the scrub sink;

d. The hospital did not have a system to ensure the automated-mixed disinfectant for floor and surfaces cleaning/disinfection was effectively mixed and functioning properly;

4. The hospital failed to have an effective system to ensure endoscopes were cleaned and stored in accordance with nationally accepted standards. Examples that validated a system-wide failure were:

a. Endoscopes were stored wet in an open storage cabinet and no system was in place to ensure endoscopes were dry prior to use (Campus 1).

b. Staff 50 (Director of the Operating Room Campus 1) was not able to determine the processing dates of the endoscopes of various types in the storage cabinet and staff confirmed there was no system to reprocess the endoscopes before use if they were unused for more than five days;

5. The hospital failed to have a system to ensure staff cleaned and disinfected equipment effectively between patient use in accordance with the nationally recognized infection control guidelines. Examples that validated a system-wide failure were:

a. One staff member (Staff 4) wiped the soiled instrument container with disinfectant followed by drying with a clean cloth, which could not achieve the disinfecting purpose;

b. The radiology machine and the lead apron were not effectively disinfected between use;

c. The reusable arm board strap was not disinfected between patient use;

d. The glucometer was not effectively cleaned and disinfected between patient use.

e. Non-intact surfaces on patient's arm board and slider board were not disinfected effectively and items with porous materials were found in the Operating Rooms on Campus 2.

6. Three of four staff members (Staff 29, Staff 39, and Staff 47) were unable to access the chemical information in the MSDS (Materials Safety Data Sheet - information for potentially hazardous chemical including identification, precautions, signs and symptoms of toxic exposure, and first aid treatments) binder on various units of the hospital;

7. The hospital failed to have an effective system to ensure staff complied with the nationally recognized infection control guidelines, the manufacturer's specifications, and the hospital's policies and procedures. Examples that validated a system-wide failure were:

a. The staff did not soak and brush soiled instruments prior to placing them in the washer/disinfector;

b. The staff did not mix the enzymatic disinfectant in accordance with the manufacturer's specifications;

c. The staff washed hands in the instrument sink;

d. The staff did not operate the washer/disinfector in accordance with the manufacturer's specifications such as:

i. Checking the adequacy of detergents and the functions of the spray arms prior to operating the machine;

ii. Two of two washers/disinfectors (washer 1 and washer 2) were not serviced regularly;

e. The staff did not ensure the surgical instruments were effectively sterilized when: 93 of 165 pairs of scissors and clamps of various types were observed in the sterile pouches with blades closed;

f. The hospital used flash-sterilization as a substitute for sufficient instrument inventory;

8. Staff routinely reused single-use items. The hospital failed to ensure disposal of single-use items in accordance with manufacture's specifications. Examples of this failure were:

a. The sterile processing staff used a single-use brush on more than one set of soiled instruments;

b. Single use Velcro strap for positioning and single-use Infusion cuffs were observed to be reused in Operating Room 4 Campus 1.

9. The hospital failed to have an effective system to ensure the physician performed daily assessment of central line (a tube that healthcare providers place in a large vein in the neck, chest, or arm to give fluids, blood, or medications or to do certain medical tests quickly) necessity for all patients with central lines. The central line necessity documentation did not indicate the assessment of central line necessity was documented or authenticated by the attending physician;

10. The hospital failed to transport, distribute, and store clean linens and surgical scrubs in accordance with nationally recognized infection control guidelines and the hospital's policy and procedure. Examples of these failures were:

a. Clean surgical attire was observed stored on uncovered shelves in the female locker room in the operating suite on Campus 2. The bottom shelf was neither solid nor lined with an impervious material;

b. Clean linen was not stored in a designated clean linen supply room;

c. Staff handled dirty linen and clean linen with out proper hand hygiene;

d. Staff transported clean linen throughout the hospital without a protective cover;

e. Clean linen was placed on unclean surfaces prior to being placed in the clean linen storage cart.

11. The hospital failed to ensure the separate location of clean and soiled supplies in accordance with nationally recognized infection control guidelines. Examples of this failure were:

a. A hopper (container used to collect liquid waste) was located in close proximity to patient, nurse's hand washing sink, personal protective equipment for staff, and an emergency supply cart;

b. Clean equipment was stored with soiled equipment;

c. Clean lines were transported without adequate coverage, cross-contaminated with soiled linen, and handled without hand washing.

12. The hospital failed to have an effective system in place to ensure participating physicians were consistently screened for infectious disease, including blood borne pathogens in accordance with its policy and nationally accepted standards.

13. The hospital failed to maintain three of eight ice machines in a safe and sanitary manner.

14. The hospital failed to have an effective quality management and performance improvement program in place to ensure infection control issues were identified and resolved.

These failures had the potential for obstructing the infection control and prevention process and put patients and hospital personnel at risk for exposure to blood-borne pathogens and transmission of communicable diseases.

Findings:

1. On 11/1/11 at 10:15 a.m., during an observation in the GI (gastrointestinal) endoscopy procedure area (area where invasive procedures were performed) of Campus 2, a door creating separation from the hospital was found. There were no signs to indicate this area was restricted to authorized personnel and surgical attire was required.

Examples of the types of GI procedures performed in this area included endoscopy with biopsy (direct visualization of the throat, esophagus, stomach and/or small intestines with a device and removal of tissue to examine for diseases), colonoscopy with biopsy (direct visualization of the colon with a device and removal of tissue to examine for diseases), and insertion of a tube into the stomach.

On 1/12/12 at 1:45 p.m., during an interview in the GI procedure area on Campus 2, Staff 12 (Operating Room Director) stated he was not aware the area was considered a restricted access area.

On 1/12/12 at 1:30 p.m., during an interview at Campus 2, Staff 1 (Infection Control Director) stated the GI area should be a restricted area. Staff 1 confirmed the lack of a red line and signage area did not conform to current standards set by the facility.

The Perioperative Standards and Recommended Practices published by the AORN (Association of perioperative Registered Nurses), 2011 edition, page 95 indicated "Traffic patterns should be designed to facilitate movement of patients and personnel into, through, and out of defined areas within the surgical suite. Signs should clearly indicate the appropriate environmental controls and surgical attire required. The semi restricted area includes the peripheral support areas of the surgical suite. It has storage areas for clean and sterile supplies, work areas for storage and processing of instruments, scrub sink areas, and corridors leading to the restricted areas of the surgical suite. Traffic in this area is limited to authorized personnel and patients. The restricted area includes operating rooms, procedure rooms, and the clean core area."

2.a. On 1/12/12 at 1:30 p.m., during concurrent observation and interview with Staff 49 (OR Registered Nurse) and Staff 1 (Infection Control Director), a staff member wearing a short-sleeved surgical scrub, gloves and a mask was working in OR 2 where open sterile supplies were located. Staff 49 stated the staff member wearing short-sleeved scrub was a scrub technician who was preparing the sterile field for the following surgery. Staff 49 stated the scrub technician was not required to cover her upper arms with the long-sleeved jacket since the scrub technician had scrubbed her upper arms multiple times throughout the day. Staff 1 stated the scrub technician should have worn a long-sleeved jacket to cover her upper arm in the presence of open sterile supplies.

On 1/12/12 at 1:45 p.m., a review of the hospital's Policy and Procedure (Policy No.[number]: 7420.15.02) titled "Operating Room Aseptic Technique Practices" dated 2/16/11 (effective date) indicated "A.2. Methods of disinfecting, sterilization, storage, and handling of sterile items should meet the AORN (the Association of periOperative Registered Nurses) "Recommended practices for chemical disinfecting and recommended practices for sterilization in the practice setting...C.1. Scrubbed personnel function within a sterile field. Sterile gowns and gloves should be used within the sterile field...K.2. All persons who perform the surgical scrub in preparation for surgery must don a sterile gown."

On 1/12/12 at 2 p.m., the 2011 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. On page 62, under Recommendation III.b., direction was given that, "When in the semirestricted or restricted areas, all nonscrubbed personnel should wear a freshly laundered or single-use long-sleeved warm-up jacket snapped closed with the cuffs down to the wrists...Long-sleeved attire helps contain skin squames shed from bare arms." On page 87, under Recommendation I.2., direction was given that, "Personnel should wear scrub attire, caps, masks...and sterile gowns and gloves to prevent microbial transference to the sterile field..."

2.b. During an observation in the sterile processing area on 1/9/12 at 3:40 p.m., Staff 6's (sterile processing technician) cap did not contain his sideburns.

On 1/11/12 at 11:40 a.m., during an interview, Staff 1 stated it was not appropriate to expose the sideburns in the sterile processing area.

On 1/12/12 at 1:07 p.m., during concurrent observation and interview with Staff 1 (Infection Control Director), Staff 44 and Staff 45 (Surgeons) were observed entering OR 3 and OR 1 respectively. Both Staff 44 and Staff 45's caps did not contain the hair at the nape of their necks and the sideburns. Staff 1confirmed that Staff 44 and Staff 45's hair should have been completely covered by hair coverings in the semi-restricted and the restricted areas.

On 1/12/12 at 1:45 p.m., a review of the hospital's Policy and Procedure (Policy No.[number]: 7420.19.12) titled "Surgical Attire" dated 1/4/2012 (effective date) indicated "All personnel should cover head and facial hair, including sideburns and the nape of the neck, when in semi-restricted and restricted areas." A review of the hospital's Policy and Procedure (Policy No.: 7420.15.02) titled "Operating Room Aseptic Technique Practices" dated 2/16/11 (effective date) indicated "...1.b. Semi-restricted area is defined as the peripheral support areas of the surgical suite and has storage areas for clean and sterile supplies, work areas for storage and processing of instruments, and corridors leading to the restricted areas of the surgical suite...Personnel are required to wear surgical attire and cover all head and facial hair...Restricted area is defined as the operating and procedure rooms, the clean core, and scrub sink areas. Surgical attire and hair coverings are required..."

On 1/12/12 at 1:50 p.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 62, under Recommendation IV, direction was given that, "All personnel should cover head and facial hair, including sideburns and the nape of the neck, when in the semirestricted and restricted areas. Under Recommendation IV.a., direction was given that, "A clean, low-lint surgical head cover or hood that confines all hair and covers scalp skin should be worn...Skull caps may fail to contain the side hair above and in front of the ears and hair at the nape of the neck."

2.c. On 1/9/12 at 2:10 p.m., during an observation in the decontamination room on Campus 1, Staff 4 (Sterile Processing Technician) did not secure the facial mask with the bottom ties when handling the soiled instruments.

During an interview with Staff 1 on 1/11/12 at 11:40 a.m., Staff 1 stated it was not acceptable to use an untied mask while handling the soiled instruments.

On 1/12/12 at 1:45 p.m., a review of the hospital's Policy and Procedure (Policy No.[number]: 7420.19.12) titled "Surgical Attire" dated 1/4/12 (effective date) indicated "Surgical masks must cover the mouth and the nose and be secured in a manner to prevent venting."

On 1/11/12 at 1:50 p.m., the "Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, 2007" published by CDC (Centers for Disease Control and Prevention), was reviewed. On page 129, under the section "Donning PPE (Personal Protective Equipment - a variety of barriers and respirators used alone or in combination to protect mucous membranes, airways, skin, and clothing from contact with infectious agents)...Mask...Secure ties or elastic band at middle of head and neck."

2.d. On 1/10/12 at 10:15 a.m., during an observation, Staff 3, Staff 18, and Staff 19 were in a semi-restricted zone of the perioperative area on Campus 1 without covering their respective beards and/or mustaches.

On 1/10/12 at 10:15 a.m., during concurrent interviews, Staff 3, 18, and 19 indicated they were not aware that their beards and mustaches were required to be covered when they were in the semi-restricted areas of the perioperative suite.

During an interview with Staff 1 on 1/10/12 at 10:10 a.m., during an interview Staff 1 stated the facility followed AORN as the standard for surgical attire. Staff 1 acknowledged Staff 3, 18, and 19 should have had all hair covered when in the semi-restricted zones.

2.e. On 1/12/12 at 1:45 p.m., during concurrent observation and interview on Campus 2 in the endoscopy area, Staff 55 (housekeeping staff) was observed cleaning the endoscopy procedure room. She was wearing street attire, no hair covering, and a pair of gloves. Staff 55 stated the only special clothing she needed to wear was gloves.

On 1/12/12 at 1:50 p.m., during an interview Staff 1 stated the facility followed AORN as the facility standard for surgical attire. Staff 1 acknowledged Staff 55 should have been wearing surgical scrubs and a hair covering, in addition to the gloves, when cleaning the endoscopy procedure room.

Review of the hospital policy titled "Floor and Equipment in Surgical Area: Cleaning: dated 4/1/09 and presented as current, was reviewed on 1/12/11 at 7 a.m. The policy stipulated, "To begin cleaning and disinfection procedure employee must be robed in proper personal protective equipment, i.e. shoe covers, surgical scrubs, cap, gloves, and mask)."

Review of the hospital policy titled "Linen: Scrubs" , dated 6/09 and presented as current, included endoscopy among the departments wearing scrubs. The policy stipulated, "Employees in the above departments (referring to departments designated to wear scrubs) must change into scrubs when they arrive in their department."

Review of the 2011 AORN Perioperative Standards and Recommended Practices, under Recommended Practices for Surgical Attire, Recommendation II documented, "clean surgical attire, including shoes, head covering, and all individuals who enter the semi restricted and restricted areas of the surgical suite should wear freshly laundered surgical attire intended for use only within the surgical suite." Item II.c. documented, "Persons entering the semi restricted or restricted areas of the surgical suite for a brief time for a specific purpose should cover all head and facial hair and should don either freshly laundered surgical attire; single-use attire, or a single-use jumpsuit designed to completely cover outside apparel."


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3.a. On 1/10/12 at 11:40 a.m., during concurrent observation and interview in the Intensive Care Unit (ICU) on the third floor, Staff 29 (housekeeping staff) performed environmental cleaning in a patient's room. Staff 29 wiped the mirror with a cleaning cloth damped with pH 7Q Ultra (a disinfectant for killing germs) followed by a dry paper towel. Staff 29 used the same cleaning cloth to wipe the soap dispenser, the sink, and the exterior surfaces of the built-in commode. When asked if multiple surfaces could be disinfected effectively by one cleaning cloth, Staff 29 stated one cloth could disinfect multiple surfaces.

On 1/10/12 at 11:50 a.m., a review of the manufacturer's printed label on the container of pH 7Q Ultra indicated the surface should remain wet for 10 minutes to serve the disinfection purpose.

During an interview with Staff 1 in the Intensive Care Unit on the third floor on 1/10/12 at 11:55 a.m., Staff 1 stated Staff 29 should have cleaned and disinfected the sink and commode with separate cleaning cloths; the high surfaces could be cleaned and disinfected with one cleaning cloth. Staff 1 acknowledged that the mirror was wiped dry right away, which could not remain wet for 10 minutes to serve the disinfection purpose. Staff 1 also stated she was unable to determine if one wipe could keep multiple surfaces wet for 10 minutes in order to achieve the disinfection purpose.

On 1/12/12 at 11:10 a.m., a review of the hospital's Policy and Procedure (Policy No.: 7000.05.04) titled "Equipment Decontamination (Non-critical)" dated 7/14/10 (effective date) indicated "All non-critical equipment (items that come in contact with intact skin) should be cleaned and disinfected between patient uses...A hospital-approved germicide should be used to disinfect equipment...Follow manufacturer's cleaning guidelines."

On 1/10/12 at 11:30 a.m., during an observation, Staff 21 (housekeeping staff) was cleaning a patient room using super sani-cloths (6x 6.5 inch cloths saturated with a solution that kills germs). Staff 21 was observed using one cloth to clean the top of a cabinet and a toilet. Staff 21 then used another cloth to clean a sink, towel dispenser, and pictures. Staff 21 wiped the sink dry after allowing the solution to remain wet on it for (1) one minute.

On 1/10/12 at 11:35 a.m., during an interview Staff 21 stated she should have let the solution dry on the surfaces and she should have used more than one cloth when she cleaned multiples surfaces.

Review of the manufacturer's instructions for use of the super sani-cloth was conducted on 1/10/12 at 5 p.m. The instruction included the following information: "Use a wipe to remove heavy soil. Then unfold a clean wipe and thoroughly wet surfaces. Treated surface must remain visibly wet for (2) full minute. Use additional wipe(s) to assure continuous (2) minute wet contact time. Let air dry."

3.b. During an observation of the environmental cleaning between surgeries in the OR 2 on Campus 2 On 1/12/12 at 1:15 p.m., during an observation Staff 48 (operating room technician) mopped the floor; she returned the used mop to the cleaning solution; and re-mopped the floor with the used mop.

On 1/12/12 at 2 p.m., during an interview Staff 1 stated the hospital used AORN and CDC guidelines as references for infection control practice.

On 1/12/12 at 3 p.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 238, under Recommendation I.c.1., direction was given that, "Reusable string and microfiber mops and cleaning cloths should be changed after each use. Used cleaning mops or cloths should not be returned to the cleaning solution container."

3.c. On 1/12/12 at 1:12 p.m., during concurrent observation and interview in the OR suite on Campus 2, Staff 47 (environmental services staff) stated she did not regularly clean or disinfect the aerator (screen used to separate water stream into droplets) on faucets of the scrub sink during the environmental cleaning.

On 1/12/12 at 2 p.m., during an interview Staff 1 stated the hospital used AORN and CDC guidelines as references for infection control practice.

On 1/12/12 at 3 p.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 242, under Recommendation V.d.1., direction was given that, "Aerators on faucets should be cleaned and disinfected weekly by removing the aerator, scrubbing it with a detergent and a brush reserved for this purpose, and immersing it in a disinfectant."

3.d. On 1/10/12 at 11:35 a.m., during an interview Staff 29 (Environmental Services Supervisor) stated the pre-mixed disinfectant (pH 7Q Ultra) was mixed in the concentration recommended by the manufacturer. Staff 29 stated she monitored the automated system regularly to ensure the pre-mixed disinfectant was in correct concentration.

On 1/11/12 at 10:30 a.m., during an interview, Staff 31 (Environmental Services Director) stated the hospital had no system to ensure the a automatically mixed disinfectant for cleaning and disinfection was mixed as recommended by manufacturer in order to achieve the disinfection purpose. Staff 31 confirmed occasionally the metering tip of the system was not in the right location, which would cause inadequate disinfectant delivered by the automated system.

On 1/11/12 at 10:40 a.m., during an interview, Staff 1 stated the hospital should have established a system to monitor the automated delivery of disinfectant to ensure the solution was in the correct concentration.

On 1/11/12 at 11 a.m., a review of the 2003 Guidelines for Environmental Infection Control in Health-Care Facilities, published by CDC and HICPAC, was reviewed. On page 133, under E.I.A., direction was given that, "Select EPA-registered disinfectants, if available, and use them in accordance with the manufacturer's instructions." Under E.I.C., direction was given that, "Follow manufacturers' instructions for cleaning and maintaining noncritical medical equipment."

4.a. On 1/10/12 at 3 p.m., during an observation in the GI (stomach and bowel) procedure area of Campus 1, endoscopes were found to be hanging in a cabinet with a wet white towel underneath.

On 1/10/12 at 3:25 p.m., during an interview, Staff 27 (Operating Room Technician) stated the moisture was caused by drainage of alcohol from the interior channel of the scopes. He stated there was no system in place to ensure the scope was dry before it was used.

On 1/10/12 at 3:30 p.m., during an interview, Staff 1 (Director of Infection Control) acknowledged the potential fire hazard posed by using a scope wet with alcohol during a procedure where there could be a source of ignition, for example, with cautery (intense electrical heating of tissue).

The Association of Registered Perioperative Nurses (AORN) Standards and Recommended Practices, 2011 edition, indicated on page 420, "After rinsing the scope with 70% ethyl alcohol or 90% ethyl alcohol the channels should be dried using low pressure forced air. Using forced air assists with the removal of moisture remaining in the channels. Dry air channels do not support microbial growth."

An AORN Journal article titled "Surgical Fires, Learn Not To Burn" published in July 2004 advised that surgical fires can occur in any setting where invasive procedures are preformed and that fires occur in any setting where the three elements that form the fire triad (ie fuel, oxygen, and heat) come together. The article further advised to minimize ignition risks, minimize oxidizer risks and minimize fuel risks by allowing flammable liquid prep solutions to fully dry and to be aware of the flammability of solutions used during surgery and to take steps to avoid igniting their vapors.

These failures placed patients and staff at risk for infection and fire that could result in serious illness, injury and death.

4.b. On 1/12/12 at 1:55 p.m., during an interview, Staff 50 (Surgery and Recovery Director) stated the processed endoscopes were usually unused for more than seven days and there was no system to identify the processing date of the endoscopes in the storage cabinet. Staff 50 confirmed that the hospital did not have a system to reprocess the endoscopes if unused for more than five days.

On 1/12/12 at 2 p.m., during an interview Staff 1 stated the hospital used AORN and CD guidelines as references for infection control practice.

On 1/12/12 at 2:15 p.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 421, under Recommendation IX.b., direction was given that, "Flexible endoscopes should be reprocessed before use if unused for more than five days...flexible endoscopes cleaned and processed as recommended and stored by hanging in closed cabinets have been shown to grow organisms after five days of no use..."

5.a. On 1/9/12 at 2:50 p.m., during concurrent observation and interview, Staff 4 (Sterile Processing Technician) cleaned and disinfected the soiled instrument container with the Action-D tb RTU Cleaner Disinfectant Spray (ready-to-use cleaner and disinfectant) by spraying the container followed by wiping it with a dry cloth. Staff 4 confirmed he wiped the soiled instrument container dry right away and there was no requirement to keep the surface wet.

On 1/9/12 at 2:55 p.m., a review of the manufacturer's instruction printed on the spray bottle with Staff 4 and a concurrent interview was conducted. The manufacturer's instruction indicated "Disinfection, deodorizing and cleaning: Remove gross filth or heavy soil prior to application of the product. Hold container 6 to 8 inches from surface to be treated. Spray area until it is covered with the solution. Allow product to penetrate and the surface to remain wet for 3 minutes. For bloodborne pathogens...allow surfaces to remain wet for 10 minutes."

On 1/12/12 at 11:10 a.m., a review of the hospital's Policy and Procedure (Policy No.: 7000.05.04) titled "Equipment Decontamination (Non-critical)" dated 7/14/10 (effective date) indicated "All non-critical equipment (items that come in contact with intact skin) should be cleaned and disinfected between patient uses...A hospital-approved germicide should be used to disinfect equipment...Follow manufacturer's cleaning guidelines."

5.b. On 1/12/12 at 10:35 a.m.,during an observation in the Radiology Department on Campus 2, Staff 43 (Radiology Technician) wiped multiple surfaces of the radiology machine with a piece of Super Sani Cloth wipe (a disinfectant wipe for killing germs). Staff 43 did not clean and disinfect all surfaces of the machine or the lead apron hanging on the machine. This surveyor touched the wiped surface of the machine after 45 seconds and no moisture was noted.

On 1/12/12 at 10:45 a.m., a review of the manufacturer's printed label on the container of the Super Sani-Cloth Germicidal Disposable Wipes indicated the surfaces should remain wet for two minutes for disinfection purpose.

On 1/12/12 at 11 a.m., during an interview in the Radiology Department, Staff 43 stated she should have cleaned and disinfected all surfaces on the radiology machine and the lead apron after each use. Staff 43 acknowledged that wiping multiple surfaces with one wipe would not achieve the contact time of two minutes in order for the germicidal disinfectant to serve the disinfection purpose as recommended by the manufacturer.

On 1/12/12 at 11:05 a.m., during an interview in the Radiology Department of Campus 2, Staff 2 (Director of Education Services) stated only the handle of the radiology machine was required to be cleaned and disinfected between patient use. Staff 2 also stated the other parts of the machine which had no contact with the patient did not require cleaning and disinfection.

On 1/12/12 at 11:10 a.m., a review of the hospital's Policy and Procedure (Policy No.: 7000.05.04) titled "Equipment Decontamination (Non-critical)" dated 7/14/10 (effective date) indicated "All non-critical equipment (items that come in contact with intact skin) should be cleaned and disinfected between patient uses...A hospital-approved germicide should be used to disinfect equipment...Follow manufacturer's cleaning guidelines."

5.c. On 1/12/12 at 1:14 p.m., during an observation of the environmental cleaning procedure between surgeries in the OR (Operating Room) 2 of Campus 2, one end of the reusable arm board strap was observed touching the floor. Without disinfecting or replacing a clean arm board strap, Staff 48 (Operating Room Technician) picked up the soiled arm board strap from floor and placed it on the OR stretcher for the next patient use.

On 1/12/12 at 1:20 p.m., a review of the hospital's Policy and Procedure (Policy No.: 7000.05.04) titled "Equipment Decontamination (Non-critical)" dated 7/14/10 (effective date) indicated "All non-critical equipment (items that come in contact with intact skin) should be cleaned and disinfected between patient uses...A hospital-approved germicide should be used to disinfect equipment...Follow manufacturer's cleaning guidelines."

On 1/12/12 at 1:25 p.m., a review of the manufacturer's washing instruction

Based on observation, staff interview, clinical and administrative document review, the hospital failed to ensure surgical services were well organized and followed acceptable standards of practice when the hospital did not have an effective system to:

1. Monitor and maintain the relative humidity, the temperature and air exchange in the perioperative areas. (refer to A951, finding 1)

2. Ensure endoscopes were cleaned and stored according to nationally accepted standards. (refer to A749, finding 4)

3. Clean and disinfect environmental surfaces in accordance with nationally accepted standards. (refer to A749, finding 3)

4. Ensure clean surgical scrub attire was stored in accordance with the nationally recognized infection control guidelines. (refer to A749, finding 10)

5. Ensure transportation, distribution, and storage of clean scrubs was in accordance with their policies and with nationally recognized guidelines. (refer to A749, finding 10)

6. Ensure the dirty processes's were separate from clean patient equipment and clean staff supplies (Personal Protective Equipment - PPE) and clean patient supplies (crash cart, handwash sink). (refer to A749, finding 11)

7. The hospital failed to have an effective system to ensure personnel wore appropriate attire in the perioperative areas (operating rooms, endoscopy rooms or suites [the room for procedures in which an instrument is passed into the body for the purpose of visual examining the interior of a bodily canal or a hollow organ such as the esophagus, bronchus, colon, bladder, stomach or intestine], decontamination room, sterile processing areas, sterile storage and post anesthesia care unit). (refer to A749, finding 2)

8. The hospital failed to ensure staff processed surgical instruments in accordance with nationally recognized infection control guidelines and/or the manufacturer's specifications and/or the hospital's policies and procedures. (refer to A749, finding 7)

9. Have a system to monitor staff compliance with the nationally recognized infection control guidelines. (refer to A749, finding 14)

These cumulative failures had the potential to create an unsanitary environment and inadequate infection control.

Based on observations, staff interviews, and administrative document review, the hospital failed to ensure surgical service practices achieved and maintained high standards of medical practice and patient care when:

1. There were no humidity, temperature and air exchange monitoring/control in the decontamination room (for Campus 1);

2. The temperature of the sterile processing and storage area was out of normal range on 1/9/12 and 1/10/12 (for Campus 1);

3. The recorded humidity levels for the Operating Room (OR) 1, OR 2, OR 3, OR 4, OR 5, and OR 6 were out of normal range on multiple occasions with no documented evidence of notification or correction for variances in accordance with the hospital's protocol (for Campus 1);

4. The recorded temperatures for the OR 1, OR 2, OR 3, OR 4, OR 5, and OR 6 were out of normal range on multiple occasions with no documented evidence of notification or correction for the variances in accordance with the hospital's protocol (for Campus 1);

5. The negative pressure in the patient-occupied AIIR (Airborne Infection Isolation Room) was not visually checked daily to maintain the desired negative pressure and the optimal operation of monitoring devices (for Campus 1).

6. Campus 2 did not provide an effective system to ensure proper humidity control in the surgical areas. Low humidity levels were observed at Campus 2 on 1/17/12. The humidity was not maintained according to hospital policy and did not meet acceptable standards of practice according to the Association of periOperative Room Nurses (AORN).

These failures had the potential for putting the patient(s) at risk due to: posing a fire hazard in an oxygen-enriched environment; facilitating the introduction of bacterial (germs that cause disease) growth which would compromise the integrity of wrapped sterile items and cause infection; interrupted airflow patterns within the operative settings that could cause contamination of the sterile field, increasing the risk of surgical site infection; or the interrupted airflow patterns within the patient-occupied AIIR could transmit the airborne infectious diseases.

Findings:

The following referred to Campus 1:

1. On 1/9/12 at 2:30 p.m., during an observation and concurrent interview in the decontamination room, no device for monitoring temperature and humidity was observed. The Sterile Processing Technician (Staff 5) confirmed there was no monitoring of humidity, temperature, and air exchanges in the decontamination room.

On 1/10/12 at 10:20 a.m., during an interview, the Assistant Director of Surgery Services (Staff 13) stated the hospital used the AORN (Association of periOperative Registered Nurses), CDC (Centers for Disease Control and Prevention), and APIC (Association for Professionals in Infection Control and Epidemiology) guidelines as references for the OR infection control and surgical services.

On 1/10/12 at 11 a.m., the 2011 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. On page 218, under Recommendation V.b., direction was given that, "Relative humidity should be maintained between 30% (percent) and 60% within the perioperative suite, including operating rooms...instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas." On page 219, under Recommendation V.c., direction was given that, "Temperature should be monitored and recorded daily..." Under Recommendation V.c.2., direction was given that, "The decontamination area temperature should be maintained between 60 degrees F to 65 degrees F." Under Recommendation V.d., direction was given that, "The air-exchange rate in the perioperative area should be carefully controlled." Under Recommendation V.d.1., direction was given that, "The minimum rate of total air exchanges per hour should be maintained at a constant level..." Under Recommendation V.e. "...Air-flow patterns within the perioperative setting should be controlled and uninterrupted."

On 1/13/12 at 11:40 a.m., during an interview, the Infection Control Director (Staff 1) stated there was no policy concerning the temperature and humidity control of the perioperative suite. Staff 1 also stated the maintenance department monitored air exchange in the perioperative and endoscopy suite annually. No documented evidence of air exchange monitoring was provided.

2. On 1/9/12 at 2:50 p.m., during an observation and concurrent interview, the Sterile Processing Technician (Staff 6) confirmed the thermostat on the wall in the sterile processing and storage area showed 66.4 degrees Fahrenheit (F).

On 1/10/12 at 9:30 a.m., during an observation and concurrent interview, the manager of the Sterile Processing Department (Staff 15) confirmed the thermostat on the wall in the sterile processing and storage area showed 64.5 degrees F. Staff 15 stated the hospital used the AORN, AAMI (Association for the Advancement of Medical Instrumentation) guidelines as references for the sterile processing infection control practice. Staff 15 confirmed there was no documentation of the temperature and humidity for the sterile processing and storage area.

On 1/9/12 at 4:45 p.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 219, under Recommendation V.c.1., direction was given that, "Temperature should be maintained between 68 degrees F to 73 degrees F within the operating room suite and general work areas in sterile processing."

3. On 1/10/12 at 9:35 a.m., a review of the document titled "(hospital) Temperature/Humidity Log" dated 3/11 through 12/11 with Staff 15 in the sterile storage area indicated "Temperature should be between 68 - 70 (degrees F), humidity 30 - 60 % , if any of these readings are off, call (phone number) and inform the charge nurse at that location." This document also indicated the recorded humidity levels for the OR 1, OR 2, OR 3, OR 4, OR 5, and OR 6 were out of normal range on multiple occasions with no documented evidence of notification or correction for variances in accordance with the hospital's protocol.

The following out-of-range humidity levels were documented. For humidity levels that were logged higher than 60%: OR 1 (24 days); OR 2 (16 days); OR 3 (16 days); OR 4 (3 days); OR 5 (12 days); OR 6 (11 days). For humidity levels that were logged lower than 30%: OR 6 (7 days).

Staff 15 confirmed that he could not determine if any implementations had been done without the documented evidence of notification or correction for variances in accordance with the protocol as stated on the hospital's Temperature/Humidity Log .

On 1/10/12 at 11 a.m., the 2011 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. On page 218, under Recommendation V.b., direction was given that, "Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms...instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas."

4. On 1/10/12 at 9:40 a.m., a review of the document titled "(Hospital) Temperature/Humidity Log" dated 3/11 through 12/11 with Staff 15 in the sterile storage area indicated "Temperature should be between 68 - 70 (degrees F), humidity 30 - 60 %, if any of these readings are off, call (phone number) and inform the charge nurse at that location." This document also indicated the recorded temperature levels for the OR 1, OR 2, OR 3, OR 4, OR 5, and OR 6 were out of normal range on multiple occasions with no documented evidence of notification or correction for variances in accordance with the hospital's protocol.

The following out-of-range temperature levels were documented. For temperature levels that were logged lower than 68 degrees F: OR 1 (249 days); OR 2 (240 days); OR 3 (243 days); OR 4 (200 days); OR 5 (244 days); OR 6 (208 days). For temperature levels that were logged higher than 73 degrees F on 4/4/11 in the OR 1, OR 2, OR 3, OR 4, OR 5, and OR 6.

Staff 15 confirmed that he could not determine if any implementations had been done without the documented evidence of notification or correction for variances in accordance with the protocol as stated on the hospital's Temperature/Humidity Log .

On 1/10/12 at 11 a.m., the 2011 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. On page 219, under Recommendation V.c., direction was given that, "Temperature should be monitored and recorded daily..." Under recommendation V.c.1., direction was given that, "Temperature should be maintained between 68 degrees F to 73 degrees F within the operating room suite and general work areas in sterile processing."

5. On 1/11/12 at 2:40 p.m., during an interview, the Maintenance Worker (Staff 67) confirmed that the negative pressure of the AIIR was checked by the PM (performance maintenance person) monthly; there was no daily visual check of the negative pressure and the staff would be alerted by the alarm system if there was any inadequacy of the negative pressure. No documented evidence of the monthly visual check of the negative pressure in the ICUs (Intensive Care Units) was provided.

On 1/11/12 at 5:15 p.m., during an interview, Staff 1 (Infection Control Director) stated the hospital used the AORN, CDC, Title 22 (California Code of Regulations, Title 22 Section) guidelines as references for the infection control practice. Staff 1 confirmed the patient-occupied AIIR was checked with smoke tubes to maintain the desired negative pressure monthly by the engineering department and there was no daily visual check to ensure effective functioning of the automated negative pressure system. Staff 1 also stated she realized that the hospital should not solely rely on the electronic alarm to detect the inadequacy of the negative pressure system.

On 1/12/12 at 9 a.m., a review of the hospital's Policy and Procedure (Policy No.[number]: 7000.01.02) titled "Negative Pressure Isolation Room Air Monitoring" dated 8/18/10 (effective date) indicated "Plant Maintenance shall complete the smoke tube test initially and daily for as long as the room is being used for Airborne Isolation. The smoke tube test will be placed on the daily work list so that notification is only required initially and again upon discontinuation of Airborne Isolation."

On 1/12/12 at 9:30 a.m., a review of the 2005 CDC's MMWR (Morbidity and Mortality Weekly Report) titled "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings" indicted "Periodic checks are required to maintain the desired negative pressure and the optimal operation of monitoring devices...When occupied by a patient, an AII room should be checked daily with smoke tubes or other visual checks for negative pressure. If pressure-sensing devices are used in ALL rooms occupied by patients with suspected or confirmed TB (tuberculosis) disease, negative pressure should be checked daily by using smoke tubes or other visual checks..."

The following referred to Campus 2:

6. On 1/17/12 at 11:55 a.m., in the operating room area on Campus 2 all three surgical suites were in use. The following was observed: Staff 46 (Surgery and Recovery Room Registered Nurse Manager) verified the gauge for Operating Room 1 indicated a humidity of 1%; Staff 46 verified the gauge for Operating Room 2 indicated a humidity of 2%; Staff 46 verified the gauge for Operating Room 3 indicated a humidity of 3%.

On 1/17/12 at 12:05 p.m., during an interview, Staff 46 stated the gauges in the operating room for Rooms 1, 2, and 3 were "difficult to read." and could not explain the unusually low readings. "Someone reads them off in the morning and Maintenance logs them in." Staff 46 was unable to explain the procedure for maintaining acceptable humidity levels.

On 1/18/12 at 10:30 a.m., during an interview, Staff 61 (Maintenance Manager for Campus 2) stated "maintenance usually makes daily rounds in the (morning)." He provided a copy of "...Maintenance Daily Rounds for 1/17/12 which documented the humidity gauges for Operating Rooms 1, 2, and 3 at Campus 2 were at low levels (LL). Staff 61 stated, "These numbers don't make sense." He was unable to explain the low humidity readings for the dates observed or what was being done to correct them.

On 1/18/12 the current hospital policy titled Preoperative Plan of Care and dated 10/29/05 was reviewed. The policy indicated under Preoperative Care 1. b "ensure room temperature is 68 - 73, with a relative humidity of 30% - 60%."

On 1/18/12 the AORN standard of practice dated 2011 was reviewed. Under "Potential hazards associated with HVAC (Heating, Ventilation, Air Conditioning) systems in the practice setting should be identified, and safe practices should be established. (PNEDS:198, 121) ... 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... which pose a fire hazard in an oxygen-enriched environment or when flammable agents are in use and increases the potential for dust...."