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Based on interview and record review, the facility failed to maintain a prospective three year capital plan which detailed expenditures over $600,000 and identified funding sources. The deficient practice had the potential to limit strategic planning and leadership regarding the facility's capital needs.

Findings:

Review of the capital plan presented by the facility indicated that it was for a 10 year period, but did not detail the proposed expenditures.

Review of two documents titled "2011 Capital Items - Approved" and "2010 Approved Capital Items" (both dated 10/12/11) indicated that both documents detailed capital expenditures, and both included items over $600,000, but neither document specified the source of funds or projected capital expenditures for the following two years.

Review of the Medical Staff Program and Budget Committee minutes dated 1/13/11 indicated that the committee prioritized capital expenditures for 2011, but not for future years.

In an interview on 10/13/11 at 4:02 p.m., Staff C stated that the 10 year plan was a summary of the types of projects. She stated that the 2012 capital expenditures were going through the various committees for review and approval. She stated that all capital expenditures were funded by routine capital, then corrected herself to state that some funding was from the hospital's foundation. Staff C stated that she did not have a listing of which items had been funded by the foundation.

Based on interview and record review, the facility failed to include the scope and nature of the service for one sampled contract (Vendor L) on its listing of contracts. The deficient practice eliminated a mechanism of effectively summarizing the facility's contracts for quality assurance purposes.

Findings:

Review of the facility's list of "Non-Physician Contracts" dated 9/1/11 indicated it had a contract with Vendor L and that the type of contract was a "Data Agreement" assigned to the medical records department.

Review of the contract between the facility and Vendor L (dated 5/21/10) indicated that the vendor would assign billing codes to emergency department medical records, provide feedback regarding the facility's clinical documentation, and keep the facility apprised of changes in the health care industry's billing practices.

In an interview on 10/14/11 at approximately 12 noon, Staff A stated that Vendor L did coding and billing. Staff B stated that Vendor L also provided data to the facility's parent organization for benchmarking and provided feedback on the quality of the facility's clinical documentation.

Based on observation and record review, the facility failed to include an outpatient radiology location in its policy regarding off-campus emergencies. The deficient practice had the potential to allow operation of hospital locations without proper consideration of how the facility would appraise the need for referral in its departments off the main campus.

Findings:

In an observation on 10/11/11 at 2:00 p.m., the facility was providing radiology services at 1375 Sutter Street Suite 101. Review of the hospital's operating license (effective 1/30/11) indicated that the hospital provided radiology, magnetic resonance imaging, and laboratory services at that location.

Review of the facility's policy addressing emergencies at various hospital locations indicated that the text of the policy only addressed locations within 250 yards of the main hospital campus. Attached to the policy, however, was a table listing how the hospital would respond to emergencies at other locations. 1375 Sutter Street was not included in the table.

Review of driving directions from the main hospital campus to 1375 Sutter Street at maps.yahoo.com indicated that driving from the main hospital to 1375 Sutter Street was 0.86 miles (1514 yards) and the return trip was 0.74 miles (1302 yards).

Based on interview and record review, the facility failed to document that the responsible party had been given a notice of patient rights in 1 of 46 sampled patient records (Patient 32). The deficient practice had the potential to limit patients' awareness of their rights.

Findings:

Review of an undated list of "Non MD/No DO Admits" indicated Patient 32 was admitted to the facility by a dentist on 8/9/11 and discharged on 8/20/11. Review of Patient 32's medical record indicated Patient 32 was a minor. Patient 32's medical record contained no documentation that the responsible party had been given a notice of patient rights.

In an interview on 10/14/11 at 3:32 p.m., Staff D stated that she would check one of the hospital's computer systems to see if there was documentation that Patient 32's responsible party had been given a notice of patient rights.

Review of the printout presented by Staff D indicated it was undated, titled "User-Defined Function COMPLIANCE SCREEN", and had Patient 32's name and date of birth in the headers. An entry on the screen printout indicated "Pt Rights/Responsibility/Safety: N/A".

In an interview on 10/17/11 at 10:59 a.m., Staff D stated that she had asked the registrar to print the screen for the same account number as Patient 32's admission from 8/9/11 to 8/20/11 and that since the number matched, the printout was the entry relevant to that admission. She stated that the screen indicated that it was "not documented" whether or not Patient 32's responsible party had been given a notice of patient rights.

Based on record review and interview, the hospital failed to ensure that patients were free from abuse and/or neglect when six of the 21 personnel files reviewed did not have evidence of ongoing training in all aspects of abuse and neglect, and the hospital's policy and procedure "Protecting Patients from Abuse, Neglect or Exploitation" was limited in scope to nursing services.

Findings:

On 10/17/11 at 1:30 PM, record review indicated that during the preceding year, Employees 1, 2, 3, 4, 7, and 8 did not participate in a training program which provided current information regarding abuse and neglect, including prevention, intervention, detection, and related reporting requirements.

The Senior Human Resources Consultant who assisted with this record review acknowledged these Employees had not participated in the hospital's online program for abuse prevention.

In an interview on 10/17/11 at 5:20 PM, the Director of Nursing Operations provided a copy of the Nursing Services' policy "Protecting Patients from Abuse, Neglect or Exploitation" dated 1/04, and stated only nurses were required to have annual training for abuse. The Director said she thought annual training would benefit all employees of the hospital.

Based on interview and record review, the facility failed to implement 2 of 7 of its own follow-up recommendations on 1 of 3 sampled root cause analyses (RCA's). The deficient practice had the potential to delay changes necessary to prevent retained surgical items.

Findings:

In an interview on 10/14/11 at 10:05 a.m., Staff H stated that a patient had a ventricular assist device (VAD) implanted in 7/10, and that 1 year later the facility discovered "on imaging" that a portion of the VAD had been left in the patient.

In an interview and record review on 10/14/11 at approximately 2:30 p.m., Staff H stated that the RCA regarding the VAD had been done on 9/19/11 or 9/20/11. Review of the RCA indicated that the facility had decided upon 7 follow-up actions to the incident; 2 of the action items were referral of the case to the radiology and intensive care unit quality committees for further review.

In an interview on 10/17/11 at 10:54 a.m., Staff H stated that she had no documentation that the VAD case had been referred for review and that the staff member who was responsible for those referrals was "not here".

In an interview on 10/17/11 at 11:32 a.m., Staff D stated that she had presented the action plan for another incident involving a retained surgical item to the perinatal quality committee, but that she "can't speak to the VAD". Staff G stated, "We don't have a paper trail on that."

Based on interview and record review, the facility failed to integrate its ophthalmology department into its hospital-wide quality assessment and performance improvement program. The deficient practice eliminated a mechanism of holding the medical staff accountable for the quality of care provided at the hospital.

Findings:

Review of Practitioner 10's credentials file indicated he was an ophthalmologist who was reappointed to the facility's teaching medical staff for 2 years effective 7/31/10. A peer reference regarding Practitioner 10's abilities was present, but there was no data regarding the quality of Practitioner 10's patient care.

In an interview on 10/13/11 at 10:01 a.m., Staff E agreed that Practitioner 10's file did not include quality data and stated that outpatient data was lacking. Staff F stated that the ophthalmology department had credentialed its volunteer faculty and maintained data regarding their individual performance in the form of resident evaluations of their teaching.

In an interview on 10/14/11 at 11:08 a.m., Staff G stated that the ophthalmology department had not reported to the Quality Improvement Committee recently, but that he had a presentation given to the medical executive committee.

Review of the "Department of Ophthalmology Biennial Report" presented by Staff G indicated it was dated 6/1/11 and discussed the department's demographics, services, finances, partnership with a service organization, residency training, advances in retinal imaging technology, strategic challenges and future directions, research, and leadership. The section on quality assurance indicated that the department had compared its consumer online ratings, peer review, and surgical outcomes; the results indicated that there was "1:1 correlation" between its peer review and surgical outcomes and "zero correlation" between consumer online ratings and surgical outcomes. The report indicated that the consumer online comments had addressed friendliness, parking, and time efficiency; no details were presented, however, indicating what the consumer ratings, surgical outcomes, or peer review results had been or how their correlation had been analyzed. The report indicated that quality of care was the department's highest accomplishment, but did not specify how that quality had been measured. The presentation indicated that "outcomes parameters" were a "Programmatic direction", but did not provide further detail on the status of that "direction".

In an interview on 10/14/11 at 11:08 a.m., Staff E and Staff G agreed that the ophthalmology department report was not the facility's best example of quality data.

Review of the facility's medical staff bylaws dated 10/6/11 indicated, "The general functions of each department shall include: i. conducting patient care reviews on a timely basis for the purpose of analyzing and evaluating the quality and appropriateness of care and treatment provided to patients within the department. The department shall routinely collect information about important aspects of patient care provided in the department, periodically assess this information, and develop objective criteria for use in evaluating patient care. Patient care reviews shall include all clinical work performed under the jurisdiction of the department..."

Review of the "Sutter Health West Bay Region Performance Improvement (PI) Plan 2011" indicated, "Quality is defined as providing the right tests, treatments, procedures, and support in the right amounts, at the right times, and in the right setting..."

Review of the American Academy of Ophthalmology website indicated that it published summary benchmarks indicating preferred practice patterns which could be adapted for measuring quality (as defined by the facility's PI plan) in its ophthalmology department (http://one.aao.org/CE/PracticeGuidelines/SummaryBenchmarks.aspx).

Based on interview and record review, the facility failed to consider the individual physician's performance on relevant quality indicators at the time of reappointment in 3 of 10 sampled credentials files (Practitioners 2, 6, and 10). The deficient practice limited the medical staff's accountability to the governing body.

Findings:

Review of Practitioner 2's credentials file indicated he was an anesthesiologist reappointed to the facility's active medical staff for two years effective 2/28/11. The file contained an evaluation by the department vice chair of Practitioner 2's performance; a notation that there had been "no adverse QI [quality improvement] reports"; and data regarding Practitioner 2's meeting attendance, medical record suspension days, and the number of cases and total minutes of anesthesia Practitioner 2 had performed. No data were present which quantified the quality of Practitioner 2's clinical performance.

In an interview on 10/12/11 at 12:45 p.m., Staff I stated that he could see the surveyor's concern about the lack of data, but that he was not an anesthesiologist. Staff J stated that the credentials files did not have additional quality data regarding the anesthesiologists.

In an interview on 10/13/11 at 10:01 a.m., Staff J stated that the notation "no adverse QI reports" in a credentials file meant the physician had not had peer review cases with adverse conclusions.

Comparison of Practitioner 2's credentials file to the Department of Anesthesiology Report to QIC (Quality Improvement Committee) dated 5/26/10 indicated that the department had data on patient satisfaction but had not calculated Practitioner 2's individual performance regarding patient satisfaction. Comparison of Practitioner 2's credentials file to the facility's "Acute Care Clinical Quality Statement Detail" (extracted 7/11/11) indicated the hospital had data on whether surgical patients received their antibiotics within one hour prior to incision, but had not calculated Practitioner 2's individual performance in this regard.

Review of the journal article "Quality and Safety Indicators in Anesthesia A Systematic Review" (Haller G et al, Anesthesiology 2009; 110:1158-75) indicated that the authors had identified 108 clinical indicators being used as measures of quality in anesthesiology, and that 24 of them had been promoted by the American Society of Anesthesiologists.

Review of Practitioner 6's credentials file indicated he was an emergency medicine physician reappointed to the facility's active medical staff for two years effective 3/31/11. The file contained an evaluation by the department vice chair of Practitioner 6's performance, a notation that there had been "no adverse QI reports", data regarding Practitioner 6's meeting attendance and medical record suspension days, and an activity log which calculated Practitioner 6's death rate. No other data were present which quantified the quality of Practitioner 6's clinical performance.

Comparison of Practitioner 6's credentials file to the executive summary of the ED (emergency department) Patient Quality of Care Committee Report to the Quality Improvement Committee (QIC) dated 2/23/11 indicated that the emergency department had data on whether patients with pneumonia received antibiotics within 6 hours of arrival, how much time elapsed between arrival and angioplasty for patients with certain types of heart attacks, the percent of stroke patients who received clot dissolving drugs, and the percent of heart attack patients who had an electrocardiogram within 10 minutes of arrival, but had not calculated Practitioner 6's individual performance on any of these indicators. The report indicated that the department would be working on improving the ED length of stay as well as its diagnosis of sepsis, but Practitioner 6's credentials file did not disclose his individual performance on these departmental goals.

Refer to A-298 regarding the lack of quality data in Practitioner 10's credentials file.

Review of the facility's medical staff bylaws dated 10/6/11 indicated, "At each meeting, the Credentials Committee will appraise the professional performance and clinical competence of those persons applying for reappointment, as indicated by: 1. the documented results of the peer review and quality assurance activities required by these Bylaws and the corporate Bylaws of the Hospital..." The bylaws section on Population-Based Quality of Care Committees stated, "These Committees shall: i. have responsibility to assure collaborative ongoing measurement, assessment and quality improvement activities designated by specific populations served..." Another section stated, "The Quality Improvement Committee shall: i. develop and maintain with the approval of the Executive Committee, a plan for monitoring patient care and improving outcomes; ii. review quality improvement activities at the Hospital through regular reporting from all quality committees; iii. monitor such activities, insuring a system is in place to resolve quality improvement issues throughout the institution..." Yet another section stated, "The general functions of each department shall include: i. conducting patient care reviews on a timely basis for the purpose of analyzing and evaluating the quality and appropriateness of care and treatment provided to patients within the department. The department shall routinely collect information about important aspects of patient care provided in the department, periodically assess this information, and develop objective criteria for use in evaluating patient care... ii. evaluating and making appropriate recommendations regarding the qualifications of applicants seeking appointment or reappointment and clinical privileges within that department..."

Based on interview and record review, the facility failed to ensure its allied health practitioner (AHP) guidelines regarding psychologist admissions were consistent with the medical staff rules and regulations appended to its medical staff bylaws. The deficient practice diminished the importance of the rules and regulations as a vehicle for the governing body and medical staff to jointly set guideposts regarding the care provided at the hospital.

Findings:

Review of the facility's medical staff bylaws dated 10/6/11 indicated that a basic qualification for medical staff membership was a "license to practice medicine, osteopathic medicine, dentistry, or podiatry", that "Practitioners who are not members of the Medical Staff may be granted temporary privileges" and that practitioners meant doctors of medicine or osteopathy, dentists, and podiatrists. The bylaws also stated that the medical staff rules and regulations were appended to the bylaws after approval by both the medical staff and the governing body.

Review of the facility's medical staff rules and regulations dated 9/7/11 indicated, "A patient may be admitted to the hospital only by a Medical Staff member or by a practitioner with temporary privileges..."

Review of the facility's AHP Guidelines dated 1/21/10 indicated, contrary to the medical staff rules and regulations, that psychologists could be granted admitting privileges.

In an interview on 10/13/11 at 3:08 p.m., Staff G stated that the allied health practitioner guidelines were in the process of being revised, that there had not been psychologist admissions since the 1980's, and that the provisions in the AHP guidelines regarding psychologist admissions were "historical language".

Based on interview and record review, the hospital failed to ensure that medications were administered in accordance with the prescriber's order. Patient 65 was administered Lortab Liquid (a narcotic pain medication) not in accordance with the physician's order. In addition, the dose of Lortab Liquid administered to Patient 65 was not in accordance with the pain level that was reported by the patient.

Findings:

A review of Patient 65's clinical record with the hospital Director of Pharmacy (DOP) showed that the following medications were ordered by the physician for pain control on 10/5/11:

Lortab (Acetaminophen 167mg/hydrocodone 2.5mg per 5ml) 15ml by mouth every 6 hours as needed for pain

Lortab (Acetaminophen 167mg/hydrocodone 2.5mg per 5ml) 30ml by mouth every 6 hours as needed for severe pain

The DOP clarified that on a 2-steps pain medication order, severe pain represented pain level of 6 to 10. In addition, the DOP stated that the lower dose of Lortab (15ml) should have been written as for mild to moderate pain (pain level 1 to 5) according to the hospital pain medication order sets.

Patient 65's Medication Administration Record (MAR) showed that the patient was administered Lortab 15ml at 11:00 a.m. and 1:00 p.m. on 10/6/11, 2 hours apart, contrary to the every 6 hours frequency prescribed by the physician. In addition, Patient 65's pain assessment record showed that the patient reported level pain at 9 (severe pain) at 10:00 a.m. and pain level of 9 (severe pain) at 1:00 p.m. on 10/6/11. According to the physician's order and the pain level reported by the patient, Patient 65 should have been administered 30ml of Lortab instead of 15ml at 11:00 a.m. on 10/6/11. The incorrect dose of pain medication administered to Patient 65 resulted in inadequate and delay in pain management.

Based on staff interview and record review, the hospital failed to ensure patient weights' were obtained in a timely manner and/or documented accurately in the medical record which could jeopardize Patient 58, 54, 55 and 43's continuing medical care, nutrition care planning, and patient education.

Findings:

1. Patient 58 was admitted 9/20/11 with nausea, vomiting, and abdominal pain. Patient's weight recorded on nursing admission assessment dated 9/20/11 was 45.8 (kg) kilograms (100.8 pounds), and height was 5 foot 4 inches.

Nutrition Assessment dated 9/20/11, stated the patient was at high nutritional risk with diagnoses of partial bowel obstruction and appendical cancer. Diet was regular as tolerated.

Nutrition assessment dated 9/29/11 stated patient was NPO (nothing orally) and on TPN (total parenteral nutrition) and high nutritional risk based on short bowel obstruction and cancer.

Review of the RD notes dated 9/30/11, 10/4/11, 10/7/11, and 10/11/11, Patient 58 continued on TPN and high nutritional risk. There were no current weights recorded on the nutrition assessments.

RN Nurse Manager on transplant unit (6th floor) stated on 10/13/11 at 2:30 p.m., that weights were only obtained on the units if the physician ordered. RN Nurse Manager confirmed hospital did not have a policy specifying when to weigh patients if the patient was hospitalized for a long time.

RD 1 acknowledged on 9/13/11 at 2:45 p.m., that the patient's weight was an essential element for complete nutrition assessment. She further acknowledged that monitoring the weigh on this patient would be necessary considering the length of stay and patient ' s medical condition, and assessed at high nutrition risk.
Review of the nursing protocol NP-P- 8 Nutrition Services Policy No:DO17, stated the "dietitian completes nutrition assessments and reassess according to policy." The policy failed to ensure the information required for assessment and reassessment was specified.

2. Patient 54 was admitted on 10/3/11 on pediatric floor with an age of 17 years. Patient 54 was diagnosed with spontaneous pneumothorax (A collapsed lung, or pneumothorax, is the collection of air in the space around the lungs. This buildup of air puts pressure on the lung, so it cannot expand as much as it normally does when you take a breath).

Nutrition assessment dated 10/7/11 stated patient weight was 60.7 kilograms (133.5 pounds), and height was 178 centimeters (70.1 inches). The height and weight were assessed at the 25-50 percentile for weight for age, and 50 to 75 percentile for height for age. Diet was regular. RD assessment was for moderate nutritional risk.

There was no assessment of the weight for age and the height for age that were below the 100 percent.

RD 2 stated that the RD would not assess a pediatric unless the heath weight was below the 3rd percentile. She stated the weights were ordered by the physician and that the rounds on the unit had identified the patient as thin and tall. She could not state why the RD did not assess the patient who was below the normal growth percentiles.

3. Patient 55 was admitted 10/5/11 with osteoarthritis of the right hip and surgery for right total hip replacement. Patient 55 was 78 years old.

RD assessment dated 10/10/11 stated weight on admission was 92.7 kilograms (203.9 pounds), and height at 5 foot 3 inches. Diet was regular as tolerated. The assessment stated the percent of food intake was 51 percent of 4 meals. The RD assessed the patient at moderate nutritional risk.

Patient 55 had been in the hospital for 7 days with no weight assessment. Patient had poor intake and was post-surgery with advanced age.

Review of the Nursing Services policy N4.05 titles Assessment of Patients states the "Assessment is the process established to obtain appropriate and necessary information about each patient. It is the identification of the patient needs through a systemic collection, analysis and synthesis of patient specific date. The information is used to match the patient needs to the care level and interventions required. Assessment is an ongoing process. Patient reassessment is to evaluate response to care and reassessment will include all elements of assessment as appropriate to patient condition."

There was no system to ensure that staff including RDs, had complete and accurate information including current weight, to accurately assess and reassess patients' response to care, nutrition status and plan nutrition care.



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4. A review of the medical record for Patient 43 on 10/12/11 at 1:45 PM revealed that the patient was admitted to the hospital on 9/30/11 with complaints of abdominal pain and diagnoses which included possible small bowel obstruction. The patient underwent exploratory abdominal surgery on 9/30/11 for a dilated small bowel with adhesions (bands of scar tissue that form between tissue and organs that should remain separate) and an inflamed appendix.

A review of the "Nursing Database Assessment" dated 9/30/11 at 2:10 PM, completed in the emergency department indicated the patient height was 5 feet 10 inches and weight was 72.8 kilograms (kg) or 160.2 pounds. Further review of the electronic medical record revealed that the patient ' s height was recorded on 9/30/11 at 3:06 PM (same day lees than 1 hour later) as 5 feet 7 inches (3 inches different). Also on the same day at 11:29 PM the patient ' s weight was recorded at 55.4 kg or 121.9 pounds (38.3 pounds difference).

A review of the initial "Nutrition Note" date 10/5/11 indicated that the nutrition assessment was based on the patient ' s height of 5 feet 7 inches and weight of 55.4 kg. A follow up nutrition note dated 10/7/11 shows that the patient's estimated nutrition needs were also based on this height and weight. Recommendations for TPN (total parenteral nutrition or nutrition fed to the patient directly into the bloodstream) were also calculated based on this height and weight.

A review of a third nutrition note dated 10/8/11 stated that the updated weight was 71.2 kg, or 156.6 pounds, with 15.8 kg or 34.8 pound discrepancy noted and an entry that stated the RN was notified of the discrepancy. Despite this noted discrepancy, the estimated nutrition needs were not recalculated and the TPN recommendations were also not re-evaluated.

A fourth nutrition note dated 10/10/11 indicated a new weight of 67.4 kg or 148.3 pounds. Again, the estimated nutrition needs of the patient were not re-evaluated and the recommendation was to continue the TPN as previously recommended.

During an interview with the patient on 10/12/11 at 2:00 PM in her room, she sated that she was 5 feet 10 inches tall and weighed 155 pounds before she came in the hospital and now weighed 146 pounds. She further stated that there was no way she could have weighed 121 pounds.

During an interview with RN X, charge nurse for Patient 43, on 10/12/11 at 2:10 PM, she stated that for the weight recorded on the "Nursing Database Assessment" form, the standard of practice was to obtain the actual weight, not a stated weight. She was unable to explain why there had been no evaluation of the discrepancy in height and weight between the database and what was recorded in the electronic medical record on the same day.

A follow up nutrition note dated 10/12/11 at 5:00 PM, after the initial review of the medical record, indicated that the estimated nutrition needs of the patient were recalculated based on "new height and weight information per RN and confirmed by patient." The recommendations based on the "new" information included an increase in the TPN to provide the patient with 100 additional calories and 25 additional grams of protein per day. The note further stated that "weight appears to be trending down over the past few days - may be related to ....suboptimal nutrition provisions "

A review of the hospital's policy titled, "Clinical Practice Documentation, Nursing" dated 1/10, stated that the purpose of the policy was that documentation communicated the nursing care provided to the patient, the nurse's evaluation of the effectiveness of interventions, and the collection, analysis and synthesis of patient specific data. And that nursing documentation was maintained to ensure safe patient care. It further stated that all documentation must be accurate.

Based on observation, interview, and document review, the hospital failed to ensure, in accordance with professional standard of practice and state regulations, that:

1. dispensing of medications for use beyond the immediate needs of the patients was performed by a pharmacist or an individual under the direct supervision of a pharmacist. Registered nurses were allowed to restock medications in Pyxis (an automated dispensing cabinet) according to hospital policy and procedures.

2. monthly medication storage area inspection by a pharmacist was conducted at the Pyxis tower for storage of large volume parenterals in 4 North unit.

Findings:

1. A review of the hospital policy and procedure on automated drug dispensing indicated that nursing staff may stock medications in Pyxis when a replacement supply was needed after the daily restocking was completed.

During an interview at approximately 11:15 a.m. on 10/12/11, the hospital Director of Pharmacy stated that nursing staff would pick up medications from pharmacy to restock into Pyxis occasionally when the stock of certain medication(s) depleted before the next scheduled restocking.

The American Society of Health-System Pharmacists published guidelines "Minimum Stardard for Pharmacies in Hospitals" indicates that pharmacy personnel must supervise the stocking of medications in automated drug dispensing machines.

California Code of Regulations Title 22 70263 (d) stipulates that there shall be a system maintained whereby no person other than a pharmacist or an individual under the direct supervision of a pharmacist shall dispense medications for use beyond the immediate needs of the patients.

2. During a medication storage inspection of the 4 North unit with the hospital Director of Pharmacy (DOP) at approximately 10:00 a.m. on 10/12/11, large volume parenterals for intravenous (into the vein) administration were observed in a Pyxis automated dispensing tower. 1-liter bags of Dextrose 5% Sodium Chloride 0.2% were stored where the label said Dextrose 5% Sodium Chloride 0.225%. Upon interview during the inspection, the DOP stated that large volume parerterals in the Pyxis tower were stocked by material services department and pharmacy personnel did not have access to the dispensing towers. The DOP further stated that pharmacists did not inspect Pyxis towers where large volume parernteral were stored during the monthly medication storage inspection.

The American Society of Health-System Pharmacists published guidelines "Minimum Stardard for Pharmacies in Hospitals" indicates that all stocks of medications shall be inspected routinely to ensure the absence of outdated, unusable, or mislabeled products.

California Code of Regulations Title 22 70263 (q) (10) stipulates that drugs maintained on the nursing unit shall be inspected at least monthly by a pharmacist and any irregularities shall be reported to the director of nursing and as required by hospital policy.

Based on observation, interviews and record reviews, the hospital failed to ensure that a patient (Patient 44) received a diet as ordered by the physician when the order to discontinue thickened liquids and provide thin liquids was written. The patient continued to receive thickened liquids for over 24 hours after the order was changed. This failure to follow a physician ordered diet had the potential to result in the patient refusing to drink the liquids and further compromising the clinical status of the patient.

Findings:

During a trayline (patient meal tray assembly) observation on 10/12/11 at 12:00 PM, the meal tray for Patient 44 was noted to contain thickened liquids and no thin liquids.

A review of the hospital's Diet List, dated 10/12/11 10:50 AM, showed that the physician ordered diet for Patient 44 was for thin liquids. The date and time the order was entered in the computer was 10/11/11 at 7:36 AM, the previous day in the morning.

During a concurrent interview with the Clinical Nutrition & Patient Services Manager (CNPSM), she confirmed that the order had been changed and thin liquids should have been placed on the patient's meal tray. She was unable to explain why the patient ' s menu did not reflect the change in the physician order.

A review of the Patient 44's medical record on 10/12/11 revealed that the patient was admitted to the hospital on 10/6/11 with diagnoses which included: chronic kidney disease; possible aspiration pneumonia; and cachexia (a wasting syndrome with loss of weight, muscle weakness, fatigue and loss of appetite).

A review of the Speech Therapy swallow evaluation dated 10/11/11 revealed a recommendation by the Speech Therapist to allow the patient to have thin liquids.

During an interview with Patient 44 and his wife on 10/12/11 at 3:20 PM, in his room, they stated that he had continued to receive thickened liquids after the order was written. He stated that his coffee at lunch that day was thickened. The patient stated that he dislikes thickened liquids and refused to drink them. He further stated that he would eat better if he didn't have to drink the thickened liquids.

Based on staff interviews and record review, the hospital failed to ensure the hospital's diet manual was readily available to the physicians and nursing staff when the portion of the diet manual (the Diet Matrix) was not published on the hospital's intranet. The Diet Matrix specified the types of diets and the description of those diets that are routinely ordered in the hospital and was only available to the food and nutrition services department. This failure had the potential to result in inaccurate diets being ordered for patients by the physicians and nursing not having the ability to verify accuracy of the diets that the patients received.

Findings:

During an interview with the Clinical Nutrition & Patient Service Manager (CNPSM) on 10/11/11 at 2:40 PM, she stated that the hospital used the American Dietetic Association's Nutrition Care Manual (ADA NCM) as their diet manual. She further stated that the ADA NCM was available to all clinical staff of the hospital's intranet. She stated that the medical staff had approved the Diet Matrix as part of the diet manual. The Diet Matrix listed and described the diets routinely ordered at the hospital. She also explained that the Diet Matrix was available to the dietary staff only and was not published in the hospital's intranet as part of the diet manual.

A review of the hospital's policy titled "Review and Approval of Diet Manual" dated 9/10, stated that, "The Diet Matrix augments these manual (ADA NCM) and serves to guide clinical nutrition staff in the provision of the Physician prescribed diets." It further stated that, "The Diet Manual must be accessible to each patient care unit and other designated areas "

Based on interview, the hospital failed to have regular local fire inspections on the Pacific and the California West campuses.

Findings:

On 10/14/11 at 10:00 AM, the Director of Safety stated the hospital had no records of local fire department inspections. The Director stated the fire department only inspected the medical office building.

At 10:53 AM on 10/14/11, the Director of Safety reported the hospital had contacted the San Francisco Fire Department to request an inspection and they were told that only high-rise buildings were inspected and, therefore, the fire department would not do an inspection of the hospital buildings.

Based on observation and interview, the facility failed to maintain adequate facilities for its services when there was no eye wash station in the decontamination area of the East and Pacific campus. This had the potential to cause serious injury to the eyes of staff members who worked in the decontamination areas.

Findings:

During an observation of the decontamination area of the East campus on 10/13/11 at 11:45 a.m., there was no emergency eye wash station. MSP (manager sterile processing)1 who was present stated the eye wash station was located outside of the decontamination area. She showed the surveyor the eye wash station which was located at a sink outside the decontamination area. To access the eye wash station, employees would have to walk through the decontamination area, open a door to an outside corridor and walk around a corner to the sink.

During an observation of the decontamination area of the Pacific campus on 10/14/11 at 2:30 p.m. there was no emergency eye wash station. MSP 2 who was present stated the eye wash station was located outside of the decontamination area and employees would have to leave the decontamination area to access it.

The Association of periOperative Registered Nurses, or AORN, is an organization with input and liaisons including CDC (Centers for Disease Control), Association for Professionals in Infection Control and Epidemiology, American College of Surgeons, American Society of Anesthesiologists and the American Association of Ambulatory Surgery Centers. The AORN position papers, standards and recommended practices are widely used not only in the perioperative clinical setting but as an authoritative guide to clarify regulatory requirements.

According to 2010 AORN PeriOperative Standards and Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, p 421, "These recommended practices are intended as achievable recommendations, representing what is believed to be an optimal level of practice."

Recommendation VII (pg. 425 & pg. 426)
Instruments should be decontaminated in an area separated from locations where clean activities are performed.

VII.b. The decontamination area should be physically separate from clean areas and include a door. This area should contain, but not be limited to, the following equipment:
? eye wash station.

An eye wash station is required by OSHA when chemicals such as those used to clean instruments are used.

Based on observation, interview, and record review, the facility failed to maintain a sanitary environment to avoid sources of infection and potential transmission of infections and communicable diseases when the hospital failed to:

1. Ensure that there were infection control measures to prevent the development of food borne illness and cross contamination in the food service departments. Also, the hospital failed to have a thorough infection control surveillance system that monitored the conditions and practices of the dietetics services staff. By not having these measures and a thorough surveillance system, potentially hazardous foods had been stored, prepared and distributed under unsafe and unsanitary conditions and there was potential for such continuation in the absence of identification and remediation in a hospital with a licensed bed capacity of 612 patients. (A 749)

2. Ensure that sanitary environment is maintained when there was no door between the decontamination area and the clean areas in the East Campus Sterile Processing Department and the humidity, temperature, air exchanges and air pressure of the decontamination area was not monitored. (A749)

3. Ensure that the risk of tuberculosis (TB) transmission was lessened when two of the 21 reviewed Employee Health files indicated Employee 7 was delinquent in their annual test for tuberculosis and was delinquent in completing annual Infection Control Training. Employee 16, when hired in 2010 did not have the results of the second baseline test recorded in his Employee Health file.(A749)

The cumulative effect of these failures had the potential for obstructing infection control and prevention process, which might put the patients at risk for possible exposure infection and transmission of communicable diseases.

Based on observation, staff interviews and record reviews, the hospital failed to:

1. Ensure that there were infection control measures to prevent the development of food borne illness ( illness acquired by the ingestion of food contaminated with disease causing bacteria) and cross contamination (transfer of disease causing bacteria) in the food service departments. Also, the hospital failed to have a thorough infection control surveillance system that monitored the conditions and practices of the dietetics services staff. By not having these measures and a thorough surveillance system, potentially hazardous foods had been stored, prepared and distributed under unsafe and unsanitary conditions and there was potential for such continuation in the absence of identification and remediation (correction) in a hospital with a licensed bed capacity of 612 patients.

2. Ensure that sanitary environment is maintained when there was no door between the decontamination area and the clean areas in the East Campus Sterile Processing Department and the humidity, temperature, air exchanges and air pressure of the decontamination area was not monitored. This could potentially increase the risk of cross contamination.

3. Ensure personnel were consistently screened for tuberculosis (infectious disease commonly affects the respiratory system) when two of the 21 reviewed Employee Health files indicated Employee 7 was delinquent in their annual test for tuberculosis and Employee 16, when hired in 2010 did not have the results of the second baseline test recorded in his Employee Health file. Employee 7 was delinquent in completing annual Infection Control Training. The facility failed to maintain an effective tracking system of employee health record which places the patients at risk to TB exposure if the employee's TB screening status is not known.

Findings:

1a. During the initial tour of the kitchen at the California Campus on 10/11/11 at 1:45 PM, the roll-in refrigerator exterior temperature read 44 degrees Fahrenheit (F). The two thermometers inside the refrigerator read 38 degrees F and 40 degrees F. Several food items contained in the refrigerator were checked for temperature and the following was noted:
Custard (individual servings) were 46.9 degrees F
Pudding (individual servings) were 44.4 degrees F
Banana Pudding (batch) was 43.3 degrees F
Chicken breasts (previously cooked) were 43.3 degrees F
Sliced Turkey (cooked) was 43.9 degrees F

During a concurrent interview with Staff 5 (S 5), she stated that the custard and pudding were prepared and placed in the refrigerator within the last 2 hours. She further stated that the chicken breasts and the turkey had been stored in the refrigerator since the previous day. She was unable to state how long the potentially hazardous foods ' (PHF) temperatures were within the food danger zone of greater then 41 degrees F. She also stated that the staff relies on the thermometers inside the refrigerators to indicate if the food inside is safely stored at less than or equal to 41 degrees F. She was unable to explain why the temperature of the PHF was not maintained at 41 degrees or below.

During a concurrent interview with the Infection Control Coordinator (ICC), he stated that he did regular surveillance in the kitchen but did not monitor the temperature of the food in the refrigerators.

A review of the hospital's policy titled, "Actions in Response to Deviant Temperature" dated 4/07, revealed that it is the hospital ' s policy that action shall be taken to preserve the wholesomeness and quality of foods exposed to improper temperatures. The policy directs the staff to take the temperatures of PHF to determine if it has exceeded 40 degrees F.

According the 2009 Food Code chilled PHF shall be maintained at 41 degrees F or less. Bacterial growth and/or toxin production can occur if PHF remains in the temperature "Danger Zone" of 41 - 135 degrees F for too long, creating the potential for food borne illness.

1b. During the initial tour of the Pacific Campus kitchen on 10/11/11 at 10:40 AM, the slicer in the cold prep area was observed to have a moderate amount of dry meat residue on the blade and the chute.

During concurrent interviews with Food Service Worker 1 (FSW 1) and FSW 2, both stated that they had been working in the cold prep area since 6:00 AM that day had not seen anyone use the slicer. They did not know when the slicer was last used.

During a concurrent interview with S 3, she stated that it was the policy for the slicer to be cleaned after each use. She did not know when the slicer was last used She was further unable to explain why the slicer was not cleaned.

During a concurrent interview with the ICC, he stated that during routine surveillance in the kitchens he monitors general cleanliness. He was unable to explain why the slicer was not cleaned after it was used.

A Review of the hospital's policy titled, "Area and Equipment Cleaning Frequency" undated, revealed that the slicer was to be cleaned and sanitized after each use.

1c. During the initial tour of the kitchens at both the Pacific and California campuses on 10/11/11, two table mounted can openers in the Pacific Campus kitchen and one in the California campus were observed to have worn, nicked blades.

During concurrent interviews with S 5 and S 3, they stated that new blades had been ordered for the can openers but they had not yet been received. Both S 3 and S 5 confirmed that the blades on all 3 can openers were worn and nicked.

During a concurrent interview with the ICC, he stated that he doesn't observe the condition of the can opener blade during routine surveillance of the dietary department.

A review of the hospital's policy titled, "Area and Equipment Cleaning Frequency" undated, revealed that the can opener blades were to be cleaned and sanitized daily. There was no direction for the staff to alert the FSSs when the blade was worn and nicked and required replacing.

According to the 2009 Food Code, cutting or piercing part of can openers shall be kept sharp to minimize the creation of metal fragments that can contaminate food when the container is open. It further stated that multiuse food contact surfaces shall be smooth and free of crevices. Surfaces which have imperfections such as cracks, chips or pits allow microorganisms to attach and form biofilms (a thin coating containing organisms that adheres to surfaces and can release pathogens in the food and prevent disinfectants from reaching surfaces that need to be cleaned). Biofilms are highly resistant to cleaning and sanitizing efforts.

1d. During the initial tour of the California Campus kitchen on 10/11/11, at 2:10 PM, the drain for the ice machine was noted to have two pipes draining from the ice machine. Both pipes did not have air gaps maintained.

During a concurrent interview with S 5 and the Vice President of Administrative Services (VPAS), they confirmed that the two pipes draining from the ice machine did not provide an air gap with the drain.

During a concurrent interview with the ICC he stated that he was aware of the importance of air gaps, but he hadn't observed the drain for the ice machine and the lack of air gap.

According to the 2009 Food Code, the presence of air gaps prevents the back flow of waste water during times of negative pressure, preventing contaminated water from being drawn into the system. The standard of practice is to ensure that all food storage equipment contain air gaps.



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2. During an observation of the Sterile Processing Department located in the perioperative area (East campus) on 10/13/11 at 11:45 a.m., it was noted there was no door between the decontamination area (where soiled surgical instruments are cleaned and disinfected) and the clean areas.

On 10/14/11 at 3 p.m., the MSS (manager surgical services) East campus acknowledged there was no door between the decontamination area and the clean areas. She said "It's always been like that." She also stated that the humidity, temperature, air exchanges and air pressure of the decontamination area was not monitored.

During an interview on 10/14/11, MSP 2 (Pacific campus) was asked if he was monitoring the humidity, temperature and air exchanges of the decontamination area. He responded "No I don't." He said he did not know if a negative air pressure was maintained in the decontamination area.

On 10/17/11 at 10:40 a.m., the ICM was interviewed regarding the lack of a door between the decontamination area and the clean areas of the East campus sterile processing department. She said "We are aware that is not an ideal situation." She said infection control staff do not monitor humidity, temperature, air exchanges and air pressure of the decontamination areas on any of the campuses (Pacific, East and West).

According to 2011 AORN PeriOperative Standards and Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment,

Recommendation VII (pg. 425 & pg. 426)
Instruments should be decontaminated in an area separated from locations where clean activities are performed.

Physical separation of decontamination areas from areas where clean items are handled minimizes the risk of cross-contamination. Cross contamination can result when soiled items are placed in close proximity to clean items or placed on surfaces upon which clean items are later placed. Aerosols created during cleaning can also cause cross-contamination.

VII.b. The decontamination area should be physically separate from clean areas and include a door. ...
The design of the decontamination area facilitates the appropriate decontamination of instruments. Having equipment and utilities in place facilitates desired infection control practices. Keeping the door closed exhausts aerosols out of the building, minimizing contamination of adjacent rooms. ...

VII.c. The decontamination area heating, ventilation, and air conditioning (HVAC) system should be controlled and monitored according to local requirements. Proper HVAC controls facilitate desired infection control practices. ...

VII.c.1. At a minimum, the following HVAC settings should be maintained in the decontamination area:

negative air pressure,
at least six air exchanges per hour,
temperature of 68 F to 73 F (20 C to 23 C), and
30% to 60% humidity.

VII.c.2. Doors to the decontamination area should be kept closed, except when moving personnel and equipment. Keeping the door closed exhausts aerosols out of the building, minimizing contamination of adjacent areas. Negative pressure within the decontamination room cannot be maintained, if the door is held open.


25730


3a1.On 10/17/11 at 1:30 PM, record review of Employee 7's Employee Health file indicated the last TB screening test was done on 1/5/10.

The Regional Employee Health Manager also reviewed Employee 7's file and stated there was no evidence TB screening was performed in 2011 in the file.

The Centers for Disease Control "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in the Health Care Setting" 2005, recommended that after baseline testing at hire "Health Care Workers should receive TB screening annually."

3a2. On 10/17/11, a review of Employee 16's health record indicated the employee was hired 9/27/10. The employee had a PPD (tuberculin skin test) done at another facility on 6/22/10 and was read negative on 6/24/10. The tuberculosis screening form indicated the employee was administered a second step test on 9/14/10 at the facility. The result of this test was not read. The section for which the result was to be recorded was blank.

The facility's policy and procedure on tuberculosis surveillance revised 4/20/10 indicated "To ensure that all employees and volunteers are free of active pulmonary tuberculosis, all CPMC employees and volunteers will be tested for TB infection with ....

Employee 16 also had a tuberculin screening form dated 9/7/11 indicating she was given a PPD skin test on 9/7/11. The form indicated the result was to be read on 9/9/11. The section where the result was to be recorded was blank.

During an interview on 10/17/11 at 4:25 PM, the Employee Health Manager (EHM) stated the employee never came back to have her PPD test read. It's the occupational health department that handles the tracking of employee health. She also stated that a notice should have been sent out to the employee's manager. The EHM said she did not know what exactly happened, but the employee should have been given a 14-day conditional clearance. A final clearance is issued when all hiring requirements were met. As for the 9/7/11 PPD skin tests, the manager said she did not know what happened.

During a phone conversation with the Director of Accreditation in the afternoon of 10/18/11, she stated the employee had her own copy of the result. She was told by the Director of Physical Medicine and Rehabilitation Services (DPMRS) that when the test was administered, a copy of the form was sent with the employee so that when the test was due for reading, a nurse at the hospital campus where the employee was working at that time, could read the result.

The facility policy and procedure indicated "PPD test results will be read by designated, trained personnel.... The result of the test is based on the presence or absence of an induration at the injection site."

The test result (employee copy) that was faxed to the department on 10/18/11 was read as negative. The section for "induration in mm(millimeter)" was not filled out. This could potentially affect future readings of the employee's TB tests.


16951


3b. During the 10/17/11 record review it was noted that Employee 7 had not taken the online Infection Control Training since 2/26/10.

This Manager also acknowledged that there was no indication that Employee 7 had taken an Infection Control Training Program in 2011.

The Center for Disease Control "Recommendations for prevention of infections in health care personnel", dated 1998, stated "Provide personnel, annually and whenever the need arises, with inservice training and education in infection control appropriate and specific for their work assignments..."

Based on interview, and record review, the facility failed to ensure that surgical services were provided in accordance with acceptable standard of practice and staffed in a manner that would ensure the health and safety of patients.

1. The facility failed to develop and implement a policy regarding flash sterilization (a very short sterilization cycle) which specified that flash sterilization should be kept to a minimum and not used as a substitute for sufficient instrument inventory (as recommended by AORN-American Association of periOperative Nurses). (A 951)

2. Develop and implement a policy regarding monitoring temperature and humidity levels in the operating rooms that was based on AORN (American Association of periOperative Nurses) recommended practices. (A 951)

3. The facility failed to delineate specific surgical privileges for 1 of 10 sampled credentials files (Practitioner 10), and failed to follow its own policies regarding required experience to grant a specific privilege in 1 of 10 sampled credentials files (Practitioner 4). The deficient practices eliminated mechanisms by which the facility could ensure that it only granted surgical privileges each physician was competent to perform. (A 945)

4. The facility failed to integrate its ophthalmology department into its hospital-wide quality assessment and performance improvement program. The deficient practice eliminated a mechanism of holding the medical staff accountable for the quality of care provided at the hospital. (298)

The cumulative effect of these failures resulted in the facility's inability to ensure the provision of quality health care in a safe environment.

Based on interview and record review, the facility failed to delineate specific surgical privileges for 1 of 10 sampled credentials files (Practitioner 10), and failed to follow its own policies regarding required experience to grant a specific privilege in 1 of 10 sampled credentials files (Practitioner 4). The deficient practices eliminated mechanisms by which the facility could ensure that it only granted surgical privileges each physician was competent to perform.

Findings:

Review of Practitioner 10's credentials file indicated he was an ophthalmologist reappointed to the facility's teaching staff for two years effective 7/31/10. Practitioner 10's delineation of privileges indicated he had "Level 1 Teaching" privileges as well as "Level 2 Core Ophthalmology (health science dealing with the eyes and its diseases)" privileges. The description of the teaching privileges stated, "Privileges include... providing surgical and non-surgical treatment (in a teaching capacity) to patients in the inpatient & outpatient ophthalmology service." Unlike the Level 2 Core privileges, the Level 1 Teaching privileges did not specify which specific surgical procedures were included.

In an interview on 10/13/11 at 10:01 a.m., Staff F confirmed that the Level 1 Teaching privileges included all surgical procedures.

Review of Practitioner 4's credentials file indicated he was a pulmonologist ( a physician trained and certified to treat pulmonary diseases) reappointed to the facility's active medical staff for two years effective 3/31/10. Practitioner 4's privileges indicated he had requested and been granted privileges to perform pleural biopsies even though he had not done any pleural biopsies in the past 2 years and therefore had not met the facility's requirement for performing at least 2 cases in the previous two years. A notation at the top of the list of specific privileges stated, "To qualify for each privilege you must meet the total number of cases/patients recommended." A notation on the department's recommendation dated 2/10/10 regarding Practitioner 4 stated, "Pleural Biopsy is a rare procedure. His accumulated experience is adequate for ongoing priveleges (sic) without proctoring. Will re review at next appointment". No documentation was present indicating what accumulated experience had let to the noted recommendation.

In an interview on 10/12/11 at 12:45 p.m., Staff J stated that there were alternatives to the required number of cases which considered other experience and required the department chair's recommendation; she handed the surveyor a policy on the topic.

Review of the facility's policy "Consideration of clinical privileges request when threshold numbers are not met" (effective 2/10) indicated that an established member of the medical staff who requested a privilege but did not meet threshold criteria would have to submit: "a. operative reports/clinical activity data from other institution(s) b. completed Special Procedure Request Form c. documentation of CME [continuing medical education]/updated training relevant to the privilege(s) requested d. other data, as requested". The policy also stated, "Upon evaluating the above elements, if the department chair decides to recommend approval of requested privilege(s) given the alternative demonstration of qualifications, s/he must submit to the Credentials Committee in writing the rationale for that finding, including a recommended, specifically-designed proctorship program."

Comparison of the section of Practitioner 4's credentials file regarding his most recent reappointment to the facility policy on thresholds indicated that the file did not contain evidence of activity elsewhere, a special procedure request form for pleural biopsies, documentation of CME or updated training regarding pleural biopsies, or a proctorship program for Practitioner 4.

Based on interview and record review the facility failed to develop and implement surgical services policies in accordance with acceptable standards of practice when they failed to:

1. Develop and implement a policy regarding flash sterilization which specified that flash sterilization should be kept to a minimum and not used as a substitute for sufficient instrument inventory (as recommended by AORN-American Association of periOperative Nurses). This could potentially increase risk of infection to patients.

2. Develop and implement a policy regarding monitoring temperature and humidity levels in the operating rooms that was based on AORN (American Association of periOperative Nurses) recommended practices. Absence of temperature and humidity monitoring limited the facility's ability to identify problems in the system that controls temperature and humidity and circulates air and remove bacteria and contaminants from the air.

Findings:

1. During a tour of the East campus surgical area on 10/13/11 at 11:50 a.m., SPT 1 (Sterile Processing Technician 1) was asked about the facility's use of flash sterilization. She said the facility did "a lot of flash sterilization" especially when they were doing back to back cataract (eye surgery) cases because they were short of instruments. She stated one eye instrument (Dr. Horns Chopper) would be flashed frequently as it would be required for each case. She said one eye surgeon (Surgeon 1) had his own "one of a kind" instrument set which would be flash sterilized before each case. She stated other eye doctors brought their own instrument sets in the morning of the surgery and the set would go through a regular sterilization cycle prior to the first case. However, for any other surgery scheduled that day, the set would be flash sterilized.

The flash sterilization log for 10/5/11, 10/11/11 and 10/12/11 were reviewed and indicated the following:

10/5/11
Surgeon 1's instrument set was flash sterilized at 9:21 a.m., 10:49 a.m. and 11:51 a.m.
Surgeon 2 had an instrument that was flash sterilized at 8:50 a.m. and 10:24 a.m.
Surgeon 3 had instruments flash sterilized at 8:22 a.m., 9:06 a.m., 10:10 a.m., 11:25 a.m., 12:18 p.m. and 13:07 p.m.

10/11/11
Surgeon 4 had an instrument that was flash sterilized at 8:59 a.m., 9:39 a.m. and 10:32 a.m.

10/12/11
Surgeon 1's instrument set was flash sterilized at 8:26 a.m., 10:06 a.m. and 10:35 a.m.

On 10/17/11 at 10:40 a.m., the ICM (infection control manager) was interviewed regarding the use of flash sterilization at the East campus. She stated that the Infection Control committee reviews the flash sterilization reports from all the campuses and checks to see that sterilization was achieved. She said the East campus has an ongoing high rate of flash sterilization because they do a lot of eye surgery there and the surgeons like to use their own particular instruments that are very expensive. When asked if she had concerns about the high rate of flash sterilization at the East campus, she responded "Yes."

During an interview on 10/17/11 at 1:55 p.m., the VPSS (vice president of surgical services) stated the use of flash sterilization on all campuses is reviewed quarterly. She said the rate of flash sterilization at the East campus was high because of the number of ophthalmology cases done there. She said "Ophthalmology as a service historically has a high rare of flash sterilization." She said the facility had bought instruments to try to reduce the incidence of flash sterilization.

The data on flash sterilization for quarter 1 and 2 of 2011 was reviewed with the VPSS. The percent of CSSL (case specific sterilization loads) that were instrument set to case volume ( total instrument sets divided by total number of cases/quarter = percent) was reviewed for all three campuses and indicated the following:

1st Quarter 2 nd Quarter

East Campus: 37% 42%

Pacific Campus: 6% 4%

West Campus: 14% 13%

The VPSS acknowledged the rate of flash sterilization was significantly higher on the East campus but said this was because of the ophthalmology surgery done there.

The facility's Immediate-Use Sterilization in the Operating Room (formerly Flash Sterilization) policy (revised 8/11) was reviewed. The policy indicated that one of the references it was based on was AORN Standards of Practice, 2011. The policy detailed how instruments should be flash sterilized, flash sterilization times and how to complete the flash sterilization log. The policy did not indicate that flash sterilization should be kept to a minimum and not used as a substitute for sufficient instrument inventory.

According to 2010 AORN PeriOperative Standards and Recommended Practices for Sterilization in the Perioperative Practice Setting, pg. 457, "These recommended practices are intended as achievable recommendations, representing what is believed to be an optimal level of practice."

Recommendation IV (pg. 460 & pg. 464).
Use of flash sterilization should be kept to a minimum. Flash sterilization should be used only in selected clinical situations and in a controlled manner.

Flash sterilization may be associated with increased risk of infection to patients because of pressure on personnel to eliminate one or more steps in the cleaning and sterilization process.

IV.a Flash sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method. Flash sterilization should not be used as a substitute for sufficient instrument inventory.

2. The facility's operating room temperature and humidity logs for all three campuses were reviewed on 10/17/11. The Pacific campus log for May 2011 indicated the humidity should be 30 % to 60 % and the temperature 68 to 73 degrees Fahrenheit. The East and West campus logs for May 2011 indicated a desired humidity range of 35 % to 60 % and the temperature 68 to 73 degrees Fahrenheit. The instructions for completing the logs included the following:

1. Read the temperature /humidity in each OR and document in log.
2. Any variation requires a repeat reading of the out-of-range room in one hour. Document the variation in Re-read box.
3. Call Service Center to contact Engineering. Call the Boiler Room during off hours.

The Pacific campus log for April 2011 showed out of range temperatures on 4/3, 4/9, 4/12, 4/16, 4/17, 4/23, 4/24 and 4/30. The temperatures recorded ranged from 62 to 65 degrees Fahrenheit. There was no documentation that the temperatures had been rechecked in one hour per the instructions.

The East campus log for February 2011 showed out of range humidity levels on 2/2, 2/4, 2/9, 2/22, 2/23 and 2/24. The humidity levels recorded ranged from 20 % to 29 %. There was no documentation that the humidity levels had been rechecked in one hour except on 2/2 when the level dropped from 24 % to 22 % on the recheck. There was no documentation that the Engineering department was contacted.

The West campus log for June 2011 showed out of range temperatures on 6/14, 6/15, 6/16, 6/17, 6/20, 6/21, 6/22, 6/23, 6/24 and 6/28. The temperatures recorded were 65 degrees Fahrenheit but there was no documentation that the temperature was rechecked in one hour.

During an interview on 10/17/11 at 10:30 a.m., the DOS (director of safety) stated the facility was initially using a humidity range of 35 % to 60 % because this was the Joint Commission guideline but then they changed to 30 % to 60 % because this was the range recommended by CMS (Centers for Medicare & Medicaid Services). She stated some of the old forms were still being utilized and this accounted for the discrepancy in the desired humidity range listed on the logs. The DOS was shown the out of range humidity and temperature logs and said "We didn't follow our protocol." She said all out of range temperatures and humidity levels should be rechecked in one hour and if they are still out of range the Engineering department should be notified. She said sometimes the temperatures will be out of range because the surgeon will request a lower temperature in the operating room but when this happens staff should make a notation.

On 10/17/11 at 11:10 a.m., the VPSS submitted the facility's "Temperature Humidity, Monitoring of Operating Rooms" policy and stated the surveyor had been given the "wrong information" regarding the humidity ranges. She said the facility's desired humidity range in the operating room was 35 % to 60 % and that the log with the humidity range of 30 % to 60 % was the wrong form and shouldn't have been used. She said the facility's policy specifies a humidity range of 35 % to 60 % per AORN guidelines. When told the AORN's recommended humidity range is 30 % to 60 %, the VPSS stated "We will have to look at that."

A review of the policy (revised 2/10) indicated the following:
Policy

II. Monitoring Ranges for Operating Rooms

a. Temperatures ranges are ideally 68-73 F.
This temperature range may be altered per the physician, depending on the clinical needs of the patient or the procedure (i.e., infants and pediatric patients).

b. Relative humidity ranges are ideally 35% - 60%.
This humidity range may be altered per the physician, depending on the clinical needs of the patient or procedure.

IV. reporting and Corrective Action

a. Humidity/Temperature

1. If the range is not 35%-60% (Humidity) and/or is not 68-73 F (Temperature)

Report variance to department manager/designee.
Repeat readings in one hour.
If the readings are still above or below the range of 35%-60% (Humidity) and/or 68-73 F (Temperature), report the variance to the department manager/designee who will contact the Service Center.
The Service Center will also report the variance to the Engineering Department.
...

The VPSS stated staff had not followed the facility policy when they failed to recheck out of range temperatures and humidity levels after one hour and failed to call engineering when a recheck showed the humidity level was still out of range.

According to 2011 AORN PeriOperative Standards and Recommended Practices for a Safe Environment of Care, pg. 220 & pg. 221).

Recommendation V

Potential hazards associated with HVAC systems in the practice setting should be identified, and safe practices should be established.

Air in the perioperative environment contains microbial-laden dust, lint, skin squames, and respiratory droplets. The number of microorganisms in the air in an operating room is directly proportional to the number of personnel moving in and around the room. Outbreaks of surgical-site infections have been traced to airborne contamination from colonized health care workers. Heating, ventilation, and air conditioning systems dilute and remove contaminants from the air and control air-flow patterns. Key components of an effective HVAC system are proper air quality, air volume changes, and air flow direction. In an operating room or procedural area, proper functioning of these components minimizes the contamination of the sterile field and risk of infection to the patient. A properly functioning HVAC system carries microbial-laden skin squames, dust, and lint away from the sterile field, and removes these contaminants through the exhaust ducts at the periphery.

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

V.b.2. Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC system.

V.c. Temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC system.

V.c.1. Temperature should be maintained between 68 F to 73 F (20 C to 23 C) within the operating room suite and general work areas in sterile processing.