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Based on observations, staff interviews, and document review, the hospital failed to have an effective governing body responsible for the conduct of the hospital as an institution when:

1. The governing body failed to ensure an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program (QAPI) recognized that effective infection control policies and procedures were not implemented hospital wide and to include offsite campus'. (refer to A 263)

2. The governing body 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 infection control policies and procedures were not implemented hospital wide to include offsite campus'. (refer to A 747, A 0749 and A 0726)

The cumulative effect of these systemic problems resulted in the hospital's failure to function in a manner to establish a QAPI system to recognize sources of infection to prevent transmission of infections and communicable diseases throughout the organization.

Based on administrative document review and staff interview the hospital failed to ensure the governing body was responsible for the services furnished by contractors when 10 of 13 contracts reviewed lacked assurance the hospital would retain responsibility for the services provided. This placed the patients at a potential risk to receive services that were not monitored.

Findings:

A review of contracts was conducted on 5/8/12 and 5/9/12. Ten of thirteen contracts failed to contain language maintaining hospital responsibility for the services provided. The contracts were dated 6/20/12 for registry staff, 1/2007 as an evergreen contract for coding services, 2/9/12 for blood product services, 5/21/10 for dietary services, 2/13/09 for anesthesia services, 2/4/11 for registry staff, a current record consulting agreement, a revised 2/3/00 contract with an updated letter dated 6/10/03 (as an evergreen contract - a contract that is ongoing until one of the parties involved terminates the contract) tissue procurement, an individual contract for medical consulting dated 10/1/11, an evergreen contract dated 1/23/08 for waste services, and a transcription services contract dated 8/1/05.

On 5/8/12 at 10:00 a.m., Staff 1 stated she was not aware the contract needed to contain a statement that the hospital retained responsibility for the services.

On 5/10/12 at 10:00 a.m., DQ listened to the concern about the failure of the hospital to retain responsibility for the contracted services, slightly nodded her head up and down but made no comment.

Based on observations, staff interviews, and document review, the hospital failed to have an effective governing body responsible for the conduct of the hospital as an institution when it failed to ensure an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program (QAPI) failed to recognize that infection control policies and procedures were not implemented hospital wide and to include offsite campus' when:

1. Traffic patterns in the endoscopy suite and the outpatient surgery center (Campus 2) did not conform to nationally recognized infection control standard of practice (refer to A 0749 items 1.a. to 1.b.);

2. The hospital failed to have an effective system to ensure personnel wore appropriate attire in the operating suite of Campus 1, Campus 2, and the endoscopy suite (refer to A 0749, items 2.a. to 2.f.);

3. 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) when handling contaminated endoscopic equipment (refer to A 0749, item 3);

4. The hospital failed to have an effective system to ensure endoscopes were processed and transported in accordance with nationally accepted standards (refer to A 0749, items 4.a. to 4.b.);

5. The hospital failed to ensure staff decontaminated and processed surgical instruments in accordance with nationally recognized infection control guidelines and/or the manufacturer's specifications and/or the hospital's policy and procedure (refer to A 0749, items 5.a. to 5.h.);
(refer to A 747, A 0749 and A 726)

6. The hospital failed to ensure staff cleaned and disinfected the equipment effectively between patient use (refer to A 0749, item 6);

7. The hospital failed to have a system to ensure the staff used safe medication vial practices in the clinical setting (refer to A 0749, item 7);

8. 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) was readily available (refer to A 0749, item 8);

9. The hospital failed to ensure staff maintained the fluid warmer temperature in accordance with the hospital's policy and procedure (refer to A 0749, item 9);

10. The hospital failed to ensure staff performed hand hygiene after removing gloves (refer to A 0749, item 10);

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

12. Hand-washing facility was not available in the decontamination area of the operating suite in Campus 1 and Campus 2 as well as the endoscopy suite (refer to A 0749, item 12);

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, items 13.a. to 13.g.); and

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, colon, bladder, stomach or intestine], decontamination room, sterile processing areas, sterile storage and post anesthesia care unit) (refer to A 0726 ).

The cumulative effect of these systemic problems resulted in the hospital's failure to function in a manner to recognize and establish a QAPI program to identify and prevent transmission of infections and communicable disease throughout the organization.

Based on administrative document review and staff interview the hospital failed to ensure quality indicators included aspects of performance that assessed hospital contracted services for 11 of 13 hospital contracts reviewed. This placed patients at risk of receiving less than quality care.

Findings:

A review of contracts was conducted on 5/8/12 and 5/9/12. The contracts which lacked the hospital's assurance that the services provided would be included in the hospital wide Quality Assessment and Performance Improvement (QAPI) program included the following. A contract dated 1/2007 as an evergreen (contract that is on-going until terminated by one of the parties) contract for coding services, a contract dated 2/9/12 for blood product services, a contract dated 5/21/10 for dietary services, a 2/13/09 contract for anesthesia services, a 2/4/11 contract for registry staff, a current record consulting agreement, a revised 2/3/00 contract with an attached updated letter dated 6/10/03 as an evergreen contract for tissue procurement, an individual contract for medical consulting dated 10/1/11, an evergreen contract dated 1/23/08 for waste services, a transcription services contract dated 8/1/05 and a pathology contract which was to expire on 8/1/13.

On 5/8/12 at 10:00 a.m., Staff 1 stated she was not aware the contract needed to ensure that the hospital included contracts as a part of the hospital wide Quality Assessment and Performance Improvement (QAPI).

On 5/10/12 at 10:00 a.m., DQ listened to the concern about the failure of the hospital to indicate contracts were included in the hospital wide QAPI program, slightly nodded her head up and down but made no comment.

Based on observation, review of administrative documents, and staff interview, the hospital failed to:

1. Obtain and review quality assurance information regarding two medications prepared by compounding pharmacies. This failure potentially exposed patients to contaminated and/or deteriorated medications.

2. Have the consulting pharmacist develop and coordinate all of the quality assurance activities of the pharmacy services. This failure potentially exposed patients to avoidable medication errors and other adverse effects of medications

Findings:

1. On 5/7/12 at 1:20 p.m., medications stored in a cabinet in the Preoperative area were inspected. LN (Licensed Nurse) 1 was present. An ophthalmic solution (eye drops) compounded (prepared) by the Apothecary Shop of Deer Valley (a pharmacy) was observed to contain six ingredients. The ingredients were cyclopentolate (dilates pupil of eye), tropicamide (dilates pupil), flurbiprofen (relieves inflammation), gatifloxacin (antibiotic), lidocaine (pain relief), and phenylephrine (dilates pupil). LN 1 and DQ (Director of Quality) were both asked for data (information) from the pharmacy which demonstrated that all six ingredients were compatible with one another and for data which showed solutions compounded by the pharmacy were sterile and maintained their potency (strength). These data should be provided on a regular basis by the compounding pharmacy to let the hospital know that the product would produce the desired effects on the eye and was sterile and would not cause infections in the eye. Both LN 1 and DQ indicated that they did not have such information.

On 5/9/12 at 8:50 a.m., a 100 ml (milliliters) bag of intravenous (IV) hydromorphone (narcotic type pain relief drug), 0.2 mg (milligrams)/ml, was observed in the medication room in the MedSurg area of the hospital. LN 7 was present during the observation. The hydromorphone was compounded by PharMedium. At 9:50 a.m. the DQ was asked for quality assurance data for the hydromorphone and again for the ophthalmic solution (above paragraph). The DQ said the hospital did not have any quality assurance information regarding either compounded medications.

2. On 5/8/12 at 9:00 a.m., Pharm (Pharmacist) 1 was questioned regarding developing and coordinating all the activities of the pharmacy services. She was asked what reports she provided to hospital administration regarding actual and potential problems and recommended improvements in pharmacy services at the hospital. She said she provided monthly findings regarding portable emergency carts and patient care unit inspections. Pharm 1 was asked if she participated in the multidisciplinary medication error reduction plan process. She said "I am not on it" meaning she was not part of the process or committee. At 10:25 a.m., Pharm 1 was asked if she maintained a quality assurance program for pharmaceutical services. She said she did not. She also said she did not provide quarterly reports to hospital administration regarding pharmacy operations.

DQ provided the hospital's contract with the consultant pharmacist ("Stanislaus Surgical Hospital Proposal for Pharmacy Services, PharMerica Corporation"). The requirements listed in the contract included: "Maintain criteria based Quality Assurance Program"; "Quarterly written report to Hospital administration regarding pharmacy operations"; and "Quarterly visits by a Regional Director to evaluate and review with the pharmacy manager the operations of Pharmceutical Services as well as meet with the Hospital's administration to review pharmaceutical services." Pharm 1 said there have been no quarterly visits by a Regional Director.

Based on staff interview and administrative document review, the facility failed to implement a Quality Assessment Performance Improvement (QAPI) plan for various departments of the facility and to failed to provide feedback and education of the QAPI plan throughout the facility. These failures had the potential to miss opportunities to improve the quality of care delivered to the patients.

Findings:

1. On 5/8/12 at 9:05 a.m. during an interview on the surgical floors waiting area, LN 19 and LN 20 stated they were aware they were to remove indwelling catheters (tubing inserted into the body to remove urine) as soon as possible. They were unaware of the role they were to play in the QAPI program regarding these indwelling catheters. They were unaware of any other nursing QAPI programs. As examples those QAPI programs included: Patient falls with injury, medication errors and adverse drug event.

2. On 5/10/12 at 10:20 a.m., during an interview near the conference room, Staff 21 stated the radiology department only monitored the staff radiation exposure badges, and was not aware of anything else for quality assessment or process improvement. The QAPI program approved by the governing body did not address any items for the radiology department based on their 2011 indicator report.

On 5/10/12 at 11:50 a.m., during a telephone interview, MD 20 stated that if any problems
(in the radiology department) were brought forward to him at committee meetings when he attends, then they are addressed. He stated the contracted group (at Campus 2) does not have a presence at Campus 1.

On 5/8/12 during review of the current, "Medical Staff Guidelines" dated 7/10/07, "Article III - Medical Director"...section "3.1 Duties and Responsibilities...subsection 3.1.3(b)(c)...the medical director assures that the Department complies with all state and federal regulations concerning the medical standards and procedures applicable to the provision of services...and indicates...the Medical Director shall have duties and responsibilities...under all applicable federal, sate and local laws, rules and regulations...(c)...assisting in the establishment, maintenance, review and implementation of quality assurance and utilization review programs...to the department."

Based on administrative document review and clinical record review, the facility failed to ensure patients had the right to participate in the development and implementation of their plans of care when:

1. Patient care plans did not demonstrate assessments for initial and continuing care needs.

2 Nursing interventions were not documented in response to each problem specific to patient circumstances for 18 of 32 sampled patients (Patients 6, 7, 8, 16 - 30).

These failures placed patients at risk of not receiving individualized care

Findings:

A review of the medical records was conducted on 5/8/12 and 5/9/12. A care plan review of nineteen records demonstrated they lacked plans for the time prior to surgery and immediately after surgery. The care plans did not demonstrate individualization when the space provided for that purpose was left blank for Patients 6, 7, 8, 12, 16 - 30.

1. On 5/8/12 during clinical record review, the following preprinted nursing diagnoses on the care plans for Patients 6, 7, 8, 12, and 16- 30 were: Pain, surgical wound, discharge planning, respirations, urinary output, nausea and vomiting, activity and altered bowel function. The care plans for Patients 6, 7, 8, and 12 had identical documentation in the same boxes on the care plans of checks and circles. The sub-titles included in the care plan were Goals, Interventions/Instructions, Participant, Items Taught, Outcome Code, Resolved, and Signature/Title.

On 5/8/12, during a clinical record review for Patient 6, the following history was identified: blood clots, high blood pressure, gastritis, renal insufficiency (decreased kidney function) and swelling. None of these issues were identified on Patient 6's care plan even though her course of treatment included increased fluids and diuretics (medication to reduce swelling) and eventually was transferred to a higher level of care due to renal failure (kidneys were not working correctly).

2. On 5/9/12 during a clinical record review of Patient 7, the following history was identified Depression and shortness of breath. These issues were not identified on the care plan and eventually Patient 7 was transferred to a higher level of care for respiratory distress.

3. On 5/8/12 during review of the clinical record for Patient 8's the following history was identified: Atrial Fibrillation (irregular heart beats causing blood to not pump normally and clots to form in the heart), medication to prevent blood clotting, and diabetes requiring frequent blood sugar monitoring. These concerns were not identified on the care plan. Eventually the patient was transferred to a higher level of care because of continued shortness of breath and to rule out pulmonary embolism (blood clot to the lungs).

The facility's policy and procedure titled ,"Admission assessment - Plan of care" dated 12/16/10 was reviewed. The policy and procedure indicated the following: "...to determine the care, treatment, and services that meet the patient's initial and continuing needs...Procedure: Plan of Care...1. A nursing care plan will be implemented for each patient upon admission...2. The plan of care will be developed in conjunction with the patient and family...Standardized care plans may be utilized provided the care plan is individualized for each problem specific to patient circumstances..."

Based on observation, staff interview, clinical record and administrative document review, the facility failed to ensure that documentation in Patient 13's clinical record by Physician Assistant 1 (PA 1) was completed based on an updated evaluation of Patient 13. This failure had the potential to place Patient 13 at risk of harm during surgery due to incorrect information.

Findings:

1. On 5/8/12 at 9:15 a.m., during review of Patient 13's clinical record, a preoperative update of the history and physical was noted to have not been completed. At 9:17 - to 9:35 a.m., while interviewing Patient 13, PA 1 entered the preoperative cubicle at 9:30 a.m. and introduced himself and marked the right great toe, indicating the surgical site. Patient 13 arrive in the pre-operative area at 9 a.m. The first contact by PA 1 was when he saw Patient 13 to mark the toe.

On 5/8/12 at 9:35 a.m., during a concurrent interview and clinical record review, Licensed Nurse (LN) 16 reviewed the completed History and Physical (H&P). LN 16 stated...the clinical record date and time are 5/8/12 at 9:00 a.m., the updated evaluation was supposed to be completed ahead of time, but not before the patient is seen or has surgery.

On 5/8/12 during review of Administrative Policy MR.024, titled "History and Physical Requirements" dated 4/2/10, indicated the following: "...All patient's presenting for surgery must have a history and physical on the medical record prior to starting the procedure...Procedure: the patient's surgeon or attending physician will perform a history and physical on the patient...it is required to be updated within 24 hours of the surgical procedure."

Based on staff interview, clinical record reviews and administrative document review, the facility failed to document that Patient 12 had been informed that a medication error had been made. The post operative evaluation did not contain a re-evaluation of Patient 12's medication reaction. The failure to provide information to the hospital staff regarding Patient 12's medication reaction had the potential to create a delay in response and interventions to a medication reaction.

Findings:

1. On 5/8/12 at 2:30 p.m., during a concurrent interview and clinical record review in the Administrative Conference room, the Director of Quality (DQ) indicated that the medication Patient 12 was allergic to, should not have been given. The DQ further indicated, the post operative assessment should have had a reassessment of Patient 12, and should have been disclosed to other team members caring for Patient 12.

On 5/18/12 during review of the clinical record, the preoperative orders had the following date and time, "9/16/2011 at 11:30." The post operative nursing documentation was dated 8/22/11 at 10:22 a.m., as arrival time to the recovery area with MD 12. The post operative documentation indicated the lung sounds had crackles (sounds like popping soda bubbles), followed by wheezing (squeaky sounds) in the chest areas. MD 19's postoperative evaluation form dated 8/22/11 at 12:00 contained checkmarks in the areas: "...respiratory function stable...airway patent..." the comment lines were left blank.

On 5/9/12 during review of an Administrative Policy titled, "Adverse Drug Reaction Reporting" dated 7/1/11 indicated the following: "Purpose...define reporting of adverse dug reactions, medication errors...Medication Error ...a significant medication error...results in temporary or permanent harm to patient...or where a potential for harm to occur...Physician: document occurrence, treatment and sequelae of the adverse drug reaction..."

2. On 5/8/12 at 2:30 p.m., during the same concurrent interview and clinical record review in the Administrative Conference room, the DQ indicated that the medication Patient 12 was allergic to, should not have been given. The DQ further stated, the anesthesia record under comments, listed the complaints and reactions Patient 12 had and that these concerns had been told to MD 19. No assessment was in the clinical record, a sedative and pain medication was given intravenous (IV) and MD 19's entry read, "made him better." DQ stated, an assessment of Patient 12 should have been done at the time of the complaint and a reassessment of Patient 12 should have been done postoperatively. The clinical record documentation indicated that the medication reaction had not been disclosed to Patient 12 or other team members providing care to Patient 12.

On 5/18/12 during review of the clinical record, the preoperative anesthesia assessment by MD 19, indicated that Patient 12 was allergic to Reglan. In the findings and comment area on the same form, MD 19 indicated that Reglan 10 mg was given IV for an upset stomach. On the anesthesia record under notes, MD 19's only entry indicated that 5 to 10 minutes after the intravenous Reglan, Patient 12 complained he was perspiring, felt anxious, and like he needed to move his bowels. MD 19 did not document an assessment. In the space allowed for comments the notes indicated Patient 12 had felt better after sedation and pain medications. Patient 12 was sent to the recovery room and 18 minutes after arrival had began wheezing, requiring IV medications and inhaled medication to stop the wheezing. Patient 12 continued to experience intermittent shortness of breath and wheezing until he was transferred to another facility the following day. The documented preoperative evaluation indicated the orders had been written "9/16/2011 at 11:30." The post operative nursing documentation was dated 8/22/11 at 10:22 a.m., as arrival time to the recovery area with MD 12. The post operative documentation indicated the lung sounds had crackles (sounds like popping soda bubbles), followed by wheezing (squeaky sounds) in the chest areas. The MD postoperative evaluation form dated 8/22/11 at 12:00 contained checkmarks in the areas: "...respiratory function stable; airway patent..." the comment lines were left blank.

Based on observation, staff interview, and review of administrative documents, the hospital failed to ensure medications were stored under correct temperatures in two medication refrigerators and two solution warmers. These failures could have resulted in impotent and/or deteriorated medications being administered to patients.. Administration of such medications could have prevented patients from recovering from illnesses and/or surgical procedures.

Findings:

1. On 5/7/12 at 2:35 p.m., the malignant hyperthermia refrigerator temperature log ("Malignant Hyperthermia Refrigerator Temperature Log") in the Operating Rooms area demonstrated that temperatures were not checked and recorded for Saturdays and Sundays in April and May, 2012. Also, the temperature log indicated the hospital had recorded ranges (36 to 46 degrees Fahrenheit), which were the required temperature ranges for storing most medications requiring refrigeration. The log did not indicate that the hospital was recording temperatures which had actually occurred or had been observed in the refrigerator. LN (Licensed Nurse) 1 said they were "just listing ranges". Likewise, the medication refrigerator in the Preoperative area indicated that temperatures were not recorded for April 21 and 22 (weekend) and April 13.

The hospital's policy and procedures ("Medication Storage Temperature Monitoring") read "Check the temperature daily. Record the temperature in the Medication and Intravenous Solution Temperature Log."

2. On 5/7/12 at 2:50 p.m., a solution warmer was observed with LN 2 in the Substerile 5/6 area of the Operating Rooms. The temperature log ("Medication and Intravenous Solutions Temperature Log Operating Room") demonstrated that temperatures were not monitored Saturdays and Sundays (weekends). Temperatures recorded on the log for May 1 through May 4 were 105 degrees Fahrenheit. LN 2 said they (workers) were "not here" on weekends and that was why temperatures were not recorded. The warmers contained intravenous (IV) and irrigation solutions. On 5/8/12 at 2:00 p.m., temperature logs for the IV and irrigation solution warmers in the Campus 2 Center also demonstrated that temperatures were not monitored on weekends.

The hospital's policy and procedures ("Solution Warming of B. Braun Products") read intravenous "Solutions can be warmed in their overpouches to temperatures not exceeding 104 degrees Fahrenheit for a period of no longer than 14 days." "Irrigation Solutions can be warmed to temperatures not exceeding 104 degrees Fahrenheit and for a period no longer than 30 days."

Based on staff interview and review of administrative documents, the consulting pharmacist failed to develop and coordinate all of the activities of the pharmacy services including quality assurance activities. This failure potentially exposed patients to avoidable medication errors and other adverse effects of medications.

Findings:

On 5/8/12 at 9:00 a.m., Pharm (Pharmacist) 1 was questioned regarding developing and coordinating all the activities of the pharmacy services. She was asked what reports she provided to hospital administration regarding actual and potential problems and recommended improvements in pharmaceutical services at the hospital. She said she provided monthly findings regarding portable emergency carts and patient care unit inspections. Pharm 1 was asked if she participated in the multidisciplinary medication error reduction plan process. She said "I am not on it" meaning she was not part of the process or committee. At 10:25 a.m. Pharm 1 was asked if she maintained a quality assurance program for pharmaceutical services. She said she did not. She also said she did not provide quarterly reports to hospital administration regarding pharmacy operations.

DQ (Director of Quality) provided the hospital's contract with the consultant pharmacist ("... Hospital Proposal for Pharmacy Services,...Corporation"). The requirements listed in the contract included: "Maintain criteria based Quality Assurance Program"; "Quarterly written report to Hospital administration regarding pharmacy operations"; and "Quarterly visits by a Regional Director to evaluate and review with the pharmacy manager the operations of Pharmaceutical Services as well as meet with the Hospital's administration to review pharmaceutical services." Pharm 1 said there have been no quarterly visits by a Regional Director.

Based on observation, review of administrative documents, and staff interview, the hospital failed to keep accurate records of one scheduled medication (also called a controlled drug).

Findings:

On 5/7/12 at 1:20 p.m., a controlled substances cabinet in the Pre-Operative area was inspected with LN (Licensed Nurse) 1. Controlled substances include narcotic type medications such as morphine and Vicodin and sedative type medications such as diazepam (Valium) and midazolam. A bottle of midazolam (2 milligrams/milliliter) oral liquid (given by mouth) was examined. It contained 95 ml (milliliters). The controlled substance record upon which a running inventory was maintained indicated that there should have been 105 ml in the bottle. Therefore, there was a discrepancy of 10 ml because the amount in the bottle did not correspond (was not identical) with the accountability (inventory) record. LN 1 agreed that 10 ml was missing and said there were two additional errors elsewhere in the inventory records.

Hospital policy and procedures ("Controlled Substances Records and Procedures") read "Nursing is responsible for maintaining accurate counts for controlled medications used by nursing."

Based on observation, staff interviews, and review of administrative documents and patient care records, the hospital failed to:

1. Indicate the correct medications on the outside cover of one emergency cart which contained medications. An incorrect listing of the medications in the emergency cart could lead to a medication error. A medication error during a medical emergency could cause injury and/or prevent a patient from recovering from illness or surgery.

2. Ensure that two of two tested licensed nurses could quickly and accurately draw up into syringes doses of three different emergency medications. The failure to quickly and accurately draw up emergency medications could result in injury to a patient and/or prevent him/her from recovering from a medical emergency.

3. Have a pharmacist review new medication orders for patients in the offsite imaging facility. This failure could result in the administration of inappropriate medications and the occurrence of unnecessary adverse effects of medications such as a medication error. Either undesirable outcome could be detrimental to the recovery of patients who had received surgery or were suffering from disease/disorders.

4. Provide for the safety of patients who received opioids (narcotic type pain relief medications) by PCA (patient controlled analgesia) pumps. The hospital's PCA preprinted order form and PCA policy and procedures for administering opioids by PCA pumps did not sufficiently protect patients from overdose. The lack safety also included the observation that a PCA pump was not set up (programmed) correctly for one patient. The inability of nurses to set up PCA pumps correctly could result in either overdose or insufficient pain relief. Overdose of opioids could result in breathing difficulty such as respiratory failure and death.

Findings:

1, On 5/7/12 at 1:40 p.m., a portable emergency cart containing medications (Broselow cart) in the Preoperative area was examined with LN (Licensed Nurse) 1. The list on the outside cover indicated that the cart contained dextrose injection (sugar solution), 25 grams. However, an inspection of the cart revealed that it contained only dextrose injection 2.5 grams. LN 1 said it was a "typo" meaning it was a typographical error on the list.

The California Code of Regulations, Title 22, 70263(f)(2) requires "The contents of the container shall be listed on the outside cover ..." regarding portable emergency containers.
An incorrect listing of the medications in the emergency cart could lead to a medication error. A medication error during a medical emergency could cause injury and/or prevent a patient from recovering.

2. On 5/8/12 at 11:16 a.m., LN 6 in the Surgical Nursing Unit was asked to draw up into syringes specific doses of three emergency medications. The DQ (Director of Quality) was present. She drew up atropine (increases heart rate) and sodium bicarbonate (decreases acid in the blood) correctly. She was asked to draw up 75 mg of lidocaine (decreases heart rhythm disturbances), 20 milligrams (mg)/milliliters (ml). However, she drew up only 70 mg and it required six minutes for her to complete the process of drawing up the lidocaine. On 5/8/12 at 12:50 p.m., LN 4 in the Preoperative area was asked to draw up into syringes specific doses of three emergency medications. Pharm (Pharmacist) 1 was present and observed LN 4 as she drew up the medications. LN 4 correctly drew up into syringes sodium bicarbonate and epinephrine (increases heart rate and blood pressure). However, she incorrectly drew up 0.21 ml of atropine (0.1 mg/ml) instead of 2.1 ml. The correct dose was 2.1 ml and she required 13 minutes to complete the process of drawing up the atropine. LN 4 also appeared not to know which drawers in the portable emergency cart contained the medications. She open two other drawers before finally discovering the medications in the third drawer.

Hospital policy and procedures ("Code Blue Procedure") read "One RN (Registered or Licensed Nurse) will be assigned to prepare and administer appropriate drugs. The failure to quickly and accurately draw up emergency medications could result in injury to a patient and/or prevent him/her from recovering.

3. On 5/8/12 at 3:00 p.m., the offsite Imaging facility was visited with the DQ and Pharm 1. Many containers of medications were observed in the facility which largely were composed of contrast media (used for procedures such as X-rays). Pharm 1 said she did not review new medication orders for patients in the Precision Health Imaging facility, although she said she did review all new medication orders for patients in the hospital. Pharmacists reviewed new medication orders to ensure safety and efficacy (correct and best medication for the disease or disorder). Safety reviews by pharmacists included ensuring patients did not suffer from adverse effects of medications resulting from unwanted events including medication errors, incorrect doses, adverse drug reactions, unwanted drug-drug interactions, and medication allergies. These undesirable outcomes could be detrimental to the recovery of patients who had received surgery or were suffering from diseases or other health disorders.

4. On 5/8/12 at 4:10 p.m., the DQ was asked whether the hospital had safeguards for patients receiving PCAs (patient controlled analgesia). PCAs are continuous intravenous infusions of opioids (narcotic type pain relief drugs such as morphine). She said "I don't know". PCAs allowed patients to press a button which would provide them with a dose of opioid. The button was connected to an intravenous pump (pumped into a vein) which was programmed by nurses according to the prescriber's orders. The programmed pump would allow the patient to receive a specific dose when he/she pressed the button. However it would prevent the patient from receiving another dose for a specific period of time (lockout period). The specific dose and lockout period were determined by the prescriber and programmed into the pump for each patient.

Patient 1's "Patient Controlled Analgesia (PCA) Narcotic Flow Record" was examined. It showed that the patient was started on the PCA on 4/17/12 at 9:25 a.m. From 2:00 a.m. to 6:30 a.m. on 4/18/12, observations of the patient's pain level, sedation, respiratory rate, blood pressure, and blood oxygen saturation (vital signs) were not made. The hospital's policy and procedures "Patient-Controlled Analgesia PCA Procedure" read "Vital signs: a. Check every 15 minutes times one hour; b. Every one hour times two hours. c. Every four hours thereafter." The policy and procedures, therefore, allowed monitoring the patient's vital signs only every four hours after the initial first three hours the patient was placed on the PCA pump. Furthermore, the hospital's "PCA (Patient-Controlled Analgesia) Orders" allowed the prescriber to determine the doses and lockout intervals for patients. The orders did not place any limits on the amount of opioid and the lockout intervals which could be prescribed.

Opioids can and have caused respiratory depression (decreased ability to breathe) and death when prescribed and administered in accidental overdose. Opioids have a narrow therapeutic index. A narrow theraputic index means there is not much difference in doses and dosing intervals between therapeutic ("correct or best") doses and toxic doses which can cause respiratory depression and death. The US Food and Drug Administration (FDA) has defined opioid tolerance (package insert, fentanyl transdermal systems). The FDA has indicated that opioid tolerant patients can receive greater doses of opioids than those who are not tolerant (naive). Patients who are not tolerant are more sensitive and require smaller doses than patients who are tolerant. Tolerance is a unique characteristic of opioids. Therefore, the hospital's PCA orders and policy and procedures for administering opioids by PCA pumps did not sufficiently protect patients from overdose as a result of the following failures:

a. The absence of a procedure to identify patients who were opioid naive,
b. The absence of limits on starting doses of opioids in their PCA order form and policy and procedures,
c. The absence of limits on lockout intervals in their PCA order forms and policy and procedures. Short lockout periods could result in drug overdoses (for example, too many doses per hour),
d. The four hour time periods allowed in their policy and procedures for monitoring patients vital signs after the first three hours.

On 5/8/12 at 4:35 p.m., the PCA pump in Patient 2's room was examined with LN 7 and LN 8. Patient 2 was currently receiving hydromorphone (an opioid) from the PCA pump. LN 8 said the date and time were not set on the PCA pump for Patient 2. LN 8 said, "yes, not everyone knows how to set PCA machines". Nurses who are not well trained and knowledgeable in setting up the pumps correctly to administer opioids to patients present a danger in administering too much or too little opioid. Such a danger could result in breathing difficulty and death or insufficient pain control for a patient.

Based on observation, staff interview, and review of administrative records, the hospital contained expired medications and potentially deteriorated medications from improper storage throughout the hospital. The administration of expired and/or deteriorated medications could prevent patients from recovering from illnesses and surgery procedures.

Findings:

1. On 5/7/12 at 2:40 p.m., the anesthesia cart located in Operating Room 5 was examined with LN (Licensed Nurse) 1. It contained vercuronium (causes muscle paralysis), 10 mg (milligrams)/ml (milliliters), 5 ml. The manufacturer's label indicated it should be stored in the refrigerator but could be stored outside the refrigerator for 60 days. The vercuronium was outside of refrigeration and was not dated regarding when it was removed from refrigeration. A vial (container) of lidocaine (for pain relief), 20 mg/ml, 50 ml, had been opened and partially used and was labelled with the date 5/2/12. LN 2 said it was supposed to have a 28 day expiration dating; that is, it should be dated with the expiration date. It, therefore, indicated that it was expired and should have been removed from use. Two vials of succinylcholine (causes muscle paralysis), 20 mg/ml, 10 ml, were labeled by the manufacturer to be refrigerated but could remain outside refrigeration for 14 days. Neither vial had been dated regarding expiration dates after being removed from refrigeration. Sensorcaine (for pain relief), 0.25%, 50 ml was opened and labeled with the expiration date of 5/2. Lidocaine 2% with epinephrine 1:100/000 (for pain relief), 30 ml, was opened and labeled with the expiration date of 5/2.

2. On 5/7/12 at 2:50 p.m., a solution warmer in the Substerile 5/6 room was examined with LN 3.
The warmer contained the following intravenous (IV) fluids with expiration dates (exp.) affixed to the containers:

2 - 1000 ml normal saline (salt solution) solutions, exp.: 5/7/12
1 - 500 ml lactated ringers (salt solution) solution, no exp. date
1 - 1000 ml lactated ringers solution, exp. 5/1/12
1 - 1000 ml lactated ringers solution, exp. 3/1/12
25 % mannitol (several uses including decreasing pressure on the brain) was stored in the warmer. The manufacturer's label indicated it could be warmed to 80 degrees Fahrenheit to dissolve crystals. The manufacturer's label, however, did not indicate it could be stored at 105 degrees Fahrenheit which was the temperature recorded in the warmer.
1000 ml irrigation solutions of sterile water and normal saline also were stored in the warmer. The sterile water solutions had labels which indicated they expired on 4/17/12 and saline solutions were labeled with expiration dates of 5/1/12.

3. A cabinet in the nursing station in the Operating Rooms area was inspected with LN 2 on 5/7/12 at 3:15 p.m. It contained a product, noclot-50 (anticoagulant citrate dextrose solution, decreases blood clotting) which had an expiration date of 2/12.

4. A cabinet in the Post Anesthesia Care Unit (PACU) nursing station was examined with LN 1 on 5/7/12 at 4:05 p.m. It contained an opened vial of lidocaine, 1 %, 50 ml, with an expiration date of 6/25/12. LN 2 said vials were supposed to list a 28 day expiration date after opening.

The hospital's policy and procedures regarding drug storage ("Storing Drugs") read, "Immediately withdraw any drug from stock which is a. Outdated ...". Another policy and procedures ("Administration of Medications and Treatments") read, "Verifies based on visual examination that the medication is stable and has not expired". The hospital policy and procedures regarding dating of opened multi-dose vials ("Dating of Opened Multi-Dose Vials") read "Opened multi-dose vials expire in 28 days. Mark multi-dose vials with the date that falls 28 days from opening ..." The United States Pharmacopoeia (797), "Pharmaceutical Compounding-Sterile Preparations" is the standard of practice regarding the use of sterile preparations (medications). It read, "multiple-dose containers (e.g., vials) are formulated for removal of portions on multiple occasions because they contain antimicrobial preservatives. The beyond-use date after initially entering or opening (e.g., needle-punctured) multiple-dose containers is 28 days."

The medication room in the PACU contained two bags of morphine, 100 mg/100 ml of normal saline, with expiration dates of 5/6/12.

5. On 5/8/12 at 3:00 p.m., The Computerized Tomography room at the offsite Imaging site was inspected with Pharm (Pharmacist) 1 and the DP (Director of Quality). It contained three vials of dexamethasone injection (antiinflammatory), 4 mg/ml, 1 ml, with expiration dates of 11/11.

Based on staff interview and review of administrative documents, the hospital failed to follow their non-formulary drug request process to ensure the purchase, supply, and administration of quality medications. Such a failure could be detrimental to the health of patients suffering from illnesses and/or surgical procedures.

Findings:

On 5/9/12 at 8:50 a.m., LN (Licensed Nurse) 7 on the Medicine/Surgery unit said physicians did not have to complete (fill out) a non-formulary drug request for medications not on the hospital's drug formulary. She said nurses "just faxed the order to a retail pharmacy". At 11:40 a.m., Pharm (Pharmacist) 1 said "yes, that is a correct statement" when the surveyor asked, "the hospital just orders drugs from a local pharmacy and doesn't go through with this non-formulary procedure?"

Hospital policy and procedures ("Non-Formulary Drug Procedure") read, "Upon receipt of a non-formulary drug request, the Pharmacy Nurse or Pharmacist Consultant will consult with the Physician to assess the appropriateness of the medication order and identify existing therapeutic alternatives on the Formulary. If indicated, a PH.0014 Formulary Addition Request (see Attachment A) form is completed by the Physician and returned to the Pharmacy Nurse or Manager. The request is forwarded to the Contract pharmacy."

Based on observation, staff interview, and administrative document review, the facility failed to use radiology safety equipment during surgery for Patient 13. These failures placed Patient 13 at risk of scatter radiation during the surgery.

Findings:

1. On 5/8/12 at 10:45 a.m., during an observation in the operating room, MD (physician) 20 used the fluoroscopy machine periodically through out the surgery. The start of the use of the fluoroscopy process was at 10:45 a.m. The end was 11:10 a.m. with the result of 25 minutes during which Patient 13 was exposed to bursts of radiation while the fluoroscopy equipment was used. Patient 13 was not covered with a lead apron or protected from exposure to the radiation emitted.

On 5/10/12 at 11:50 a.m., MD 20 was contacted about the fluoroscopy process and stated that lead aprons should always be used for any fluoroscopy procedures.

On 5/10/12 during an administrative document review, titled,"Radiation Safety Policy Pursuant to Title 17: California Radiation Control Regulation 6. Lead shields...will be provided for patients who request it to protect them from scatter radiation."

Based on staff interview and adminstrative document review the facility failed to ensure the agreement with the outside blood collecting agency included provisions for notification to the hospital within three calendar days in the event blood from a previously negative donor were to become reactive for HIV or HCV on a later donation. This failure resulted in the potential for exposing patients to infectious blood products.

Findings:

On 5/10/12 during a record review of the facility's "Blood Services Agreement" a clause requiring the blood bank to notify the hospital within three days in the event a previously negative donor subsequently became positive for HIV or HCV could not be found.

On 5/10/12 at 10:25 a.m., during a concurrent record review and interview, Staff 4, stated he could not find a clause requiring the blood bank to notify the hospital in the event of a positive reaction for HIV or HCV in a previously negative donor.

Based on observation and staff interview the facility failed to ensure equipment was maintained at an acceptable level of safety when two of two wire racks used for food tray delivery to the patients and measured about 6 1/2 feet long and about 5 1/2 feet tall with 5 shelves were noted to have numerous areas covered in rust on all of the shelves.

Findings:

On 5/9/12 at 11:40 a.m. during an observation in the kitchen of two of two carts had rusted areas on all the shelves. The carts were used to transport food trays to the patients. The two wire racks were about 6 1/2 feet long and about 5 1/2 feet tall and each wire rack contained five shelves. Each shelf was noted to have numerous areas where the original non-porous coating had worn away and rusted areas were present. Some of the rusted areas were in patches covering a 12 inch area by 12 inch area at the corners of the shelves and then smaller patches of rust noted along the length of the shelves.

Staff 8 stated on 5/9/12 at 11:43 a.m., the discoloration that was noted was due to rust. She acknowledged the rust left a surface that could not be completely cleaned and this could expose patients to microorganisms.

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

1. One (1) of 8 operating room's temperature (Operating Room [OR] 6) was out of normal range on 5/8/12; the recorded temperatures in 8 of 8 ORs (OR 1, 2, 3, 4, 5, 6, 7, and 8) and the recorded humidity levels in 8 of 8 ORs (OR 1, 2, 3, 4, 5, 6, 7, and 8) were out of normal range during the period between November 2011 and April 2012; the documentation of air exchanges in the ORs was not provided upon request;

2. The hospital did not ensure the staff monitored/controlled the humidity, temperature and air exchanges of the sterile storage, sterile processing area, and decontamination room in the operating suite of the hospital (Campus 1); the endoscopy suite; and the operating suite of the outpatient surgery center (Campus 2);

3. There was no door between the decontamination area and Procedure Room 1 in the endoscopy suite.

These failures had the potential for putting the patient(s) and employee(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 contamination of the sterile field and increasing the risk of surgical site infection by the uncontrolled airflow patterns within the operative setting; or exposure by the aerosolized contaminants from the decontamination room to the procedure room.

Findings:

1. During an interview with the operating room manager (LN 2) in the operating suite on 5/8/12 at 8:50 a.m., LN 2 stated the hospital used the AORN (Association of periOperative Registered Nurses), CDC (Centers for Disease Control and Prevention), APIC (Association for Professionals in Infection Control and Epidemiology), and AAMI (Association for the Advancement of Medical Instrumentation) guidelines as references for the OR infection control practice.

During an observation and a concurrent interview with LN 2 in the operating room (OR) 6 on 5/8/12 at 9:10 a.m., the displayed temperature of the thermostat was 62.7 degrees Fahrenheit (F). LN 2 confirmed the displayed temperature in the OR 6 was lower than the normal range, which was between 68 degrees F and 73 degrees F. LN 2 stated the physicians preferred cooler temperature in the ORs and it was the Plant Operations Department's responsibility to monitor the temperature, humidity, and air exchanges in the operating rooms, sterile storage, sterile processing area, and decontamination room in the operating suite.

During an interview with the Plant Operations Director (Staff 38) on 5/10/12 at 9:20 a.m., Staff 38 stated the OR staff of Campus 1 monitored the temperature and humidity in the ORs and they were allowed to adjust the OR temperature by increasing or decreasing 5 degrees F as needed. Staff 38 also stated many physicians preferred cooler temperature in the ORs and the hospital "dictated" to lower the OR temperature to 60 degrees F which was out of the normal range. Staff 38 further stated the PO staff were not able to decrease the OR humidity if it was higher than normal range.

On 5/10/12 at 1 p.m., a review of the document titled "(Name of hospital) Temperature and Humidity Log" dated 11/2011 through 4/2012 indicated "Temperature Range - 60 degrees to 73 degrees F; Humidity Range - 20 % (percent) to 60 %" The aforesaid document indicated the required temperature and humidity levels for the ORs were different from nationally recognized infection control standards (the recommended OR temperature was 68 degrees F to 73 degrees F; the recommended OR humidity level was 30% to 60 %). The documented temperature and humidity 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 as recommended by the nationally recognized infection control standard on multiple occasions. The out of normal temperature levels were listed as follows:

i. One hundred and eleven (111) of 111 days in OR 1; OR 3; OR 5; OR 6; and OR 7;

ii. One hundred and seven (107) of 111 days in OR 2 and OR 4;

iii. One hundred and ten (110) of 111 days in OR 8.

The out of normal humidity levels were listed as follows:

i. OR 1 - 20 of 111 days

ii. OR 2 - 15 of 111 days

iii. OR 3 - 20 of 111 days

iv. OR 4 - 11 of 111 days

v. OR 5 - 25 of 111 days

vi. OR 6 - 27 of 111 days

vii. OR 7 - 23 of 111 days

viii. OR 8 - 28 of 111 days

The document for air exchanges in the ORs was not provided upon request.

On 5/10/12 at 2 p.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...instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas. 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...Recommendation V.d.1. The minimum rate of total air exchanges per hour should be maintained at a constant level as follows. Operating room: Minimum of 15 air exchanges per hour with a recommended range of 20 to 25 air exchanges...Recommendation V.e. Air-flow patterns within the perioperative setting should be controlled and uninterrupted."

2. During an observation and a concurrent interview with the endoscopy suite manager (Staff 6) in the decontamination/processing room of the endoscopy suite on 5/7/12 at 1:40 p.m., the temperature in the decontamination/processing room was 67 degrees F. Staff 6 stated the hospital used the SGNA (Society of Gastroenterology Nurses and Associates) and the AORN guidelines as references for the infection control practice in the endoscopy suite. Staff 6 also stated the staff monitored the temperature and humidity in the procedure rooms; there was no requirement to monitor the humidity of the decontamination/processing area in the endoscopy suite. Staff 6 also stated that it was the Plant Operations Department's responsibility to monitor the air exchanges in the endoscopy suite; the engineering (Plant Operations) staff were not able to fix the humidity level when it was out of normal range. Staff 6 confirmed that the hospital had no policy and procedure on the temperature, humidity, and air exchanges control/monitoring for the endoscopy suite.

During an observation and a concurrent interview with LN 2 in the processing area on 5/8/12 at 9:55 a.m., the displayed temperature of the thermostat was 78.3 degrees F. LN 2 confirmed the displayed temperature in the processing area was higher than the normal range, which was between 68 degrees F and 73 degrees F. LN 2 stated the OR staff did not monitor and control the temperature and humidity in the OR suite; it was the Plant Operations Department's responsibility to monitor the temperature, humidity, and air exchanges in the operating rooms, sterile storage, sterile processing area, and decontamination room in the operating suite.

During an interview with the Surgery Center manager of Campus 2 (Staff 6) on 5/9/12 at 3 p.m., Staff 6 stated the staff monitored the temperature of the central supply room; the humidity of the central supply room was not monitored; the temperature and humidity levels in the OR, decontamination area, processing area, and the sterile storage were not monitored. Staff 6 also stated she did not know if the Plant Operations (PO) staff monitored the air exchanges of Campus 2 or not.

During an interview with Staff 38 on 5/10/12 at 9:20 a.m., Staff 38 stated the PO staff did not monitor the temperature, humidity, and air exchanges in the endoscopy suite and Campus 2. Staff 38 also stated the PO staff did not monitor the temperature and humidity levels in the sterile storage, sterile processing area, and decontamination room of Campus 1.

On 5/10/12 at 1:30 p.m., a review of the document titled "Medication and Intravenous Solutions Temperature/Humidity Log Endoscopy Room" dated 11/2011 through 4/2012 indicated "Temperature Range - 68 degrees to 77 degrees F; Humidity Range - 35 % to 60 %" The aforesaid document indicated the required temperature and humidity levels for the Endoscopy Room were different from the nationally recognized infection control standard (the recommended endoscopy room temperature was between 68 degrees F and 73 degrees F; the recommended endoscopy room humidity level was between 30% and 60 %). The documented temperature and humidity levels of the Endoscopy Room 1 and 2 were out of normal range as recommended by the nationally recognized infection control standard on multiple occasions and were listed as follows:

i. 10 of 119 days temperatures and 5 of 119 days humidity levels were out of normal range in Endoscopy Room 1;

ii. 1 of 119 days temperature and 1 of 119 days humidity level were out of normal range in Endoscopy Room 2.

On 5/10/12 at 1:45 p.m., a review of the document titled "(Name of Campus 2) Intravenous Solutions Temperature Log (,) Central Supply" dated 7/2011 through 12/2011 indicated "Temperature Range - 68 degrees to 77 degrees F (21 degrees Celsius [C] to 25 degrees C)." The aforesaid document indicated the required temperature level for the Central Supply Room was different from the nationally recognized infection control standards. The documented temperature of the Central Supply room was out of normal range as recommended by the nationally recognized infection control standard on 29 of 97 days between July and December in 2011.

On 5/10/12 at 2 p.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 "These recommended practices are intended as guidelines adaptable to various practice settings. These practice settings include traditional operating rooms, ambulatory surgery centers...endoscopy suites...Recommendation V.b. Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms...endoscopy rooms, instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas. 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.1. The minimum rate of total air exchanges per hour should be maintained at a constant level as follows. Operating room: Minimum of 15 air exchanges per hour with a recommended range of 20 to 25 air exchanges...Sterile storage area: 4 air exchanges per hour...Recommendation V.e. Air-flow patterns within the perioperative setting should be controlled and uninterrupted."

3. During an observation and a concurrent interview with Staff 6 in the decontamination/processing room of the endoscopy suite on 5/7/12 at 2:20 p.m., there was no door between the decontamination/processing room and Procedure Room 1. Staff 6 stated a screen would be placed between the decontamination/processing room and Procedure Room 1 when there were endoscopy procedure in progress. Staff 6 acknowledged that the high-level disinfecting fumes and the aerosolized contaminants created during the decontamination and high level disinfection process of the endoscopes were potentially transmitted from the decontamination room to Procedure Room 1 where the patient(s) and employee(s) stayed. Staff 6 confirmed that the airflow in the decontamination/processing room and Procedure Room 1 was disrupted. Staff 6 stated she had requested a door for the decontamination/processing room many times in the past. Staff 6 also stated the hospital used the SGNA and the AORN guidelines as references for the infection control practice in the endoscopy suite.

On 5/7/12 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 XI. Flexible endoscopes should be decontaminated in an area physically separated from locations where clean items are handled and patient care activities are performed...Aerosols created during cleaning can also cause cross-contamination. Recommendation XI.a. The decontamination area should be physically separated from clean patient care areas and include a door...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 adjacent areas."

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

1. Traffic pattern in the endoscopy suite and the outpatient surgery center (Campus 2) did not conform to nationally recognized infection control standard of practice (refer to A 0749 items 1.a. to 1.b.);

2. The hospital failed to have an effective system to ensure personnel wore appropriate attire in the operating suite of Campus 1, Campus 2, and the endoscopy suite (refer to A 0749, items 2.a. to 2.f.);

3. The hospital failed to ensure staff worn 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) when handling contaminated endoscopic equipment (refer to A 0749, item 3);

4. The hospital failed to have an effective system to ensure endoscopes were processed and transported in accordance with nationally accepted standards (refer to A 0749, items 4.a. to 4.b.);

5. The hospital failed to ensure staff decontaminated and processed surgical instruments in accordance with nationally recognized infection control guidelines and/or the manufacturer's specifications and/or the hospital's policy and procedure (refer to A 0749, items 5.a. to 5.h.);

6. The hospital failed to ensure staff cleaned and disinfected the equipment effectively between patient use (refer to A 0749, item 6);

7. The hospital failed to have a system to ensure the staff used safe medication vial practices in the clinical setting (refer to A 0749, item 7);

8. 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) was readily available (refer to A 0749, item 8);

9. The hospital failed to ensure staff maintained the fluid warmer temperature in accordance with the hospital's policy and procedure (refer to A 0749, item 9);

10. The hospital failed to ensure staff performed hand hygiene after removing gloves (refer to A 0749, item 10);

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

12. Hand-washing facility was not available in the decontamination area of the operating suite in Campus 1 and Campus 2 as well as the endoscopy suite (refer to A 0749, item 12);

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, items 13.a. to 13.g.); and

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, colon, bladder, stomach or intestine], decontamination room, sterile processing areas, sterile storage and post anesthesia care unit) (refer to A 0726 ).

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

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

1. Traffic patterns in the outpatient surgery center (Campus 2) and the endoscopy suite did not conform to nationally recognized infection control standards of practice when:

a. There was no defined restricted (includes the operating rooms [ORs], procedures rooms, and the clean core areas), semi-restricted (includes 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. Traffic in this area is limited to authorized personnel and patients), and unrestricted (street clothes are permitted in this area, and traffic is not limited) areas in Campus 2; the signs of the defined restricted/semirestricted areas and surgical attire requirement did not apply to Campus 2;

b. There was no defined restricted, semi-restricted, and unrestricted areas in the endoscopy suite; there was no sign of surgical attire requirement to indicate the dress code in the endoscopy suite;

2. 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) when:

a. Five (5) of 5 staff members (LN 2, LN 11, Staff 18, Staff 19, and MD 1) did not cover the head and/or facial hair completely in the restricted area (includes the 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) of 1 staff member (LN 11) wore mask hanging down from neck in the perioperative areas;

c. Two (2) of 2 staff members (Staff 17, Staff 18) did not cover the personal clothing completely with surgical attire in the restricted and semi-restricted areas;

d. Personnel were not required to wear shoe covers or dedicated shoes in the restricted and semi-restricted areas; visitor was not required to wear surgical attire in the semi-restricted area;

e. The physicians were not required to wear surgical attire; personnel were not required to wear head cover; and there was a choice to wear shoe covers/dedicated shoes in the endoscopy procedure rooms where the procedures in process;

f. The staff members, who worked in the endoscopy suite, were allowed to launder the scrub suits from home and travel in the scrub suit from home to the endoscopy suite and vice versa;

3. The hospital failed to ensure staff worn 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) when handling contaminated endoscopic equipment;

4. The hospital failed to have an effective system to ensure endoscopes were processed and transported in accordance with nationally accepted standards when:

a. A vial of test strip for testing the minimum effective concentration of the high-level disinfectant, which expiration date had been passed, was available for use in the processing room;

b. The contained contaminated endoscope was not labeled to indicate biohazardous contents during transport to the decontamination area;

5. The hospital failed to have an effective system to ensure staff decontaminated and 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 member (Staff 19) did not mix the enzymatic detergent in accordance with manufacturer's specification; the contaminated probes were not submerged into enzymatic detergent as soon as possible after use and they were not rinsed thoroughly with water in accordance with manufacturer's specification;

b. The staff member used the enzymatic solution on multiple sets of contaminated probes/instruments;

c. The staff did not clean and disinfect the reusable brush after use and it was available for use on the following set of contaminated instruments;

d. The staff did not clean the sterilizer in accordance with the manufacturer's specifications;

e. The user manual for the sterilizer was not readily available to the sterilizer operators;

f. The hospital did not ensure staff performed a valid biological indicator (BI) test (a measure for testing the effectiveness of the method of sterilization being used. The indicator is used to demonstrate that conditions necessary to achieve sterilization were met during the sterilizer cycle being monitored) when:

i. The lot number of the BI test vial and the control vial were different;

ii. The BI test results were not interpreted by staff members in the time frame specified by the BI manufacturer;

g. The staff did not ensure the surgical instruments were effectively sterilized when: 50 of 145 pairs of scissors of various types were observed in the sealed peel pouches (self-sealable pouches that contain surgical instruments during the sterilization process) with blades closed;

h. The hospital used flash-sterilization (a process designed for the steam sterilization of patient care items for immediate use) as a substitute for sufficient instrument inventory;

6. The hospital failed to ensure the medical device was disinfected in accordance with nationally recognized infection control guidelines when: The staff member (LN 6) used alcohol, which was not an EPA (Environmental Protection Agency)-registered disinfectant, to disinfect the glucometer (a device for checking blood glucose) between patient use;

7. The hospital failed to have an effective system to ensure the staff used safe medication vial practices in accordance with nationally recognized infection control guidelines when the spike device was left inserted into the medication vial rubber stopper for multiple entries;

8. 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) was readily available;

9. The hospital failed to ensure staff maintained the fluid warmer temperature in accordance with the hospital's policy and procedure;

10. The hospital failed to ensure staff member (Staff 5) performed hand hygiene after removing gloves;

11. The hospital failed to ensure the surgical scrub suits were stored in accordance with nationally recognized infection control guidelines when some of them were observed being stored on the uncovered shelves and some of them were stored in the locker with street clothes;

12. Hand-washing facility was not available in the decontamination area of the operating suite in Campus 1 and Campus 2 as well as the endoscopy suite;

13. 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. One (1) of 9 healthcare workers' files reviewed (MD 16) showed no annual TST (Tuberculin skin test);

b. Six (6) of 9 healthcare workers' files reviewed (Staff 20, LN 12, LN 13, MD 2, MD 3, MD 16) showed no annual TB (tuberculosis) symptom screen;

c. One (1) of 9 healthcare workers' files reviewed (Staff 20) showed the aforesaid newly hired healthcare worker did not receive the second-step TST (Tuberculin Test) upon hire;

d. Two (2) of 9 healthcare workers' files reviewed (LN 13, MD 2) showed the aforesaid healthcare workers did not receive the baseline testing for M. (Mycobacterium) tuberculosis infection upon hire/first appointment;

e. Three (3) of 9 healthcare workers' files reviewed (MD 2, MD 3, MD 16) indicated the aforesaid healthcare workers did not have documented immunity to (or have vaccination against) hepatitis B virus;

f. Seven (7) of 9 healthcare workers' files reviewed (Staff 5, Staff 20, LN 13, MD 2, MD 3, MD 16, and DQ) indicated the aforesaid healthcare workers did not have documented immunity to (or have vaccination against) varicella (chicken pox); and

g. Nine (9) of 9 healthcare workers' files reviewed (Staff 5, Staff 6, Staff 20, LN 12, LN 13, MD 2, MD 3, MD 16, and DQ) indicated the aforesaid healthcare workers did not have documented immunity to (or have vaccination against) MMR (mumps, measles, rubella).

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:

1. During an observation and a concurrent interview with the registered nurse (LN 5) of Campus 2 and the Campus 2 manager (Staff 6) in Campus 2 on 5/9/12 from 8:25 a.m. to 8:50 a.m., a red line on floor and a sign indicated "Surgery suite, appropriate attire required" were observed. LN 5 stated the red line on floor and the sign of the attire requirement belonged to the old surgery center and they did not apply to Campus 2. LN 5 stated there were no define restricted, semi-restricted, and unrestricted areas in Campus 2. Staff 6 stated Campus 2 surgery did not utilize the red line on floor and the red line would be removed. Staff 6 further confirmed this surveyor was not required to wear surgical scrub and shoe covers during the tour throughout the surgery center which included the decontamination area, processing area, and the sterile storage area.

During an interview with the Director Quality of Care (DQ), who oversaw the department functions of the infection control in the hospital, on 5/9/12 at 11:50 a.m., the DQ stated Campus 2 followed the hospital's operating room (OR) policies and procedures and also used the AORN (Association of periOperative Registered Nurses) guidelines as references for the OR infection control practice.

On 5/9/12 at 11:55 a.m., a review of the hospital's policy and procedure titled "Traffic Control" dated 4/2/10 (Broad approval date) indicated "Signs shall clearly indicate the appropriate environmental controls and surgical attire required. The surgical suite shall be divided in to three designated areas defined by the physical activities performed in each area: Unrestricted, semi-restricted, restricted..."

1.b. During an observation and a concurrent interview with the endoscopy manager (Staff 6) in the endoscopy suite on 5/7/12 at 1:40 a.m., there was no defined restricted, semi-restricted, and unrestricted areas and there was no sign of surgical attire requirement to indicate the dress code in the endoscopy suite. Staff 6 stated the hospital used the SGNA (Society of Gastroenterology Nurses and Associates, Inc. [Incorporation]) and the AORN (Association of periOperative Registered Nurses) guidelines as references for the endoscopy infection control practice.

During an interview with Staff 6 and the DQ on 5/9/12 at 3 p.m., Staff 6 confirmed that there was no red line on floor to define the restricted and semi-restricted areas in the endoscopy suite; there was no sign of surgical attire requirement to indicate the dress code in the endoscopy suite. The DQ confirmed that the endoscopy suite was not defined as restricted, semi-restricted, and unrestricted area.

On 5/9/12 at 3:30 p.m., the 2012 Perioperative Standards and Recommended Practices, published by the AORN, was reviewed. The section titled "Recommended Practices for Traffic Patterns in the Perioperative Practice Setting" indicated "These practice settings include traditional operating rooms, ambulatory surgery centers...endoscopy suites... and all other areas where operative and other invasive procedures may be performed. Recommendation I. Traffic patterns should be designed to facilitate movement of patients and personnel into, through, and out of defined areas within the surgical suite. Signs should clearly indicate the appropriate environmental controls and surgical attire required...should be divided into three designated areas that are defined by the physical activities performed in each area...The unrestricted area...The semirestricted area...The restricted area..."

2.a. During an observation and a concurrent interview in the operating suite of Campus 1 on 5/8/12 at 8:50 a.m., the OR manager (LN 2) accompanied this surveyor touring the semi-restricted and the restricted areas. LN 2's head cover did not contain the side hair above and in front of the ears and hair at the nape of the neck. LN 2 stated the hospital used the AORN, the CDC (Centers for Disease Control and Prevention), the APIC (Association for Professionals in Infection Control and Epidemiology), and the AAMI (Association for the Advancement of Medical Instrumentation) guidelines as references for the OR infection control practice.

During an observation in the hallway of the Campus 1 OR suite close to the nurse station on 5/8/12 at 9:25 a.m., the OR registered nurse (LN 11)'s head cover did not contain the hair at the nape of the neck and his facial hair was not covered.

During an observation and a concurrent interview in the hallway of the Campus 1 OR suite close to the scrub sink on 5/8/12 at 3 p.m., the Ancillary Supervisor (Staff 18)'s head cover did not contain the side hair above and in front of the ears and hair at the nape of the neck and his facial hair was not covered. Staff 18 stated his facial hair was only required to be covered in the presence of the sterile field.

During an observation in the OR 2 of Campus 2 on 5/9/12 at 8:30 a.m., the physician (MD 1)'s head cover did not contain the side hair above and in front of the ears and hair at the nape of the neck.

During an observation in the decontamination room of Campus 2 on 5/9/12 at 9:30 a.m., the Medical Assistant (Staff 19)'s head cover did not contain the bangs on the forehead.

During an interview with the DQ on 5/10/12 at 7:25 a.m., the DQ confirmed that the staff members should have covered the head and/or facial hair completely when in the restricted and semi-restricted areas.

On 5/10/12 at 9 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 semi-restricted and restricted areas."

2.b. During an observation in the hallway of the Campus 1 OR suite close to the nurse station on 5/8/12 at 9:25 a.m., LN 11 wore mask hanging down from neck.

During an interview with the DQ on 5/10/12 at 7:25 a.m., the DQ stated that the staff member should not have worn mask hanging down from neck in the restricted and semi-restricted areas.

On 5/10/12 at 9 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. Masks should not be worn hanging down from the neck."

2.c. During an observation in the OR 5 of Campus 1 on 5/8/12 at 2:55 p.m., the clinical housekeeping staff (Staff 17), whose personal clothing was not completely covered by the surgical attire at the V-neck area, was performing environmental cleaning between surgeries.

During an observation in the hallway of the Campus 1 OR suite close to the scrub sink on 5/8/12 at 3 p.m., Staff 18's personal clothing was not completely covered by the surgical attire at the V-neck area.

During an interview with LN 2 in the OR suite on 5/8/12 at 3:02 p.m., LN 2 stated the staff members should have covered the personal clothing completely with the surgical attire.

On 5/10/12 at 9 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 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."

2.d. During an observation and a concurrent interview with LN 5 and Staff 6 in Campus 2 on 5/9/12 between 8:25 a.m. and 8:50 a.m., a sign indicated "Surgery suite, appropriate attire required" was observed. LN 5 stated the sign of the attire requirement belonged to the old surgery center and they did not apply to Campus 2. LN 5 stated there were no define restricted, semi-restricted, and unrestricted areas in Campus 2. Staff 6 further confirmed this surveyor was not required to wear surgical scrub and shoe covers during the tour throughout the surgery center which included the decontamination area, processing area, the sterile storage area, and central supply room.

During an interview with Staff 6 in the OR suite of Campus 2 on 5/9/12 at 10:15 a.m., Staff 6 confirmed that personnel were allowed to wear street shoes in the OR and shoe covers were not required. Staff 6 further stated that personnel were allowed to wear street clothes in the decontamination room, the sterile storage, and OR when no surgical procedure was in process.

During an interview with the DQ on 5/9/12 at 11:50 a.m., the DQ stated the staff of Campus 2 should follow the hospital's operating room (OR) policies and procedures and also use the AORN guidelines as references for the OR infection control practice

During an interview with the DQ on 5/10/12 at 7:25 a.m., the DQ stated the OR staff members of Campus 2 should have followed the surgical attire in OR setting.

On 5/10/12 at 9 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 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.e. During an interview with the Endoscopy Technician (Staff 5) in the endoscopy procedure room 1 on 5/7/12 at 1:20 p.m., Staff 5 stated personnel were allowed to enter the procedure room in street clothes and shoes when there was no procedure in process.

During an observation and a concurrent interview with Staff 6 in the endoscopy suite on 5/7/12 at 1:25 p.m., there was no sign of surgical attire requirement to indicate the dress code in the endoscopy suite. Staff 6 stated the physicians were allowed to wear street clothes covered by gowns and personnel were not required to wear head covering, as well as wearing shoe covers was optional during the endoscopy procedures. Staff 6 also confirmed that there was no sign to define the restricted and semi-restricted areas in the endoscopy suite; there was no sign of surgical attire requirement to indicate the dress code in the endoscopy suite. When asked the types of procedures usually performed in the endoscopy procedure rooms, Staff 6 stated the procedures that were performed in the endoscopy procedure rooms included EGD (Esophagogastroduodenoscopy - a test to examine the lining of the tube that connects throat to stomach, stomach, and first part of the small intestine using a small camera which is inserted down the throat) and colonoscopy (the visualization of the colon [portion of the large intestine] with a long, flexible instrument consists of a tube and a light). Staff 6 also stated about 60% (percent) to 70% of the procedures required biopsy (the removal of a small piece of living tissue from an organ or other part of the body for microscopic examination) and polypectomy (removal of polyps).

On 5/7/12 at 1:45 p.m., a review of the definition of surgery developed by the American College of Surgeons dated 4/2007 with Staff 6 and a concurrent interview 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." Staff 6 acknowledged that biopsy and polypectomy were considered as surgery which should have been performed in the restricted zone of the operating room (OR) setting. Staff 6 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 procedure room. Staff 6 further stated the AORN's recommendations on dress code in the endoscopy suite should have been followed.

On 5/9/12 at 3:15 p.m., a review of the hospital's policy and procedure titled "Endoscopy Dress Code" dated 8/15/11 (date of approval) indicated "References: 1. Society of Gastroenterology Nurses and Associates, Inc. (Incorporation); 2. Association of Operating Room Nurses (AORN); 3. Occupational Safety and Health Administration (OSHA)."

On 5/10/12 at 9 a.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. These practice settings include traditional operating rooms (ORs), ambulatory surgery centers...endoscopy suites...and all other areas where surgery 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.f. During an interview with Staff 5 in Procedure Room 1 at the endoscopy suite on 5/7/12 at 1:20 p.m., Staff 5 stated the staff members wore the scrub suits which were laundered from home.

During an interview with Staff 6 on 5/9/12 at 3 p.m., Staff 6 confirmed the endoscopy staff members were allowed to launder the scrub suits from home and travel in scrub suits from home to the endoscopy suite and vice versa. Staff 6 acknowledged that she was not able to ensure the home-laundered scrub suits had been effectively sanitized from home and there was a risk of cross-contamination when the staff members traveled in scrub suits from home to the endoscopy suite and vice versa.

During an interview with the DQ on 5/10/12 at 7:30 a.m., the DQ stated the endoscopy staff should not have laundered the scrub suits from home as well as traveled in scrub suits from home to the endoscopy suite and vice versa.

On 5/10/12 at 7:45 a.m., a review of the hospital's policy and procedure titled "Endoscopy Dress Code" dated 8/15/11 (date of approval) indicated "References: 1. Society of Gastroenterology Nurses and Associates, Inc. (Incorporation); 2. Association of Operating Room Nurses (AORN); 3. Occupational Safety and Health Administration (OSHA)."

On 5/10/12 at 9 a.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. These practice settings include traditional operating rooms (ORs), ambulatory surgery centers...endoscopy suites...and all other areas where
surgery and other invasive procedures may be performed...Recommendation II.a.3. Health care personnel should change into street clothes whenever they leave the health care facility or when traveling between buildings located on separate campuses. Surgical attire may become contaminated by direct or indirect contact with the external environment... Recommendation V. 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."

3. During an observation and a concurrent interview in the decontamination room of the endoscopy suite on 5/7/12 at 2 p.m., Staff 5 did not wear mask or face shield when decontaminating the contaminated colonoscope.

On 5/7/12 at 3 p.m., a review of the hospital's policy and procedure titled "Endoscopy Dress Code" dated 8/15/11 (date of approval) indicated "All staff who are reprocessing the scopes or...will wear the following protective clothing...full face shield...References...Association of Operating Room Nurses (AORN)..."

On 5/7/12 at 3:15 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 XII Personnel handling contaminated endoscopic equipment must wear appropriate PPE...Recommendation XII.a. The appropriate PPE for these types of exposures include, but is not limited to...a mask, and face protection..."

4.a. During an observation and a concurrent interview in the endoscope processing room on 5/7/12 at 1:45 p.m., a vial of Acecide Peractic Acid test strips (the test strip for testing the minimum effective concentration of the high-level disinfectant), which open date was on 3/27/12 and use by date was on 4/27/12, was available for use. The printed manufacturer's instruction on the vial indicated "Use within 30 days of opening." Staff 6 acknowledged that the vial of test strips had been expired and it should have been removed.

On 5/7/12 at 3:15 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. Manufacturers' written instructions should be followed when preparing disinfectant solutions, calculating expiration dates...The test strip expiration date should be checked..."

4.b. During an observation and a concurrent interview in the decontamination room of the endoscopy suite on 5/7/12 at 2 p.m., Staff 5 transported the contaminated endoscope in a green plastic bag from Procedure Room 1 to the decontamination room. The contained contaminated endoscope was not labeled to indicate biohazardous contents during transport.

On 5/7/12 at 3:15 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 III.b. The transport container must be labeled to indicate biohazardous contents...Labeling the transport container communicates to others that the items are potentially infectious."

5.a. During an observation in the decontamination room of Campus 2 on 5/9/12 at 8:50 a.m., there were 4 probes in the decontamination sink which was not filled with any solution or water and there was a container of solution (approximately 1 to 1.5 inches in height) close to the probes in the sink.

During the observations and a concurrent interview in the decontamination room of Campus 2 on 5/9/12 from 8:50 a.m. to 10 a.m., Staff 19 allowed the probes staying in the decontamination sink without being soaked in the enzymatic solution until 9:50 a.m. Staff 19 confirmed the 4 probes were contaminated and she wiped the probes with paper towels in the enzymatic solution in the container. Then Staff 19 rinsed the channels of the probes in a weak stream of running water and the cords were hardly rinsed. When asked how to prepare the enzymatic solution for soaking the soiled probes, Staff 19 stated she poured the enzymatic detergent from the bottle and mixed with water. Staff 19 confirmed that she did not measure the amount of the enzymatic detergent and water used. A review of the manufacturer's instruction on the bottle of Endozime AW Plus (enzymatic detergent) with Staff 19, the manufacturer's instruction indicated "1/2 ounce of Endozime AW Plus to 1 gallon of water (17c.c. (cubic centimeter - volumetric measurement)/4 liters). Submerge instruments to be cleaned as soon as possible after use. Soak for 2 minutes. Rinse thoroughly with water." Staff 19 acknowledged that she did not rinse the probes thoroughly with water after soaking in the enzymatic solution.

On 5/9/12 at 3 p.m., a review of the hospital's policy and procedure titled "Care of Instruments, Scopes, and Powered Surgical Instruments" dated 4/2/10 (date of approval) indicated "Decontamination of instruments shall occur immediately after completion of the surgical procedure...Manufacturers' written instructions shall be followed for the detergent selection and the proper use, care, and maintenance of instruments."

5.b. During an interview with Staff 19 in the decontamination room of Campus 2 on 5/9/12 at 10:05 a.m., Staff 19 stated she saved the enzymatic solution for the following contaminated sets of instruments/probes. Staff 19 further stated she used the same container of enzymatic solution on approximately 3 sets of contaminated instruments/probes.

On 5/9/12 at 11:10 a.m., a review of an undated document titled "Endozime AW Plus" indicated "Direction for use...1. Add...2. Submerge instruments...3. Soak for two minutes...4. Rinse...5. Discard used solution."

5.c. During an observation and a concurrent interview with the Sterile Processing Department Technician (Staff 16) in the decontamination room on 5/8/12 at 11:10 a.m., a brush was placed on the countertop by the instrument decontamination sink. Staff 16 stated the brush was reusable and had been used on the contaminated instruments and was ready to be used on the following sets of contaminated instruments. Staff 16 further confirmed that the reusable brush were used on multiple sets of contaminated instruments and no cleaning, disinfection or sterilization was required between each use.

During an interview in the operating suite of Campus 1 on 5/8/12 at 3:45 p.m., LN 2 stated the hospital used the AORN, the CDC, the APIC, and the AAMI guidelines as references for the OR infection control practice.

On 5/8/12 at 4 p.m., the 2009 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, published by AAMI, was reviewed. On page 49, under Section 7.5.6 Cleaning of instruments...Brushes used for decontamination must themselves be cleaned and disinfected or sterilized..."

5.d. During an interview with the Sterile Processing Technician (Staff 15) in the sterile processing room on 5/8/12 at 11:05 a.m., Staff 15 stated the sterilizers were cleaned once a month by spraying the chambers with Autoclave Cleaning Treatment System (ACTS followed by wiping with wet cloth. Staff 15 further stated no rinsing of the chamber was required.

During an interview with Staff 19 in the processing area of Campus 2 on 5/9/12 at 9:35 a.m., Staff 19 stated the sterilizer was cleaned once a month by spraying the chamber with FACTS (Foaming Autoclave Cleaning Treatment System) followed by wiping with wet cloth and no rinsing with water was required.

On 5/9/12 at 9: 40 a.m., a review of the manufacturer's instruction printed on the bottle of the FACTS (Foaming Autoclave Cleaning Treatment System) indicated "Directions for use...Spray...inside of the chamber...Rinse walls with copious amounts of water."

5.e. During an interview with LN 2 in the processing area of Campus 1 on 5/8/12 at 11:05 a.m., when asked the sterilizer manufacturer's written instructions for cleaning, LN 2 stated the manufacturer's manual for Sterilizer 1 (AMSCO 3043) was not available since Ste

Based on staff interview and administrative document review, the facility failed to ensure the Organ and Tissue Donation policy and procedure was implemented when 4 of 4 staff (Licensed Nurses 7, 8, 17 and 18) were unaware of the policy and its requirements. This failure had the potential for the hospital to miss the opportunity to provide the patient's families with the ability to fulfill the patient's last wishes.

Findings:

On 5/9/12 at 4:48 p.m., during an interview, LN 17 stated there was not a process in place for organ or tissue donation.

On 5/9/12 at 5:00 p.m., during an interview, LN 18 stated she was not sure there was a policy in place for organ and tissue donation and would have to ask the charge nurse.

On 5/9/12 at 5:01 p.m., during an interview, the charge nurse, LN 7 stated she was not sure if there was a procedure in place. .

On 5/9/12 at 5:03 p.m. during an interview, LN 8 stated she was not sure if there was a policy and procedure.

The facility policy and procedure titled "Organ and Tissue Donation" dated 4/14/2010, indicated "State Law...requires that organ and tissue donation be offered to the family of every eligible patient..."

Based on staff interview and administrative document review, the facility failed to ensure the staff was educated on donation issues when 4 of 4 staff Licensed Nurses 7, 8, 17, and 18) were unaware of the policy and its requirements. This failure had the potential for the hospital to miss the opportunity to provide patient's families with the ability to fulfill the patient's last wishes.

Findings:

On 5/9/12 at 4:48 p.m., during an interview, LN 17 stated there was not a process in place for organ or tissue donation.

On 5/9/12 at 5:00 p.m., during an interview, LN 18 stated she did not recall ever having had training on a process for organ and tissue donation.

On 5/9/12 at 5:01 p.m., during an interview, the charge nurse, LN 7 stated she did not recall having had training on any process for organ and tissue training.

On 5/9/12 at 5:03 p.m. during an interview, LN 8 stated she did not recall having had training.

The facility DQ was not able to provide documentation of education provided for staff.

The facility policy and procedure titled "Organ and Tissue Donation" dated 4/14/2010, indicated "State Law...requires that organ and tissue donation be offered to the family of every eligible patient..."

Based on observation, staff interview and administrative record review, the facility failed to conduct a timeout prior to surgery. This failure had the potential of becoming a wrong site surgical procedure for Patient 13.

Findings:

1. Patient 13's surgery was observed on 5/8/12 at 11:21 a.m., in the Operating room (OR) 6. Patient 13 had received general anesthesia, when LN 16 called for the time out prior to surgery. MD 18 read the information from the anesthesia record and verbally confirmed the information with LN 16. Through out the required time out, MD 20 and PA 1 talked to each other and continued repositioning Patient 13 instead of following the policy and procedure "Marking and Verification of Surgical Procedure / Site Universal Protocol," revised and dated 1/25/11 which was for "All members of the surgical team: ...Must verbally agree"... "Correct surgical site marked with the initials of the surgeon or Physician Assistant actively involved".

On 5/8/12 at 11:25 a.m., during an interview in the OR, LN 16 stated, during the time out, 1 person reads the information and the others just listen and agree.

On 5/8/12 at 2:45 p.m., during an interview in his office, LN 2 stated during the time out, everyone should stop what they are doing, listen and verbally verify the information, prior to the start of surgery.

On 5/8/12 the current administrative policy revised and dated 1/25/11, had been reviewed. The policy titled, "Marking and Verification of Surgical Procedure / Site Universal Protocol," was reviewed and indicated... " 3. Prior to incision...circulating nurse conducts the "Time Out" d. All members of the surgical team: Surgeon, Anesthesiologists, Circulating Nurse, Surgical Technician and Surgical Assistant, Must verbally agree at a minimum on the following: i. Identity of the patient using two patient identifiers: date of birth and medical record number ii. Correct surgical site marked with the initials of the surgeon or Physician Assistant actively involved and present in the procedure is visible after the draping is complete..."

Based on observation, staff interview, clinical record and administrative document review, the facility failed to ensure that documentation in Patient 13's clinical record by Physician Assistant 1 (PA1) was accurate, and reflected Patient 13's actual preoperative evaluation. These failures had the potential to misrepresent the actual physical evaluation of Patient 13 placing Patient 13 at risk of harm during surgery.

Findings:

1. On 5/8/12 at 9:15 a.m., during review of Patient 13's clinical record, a preoperative update of the history and physical had not been completed. At 9:17 - to 9:35 a.m., while interviewing Patient 13, PA 1 entered the preoperative cubicle at 9:30 a.m. and marked the right great toe, indicating the surgical side of the body.

On 5/8/12 at 9:35 a.m., during a concurrent interview and clinical record review, Licensed Nurse (LN) 16 reviewed the completed History and Physical (H&P), Post Operative Progress note, and Post Operative Physician orders. LN 16 stated...the clinical record date and time are 5/8/12 at 9:00 a.m., the H&P, Progress notes, and Physician Orders are not supposed to be completed ahead of time, (before the patient is seen, has surgery, or assessed (evaluation) had been made."

On 5/8/12 during review of Administrative Policy MR.024, titled "History and Physical Requirements" dated 4/2/10, indicated the following: "...All patient's presenting for surgery must have a history and physical on the medical record prior to starting the procedure...Procedure: the patient's surgeon or attending physician will perform a history and physical on the patient...it is required to be updated within 24 hours of the surgical procedure."