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Based on observation, staff interviews, medical record and document reviews, the hospital failed to demonstrate an effective governing body responsible for the conduct of institutional operations in order to ensure safe and effective care for all patients as evidenced by:

1. The failure to assess the quality of the service provided under contracts. The hospital did not have a quality assurance program to evaluate the nuclear medicine service provided under contract (A-083);

2. The failure to develop performance improvement activities that accurately reflected the scope and nature of the dietetic services(A-02630)

3. The failure to ensure the provision of pharmaceutical services that met the needs of patients (A-490)

4. The failure to ensure the implementation of dietetic services in an effective and organized manner (A-618)

5. The failure to provide and maintain a sanitary and safe environment for the patients and employees to avoid sources and transmission of infections and communicable diseases (A-0747)

The cumulative effects of these systemic problems resulted in the hospital's failure to meet statutorily mandated compliance with the Condition of Participation for Governing Body.

Based on record review and interview, the hospital governing body failed to assess the quality of the service provided under contracts. The hospital did not have a quality assurance program to evaluate the nuclear medicine service provided under contract.

Findings:

A review of the hospital contract with the nuclear medicine vendor showed that the contracted vendor was not required to provide quality assurance data or report to the hospital to allow the hospital quality assurance and performance improvement program to assess the services provided under the contract.

During an interview at approximately 2:15 p.m. on 3/15/12, the hospital Director of Pharmacy stated that the hospital had not received any quality assurance data or report from the nuclear medicine contracted vendor.

Based on observation , staff interview, and document review the hospital failed to maintain an effective ongoing hospital wide data driven quality assessment program involving the Dietary Services when:

1. There was no analysis or tracking of issues to evaluate scope of Food Services including failure to develop an effective quality appraisal and performance approval program (A267, A276);

2. Quality Assurance Performance Improvement (QAPI) program did not measure, analyze or track the quality indicators in the department including food safety. There were breaks in infection control that could result in patient developing food borne illness when there was inadequate hand washing and staff knowledge for cool down procedures and potential of cross contamination from continuous use of utensils and knives for raw and cooked potentially hazardous food on room service production line (A618, A629, A630, A631, A748, and A749);

3. The quality program failed to include indicators relative to the scope of the department that identified opportunities for improvement and will lead to improvement (A619, A620, A630, A631, A748, and A749).

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

Based on staff interview and document review the hospital failed to ensure that the hospital measured, analyze, and track the services provided by Dietary Service Quality Assurance Performance Program (QAPI) that included indicators relative to the current scope of service as evidenced by the lack of activities surrounding identified food service issues and clinical nutrition care issues. The failure to measure, analyze, and track the deficient practices in dietary department would allow the failures to continue.

Findings:

On 3/15/12 at 3:00 p.m., RD1 and Food Service Management 1 were asked about the Department's quality appraisal and performance approval program. Food Service Management 1 stated there was none for the food service areas. RD 1 stated she had monitored carbohydrate servings for the diabetic patients using room service during the month of august 2011.

Review of the Food Service Director job description and the Chief Clinical Dietitian job description showed no job duties that included developing or monitoring department quality performance programs.

Documents provided by Quality staff on 12/16/12 at 9:39 a.m. were reviewed. The PI (performance improvement) Activities 2012 showed the Food Service had one activity " to increase proper technique of hand washing. Review on 3/16/12 at 9:39 a.m. of Patient Quality Committee report for January 12, 2011 showed the Dietary report of four indicators for the department that included nursing screen completion, RD notified by nursing, food and drug interactions education, and dietary consults completed.

There was one indicator for the 2012 that addressed handwashing. There were no indicators for evaluating staff compliance with multiple food safety and sanitation issues identified during the survey. There were no indicators regarding the diet manual development or menu analysis. There were no indicators regarding the food service operation at the Mills campus or clinical physician prescribing and meeting physician diet orders.

Based on staff interview and document review the medical staff failed to ensure that patient diets were ordered by the practitioner responsible for the medical care of the patient.

Findings:

On 3/15 12 at 1:00 p.m., the Staff M stated that the physicians were not concerned with the RD doing supplement orders. He could not verify that a protocol was in place and approved through the medical staff committee that established the ability for RD ordering of supplements.

Review of the bylaws on 3/15/12 at 4:00 p.m. showed there were no provisions for the registered dietitians to order patient supplements.

Based on document review and staff interview, the facility failed to ensure that the medical staff enforced their bylaws regarding the suspension of physician's privileges for failure to complete medical records within the required time period.

Findings;

On 3/12/12 at 1:35pm, review of the "Medical Staff Bylaws" approved on July 7, 2011, revealed the following: "Automatic Suspension:
A temporary suspension of privileges to care for patients not in the Hospital at the time of imposition shall be imposed after warning of delinquency for failure to complete medical records, as prescribed in the Rules and Regulations. This suspension shall continue until the delinquent medical records are completed." (Bylaws Section #8.3.1, Page 25)

On 3/12/12 at 10:30am, analysis of the "Rules and Regulations" approved on April 9, 2009 stipulated: "Medical records shall be completed and authenticated by a physician, dentist or podiatrist within two weeks following the patient's discharge.' (Rules and Regulations, Section #3.4.2; Page 8).

On 3/14/12 at 2:00pm, review of the "Suspended Providers Report" printed on 3/14/12 revealed that there were 2 physicians on suspension. However, subsequent review of the " Deficiency Report" printed on 3/13/12 at 9:31pm, revealed that there were an additional 26 physicians with 46 delinquent records (those not completed within 14 days of patient discharge). The oldest record dated back to patient discharge date of 3/15/2011.

Staff Member Y stated in an interview on 3/14/12 at 3:00pm, that the Health Information Department notifies professional staff members on a weekly basis regarding incomplete/delinquent charts.

Based on observation and document review, the hospital failed to evaluate the nursing care for one patient (Patient 84) when patient meal service was not supervised by licensed staff. This is a potential of compromising patient medical care.

Findings:

On 3/13/12 at 1:00 p.m. in the adult chemical dependency lounge, Patient 84 was observed to take a lunch tray from the lunch transport cart and sit at the table and eat. The staff present in the chemical dependency lounge identified herself as the social worker therapist and stated there were two trays in the cart and one was for a patient who had been discharged in the morning.

There was no licensed staff present in the chemical dependency lounge during the lunch meal and no licensed staff verified the diet or correct delivery to Patient 84.

Based on observation, interviews and document reviews, the hospital failed to ensure the provision of pharmaceutical services and care that met the needs of the patients as evidenced by:

1. Failure to ensure the safe use of droperidol (an anti-nausea medication) to reduce the risk of severe and potentially fatal adverse drug outcomes. Patient 101, 102, and 103 with prolonged QTc interval on EKG (electrocardiogram), a contraindication for the use of droperidol, were ordered and administered droperidol contrary to the manufacturer's prescribing information and the boxed warning issued by the FDA (Food and Drug Administration) (A 500);

2. Failure to monitor patients on patient controlled analgesia (a pain control therapy) for vital signs and adverse effects to minimize the occurrence of adverse events and to ensure patient safety. Patient 106, 107, 108, 109, and 110 were not monitored for respiratory rate and sedation level in accordance to hospital policy and procedure to ensure patient safety (A 500);

3. Failure to ensure that the distribution of concentrated potassium chloride (a concentrated electrolyte), a high risk medication, was in accordance with standard of practice to prevent inadvertent administration of concentrated potassium chloride which could result in death. Twenty 20-ml vials of potassium chloride 40 mEq were stored in the automated dispensing cabinets located in the operating rooms (A 500);

4. Failure to ensure that preparation of intravenous medications (medications to be administered into the vien) was in accordance with accepted standards of practice to ensure patient safety. Environmental monitoring was not performed in the IV (intravenous) room to ensure the quality and safety of the compounded sterile preparations. (A 491);

5. Failure to ensure that medications were securely stored to prevent unauthorized access. A mobile supply cart containing medications was not locked or secure allowing access to the contents of the cart by unauthorized individuals (A 502).

The cumulative effects of these systemic problems resulted in the inability of the hospital to provide pharmaceutical services and care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Pharmaceutical Services.

Based on interview and record review, the hospital failed to ensure that preparation of intravenous (into the vein) medications was in accordance with accepted standards of practice to ensure patient safety. Environmental monitoring was not performed in the IV room (a room where medications for intravenous use were prepared) to ensure the quality and safety of the compounded sterile preparations. No viable air and surface sampling was performed to monitor the risk of microbial contamination of compounded sterile preparations prepared in the IV room.

Findings:

A review of the Peninsula campus pharmacy IV room recertification reports dated 8/2010, 2/2011, 5/2011 and 11/2011 showed that no airborne and surface viable particle sampling was performed as a means of evaluating the overall control of the compounding environment.

During an interview at approximately 2:00 p.m. on 3/13/12, the hospital pharmacy supervisor stated that no airborne and surface viable particle sampling was included in the semi-annual recertification of the IV rooms and equipment in both the Mills and Peninsula campuses.

Viable particle sampling measures particles that are living organisms (typically bacterial and fungal spores). Airborne bacteria and fungi can pose a significant threat of contamination during the manufacture of compounded sterile preparations. Viable airborne particle testing is performed to monitor this threat and to ascertain that physical and procedural controls in place are keeping the airborne microbial load of a facility's air to an acceptable level.

USP 797 for Pharmaceutical Compounding - Sterile Preparations Sterile compounding procedures requires air quality evaluations to ensure the control of the compounding environment. Both viable air and surface sampling are required in all settings were sterile preparations are compounded to minimize the risk of microbial contamination of compounded sterile products. Environmental monitoring data must be collected and trended as a means of evaluating the overall control of the compounding environment. In addition, "media-fill tests" must be conducted at least annually by each person authorized to make sterile compounds to verify that they can do so aseptically.

USP 797 refers to chapter 797 "Pharmaceutical Compounding - Sterile Preparations," in the USP National Formulary. It is sterile compounding standards issued by the United States Pharmacopeia (USP). USP 797 describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.

A review of the hospital policy and procedure on compounding sterile preparations showed that the hospital did not have established procedures to ensure proper environmental monitoring of the IV room to ensure the quality and safety of compounded sterile preparations.

Based on observation, interviews, and record review, the hospital failed to deliver pharmaceutical services to meet the needs of the patients when medications were not controlled and distributed in accordance with standards of practice, federal and state laws as evidenced by:

1. Failure to ensure the safe use of droperidol (an anti-emetic) Patient 101,102 and 103 with prolonged QTc interval on EKG (electrocardiogram), a contraindication for the use of droperidol, were ordered and administered droperidol, contrary to the warning issued by the manufacturer and the FDA (Food and Drug Administration) to ensure patient safety.

2. Failure to monitor patients on patient controlled analgesia for vital signs and adverse effects to minimize the occurrence of adverse events and to ensure patient safety. Patient 106, 107, 108, 109 and 110 were not monitored for respiratory rate and sedation level while receiving narcotic pain medication via patient controlled infusion pump in accordance to hospital policy and procedure to ensure patient safety.

3. Failure to ensure that the distribution of concentrated potassium chloride, a high risk medication, was in accordance with standard of practice to prevent inadvertent administration of concentrated potassium chloride which could result in death. Twenty 20-ml vials of potassium chloride 40 mEq were stored in the automated dispensing cabinets located in the operating rooms.

Findings:

1a. A review of Patient 101's clinical record showed that the patient was seen at the emergency department on 12/27/11. Droperidol 1.25mg intravenously (IV) was ordered by Physician 101 at 9:35 a.m. and administered at 10:28 a.m. The medication order included the black box warning issued by the FDA which stated that the medication was not to be administered to patients with QTc interval greater than 400 millisecond (msec) in males or 450 msec in females and that QTc prolongation/Torsades de Pointes (a potentially fatal form of irregular heart rhythm) have been reported at or below recommended doses.

An electrocardiogram (EKG or ECG) monitoring was performed at 7:11 a.m. on 12/27/11 with a reported QTc interval of 556 ms (milliseconds). There was no documented clinical rationale to justify the use of droperidol in Patient 101 in the presence of a clinical contraindication which put the patient at risk for serious and potentially fatal adverse effect.

EKG is an interpretation of the electrical activity of the heart over a period of time, as detected by electrodes attached to the outer surface of the skin and recorded by a device external to the body. QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle on an electrocardiogram. . In general, the QT interval represents electrical depolarization and repolarization of the left and right ventricles. The American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation and the Heart Rhythm Society endorsed by the International Society for Computerized Electrocardiology published Recommendations for the Standardization and Interpretation of the Electrocardiogram: Part IV indicated that the adjusted QT of 460 ms or longer in women and 450 ms or longer in men be considered a prolonged QT interval. The QTc interval is a corrected QT interval which represents the QT interval at standard heart rate of 60 beats per minute. Prolonged QT interval is a biomarker for ventricular arrhythmias like torsades de pointes and a risk factor for sudden death. Torsade de pointes is a malignant ventricular arrhythmia that is associated with syncope and sudden death.

1b. A review of Patient 102's clinical record with the hospital Director of Pharmacy (DOP) showed that the patient was seen in the emergency department on 1/10/12 for inferior acute myocardial infarction (heart attack). Droperidol 1.25mg intravenously (IV) was ordered by Physician 101 at 3:51 a.m. and administered to Patient 102 at 3:52 a.m. The medication order included the FDA issued black box warning on the administration instructions. An EKG monitoring performed at 12:22 a.m. on 1/10/12 showed that Patient 102's QTc interval was 448 ms. There was no record that other anti-emetic medications had been tried prior to the ordering of droperidol. There was no documented clinical rationale to justify the use of droperidol in Patient 102 in the presence of a clinical contraindication which put the patient at risk for serious and potentially fatal adverse effect.

1c. A review of Patient 103's clinical record showed that the patient was seen in the emergency department on 3/7/12 for syncope and collapse. Droperidol 1.25mg IV was ordered by Physician 101at 6:56 p.m. and was administered to Patient 101 at 7:19 p.m. The medication order included the FDA issued black box warning on the administration instructions. An EKG monitoring performed at 6:20 a.m. on 3/7/12 showed that Patient 103's QTc interval was 472 ms. There was no record that other anti-nausea medications had been tried prior to the ordering of droperidol. There was no documented clinical rationale to justify the use of droperidol in Patient 102 in the presence of a clinical contraindication which put the patient at risk for serious and potentially fatal adverse effect.

Droperidol is an anti-emetic indicated for the prevention and/or treatment of nausea and vomiting from surgical and diagnostic procedures. A boxed warning (also known as Black Box Warning) was issued by the FDA (Food and Drug Administration) pertaining to the use of the medication which included the following:

" Cases of QT prolongation and/or torsade de pointes have been reported in patients receiving droperidol at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal.

Due to its potential for serious proarrhythmic effects and death, droperidol should be reserved for use in the treatment of patients who fail to show an acceptable response to other adequate treatments, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs (see Warnings, Adverse Reactions, Contraindications, and Precautions).

Cases of QT prolongation and serious arrhythmias (e.g., torsade de pointes) have been reported in patients treated with droperidol. Based on these reports, all patients should undergo a 12-lead ECG prior to administration of droperidol to determine if a prolonged QT interval (i.e., QTc greater than 440 msec for males or 450 msec for females) is present. If there is a prolonged QT interval, droperidol should NOT be administered. For patients in whom the potential benefit of droperidol treatment is felt to outweigh the risks of potentially serious arrhythmias, ECG monitoring should be performed prior to treatment and continued for 2-3 hours after completing treatment to monitor for arrhythmias. "

During a group interview at approximately 2:10 p.m. on 3/15/12, Physician 102 stated that Physician 101 preferred to use droperidol to prevent post anesthesia nausea and vomiting over other anti-nausea medications because the medication also had a sedative effect which might help patients to better tolerate the cardiac (heart) catheterization procedure. Physician 102 agreed that Patient 101, 102 and 103, based on the their prolonged QTc intervals, were not good candidate for the use of droperidol and other anti-nausea agents would have been more appropriate in those cases without putting patients at risk for serious adverse drug effect. Physician 102 acknowledged that although patients were all under cardiac monitoring during procedures and prompt intervention would be initiated should the patients develop torsade de pointes (a potentially fatal form of irregular heart rhythm), intervention for the management of Torsade de pointes was not always effective.

2a. A review of Patient 106 ' s electronic medical record with DOP and the pharmacy supervisor at approximately 3:30 p.m. on 3/14/12 showed that Patient Controlled Analgesia was ordered for Patient 106 on 1/12/12 at 2:16 p.m. as follow:

Hydromorphone
Demand Dose: 0.2mg IV every 8 minutes

Patient 106's clinical record showed that PCA was started at 2:38p.m. on 1/12/12. Respiratory rate was reassessed at 3:39 p.m. (1 hours after initiation of PCA) , 9:58 p.m., 11:34 p.m. on 1/12/12 and 4:46 a.m. and 7:40 a.m. on 12/4/11. The first pain reassessment was documented at 6:10 p.m., over 3 hours after the initiation of the PCA.

2b. A review of Patient 107's clinical record with DOP and the pharmacy supervisor at approximately 3:30 p.m. on 3/14/12 showed that Patient Controlled Analgesia was ordered for Patient 107 on 2/18/12 at 7:50 p.m. as follow:

Hydromorphone
Demand Dose: 0.2mg IV every 15 minutes
Basal rate: 0.5mg every hour

Patient 107's clinical record showed that PCA was started at 9:24 p.m. on 2/18/12. Respiratory rate was reassessed at 9:26 p.m. 2/18/12 and 12:25 a.m., 9:43 a.m., 3:49 p.m. on 2/19/12. Pain reassessment was documented at 9:26 p.m. and 11:40 p.m. on 2/18/12 and 12:25 a.m., 7:32 a.m. and 10:21 a.m. on 2/19/12.

2c. A review of Patient 108's clinical record with DOP, RN 101 (Registered Nurse 101) and the pharmacy supervisor at approximately 10:00 a.m. on 3/15/12 showed that Patient Controlled Analgesia was ordered for Patient 108 on 12/6/11 at 5:35 p.m. as follow:

Hydromorphone
Demand Dose: 0.4mg IV every 6 minutes

Patient 108's clinical record showed that PCA was started at 7:43 p.m. on 12/6/11. Respiratory rate was reassessed at 12:00 a.m. (over 4 hours after the initiation of PCA), 7:00 a.m. and 12:00 noon on 12/7/11.

2d. A review of Patient 109's clinical record with DOP, RN 101 and the pharmacy supervisor at approximately 10:00 a.m. on 3/15/12 showed that Patient Controlled Analgesia was ordered for Patient 109 on 2/17/12 at 1:24 p.m. as follow:

Hydromorphone
Demand Dose: 0.2mg IV every 6 minutes

Patient 109's clinical record showed that PCA was started at 2:12 p.m. on 2/17/12. Respiratory rate was reassessed at 3:46 p.m. on 2/17/12 (over 1 hour after the initiation of PCA) followed by 2:11 a.m., 8:00 a.m., 8:16 a.m. on 2/18/12.

2e. A review of Patient 110's clinical record with DOP, RN 101 and the pharmacy supervisor at approximately 10:00 a.m. on 3/15/12 showed that Patient Controlled Analgesia was ordered for Patient 110 on 2/29/12 at 11:19 a.m. as follow:

Hydromorphone
Demand Dose: 1mg IV every 15 minutes
Basal rate: 4mg every hour

Patient 110's clinical record showed that PCA was started at 2:26 p.m. on 2/29/12. Respiratory rate was reassessed at 4:00 p.m., 7:44 p.m., 9:09 p.m. and 11:28 p.m. on 2/29/12.

During an interview at approximately 10:10 a.m. on 3/15/12, RN 101 stated that she monitored patients on PCA for vital signs every 2 hours initially and then change to every 4 hours.

Patient controlled analgesia is a drug-delivery system that dispenses a preset intravenous dose of a narcotic analgesic when the patient pushes a switch connected to the system. The device consists of a computerized pump with a chamber containing the drug. The patient administers a dose of narcotic when the need for pain relief arises.

Hydromorphone and is an opiate analgesic for the management of moderate to severe pain. According to Lexi-Comp, a national drug information provider for health care professionals, patients on hydromorphone should be monitored for respiratory, mental status, blood pressure and pain relief. Overdose of opiates may cause excessive sedation, respiratory depression.

A review of the hospital policy and procedure titled " Patient Controlled Analgesia " indicated that respiration rate should be reassessed for one full minute every 30 minutes for 2 times followed by every 2 hours during PCA therapy or more frequent per nursing judgment and record in patient ' s medical record. In addition, pain level and level of consciousness should be assessed and documented in the medical record every 2 hours during PCA therapy or more frequent per nursing judgment.

3. A review of the inventory list of Pyxis stations (automated dispensing cabinet) located in operating room 8 and 9 showed that a total of 20 vials of potassium chloride 40 mEq/20ml (milliequivalents per milliliter, concentration unit) were stocked in the automated dispensing cabinets of the 2 operating rooms.

During an interview at approximately 9:45 a.m. on 3/16/12, the hospital Director of Pharmacy (DOP) stated that concentrated potassium chloride were stocked in the automated dispensing cabinets (ADC) of 2 operating rooms usually reserved for cardiac (heart) procedures. The DOP also stated that the ADCs in operating rooms were non-profiled which allowed personnel with access to remove medications without a matching physician ' s order and to return medications to different compartments of the ADCs. The DOP stated that concentrated potassium chloride were stocked in a matrix drawer without individual lids which increased the risk of drug selection error and drug returning error and hence increased the risk of inadvertent administration of the drug. The director also stated that unlike other patient care areas, medication administration in operating rooms did not require barcode scanning verification and that the pharmacy did not employ a system to track and reconcile the usage concentrated potassium chloride with inventory level.

Concentrated potassium chloride for Injection is to be administered by intravenous infusion only after dilution in a larger volume of fluid. Concentrated potassium chloride has been identified as a high-risk medication by organizations worldwide. The inadvertent administration of concentrated potassium chloride may result in patient death. In the United States, ten patient deaths from misadministration of concentrated potassium chloride (KCl) solution were reported to the Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) in the first two years of its sentinel event reporting program from 1996 to 1997. JCAHO issued a Sentinel Event Alert in February 1998, suggesting hospital facilities not make concentrated potassium chloride available outside of the pharmacy unless appropriate specific safeguards are in place.

The institute for Safe Medical Practice is a nationally recognized organization that promotes the safe use of medications. It has documented instances where concentrated potassium chloride solutions have been accidentally infused as a flush into IV lines resulting in death. ISMP has also published many articles and alerts on the high risk of using potassium chloride since 1990s. ISMP recommended that the most effective way to avoid potassium chloride accidents is to remove concentrated potassium chloride from patient care areas. The October 2007 issue of ISMP mentioned that the availability of concentrated potassium chloride in specialty areas such as the cardiac bypass surgical suite for use during surgery posed risk of accidental IV administration of the undiluted drug.

Based on observation and interview, the hospital failed to ensure the secure storage of medication. A supply cart containing prescription medications in the emergency room was unlocked allowing access to medications by unauthorized personnel.

Findings:

During a tour of the emergency department at approximately 3:45 p.m. on 3/15/12, a mobile supply cart was observed in a side hallway. Upon inspection of the supply cart with RN 102, the supply cart was found to be unlocked and contained prescription medication and supplies as follow:

4 bottle of betadine (an antiseptic)
1 500-milliliters bottle of 0.9% sodium chloride (solution for irrigation or wound care)
1 500-milliliters bottle of sterile water for irrigation
10 packets of chlorhexadine gluconate 4% scrub (an antiseptic scrub)

RN 102 stated that supply carts containing drugs and biologicals should be locked and secure to prevent unauthorized access.

Based on observation, interview, and document review, the hospital failed to ensure that dietary services met the needs of all patients as evidenced by failure to:

1. Ensure the implementation of dietetic services in an effective and organized manner ( A 619, A620);

2. Develop performance improvement activities that accurately reflected the scope and nature of the services ( A267, A276);

3. Ensure safe and effective food storage/production practices (A 748, A749);

4. Develop comprehensive organizational structure to ensure the nutritional needs of patients were met ( A628, A629, A630, A631);

5. Ensure maintenance of equipment per manufacturers' instructions (A724).

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

Based on dietetic services observations, food service management interview and dietary document review the hospital failed to ensure that dietetic services were effectively organized as evidenced by 1) One of four patients reviewed at the behavioral health hospital (Patient 86) did not receive the patient selected diet and 2) lack of development of comprehensive standardized policies/procedures related to offsite meal service to the Mills campus. Failure to effectively organize patient care services may result in compromised medical and nutritional status.

Findings:

1. On 3/13/12 beginning at 10 am, trayline observations were conducted. In an interview with Food Service Manager (FSM) 2 she stated that patients in the behavioral health unit had the opportunity to self-select their menu options. If patients were unable to select menu options a non-select menu would be provided. It was also noted that during the trayline observation there were three patients (2 random observations and Patient 86) with physician ordered vegetarian diets. Two of the patients received a hot vegetarian entree.

On 3/13/12 at 11:50 am, the tray for Patient 86's, vegetarian meal tray consisted of rice, green beans, yogurt, crackers, cottage cheese and soy sauce. It was also noted that the tray ticket was a pre-printed tray ticket with Patient 86's name on it.

In an interview on 3/13/12 at 4 pm, Registered Dietitian (RD) 1 was asked to describe the process for Patient 86's limited meal selection. She stated that Patient 86 must have chosen those items. In a follow up interview on 3/14/12 beginning at 8:30 am, with RD 1 she stated that Patient 86 was able to select her own meal and that she selected a meal that consisted of sweet and sour tofu, asparagus/carrots, a fresh fruit cup and soy milk. She further stated that Patient 86 was a patient at the main campus prior to being transferred to the behavioral health unit. She also stated that the noon meal was developed from her food preferences while at the main general acute campus. She also stated she was unsure of why her food selections prior to transfer were sent rather than her self-selected menu. Patient 86 was admitted to the behavioral health unit on 3/6/12. RD 1 stated she was unsure of the number of days that the limited selections were being sent.

2. On 3/13/12 from 12:20-1:30 pm, food service observations were conducted at the Mills campus. It was noted that the meals were delivered to the stand by kitchen at 12:25 pm at which time Food Service Supervisor (FSS) 2 and 3 were observed transferring the trays to the heating unit. In a concurrent interview with FSS 2 he explained that the units were plugged in and would heat up for 20 minutes at which point trays would be delivered to the patients. On 3/13/12 at 1pm, FSS 3 was observed taking temperatures of the hot items on a tray. The following temperatures were noted: mashed potatoes-82?F; meat-72?F; carrots-74?F. After taking the temperatures of the tray Dietary Staff (DS) 2 removed the tray from the cart, placed it in the sink area and touched the heating units under two of the remaining trays. There were no additional temperatures taken of any of the meals on this cart. FSS 2 and 3 proceeded to deliver the trays to patients.

In an interview on 3/14/12 beginning at 8:30 am, with RD 1 and FSM 1 the observations were discussed. The surveyors asked if there was a documented system to monitor transportation, distribution and serving temperatures to the Mills campus to ensure food safety and palatability. They acknowledged that with the exception of an interruption of meal service plan there was no developed policy and/or standardized procedures related to patient meal service at the Mills campus.

Based on observation, staff interview and document review, the hospital failed to have the Food Services Director responsible for the daily management of the department who: 1) ensured food service staff were knowledgeable in food safety practices including cool down and handwashing procedures, and there was a system to ensure staff competencies; 2) Developed and monitored quality appraisal and performance improvement program for the complexity and scope of the Dietary Services. Failure to evaluate the comprehensive scope of operational processes may result in patient exposure to unsafe food handling practices and/or food production systems that may not meet the nutritional needs, result in foodborne illness and compromising patients medical status.

Findings:

1. On 3/12/12 starting at 10:00 a.m. the production kitchen was observed. Cook 1 was interviewed regarding the cool down of foods prepared for service the next day. He stated that the foods were put in the blast chiller and cooled to 90 or 98 degrees Fahrenheit (F) in 2 hours and in 4 hours to 35 to 38 degrees F. The Production Manager identified Cook 1 as being a per diem staff.

Review of the Department Orientation check list dated 4/8/11 showed the Cook 1 was oriented to the blast chiller. Review of the October 20, 2011 Food Service Department Meeting from 1:00 to 2:00 p.m. showed a topic discussed "chill prepared food to a temperature of 70 degrees F or less in 2 hours and 41 degrees F or less within an additional 4 hours" which would be consistent with the standard of practice (Food Code 2009). This was marked as a handout. RD1 confirmed that Cook 1 attended the October 20, staff meeting.

On 3/15/12 at approximately 3:00 p.m., RD 1 stated that the food service staff competencies were tested after the staff meeting in services information was discussed but there was no documentation of this practice.

When foods are held in the danger zone from 135 degrees F to 41 degrees F and not cooled within the time temperature parameters established in the FDA Food Code 2009 patients may be exposed to unsafe food and food borne illness (Cross Reference A749).

2. On 3/15/12 at 3:00 p.m. RD1 and Food Service Management 1 were asked about the Department's quality appraisal and performance approval program. Food Service Management 1 stated there was none for the food service areas. RD 1 stated she had monitored carbohydrate servings for the diabetic patients using room service during the month of august 2011.

Review of the Food Service Director job description and the Chief Clinical Dietitian job description showed no job duties that included developing or monitoring department quality performance programs (Cross Reference A267).

3. On 3/13/12 from 12:20 to 1:30 pm, meal preparation observations were conducted at the behavioral health hospital. During these activities it was noted there was lack of handwashing (Cross Reference A749).

Based on observation, staff interview, and document review the hospital failed to ensure the menu was served to ensure they meet the needs of the patients. Failure to serve menus as approved resulted in in patients physician ordered diets not being followed which in turn may compromise medical status.

Findings:

On 3/13/12 starting at 10:00 a.m. the tray service for the Mills campus was observed. The menu and printed patient tray tags were observed for Day 3 lunch. Patient menus for the meal specified serving sizes for the regular diet for 4 ounces starch, 4 ounces vegetable and 3 ounces for meat serving. The patient tray ticket for the dysphagia (a mechanically altered diet for patients with swallowing disorders) small portion stated ? scoop vegetable, ? scoop rice, and ? scoop meat. The cook served the regular portion with 4 and 3 ounce measured scoops and then estimated the ? serving size for the small portion using the 4 ounce or 3 ounce measured scoop.

RD 1 acknowledged on 3/13/12 at 11:30 a.m. that the patient tray tickets should have specified 2 and 1 ? ounce servings and the cook should have used the correct measured serving scoops to ensure the accurate portions.

Based on staff interview and document review the hospital failed to ensure therapeutic diets were prescribed by the practitioners responsible for the care of 2 of 10 patients reviewed for nutrition care (Patients 83 and 90). This had the potential of compromising patient medical care.

Findings:

1. On 3/14/12 at 10:00 a.m. the medical record of Patient 83 was reviewed. The diet order dated 3/9/12, was puree diet. The nutrition communication order #206352275 dated 3/9/12 with a heading " verbal order info. " The entry was " please add magic cup to lunch and Ensure Pudding to dinner meal. " The verbal order stated " protocol order " was entered by the RD and " signature not required. "

RD 1 stated on 3/14/12 at 10:00 a.m., that the RD (Registered Dietitian) could order supplements to the patient diets and the RN then acknowledged the order.

Review of the policy titled " Diet Orders (IV-10) " dated 1/12 stated " Therapeutic diets must be prescribed by the practitioner or practitioners responsible for the care of the patient. " The procedure states the physician prescribes the diet and enters into EPIC (electronic medical record system).

Review of the Diet Reference Manual 1211 document (not dated) showed a column for Food Allowed including foods of pudding consistence for the pureed diet.

RD 1 stated on 3/14/12 at 10:30 a.m., this diet reference manual section for foods allowed gave the RD the prescribing authority to order the supplements. RD 1 stated that she had approval from the Pharmacy and Therapeutics Committee, dated October 19/ 2012 for formulary change for Ensure Clinical Strength. She also provided a Medical Staff approval, dated 5/10/10, for the use of the online " Diets offered at MPHS. ' She stated this was the protocol (Diet reference Manual 1211) for the clinical dietitian to order supplement (s) to the patient ' s diets through the medical record ordering system.

On 3/15 12 at 1:00 p.m., the Staff M, a medical staff representative, stated that the physicians were not concerned with the RD doing supplement orders. He could not verify that a protocol was in place and approved through the medical staff committee that established the protocol for RD ordering of supplements.

The practitioner responsible for the care of the patient and the ordering of diets is the patient physician.

Medical Nutrition Therapy protocols are a plan or set of steps, which are based on systematically analyzed evidence and clearly define the level, content, and frequency of nutrition care that is appropriate for a disease or condition in settings in which they are implemented. The protocols are predefined written procedural methods patient and diagnosis specific and approved through the hospital medical staff. (The Academy of Nutrition and Dietetics.)

There was no documentation provided to establish medical staff approval of protocol for non-physician ordering patient nourishments or supplements.

2. Patient 90 was admitted with symptoms including alteration in consciousness and blood in the urine. Medical record review was conducted on 3/14/12 between the hours of 10:30 am and 3 pm. Admission height was 5 feet 8 inches and admission weight was 184 pounds. Diet order dated 3/8/12 was a no added salt, advanced pureed diet with honey thickened liquids. A comprehensive nutrition assessment dated 3/9/12 completed by RD 3 noted that the patient was at high nutrition risk secondary to clinical status and poor dietary intake. The assessment also noted the intervention "will send nutrition supplements with meals." There was no documentation that a physicians' order was obtained prior to initiation of the supplement.

In an interview on 3/14/12 beginning at 11 am, with RD 3 the surveyor asked him to explain the system for ordering nutritional supplements. He stated that the hospital had a "protocol order" policy that allowed RD's to order supplements based on a nutrition assessment. He described that the electronic medical allowed him to access the "order entry" portion of the record. He would then enter the supplement order in the "nutrition communication note." This order was then transmitted to the diet office, entered into the menu system then printing out on the tray ticket.

The nutrition communication order #20622985 was dated 3/9/12 with a heading " verbal order info. " The entry was " ensure with breakfast, magic cup lunch and dinner " The verbal order stated " protocol order, " was entered as a "routine order" by the RD, " signature not required. "

Review of the policy titled " Diet Orders (IV-10) " dated 1/12 stated " Therapeutic diets must be prescribed by the practitioner or practitioners responsible for the care of the patient. " The procedure stated the physician prescribed the diet and enters into EPIC (electronic medical record system). The practitioner responsible for the care of the patient and the ordering of diets is the patients' physician.

Review of the undated hospital document titled "Mills-Peninsula Menu/Diet Reference Manual" showed a column for foods allowed; however it did not indicate the ability for RD's to independently order nutritional supplements.

In an interview on 3/15/12 beginning at 8:30 a.m., RD 1 stated that this diet reference manual section for foods allowed gave the RD the prescribing authority to order the supplements. RD 1 stated that she had approval from the Pharmacy and Therapeutics Committee, dated October 19/ 2012 for formulary change for Ensure Clinical Strength. She also provided a Medical Staff approval, dated 5/10/10, for the use of the online " Diets offered at MPHS." She stated this was the protocol (Diet reference Manual 1211) for the clinical dietitian to order supplement (s) to the patient ' s diets through the medical record ordering system.

On 3/15 12 at 1:00 p.m., the Staff M, a representative of the medical staff, stated that the physicians were not concerned with the RD doing supplement orders. He could not verify that a protocol was in place and approved through the medical staff committee that established the protocol for RD ordering of supplements.

In an interview on 3/15/12 beginning at 1:15 pm, with Information Management Staff (IS 1) she demonstrated that all disciplines, including RD's had access to the order entry system. She also stated that if an order was entered in the "communication" section of the electronic health record there was no mechanism within the electronic record that would obtain an electronic signature prior to implementation of the order.

Medical Nutrition Therapy protocols are a plan or set of steps, which are based on systematically analyzed evidence and clearly define the level, content, and frequency of nutrition care that is appropriate for a disease or condition in settings in which they are implemented. The protocols are predefined written procedural methods patient and diagnosis specific and approved through the hospital medical staff. (The Academy of Nutrition and Dietetics).

There was no documentation provided to establish medical staff approval of a protocol for non-physician staff ordering patient nourishments or supplements.

Based on staff interviews and review of hospital documents the hospital failed to ensure standard menus were analyzed for the nutritional components to meet the current national standards including the RDA (Recommended Dietary Allowances) and the DRI (Dietary Reference Intake) of the Food and Nutrition Board of the National Research Council. This has the potential for the patients in the hospital to not receive adequate nutrition and to meet the estimated recommended dietary allowances for all nutrients.

Findings:

On 3/14/12 at 3:00 p.m., the hospital's nutrient analysis for the regular and therapeutic diet menus were reviewed that included adult and pediatric population. The analysis provided showed the no analysis for calcium or zinc and daily nutrients provided for fiber or micro nutrients (essential dietary elements that are needed only in very small quantities that include copper, zinc, selenium, iodine, magnesium, iron, cobalt, and chromium) and are specified in the RDA or DRI.

Review of the Dietary Reference Intakes (DRIs): Recommended Dietary Allowances and Adequate Intakes for Elements indicated for Calcium that males and females between nine through 18 years of age to receive 1,300 mg; females between the age of 51 through 70 to receive 1,200 mg; and females and males greater than 70 years of age is 1,200 mg. The DRIs for Calcium are dated 1997. The hospital menus were not evaluated for calcium so there was no way to ensure the menus served the patient population met the RDAs or RDIs. It indicated for Zinc that males between 14 through greater than 70 years of age are to receive 11 mg. The DRIs for Zinc are dated 2001. The hospital menu was not evaluated for zinc and there was no way to ensure the menus met the RDA and DRI requirements. Zinc is an essential nutrient in healing and metabolic functions.

Review of the DRI for Macronutrients, dated 2002/2005, indicated total fiber for males nine through 13 years of age is 31 g; 14 through 50 years of age is 38 g; and 50 years through greater than 70 years of age is 30 g; females nine through 18 years of age is 26 g; 19 through 50 years of age is 25 g; 50 through greater than 70 years of age is 21 g.

RD1 provided an analysis for fiber for the21 day select diabetic diet that contained 20.6 grams to 21.7 grams average, and regular 21 day diet provided 23.3 to 24.4 grams average. RD1 stated that she had just done these calculations the day before when asked for the menu analysis.

The hospital menus were inadequate in Fiber depending on the age and gender.

On 3/14/12 at 3:00 p.m., RD 1 was interviewed regarding the nutrition analysis of the regular and therapeutic menus. RD 1 states that she had evaluated the menus for calories, protein, fat, cholesterol, sodium, and potassium. The only diet evaluated for fiber was the high fiber diet and it provided a 21 day average of 33 grams. She stated the adult and pediatric menus were not compared to the RDA or DRI standards for age and gender.

Review of the policy titled Nutritional considerations in menu planning revised 10/11 stated "The provisions of the Dietary Reference Intakes, which include the Recommended Dietary Allowances (RDA ' s) Adequate intake, and Acceptable Macronutrient distribution Range, developed by the Food and Nutrition Board under the aegis of the Institute of Medicine are used to evaluate nutritional adequacy of patient/resident menus."

The menus used were not evaluated to ensure they met the required nutrients or deficiencies in nutrients were noted in the diet manual.

Based on trayline observations, dietary staff interview and dietary document review the hospital failed to have a therapeutic diet manual that accurately reflected physician ordered diets and current standards of practice. Lack of a current and comprehensive diet manual that reflected hospital developed diets may result in inaccurate guidance to dietary and hospital staff when meeting the nutritional needs of patients, further compromising medical status.

Findings:

During trayline observation on 3/12/12 beginning at 11:15 am, it was noted that 3 random patients (Patients 93, 94 and 95) had tray tickets with physician ordered 1800 calorie consistent carbohydrate diets. Calorie controlled diets, such as an 1800 calorie diet, limits the amount of calories consumed within a 24 hour period. In contrast, a consistent carbohydrate diet(CCHO), indicated as part of the treatment for diabetes diagnosis, generally would not limit the number of calories consumed rather limits the amount of carbohydrate per meal. In addition the number of carbohydrates would be consistent between breakfast, lunch and dinner each day (American Diabetes Association).

In an interview on 3/14/12 beginning at 8:30 am, with RD 1 she stated that the hospital utilized the American Dietetic Association Nutrition Care Manual as well as the hospital developed "Diet Manual Reference." The surveyor asked RD 1 to describe the mechanism for combining diets with two distinct, unrelated parameters such as carbohydrates and calories. She stated that they grouped together several calorie levels of diets to the carbohydrate consistent diet. She also stated that since the implementation of the electronic medical the only way physicians' could order a diet for diabetes treatment was to combine the two opposing parameters of counting carbohydrate and calories.

In a follow up review on 3/15/12 beginning at 9:30 a.m., RD 1 was asked to demonstrate a non-select meal pattern for a patient who had a 2,000 calorie carbohydrate controlled diet. Based on the non-select menu for this diet the caloric content for the selected day was 2200 calories/day. RD 1 also acknowledged that the calorie content of 1800 and 1600 calorie, carbohydrate controlled diets would be similar and would likely be greater than the physician specified calorie limits.

Comparison of the nutrition care manual on 3/15/12 at 12:30 pm, with the hospitals' undated "Diet Reference Manual" for the CCHO revealed that the Nutrition Care Manual was a conceptual description of diets. Review of the hospitals Diet Reference Manual revealed that multiple calorie levels were combined under the auspice of carbohydrate controlled diets.

In an interview on 3/15/12 beginning at 1 pm, with Information Management Staff (IS 1) she demonstrated and confirmed that when physicians' ordered diets in the EPIC system their only choice was to order either calorie levels alone and/or a calorie level in combination with a consistent carbohydrate diet. There was no option for physicians to order only a consistent carbohydrate diet, the current standard of practice (American Diabetes Association, 2012).

Similarly, comparison of the nutrition care manual on 3/15/12 at 12:30 pm, with the hospitals' Diet Reference Manual noted that the reference manual described a cardiac diet as a diet that had the following restrictions: fat-60 grams; sodium-2400 milligrams; and saturated fat less that 7% of calories. There was no cardiac diet in the Nutrition Care Manual; rather there was a sample meal plan for heart failure which recommended 2,000 milligrams/day of sodium and a fat restriction of 50 grams/day.

Similarly, the hospital had multiple levels for a gastric bypass diet. While the reference manual described the diet as "very low and/or low calorie" there were no calorie parameters. Similarly there was no defined meal pattern for the diet; rather noted food selections that may be offered on any one of the four levels of diets. A diet manual would ensure that the diets offered met the current standards of practice, included a comprehensive description of the therapeutic diets offered by including the purpose of the diet, indications of the diet, nutritional adequacy, sample meal plans consistent with the hospitals' menu and standard of practice references for the diets. While the hospitals' system for using the Nutrition Care Manual in conjunction with the hospital developed "Diet Reference Manual" had some of the elements, not all elements were present for each routinely ordered hospital diet.

Based on observation of food storage equipment, dietary staff interview and dietary document review the hospital failed to ensure timely repair of the blast chiller. Failure to repair equipment in a timely manner may result in lack of effective monitoring of food temperatures putting patients at risk for foodborne illness.

Findings:

During food production observations and concurrent interview on 3/12/12 beginning at 11:45 am, with FSS 4 he was describing the use of the blast chiller. He stated that the probes used to measure food temperatures were not working properly and was unsure of how long the equipment was broken. He further stated that a yellow-orange light on the panel indicated the probes were not functioning.

In an interview on 3/12/12 from 12-12:15 pm, FSM 1 was asked to describe the system for equipment maintenance. He demonstrated an electronic system that allowed communication between the department and engineering to initiate work orders; however he was unable to locate a work order for the temperature probes.

In a follow up interview on 3/12/12 at 1:30 with FSM 1 and FSM 2 he stated that he located a work order dated 2/29/12 indicating that the temperature probes were repaired and functional. A concurrent observation revealed that the light indicating malfunction of the probes continued to be illuminated. FSM 2 stated that the blast chiller representative was scheduled to be in the facility on 3/15/12 and would request that the repair be addressed at that time. While the facility was able to demonstrate repair of the probes on 2/29/12 they were unable to demonstrate that the repair was sustainable or that staff advised food service management staff that the probes were not functioning properly.

Based on observations, staff interviews, and document review, the hospital failed to monitor/maintain the relative humidity, temperature, and/or air exchanges in the perioperative areas such as operating rooms, sterile storage, sterile processing area, decontamination room, and endoscopy (the procedure 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) suite within acceptable standards in accordance with nationally recognized infection control guidelines when:

1. There were no humidity, temperature and air exchange monitoring/control in the central sterile processing department included the sterile processing area, decontamination room, and the sterile storage area;

2. The recorded humidity levels for the Operating Room (OR) 1, OR 2, OR 3, OR 4, OR 5, OR 6, OR 7, and OR 8 in Campus 2 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 recorded humidity levels for the OR 1, OR 2, OR 3, OR 6, OR 7, OR 9, OR 10, Endoscopy Procedure Room (Endo Room) 1, Endo Room 2, and Endo Room 3, and the LDRP (Labor and Delivery) OR 1, LDRP OR 2 in Campus 1 were out of normal range on multiple occasions with no documented evidence of correction for variances; and

3. The recorded temperatures for the OR 1, OR 2, OR 3, OR 4, OR 5, OR 6, OR 7, and OR 8 in Campus 2 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.

These failures had the potential for putting the patient(s) at risk due to posing a fire hazard in an oxygen-enriched environment; or conducing bacterial growth which would compromise the integrity of wrapped sterile items and cause infection; or the interrupted airflow patterns within the perioperative settings would cause environmental contamination.


Findings:

1. During the observations in the central sterile processing department of Campus 1 and Campus 2 on 3/13/12 at 11:45 a.m. and 3/14/12 at 11 a.m. respectively, there was no device for monitoring temperature and humidity observed.

During an interview with the Director of perioperative suite (Staff H) on 3/14/12 at 11:05 a.m., Staff H confirmed there was no device for monitoring temperature and humidity in the central sterile processing department and it was the engineering's responsibility to monitor the humidity, temperature, and air exchanges in the decontamination room, sterile processing area, and the sterile storage area.

During an interview with the Central Sterile Processing Manager (Staff O) on 3/14/12 at 11:30 a.m., Staff O stated the hospital used the AORN (Association of periOperative Registered Nurses) and the AAMI (Association for the Advancement of Medical Instrumentation) guidelines as references for the operating room (OR) and the sterile processing infection control practice.

A review of the humidity and temperature log provided by the hospital and a concurrent interview with the Director of Engineering (Staff R) was conducted on 3/14/12 at 3 p.m. The humidity log documented the humidity levels of various ORs, cardiac catheterization rooms (the room for procedures in which a very small hollow tube [catheter] is advanced from a blood vessel in the groin or arm through the aorta into the heart for diagnostic purpose), endoscopy procedure rooms (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) in Campus 1; the humidity levels of the central processing department was not documented. Staff R stated the engineering staff were responsible to monitor the humidity, temperature, and air exchanges in the operating rooms, endoscopy procedure rooms, and cardiac catheterization laboratory. Staff R also stated monitoring the temperature, humidity, and air exchanges of the central processing department, which included the sterile processing room, the decontamination room, and the sterile storage area, was not in the system.

A review of a document regarding the alarm limit of the decontamination room temperature provided by the hospital and a concurrent interview with the engineer (Contractor 1) was conducted on 3/16/12 at 11:30 a.m. The aforesaid document revealed the high alarm limit and the low alarm limit of the decontamination room temperature were 75 degrees Fahrenheit (F) and 70 degrees F respectively. The document indicated the zone temperature was 70.4 degrees F. Contractor 1 stated the hospital had an alarm system set up for monitoring the temperature of the decontamination room with the parameters between 70 degrees F and 75 degrees F. Contractor 1 further stated the alarm would go off if the temperature was not within the range of 70 to 75 degrees F. When asked what standard for the temperature parameters that the hospital followed, Contractor 1 stated the hospital followed the 2010 California Mechanical Code.

During an interview with Staff R on 3/16/12 at 11:35 a.m., Staff R confirmed that no document was available to show the monitoring of the humidity, temperature levels, and the air exchanges in the central processing department including the sterile processing area, the decontamination room, and the sterile storage area in Campus 1.

During an interview with the Director of Regulatory Compliance (Staff A) on 3/16/12 at 11:45 a.m., Staff A stated the engineering department was not able to provide document showing the temperature, humidity, and air exchanges monitoring of the central processing department in Campus 2.

On 3/16/12 at 11:50 a.m., the 2012 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. The section titled "Recommendation Practices for a Safe Environment of Care" indicated "Recommendation V.b. 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. Recommendation V.b.2. Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC (humidity, ventilation and air conditioning) system. Recommendation V.c. Temperature should be monitored and recorded daily...Recommendation V.c.1. Temperature should be maintained between 68 degrees F to 73 degrees F within the operating room suite and general work areas in sterile processing. Recommendation V.c.2. The decontamination area temperature should be maintained between 60 degrees F to 65 degrees F. Recommendation V.d. The air-exchange rate in the perioperative area should be carefully controlled. Recommendation V.d.1. The minimum rate of total air exchanges per hour should be maintained at a constant level...Recommendation V.e. Air-flow patterns within the perioperative setting should be controlled and uninterrupted."

On 3/16/12 at 11:55 a.m., the document titled "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, 2009" published by the AAMI, was reviewed. On page 23, under 3.3.6.4 Ventilation, direction was given that, "The soiled and decontamination area should be designed so that air flows into the area (negative pressure), with a minimum of 10 air exchanges per hour..." On page 25, under 3.3.6.5 Temperature, direction was given that, "...The decontamination area should have a temperature controlled between...60 degrees F and 65 degrees F...Independent monitors should be located in each of the areas where temperature should be controlled; temperature should be recorded daily...cool temperatures in the decontamination area may help minimized bioburden..." Under 3.3.6.6 Relative humidity, direction was given that, "Relative humidity should be controlled between 30% and 60% in all work areas except the sterile storage area, where the relative humidity should not exceed 70%. An independent humidity monitor should be located in each area that requires controlled relative humidity. Relative humidity should be recorded daily."

2. On 3/14/12 at 9:20 a.m., the document titled "Daily Room Checklist" dated from 1/2011 to 11/2011 and 3/2012 regarding the humidity levels of various ORs (OR 1 through OR 8) in Campus 2 was reviewed. The aforesaid document indicated the humidity range was 30% to 60% and "If out of range, adjust controls and/or contact Charge Nurse to notify Engineering Department if does not correct in one hour." The recorded humidity levels for the OR 1, OR 2, OR 3, OR 4, OR 5, OR 6, OR7, and OR 8 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 number of days that the humidity levels fell out of normal range was listed as follows:

a. March 2011 - 1 day in OR 6; 3 days in OR 8;
b. June 2011 - 5 days in OR 8;
c. July 2011 - 9 days in OR 8;
d. August 2011 - 1 day in OR 1; 15 days in OR 8;
e. September 2011 - 12 days in OR 8;
f. October 2011 - 3 days in OR 5; 14 days in OR 8.

On 3/15/12 at 4 p.m., the printout of the relative humidity levels for various ORs, Endoscopy Procedure Rooms at Campus 1 for the period 12/1/11 to 1/31/12 between 5 a.m. to 6 a.m. was reviewed. The recorded humidity levels for the aforesaid locations were out of normal range (30% to 60%) on multiple occasions which lasted for 30 to 57 minutes with no documented evidence of notification or correction for variances. The lowest recorded humidity level was 15% for 46 minutes.

On 3/16/12 at 11:30 a.m., a review of the document titled "2010 California Mechanical Code" dated 11/18/2011 with Staff R and a concurrent interview was performed. The aforesaid document indicated the relative humidity for the operating room and delivery room was between 30% and 60%. Staff R confirmed the hospital used the 2010 California Mechanical Code requirement as the relative humidity standard.

On 3/16/12 at 11:45 a.m., the hospital's policy and procedure titled "Maintaining Proper Room, Refrigerator and Freezer Temperatures" dated 9/11 indicated "Procedural Rooms: Temperature and Humidity...Humidity ranges are the same for all procedural areas and should be maintained between 30 - 60%...References...Association of Operating Room Nurses (AORN)..."

On 3/16/12 at 11:50 a.m., the 2012 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. The section titled "Recommended Practices for a Safe Environment of Care" indicated Recommendation 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. Recommendation V.b.2. Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC (humidity, ventilation and air conditioning) system."

3. On 3/14/12 at 9:20 a.m., the document titled "Daily Room Checklist" dated from 1/2011 to 11/2011 regarding the temperature levels of various ORs (OR 1 through OR 8) in Campus 2 was reviewed. The aforesaid document indicated the temperature range was 68 degrees F to 73 degrees F and "If out of range, adjust controls and/or contact Charge Nurse to notify Engineering Department if does not correct in one hour." The recorded temperature levels for the OR 1, OR 2, OR 3, OR 4, OR 5, OR 6, OR 7, and OR 8 were out of normal range on multiple occasions with no documented evidence of notification or correction for variances on some days in accordance with the hospital's protocol. During the period from Janauary through November in 2011 (334 calendar days), the number of days that the temperature levels fell out of normal range in various ORs was listed as follows:

a. OR 1 - 96 out of 334 days
b. OR 2 - 130 out of 334 days
c. OR 3 - 107 out of 334 days
d. OR 4 - 116 out of 334 days
e. OR 5 - 150 out of 334 days
f. OR 6 - 162 out of 334 days
g. OR 7 - 215 out of 334 days
h. OR 8 - 188 out of 334 days

During an interview with Staff R on 3/14/12 at 3 p.m., Staff R confirmed the temperature had not been adjusted if there was no documentation of the adjustment on the log when the temperature was out of normal range. Staff R stated that the staff did not recheck the temperature after adjusting the temperature and the staff should have rechecked the adjusted temperature. The temperature monitoring log of Campus 1 was not provided upon request.

On 3/16/12 at 11:45 a.m., the hospital's policy and procedure titled "Maintaining Proper Room, Refrigerator and Freezer Temperatures" dated 9/11 indicated "The Engineering Department shall have overall responsibility for the hospital-wide wireless electronic temperature monitoring system and shall respond to notification that a temperature is out of acceptable range after the responsible department, Operating Room...has responded to the initial alert...Documentation...Temperature monitoring documentation shall be stored electronically in the hospital-wide electronic temperature monitoring system and maintained in readily retrievable form for 3 years. Manuals logs, if required during sensor malfunction, will be maintained for 3 years...References...Association of Operating Room Nurses (AORN)..."


On 3/16/12 at 11:50 a.m., the 2012 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. The section titled "Recommended Practices for a Safe Environment of Care" indicated "Recommendation V.c. Temperature should be monitored and recorded daily...Recommendation V.c.1. Temperature should be maintained between 68 degrees F to 73 degrees F within the operating room suite and general work areas in sterile processing. Recommendation V.c.2. The decontamination area temperature should be maintained between 60 degrees F to 65 degrees F."

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. The hospital failed to have an effective system to ensure personnel wore appropriate attire in the operating suite, the endoscopy suite (the place 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), and the cardiac catheterization laboratory (the place for procedures in which a very small hollow tube [catheter] is advanced from a blood vessel in the groin or arm through the aorta into the heart for diagnostic purpose) ( A 0749);

2. The hospital failed to have an effective system to ensure environmental cleaning was performed in accordance with nationally accepted standards and the manufacturer's specifications (A 0749);

3. The hospital failed to have an effective system to ensure endoscopes were stored in accordance with nationally accepted standards ( A 0749);

4. The hospital failed to ensure staff cleaned and disinfected the equipment effectively between patient use (A 0749);

5. 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 (A 0749);

6. The hospital failed to ensure staff used the single-use items in accordance with manufacturer's specifications (A 0749);

7. The hospital failed to ensure staff wore appropriate 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) upon entering the isolation room (A 0749);

8. The hospital failed to ensure staff performed hand hygiene in accordance with the hospital's policy and procedure ( A 0749);

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 on units (A 0749);

10. The hospital failed to have an effective system to ensure personnel were consistently screened for infectious diseases in accordance with nationally accepted standards ( A 749); and

11. The hospital failed to have an effective system to monitor and maintain the relative humidity, the temperature, and air exchanges in the perioperative areas in accordance with nationally recognized infection control guidelines (perioperative areas include operating rooms, endoscopy rooms [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) (A 0726).

12. Failed to develop a system for identifying potential food borne illness in the Dietary Dept. (A748)

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 observation, staff interview, and document review, the hospital failed to ensure the infection control officer developed a system for identifying potential for food borne illness in the Dietary Department when: 1) Hospital failed to ensure that approximately 33 ice machines were cleaned and sanitized in accordance with the manufacturer's directions. 2) Food Service staff did not demonstrate correct handwashing technique. These failures placed patient at risk of food borne illness.

Findings:

1. On 3/12/12 at 10:30 a.m., the ice machine bin was observed in the kitchen. The Food Service Management 3 stated that the bin was cleaned by the food service staff and the engineering department was responsible for the ice making parts.

On 3/12/12 at 1:30 p.m., Engineer 2 stated he was responsible for the maintenance of the hospital ice machines. He stated there were approximately 23 ice machines at the hospital and 10 ice machines at the Mill campus. He stated he used a chlorine bleach solution for the bin part of the ice machine. He stated that he used a chemical ice machine cleaner solution for the internal ice making part of the machine and this was the only chemical he used. He stated this was how he had been trained by an ice machine manufacturer.

O 3/12/12 at 1:30 p.m., the ice cleaner solution package label was reviewed. The product was labeled " Ice Machine Cleaner " and stated " SafeClean is intended to remove scale only. Ice machines must be sanitized following cleaning. Refer to instructions in service manual for sanitizing agent and procedures. "

Review of the manufacturer 's icemaker cleaning and sanitizing directions on 3/15/12 at 4:00 p.m., stated recommended semi-annual cleaning of ice making system was to use the Safe clean ice machine cleaner in one gallon of water. The directions continued to prepare one gallon of 200 ppm (part per million concentration) 5.25 percent Sodium Hypochlorite solution and run the ice maker for 20 minutes with the sanitizing solution. Drain the sanitizing solution and rinse the reservoir with clean 120 degree Fahrenheit water repeating three times.

Review of the policy titled "Cleaning of the Environment, Equipment and Common Areas," stated " Manufacturer recommendations should always be followed." The section on Ice Machines stated "Engineering: Preventive maintenance."

2. On 3/13/12 starting at 12:30 p.m., the food delivery to the Mills campus receiving pantry was observed. Food Service Staff drivers 1 and 2 delivered food prepared at the at Peninsula production kitchen. Food Service Staff 1 and 2 entered the kitchen and proceeded to transferred food trays to the heating carts. Neither food service staff washed their hands on entrance to the pantry area. Food Service Staff 2 did put on plastic disposable gloves.

Food Service Staff 1 was observed 3/13/12 at 12:45 p.m., placing his hands under running water at the handwashing sink. There was no application of soap or washing with soap before the running water. He was asked if this was his practice for washing his hands. He stated this was handwashing.

On 3/13/12 at 12:50 p.m., Food Service Staff 2 was observed washing his gloved hands.

Interview with the RD 1 on 3/13/12 at 12:50 p.m., acknowledged the food service staff were to wash their hands when entering the pantry before transferring the patient trays and Food Service Staff 1 or 2 did not follow proper handwashing procedures. She stated the food service staff were supervised by Food Service Management 4 from the Peninsula campus but did not know when this supervisor came to observe the Mills campus food service.

Review of the policy titled XIII-4 Personal Hygiene and Dress Code, revision dated 5/11, stated " good personal hygiene is the key to the prevention of food borne illness ... " The handwashing frequency stated " food handlers must wash their hands before they start work ... " The procedures stated to wet hands and arms and apply soap, scrub hands and arms vigorously for 20 seconds, clean under fingernails and between fingers and, rinse hands and arm thoroughly with running water.

The Infection Control Staff 1 was interviewed 3/15/12 at 1:00 p.m. She stated that she participated in quarterly sanitation rounds in the production kitchen and used the same form titled Food Service Sanitation Audit Rounds the Food Service Department used. She confirmed that infection control staff was involved with the hand washing training in the food service department. She confirmed that the ice machines were cleaned by housekeeping and engineering but did not know the specific cleaning or sanitizing practice. She did not know if the engineering department was following the manufacturer ' s directions to clean and sanitize all parts of the ice machines.

During the interview the Infection Control Staff 1 stated that she was not aware of the food service practice of using the knives and the utensils that were held in 130 F to 140 F degree water during service. She stated that she was not familiar with the practice to ensure the knives and utensils that were used for raw and cooked foods met the sanitation standard.

In addition, she stated that the infection control inspections and oversight did not include review of the safe food practices as specified in the FDA Food Code and HACCP (Hazard Analysis Critical Control Point Program).

Based on observations, staff interviews, and 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, communicable diseases, and food-borne illnesses were not fulfilled as evidenced by:

1. The hospital failed to have an effective system to ensure personnel wore appropriate attire in the perioperative areas (operating rooms, endoscopy rooms [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), and the cardiac catheterization laboratory (the place for procedures in which a very small hollow tube [catheter] is advanced from a blood vessel in the groin or arm through the aorta into the heart for diagnostic purpose) when:

a. Three of three staff members (Orderly 1, Orderly 2, an un-named staff) wore cloth head covers, which were laundered from home, in the surgical suite;

b. Five of five staff members (Orderly 2, Staff P, Staff O, EVS B, and Cath Lab Technician 1) did not cover the facial hair in the semirestricted and restricted area;

c. One staff member (RN 8) did not completely cover the hair in the semirestricted and restricted area;

d. Three staff members (RN 8, RN 14, and RN 16) wore masks hanging down from the neck in the semirestricted and restricted area;

e. Six staff members (Central Processing Technician 2, Endoscopy Technician 1, RN 8, EVS B, EVS C, and Anesthesiologist 1) did not completely cover the personal clothing in the semirestricted and the restricted areas;

f. The staff were not required to wear hair cover and shoe cover or dedicated shoes in the endoscopy suite where surgical procedures were performed;

2. The hospital failed to have a system to ensure staff performed effective environmental cleaning in accordance with nationally accepted standards and the manufacturer's specifications when:

a. The staff member (Orderly 2) mopped the fluid (bodily fluid or irrigation fluid) on floor in the operating room and used the same mop head, which was saturated with the fluid, to mop other areas in the operating room;

b. The hospital did not ensure the unused operating room for cesarean section (a surgical procedure in which the abdomen and uterus are incised and a baby is delivered transabdominally) be cleaned daily during the regularly scheduled work week;

c. The hospital did not ensure the keyboard in the isolation room was cleaned and disinfected with an appropriate disinfectant;

3. The hospital failed to have an effective system to ensure endoscopes were stored in accordance with nationally accepted standards when the processed endoscopes were stored in the opened cabinets with visible dust and hair observed; the endoscopes were touching the side of the cabinet and other items stored at the bottom of the cabinet.

4. The hospital failed to have a system to ensure staff cleaned and disinfected the equipment effectively between patient use in accordance with nationally recognized infection control guidelines when:

a. Three staff members (RN 6, RN 7, and RN 11) were not familiar with the cleaning and disinfecting process on the glucometer (the equipment for checking blood glucose) in accordance with the manufacturer's specifications and the hospital's policy and procedure;

b. One staff member (Radiology Technician 1) did not clean and disinfect the portable radiology machine after use;

5. The hospital did not have an effective system 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 when:

a. The staff did not operate the washer/disinfector in accordance with the manufacturer's specifications such as checking the adequacy of detergents prior to operating the machine;

b. The staff did not ensure the surgical instruments were effectively sterilized when: 8 of 28 pairs of scissors and clamps of various types were observed in the sterile pouches (self-sealable pouches that contain surgical instruments during the sterilization process) with blades closed;

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

d. The hospital did not ensure the BIOM (the lens of the microscope - a component of the wide angle observation system) was sterilized in accordance with the manufacturer's specification;

e. The staff members did not disinfect or sterilize the reusable brushes after using on each set of contaminated instruments;

f. The hospital did not have an effective system to prevent contamination of the processed LMAs (Laryngeal Mask Airway - a tube with an inflatable cuff that is inserted into the pharynx, which is used in anesthesia and sometimes in emergency medicine for airway management) when the staff member (OR Technician 3) was observed handling the processed LMAs with un-gloved (bare) hands and the LMAs were stored in the unsealed peel pouches (self-sealable pouches that contain surgical instruments during the sterilization process) for future use;

6. The hospital failed to ensure staff used the single-use items in accordance with manufacturer's specifications and nationally recognized infection control guidelines when 1 of 2 staff members (Central Processing Technician 4) used the single use syringe for flushing multiple sets of contaminated instruments;

7. The hospital failed to ensure staff wore appropriate 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) upon entering the isolation room;

8. The hospital failed to ensure staff performed hand hygiene in accordance with nationally recognized infection control guidelines and the hospital's policy and procedure when:

a. Three staff members (OR Technician 2, Orderly 2, and an unnamed staff) did not perform hand hygiene between gloves change;

b. Two Food Service staff members (Food Service Staff 1 and 2) did not demonstrate correct handwashing technique;

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 on units when 4 of 4 selected patients' file reviewed (Patient 130, Patient 131, Patient 132, and Patient 133) did not show documentation of daily assessment of central line;

10. The hospital failed to ensure clean linen storage rooms were not used for storage of other items in accordance with the State regulations and the hospital's policies and procedures; and

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

a. Six (6) of 6 Physicians' records (Physician 103, Physician 104, Physician 105, Physician 106, Physician 107, Physician 108) reviewed did not show the documentation of baseline TB (Tuberculosis) screening at time of first appointment and/or annual TB screening;

b. Six (6) of 6 Physicians' records reviewed (Physician 103, Physician 104, Physician 105, Physician 106, Physician 107, Physician 108) did not show the documentation of vaccinated against (or have documented immunity to) hepatitis B, mumps, rubella, and varicella;

c. Two (2) of 6 Physicians' records reviewed (Physician 106, Physician 107) did not show the documentation of vaccinated against (or have documented immunity to) measles;

13. Failure to ensure that approximately 33 ice machines were cleaned and sanitized in accordance with the manufacturer's directions.

These failures had the potential for obstructing the infection control and prevention process, which put the patient(s) and hospital personnel at risk for possible exposure to blood-borne pathogen(s) and/or transmission of communicable diseases, as well as put the patient(s) at risk for food-borne illnesses.

Findings:

1.a. During a tour accompanied by the OR manager (Staff K) in the operating suite on 3/12/12 at 2:20 p.m., an observation and a concurrent interview was conducted. A staff member wearing a cloth head cover was observed coming out from the soiled instrument elevator. Staff K identified the staff was the patient care orderly (Orderly 2) and confirmed that Orderly 2 was wearing a cloth head cover and the cloth head cover was home-laundered by staff. Staff K stated the hospital used AORN standards and recommended practices as the infection control guidelines.

During an observation and a concurrent interview with the patient care orderly (Orderly 1) in hallway of the operating suite on 3/12/12 at 2:25 p.m., two staff members wearing cloth head covers were observed. Orderly 1, one of the staff members who wore cloth head cover, stated she changed the cloth head cover once a day and she laundered the cloth head covers from home.

On 3/12/12 at 3 p.m., a review of the hospital's policy and procedure titled "Surgical Attire and Infection Control in the Surgical Suite" dated 2/2012 indicated "All personnel entering restricted or semi-restricted areas of the Surgical Suite are required to wear clean Operating Room apparel provided by the hospital and laundered by a hospital approved facility. All possible head and facial hair should be covered completely by a surgical hat or hood...if cloth is used, they must be laundered and cleaned daily...References: AORN Standards, Recommended Practices, and Guidelines, 2010 Edition"

On 3/12/12 at 3:10 p.m., the 2012 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. Under the section titled "Recommended Practices for Surgical Attire", direction was given that, "Recommendation IV.a.2. Reusable head coverings should be laundered in a health care-accredited laundry facility after each daily use." Under Recommendation V, direction was given that, "Surgical attire should be laundered in a health care-accredited laundry facility...Home laundering has been shown to be less effective for cleaning surgical attire than attire laundered by health care facilities or commercial laundries."

1.b. During an observation in the operating room (OR) 6 on 3/13/12 at 10:20 a.m., Orderly 2, whose facial hair was not covered, was observed mopping the floor between surgeries.

During an interview with Staff K on 3/13/12 at 10:50 a.m., Staff K stated Orderly 2 should have covered his facial hair when working in the OR.

During the observations in the central sterile processing (CSP) department of Campus 1 on 3/13/12 between 11:05 a.m. to 12:10 p.m., the CSP supervisor (Staff P) did not have facial hair covered when he was in the decontamination room. The CSP manager (Staff O) did not have facial hair covered when he accompanied this surveyor touring the decontamination area, the sterile processing area, and the sterile storage.

During an interview with Staff O in the CSP department on 3/13/12 at 12:20 p.m., Staff O stated staff were not required to cover the facial hair in the decontamination area, the sterile processing area, and the sterile storage at all times. Staff O also stated he would cover his facial hair as necessary if he was performing the instrument assembling task.

During an observation in the OR 2 on 3/13/12 at 3:35 p.m., the Environmental Services Assistant (EVS B) did not have facial hair covered when he was performing the cleaning task in OR 2.

During an observation and a concurrent interview in the cardiac catheterization laboratory on 3/14/12 at 2:25 p.m., the catheterization laboratory technician (Cath Lab Technician 1) did not have the facial hair covered when he was touring this surveyor in the cardiac catheterization laboratory. Cath Lab Technician 1 stated that the hospital followed AORN standards and recommended practices as the infection control guidelines. Cath Lab Technician 1 acknowledged that he should have used the mask to cover his facial hair when he was in the restricted and semirestricted area of the cardiac catheterization laboratory.

During an interview with Staff K in the operating suite on 3/15/12 at 4:45 p.m., Staff K stated the hospital used AORN standards and recommended practices as the infection control guidelines. Staff K also stated the staff members were required to cover facial hair as needed when sterile equipment and supplies were open.

On 3/15/12 at 4:55 p.m., a review of the hospital's policy and procedure titled "Surgical Attire and Infection Control in the Surgical Suite" dated 2/2012 indicated "All possible head and facial hair should be covered completely...References: AORN Standards, Recommended Practices, and Guidelines, 2010 Edition"

1.c. During an observation and a concurrent interview in the OR 2 of Campus 1 on 3/13/12 at 3:40 p.m., the registered nurse (RN 8)'s sideburns and hair at the nape of neck were not completely covered. The Infection Control Staff 1 confirmed RN 8's sideburns and hair at the nape of his neck were not covered.

On 3/15/12 at 4:55 p.m., a review of the hospital's policy and procedure titled "Surgical Attire and Infection Control in the Surgical Suite" dated 2/2012 indicated "All possible head and facial hair should be covered completely...References: AORN Standards, Recommended Practices, and Guidelines, 2010 Edition"

On 3/15/12 at 5 p.m., the 2012 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. The section titled "Recommended Practices for Surgical Attire" indicated "...These recommended practices are intended as guidelines adaptable to various practice settings...include traditional operating rooms..." 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 area."

1.d. During an observation and a concurrent interview in the OR 2 of Campus 1 on 3/13/12 at 3:40 p.m., RN 8 wore mask hanging down from the neck. The Infection Control Staff 1 confirmed RN 8 wore mask hanging down from the neck.

During an observation in the OR of Campus 2 on 3/14/12 at 10:25 a.m., the registered nurse (RN 16) wore mask hanging down from the neck.

During an observation and a concurrent interview in the cardiac catheterization laboratory of Campus 1 on 3/14/12 at 2:35 p.m., the registered nurse (RN 14) wore mask hanging down from the neck. RN 14 acknowledged that she should not have worn mask hanging down from the neck in the cardiac catheterization laboratory.

On 3/15/12 at 5 p.m., the 2012 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. The section titled "Recommended Practices for Surgical Attire" indicated "...These recommended practices are intended as guidelines adaptable to various practice settings...include traditional operating rooms...cardiac catheterization laboratories..." Under Recommendation VI.b.1, direction was given that, "Masks should not be worn hanging down from the neck."

1.e. During an observation in the decontamination of the CSP department of Campus 1 on 3/13/12 at 12:12 p.m., the Central Processing Technician 2's personal clothing was seen above the V-neck of the surgical scrub suit.

During an observation and a concurrent interview in the endoscopy department on 3/13/12 at 1:45 p.m., the Endoscopy Technician (Endoscopy Technician 1)'s gray personal clothing was seen above the V-neck and below the sleeve of the surgical scrub suit. RN 5 stated it was not acceptable when the staff's personal clothing was not completely covered by the surgical attire if the hospital followed the OR standard in the endoscopy department.

During the observations in the OR of Campus 1 on 3/13/12 between 3:35 p.m. and 3:50 p.m., RN 8, EVS B, and the Environmental Services Technician (EVS C)'s personal clothing were seen above the V-neck of the surgical scrub suits. EVS C's personal clothing was also seen below the sleeve of the surgical scrub suit.

During an observation and a concurrent interview in the OR of Campus 2 on 3/14/12 at 11:05 a.m., the Anesthesiologist 1, whose green personal clothing was seen below the sleeve of the surgical scrub suit, entered OR 6 where the surgery was in progress. The OR registered nurse (RN 12) stated it was not acceptable when the staff's personal clothing was not completely covered by the surgical attire.

On 3/14/12 at 3:55 p.m., a review of the hospital's policy and procedure titled "Surgical Attire and Infection Control in the Surgical Suite" dated 2/2012 indicated "...References: AORN Standards, Recommended Practices, and Guidelines..."

On 3/14/12 at 4 p.m., the 2012 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. The section titled "Recommended Practices for Surgical Attire" indicated "...These recommended practices are intended as guidelines adaptable to various practice settings...include traditional operating rooms...endoscopy suites...and all other areas where operative and other invasive procedures may be performed." Under Recommendation III.b.1., direction was given that, "All personal clothing should be completely covered by the surgical attire...personal clothing that extends above the scrub top neckline or below the sleeve of the surgical attire should not be worn."

1.f. During an interview with Staff H in the endoscopy suite of Campus 1 on 3/12/12 at 2:35 p.m., Staff H stated the staff members were not required to wear head cover and shoe covers or dedicated shoes in the endoscopy department.

During an interview with RN 5 on 3/12/12 at 3:15 p.m. in the endoscopy suite, RN 5 confirmed personnel were not required to wear head cover and shoe covers or dedicated shoes in the endoscopy procedure rooms. When asked the types of procedures usually performed in the endoscopy procedure rooms, RN 5 stated the procedures that were performed in the endoscopy procedure rooms included bronchoscopy, upper endoscopy, and colonoscopy. RN 5 also stated about 60% to 70% of the procedures required biopsy and polypectomy.

On 3/12/12 at 3:20 p.m., an interview with RN 5, Staff H, and the Infection Control Staff 1 was conducted and a concurrent review of the definition of surgery developed by the American College of Surgeons dated 4/2007 was done. The definition of surgery indicated "...Surgery is also the diagnostic or therapeutic treatment of conditions or diseases processes by any instruments causing localized alteration or transposition of live human tissue which include lasers...The tissue can be...altered by any mechanical thermal, light-based...All of these surgical procedures are invasive, including those that are performed with lasers, and the risks of any surgical intervention are not eliminated by using a light knife or laser in place of a metal knife or scalpel." RN 5, Staff H, and the Infection Control Staff 1 acknowledged that biopsy and polypectomy were considered as surgery which should have been performed in the restricted zone of the operating room (OR) setting. RN 5, Staff H, and the Infection Control Staff 1 also acknowledged that the current practice in the endoscopy suite was not the same as the OR practice such as there was no requirement of using head cover and shoe covers/dedicated shoes in the endoscopy procedure rooms.

On 3/12/12 at 4 p.m., the 2012 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. The section titled "Recommended Practices for Surgical Attire" indicated "...These recommended practices are intended as guidelines adaptable to various practice settings...include traditional operating rooms...endoscopy suites...and all other areas where operative and other invasive procedures may be performed. Recommendation II. Clean surgical attire, including shoes, head covering, masks, jackets, and identification badges should be worn in the semirestricted and restricted areas of the surgical or invasive procedure setting."

2.a. During an observation of the environmental cleaning between surgeries in the OR 6 of Campus 1 on 3/13/12 at 10:20 a.m., Orderly 2 was observed mopping the floor started from one side of the room (area A), the center of the room where fluid was seen on floor (area B), the other side of the room (area C). Orderly 2 was observed re-mopping the side of the room (area A), the center of the room (area B) with the same mop-head.

During an interview with Orderly 2 on 3/13/12 at 10:45 a.m., Orderly 2 stated the fluid on the OR floor was the irrigation fluid left on floor during the previous surgery. When asked if cross-contamination would occur when he mopped the fluid in the center of the room (area B) followed by mopping the other side of the room (area C) and re-mopping the side of the room (area A), and the center of the room (area B), Orderly 2 stated he should have used a new mop-head when re-mopping the floor. Orderly 2 also stated he mopped the sides of the room first prior to mopping the fluid in the center of the room.

During an interview with Staff K in the hallway of OR on 3/13/12 at 10:50 a.m., Staff K stated Orderly 2 understood that he should have mopped the sides of the room first followed by mopping toward the center of the room. Staff K also confirmed when Orderly 2 was mopping the side of the room, the mop-head touched the fluid in the center of the room as well. Staff K acknowledged that cross contamination might occur when Orderly 2 mopped the fluid in the center of the room (area B) followed by mopping the other side of the room (area C) and re-mopping the side of the room (area A) and the center of the room (area B) with the same mop-head.

2.b. During an interview with the Director of Perinatal Newborn/Labor and Delivery (Staff Q) in the Family Birth Center on 3/14/12 at 2:15 p.m., Staff Q stated the unused OR for cesarean section was not required to be cleaned daily during the regularly scheduled work week.

During an interview with the Infection Control Staff 1 on 3/16/12 at 10:30 a.m., the Infection Control Staff 1 stated Staff H confirmed the unused OR for caesarean section was required to be cleaned daily during the regularly scheduled work week.

On 3/16/12 at 11 a.m., the 2012 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. The section titled "Recommended Practices for Environmental Cleaning in the Perioperative Setting" indicated "...These recommended practices are intended as guidelines adaptable to various practice settings...include traditional operating rooms...endoscopy suites...and all other areas where operative and other invasive procedures may be performed." Under Recommendation IV.a.1., direction was given that, "Unused rooms should be cleaned once during each 24-hour period during the regularly scheduled work week."

2.c. During an interview with the Registered Nurse (RN 4) in the intensive care unit (ICU) of Campus 1 on 3/12/12 at 11:10 a.m., RN 4 stated she used the Sani-Cloth germicidal disposable wipes to disinfect the keyboard which located in a patient's room and the patient was put on contact precautions for Clostridium difficile (C. difficile - a microorganism is transmitted from person-to-person via fecal-oral transmission and by touching surfaces and objects in the contaminated environment. In its spore form, C. difficile can survive up to 5 months in the environment) infection.

On 3/12/12 at 11:15 a.m., a review of the manufacturer's instruction printed on the Sani-Cloth container indicated Sani-Cloth killed a list of microorganisms, but C. difficile was not on the list.

During an interview with and the Infection Control Staff 1 on 3/14/12 at 11 a.m., and the Infection Control Staff 1 stated the keyboard, which located in an isolation room resided by a patient who suffered from C. difficile infection, should have been disinfected by the bleach wipes.

On 3/14/12 at 11:30 a.m., the 2012 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. The section titled "Recommended Practices for Environmental Cleaning" indicated "Recommendation VII.c. An EPA (Environmental Protection Agency)-registered, hypochlorite-based disinfectant (household bleach solution) should be used to clean a patient area when the patient is diagnosed or suspected of infection with Clostridium difficile."

On 3/14/12 at 11:45 a.m., the CDC's document titled "Frequently Asked Questions about Clostridium difficile for Healthcare Providers" dated 3/6/12 stated "EPA-registered disinfectants with a sporicidal claim have been used with success for environmental surface disinfection in those patient-care areas where surveillance and epidemiology indicate ongoing transmission of Clostridium difficile...EPA-registered disinfectants are recommended for use in patient-care areas. When choosing a disinfectant, check product labels for inactivation claims, indications for use, and instructions."

3. During an observation and a concurrent interview in the nursing station of the endoscopy suite of Campus 1 on 3/12/12 at 3 p.m., two endoscope storage cabinets with door opened were observed. Visible grayish black particles were observed at the bottom of the first endoscope storage cabinet. There were 2 lower endoscopes (colonoscope(s)- a long, flexible instrument consists of a tube and a light used in colonoscopy procedure) and 7 upper endoscopes (a long, flexible instrument consists of a tube and a light that is inserted through the mouth and down the intestinal tract used in upper endoscopy procedure) stored in the first storage cabinet. The tip of one of the colonoscopes (serial number: 2339111) was touching the side of the cabinet; the plug end of 2 endoscopic ultrasound (Olympus type GF UE160-AL5 and Olympus type GF UC 140P-AL5) were touching the bottom of the cabinet. There were 4 bronchoscopes (a curved, flexible instrument consists of a tube and a light used in the bronchoscopy procedure), 3 upper endoscopes and 1 colonoscope stored in the second storage cabinet. Visible grayish black particles and hair were observed at the bottom of the second endoscope storage cabinet. The tip end of the colonoscope and two upper endoscopes were touching 3 containers (two gray containers and 1 black case) which were stored at the bottom of the second storage cabinet. RN 5 confirmed the visible grayish black particles at the bottom of two endoscope storage cabinet were scattered dust. When asked how often the the storage cabinets were cleaned, RN 5 stated the storage cabinets were supposed to be cleaned daily. RN 5 confirmed that the storage cabinet cleaning was not addressed in the hospital's policy and the storage cabinet cleaning was not documented.

During an interview with the Infection Control Staff 1 on 3/12/12 at 3:15 p.m., the Infection Control Staff 1 stated that the endoscopy department used the SGNA (Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes), the APIC (Association for Professionals in Infection Control and Epidemiology), and the CDC (Centers for Disease Control and Prevention) guidelines as infection control guidelines.

On 3/13/12 at 9:55 a.m., a review of the hospital's policy and procedure titled "Storage of Endoscopes" dated 3/2011 indicated "Distal tips should hang freely in a well ventilated, dust free area."

On 3/13/12 at 10 a.m., the document titled "Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes" dated 2008, published by the SGNA, was reviewed. The aforesaid document indicated "the Society of Gastroenterology Nurses and Associates, Inc.(Incorporation) presents this guideline for use in developing institutional policies, procedures, and /or protocols. Information contained in this guideline is based on current published data and current practice at the time of publication. The Society of Gastroenterology Nurses and Associates, Inc. assumes no responsibility for the practices or recommendations of any member or other practitioner, or for the policies and practices of any practice setting..." On page 16, the section titled "Storage" indicated "Hang the endoscope vertically with the distal tip hanging freely in a well-ventilated, dust-free area..."

On 3/13/12 at 10:10 a.m., a review of the document titled "APIC guideline for infection prevention and control in flexible endoscopy" dated 2000 indicated "Storage: Endoscopes should be stored in a manner to prevent recontamination...There should be adequate space to keep the endoscopes and other equipment from coming into contact with each other..."

On 3/13/12 at 10:15 a.m., a review of the document titled "Guideline for Disinfection and Sterilization in Healthcare Facilities" dated 2008, published by the CDC, indicated "Store the endoscope in a way that prevents recontamination and promote drying."

On 3/13/12 at 11 a.m., the 2012 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. The section titled "Recommended Practices for Cleaning and Processing Flexible Endoscopes and Endoscope Accessories" indicated "Recommendation IX.a. Flexible endoscopes should be stored in a closed cabinet... adequate height to allow flexible endoscopes to hang without touching the bottom of the cabinet, and sufficient space for storage of multiple endoscopes without touching. Recommendation IX.d. Storage cabinets should be cleaned and disinfected with Environmental Protection Agency (EPA)-registered disinfectant when visibly soiled and on a weekly or monthly schedule."

4.a. During an interview with the registered nurse (RN 6) in the endoscopy department on 3/13/12 at 8:40 a.m., when asked how to clean and disinfect the glucometer, RN 6 stated the screen and the strip holder of the glucometer should be cleaned with a piece of gauze dampened with water followed by drying with a dry gauze.

During an interview with the registered nurse (RN 7) in the PACU (Post Anesthesia Care Unit) on 3/13/12 at 10:55 a.m., when asked how to clean and disinfect the glucometer, RN 7 stated the strip holder of the glucometer should be cleaned after each use with Sani-Cloth bleach wipe (a disposable germicidal wipe). RN 7 also stated other parts of the glucometer were not required to be cleaned or disinfected.

During an interview with the registered nurse (RN 11) in the OR of Campus 2 on 3/14/12 at 10:05 a.m., when asked how to clean and disinfect the glucometer, RN 11 stated the staff used one wipe of Sani-Cloth wipe (a disposable germicidal wipe) to clean and disinfect the strip holder of the glucometer after each use. RN 11 also stated other parts of the glucometer were not required to be cleaned or disinfected after each use.

On 3/14/12 at 10:10 a.m., a review of the manufacturer's instructions on the Sani-Cloth container indicated "To Disinfect...Use a wipe to remove heavy soil. Unfold a clean wipe and thoroughly wet surface. Treated surface must remain visibly wet for 3 minutes. Use additional wipe(s) if needed to assure continuous 3 minute wet contact time..."

On 3/14/12 at 10:15 a.m., a review of the hospital's policy and procedure titled "Cleaning of Environment, Equipment and Common Areas" dated 4/11 indicated "Manufacturer recommendations should always be followed. Prior to disinfection, any visible soil must be removed. The key of effectiveness for all disinfectants is wet contact time. That is, the amount of time a disinfectant must remain wet on a surface to kill the organisms...To reduce the risk of microbial spread, a disinfectant wipe should not be used on more than one small surface...Glucometer (to be cleaned and disinfected with) disinfectant wipes after each use."

On 3/14/12 at 10:20 a.m., a review of the glucometer manual titled "Meter Quick Reference Guide" indicated "Cleaning the outside of the meter...with a cloth dampened with a 10% (percent) bleach solution...Cleaning the test strip holder...with a cotton swab dampened with a 10% bleach solution..."

On 3/14/12 at 11:20 a.m., the 2003 Guidelines for Environmental Infection Contr