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Based on observation, staff interviews and administrative document reviews, the hospital failed to adhere to state laws and regulations requiring prior approval for change in patient use areas when no request for licensing or building authority approval was received or approved for the Observation Unit. This failure resulted in the hospital not following state regulations and guidelines to obtain approval prior to any change of patient use.

Findings:

On 7/19/12 at 11 a.m., during a concurrent observation and interview, the Observation Unit (OU) was toured accompanied by the Observation Unit Manager (OUM). The OU was accessed off the main first floor corridor of the hospital and entrance into the OU was restricted. The OU was equipped with 10 patient bays separated by privacy curtains and each patient bay was equipped appropriately. At the time of the tour, the OU was occupied by 10 patients.

The OUM stated the OU had been treating patients since January 2011. The OUM stated the purpose of the OU was for short stays of patients, ideally less than 48 hours and the criteria were strict as to what type of patients were accepted into the OU. The OUM described the OU as neither an in-patient service nor as solely an out-patient service. The OUM stated the OU was not part of the Emergency Department (ED), although patients were admitted to the OU from the ED. The OUM stated the goal of the OU was to provide specific treatment that would get the patients home within 48 hours. The OUM stated this goal was supported by the protocol for admission into the OU. The OUM stated that, in general, patients were sent home within the 48 hours. The OUM stated there have been no negative outcome events while patients were cared for in the OU.

The OUM stated that prior to becoming the OU, the space was utilized for post-surgical care (after surgery). The OUM stated the space was vacated by the post-surgical care service for about six months before the decision was made to convert the space to the OU. The OUM stated she did not know the specific time frame that the space was empty and that she did not think any physical changes were made prior to providing service as an OU.

When asked to provide evidence of state approval for use of the space as an OU, the OUM stated she did not know anything about that. The OUM stated she understood that each part of the hospital required state approval for patient use. The OUM stated she was not part of the hospital staff assigned to submit documents to the state licensing agency for approval.

On 7/19/12 at 2 p.m., during an interview, the Office of Statewide Health Planning and Development (OSHPD) inspector stated that no permits for change of patient use were submitted by the hospital for the space occupied by the OU. (OSHPD is the state agency that oversees all building requirements for hospitals.) The OSHPD inspector stated for this type of change in patient use, the expectation and requirement would be to obtain a permit and approval prior to patient use.

On 7/20/12 at 9 a.m., during an interview, the Quality Improvement Manager of the hospital, the Regional Quality Improvement Manager of the hospital system, the Chief Executive Officer, The Chief Medical Officer and the Governing Body Chairman discussed the process of submitting requests for patient use changes and hospital projects to the appropriate state agencies. In regards to the OU, the interviewees confirmed that no request was submitted to the state licensing agency or to OSHPD prior to patient use. The interviewees stated that they collectively understood and acknowledged the requirement to submit requests for any patient use change to both the licensing agency and to OSHPD. The interviewees could not explain specifically the reason(s) why a request for approval of patient use change was not submitted to the state agencies prior to patient use for the OU. The interviewees stated that the likelihood was that there was a communication lapse some where in the decision making tree within the hospital. No other explanations were given.

The California Health and Safety (CA H&S) Code section 1253 indicated the following: "...No person, firm, partnership, association, corporation, or political subdivision of the state, or other governmental agency within the state shall operate, establish, manage, conduct or maintain a health facility in this state, without first obtaining a license therefor as provided in this chapter, nor provide, after July 1, 1974, special services without approval of the state department..."

The CA H&S Code section 1254(a) indicated "... the state department shall inspect and approve a general acute care hospital to provide special services as specified in Section 1255..."

The CA H&S Code section 1256.1 "No general acute care hospital shall hold itself out directly or indirectly by any sign, brochure, or advertisement as providing any service or services which require a supplemental or special service unless that general acute care hospital has first obtained a supplemental or special service approval from the State Department of Health Services to operate such a service..."

The OSHPD Inspector provided the following reference for the requirement of obtaining building permit prior to patient use in hospital. The California Code of Regulations Title 24, Part 1 from the California Building Standards Commission under Article 3 Approval of Construction Documents section 7-113 indicated "...Application for plan, report or seismic compliance extension review. Except as otherwise provided in this part, before commencing construction or alteration of any health facility, the governing board or authority thereof shall submit an application for plan review to the Office, and shall obtain the written approval thereof by the Office describing the scope of work included and any special conditions under which approval is given..."

Based on observation, patient and staff interview and administrative document review, the hospital failed to inform each patient or the patient's representative, in a language or manner that can be understood, of the patient's rights when Patient 1 did not receive patient rights information prior to the scheduled procedure. This failure resulted in not protecting the patient's right to be informed prior to making the decision for care.

Findings:

On 7/18/12 at 8:15 a.m., during an observation, Patient 18 was in the pre-operative (before surgery) area of the Endoscopy Unit (area of surgery where the predominant procedures are gastrointestinal viewing - looking directly at the stomach and intestines). Patient 18 was Spanish-speaking and was to have a colonoscopy (direct viewing of the colon and large intestines with a medical device).

On 7/18/12 at 8:18 a.m., during an interview conducted in Spanish, Patient 18 stated no patient rights information had been given to her or verbally explained. Patient 18 stated she had shared that her primary language was Spanish and she did not understand or speak English.

On 7/18/12 at 8:20 a.m., during an interview, the Endoscopy Admissions Clerk (Cl/Endo) stated one of her roles was to provide patient rights information to patients. The patient rights information was provided in the form of a brochure. The Cl/Endo stated that Patient 1 should have received the patient rights brochure, but should could have forgotten. Cl/Endo stated that in the seven years she had worked at the hospital she was not aware of the brochure provided in Spanish. The Cl/Endo estimated the number of Spanish speaking patients per week seen in Endoscopy as three to five.

On 7/18/12 at 8:30 a.m., during a concurrent interview, Staff 6 and the Nurse Manager of Endoscopy (OR/MG) confirmed Patient 18 had not received a copy of the patient's rights in a language that could be understood. Staff 6 and OR/MG stated that the hospital was in possession of Spanish language patient rights brochures and did not know the reason why the brochures were not accessible in Endoscopy.

The hospital's "Patient and Family Guide" dated 5/12 on page 17 indicated "... Patient Rights and Responsibilities ... These rights and responsibilities are provided in English and Spanish ... Patient right to receive information ..."

Based on observation, patient and staff interview and administrative document review, the hospital failed ensure patient privacy when a sign in bold print was placed in Patient 12's room indicating "GUAIAC STOOL X 3" (three samples of stool for special testing). The sign was easily viewed from the public access corridor in front of Patient 12's room. This failure resulted in the loss of Patient 12's dignity and privacy.

Findings:

On 7/17/12 at 12:35 p.m., during an observation on the 2nd floor of the hospital, a sign placed near Patient 12's bedside could easily be seen from the public access corridor. The sign was in blue bold capitalized large print and indicated "GUAIAC STOOL X 3" (a method of testing fecal matter in order to detect blood in the stool).

On 7/17/12 at 12:40 p.m., during an interview, Patient 12 discussed her feelings about the sign and that the sign could be seen from the corridor. Patient 12 stated, "I don't like it; it's embarrassing to have it up there for everyone to see." Patient 12 stated that the sign had been posted for about one week.

On 7/17/12 at 12:45 p.m., during an interview, the Chief Nursing Executive (CNE) 1 stated that the sign should not have been posted where everyone could see. CNE 1 agreed that the dignity and privacy of Patient 12 was not protected.

The facility's "Patient and Family Information Guide" dated 5/12, page 8 indicated "... Have personal privacy respected ... Case discussion, consultation, examination and treatment are confidential and should be conducted discreetly ..."

Based on observations, staff interviews and administrative document reviews, the hospital's Quality Assessment and Performance Improvement program failed to allocate sufficient resources in order to improve performance in the areas Surgical Services and Infection Control. These failures resulted in the increased risk to patients of possible preventable infections.

Findings:

On 7/20/12 at 10 a.m., during an interview, the Quality Improvement Manager for the hospital and the Regional Manager for Quality Improvement for the hospital system discussed the role of the Quality Improvement (QI) Program. The interviewees stated that the QI program had concurrent (prospective) projects with the objective to improve infection control and hand hygiene in the hospital and specifically in Surgical Services. The interviewees confirmed that the QI program was data driven and concentrated on high volume, high risk areas of the hospital.

The interviewees were asked to respond to the following observations and interviews of staff performing tasks that did not follow established standards of practice and did not follow hospital policy and procedures.

Example 1.: On 7/18/12 at 9:06 a.m., during an observation in the GI pre-op unit, MD 3 examined Patient 18. MD 3 was observed listening to Patient 18's chest and abdomen with a stethoscope [a medical device for listening to internal organs]. MD 3 did not clean the stethoscope before or after the examination. MD 3 did not wash his hands or use hand sanitizer before or after examining Patient 18's ankles and feet.

Example 2: During an observation and a concurrent interview in the decontamination room of the sterile processing department on 7/17/12 at 3:15 p.m., the decontamination room technician (DRT) was wearing a mask; the mask did not cover his nose and did not cover his facial hair completely. The director of the central processing department (DCP) stated the DRT should have covered his facial hair and nose completely in the decontamination room which was a semirestricted area.

During an observation and a concurrent interview in the operating room (OR) 3 on 7/18/12 at 10 a.m., the scrub technician (ST 1) did not cover his facial hair in the OR 3. The ICP stated ST 1 should have covered his facial hair in the OR.

The interviewees acknowledged the examples were indicative that the on-going Quality Improvement projects required additional programs to capture real-time tasks of hospital staff performing critical daily tasks. The interviewees acknowledged that additional resources were required to improve the hospital wide Quality Improvement program.

Based on staff interview, clinical record and administrative document review, the hospital failed to ensure nursing staff kept current a nursing care plan for each patient when nursing did not care plan Patient 1's documented diagnosis of MRSA (Methicillin Resistant Staphylococcus aureus - a serious bacterial infection that is resistant to the treatment with antibiotics similar to methicillin). This failure placed Patient 3 at risk of not receiving adequate care for his medical condition.

Findings:

On 7/17/12 the clinical record for Patient 3 was reviewed. Patient 3 was admitted on 7/12/12 with a diagnosis of MRSA. A nursing care plan for the treatment of this condition had not been initiated and kept current.

On 7/17/12 at 10:14 a.m., during an interview, Registered Nurse (RN) 24
charge nurse 3rd floor) acknowledged the missing nursing care plan for Patient 3. RN 24 stated the expectation for nurses was to develop and keep current the nursing care plan for each patient for each diagnosis upon admission. RN 24 did not comment on the reason why the nursing care plan was missing for MRSA.

On 7/17/12 at 10:20 a.m., during an interview, the Chief Nursing Executive (CNE) 1 acknowledged there was no MRSA care plan for Patient 3 in the clinical record. CNE 1 stated the expectation for nurses was to develop and keep current the nursing care plans for each patient for each diagnosis upon admission. CNE 1 did not comment on the reason why the nursing care plan was missing for MRSA.

The hospital's policy and procedure titled, "Care Plan (Interdisciplinary)" dated 7/12, indicated "F. The care plan will be initiated within 24 hours of admission by a Registered Nurse based on patient assessment and information collected during the admission process, which may include physiologic, psychosocial, and educational and/or discharge planning needs."

Based on observation, staff interview, and administrative document review, the facility failed to secure Schedule II (narcotic medication) controlled substance when a narcotic medication was found unattended and unsecured in the Dialysis treatment area. This failure had the potential for unauthorized use of a high risk prescription medication.

Findings:

On 7/19/12, at 12:40 p.m., during an observation in the Dialysis treatment unit, a 1 ml (milliliter, unit of measurement) vial of Hydromorphone (narcotic pain reliever) was found on the top of an unattended dialysis machine. The vial contained approximately .5 ml of clear liquid. Stored next to the vial was a syringe with the needle attached.

On 7/19/12, at 12:42 p.m., during an interview RN 16 (5th floor manager), confirmed the medication should not have been left unsecured and the syringe and needle should have been placed in the proper receptacle.

On 7/23/12, during an administrative document review, the facility policy titled, "MEDICATIONS: STORING" revision dated, 7/12, indicated, "B. Medications must be kept in a secure and locked area when appropriate.... 5. Drugs listed in schedules II, III, IV, and V of the Comprehensive Drug Abuse and Prevention Control Act of 1970 must be kept locked within a secure area."

On 7/23/12, during an administrative document review, the California Health and Safety Code, Chapter 9, section 118275-118320, dated 2010, indicated, "e. [sharps]...shall be placed in sharps containers labeled in accordance with industry standards."

Based on observation, staff interview, and administrative document review, the hospital failed to ensure that only authorized personnel had access to locked areas where medications and biologicals were stored. This failure resulted in the potential of unauthorized personnel access to medications.

Findings:

On 7/16/12 at 3:05 p.m., during a concurrent observation and interview in the Radiology Department, Radiology Technician (RT) 3, an unlicensed staff, was observed with keys to locked areas that contained medications. RT 3 stated she had keys to locked medication cupboards that she accessed for the physicians when needed.

On 7/16/12 at 3:10 p.m., during an interview with the chief nursing executive (CNE) 1, and Radiology Department Manager (RDM) validated the RT's had keys to the locked medication cupboards in the procedure rooms and access to the medications for the physician as needed.

On 7/17/12 at 11:30 a.m., during observation of the Post Anesthesia Care Unit (PACU), a ring of keys was observed laying on the counter unattended accessible to all staff, patients and visitors. This was validated by CNE1, and RN 32.

On 7/17/12 at 11:35 a.m., during an interview, Charge Nurse of the PACU (RN 32), validated the ring of keys on the counter unattended and stated the keys belonging to the locked medication, syringes, needles and other items. RN 32 stated "keys to the locked areas should not be on the counter in public, but should be secured in my pocket or in the (secured medication dispensing unit), which only authorized personnel have access to".

The facility policy and procedure titled, "Medications: Storing" revised, 7/12, indicated,..."Medications...must not be stored in areas that are not readily accessible to authorized individuals...access to medication shall be limited to authorized personnel...individuals licensed to prescribe medication, e.g., licensed independent practitioners...individuals licensed to administer medications within their scope of practice as allowed by law."

Based on observation, staff interview and administrative document review, the hospital failed to eliminate outdated medications from patient care areas. Manufacturers of medications do not ensure the potency and integrity of medications beyond their expiration dates. This failure resulted in the potential to administer medications to patients that have lost their potency and/or integrity and could have an adverse effect on patients' health.

Findings:

On 7/16/12 at 10:00 a.m., during an observation of the Neonate Intensive Care Unit (NICU) with the Clinical Nurse Educator of the NICU (registered nurse RN 20) and the Chief Nursing Executive (CNE) 1, the refrigerator had in it a syringe of Intravenous gentamicin (an antibiotic - a medication to treat infections) 2 milligrams/milliliter (mg/ml) (units of measure), in sodium chloride (a salt solution) 0.9 per cent. The date on the gentamicin syringe had an expired date of 7/11/12 for Patient 34.

On 7/16/12 at 10:10 a.m., during an observation of the NICU, a "Doctors red bag" (used for emergency use of medications) was opened to view the medications inside it. Inside the doctor's red bag contained the following expired medication: Epinephrine (medication to increase heart rate) 1:10,000 syringe 1 mg (0.1 mg/ml) expired on 6/1/12.

On 7/16/12 at 10:18 a.m., during an observation, a medication cart in the NICU was observed to have a 5% dextrose (sugar) in 100 milligrams/milliliter (mg/ml) Intravenous (through the veins) bag of fluid expired 6/12.

On 7/16/12 at 10:20 a.m., during an interview, RN 20, RN 31 and CNE 1 acknowledged the expired medications and agreed that the expired medications should have been discarded.

On 7/19/12 at 8 a.m., during an interview, the Director of Pharmacy (DOP)stated it was the responsibility of the assigned pharmacist to remove all outdated drugs from the refrigerator and doctor's red bag. The DOP stated the pharmacist "missed it" in reference to the expired gentamicin and expired epinephrine.

On 7/16/12 at 10:45 a.m., during an observation of the labor and delivery unit, an anesthesia cart located near the nurses' station had one 30 ml (ml) multidose (multiple use) vial of xylocaine (local anesthetic) 1 per cent opened unlabeled, and undated. The container was not labeled regarding when it was opened.

The hospital's policy and procedures titled, "Medications: Expiration dating of injectable sterile solutions containers" revised 7/10, indicated multiple-dose vials (with preservatives) shall be discarded after the 28 th day from removing the vial cap...has occurred...Expiration dating of multi-dose vial will occur when the vial is opened...The 28-day expiration date...will be written on the label/vial.

The California Code of Regulations, Title 22, 70263(q)(9) and (10) read, "Drugs shall not be kept in stock after the expiration date on the label and no contaminated or deteriorated drugs shall be available for use. Drugs maintained on the nursing unit (patient care areas) shall be inspected monthly by a pharmacist."

On 7/19/12 at 12:40 p.m., during an observation on the fifth floor dialysis unit, an approximate twenty-four inch section of vinyl floor covering was found to be loose and raised from the sub-floor. The cement floor and an accumulation of debris was visible.

On 7/19/12 at 12:43 p.m., during an interview the Nurse Manager stated she was not aware of this condition.

On 7/23/12 during an administrative document review, the facility policy "Safety Management Overview" revise dated, 9/06 indicated, "III. Responsibility and Authority. F. Department Managers: Support a safe environment of care through the development, implementation and enforcement of the Safety Management Program elements. G. Employees: Are responsible for maintain a safe environment through participating in training and drills, prompt identification and reporting of hazards, utilization of safe work practices and adhering to all safety policies and procedures."





28773

Based on observation, staff interview and administrative document review, the hospital failed to ensure the safety and the well-being of patients when:

1. The hospital identified food supplies needed in the event of an emergency did not match the observed inventory. The disaster plan menu did not include portion sizes and did not include pureed food items for patients on specialized therapeutic diets.

2. A section of the floor covering on the fifth floor dialysis unit was raised and detached from the floor.

These failures resulted in 1) the potential harm of not meeting the dietary needs of patients in the event of an emergency; and 2) possibly leading to preventable accidents.

Findings:

On 7/17/12 at 8:25 a.m., during a concurrent observation, interview and record review, the inventory list of disaster food on hand was reviewed with the Director of Dining and Nutrition Services (DD&NS). The hospital's "Sample Menu Supply List" was compared to supplies on hand. The document indicated that the inventory was last verified on 6/4/12 by a food service worker. The document indicated not all items on the inventory list were present in the quantities indicated or required. Review of the Emergency Meal Plan did not indicate portion sizes or quantities that would need to be given to the patients or staff in the event of an emergency or disaster. the inventory contained puree items but did not contain a menu for these items.

The Emergency Meal Plan listed beef stew as an item, but the disaster food on hand in the secondary kitchen did not include this item. The inventory list was also missing beef stew. The disaster plan required six cases of peanut butter and only four were observed. No inventory of puree vegetables was noted.

The DD&NS stated the puree vegetable order was blank and it should have been ordered if they were out. The DD&NS acknowledged they needed to look over all of the items on the inventory and have them on hand at all times. The DD&NS stated she was unsure why the beef stew was no longer on the inventory list but confirmed it should be on the list. The DD&NS acknowledged that a menu without portion sizes could affect how much food was given to the patients and could result in not having enough food on hand for the planned amount of time.

On 7/17/12 at 9 a.m., the observation was continued in the main kitchen. There was three-quarters of a case of peanut butter, two and one-half cases of chili, and no puree vegetables. According to the inventory list, there should have been four cases of peanut butter, two and one-half cases of chili and two cases of puree vegetables on hand in the main kitchen.

The DD&NS stated the supplies were not adequate and the dietary staff needed to spend more time on getting everything organized and a more detailed written plan to include portion sizes and the puree menu.

Based on observations, staff interviews and administrative document review, the hospital failed to maintain the relative humidity, temperature, and ventilation system in the perioperative areas such as operating rooms (ORs), sterile processing area, and decontamination room within acceptable standards in accordance with nationally recognized infection control guidelines when:

1. The staff was not able to ensure the ventilation of the scope room (decontamination room) and adjacent areas in the endoscopy department were maintained when the door was kept open throughout the day;

2. The recorded temperature for the operating room(s), decontamination room(s) and the processing room(s) in the main hospital and/or outpatient surgery were out of normal range on multiple occasions and some of them had no documented evidence of notification or correction for variances in accordance with the hospital's protocol;

3. The recorded humidity levels for the operating room(s), decontamination room(s) and the processing room(s) in the main hospital and/or outpatient surgery were out of normal range on multiple occasions and some of them had no documented evidence of notification or correction for 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 operative settings would cause contamination of the sterile field, increasing the risk of surgical site infection.

Findings:

1. During an observation and a concurrent interview in the scope room (decontamination room) of the endoscopy department on 7/17/12 from 9:20 a.m. to 10:30 a.m., the door of the scope room was kept open. The scope technician (ST) confirmed the door of the scope room was kept open at all times until the end of the day.

During an interview with the Infection Control Practitioner (ICP) on 7/18/12 at 10 a.m., the ICP stated that the hospital used the AORN (Association of periOperative Registered Nurses) and the CDC (Centers for Disease Control and Prevention) as references for the OR infection control practice. The ICP also stated that she could not ensure the ventilation system be maintained when the door was kept open at all times.

On 7/19/12 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 XI.a. The decontamination area...should contain...proper ventilation...Keeping the door closed supports the functioning of the building ventilation system which is designed to vent potentially contaminated room air out of the building, minimizing contamination of the adjacent areas." The section titled "Recommended Practices for a Safe Environment of Care" indicated "Recommendation V.e. Air-flow patterns within the perioperative setting should be controlled and uninterrupted."

2. On 7/20/12 at 9 a.m., the temperature record dated 1/2012 for the operating suite of the main hospital, the outpatient center, and the birthing center was reviewed. The recorded temperatures were out of normal range (Operating Room (OR): 68 degrees Fahrenheit (F) to 73 degrees F; Decontamination Room: 60 degrees F to 65 degrees F) on multiple occasions and some of them had no documented evidence of notification or correction for variances in accordance with the hospital's protocol. The out of range information were listed as follows:

Temperature
Main OR (third floor)
Room 1 - 31 of 31 days (the lowest temperature was 60.8 degrees F);
Room 2 - 30 of 31 days (the lowest temperature was 63.1 degrees F);
Room 3 - 28 of 31 days (the lowest temperature was 57.7 degrees F);
Room 4 - 30 of 31 days (the lowest temperature was 62.9 degrees F);
Room 5 - 30 of 31 days (the lowest temperature was 64.7 degrees F);
Room 6 - 28 of 31 days (the lowest temperature was 64 degrees F);
Room 7 - 31 of 31 days (the lowest temperature was 65 degrees F);
Room 8 - 31 of 31 days (the lowest temperature was 61.2 degrees F);
Room 9 - 30 of 31 days (the lowest temperature was 64.3 degrees F);
Room 10 - 30 of 31 days (the lowest temperature was 64.3 degrees F);
Room 11 - 31 of 31 days (the lowest temperature was 66.1 degrees F);
Room 12 - 29 of 31 days (the lowest temperature was 65.4 degrees F);

Outpatient OR
OR 1 - 18 of 19 days (the lowest temperature was 60 degrees F);
OR 2 - 20 of 20 days (the lowest temperature was 61 degrees F);
OR 3 - 20 of 20 days (the lowest temperature was 63 degrees F);

Birthing Center
OR 1 - 30 of 31 days (the lowest temperature was 62 degrees F);
OR 2 - 30 of 31 days (the lowest temperature was 62 degrees F);

Main Hospital (Sterile Processing Department)
Decontamination Room - 30 of 31 days (the highest temperature was 69.8 degrees F);
Processing Room - 6 of 31 days (from 67.3 degrees F to 76.6 degrees F);

Main OR (third floor supply rooms)
Mini Ballroom - 21 of 31 days (the lowest temperature was 60 degrees F);
Radio Shack - 31 of 31 days (the lowest temperature was 58 degrees F).

On 7/20/12 at 10 a.m., a review of the hospital's policy and procedure titled "Humidity and Room Temperature Controls" dated 6/12 indicated "Temperatures in the Operating Rooms, substerile rooms, sterile rooms and instrument processing areas should be maintained at a range of 68 - 73 degrees F."

On 7/20/12 at 11 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.

3. On 7/20/12 at 9:15 a.m., the humidity record dated 1/2012 for the operating suite of the main hospital, the outpatient center, and the birthing center was reviewed. The recorded humidity levels were out of normal range (30 % [percent] to 60 %] on multiple occasions and some of them had no documented evidence of notification or correction for variances in accordance with the hospital's protocol. The out of range information were listed as follows:

Humidity
Main OR (third floor)
Room 3 - 8 of 31 days (the lowest humidity was 15.3 %);
Room 4 - 1 of 31 days (the lowest humidity was 27.8 %);
Room 5 - 3 of 31 days (the lowest humidity was 24.8 %);
Room 8 - 1 of 31 days (the lowest humidity was 23.6 %);
Room 11 - 1 of 31 days (the lowest humidity was 29.8 %);
Room 12 - 2 of 31 days (the lowest humidity was 25.8 %);

Outpatient OR
Substerile 1/2 - 4 of 20 days (the lowest humidity was 18 %);
Substerile 3 - 3 of 20 days (the lowest humidity was 24 %);

Birthing Center
OR 1 - 7 of 31 days (the lowest humidity was 18.3 %);
OR 2 - 8 of 31 days (the lowest 13.9 %);

Main Hospital (Sterile Processing Department)
Decontamination Room - 11 of 31 days (the lowest humidity was 16.6 %);
Processing Room - 13 of 31 days (the lowest humidity was 15.3 %);

Main OR (third floor supply rooms)
Mini Ballroom - 4 of 31 days (the lowest humidity was 19 %);

On 7/20/12 at 10 a.m., a review of the hospital's policy and procedure titled "Humidity and Room Temperature Controls" dated 6/12 indicated "Relative humidity in the Operating rooms shall be maintained between 30 % - 60 %. This includes the OR suites, mini ballrooms, sub sterile area and instrument processing area...The humidity is documented in each OR, substerile room and sterile storage in the main OR...In the event that the reading is out of range, a hand held reading will be done as a second reading. This reader is kept at the charge desk. In the event that the reading continues to be out of range plant operations will be notified and the surgery will be moved to another suite until the condition is corrected."

Based on observations, staff interviews, and administrative 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 when:

1. No effective system was in place to ensure personnel wore appropriate attire in the operating suite and the endoscopy suite (refer to A 0749, items 1.a.-1.f.);

2. No effective system was in place to ensure personnel used PPE (Personal Protective Equipment -a variety of barriers and respirators used to protect personnel from contact with infectious agents) appropriately in accordance with the hospital's policies and procedures and nationally recognized infection control guidelines (refer to A 0749, items 2.a. - 2.e.);

3. No effective system was in place to ensure personnel performed hand hygiene in accordance with the hospital's policy and procedure (refer to A 0749, items 3a-3d.);

4. The hospital failed to have an effective system to ensure environmental cleaning was performed in accordance with the manufacturer's specifications (refer to A 0749, items 4.a.-4.c.);

5. The hospital failed to have an effective system to ensure endoscopes were effectively disinfected and stored in accordance with nationally accepted standards and the manufacturer's specifications and the hospital's policy and procedure (refer to A 0749, items 5.a.-5.b.)

6. The hospital failed to have an effective system to ensure staff cleaned and disinfected the equipment and/or the reusable instruments effectively between patient use in accordance with the nationally recognized infection control guidelines and/or the manufacturers' specifications (refer to A 0749 items 6.a.-6.d.);

7. The hospital failed to ensure the MSDS (Materials Safety Data Sheet - information for every potentially hazardous chemical includes identification of hazards, precautions or special handling, signs and symptoms of toxic exposure, and first aid treatments for exposure) are readily accessible to all staff (refer to A 0749 item 7);

8. The hospital failed to ensure staff processed surgical instruments in accordance with nationally recognized infection control guidelines and/or the manufacturer's specifications (refer to A 0749, item 8.c. to 8.d.);

9. The hospital failed to ensure staff used the single-use items in accordance with manufacturer's specifications and nationally recognized infection control guidelines (refer to A 0749, item 8.a.);

10. The hospital failed to have an effective system to ensure MRSA (Methicillin Resistant Staphyloccoccus aureus - the strains of Staphylococcus aureus bacteria that have acquired resistance to the antibiotics methicillin, oxacillin...) screening was performed within 24 hours of admission in accordance with the hospital's policy and procedure (refer to A 0749 item 9);

11. The hospital failed to have an effective system to ensure the physician performed daily assessment of central line (a tube that healthcare providers place in a large vein in the neck, chest, or arm to give fluids, blood, or medications or to do certain medical tests quickly) necessity for all patients with central lines on unit (refer to A 0749, item 10);

12. The hospital failed to ensure the surgical suits were stored in accordance with nationally recognized infection control guidelines (refer to A 0749, item 11);

13. The hospital failed to have an effective system to ensure personnel were consistently screened for infectious diseases in accordance with nationally accepted standards (refer to A 0749, item 12.a.-12.c.);

14. 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 (the large airway at the top of the lung), colon, bladder, stomach or intestine], decontamination room, sterile processing areas, sterile storage and post anesthesia care unit) (refer to A -726, items 1-3); and

15. The hospital failed to designate an individual as its infection control officer to develop and implement policies governing control of infections and communicable diseases (refer to A 0748).

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

Based on observations, staff interviews, and administrative document review, the hospital failed to have an active, hospital-wide infection control program reflecting the infection control practitioner's responsibilities for measures to identify, investigate, report, prevent and control infections and communicable diseases 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 {the large airway at the top of the lung}, colon, bladder, stomach or intestine], decontamination room, sterile processing areas, sterile storage and post anesthesia care unit) when:

a. Three (3) of three (3) staff members (DRT, ST1, HK 3) did not cover their facial hair completely when working in the restricted areas (operating rooms, procedure rooms, and the clean core area) and semi-restricted areas (the storage areas for clean and sterile supplies, work areas for storage and processing of instruments, scrub sink areas, and corridors leading to the restricted areas of the surgical suite);

b. One (1) staff members (MD 11) did not cover the hair completely when working in the restricted areas;

c. One (1) staff member (RN 12) did not secure the mask with the bottom ties when working in the procedure room of the cardiac catheterization laboratory;

d. One (1) staff member (MD 11) had the mask hanging around neck in the PACU (Post Anesthesia Care Unit);

e. Two (2) of 2 staff members (RN 12, ST 2) did not cover the personal clothing completely under the surgical attire while working in the restricted area;

f. The staff were not required to wear surgical attire in the endoscopy suite where procedures were performed;

2. The hospital failed to ensure staff members (ST, DRT, HK 2, RN 15) and visitors used PPE (Personal Protective Equipment -a variety of barriers and respirators used to protect personnel from contact with infectious agents) appropriately in accordance with the hospital's policies and procedures and nationally recognized infection control guidelines;

3. The staff members (ST, HK 2, LT did not perform hand hygiene in accordance with the hospital's policy and procedure;

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

a. There was no environmental cleaning between procedures in the ultrasound procedure room in the nuclear medicine department;

b. The staff member (HK 2) cleaned multiple surfaces with one cleaning cloth/wipe in the Emergency Department;

c. The dirty and clean sinks were in the Dialysis Unit of the hospital were not used according to standards of care.

5. The hospital failed to have an effective system to ensure endoscopes were effectively disinfected and stored in accordance with nationally accepted standards and the manufacturer's specifications and the hospital's policy and procedure when:

a. The Cidex solution (a high-level disinfectant for processing of endoscopes) was not monitored in accordance with nationally recognized infection control guidelines and the manufacturer's specifications and hospital's policy and procedure;

b. Six (6) processed endoscopes were not hung in the vertical position in the storage cabinets;

6. The hospital failed to have a system to ensure staff cleaned and disinfected the equipment and/or the reusable instruments effectively between patient use in accordance with the nationally recognized infection control guidelines and/or the manufacturers' specifications when:

a. Five (5) of 6 staff members (RN 1, RN 2, RN 3, RN 5, RN 11 ) did not clean and disinfect the glucometer (a device for checking blood glucose) in accordance with the manufacturer's instructions;

b. The staff member (RN 15) used one disinfectant wipe on multiple surfaces while cleaning and disinfecting the dialysis machine and clamps after patient use;

c. Yellowish residues were observed on the surgical clipper handle in the medication room of the outpatient surgery;

d. The hospital did not maintain the ventilator tubing in accordance with nationally recognized infection control guidelines;

7. The staff member (HK 4) was unable to access the MSDS (Materials Safety Data Sheet - information for every potentially hazardous chemical includes identification of hazards, precautions or special handling, signs and symptoms of toxic exposure, and first aid treatments for exposure) information in the outpatient surgery.

8. The hospital failed to have an effective system to ensure staff complied with the nationally recognized infection control guidelines and the manufacturer's specifications when:

a. The staff member (LT) used the single-use syringes and one cleaning cloth/wipe on more than one set of soiled instruments;

b. Hand-washing sink was not available in the endoscope decontamination area;

c. The staff did not ensure the surgical instruments were effectively sterilized when 10 of 76 pairs of scissors and clamps of various types were observed in the sterile pouches with blades closed;

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

9. One (1) of 8 patients' medical record reviewed (Patient 26) showed no MRSA (Methicillin Resistant Staphylococcus aureus - the strains of Staphylococcus aureus bacteria that have acquired resistance to the antibiotics methicillin, oxacillin...) screening within 24 hours of admission in accordance with the hospital's policy and procedure;

10. The hospital failed to have an effective system to ensure the physician performed daily assessment of central line (a tube that healthcare providers place in a large vein in the neck, chest, or arm to give fluids, blood, or medications or to do certain medical tests quickly) necessity for all patients with central lines when 5 of 7 patients' medical records reviewed (Patients 23, 27, 28, 30 and 31) showed no daily assessment of the central line necessity;

11. The hospital failed to store the clean surgical scrubs in accordance with the nationally recognized infection control guidelines when clean surgical scrub suits were observed being stored on the uncovered shelves in the female and male locker rooms in the operating suite of the hospital and the outpatient surgery center;

12. 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 19 healthcare workers' (HCWs') files reviewed (MD 1, MD 3, MD 6, MD 7, MD 8, and PA 1) showed no annual TB (tuberculosis) symptom screen;

b. Five (5) of 19 HCWs' files reviewed (MD 1, MD 6, MD 7, MD 8, and PA 1) showed the HCWs did not receive annual TST (Tuberculin Skin Test);

c. Nine (9) of 19 HCWs' files reviewed (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, MD 8, and PA 1) indicated the aforesaid HCWs did not have documented immunity to (or have vaccination against) MMR (mumps, measles, rubella), varicella (chicken pox), and hepatitis B.

13. The hospital failed to ensure food items on the food trays were covered.

14. The hospital failed to ensure three of three ice machines were maintained in a sanitary condition according to manufacturer's guidelines.

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.

Findings:

During an interview with the Infection Control Practitioner (ICP) on 7/20/12 at 8:15 a.m., the ICP stated the hospital had selected the CDC (Centers for Disease Control and Prevention), the AORN (Association of periOperative Registered Nurses) as infection control guidelines for its Infection Control Program.

1.a. During an observation and a concurrent interview with the housekeeping staff (HK 3) in the soiled utility specimen drop off room of the OR suite on 7/17/12 at 11:20 a.m., HK 3's facial hair was not covered. HK 3 stated he should have worn a mask in the semirestricted area.

During an observation and a concurrent interview in the decontamination room of the sterile processing department on 7/17/12 at 3:15 p.m., the decontamination room technician (DRT) was wearing a mask; the mask did not cover his nose and did not cover his facial hair completely. The director of the central processing department (DCP) stated the DRT should have covered his facial hair and nose completely in the decontamination room which was a semirestricted area.

During an observation and a concurrent interview in the operating room (OR) 3 on 7/18/12 at 10 a.m., the scrub technician (ST 1) did not cover his facial hair in the OR 3. The ICP stated ST 1 should have covered his facial hair in the OR.

On 7/18/12 at 11 a.m., a review of the hospital's policy and procedure titled "(Name of the hospital) Operating Room Department and Surgery Center - Wearing Apparel in the Operating Room" dated 6/12 indicated "Surgical hats and hoods...that completely cover all possible head and facial hair are to be worn by all persons entering the O.R. restrictive area...References...AORN Perioperative Standards and Recommended Practices (2012 edition)."

On 7/18/12 at 11:30 a.m., the 2012 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. The section titled "Recommended Practices for Surgical Attire" indicated "Recommendation IV. - All personnel should cover head and facial hair, including sideburns and the nape of the neck, when in the semirestricted and restricted areas."

1.b. During an observation and a concurrent interview on 7/17/12 at 11:25 a.m., the anesthesiologist (MD 11) did not cover his sideburns and the hair at the nape of his neck in the OR 3. The OR registered nurse (RN 25) stated MD 11 should have covered his hair and sideburns completely in the OR.

On 7/18/12 at 11:30 a.m., the 2012 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. The section titled "Recommended Practices for Surgical Attire" indicated "Recommendation IV. All personnel should cover head and facial hair, including sideburns and the nape of the neck, when in the semirestricted and restricted areas."

1.c. During an observation and a concurrent interview in the cardiac catheterization (a procedure done by the doctor by putting a plastic catheter into the leg artery or arm artery into the heart and the doctor would determine if there is any heart disease) laboratory on 7/18/12 at 2:25 p.m., the registered nurse (RN 12) did not secure the mask with the bottom ties when working in the cardiac catheterization laboratory. There was a leak at the mask-face seal while RN 12 was talking. RN 12 acknowledged that he had cut the bottom ties of the mask and he used only the upper ties at the back of his head to secure his mask. The manager of the catheterization laboratory (CLM) stated RN 12 should have secured the mask with the upper and bottom ties at the back of the head and behind the neck.

On 7/18/12 at 11:30 a.m., the 2012 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. The section titled "Recommended Practices for Surgical Attire" indicated "Recommendation VI.a. The mask should cover the mouth and nose and be secured in a manner to prevent venting. A mask that is securely tied at the back of the head and behind the neck decreases the risk of health care personnel transmitting nasopharyngeal and respiratory microorganisms to patients or the sterile field. Infectious particles can reach the wearer's nose and mouth by passing through leaks at the mask-face seal.

1.d. During an observation and a concurrent interview on 7/17/12 at 11:50 a.m., MD 11 had the mask hanging down from his neck in the PACU. The PACU registered nurse (RN 26) stated MD 11 should not have the mask hanging down from his neck.

On 7/18/12 at 11:30 a.m., the 2012 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. The section titled "Recommended Practices for Surgical Attire" indicated "Recommendation VI.b.1 Mask should not be worn hanging down from the neck."

1.e. During an observation and a concurrent interview in the OR 6 on 7/17/12 at 11:25 a.m., the scrub technician (ST 2)'s personal clothing extended above the scrub top neckline. The OR registered nurse (RN 27) stated the personal clothing should have been covered by the surgical attire.

During an observation and a concurrent interview in the cardiac catheterization laboratory on 7/18/12 at 2:25 p.m., RN 12 did not cover his personal clothing below the sleeves of the surgical attire. The CLM stated RN 12's personal clothing should have been completely covered by the surgical attire.

On 7/18/12 at 3 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 ambulatory surgery centers...endoscopy suites...and all other areas where operative and other invasive procedures may be performed...Recommendation III.b.1. - 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. On 7/18/12 at 8:15 a.m., during an observation in the GI/Endoscopy procedure area (area where invasive procedures were performed) all staff were observed not wearing surgical masks in the semi-restricted and restricted areas.

On 7/18/12 at 9:33 a.m., MD 1 and MD 3 were observed in street clothes in the GI/endoscopy unit. MD 1 and MD 3 were not wearing hospital approved scrubs, mask, or gloves. MD 1 and MD 3 did not wash hands or used hand sanitizer after completing endoscopic procedures and before using the computer keyboard for data entry.

On 7/18/12 at 10:20 a.m., during a tracer of Patient 18's surgical procedure of an endoscopy (instrument is passed into the body for the purpose of visual examining the interior of a bodily canal) and colonoscopy ( examination of the upper portion of the rectum with a scope) with multiple biopsies in the GI/Endoscopy Suite 2, RN/ENDO 1, and RN/ENDO 2, were observed not wearing masks during a surgical procedure.

On 7/18/12 at 10:15 a.m., during an interview, CNE 1 and CNE 2 confirmed MD 1 and MD 3 should have worn protective clothing and practiced hand hygiene during these procedures to prevent the cross contamination.

On 7/18/12 at 10:25 a.m., during an interview, staff 6 and Endo/Dir validated and stated that staff should have worn mask during surgical procedures in the GI/endo restricted area. CNE staff 6 and ENDO/Dir stated, it was the hospital policy. staff 6 stated, "They are aware of our infection control policy and procedure."

The hospital policy and procedure titled" dated 12/96 and revised 05/11 indicated, "Policy: A. Hand hygiene is indicated by all Medical Staff, Allied Health, and all staff ... 1. At the start of duty 2. Before: a. Patient contact b. Donning gloves c. Clean and antiseptic procedures ... 3. After: a. Patient contact b. Removing gloves."

2.a. During an observation and a concurrent interview in the scope room (decontamination room) of the endoscopy suite on 7/17/12 at 9:20 a.m., the scope technician (ST) did not wear a mask while decontaminating the contaminated endoscopes.

During an interview with the ICP on 7/18/12 at 12:05 p.m., the ICP stated ST should have worn a mask while decontaminating the soiled endoscopes.

On 7/18/12 at 1 p.m., a review of the hospital's policy and procedure titled "(Name of the hospital) GI Lab. IC: Personal Protective Equipment in the GI Lab (Gastrointestinal Laboratory)" dated 7/12 indicated "Masks will be worn and are located outside procedure room entrances and in scope cleaning room: a. when cleaning and disinfecting scopes..."

2.b. During an observation and a concurrent interview in the decontamination room of the sterile processing department on 7/17/12 at 3:15 p.m., the DRT was wearing a mask; the mask did not cover his nose. The DCP stated the DRT should have covered his nose with mask in the decontamination room while performing the decontamination task.

On 7/18/12 at 1 p.m., a review of the hospital's policy and procedure titled "(Name of the hospital) Sterile Processing Department. Decontamination of Reusable Items" dated 1/10 indicated "Basic Decontamination Procedures...Sterile Processing personnel shall wear the following personal protective equipment while working in decontamination room...Disposable mask..."

2.c. During an observation and a concurrent interview with the registered nurse (RN 28) and the emergency department manager (RN 29) in the emergency department on 7/17/12 from 4:10 p.m. to 4:20 p.m., the housekeeping staff (HK 2) was performing the environmental cleaning in the clinical area after the patient had left. HK 2 high-dusted the ceiling and the vent with no protection of eyes and face and clothing. RN 28 and RN 29 acknowledged that the dust or microorganisms might fall on HK 2's face, eyes and clothing while HK 2 was cleaning the ceiling without protection.

On 7/20/12 at 9 a.m., a review of the hospital's policy and procedure titled "(Name of the hospital) Environmental Services Policy and Procedure Manual: Cleaning Patient Rooms - Discharge and Transfers" dated 4/12 with the ICP and a concurrent interview was conducted. The aforesaid document indicated "Standard precautions will be maintained at all times with appropriate use of PPE." The ICP acknowledged that dust might fall on HK 2's face and eyes. The ICP also stated HK 2 should have used standard precautions with appropriate use of PPE such as goggles and mask for protection.

2.d. During the observations on the dialysis unit on 7/19/12 from 12:35 p.m. to 2:25 p.m., the registered nurse (RN 15) did not wear a gown for protection when performing the dialysis procedure which included the initiation and termination of dialysis (a procedure that removes waste and water from the blood).

During an interview with the ICP on 7/20/12 at 9:45 a.m., the ICP stated RN 15 should have worn gowns for protection if any blood splashing was anticipated. The ICP also stated RN 15 should have followed the CDC guidelines of appropriate PPE use.

On 7/20/12 at 10 a.m., a review of the CDC's "MMWR (Morbidity and Mortality Weekly Report): Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients" dated 4/27/2001 indicated "Infection Control Practices for Hemodialysis Units...Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood)..."

2.e. On 7/17/12 at 9:35 a.m., during an observation in Patient 10's room, two family visitors were not wearing gowns and gloves. Patient 10 was diagnosed with MRSA and C. deficile (a highly contagious bacterial infection) and the room had posted written instructions for all visitors and staff to wear the protective gown and gloves prior to entering the room.

On 7/17/12 at 9:40 a.m., during an interview, RN 35 (4th floor charge nurse) and CNE 1 validated the observation and acknowledged all visitors in Patient 10's room should have been wearing protective gowns and gloves.

2f. On 7/20/12 7:50 a.m., during an observation in Patient 35's room, a family visitor was not wearing a gown and gloves. Patient 35 was diagnosed C.deficile (a highly contagious bacterial infection) and the room had posted written instructions for all visitors and staff to wear the protective gown and gloves prior to entering the room.

On 7/20/12 at 8 a.m., during an interview, CNE 1 and CNE 2 validated this observation and acknowledged that the visitor in Patient 35's room should have been wearing the protective gown and gloves.

2g. On 7/19/12 at 8:43a.m., during a tour of the OR's (operating room's) Scrub Technician (ST 1) was observed not wearing a surgical mask or eye protection when terminally cleaning and preparing the operating room 6 for the next sterile procedure.

On 7/19/12 at 8:45 a.m., during an interview with ST 1 stated he should have been wearing eye protection and surgical mask while terminally cleaning and preparing the operating rooms for the next sterile procedure.

On 7/19/12 at 8:48 a.m., during a concurrent interview CNE 1 and OR/MG validated ST 1 should have been wearing the surgical mask and eye protection during terminally cleaning and preparing of OR 6.

3a. During the observations and a concurrent interview in the scope room (decontamination room) of the endoscopy suite on 7/17/12 between 9:20 a.m. to 9:35 a.m., ST decontaminated and processed endoscopes; ST changed gloves for 3 times; ST did not performed any hand hygiene after removing gloves for 3 times. ST acknowledged that he did not perform hand hygiene after removing gloves.

3b. During an observation and a concurrent interview with RN 28 and RN 29 in the emergency department on 7/17/12 from 4:10 p.m. to 4:20 p.m., HK 2 was performing environmental cleaning in the clinical area after the patient had left. HK 2 changed gloves twice and no hand hygiene was performed after removing gloves. RN 28 and RN 29 confirmed the above observations.

3c. On 7/18/12 at 9:06 a.m., during an observation in the GI pre-op unit, MD 3 examined Patient 18. MD 3 was observed listening to Patient 18's chest and abdomen with a stethoscope [a medical device for listening to internal organs]. MD 3 did not clean the stethoscope before or after the examination. MD 3 did not wash his hands or use hand sanitizer before or after examining Patient 18's ankles and feet.

On 7/18/12 at 10:15 a.m., during an interview, CNE1 and CNE 2 confirmed MD 1 and MD 3 should have worn protective clothing and practiced hand hygiene during these procedures to prevent the cross contamination.

3d. During the observations and a concurrent interview in the decontamination room of outpatient surgery center on 7/18/12 at 10:20 a.m., the sterile processing technician (LT) was decontaminating the soiled instrument; LT removed one glove and picked up the phone; LT put on a clean glove after answering the phone. LT did not perform any hand hygiene after removing the glove. The ICP confirmed the above observations.

3e. On 7/18/12 at 10:20 a.m., during a tracer of Patient 18's surgical procedure (endoscopy and colonoscopy with multiple biopsies) in GI/Endoscopy Suite 2, RN/ENDO 2 was observed removing gown and gloves, leaving the ongoing surgical procedure in Suite 2 for supplies and returning with out washing of hands prior to regowning and donning of gloves.

3f. On 7/17/12 1:10 p.m. duirng an observation, Host A was observed delivering food trays on the fifth floor of the surgical unit to patient rooms 5202-5246. Host A was observed setting up bedside tables, touching food trays, and patient curtains in multiple rooms without using hand hygiene between each room.
On 7/17/12 at 1:35 p.m., during an interview, the RDC acknowledged Host A did not use hand hygiene when passing food trays to the patients. The RDC stated the host should have used hand sanitizer between patients.
On 7/18/12 at 8:35 a.m., during an interview, the DD&NS stated the host should use hand hygiene when delivering patient trays. She stated dietary staff follow hospital policy on hand hygiene. The DD&NS stated this had not been looked at when they did host audits.
On 7/19/12 at 10:35 a.m., during an interview the ICP stated, she does environmental rounds twice a year in the kitchen. At times, she would observe tray delivery. The ICP stated, it is her expectation for the hosts to use either hand sanitizer or wash hands between deliveries of trays.
On 7/20/12 at 9 a.m., a review of the hospital's policy and procedure titled "(Name of the hospital) Interdisciplinary Policy and Procedure Manual - Hand Hygiene" dated 5/11 indicated "Hand hygiene is indicated by all Medical Staff, Allied Health, and all staff at the following times...After removing gloves..."

4.a. During an interview with the Ultrasound Supervisor (USS) in the ultrasound procedure room of the Nuclear Medicine Department on 7/17/12 at 8:40 a.m., the USS stated there was no environmental cleaning between procedures.

During an interview with the ICP on 7/18/12 at 12:15 p.m., the ICP stated the staff members should have performed environmental cleaning between procedures.

On 7/18/12 at 12:30 p.m., a review of the hospital's policy and procedure titled "Nuclear Medicine General Rules" dated 3/12 indicated "Camera preparation between patients. 1. Prior to placing on the table wipe with Clorox Wipes or Oxivir depending on prior patient condition. 2. Clean linen always applied when new patient goes on table...4. Table cleaned with Oxivir or Clorox wipes once patient is completed from table and prior to next patient..."

4.b. During an observation and a concurrent interview with RN 28 and RN 29 in the emergency department on 7/17/12 from 4:10 p.m. to 4:20 p.m., HK 2 was performing environmental cleaning with Quat (a disinfectant cleaner) in the clinical area after the patient had left. HK 2 used 1 disinfectant wipe/cloth on multiple surfaces such as pillow, wall on 3 sides; HK 2 used another disinfectant wipe/cloth on both side rails, the mattress, and the bottom of bed...etc. When asked how long the disinfectant should stay on the surfaces in order to be effectively disinfected, HK 2 stated that the contact time was 10 minutes. RN 28 and RN 29 confirmed the above observations.

During an interview with the ICP on 7/18/12 at 12:05 p.m., the ICP acknowledged that 1 disinfectant wipe/cloth on multiple surfaces would not keep the wiped surfaces wet for 10 minutes and would not achieve the disinfecting purpose.

On 7/18/12 at 12:15 p.m., a review of an undated document titled "Neutral Quat Disinfectant Cleaner" indicated "HBV (hepatitis B virus) and HCV (hepatitis C virus) are inactivated after a 10-minute contact time. Use a 10-minute contact time for all other viruses, bacteria and fungi listed...Disinfection/Cleaning Directions...Remove heavy soil deposits from surface. Then thoroughly wet surface with a use-solution of 1/2 oz. (ounce) of concentrate per gallon of water. The use-solution can be applied with a cloth...Let solution remain on surface for a minimum of 10 minutes. Rinse or allow to air dry..."

4c. On 7/19/12 at 12:40 p.m., during an observation in the Fifth Floor Dialysis Unit, two sinks were observed in the patient care area. The sink on the left hand side was designated as "Clean" by a sign directly above the sink faucets. The sink on the right hand side was designated as "Dirty" by a sign directly above the sink faucets. The sinks were divided by a physical barrier.

During the observation, staff members were observed washing hands in both sinks multiple times. Soiled patient care items were placed in the right hand sink for cleaning and disinfection. Items previously cleaned and disinfected were stored on the counter top next to the designated "Dirty" sink.

On 7/19/12 at 12:42 p.m., during an interview, RN 15 stated she and other staff members were confused about which sink to use for hand washing and pointed out there was inadequate counter top storage space on the "Clean" side to store clean and disinfected patient care items.

In a cabinet immediately above the "Dirty" sink, food items were found to include: soda, juices, crackers, peanut butter, and jelly. In a cabinet immediately bellow the "Dirty" sink, seven packages of sterile blood sample collection tubes were stored on a shelf.

On 7/19/12 at 12:43 p.m., during an interview, RN 15 stated the food items were intended for patient use and the blood collection tubes were stored in the cabinet for convenience.

O 7/19/12 during an administrative document review, The Center for Disease Control document titled, "GUIDELINE for HAND HYGIENE in HEALTH-CARE SETTINGS" dated, October 25, 2002 indicated, "...investigations have indicated an association between infections and linked with poor adherence to hand hygiene."

5.a. During an interview with ST in the scope room of the endoscopy suite on 7/17/12 at 9:20 a.m., ST stated the Cidex solution was monitored and tested daily.

On 7/17/12 at 9:25 a.m., a review of the manufacturer's specification printed on the Cidex OPA solution Test Strips vial indicated "Direction for use: When to test - Test solution before each usage to guard against dilution, which may lower the ortho-phthaldehyde level of the solution below its MEC (minimum effective concentration)..."

On 7/18/12 at 3 p.m., the 2012 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. The section titled "Recommended Practices for High-Level Disinfection" indicated "Recommendation IV.c.2. A test strip...for the disinfectant and minimum effective concentration of the active ingredient should be used for monitoring solution potency prior to each use."

5.b. During an observation and a concurrent interview in the endoscope storage area of the endoscopy suite on 7/17/12 at 9:50 a.m., the endoscopy registered nurse (RN 30) stated the hospital had selected AORN recommendations for guidance of infection control practice in the endoscopy department. Five (5) bronchoscopes (the lighted flexible tubular instrument that is inserted into the airway to diagnose and to remove inhaled objects) (BF P60; 3C 40; BF Q180; BF IT60; and BF UC180F) and an endoscopic ultrasound (GF-UCT140) were not vertically hung in 2 of 4 storage cabinets. The bronchoscopes and the endoscopic ultrasound were coiling on the built in hooks in the cabinets. Portion of the endoscopic ultrasound stayed on the bottom of the storage cabinet. RN 30 acknowledged that the bronchoscopes and the endoscopic ultrasound were not vertically hung.

On 7/18/12 at 9 a.m., a review of the hospital's policy and procedure titled "(Name of the hospital) Sterile Processing Department - Cleaning and Processing Flexible Endoscopes" dated 11/11 indicated "Storage...Endoscopes are returned to the proper storage cabinet using a covered transport bin and hung vertically in their designated spot...References...AORN Perioperative Standards and Recommended Practices...2010 Edition."

On 7/18/12 at 3 p.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 with...adequate height to allow flexible endoscopes to hang without touching the bottom of the cabinet...hanging in a secure vertical position...When flexible endoscopes are hung in the vertical position, coiling or kinking is prevented..."

6.a. During an interview with the registered nurse (RN 2) in the intensive care unit (ICU) on 7/16/12 at 12:05 p.m., RN 2 stated the glucometer was disinfected every 24 hours and as needed when visibly soiled or failed in the quality control test. RN 2 also stated he had used the glucometer on that day, but he did not clean and disinfect the device because the strip holder and the exterior portion of the glucometer did not look soiled.

During an interview with the registered nurse (RN 3) in the ICU on 7/16/12 at 12:20 p.m., RN 3 stated the glucometer was disinfected every 24 hours and as needed when visibly soiled. RN 3 also stated she had used the glucometer every 6 hours on that day; she cleaned and disinfected the device about 1 month ago when the device looked soiled to her. RN 3 also stated she cleaned the exterior portion of the device only and she did not clean the strip holder.

During an interview with the ICU Charge Nurse (RN 1) on 7/16/12 at 1:30 p.m., RN 1 stated she used Gluco-Chlor wipe (a disinfectant wipe) for cleaning and disinfection of the glucometer. RN 1 also stated the wipe needed to stay on the surface for

Based on observation, staff interview, and administrative document review, the hospital failed to ensure surgical services were well organized and followed acceptable standards of practice when:

1. No system was in place to ensure relative humidity, temperature and ventilation systems in the perioperative areas (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 (the large airway at the top of the lung), colon, bladder, stomach or intestine], decontamination room, sterile processing areas, sterile storage and post anesthesia care unit) were maintained within nationally recognized guidelines. (refer to A726, findings 1, 2 and 3)

2. No effective system was in place to ensure personnel wore appropriate attire in the operating suite and the endoscopy suite. (refer to A 749 findings 1a-1f, A 951, finding 1)

3. No effective system was in place to ensure endoscopes were disinfected and stored in accordance with nationally accepted standards. (refer to A 749, findings 5a, 5b)

4. No effective system was in place to ensure staff processed surgical instruments in accordance with nationally recognized standards and/or manufacturer's guidelines. (refer to A 749, finding 8c, 8d)

5. No effective system was in place to ensure surgical attire were stored in accordance with nationally recognized guidelines. (refer to A 749, finding 11).

6. No system was in place to ensure Central Supply equipment carts were not stored in surgical suites while procedures were occurring. (refer to A 951, finding 2)

7. No system was in place to ensure surgical staff performed hand hygiene in accordance with accepted standards and hospital policy and procedure. (refer to A 749, findings 3a, 3c, 3d)

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

Based on observation, staff interview, and administrative document review, the hospital failed to maintain high standards of medical practice and patient care when:

1. MD 1 and MD 3 performed esophagogastroduodenoscopy (EGD - a visual examination of the lining of the tube that connects the mouth to the stomach and first part of the intestines) without wearing surgical attire.

2. A Central Supply equipment cart was placed in the operating room while a surgical procedure was ongoing.

These failures had the potential to cause cross contamination.

Findings:

1. On 7/18/12 at 9:30 a.m. during an observation, MD 3 had completed an EGD procedure in Gastrointestinal (GI Lab) Laboratory 2 suite. MD 3 was wearing street clothes.

On 7/18/12 at 9:33 a.m., during an interview, MD 3 stated, "These are my personal clothes from home," referring to the clothes he was wearing in the GI lab while perfomring the EGD procedure. MD 3 indicated that he came into the hospital from home in the clothes he was wearing.

On 7/18/12 at 10:07 a.m. during an observation, MD 1 walked out from the GI Lab 1 suite after completing a colonoscopy (examination of the large intestine with a medical device equippped with a camera) procedure in street clothes.

On 7/18/12 at 10:10 a.m. during an interview, MD 1 stated, "I have been doing this for (performing colonoscopy) 25 years. I have never worn scrubs and hair net or mask."

On 7/18/12 at 10:15 a.m. during an interview, Chief Nursing Executive (CNE) 1 stated, "They (referring to MD 1 and MD 3) are made aware they have to wear PPE (personal protective equipment [gowns, gloves, masks, hair net, and shoe coverings) in restricted areas."

The hospital policy and procedure titled, "Memorial Medical Center Modesto Operating Room Department ... IC: Wearing Apparel in the Operating Room" dated 10/85 and revised 6/12 indicated, "I. Policy: A. All persons entering the operating room suite will be attired appropriately ... B. Surgical attire will be worn that will provide a barrier to outside contamination that may pass from personnel to patient as well as from patient to personnel. II. Purpose: A. To provide guidance and direction to all persons entering the O.R. (operating room). V. Procedure: B. Street clothes are not to be worn within O.R. restricted areas. 1. All persons entering the main O.R. semi restricted areas, restricted areas, and sterile supply rooms shall wear only approved, professionally laundered scrub clothing provided by Memorial Medical Center."

2. 7/19/12 at 8:30 a.m., central supply cart with sterile surgical supplies was observed in the operating room. Some of the sterile supplies were wrapped and some were exposed to the element. A surgical procedurd was in progress.

On 7/19/12 at 8:35 a.m., Assistant Manager of Surgery, AMS stated that the cart should never be in the operating room. She indicated that the central supply cart should have been in the semi sterile room. She also indicated that the unwrapped surgical supplies should have been separated from the wrapped surgical supplies.

On 7/19/12 at 1:30 p.m., during an interview, the Director of Central Processing, DCP stated, "All supplies should be kept in substerile room (semi sterile room) during cases." She also stated that sterile supply cart should not be in the operating room at any time.