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

1. The failure to ensure the provision pf pharmaceutical services that met the needs of patients. (A-0491, A-0500, A-0505)

2. The failure to provide and maintain a sanitary and safe environment for the patients and employees to avoid sources and transmission of infections and communicable diseases. (A-0726, A-0749)

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

25093

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

1. Failure to ensure that environmental monitoring was performed in the IV (intravenous) room to ensure the quality and safety of the compounded sterile products. No viable air and surface sampling was performed to monitor the risk of microbial contamination of compounded sterile products prepared in the IV room (A491).

2. Failure to ensure that policy and procedures in the preparation of intravenous products were consistently implemented. Media-fill tests were not performed by all personnel working in the IV room annually to ensure the safety and quality of the compounded sterile products (A491).

3. Failure to ensure that pharmacy staff wears proper attire when entering the IV room to minimize particulate contamination. Pharmacy staff was entering IV room without proper IV room attire (A491).

4. Failure to ensure that medications were properly stored and outdated and unusable drugs were not available for patient use (A505).

5. Failure to develop policies and procedures to ensure the safe use of fentanyl transdermal patches. Patient 81, 82 and 83 were prescribed and administered fentanyl transdermal patches not in accordance with Boxed warning issued by the FDA and the manufacturer ' s prescribing information. In addition, pharmacy staff and nursing staff failed to demonstrate competency in safe use of fentanyl patches (A500).

6. Failure to ensure that pre-printed medication orders approved by the pharmacy and therapeutics committee were developed to ensure patient safety. Medication orders for acetaminophen and acetaminophen containing products exceeding the maximum daily dose of acetaminophen were available for ordering on preprinted order forms (A500).

7. Failure to ensure the safe and effective distribution of controlled substances. Controlled substances were stored in nursing station as floor stock and could be administered to patient prior to pharmacist review of order (A500).

8. Failure to ensure that emergency drug supply was sealed by pharmacist in such a manner that a seal must be broken to gain access to the drugs (A500).

9. Failure to ensure that medication orders were reviewed for appropriateness by a pharmacist before the first dose was dispensed. Medication orders written when the pharmacy was closed were not reviewed prior to the first dose being administered and medications ordered on Saturday might take up 16 hours before review by a pharmacist for appropriateness (A500).

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

25093

Based on observation, interview and record review, the hospital failed to ensure that the pharmacy was administered in accordance with accepted professional principles as evidenced by:

1. Failure to ensure that environmental monitoring was performed in the IV (intravenous) room to ensure the quality and safety of the compounded sterile products. No viable air and surface sampling was performed to monitor the risk of microbial contamination of compounded sterile products prepared in the IV room.

2. Failure to ensure that policies and procedures in the preparation of intravenous products were consistently implemented. Media-fill tests were not performed by all personnel working in the IV room annually to ensure the safety and quality of the compounded sterile products.

3. Failure to ensure that pharmacy staff wears proper attire when entering the IV room to minimize particulate contamination. Pharmacy staff was entering IV room without proper IV room attire.


Findings:

During a tour of the hospital pharmacy at approximately 10:10 a.m. on 12/13/11, a laminar flow hood was observed in the IV preparation room (IV room) located by the staff entrance of the pharmacy. There was no physical barrier separating the traffic of the IV room and the rest of the pharmacy. A medication storage refrigerator was located inside the IV room. Medications stored in the refrigerator included vaccines, insulin and medicated eye drops. Pharmacist 1 was observed walking in the IV room to retrieve medications from the refrigerator without proper IV room attire and hand washing prior to entry. Two additional pharmacy staff members were observed entering the IV room without proper IV room attire and hand washing before entering the IV room.

During an interview at approximately 10:30 a.m. on 12/13/11, Pharmacy Technician 1 stated that anyone entering the IV room should be gowned up minimally with a disposable gown and a disposable hair cover.

During an interview at approximately 10:40 a.m. on 12/13/11, the hospital Director of Pharmacy (DOP) stated that due to space issue, the medication storage refrigerator was installed inside of the IV room. The DOP also stated that staff possibly had to enter the IV room to obtain medications from the refrigerator more than 15 times a day.


A review of the pharmacy laminar flow hood inspection reports dated 8/6/11 and 1/25/11 showed that no viable air or surface sampling was performed as a means of evaluating the overall control of the compounding environment.

During an interview at approximately 4:00 p.m. on 12/14/11, the DOP stated that no viable air or surface sampling was performed either by the inspection company or by the pharmacy staff. The DOP also stated that the pharmacy had 5 full time pharmacists and 5 full time technicians on staff. One pharmacy technician (Pharmacy Technician 1) was mainly responsible for the preparation of intravenous products and other technicians would provide coverage as needed. Also, preparing and checking of intravenous products were the responsibilities of all pharmacists except for one pharmacist on staff who was solely assigned to outpatient responsibilities.

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

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

A review of the media-fill tests record showed that medium risk media tests were conducted by 3 of the pharmacy staff on 1/19/2010 and a low risk media tests were conducted by 3 pharmacy staff on 5/12/11. There was no record indicating that media-fill tests were conducted by all pharmacy personnel responsible for the preparation of intravenous products.

A review of the hospital policy and procedure titled " Working Guidelines in the Laminar Flow Hood " indicated that all personnel working in the IV room should pass the media-fill testing according to the USP- NF (797) guideline annually.

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

1. Failure to develop policies and procedures to ensure the safe use of fentanyl transdermal patches. Patient 81, 82 and 83 were prescribed and administered fentanyl transdermal patches not in accordance with Boxed warning issued by the FDA and the manufacturer's prescribing information. In addition, pharmacy staff and nursing staff failed to demonstrate competency in safe use of fentanyl patches

2. Failure to ensure that pre-printed medication orders approved by the pharmacy and therapeutics committee were developed to ensure patient safety. Medication orders for acetaminophen and acetaminophen containing products exceeding the maximum daily dose of acetaminophen were available for ordering on preprinted order forms.

3. Failure to ensure the safe and effective distribution of controlled substances. Controlled substances were stored in nursing station as floor stock and could be administered to patient prior to pharmacist review of order.

4. Failure to ensure that medication orders were reviewed for appropriateness by a pharmacist before the first dose was dispensed. Medication orders written when the pharmacy was closed were not reviewed prior to the first dose being administered and medications ordered on Saturday might take up 16 hours before review by a pharmacist for appropriateness.

5. Failure to ensure that emergency drug supply was sealed by pharmacist in such a manner that a seal must be broken to gain access to the drugs.

Findings:

1a. A review of Patient 81's clinical record with the hospital director of pharmacy (DOP) showed that the patient was admitted to the hospital on 11/12/11 for abdominal pain. Patient 81's medication list indicated that the patient was not on any narcotic (opioid) pain medication prior to admission. Patient 81 was ordered and administered Fentanyl Transdermal Patch 25 mcg/hr (micrograms per hour, delivery rate) on 11/18/11. Patient 81's usage of narcotic (opioid) medications for pain control was as follow:

On 11/12/11, Patient 81 was administered a total daily dose of morphine 6 mg by intravenous route

On 11/13/11, Patient 81 was administered a total daily dose of morphine 2 mg by intravenous route

On 11/14/11, Patient 81 was administered a total daily dose of morphine 6 mg by intravenous route

On 11/15/11, Patient 81 was administered a total daily dose of morphine 2 mg by intravenous route

On 11/15/11, Patient 81 was administered a total daily dose of Vicodin (Hydrocodone/Acetaminophen 5/500 mg) one tablet by mouth

On 11/16/11, Patient 81 was administered a total daily dose of morphine 8 mg by intravenous route

On 11/17/11, Patient 81 was not administered any narcotic pain medication until 6:00 p.m. when Fentanyl patch 25 mcg/hr was ordered and administered.

Based on the opioid usage prior to the administration of the fentanyl patch, Patient 81 was prescribed and administered fentanyl transdermal patch not in accordance with the manufacturer's prescribing information to minimize potentially fatal side effects of the medication. Patient 81 had been on low dose of opioid analgesics for 6 days (11/12/11 to 11/17/11) prior to the initiation of fentanyl patch on 11/18/11. Patient 63 was not opioid tolerant based on the manufacturer's prescribing guidelines prior to the administration of the fentanyl patch on 11/18/11.

1b. A review of Patient 82's clinical record with the DOP showed that the patient was admitted to the hospital on 10/12/11 for shortness of breath and epigastric (upper/mid abdominal region) pain. Patient 82's medication list showed that the patient was on Vicodin 1 to 2 tablets 3 times daily as needed prior to admission with no indication of usage history. Patient 82 was ordered and administered Fentanyl Transdermal Patch 12 mcg/hr on 10/12/11. Patient 82's fentanyl patch dose was increased to 37mcg/hr on 10/14/11 and to 50 mcg/hr on 10/16/11. A review of Patient 82's medication administration record (MAR) showed that no additional pain medications was administered for pain control from 10/12/11 to 10/16/11 to justify the frequency increase in fentanyl dosage.

Lexi-Comp, a national drug information provider to health care professional, indicated that dosage of fentanyl transdermal patch should not be titrated more frequently than every 3 days after the initial dose or every 6 days thereafter. Patients should wear a consistent fentanyl dosage through two applications (6 days) before dosage increase based on supplemental opiate dosages can be estimated.

1c. A review of Patient 83's clinical record with the DOP showed that the patient was admitted to the hospital on 11/6/11. Patient 83's medication reconciliation form indicated that the patient was not on any narcotic medications prior to admission. Fentanyl patch 25 mcg/ hr was ordered by the physician on 11/8/11. Patient 83's medication administration record (MAR) showed that the patient did not receive any narcotic medication on 11/6/11 and 11/7/11 prior to the initiation of fentanyl patch.

There was no documented record indicating that Patient 83 was opioid tolerant in accordance with the manufacturer ' s guidelines prior to the initiation of the fentanyl patch.

According to the manufacturer's prescribing information, a boxed warning (Black Box Warning) was issued on fentanyl patches which indicated that (1) fentanyl patch is indicated for management of persistent, moderate to severe chronic pain. (2) fentanyl patch should ONLY be used in patients who are receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl transdermal system 25 mcg/hr. Patient who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid. (3) Fentanyl transdermal system is ONLY for use in patients who are already tolerant to opioid therapy of comparable potency. Use in non-opioid-tolerant patients may lead to fatal respiratory depression.

During an interview at approximately 1:30 p.m. on 12/15/11, Registered Nurse 61 was unable to state the boxed warning of fentanyl transdermal patch.

During an interview at approximately 2:07 p.m. on 12/15/11, Pharmacist 1 stated that patients who had been on short acting opioid (dose and duration not specified) were candidate for fentanyl patch. When being asked by the surveyor how to handle a situation of a patient who had been receiving opioid for 3 days prior to physician ' s order for fentanyl patch 25 mcg/hr, Pharmacist 1 responded that she would contact the prescribing physician and if the prescribing physician considered the patient to be opoid tolerant, she would dispense the medication as ordered.

2. During an interview at approximately 4:00 p.m. on 12/14/11, the hospital Director of Pharmacy (DOP) stated that general and physician specific preprinted orders were used in the hospital and such forms were approved by the hospital Pharmacy and Therapeutics Committee for use in the hospital.

A sampled review of the preprinted medication order forms used in the hospital showed that 3 preprinted order forms contained medication orders which were unsafe for patient administration as follow:

Same Day Surgery GYN post-operative order form contained the order for Hydrocodone/Acetaminophen 5/500 mg 2 tablets every 3 hours as needed for moderate pain and Acetaminophen/Codeine 325/30 mg 2 tablets every 3 hours as needed for mild pain. Both orders, when used at maximum allowable dose, would exceed the daily maximum dose of acetaminophen of 4000 mg

Post-operative inpatient GYN order form contained the order for Hydrocodone/Acetaminophen 5/500 mg 2 tablets every 4 hours as needed for pain. The order, when used at maximum allowable dose, would exceed the daily maximum dose of acetaminophen of 4000 mg

Post-operative Shoulder/Knee order form for Physician 61 contained the order for Hydrocodone/Acetaminophen 5/500 mg 2 tablets every 3 hours for severe pain. The order, when used at maximum allowable dose, would exceed the daily maximum dose of acetaminophen of 4000 mg.

Acetaminophen overdose is the leading cause of acute liver failure in the United States and in some cases may require liver transplant. Lexis-Comp, a national drug information provider to health care professional, indicated that the maximum dose of acetaminophen should not exceed 4000 mg per day.

3. During an inspection of the medication storage cart on the third floor with Registered Nurse 61 (RN 61) at approximately 3:15 p.m. on 12/13/11, over 400 doses of over 20 different controlled substances were found in a locked compartment of the medication storage cart. RN 61 stated that the identified controlled substances were floor stock for that nursing station. RN 61 stated that access to the locked compartment was by a key which was shared between nurses but there was no mechanism to track individual access to the compartment in the event of drug diversion. RN 61 further explained that controlled substances ordered by physicians could be administered at once without having to wait for the pharmacist to review orders because the medications were readily available at the nursing station.

The SPH (American Society of Health System Pharmacists) published guidelines on minimum standard for pharmacies in hospitals indicated that floor stocks of medications generally shall be limited to medications for emergency use and routinely used safe items (e.g., mouthwash, antiseptic solutions). The potential for medication errors and adverse effects must be considered for every medication allowed as floor stock.

During an interview at approximately 3:25 p.m. on 12/13/11, the DOP stated that because of the fact that the controlled substances were stored at the nursing station, there was no mechanism to ensure that such medications would be not administered prior to pharmacist review of the physicians ' orders.

4. During an interview at approximately 10:00 a.m. on 12/13/11, the DOP stated that the inpatient pharmacy was staffed from 8 a.m. to 8 p.m. Monday to Friday and 9 a.m. to 5 p.m. on Saturdays and Sundays. Medication orders written by physicians when the pharmacy was closed would be not reviewed by a pharmacist until the next morning while medications could be obtained for administration from the night medication cart or floor stock.

During an interview at approximately 1:30 p.m. on 12/15/11, RN 61 stated that evening medication orders were not reviewed for appropriateness until the pharmacy opened the next day. RN 61 added that medications could be obtained by accessing the medications in the night cart by the nursing supervisors. RN 61 also stated that patients admitted to the hospital on a Saturday at 5:00 p.m. might not have his/her admission orders reviewed by a pharmacist until the pharmacy reopened at 9:00 a.m. on Sunday, a 16 hours delay.

ASH (The American Society of Health System Pharmacists) published guidelines on minimum standards for pharmacies in hospitals indicated that all prescribers' medication orders (except in emergency situations) must be reviewed for appropriateness by a pharmacist before the first dose is dispensed. Any questions regarding the order must be resolved with the prescriber at this time, and a written notation of these discussions must be made in the patient's medical record or pharmacy copy of the prescriber's order. Information concerning changes must be communicated to the appropriate health professional.

5. During a tour of the surgical department at approximately 2:30 p.m. on 12/13/11, malignant hyperthermia supplies were observed being stored in a cart with no tamper-proof seal on the cart to indicate to staff if the cart had been opened or if inspection and/or replacement of supply was warranted.

California Code of Regulations Title 22 70263 (Hf) (2) stipulates that emergency drug supply shall be stored in a clearly marked portable container which is sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs. Such system allows the hospital to know if supplies have been removed from the emergency supply which warrants inspection by appropriate staff and replacement of removed supply.

23107



25093

Based on observation, document review and interview, the hospital failed to ensure that outdated and unusable drugs were not available for patient use. Improperly stored medications were found in the pharmacy. Large volume parenterals were not labeled with expiration dates after removal from protective outer wrapping as recommended by the manufacturers. Medications required refrigeration were found frozen in the refrigerator of the emergency department.

Findings:

1. During a tour of the hospital pharmacy with the hospital Director of Pharmacy (DOP) at approximately 10:20 a.m. on 12/13/11, 5 bags of Metronidazole (an antibiotics) 500 mg/100 ml (milligrams per milliliters, concentration unit) without the outer light-protecting wrappings were observed on the shelf exposed to light. Three of the bags were not labeled with a preparation date. The other 2 bags were labeled with preparation dates of 12/8/11 and 12/9/11 respectively. In addition, eight bags of 1-liter large volume parenterals with potassium chloride as an additive were observed on the shelf without the manufacturer ' s outer protective wrappings. There was no indication on the bags of the dates when the products were removed from the outer wrappings. The DOP stated that the identified Metronidazole products were likely returned from the nursing stations and acknowledged that the products had been improperly stored and were not suitable for patient use. The DOP also stated that he was not aware of the shortened expiration of large volume parenterals after removal from outer wrappings.

Bags for intravenous fluid were made of PVC, a material that is permeable to moisture vapor. Once the overwrap is removed, moisture escaped from the bag at a faster rate than when the overwrap was in place. IV bags should be appropriately dated to reflect the new expiration date as recommended by the manufacturers. The manufacturer of the identified products recommended that IV bags with fill volumes greater than 25 ml should be used within 30 days after removal from their overwrap.

A review of the manufacturer's prescribing information by Hospira, Inc. indicated that Metronidazole Injection should be stored at 20 to 25?C (68 to 77?F) and protected from light during storage.

2. During an inspection of the medication storage refrigerator located in the emergency department at approximately 3:00 p.m. on 12/13/11, 8 syringes of Bicillin L-A (an antibiotics) were found frozen beneath the built-in freezer compartment in the refrigerator. The DOP stated that the identified products were improperly stored and were no longer suitable for patient use.

A review of the manufacturer's prescribing information by Kings Pharmaceuticals indicated that Bicillin L-A should be stored under refrigeration between 36?F and 46?F and be kept from freezing.

Based on observations, staff interview, and the hospital's policy and procedure review, the hospital failed to follow the hospital's laboratory service procedures when the discard date (the new expiration date) of the blood glucose control test solutions could not be determined and they were ready for use. This failure had the potential for the blood glucose checking system giving unreliable results, which could affect the patient's treatment plan and put the patient(s) at risk.

Findings:

During an observation and a concurrent interview with the registered nurse (RN 8) in the Intensive Care Unit (ICU) on 12/14/11 at 2:45 p.m., the printed manufacturer's specification on the blood glucose control test solution vials (high and low levels) indicated the control test solutions were good for 90 days after first opened. There was no discard date or first open date labeled on the control test solution vials and the vials were ready for use in the nurse station. The RN 8 confirmed that she could not determine the discard date of the blood glucose control test solutions with no information of the first open date.

On 12/15/11 at 9 a.m., review of the hospital's policy and procedure (number: 6170 - 3.02) titled "Policy and Procedure for Quality Control (QC) Testing of the Blood Glucose Meter" dated 7/11 (review/revision date) indicated "High and low levels of control solutions are used for quality control tests...Quality control (QC) solution has an open vial stability of 90 days. Upon opening, label the open vial's expired/discard date. Dispose properly any outdated vials or expired solution (open vial over 90 days), whichever comes first."

Based nursing staff interview, medial record review and dietary document review the hospital failed to ensure diet orders were written by physicians prior to diet advancement of post-surgical patients for 1 patient (Patient 50). Failure to ensure written physicians orders may result in patients receiving diets that conflict with their medical status.

Findings:

Patient 50 was admitted for a surgical procedure to remove kidney stones. Medical record review was conducted on 12/13/11 beginning at 10 am. Admission nutrition screening dated 12/9/11 noted that the patient was at high nutritional risk. A Physicians' order dated 12/12/11 noted patient was to be NPO (nothing by mouth) until after the surgical procedure. There were no additional physician ordered diets. Concurrent review of hospital document titled "Diet List" dated 12/13/11 revealed that Patient 50 was receiving a 2000 calorie diabetic diet. In an interview on 12/12/11 at 10:30 am, with RN 14 he stated that if there was no follow up physician ordered diet, post-surgical patients would receive a clear liquid diet to start. If that diet was tolerated he would then enter the admission diet order into the electronic medical record.

Hospital procedure titled "Diet Orders and Changes, Verbal Orders" dated 7 /11 noted that "All regular and therapeutic diets shall be prescribed by the attending physician."




20245

Based on observations, staff interviews, and document review, the hospital failed to maintain the relative humidity and temperature in the operating suite and the endoscopy suite as well as the air exchanges in the endoscopy suite and perioperative areas such as the sterile storage, sterile processing area and PACU (Post Anesthesia Care Unit) within acceptable standards in accordance with nationally recognized infection control guidelines when:

1. There were no humidity, temperature and airflow exchanges monitoring/control in the endoscopy suite and majority of the operating suite;

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

3. The recorded temperatures for the PACU were out of normal range on multiple occasions with no documented evidence of notification or correction for the variances.

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

Findings:

1. During the initial tour in the operating suite on 12/13/11 starting 11 a.m., there was no device for monitoring temperature and humidity observed in the sterile storage; the sterile processing area; and the area where the hand scrub sinks located.

During an interview with the Surgical Services Unit Coordinator (SCUC) on 12/13/11 at 11:50 a.m., the SCUC stated the temperature and humidity were monitored only in the OR 1 and OR 2, but were not monitored in the sterile storage, the sterile processing area; and the hand scrub sink area.

During an observation and a concurrent interview with the registered nurse in charge of the endoscopy suite (RN 5) in the small endoscopy room on 12/13/11 at 11:55 a.m., there was no device for monitoring temperature and humidity observed. RN 5 stated the temperature and humidity were not monitored in the endoscopy suite.

During an observation in the decontamination room of the central supply department on 12/13/11 at 3:15 p.m., there was no device for monitoring temperature and humidity observed.

During an interview with the Central Sterilization Staff (CSS M) in the sterile processing area at the central supply department on 12/13/11 at 4:10 p.m., the CSS M confirmed that there was no monitoring of humidity and temperature in the central supply department including the decontamination room, the sterile processing area and the sterile storage area.

During an interview with the Infection Control Practitioner (ICP P) on 12/14/11 at 9 a.m., the ICP P confirmed that the staff monitored the humidity in OR 1 and OR 2 only, but not the decontamination room, sterile processing area, sterile storage, the endoscopy suite and the central supply department.

During an interview with the ICP P on 12/15/11 at 2:40 p.m., the ICP P stated the hospital used AORN (Association of periOperative Registered Nurses), CDC (Centers for Disease Control and Prevention), and APIC (Association for Professionals in Infection Control and Epidemiology) guidelines as references for infection control practice. The ICP P confirmed that there was no air exchange monitoring in the perioperative areas except OR 1 and OR 2 (the perioperative areas with no air exchanges monitoring included the sterile processing area, the sterile storage, and the PACU) as well as the endoscopy suite. The ICP P also stated there was no specific policy and procedure concerning the temperature and humidity monitoring/control in the operating suite and the endoscopy suite and there was no specific policy and procedure concerning the air exchanges monitoring in the sterile storage, decontamination room, sterile processing area, PACU and the endoscopy suite.

On 12/15/11 at 2:42 p.m., the hospital's policy and procedure titled "Hospital's name utility systems failure responses: Hospital air quality policy" dated 7/07 indicated "Test...and positive pressure room balance in OR Room 1 & 2 - Annually record data on P.M. (performance maintenance) sheet..." Air exchanges monitoring in the sterile processing room, sterile storage, decontamination room, PACU, and the endoscopy suite was not addressed.

On 12/15/11 at 2:45 p.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 215, direction was given that, "Recommended practices for a safe environment of care...These practice settings include traditional operating rooms...endoscopy suites...and all other areas where surgery may be performed." On page 218, under Recommendation V.b., direction was given that, "Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas." On page 219, under Recommendation V.c., direction was given that, "Temperature should be monitored and recorded daily..." Under recommendation V.c.1., direction was given that, "Temperature should be maintained between 68 degrees F (Fahrenheit) to 73 degrees F within the operating room suite and general work areas in sterile processing." Under Recommendation V.c.2., direction was given that, "The decontamination area temperature should be maintained between 60 degrees F to 65 degrees F." Under Recommendation V.d., direction was given that, "The air-exchange rate in the perioperative area should be carefully controlled." Under Recommendation V.d.1. 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...Postanesthesia care unit: Six air exchanges per hour...Sterile storage area: four air exchanges per hour. Under Recommendation V.e. Air-flow patterns within the perioperative setting should be controlled and uninterrupted."

2. During an observation and a concurrent interview in OR 1 on 12/13/11 at 12 p.m., the device on the wall indicated the temperature was 68 degrees F and the humidity was 78 percent (%). The SCUC confirmed the humidity in OR 1 was 78%.

On 12/13/11 at 2:20 p.m., review of the document titled "Name of Hospital: Surgical Suite Humidity Record & (and) Crash Cart & Warmer Temperature Check Sheet" dated July 2011 through December 2011 with the SCUC and a concurrent interview was performed. The documented humidity levels in OR 1 were ranging from 72% to 92% while the documented humidity levels in OR 2 were ranging from 64% to 88%. When asked the normal humidity level in the OR, the SCUC stated she did not know the normal range of humidity level in OR; it should not below 50%. The SCUC further indicated that it would be "OK" if the humidity was 78% to 80%.

On 12/13/11 at 2:25 p.m., review of the document titled "Name of Hospital: Surgical Suite Humidity Record & (and) Crash Cart & Warmer Temperature Check Sheet" dated December 2011 with the ICP P and a concurrent interview was conducted. The aforesaid document indicated "Notify engineering when needed." When asked to explain "when needed" per protocol, the ICP P stated he did not know the meaning of "when needed" and the document should have addressed the criteria of notifying the engineering. The ICP P further stated he did not know the normal humidity range in the OR, and the engineering should know.

During an interview with the ICP P on 12/15/11 at 2:40 p.m., the ICP P stated the hospital used AORN, CDC, and APIC guidelines as references for infection control practice. The ICP P also stated that the humidity monitors in OR 1 and OR 2 did not function, and the hospital did not have a system to monitor the humidity and temperature in order to meet the infection control standard. The ICP P confirmed that there was no specific policy and procedure concerning the temperature and humidity monitoring/control in the operating suite and the endoscopy suite.


On 12/15/11 at 10 a.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 218, under Recommendation V.b., direction was given that, "Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms..."

3. On 12/14/11 at 8:35 a.m., review the PACU temperature recorded on the document titled "Name of Hospital: Surgical Suite Humidity Record & (and) Crash Cart & Warmer Temperature Check Sheet" dated July 2011 through December 2011. There were 4 recorded temperatures higher than 75 degrees F (3 days in September 2011; 1 day in November 2011) and 14 recorded temperatures lower than 70 degrees F (2 days in October 2011; 5 days in November 2011; and 7 days in December 2011).

During an interview with the ICP P on 12/14/11 at 9 a.m., the ICP P stated he did not know the normal temperature range in the PACU.

During an interview with the ICP P on 12/15/11 at 2:40 p.m., the ICP P stated the hospital used AORN, CDC, and APIC guidelines as references for infection control practice. The ICP P also stated the hospital did not have a system to monitor the temperature and humidity in order to meet the infection control standard. The ICP P confirmed that there was no specific policy and procedure concerning the temperature and humidity monitoring/control in the operating suite and the endoscopy suite.

On 12/15/11 at 10 a.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 219, under Recommendation V.c.3., direction was given that, "A temperature of 70 degrees F to 75 degrees F should be maintained in recovery areas and cardiac catheterization rooms."

28798

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

1. The hospital failed to have an effective system to 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) (cross-reference to A 0726 );

2. The hospital failed to have an effective system to ensure environmental cleaning was performed in accordance with nationally accepted standards and the hospital's policy and procedure (cross-reference to A 0749, item 2.a. - 2.e.);

3. The hospital failed to have an effective system to ensure endoscopes were cleaned and stored in accordance with nationally accepted standards (cross-reference to A 0749, item 3.a. - 3.d.);

4. The hospital failed to ensure staff cleaned and disinfected the equipment effectively between patient use (cross-reference to A 0749, item 5.a. - 5.c.);

5. The hospital failed to ensure staff operated the washer/disinfector in accordance with the manufacturer's specifications and/the hospital's policy and procedure (cross-reference to A 0749, item 6);

6. The hospital failed to ensure the MSDS (Materials Safety Data Sheet) was readily available in various units of the hospital (cross-reference to A 0749, item 11);

7. The hospital failed to have a system to ensure daily assessment of central line (a tube that healthcare providers place in a large vein in the neck, chest, or arm to give fluids, blood, or medications or to do certain medical tests quickly) necessity for all patients with central lines on units (cross-reference to A 0749, item 12);

8. The hospital failed to monitor staff compliance with the nationally recognized infection control guidelines and/or the hospital's policies and procedures regarding the use of surgical attire in the operating suite and the endoscopy suite; the use of PPE (personal protective equipment - protective gowns, gloves, masks, protective eyewear, and/or face shield) in the decontamination room; the processing of the surgical scissors in the open position; the use of expired hand antisepsis in the operating suite; and food refrigerator was observed in the sterile storage area (cross-reference to A 0 749, items 1.a.-1.c; 4.a. - 4.b.; 7; 8; 9; )

9. The clean surgical scrubs was not stored in accordance with the nationally recognized infection control guidelines (cross-reference to A 0749, item 10);

10. The hospital failed to have an effective system to ensure personnel were consistently screened for infectious diseases in accordance with nationally accepted standards (cross reference to A 0749, item 14.a. - 14.b.); and

11. The hospital failed to ensure the policies and procedures for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases of patients and hospital personnel were consistent with the nationally recognized infection control guidelines and manufacturer's specifications (cross-reference to A 0749, item 13.a. - 13.g.).

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.

21155




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23107




28798

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

b. Four of six staff members (Physician 1, 2, 3, and ES Q) did not cover the hair completely when working in the restricted areas (operating rooms [ORs], 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);

c. One of one staff member (NA 5) did not use hair covering when working in the decontamination and endoscope processing area of the endoscopy suite;

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

a. Two of two staff members (ES Q, RN 6) cleaned multiple surfaces with one cleaning cloth/wipe;

b. The staff returned the used cleaning mop to the cleaning solution container during the between surgeries cleaning procedure in the OR 1;

c. The staff prepared a pile of cleaning cloths ready for use throughout the day;

d. All horizontal surfaces in the endoscopy rooms were not required to be cleaned and disinfected between procedures;

e. Layers of dust, a piece of glove, and missing tiles were observed on floor of the decontamination room in the central supply department;

3. The hospital failed to have an effective system to ensure endoscopes were cleaned and stored according to nationally accepted standards when:

a. Two of two staff members (NA 5 and RN 4) washed hands in the instrument sink located in the decontamination room of the endoscopy suite;

b. The soiled endoscope was not soaked and was not completely submerged in the enzymatic detergent; the internal channels of the soiled endoscope was brushed once with the enzymatic detergent during the decontamination process; the single-use plastic syringe was saved for multiple-use;

c. Visible grayish black particles and wet spots were observed at the bottom of the endoscope storage cabinet; a stick and an endoscope case were observed being stored in the endoscope storage cabinet;

d. Two of two staff members (RN 4; RN 5) were not able to determine the processing dates of the processed endoscopes of various types in the storage cabinet and the staff confirmed that there was no system to reprocess the endoscopes before use if unused for more than five days;

4. Two of two staff members (NA 5, CSS M) were not protected by the 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) during the decontamination process when:

a. The NA 5 did not use any face shield or goggles for eye protection when decontaminating the used endoscope;

b. The CSS M's anterior chest and upper limbs were not protected when using an apron as the PPE during handling the soiled equipment;

5. The hospital failed to ensure staff cleaned and disinfected the equipment effectively between patient use in accordance with the nationally recognized infection control guidelines;

6. The hospital failed to ensure staff operated the washer/disinfector in accordance with the manufacturer's specifications and the hospital's policy and procedure;

7. The hospital failed to ensure the surgical scissors had been effectively sterilized when 5 of 25 (estimated) pairs of surgical scissors of various types were observed in the sterile pouches with blades closed;

8. A food refrigerator was observed in the sterile storage area of the central supply department;

9. Four of four bottles of surgical hand scrub with the "use by" dated 2009 and 2010 were ready for use at the hand scrub sink area in the operating suite;

10. The clean surgical attire was observed being stored on the uncovered shelves with various items in the female locker room in the operating suite;

11. Three of three staff members (ES Q, RN 8, and RN 9) were unable to access the chemical information in 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) on various units of the hospital;

12. The hospital failed to have a system to ensure daily assessment of central line (a tube that healthcare providers place in a large vein in the neck, chest, or arm to give fluids, blood, or medications or to do certain medical tests quickly) necessity for all patients with central lines on unit when: One of one selected patient (Patient 73) file reviewed on the Intensive Care Unit (ICU) did not indicate documentation of the daily assessment of central line necessity;

13. Seven hospital's policies and procedures reviewed (TB [Tuberculosis] screening procedures for health-care workers; The varicella [chicken pox]; MMR [Measles, Mumps, Rubella] screening procedures; Use of Metricide in Central Supply; Bloodborne pathogens/sharps injury prevention program; Standard Precautions; Contact Precautions; and Patient Blood Glucose Testing) were not consistent with the hospital's selected nationally recognized infection control guidelines and/or the manufacturer's specifications; and

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

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.a. During an interview with the Infection Control Practitioner (ICP P) on 12/13/11 at 2:45 p.m. in the endoscopy room 1, the ICP P stated the staff were not required to wear surgical attire and they might wear street clothes in the endoscopy room. When asked the types of procedures that were performed in the endoscopy room, the ICP P stated the procedures performed included colonoscopy (the visualization of the colon [portion of the large intestine] with a long, flexible instrument consists of a tube and a light), endoscopy (the visualization of the interior of organs and cavities of the body with a long, flexible instrument consists of a tube and a light), bronchoscopy (the visual examination of the trachea [windpipe] and bronchi [air passages in the lungs] with a curved, flexible instrument consists of a tube and a light) and biopsy (the removal of a small piece of living tissue from an organ or other part of the body for microscopic examination) was performed as indicated. Policy and procedure regarding endoscopy room attire was not available upon request.

During an interview with the registered nurse in charge of the endoscopy suite (RN 5) in the small endoscopy room on 12/14/11 at 12 p.m, when asked if the staff were required to wear surgical attire in the endoscopy room, RN 5 stated the staff might wear street clothes in the procedure room; scrub suit, hair covering, and shoe covers were not required as practiced in the operating room setting. When asked the types of procedures were performed in the endoscopy rooms, RN 5 stated the procedures performed daily included colonoscopy; upper endoscopy (the visualization of the interior of organs and cavities of the body with a long, flexible instrument consists of a tube and a light that is inserted through the mouth and down the intestinal tract); bronchoscopy; sigmoidoscopy (the inspection of the rectum and sigmoid colon [portions of large intestine] by the aid of an instrument consists of a tube and a light); biopsy and polypectomy (removal of a small tumorlike growth that projects from a mucous membrane surface) were performed as indicated.

On 12/14/11 at 12:10 p.m., an interview with RN 5 was conducted and a concurrent review of the definition of surgery developed by the American College of Surgeons dated 4/2007 was done. The definition of surgery indicated "Surgery is performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. 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, ultrasound, ionizing radiation, scalpels, probes, and needles......All of these surgical procedures are invasive, including those that are performed with lasers, and the risks of any surgical intervention are not eliminated by using a light knife or laser in place of a metal knife or scalpel" RN 5 acknowledged that biopsy and polypectomy were procedures constituted surgery and those procedures should have been performed in the same setting as in the operating room.

On 12/14/11 at 1 p.m., the 2011 Perioperative Standards and Recommended Practices, published by the Association of periOperative Registered Nurses (AORN), was reviewed. On page 57, under Recommendation Practices for Surgical Attire, direction was given that, "These recommended practices are intended as guidelines adaptable to various practice settings. These practice settings include traditional ORs, ambulatory surgery centers, physicians' offices, cardiac catheterization laboratories, endoscopy suites, radiology departments, and all other areas where surgery and other invasive procedures may be performed." Under Recommendation II, direction was given that, "Clean surgical attire, including shoes, head covering, masks, jackets, and...should be worn in the semirestricted and restricted areas of the surgical or invasive procedure setting." On page 95, under Recommendation I.1., direction was given that, "...The semirestricted area includes the peripheral support areas of the surgical suite...Personnel are required to wear surgical attire and cover all head and facial hair. The restricted area includes ORs, procedure rooms, and the clean core area. Surgical attire and hair coverings are required..."

1.b. During an observation and a concurrent interview with the Surgical Services Unit Coordinator (SCUC) at the door of OR 2 on 12/13/11 at 12:05 p.m., a surgeon (Physician 1), an anesthesiologist (Physician 3), and a registered nurse were observed working in OR 2 during the surgical procedure. Physician 1's cap did not contain the hair at the nape of his neck; Physician 3's cap did not contain the hair at the nape of his neck and the sideburns. The SCUC identified the physicians and confirmed that Physician 1 and Physician 3's hair were not completely covered by the hair coverings during the surgical procedure in OR 2.

During an observation in the OR 1 on 12/13/11 at 12:15 p.m., the Environmental Services Staff (ES Q)'s hair at the nape of his neck and the sideburns were not covered.

During an observation and a concurrent interview with the Surgical Services Unit Coordinator (SCUC) at the door of OR 2 on 12/13/11 at 2:35 p.m., a surgeon (Physician 2), an anesthesiologist (Physician 3), and a registered nurse were observed working in OR 2 during the surgical procedure. Physician 2's cap did not contain the hair at the nape of his neck; Physician 3's cap did not contain the hair at the nape of his neck and the sideburns. The SCUC identified the physicians and confirmed that Physician 2 and Physician 3's hair were not completely covered by the hair coverings during the surgical procedure in OR 2.

During an interview with the ICP P on 12/14/11 at 9 a.m., the ICP P stated the personnel should have covered all hair in the OR.

On 12/15/11 at 10 a.m., review of the hospital's policy and procedure (number: 7420 - 4008) titled "Policy for Surgical Suite Attire" dated 12/10 (revision/review date) indicated "All head and facial hair, side burns and beards are to be covered completely with surgical hat or hood while in the restricted area..."

On 12/15/11 at 1:50 p.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 62, under Recommendation IV, direction was given that, "All personnel should cover head and facial hair, including sideburns and the nape of the neck, when in the semirestricted and restricted areas. Under Recommendation IV.a., direction was given that, "A clean, low-lint surgical head cover or hood that confines all hair and covers scalp skin should be worn...Skull caps may fail to contain the side hair above and in front of the ears and hair at the nape of the neck."

1.c. During an observation in the decontamination room of the endoscopy suite on 12/14/11 at 10:10 a.m., the NA 5 did not use head covering while she was decontaminating the soiled endoscope.

During an interview with the ICP P on 12/15/11 at 9 a.m., the ICP P stated the NA 5 should have used head covering when working in the decontamination area.

On 12/15/11 at 1:50 p.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 62, under Recommendation IV, direction was given that, "All personnel should cover head and facial hair, including sideburns and the nape of the neck, when in the semirestricted and restricted areas. On page 57, under Recommendation Practices for Surgical Attire, direction was given that, "These recommended practices are intended as guidelines adaptable to various practice settings... include traditional operating rooms (ORs)...endoscopy suites...and all other areas where surgery and other invasive procedures may be performed. Under Recommendation II, direction was given that, "Clean surgical attire, including shoes, head covering, masks, jackets...should be worn in the semirestricted and restricted areas of the surgical or invasive procedure setting." On page 95, under Recommendation I.1., direction was given that, "...The semirestricted area includes the peripheral support areas...work areas for storage and processing of instruments...Personnel are required to wear surgical attire and cover all head and facial hair."

2.a.i. During an observation of the terminal cleaning (cleaning that is performed at the completion of daily surgery schedules) in the OR 1 on 12/13/11 at 2:40 p.m., the ES Q wiped multiple surfaces with one cleaning cloth. The multiple surfaces included the IV (intravenous) pole (a pole for hanging the intravenous fluid); the top and bottom surfaces of the surgical light; and the horizontal surfaces.

During an interview with the ES Q on 12/13/11 at 2:45 p.m. at the door of OR 1, when asked if he could disinfect multiple surfaces effectively by using one cleaning cloth, the ES Q stated he wiped the surfaces earlier.

During an interview with the ICP P on 12/15/11 at 3:30 p.m., the ICP P confirmed that transmission of microorganism and cross-contamination might occur from one surface to other surfaces if using one cleaning cloth for multiple surfaces during the environmental cleaning process. The ICP P also stated the hospital policy and procedure did not address the technique for environmental cleaning such as one wipe/cleaning cloth for one surface.

Review the hospital's policy and procedure (number: 115.100) titled "Terminal Cleaning for the Operating Room/Surgical Suite" dated 8/11 (revision/review date) on 12/15/11 at 4 p.m., indicated "...disinfect the entire Operating Room/Surgical Suite to prevent the transmission of microorganism, and reduce any microorganism, thereby maintain a clean, safe environment for patient(,) staff and visitors." The aforesaid document referenced AORN (undated) guidelines and it did not address the technique of environmental cleaning/ disinfection.

On 12/15/11 at 4:30 p.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 238, under Recommendation I.c.1, direction was given that, "Reusable string and microfiber mops and cleaning cloths should be changed after each use..."

2.a.ii. During an observation of the exterior (surface) cleaning and disinfection of the used dialysis machine in the Intensive Care Unit (ICU) on 12/15/11 at 12 p.m., the Acute Dialysis Nurse (RN 6) wiped multiple surfaces with one wipe of Super Sani Cloth Germicidal (agent that kills germs) Disposable Wipe. The multiple surfaces included a pair of scissors; the top surface, the anterior surface, and the screen of the dialysis machine; as well as the IV pole.

On 12/15/11 at 12:30 p.m., an interview with the RN 6 and the Chief Nursing Officer (CNO 7) was conducted at the nurse station of the ICU. When asked if the RN 6 could disinfect multiple surfaces effectively by using one germicidal disposable wipe, the RN 6 stated she considered the areas she had wiped as one surface. When asked if one wipe of Super Sani Cloth Germicidal Disposable Wipe on multiple surfaces as listed previously could remain wet and achieve the contact time (the time that the surface remains visibly wet) of 2 minutes as specified by the manufacturer, the CNO 7 confirmed that the contact time of 2 minutes could not be achieved when applying one germicidal disposable wipe on multiple surfaces.

On 12/15/11 at 4 p.m., review the document titled "Sani-Cloth Brand Germicidal Disposable Wipes: Technical Summary and Data" dated 2011, published by Professional Disposables International, Inc. (Incorporation), indicated the contact time for Super Sani-Cloth Germicidal Disposable Wipes was two minutes.

On 12/15/11 at 4:15 a.m., the 2003 Guidelines for Environmental Infection Control in Health-Care Facilities, published by Centers for Disease Control and Prevention (CDC) and Healthcare Infection Control Practices Advisory Committee (HICPAC), was reviewed. On page 133, under E.I.A., direction was given that, "Select EPA (Environmental Protection Agency)-registered disinfectants, if available, and use them in accordance with the manufacturer's instructions." Under E.I.C., direction was given that, "Follow manufacturers' instructions for cleaning and maintaining noncritical medical equipment."

2.b. During an observation of the environmental cleaning between surgeries in the OR 1 on 12/13/11 at 12:15 p.m., the ES Q mopped the floor; he returned the used mop to the cleaning solution; and he re-mopped the floor with the used mop head after squeezing excessive cleaning solution in the bucket.

During an interview with the ICP P on 12/15/11 at 3:25 p.m., the ICP P stated the staff should have used a new mop head when he re-mopped the floor in OR 1. The ICP P also stated the hospital used AORN, CDC, and APIC (Association for Professionals in Infection Control and Epidemiology) guidelines as references for infection control practice; there was no specific policy and procedure regarding to change a mop head after each use.

On 12/15/11 at 4 p.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 238, under Recommendation I.c.1., direction was given that, "Reusable string and microfiber mops and cleaning cloths should be changed after each use. Used cleaning mops or cloths should not be returned to the cleaning solution container."

2.c. During an interview with the ES Q on 12/13/11 at 12:20 p.m. at the janitor's closet in the operating suite, the ES Q stated he prepared a pile of cleaning cloths (approximately twenty pieces) by soaking them in the Virex II 256 solution (a germicidal cleaner for environmental cleaning) for 15 minutes; wringing them dry; and putting the damp cleaning cloths in a bag/container ready for use throughout the day.

During an interview with the ICP P on 12/15/11 at 2:40 p.m., when asked if the damp cleaning cloths were adequately wet for disinfecting the environmental surfaces, the ICP P stated the staff should have placed the soaked cleaning cloths in a sealed proof container and the staff should have re-applied Virex II 256 before the cleaning/disinfecting process. The ICP P further stated applying the prepared cleaning cloth on environmental surfaces would not achieve the specific contact time for disinfection purposes.

On 12/15/11 at 10 a.m., review of the manufacturer's information titled "Virex II 256 - One Step Germicidal Cleaner and Deodorant" indicated "to disinfect hard, non-porous surfaces, treated surfaces must remain wet for 10 minutes."

On 12/15/11 at 4:15 a.m., the 2003 Guidelines for Environmental Infection Control in Health-Care Facilities, published by CDC and HICPAC, was reviewed. On page 133, under E.I.A., direction was given that, "Select EPA-registered disinfectants, if available, and use them in accordance with the manufacturer's instructions." Under E.I.C., direction was given that, "Follow manufacturers' instructions for cleaning and maintaining noncritical medical equipment."

2.d. During an interview with the registered nurse (RN 12) in the endoscopy room on 12/13/11 at 2:55 p.m., the RN 12 stated environmental cleaning between the endoscopic procedures included wiping the Endoscopy work station (Olympus WM - N60 Mobile Workstation) with one wipe of Super Sani Cloth and changing the suction tubing. The RN 12 also stated disinfection of the countertops and floor mopping were not required; floor mopping between procedures would be performed as needed if visibly soiled. When asked how long she would maintain the surfaces wet with the disinfectant, RN 12 stated the surfaces were kept wet for about one minute.

During an interview with the RN 5 in the small endoscopy room on 12/14/11 at 12 p.m, when asked the types of procedures were performed in the endoscopy rooms, the RN 5 stated the procedures performed daily included colonoscopy; upper endoscopy; bronchoscopy; and sigmoidoscopy; biopsy and polypectomy were performed as indicated.

On 12/14/11 at 12:10 p.m., an interview with RN 5 was conducted and a concurrent review of the definition of surgery developed by the American College of Surgeons dated 4/2007 was done. The definition of surgery indicated "Surgery is performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. 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, ultrasound, ionizing radiation, scalpels, probes, and needles......All of these surgical procedures are invasive, including those that are performed with lasers, and the risks of any surgical intervention are not eliminated by using a light knife or laser in place of a metal knife or scalpel." RN 5 acknowledged that biopsy and polypectomy were procedures constituted surgery and those procedures should have been performed in the same setting as in the operating room.

On 12/15/11 at 3:45 p.m., review of the hospital's policy and procedure (number: 115.100) titled "Terminal Cleaning for the operating room/surgical suite" dated 8/11 (revision/review date) indicated "Clean between Cases: Clean operating room table, lights, counters and furniture using hospital-approved germicidal solution...Mop floor using hospital-approved germicidal solution."

On 12/15/11 at 3:50 p.m., review of the hospital's policy and procedure (number: 7430 - 1100) titled "Endoscopy Suite Standard of Care" dated 12/08 (revision/review date) indicated "Demonstrates knowledge of infection control measures within the Endo (endoscopy) Suite. This includes equipment, personal protection, the unit itself, waste disposal, and patient protection."

On 12/15/11 at 3:55 p.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 237, under "Recommended Practices for Environmental Cleaning in the Perioperative Setting", direction was given that, "These practice settings include traditional ORs, ambulatory surgery units, physicians' offices, cardiac catheterization suites, endoscopy suites, radiology departments, and all other areas where operative and other invasive procedures may be performed." On page 238, under Recommendation II., direction was given that, "A safe, clean environment should be reestablished after each surgical procedure."

On 12/15/11 at 4 p.m., review of the document titled "Sani-Cloth Brand Germicidal Disposable Wipes: Technical Summary and Data" dated 2011, published by Professional Disposables International, Inc. (Incorporation), indicated the contact time for Super Sani-Cloth Germicidal Disposable Wipes was two minutes.

On 12/15/11 at 4:15 a.m., the 2003 Guidelines for Environmental Infection Control in Health-Care Facilities, published by CDC and HICPAC, was reviewed. On page 133, under E.I.A., direction was given that, "Select EPA-registered disinfectants, if available, and use them in accordance with the manufacturer's instructions." Under E.I.C., direction was given that, "Follow manufacturers' instructions for cleaning and maintaining noncritical medical equipment."

2.e. During an observation and a concurrent interview with the Central Sterilization Staff (CSS M) in the decontamination room of Central Supply Department on 12/14/11 at 12:45 p.m., scattered layers of visible black particles and a piece of glove were observed on floor. There were 2 missing tiles (approximate 3 feet times 2 feet in size) with visibly black particles observed on floor, which were close to the storage cabinet. When asked how often the decontamination room was cleaned, the CSS M stated the housekeeping staff cleaned the decontamination room once a day. When asked if the areas with missing tiles could be effectively sanitized by daily mopping, the CSS M stated "Probably not. I don't know."

During an interview with the ICP P on 12/14/11 at 12:48 p.m. in the decontamination room of Central Supply Department, the ICP P stated the layers of visible black particles were dust scattered on floor. The ICP P further confirmed that the areas with missing tiles could not be effectively sanitized by daily mopping.

On 12/15/11 at 4:15 a.m., the 2003 Guidelines for Environmental Infection Control in Health-Care Facilities, published by CDC and HICPAC, was reviewed. On page 74, under 2.b., direction was given that, "Housekeeping surfaces require regular cleaning and removal of soil and dust. Dry conditions favor the persistence of gram-positive cocci...(a type of micro-organism) in dust and on surfaces, whereas moist, soiled environments favor the growth and persistence of gram-negative bacilli. Fungi are also present on dust and proliferate in moist, fibrous material..."

3.a. During observations in the decontamination room of the endoscopy suite on 12/14/11 from 10:10 a.m. to 11:15 a.m., the Nursing Assistant (NA 5) was observed washing her hands in the empty instrument sink at 10:10 a.m. After brushing the soiled endoscope under the enzymatic solution, the NA 5 was observed washing her hands twice in the instrument sink which contained the brushed instruments submerging in the enzymatic solution at 11 a.m. and 11:12 a.m. The RN 4 was observed washing his hands once in the instrument sink which contained the brushed instruments submerging in the enzymatic solution at 11:10 a.m.

During an interview with the ICP P on 12/15/11 at 9:30 a.m., the ICP P stated it was not correct to use the instrument sink for hand washing due to cross-contamination.

On 12/15/11 at 1:50 p.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN was reviewed. On page 433, under Recommendation VII, direction was given that, "Instruments should be decontaminated in an area separated from locations where clean activities are performed."

3.b. During the observations in the decontamination room of the endoscopy suite on 12/13/11 at 10:55 a.m., the NA 5 mixed the Medical Enzyme Detergent (a multi-enzyme detergent concentrate for removal of organic material such as blood, tissue, mucus, feces, and other organic material found on instruments) with water in the instrument sink. A portion of the endoscope was not completely submerged in the enzymatic solution. The NA 5 was observed brushing the channels of the endoscope in the enzymatic solution without any soaking process. After flushing the channels with water, the NA 5 discarded the disposable brush and kept the plastic syringe by the sink.

During an interview with the NA 5 in the decontamination room of the endoscopy suite on 12/13/11 at 11:10 a.m., when asked why the endoscope was not completely immersed in the enzymatic detergent solution, the NA 5 stated complete immersion was not required for the cleaning process, but only for the disinfecting process. When asked how many times she needed to brush the channel(s), the NA 5 stated she brushed each channel once through each port; she would brush the channel twice only if the solution coming from the channel was visibly dirty. When asked if the plastic syringe for flushing was ready for use on another endoscope, the NA 5 stated she would clean the plastic syringe with water and it would be ready for use on another endoscope.

During an interview with the ICP P on 12/15/11 at 4 p.m., the ICP P stated the NA 5 should have followed the AORN recommendations for the decontamination process. The ICP P indicated that brushing the channel once was not enough, and he would provide more information regarding the requirement of soaking and brushing the endoscope during the decontamination process. The ICP P also stated the NA 5 should not have kept the plastic syringe, which was a single-use device, for multiple-use because cross-contamination might occur.

On 12/15/11 at 4:30 p.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 418, under Recommendation V.a., direction was given that, "When manually cleaning flexible endoscopes: (1) The flexible endoscope should be submerged in an enzymatic detergent solution...(3) All internal channels should be flushed thoroughly with an enzymatic detergent using manufacturer-provided channel cleaning adapters...(6) The brush should be inserted through the channel with the entire endoscope submerged to prevent aerosolization...All channels should be flushed thoroughly..." On page 419, direction was given that, "Submersion of the flexible endoscope in enzymatic detergent solution helps ensure contact between the solution and all surfaces of the endoscope and decreases the potential for the cleaning solution to splash...Flushing all internal channels with detergent solution exposes these surfaces to the enzymatic detergent solution...Thorough flushing of the channels and rinsing of the flexible endoscope and accessories with potable tap water removes residual debris and cleaning agents."

On 12/16/11 at 10:45 a.m., review of an undated document titled "All purpose multi-enzyme detergent: Medical Enzyme Detergent" indicated "Directions:...Soak instruments and equipment after use at least two minutes or until organic material is lifted off. Longer soaking time may be required for tougher or dried on matter. Flush detergent through channels to ensure thorough cleaning..."

On 12/16/11 at 11 a.m., the ICP P indicated that the hospital had no policy and procedure on the single-use items.

On 12/16/11 at 11:05 a.m., review of an document titled "Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions for Reprocessed Single-Use Medical Devices" dated 9/25/2006, published