HospitalInspections.org

Based on document review and interview, the facility failed to ensure that approval was obtained from the local department of health for the storage of medical records off the hospital premises, as required by State regulation.
Findings:
On 12/1/15 beginning at 8:35 a.m., during an interview with Staff MR, she stated that the facility had been storing medical records in an off-site location for many years. The facility did not have a letter from the local department of health granting approval for the storage arrangement, as required by California Code of Regulations, Title 22, section 70751(f). On 12/3/15 beginning at 1:20 p.m., during another interview with Staff MR, she stated that there were no written policies and procedures addressing the transporting, retrieval, retention, maintenance of confidentiality and security of the medical records in the off-site storage facility.
On 12/4/15 at 3:25 p.m., the service agreement with the records storage facility, effective 11/4/1997 was reviewed with Staff MR and PFS . They confirmed that there was no Business Associate Agreement, which is a Federal requirement to ensure confidentiality of the medical records in possession of the storage company, a third-party contractor.

Based on observation, staff interviews, clinical record and administrative document review, the hospital failed to have an effective governing body legally responsible for the conduct of the hospital when:

1. An effective infection prevention program was not implemented and maintained to provide a safe and sanitary environment for surgical services. The processing and sterilization of surgical instruments did not follow nationally recognized standards of practice. The cleaning, decontamination, sterilization and processing of surgical instruments did not follow nationally recognized standards. The hospital infection control preventionist was ineffective in ensuring a quality infection control program that followed hospital procedures and nationally recognized standards to ensure the sterility of surgical instruments. (refer to A749 finding 1, A951 finding 1)

Because of the serious potential harm to all patients who have surgery at the hospital related to the practice of not ensuring the sterility of surgical instruments, an Immediate Jeopardy (IJ) situation was called under Infection Control tag A 749 on 12/1/15 at 1:30 p.m. with the hospital's Chief Nursing Officer, Chief Operating Officer and Chief Medical Officer. The hospital submitted an approved written Action Plan and implementation of corrective actions that addressed the immediate jeopardy situation led to the removal of the IJ on 12/2/15 at 4 p.m.

2. The Quality Assessment and Performance Improvement (QAPI) program did not collect accurate and complete data in order to ensure the quality of services provided in the hospital. No data was collected and no system was put into place to monitor and ensure the sterility of surgical instruments. No direct oversight of staff was provided and no monitoring system was in place to ensure staff followed hospital policies and procedures and nationally recognized standards of practice when performing duties in the sterile processing area. No quality assurance program was in place to ensure the cleanliness of ice machines and the maintenance of filter and vents associated with the HVAC system. (refer to A 283, A 749)

3. No system was in place to ensure professional standards of practice were followed and a safe and sanitary environment was maintained hospital wide and in accordance with the National Fire Protection Association (NFPA) 101 Life Safety Code (LSC) 2000 Edition and the NFPA 72 National Fire Alarm Code 1999 Edition. The hospital failed to follow the provision of maintaining a building construction type permitted for healthcare occupancies. (see LSC K11). The hospital failed to maintain a reliable fire alarm system (in the Psychiatric Unit) that is approved by the authority having jurisdiction. (refer to LSC K-51).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe environment.

Based on observation, staff interview, reviews of administrative documents and national standards of practice, the hospital failed to develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program when:

1. No system was put into place to ensure the sterility of surgical instruments. The hospital did not collect data and did not implement a monitoring system to track whether or not staff were following accepted national standards of practice and hospital policy and procedure for sterilizing surgical instruments. (refer to A 283, A 749 finding 1, A 951).

2. No quality assurance program was in place to ensure the sanitary condition of ice machines. (refer to A 283, A 749, finding 3)

3. No quality assurance program was in place to ensure the cleanliness and functionality of filters and vents associated with the HVAC (Heating, Ventilation and Air Conditioning) system. (refer to A 283, A 749 finding 5, LSC K 67)

4. No quality assurance program was in place to ensure Life Safety measures for fire alarms and construction followed national recognized standards. (refer to A 700, LSC K-11)

Based on observation, staff interview and review of administrative documents and professional standards of practice, the hospital failed to take action aimed at performance improvement when:

1. Concerns regarding not ensuring the sterility of surgical instruments did not prompt the Quality Improvement Committee of the hospital to implement actions that could measure success and track performance.

2. There was no quality assurance program to track and monitor the maintenance and sanitary condition of ice machines.

3. There was no quality assurance program to track and monitor the filters and vents associated with the HVAC (Heating, Ventilation and Air Conditioning) System in accordance with accepted sanitary practices and standards of practice and manufacturer's instructions.

These failures resulted in the potential harm of not ensuring the sterility of surgical instruments used for patient services and possible cross contamination of infections and not providing and maintaining a sanitary environment.

Findings:

1. On 12/2/15 at 2 p.m., during a group interview with the Quality Committee, the role of the quality committee was discussed. The interviewees included the Chief MD of the hospital Quality Committee (CMDQ), the CNO and CMO. The Quality Committed was aware of the previous survey findings during August of 2015 concerning the failure to ensure the sterility of surgical instruments and not following accepted standards of practice and hospital policy and procedures related to sterilization. The Quality Committee was informed of the current survey findings related to the failure to ensure the sterility of surgical instruments. The CMDQ and CMO agreed with the serious nature of the findings related to not ensuring the sterility of surgical instruments. The CMDQ and CMO confirmed that no data had been collected that related specifically to the quality assurance for the sterility of surgical trays. The CMDQ and CMO confirmed the Quality Committee had not established an effective monitoring process to ensure CSP staff followed accepted standards of practice for decontamination of surgical instruments in preparation for the sterile processing. The CMDQ and CMO confirmed the Quality Committee had not established an effective process to ensure CSP staff adhered to the standards of practice that would ensure proper positioning of instruments in the sterile tray. The CMDQ and the CMO confirmed the Quality Committee had not established a process to measure the quality of sterility of surgical trays in the OR by opening and examining sterile trays for effectiveness of the sterilization process. (cross reference A 749, finding 1)

2. On 12/2/15 at 10:11 a.m., during and interview, the Plant Services Director (PSD) described the process of ice machine maintenance. The PSD stated each ice machine was in a computer data base and the maintenance schedule for each ice machine was computer generated. As each ice machine needed to be serviced, the computer generated a work order for the items needing maintenance. The PSD stated the work orders were routed to two technicians for the work to be done. When asked whether the work order for the scheduled maintenance matched the instructions from the manufacturer for that ice machine, the PSD stated he did not know. When asked whether the maintenance work conducted by the technicians was followed up for for quality assurance, he stated that there was no quality assurance on the ice machine maintenance.

During the survey, ten of thirty-eight ice machines located in various areas of the hospital were not maintained in a sanitary manner and hospital staff did not follow manufacturer's instructions for maintenance. (Cross reference A 749, finding 3)

3. On 12/2/15 at 10 a.m. the Plant Services Director stated there was no quality assurance program to ensure filters and vents were maintained in a sanitary manner and that the HVAC system was not maintained according to nationally recognized standards.

On 12/1/15 at 9:15 a.m., during a concurrent observation and interview, the CSP area was noted to have dust and debris covering surfaces directly below an HVAC (Heating/ventilation/air-conditioning) vent. The area below the vent was a worktable used to wrap surgical trays. The CSP Manager and ICP confirmed the layer of dust and debris directly below the vent. The covering of the vent appeared dirty. The CSP Manager and ICP stated they were unsure as to whose responsibility it was to clean and maintain the exterior and interior of the vents. (cross reference A 749, finding 5)

Based on interviews and a review of the credentials files and medical privileges for 6 emergency department physicians, the hospital failed to ensure appropriate credentialing for 6 of 6 physicians.

This could result in the performance of procedures for which a practitioner is not qualified.

Findings:

On 12/2/15 at 1:45 p.m., during a concurrent interview and document review, the privileges of six emergency medicine physicians were reviewed with Medical Director of EMergency Department (MDED). On the form titled "Clinical Privileges", in the section of "Core emergency medicine privileges", under the item "anesthesia", the following items were listed "a) local anesthesia; b) regional nerve block; c) short term general anesthesia". All three items were marked requested and approved. When interviewed on 12/3/2015 at approximately 1:30 p.m., the medical director of anesthesia Medical Doctor (MD) 3 was asked to clarify "short term general anesthesia", MD 3 stated that it meant the emergency medicine physicians may intubate patient under rapid sequence intubation (emergent introduction of tube into patient's trachea in patient under cardiopulmonary arrest, i.e., no spontaneous heartbeat or breathing, or when patient's airway is compromised). When MDED was asked "Who approved the privilege of emergency medicine physicians", MDED replied, "The ER [emergency room] department would approve first, then submit [the approval] to MEC [medical executive committee]." When asked whether the ER department would involve the anesthesia department during the privilege granting process, MDED stated, "No." MD 3 agreed that granting the emergency medicine physicians with "short term general anesthesia", would suggest that those physicians were granted privileges to provide general anesthesia in the operating room. Both MD 3 and MDED agreed that the granted privileges were beyond the scope of practice of the emergency department physicians.

Review of rules and regulations titled "Emergency Medicine Section" dated September 2015, indicated that Emergency Medicine Department would recommend clinical privileges for each member of the section and recommend criteria for granting clinical privileges within the Emergency Medicine Section.

Cross Reference A0044

Based on staff interview, clinical record and administrative document review, the facility failed to appropriately assess Patient 1's pain level when no pain assessment was done before or after the administration of pain medications. This failure had the potential for Patient 1 to receive too little or too much pain medication.
Findings:
On 12/1/15 at 8 a.m., during a concurrent interview and record review, Patient 1's clinical record indicated Patient 1 was assessed for pain on 11/30/15 at 3:18 p.m. Patient 1's pain level was recorded at 5/10 (moderate pain). He was medicated with one tablet of hydrocodone-acetaminophen 5 mg (milligrams)-325 mg (Norco), taken by mouth. The next pain assessment was recorded on 11/30/15 between 9 and 10 p.m., with Patient 1's pain level recorded at zero. Registered Nurse (RN) 3 stated required reassessment times vary and depend on the medication administered. He acknowledged approximately one hour after an oral pain medication was administered would be an appropriate time to reassess for pain. On 11/30/15 at 10:17 p.m., Patient 1 was medicated with one tablet of hydrocodone-acetaminophen 5 mg-325 mg . RN 3 verified there was no pain assessment documented prior to or after the administration of this dose of medication. RN 3 acknowledged there should have been documentation of a pain assessment and reassessment.
The facility policy and procedure titled, "Pain Management" dated 9/15, indicated " .... Continuing Pain Assessment (after Pain Assessment completed on Admission): ... 2. The patient will be assessed:
· Before each administration of pain medication, the patient's pain level will be recorded. Elements of the above will be documented as indicated.
· Reassessment of at least the pain level (score) after pain medication administration will be performed periodically to determine
o If the pain medication was effective
o The need for future doses
o If there is a need for another pain management medication
Timing of these reassessments may be guided
o By the onset and duration of action of the medication(s) being used ...."
The facility policy and procedure does not contain recommended timing of reassessments other than noted above.

Based on staff interview and clinical and administrative document review, the hospital failed to develop current nursing care plans for each patient when one (Patient 2) of twenty patient charts reviewed did not contain nursing care plans.

This failure had the potential to place patients at risk of not having nursing care needs addressed and cause possible delays in treatment goals which could result in patient harm and/or prolonged hospitalization.

Findings:

On 12/2/15 at 2:35 p.m., during a concurrent interview and record review, the clinical record indicated Patient 2 was admitted to the hospital on 11/30/15 with diagnoses of anxiety, alteration in comfort (pain), diabetes, high blood pressure, GERD (Gastroesophageal reflux disease- GERD is a chronic digestive disease. GERD occurs when stomach acid or, occasionally, stomach content, flows back into your food pipe [esophagus]. The backwash [reflux] irritates the lining of your esophagus and causes GERD.), and TIA (A transient ischemic attack [TIA] is like a stroke, producing similar symptoms, but usually lasting only a few minutes and causing no permanent damage.) No nursing care plans had been developed or initiated for this patient. When asked how soon after admissio a care plan should be initiated, Registered Nurse (RN) 3 stated, "Within 24 hours of admission." RN 4 verified that there were no care plans in Patient 2's chart. RN 4 agreed with RN 3 and stated, "Our policy says all patients should have care plans initiated within 24 hours of admission, I'm not sure why there aren't any on this chart."
The policy and procedure titled, "Interdisciplinary Plan of Care (IPOC)" dated 6/15 indicated, "POLICY STATEMENT: A...Registered Nurse (RN) caring for the patient initiates plans of care within 8 hours of admission..." and, "PROCEDURE: I. Personnel: ...The IPOC will be operational within 24 hours of patient admission to a patient care unit..."

Based on observation, staff and patient interview and clinical and administrative document review, Five of twelve patients (Patient's 37, 40, 42, 43, and 46) did not have documentation of vital sign monitoring in accordance with hospital policy and procedure during blood transfusions.
This failure resulted in an incomplete medical record and had the potential for delay in treatment of adverse reactions to blood products.
Findings:
On 12/1/15 at 9:35 a.m., during an initial tour of the facility, Patient 12 was selected for an inpatient clinical record review. The clinical record indicated Patient 12 had received several blood transfusions.
On 12/1/15 at 9:45 a.m., an interview was conducted with Registered Nurse (RN) 8 about the hospital policy and procedure for blood products administration. She stated RN's giving blood products perform vital signs (blood pressure, temperature, respirations and pulse rate) on patients before the transfusion begins, and 15 minutes after the blood is started. RN 8 stated the nurses document on the Transfusion Record either in paper form or on the electronic medical record (EMR) and usually both. She stated if the patient exhibits any type of reaction to the blood product such as anaphylaxis (coughing, throat tightening, respiratory distress, anxiety) the blood transfusion is to be stopped immediately and the patient's doctor and blood bank are notified.
On 12/1/15 at 2:35 p.m., an interview was conducted with RN 9. She stated before administering a blood transfusion she goes over the informed consent with the patient per hospital policy. She stated she explains possible reactions (fever, chills, difficulty breathing), which could occur once the blood is started and reminds the patient to call the nurses for help, if they have a reaction to the blood.
On 12/2/15 at 2:40 p.m., during an interview, RN 10 stated the hospital policy for monitoring a patient receiving a blood transfusion included vital signs before the blood is started, and 15 minutes after. RN 10 stated she documents on the blood transfusion record and puts the information in the EMR. For patients experiencing a reaction she stated she stops the transfusion immediately, notifies the charge nurse, patients doctor and the blood bank. All the tubing and remaining blood is returned to the blood bank for testing.
On 12/2/15 at 8:20 a.m., during an interview, RN 11 stated for a blood transfusion the vital signs are performed at the start of the transfusion and 15 minutes after. She stated the hospital policy reads nurses should stay with the patient at least 15 minutes to observe for reactions.
On 12/2/15 at 1:16 p.m., a tour of the blood bank and concurrent interview was conducted with the Blood Bank Supervisor. She stated there are 22 employees working in the blood bank who type and crossmatch patients with orders for blood products. She stated on average the blood bank prepares 700 units of blood products a month. She stated any adverse reactions to blood products are handled immediately.
The facility provided a list of patients who experienced adverse reactions to blood products from January-September 2015. Of the 22 patients with reactions, Patient's 37, 40, 42, and 43 were randomly selected for a blood administration record review.
On 12/3/15 at 9 a.m., a record review and concurrent interview was conducted with RN 3 and RN 4, for Patients 37, 40, 42, and 43. Patient 37's clinical record indicated she was 64 years old and was admitted to the facility on 3/26/15 for treatment of anemia (low iron in the blood). She had a history of breast cancer and was undergoing chemotherapy. On 3/26/15 at 12:35 p.m., Patient 37's doctor ordered, "Transfuse two units of PRBC's (packed red blood cells) today over 3-4 hours each, per policy 8740.185, direct observation of patient occurs for at least the first 5-15 minutes and vital signs taken after 15-30 minutes after initiation." On 3/26/15, the hand written Transfusion Record indicated a blood transfusion was started at 3:15 p.m. There were no vital signs written at 15 minutes or post transfusion. RN 4 stated the nurses can record vital signs in two places, in the EMR or on the hand written Transfusion Record. Patient 37's EMR was accessed and navigated by RN 3. The EMR read on 3/26/15, at 2 p.m., the blood transfusion was started. Vital signs were recorded at 3 p.m., and again at 5 p.m. RN 3 stated hospital policy dictates the nurse administering blood must document a set of pre-vital signs no more than 1 hour before blood is started, 15-30 minutes after the transfusion and post-vital signs. He stated when he gives blood this is how he records the vital signs. He stated there is a lack of documentation on both the EMR and hand written Transfusion Record regarding vital signs. On 3/26/15, Patient 37 received a transfusion of platelets (a component of blood) beginning at 6:15 p.m. The Transfusion Record showed vital signs were written at the time the infusion started, (6:15 p.m.), again at 6:30 p.m. When the platelets were finished at 7:10 p.m., documentation by nursing staff read, at 1910 (7:10 p.m.) platelet pherisis (transfusion) completed and patient found shaking, dyspneic (short of breath), tachycardic (rapid heartbeat) and hypoxic (deficiency in the amount of oxygen delivered to the body tissues). Patient awake and alert. Stated she can't stop shaking. Unable to get a blood pressure and O2 saturation (reading to determine amount of oxygen in the blood, normal is greater than 94%). Rapid response (a call for designated emergency staff to assist with the patient) activated. Patient 37 was given Benadryl (antihistamine medication for allergic reactions) and stabilized. Documentation in the EMR showed vital signs were recorded at 6 p.m. There were no further vital signs recorded in the EMR. Patient 37 received the second unit of blood on 3/26/15. Written documentation on the Transfusion Record read the blood was started at 10:58 p.m. There were no written vital signs pre-transfusion. A vital sign was written in at 11:30 p.m. There were no written post-transfusion vital signs. The EMR showed one set of vital signs was recorded at 11:30 p.m., and at the completion of the transfusion on 3/27/15 at 2:40 a.m. On 3/27/15 at 10:30 a.m., written documentation on the Transfusion Record showed Patient 37 received a transfusion of platelets beginning at 10:30 a.m. A set of vital signs was written pre-transfusion at 10:15 a.m. There was no further documentation. The EMR showed vital signs were recorded at 10 a.m. and no further vital signs until 2 p.m. RN 4 stated she could see the discrepancies in documentation on both the written and recorded vital signs in Patient 37's medical record, and lack of vital signs for the platelet transfusion.
Patient 40, 25 years old was admitted to the hospital on 6/22/15 for weakness, feeling dizzy and black tarry stools. Past medical history included migraine headaches. A complete blood count (CBC) revealed she was severely anemic with a hemoglobin (protein in red blood cells that carries oxygen to organs and tissue) of six (Normal 12-15.5). On 6/22/15 at 5:59 p.m., Patient 40's doctor ordered, "Transfuse four units of PRBC's in total, Rapid Blood Loss, per policy 8740.185, direct observation of patient occurs for at least the first 5-15 minutes and vital signs taken after 15-30 minutes after initiation." On 6/22/15 at 8:08 p.m. a pre-transfusion vital sign was written on the Transfusion Record. The transfusion was documented starting at 8:30 p.m. and a vital sign was taken five minutes later at 8:35. No further vital signs were written until 10 p.m. when Patient 40 was found with a temperature of 103.1 degrees, complaints of dizziness and a witnessed fall in her room. A rapid response was called and Patient 40 was stabilized. A review of the EMR showed Patient 40 had vital signs recorded at 6:19 p.m., the blood transfusion was started at 8 p.m., and vital signs were recorded at 8:08 p.m. No further vital signs were recorded in the EMR until 10 p.m., when Patient 40 required rapid response. On 6/23/15 an infusion of blood was documented as starting at 2:45 a.m. on the Transfusion Record. Pre-transfusion vital signs were written at 2:33 a.m. and the next vital sign was written at 3:36 a.m. The EMR indicated a set of vital signs were recorded at 2:33 a.m. when the blood transfusion was started, and the next set of vital signs was recorded at 3:35 a.m. The Transfusion Record showed documentation the transfusion was complete at 5:15 a.m. and the next unit of blood was started at 5:39 a.m. The 5:15 a.m. vital signs flowed to the next Transfusion Record as the pre vital signs and the next vital sign recorded was at 6:15 a.m. The EMR showed the pre-transfusion vital signs were recorded at 5:20 a.m., and the next recorded vital signs were at 6:15 a.m. RN 3 stated this does not follow the hospital policy for administering blood, and there were gaps in time when vital signs should have been written and/or recorded.
Patient 42, 29 years old was admitted to the hospital on 9/6/15 with complaints of nausea and vomiting after gallbladder surgery. Patient history included thalassemia major (a hereditary form of anemia requiring frequent blood transfusions) and Hepatitis C. On 9/7/15 at 12:29 p.m., Patient 42's doctor ordered, "Transfuse two units of PRBC's in total, per policy 8740.185, direct observation of patient occurs for at least the first 5-15 minutes and vital signs taken after 15-30 minutes after initiation." On 9/7/15 at 7 p.m. a unit of blood was started. The transfusion record shows written pre-transfusion vital signs at 5 p.m. and a set of written vital signs with no documented time. At 9 p.m., patient was noted to have hives and itching, nausea and chills. Benadryl was administered and the rash improved. A review of the EMR showed patient had vital signs recorded at 4 p.m., the blood transfusion was started at 6 p.m. and the next recorded vital sign was at 7:30 p.m., followed by vital signs at 9:10 p.m. The next recorded vital signs were at 1 a.m. RN 3 stated the hospital policy for blood administration was not followed because vital signs need to be monitored less than 1 hour before, 15-30 minutes after the transfusion starts and there were no vital signs documented post-procedure, after the patient had a reaction.
On 12/3/15 at 12:28 p.m., an observation of the blood administration process and concurrent interviews were conducted with Patient 45 and RN 12. Patient 45 states he was admitted on 11/24/15 with a high white blood cell count and was undergoing tests. He stated he had received about six blood transfusions over the last few days. When asked if blood reactions had been explained to him, he stated yes, but I don't remember, I leave my care to the professionals, they know what they are doing. RN 12 documented the pre-vital signs, which were taken and recorded in the EMR at 11:50 a.m. and the transfusion was started at 100 milliliters/hour via intravenous (IV) pump at 12:50 p.m. Fifteen minutes later, at 1:05 p.m. Patient 45's vital signs were obtained and documented in the EMR and on the transfusion record. RN 12 stated she likes to document in both places, "because then I create a paper trail which can be followed if the patient has any problems with the transfusion." When asked how she would care for a patient who was mentally or physically unable to call for help during a transfusion she stated hospital policy says to stay for 15 minutes to make sure they are doing alright before leaving the room.
On 12/4/15 at 7:30 a.m., record reviews and staff interviews were conducted with RN 3 and RN 4. Patient 43, 52 years old was admitted to the hospital on 6/14/15 for SIRS (Systemic inflammatory response syndrome, causing fever, increased heart rate, and abnormal white blood cells). Patient has a history of pancreatic cancer and high blood pressure. On 6/14/15 at 1:32 p.m., Patient 43's doctor ordered, "Transfuse red blood cells (RBC) today over 2 hours each, Hemoglobin under 8 gms (grams), Symptomatic per policy 8740.185, direct observation of patient occurs for at least the first 5-15 minutes and vital signs taken after 15-30 minutes after initiation." The first unit of blood was written on the Transfusion Record as starting on 6/14 15 at 3:40 p.m. Patient 43's vital signs were written on the Transfusion Record pre-transfusion at 2:30 p.m. Vital signs were written 30 minutes after the transfusion started at 4:10 p.m. The blood was written as completed at 6:25 p.m. The EMR read pre-transfusion vital signs at 2:30 p.m., blood was started at 3 p.m.; the next recorded vital signs were at 4:18 p.m. The second unit of blood was written on the Transfusion record as starting on 6/14/15 at 9:07 p.m. The pre-transfusion vital signs were written at 8:30 p.m., the next vital signs were written at 9:35 p.m. At 11 p.m., Patient 43 was found with an increased heart rate and chills. Nursing notes indicated the nursing staff contacted Patient 43's doctor at 11:09 p.m., regarding Patient 43's condition. There were no orders given for medications, they were told to just stop the transfusion. At 11:37 p.m., a rapid response was called because Patient 43's condition changed to include high blood pressure and a fever. Patient 43 was given medication and transferred to the ICU. The EMR for 6/14/15 showed Patient 43's vital signs were recorded at 8 p.m. when the blood was started. The next set of vital signs was recorded at 8:35 p.m. and no further vital signs or monitoring were recorded until she was found in distress at 11:05 p.m. RN 4 stated the nursing staff are trained in hospital orientation and yearly on blood administration policy and procedure, and monitoring for blood reactions.
On 12/4/15 at 9:30 a.m. an interview was conducted with Patient 46. Patient 46 is a 52 year old admitted on 12/1/15 for treatment of breast cancer. Patient 46 stated her blood count had dropped on 12/2/15 and the doctor looked at her and recommended a blood transfusion. She stated the nurse took her temperature and blood pressure before the blood started and the nurse stayed with her for 15 minutes. She stated the RN told her to tell her immediately if she had any rashes, dizziness or itching hives. Patient 46 stated she did not have a reaction. A review of the Transfusion Record showed the transfusion was written as starting on 12/2/15 at 9:35 a.m. No documentation of vital signs was written on the Transfusion Record. A review of the EMR showed a set of vital signs was recorded at 9:00 a.m., when blood transfusion was recorded as starting, again at 10 a.m., and 11:00 a.m.
On 12/4/15 at 9:45 a.m., during an interview, RN 13 stated she stays at her patients' bedside for 5 minutes after a blood transfusion begins to monitor for a reaction per hospital policy. She checks the vital signs 15 minutes after the blood has infused and after the transfusion is completed.
Patient 46 received a second blood transfusion on 12/4/15. Documentation on the Transfusion Record showed the blood was written as starting at 2:45 a.m. A pre-transfusion set of vital signs was written on the Transfusion Record at 2:45 a.m., and no further vital signs were written. A review of the EMR showed vital signs were recorded at 2:50 a.m. and the next recorded vital sign was at 4:30 a.m.
On 12/4/15 at 1 p.m., during navigation of the EMR, an interview was conducted with RN 3. He stated he didn't understand what is going on with the staff; this is not following hospital policy for administering blood transfusions.
Review of the facility policy and procedure No. 8740.185 titled, "Blood Transfusion", dated 09/14 indicated, "...Procedure ...III. Transfusion Administration: G. Obtain and record baseline vital signs. Baseline vital signs must be taken no more than 60 minutes before the start of the infusion ...K. Direct, visual observation of the patient occurs for at least the first 5-15 minutes after the blood enters the vein for any adverse effects to the transfusion ...M. Take vital signs after 15-30 minutes and record them on the Blood Transfusion Record in the EHR, or on the Transfusion record ...P. Take post transfusion vital signs no more than 60 minutes after completion of the transfusion and document them on the Blood Transfusion Record ...R. If the patient demonstrates any symptoms that may be indicative of a possible transfusion reaction, initiate a transfusion reaction investigation..."
Review of the facility policy and procedure titled, "Blood Transfusion Reaction Investigation", dated 9/14 indicated, "...Policies: Any adverse reaction by a patient undergoing a blood transfusion should be considered a transfusion reaction until otherwise proven ...Procedure: I. Transfusion reaction investigation: Reactions may be immediate or delayed..."

Based on observation and staff interview, the facility failed to ensure that records were promptly processed after discharge. This failure had the potential to impact the timely completion of records by physicians.
Findings:
On 12/2/15 beginning at 11:20 a.m. a tour of the medical records department was made with Staff MR. A file cabinet with stacks of records was observed and Staff MR stated that they were records of recently discharged patients that were awaiting analysis by the staff. She further explained that this 8-day backlog was a bit more than usual due to a holiday and staff time off. These records needed to be checked for reports and entries that physicians had to complete and/or sign. This delay in analysis, would result in less time for physicians to complete the records within the period required.
The Medical Staff Rules and Regulations, September 2014, were reviewed on 12/2/15. Section 3.8-1 stated: " Medical records shall be completed within 14 days from the date of discharge. "

Based on staff interview, clinical record and administrative document review, the facility failed to ensure that medical records were accurately written in 2 of 5 records due to abbreviations used that were not on the hospital's approved list. This failure resulted in the potential for errors to occur in patient care due to misinterpretation of abbreviations.
Findings:
On 12/2/15, the Administrative policy # 401 " Hospital Abbreviations, " effective 12/1/14, was reviewed. This policy included a 26-page list of abbreviations and their meanings that were acceptable for use in medical record entries. On the afternoon of 12/2/15, clinical records for Patients 19 and 20 were reviewed and were noted to contain abbreviations that were not on the approved list and/or were being used for a different meaning than was on the list. Staff MR confirmed this finding concurrently during the record review.

Based on staff interview, clinical record and administrative document review, the facility failed to ensure all telephone orders are authenticated promptly by the ordering practitioner for 1 of 60 sampled patients when a telephone order was entered in Patient 1's clinical record on 11/26/15 at 5:43 p.m. by Registered Nurse (RN) 14 but was not signed by Medical Doctor (MD) 2.

This failure had the potential for an incorrect order to go unnoticed by the prescribing MD.

Findings:

On 12/1/15 at 7:50 a.m., a concurrent interview and clinical record review was conducted. Patient 1's clinical record contained an order placed in the record on 11/26/15 at 6:43 a.m. by RN 14. RN 3 verified the order was not signed by a physician. RN 3 stated the MD should have signed the order within 48 hours.

The facility Medical Staff General Staff Rules and Regulations, dated 9/14, indicated ".... 2.4 Physician orders. The staff physician is responsible for orders for care prior to or promptly after admission. Verbal orders are discouraged. Telephone and/or verbal orders must be authenticated by the ordering physician within 48 hours. All entries in the medical record must be dated, timed and authenticated...."

Based on document review and staff interview, the facility failed to ensure that medical records, including the discharge summaries, were completed within 14 days following the patient ' s discharge. This failure had the potential to adversely impact the patient ' s continuing care, since copies of these reports are routinely shared with the post-hospital team.
Findings:
The Medical Staff Rules and Regulations, September 2014, were reviewed on 12/2/15. Section 3.8-1 stated: " Medical records shall be completed within 14 days from the date of discharge. "
On 12/1/15 beginning at 2:40 p.m., Staff MR provided the " Hospital Medical Record Statistics Form " which revealed there were a total of 1438 delinquent records (those still incomplete 14 days following discharge). Staff MR also provided the " Delinquent Document Report Summary " which revealed that there were 342 delinquent discharge summaries.
On 12/3/15 at 2:20 p.m. Staff MR provided the " Deficiency Reporting by Physician Summary Reports " (for delinquent records) which revealed there were approximately 217 physicians who had a total of 1059 records that needed signatures on various entries within the records. At least 46 of these records were more than 200 days after the patient ' s discharge. The suspension list for delinquent records issued on 12/2/15 contained only eight physicians. These findings were confirmed by Staff MR on 12/4/15 at 12:30 p.m.

Based on observation, staff interview, and document review, the hospital failed to ensure emergency medications list posted on the outside of the adult emergency crash carts (crash cart) matched medications which were inside the crash carts. In addition, the hospital also failed to ensure emergency medications had been inspected every 30 days or less as required by the state law.
The emergency crash cart is used for storing medications and medical supplies needed during a medical emergency.
This failure had a potential to result in delayed medication administration as well as expose patients to expired medications during emergency.

Findings:
a. Review of the hospital ' s P&P titled " Code Blue, Code White, and Rapid Response Team (Adult and Pediatric) Response and Equipment Management " dated 10/15, read " ...Pharmacy will maintain the lists of Crash Cart Medications and IV (intravenous) solutions, and a list included with each medication tray ... "
On 12/1/15 at 1:45 p.m., an observation on the Critical Care unit was initiated in the presence of Pharmacist 1, Pharmacy Manager 2, the Director Pharmacy/Lab services and the Maternity Manager.
Inspection of the crash cart showed medication list which had been posted outside the crash cart did not match the medications which had been stored inside the crash cart. One ampule of isoproterenol 1 mg/5 ml (to treat slow heart rate) and two vials of vasopressin 20 units/ml (used to regulate blood volume and arterial pressure) were listed outside the cart but were not found inside the crash cart.
Pharmacist 1, Pharmacy Manager 2, the Director of Pharmacy/Lab services and the Maternity Manager acknowledged isoproterenol and vasopressin were not inside the crash cart. Pharmacist 1 stated isoproterenol and vasopressin were removed from the crash cart medication list by the Code Blue committee in 2014.

b. On 12/3/15 at 2:45 p.m., the unit inspection reports were reviewed in the presence of Pharmacy Manager 1 and Pharmacy Manager 2.
Review of the Emergency Department (ED) POD A inspection reports for 2015 showed emergency medications in the emergency department (POD A) had not been inspected at intervals of 30 days or less as follows:
3/12/15 - 4/29/15 = 49 days
5/27/15 - 7/23/15 = 58 days

Pharmacy Manager 1 and Pharmacy Manager 2 both acknowledged the emergency medications were inspected at intervals greater than 30 days. Pharmacy Manager 2 also verified that emergency medications in ED POD A had not been inspected in June 2015.

Based on observation, staff interviews, and document review, the facility failed to ensure that outdated/unusable medications and supplies were not available for patient use.
This failure had the potential to result in patients receiving outdated drugs which may not provide the intended benefit.

Findings:
Review of the hospital's P&P titled "Expiration Guidelines" dated 12/14, read "...Definition: Expiration dating are those determined by the manufacturer and/or pharmacy which must be adhered to assure product quality ..."
Review of the hospital's P&P titled "Refrigerator/Freezer Records" dated 8/15, read "...The temperature for medication refrigerators shall be 36 - 46 degrees Fahrenheit ..."

a. Review of the manufacturer's package insert for multivitamin by intravenous infusion dated 9/07, which had been provided by the hospital read "... After the multivitamin is diluted in an intravenous infusion, the resulting solution should be refrigerated unless it is to be used immediately. The solution should be used within 24 hours after dilution ..."
Review of the manufacturer's package insert dated 10/11, provided by the hospital read "...Store famotidine injection at 2 - 8 degree Celsius (36 - 46 degree Fahrenheit) ..."

On 12/1/15 at 10:58 a.m., during a concurrent observation and interview in the 4 West medication room, Patient B's vancomycin (antibiotic) infusion bag with expiration date of 11/30/15 was observed inside the medication refrigerator. Pharmacist 2, Pharmacy Supervisor 1, Pharmacy Manager 1, and the Maternity Manager acknowledged the expired medication. Pharmacy Manager 1 stated the medication should not be in the refrigerator, it should have been returned to the pharmacy.

Also observed in the medication refrigerator was a 1000 ml bag of intravenous Dextrose 5 % in ½ sodium chloride (hydration fluid) with multivitamin (supplement), thiamine (supplement), folic acid (supplement) and magnesium sulfate (magnesium supplement) compounded on 12/1/15, with a beyond use date (BUD) of 72 hours which was contrary to manufacturer's guideline above. Pharmacy Manager 1 acknowledged above intravenous solution should be used within 24 hours after compounding.

Observed in the automated medication dispensing cabinets in the 4 West medication room were 20 vials of intravenous (IV) famotidine (used to treat condition in which the stomach acid irritates the food pipe lining) stored at room temperature without any BUD noted. Pharmacy Manager 2 stated IV famotidine was good for 8 weeks at room temperature. The hospital was unable to provide evidence their brand of famotidine IV was stable at room temperature. The Director of Pharmacy/Lab services acknowledged it was possible for a patient to receive famotidine IV stored at room temperature for over 8 weeks unknowingly.

b. Review of the manufacturer's package insert for epogen read "...store at 36 - 46 degrees Fahrenheit (2 - 8 degrees Celsius) ..."
On 12/1/15 at 1:45 p.m., during a concurrent observation and interview in the critical care unit medication room, one vial of epogen 10000 units/ml (used to treat a lack of red blood cells in the body) was observed in Patient C's cassette and another vial of epogen 4000 units/ml in Patient D's cassette stored at room temperature.
Pharmacist 1, Pharmacy Manager 2, the Director of Pharmacy/Lab services and the Maternity Manager acknowledged the epogen vials had been stored at room temperature. Pharmacist 1 was not sure how long the vials had been at room temperature, but she stated these vials were supposed to be refrigerated and not stored at room temperature.

c. Review of succinylcholine's (used to relax the muscles during surgery) manufacturer package insert dated 9/10, read "...The multi-dose vials are stable for up to 14 days at room temperature without significant loss of potency ..."
On 12/1/15 at 2:50 p.m., during a concurrent observation and interview in the operating room (OR) suite, one vial of succinylcholine 20 mg/ml 10 ml with an expiration date of 12/21/15 and the other vial with an expiration date of 12/18/15 were observed stored at room temperature in OR 12. One vial of succinylcholine with expiration date of 12/15/15 was also observed stored at room temperature in OR 1. The above succinylcholine vials were given beyond use dates (expiration dates) greater than 14 days at room temperature contrary to the above manufacturer's guideline.
One outdated vial of succinylcholine with expiration date of 11/27/15 was observed in OR 1.
Pharmacy Manager 1, Pharmacy Manager 2, the Maternity Manager and the OR Supervisor acknowledged the beyond use dates (BUD) on the succinylcholine vials. Pharmacy Manager 2 stated succinylcholine vials had been given a BUD of 30 days when stored at room temperature and expired succinylcholine vial should not be in the OR.

d. On 12/2/15 at 10:30 a.m., during a concurrent observation and interview in the Pharmacy department, one opened vial of tuberculin purified protein derivative (aid in the detection of infection with tuberculosis) with expiration date of 11/12/15 was observed in the pharmacy refrigerator. Three bags of azithromax 250 mg in 250 ml of dextrose 5 % in water (intravenous antibiotic) with expiration date of 12/1/15 were observed in refrigerator C.
Pharmacy Manager 2, the Director Pharmacy/Lab services and the Maternity Manager acknowledged the expired medications.

e. Review of the hospital's P&P titled "Unit Dose Packaging- Repackaging Oral Solids in Single Unit and Unit Dose Packages" dated 12/14, read "...Purpose: To assure the unit dose packaging of oral solids and liquid complies with requirement of federal and state laws and regulations ...Expiration date of repackaged product must not exceed 1 year or the time remaining of the expiration date..."
On 12/3/15 at 8:30 a.m., during a concurrent observation and interview in the Pediatric unit medication room, a 60 ml bottle of cherry syrup repackaged from a bulk bottle by the pharmacy was given a BUD of 12/18 (more than three years) which was contrary to above hospital's P&P.
Pharmacy Manager 1 and Pharmacy Manager 2 acknowledged the beyond use date was incorrect on this container and stated the dating should have been within the parameters in the hospital's P&P.



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Based on observation, staff interviews, administrative document review, and manufacturer's guidelines, the facility failed to ensure that outdated/unusable medications and supplies were not available for patient use.
This failure had the potential to result in patients receiving outdated drugs which may not provide the intended benefit.

Findings:

a. On 12/1/15 at 10:58 a.m., during a concurrent observation and interview in the 4 West medication room, Patient 30's vancomycin (antibiotic) infusion bag with expiration date of 11/30/15 was observed inside the medication refrigerator. Pharmacist 2, Pharmacy Supervisor 1, Pharmacy Manager 1, and the Maternity Manager acknowledged the expired medication. Pharmacy Manager 1 stated the medication should not be in the refrigerator, it should have been returned to the pharmacy.

Also observed in the medication refrigerator was a 1000 mL bag of intravenous (administered in a vein) Dextrose 5 % in ½ sodium chloride (hydration fluid) with multivitamin (supplement), thiamine (supplement), folic acid (supplement) and magnesium sulfate (magnesium supplement) compounded on 12/1/15, with a beyond use date (BUD) of 72 hours which was contrary to manufacturer's guideline below. Pharmacy Manager 1 acknowledged above intravenous solution should be used within 24 hours after compounding.

Observed in the automated medication dispensing cabinets in the 4 West medication room were 20 vials of intravenous (IV) famotidine (used to treat condition in which the stomach acid irritates the food pipe lining) stored at room temperature without any BUD noted. Pharmacy Manager 2 stated IV famotidine was good for 8 weeks at room temperature. The hospital was unable to provide evidence their brand of famotidine IV was stable at room temperature. The Director of Pharmacy/Lab services acknowledged it was possible for a patient to receive famotidine IV stored at room temperature for over 8 weeks unknowingly.

b. On 12/1/15 at 1:45 p.m., during a concurrent observation and interview in the critical care unit medication room, one vial of epogen 10000 units/mL (used to treat a lack of red blood cells in the body) was observed in Patient 31 cassette and another vial of epogen 4000 units/mL in Patient 32 cassette stored at room temperature.
Pharmacist 1, Pharmacy Manager 2, the Director of Pharmacy/Lab services and the Maternity Manager acknowledged the epogen vials had been stored at room temperature. Pharmacist 1 was not sure how long the vials had been at room temperature, but she stated these vials were supposed to be refrigerated and not stored at room temperature.

c. On 12/1/15 at 2:50 p.m., during a concurrent observation and interview in the operating room (OR) suite, one vial of succinylcholine 20 mg/mL 10 ml with an expiration date of 12/21/15 and the other vial with an expiration date of 12/18/15 were observed stored at room temperature in OR 12. One vial of succinylcholine with expiration date of 12/15/15 was also observed stored at room temperature in OR 1. The above succinylcholine vials were given beyond use dates (expiration dates) greater than 14 days at room temperature contrary to the above manufacturer's guideline.
One outdated vial of succinylcholine with expiration date of 11/27/15 was observed in OR 1.
Pharmacy Manager 1, Pharmacy Manager 2, the Maternity Manager and the OR Supervisor acknowledged the beyond use dates (BUD) on the succinylcholine vials. Pharmacy Manager 2 stated succinylcholine vials had been given a BUD of 30 days when stored at room temperature and expired succinylcholine vial should not be in the OR.

d. On 12/2/15 at 10:30 a.m., during a concurrent observation and interview in the Pharmacy department, one opened vial of tuberculin purified protein derivative (aid in the detection of infection with tuberculosis) with expiration date of 11/12/15 was observed in the pharmacy refrigerator. Three bags of azithromax 250 mg in 250 mL of dextrose 5 % in water (intravenous antibiotic) with expiration date of 12/1/15 were observed in refrigerator C.
Pharmacy Manager 2, the Director Pharmacy/Lab services and the Maternity Manager acknowledged the expired medications.

e. On 12/3/15 at 8:30 a.m., during a concurrent observation and interview in the Pediatric unit medication room, a 60 mL bottle of cherry syrup repackaged from a bulk bottle by the pharmacy was given a BUD of 12/18 (more than three years) which was contrary to below hospital's Policy and Procedure (P&P).
Pharmacy Manager 1 and Pharmacy Manager 2 acknowledged the beyond use date was incorrect on this container and stated the dating should have been within the parameters in the hospital's P&P.

f. On 12/2/15 at 8:05 a.m., during a concurrent observation and staff interview, a syringe of caffeine was observed in a bin for Patient 35. The syringe had medication information and patient identification on a label. The label did not include an expiration date. Pharmicist 3 stated syringes of caffeine were delivered and removed daily by pharmacy personnel. She stated if the medication was not used within 24 hours it was collected and disgarded. Pharmacist 3 was asked if a syringe was not picked up by pharmacy personnel would the nurse be able to administer the expired medication. Pharmacist 3 stated the nurse would be able to scan and administer the expired medication and that there are no hard stops to prevent the administration.

Review of the hospital's P&P titled, "Expiration Guidelines" dated 12/14, indicated "...Definition: Expiration dating are those determined by the manufacturer and/or pharmacy which must be adhered to assure product quality ...."
Review of the hospital's P&P titled, "Refrigerator/Freezer Records" dated 8/15, indicated "....The temperature for medication refrigerators shall be 36-46 degrees Fahrenheit ...."

a. Review of the manufacturer's package insert for multivitamin by intravenous infusion dated 9/07, which had been provided by the hospital indicated "....After the multivitamin is diluted in an intravenous infusion, the resulting solution should be refrigerated unless it is to be used immediately. The solution should be used within 24 hours after dilution ...."
Review of the manufacturer's package insert dated 10/11, provided by the hospital indicated "....Store famotidine injection at 2-8 degree Celsius (36-46 degree Fahrenheit) ...."

b. Review of the manufacturer's package insert for epogen indicated "....store at 36-46 degrees Fahrenheit (2-8 degrees Celsius) ...."

c. Review of succinylcholine's (used to relax the muscles during surgery) manufacturer package insert dated 9/10, indicated "....The multi-dose vials are stable for up to 14 days at room temperature without significant loss of potency ...."

e. Review of the hospital's P&P titled, "Unit Dose Packaging- Repackaging Oral Solids in Single Unit and Unit Dose Packages " dated 12/14, indicated " .... Purpose: To assure the unit dose packaging of oral solids and liquid complies with requirement of federal and state laws and regulations ....Expiration date of repackaged product must not exceed 1 year or the time remaining of the expiration date ...."

Based on observation, staff interview and record review, the hospital failed to provide buildings were constructed, arranged and maintained to ensure the safety of the patients when:

No system was in place to ensure professional standards of practice were followed and a safe and sanitary environment was maintained hospital wide and in accordance with the National Fire Protection Association (NFPA) 101 Life Safety Code (LSC) 2000 Edition and the NFPA 72 National Fire Alarm Code 1999 Edition. The hospital failed to follow the provision of maintaining a building construction type permitted for healthcare occupancies. (see LSC K11). The hospital failed to maintain a reliable fire alarm system (in the Psychiatric Unit) that is approved by the authority having jurisdiction. (refer to LSC K-51).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe environment.

Based on observation, interview, and administrative document review, the hospital failed to ensure all equipment was maintained at an acceptable level of safety and quality when two crash carts (A movable collection of emergency equipment and supplies meant to be readily available for resuscitative effort.) in two separate Critical Care Units were missing daily safety checks on two days.
This failure had the potential to result in emergency medical equipment failing or malfunctioning during an emergency.

Findings:

On 11/30/15 at 3:07 p.m., during a concurrent observation and interview, Crash cart #1 in Critical Care Unit #1, did not have the daily external equipment check done on October 9, 2015. Manager 1 verified check had not been done and stated crash carts should be checked daily when unit is open. Manager 1 verified the unit was open on October 9, 2015.
On 11/30/15 at 3:40 p.m., during a concurrent observation and interview, Crash CART #1 in Critical Care Unit #2, did not have the daily external equipment check done on October 29, 2015. Manager 1 verified check had not been done and stated crash carts should be checked daily when unit is open. Manager 1 verified the unit was open on October 29, 2015.
The policy and procedure titled, "Code Blue, Code White, and Rapid Response Teams (Adult & Pediatric) Response and Equipment Management," dated 10/15 indicated, "...III. Crash Cart-External Equipment Daily Check: A. Department RN/LVN's are responsible for checking the following a minimum of once per day ... B. Procedure: 1. Crash Cart lock integrity ... 2. Defibrillator Check ... 3. O2 tank pressure ... 4. Check for the presence of appropriate supplies on top of the crash cart ... 5. Document on the Crash Cart and Defibrillator Check Log the following: a. Date Initials, b. Lock number (s), c. O2 psi ..."

Based on observation, staff interview, and document review, the hospital failed to provide a sanitary environment to avoid sources of transmission of infections and communicable diseases and did not have an active program for the prevention, control and investigation of infections and communicable diseases when:

1. The processing and sterilization of surgical equipment and devices did not follow nationally accepted standards; hinged instruments were processed in closed positions, rigid trays were not loaded in a manner that allowed instruments to have maximum exposure to the sterilizing agent, and staff were not competent and trained on job specific current national recognized standards and policies regarding sterile processing of surgical instruments. (refer to A 749, finding 1)

Because of the serious potential harm to all patients who have surgery at the hospital related to the practice of not ensuring the sterility of surgical instruments, an Immediate Jeopardy (IJ) situation was called on 12/1/15 at 1:30 p.m. with the hospital's Chief Nursing Officer, Chief Operating Officer and Chief Medical Officer. The hospital submitted an approved written Action Plan and implementation of corrective actions that addressed the immediate jeopardy situation led to the removal of the IJ on 12/2/15 at 4 p.m.

2. The STERIS washers and sterilizers (specialized equipment used to sterilize surgical instruments) located in the Central Sterile Processing area were found to be visibly dirty and not maintained in accordance with manufacturer ' s instructions. (refer to A 749, finding 2)

3. Ten of thirty-eight ice machines located in various areas of the hospital were not maintained in a sanitary manner and hospital staff did not follow manufacturer's instructions for maintenance. (refer to A 749, finding 3A, 3B)

4. The CSP (Central Sterile Processing) area was noted to have dust and debris covering surfaces directly below an HVAC (Heating, Ventilation and Air Conditioning) vent. The area below the vent was a worktable used to wrap surgical trays. The filters associated with the HVAC system for this area of the hospital were visibly dirty. The hospital did not have a system in place to monitor and maintain the filters for the HVAC system. (refer to A 749, finding 4)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe environment.

Based on observation, interview, and and record review, the hospital failed to ensure a system was in place for identifying, reporting, investigating and controlling infections and communicable diseases when:

1. The processing and sterilization of surgical equipment and devices did not follow nationally accepted standards; hinged instruments were processed in closed positions, rigid trays were not loaded in a manner that allowed instruments to have maximum exposure to the sterilizing agent, and staff were not competent and trained on job specific current national recognized standards and policies regarding sterile processing of surgical instruments.

Because of the serious potential harm to all patients who have surgery at the hospital related to the practice of not ensuring the sterility of surgical instruments, an Immediate Jeopardy (IJ) situation was called on 12/1/15 at 1:30 p.m. with the hospital's Chief Nursing Officer, Chief Operating Officer and Chief Medical Officer. The hospital submitted an approved written Action Plan and implementation of corrective actions that addressed the immediate jeopardy situation led to the removal of the IJ on 12/2/15 at 4 p.m.

2. The STERIS washers and sterilizers (specialized equipment used to sterilize surgical instruments) located in the Central Sterile Processing area were found to be visibly dirty.

3. Ten of thirty-eight ice machines located in various areas of the hospital were not maintained in a sanitary manner and hospital staff did not follow manufacturer's instructions for maintenance.

A. Ice machines (three of three) in the Labor and Delivery, Maternity, and Maternal High Risk area were found to not have an appropriate air gap (an unobstructed vertical space between the water outlet and the flood level of the drain to prevent any contaminants from flowing into the drinkable water system by siphon) between the end of the ice machine drain hose and the upper edge of the drain.

B. Five of five ice Machines in the Emergency Department (ED) and two of two in the Psychiatric Unit were found to be visibly dirty. The dirty condition of the ice machines in the Psychiatric unit required the hospital to replace the two ice machines.

4. Flooring in the Emergency Department (ED) was visibly cracked and were not maintained.

5. The CSP (Central Sterile Processing) area was noted to have dust and debris covering surfaces directly below an HVAC (Heating, Ventilation, Air Conditioning System) vent. The area below the vent was a worktable used to wrap surgical trays. The filters associated with the HVAC system for this area of the hospital were visibly dirty. The hospital did not have a system in place to monitor and maintain the filters for the HVAC system.

Findings:

1. On 11/30/15 at 3:30 p.m., during a concurrent interview and initial tour of the Central Sterile Processing (CSP), the physical environment appeared clean and uncluttered. The Director of Sterile Process (DSP) was asked if the sterile equipment and sterile trays located in the rack were ready to be used. The DSP stated that they were ready to be used in surgery that day and opened a tray for viewing. The opened surgical tray showed several instruments that were stacked on top of each other with little or no space in between them. Forceps and scissors were in the open position. One other metal tray to be used that day was opened and there were several heavier instruments that were lying on top of other small hinged instruments. This caused the smaller hinged instruments to close. Some pitting and dents were observed on several instruments in both trays.

On 12/01/2015 at 9:00 a.m., during a concurrent observation and interview with the ICP (Infection Control Preventionist) and Manager, the decontamination process was observed with Sterile Processing Technician (SPT) 1. SPT 1 was observed to not fully submerge surgical instruments in enzymatic solution (specially formulated solution used to break down and decontaminate debris and particles on surgical instruments) and did not brush or scrub instruments in order to mechanically decontaminate those instruments. SPT 1 failed to demonstrate and verbalize the dwell time (5 minutes - the amount of time required per manufacturer's instructions for the enzymatic solution to be effective) for the disinfectant used in the decontamination room. The ICP and Manager confirmed the hospital used nationally recognized standards such as APIC (Association of Professionals in Infection Control and Epidemiology), AORN (Association of periOperative Registered Nurses), and CDC (Centers for Disease Control and Prevention) to base their policies on.

On 12/1/15 at 9:00 a.m., during an observation of CSP there were several wrapped trays stacked on top of each other throughout the area. CSP opened a tray for viewing. The opened tray showed there were instruments on top of each other with clamps (hinged instruments) closed. Several instruments were also noted to have a white film, scratches and dents on their surfaces. When asked about the condition of the instruments inside the trays, the DSP stated they needed to have a sheet to protect the instruments.

On 12/1/15 at 10:20 a.m., during a concurrent observation of the decontamination area and interview, a container of instruments returned from use in the operating room wrapped in plastic was brought into the area and placed on the sink for the decontamination process to commence. The Certified Central Service technologist (CRCST) was observed taking the container out of the plastic bag and placing the instruments into one side of a double sink. During this process the CRCST at no time changed her gloves in between the instruments she had just received and the prior instruments she had placed on the rack behind her for aeration. The CRCST took out the contents of the container and began to wash the instruments with a high pressure water spray. At no time did CRCST scrub instruments or open the hinged instruments in order to decontaminate debris on surfaces observed. At no time did the CRCST fully submerge surgical instruments in enzymatic solution. The CRCST then placed the instruments into the other side of the sink which contained an enzymatic agent, rinsed the instruments and placed them on the rack behind her for drying. The CRCST did not time the dwell time of the enzymatic solution. During the washing process several instruments were observed stacked on top of each other. The sink area had no timing device that would prompt the CRCST of the needed soaking time of 5 minutes for the instruments. CRCST described the decontamination as; the dirty instruments are brought into the area; she places them into the sink for a rough wash, then places them into the soak for two minutes, then places the instruments on the rack behind her for drying. The instruments are then placed into the washer prior to going into the sterilizing area on the clean side. CRCST failed to demonstrate and verbalize the dwell time (5 minutes) for the disinfectant used in the decontamination room.

Because of the serious potential harm to all patients who have surgery at the hospital related to the practice of not ensuring the sterility of surgical instruments, an Immediate Jeopardy (IJ) situation was called on 12/1/15 at 1:30 p.m. with the hospital's Chief Nursing Officer (CNO), Chief Operating Officer (COO) and Chief Medical Officer (CMO). The hospital submitted a written Action Plan that was approved on 12/1/15 at 6:35 p.m. The main components of the approved Action Plan included: 1) the stopping of all elective and non-emergent surgeries in the hospital; 2) the concurrent oversight by experienced and knowledgeable staff for the decontamination and sterilization process; 3) the training of CSP staff with return demonstration of following all policies and procedures for decontamination and sterilization process; 4) a quality assurance process that selects a sample of surgical trays for appropriate sterility; 5) the reprocessing of all surgical trays until 100% of trays are ensured to be sterile.

On 12/2/15 at 9 a.m., during an observation and concurrent interview, the decontamination and CSP area were toured with the ICP and CSP Manager. The CST Tech performing the decontamination activity was observed to not follow the 5-minute enzymatic solution immersion of the surgical instruments; the CRCST 2 estimated the time and the time was measured at less than two minutes. A prepared and sterilized surgical tray was opened for viewing. The opened surgical tray was observed to have closed hinged instruments, stacked surgical devices and debris on the surgical instruments. The ICP and the Manager confirmed the observations and agreed the process was not followed adequately to ensure the sterility of the surgical instruments.

On 12/2/15 at 3 pm., during an observation and concurrent interview, the decontamination and CSP area was toured with the ICP and CSP Manager. The Tech conducting the decontamination area was observed to appropriately follow all steps of decontamination. The sterile processing steps were completed according to accepted standards of practice and in accordance with hospital policy and procedure. A surgical tray was opened for viewing and instruments were appropriately positioned, all hinged instruments were in the open position and no film was observed on the instruments. Because the hospital implemented the Action Plan items, the Immediate Jeopardy was removed on 12/2/15 at 4 p.m. in the presence of the CNO, COO and CMO.

On 12/2/15 at 2 p.m., during a group interview with the Quality Committee, the role of the quality committee was discussed. The interviewees included the Chief Medical Doctor (MD) of the hospital Quality Committee (CMDQ), the CNO and CMO. The CMDQ and CMO agreed with the serious nature of the findings related to not ensuring the sterility of surgical instruments. The CMDQ and CMO confirmed that no data had been collected that related specifically to the quality assurance for the sterility of surgical trays. The CMDQ and CMO confirmed the Quality Committee had not established an effective monitoring process to ensure CSP staff followed accepted standards of practice for decontamination of surgical instruments in preparation for the sterile processing. The CMDQ and CMO confirmed the Quality Committee had not established an effective process to ensure CSP staff adhered to the standards of practice that would ensure proper positioning of instruments in the sterile tray. The CMDQ and the CMO confirmed the Quality Committee had not established a process to measure the quality of sterility of surgical trays in the OR by opening and examining sterile trays for effectiveness of the sterilization process.

On 12/3/15 at 10 a.m., during a group interview with the Infectious Disease Committee (IDC), the role of the Infectious Disease Committee meeting in hospital processes was discussed. The role of the IDC was explained by the Chief MD of ID. The survey findings related to the hospital failure to ensure the sterility of surgical instruments was discussed. The Chief MD of the IDC stated the committee was aware and acknowledged the serious potential harm related to not ensuring the sterility of surgical instruments. The IDC Chief acknowledged no data or surveillance had been recommended or established in order to ensure the sterility of surgical instruments.

On 12/4/15 at 11 a.m., during an interview, Governing Body representatives were aware of the serious findings related to not ensuring the sterility of surgical instruments. The Governing Body acknowledged the potential serious harm that could result from not ensuring the sterility of surgical instruments. The GB rep agreed that more needed to be done to ensure the standards of practice and hospital policy and procedures for the decontamination and sterile process activities were strictly followed.

The Association for PeriOperative Registered Nurses (AORN) Recommendation IV was reviewed and indicated, "Instruments should be kept free of gross soil during surgical procedures. Blood and body fluids can cause pitting of instruments and, if left to dry, can be difficult to remove. If blood and body fluids are not removed, they can prevent adequate sterilization, which could be an avenue for transmission of other potentially infectious materials. IV.a. Instruments should be wiped as needed with sterile surgical sponges moistened with sterile water during the procedure to remove gross soil. Blood and body fluids, as well as saline, are highly corrosive. Corrosion, rusting, and pitting occur when saline, blood, and debris are allowed to dry in or on surgical instruments. Dried blood and debris can be difficult, if not impossible, to remove from all surfaces during the decontamination process; therefore, subsequent disinfection or sterilization may not be achieved. AORN, Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, 2013: Instruments should be inspected for ...corrosion, pitting, burrs, nicks, and cracks ...wear and chipping of ...plated surfaces damage[d] protective surfaces of instruments, contribute to corrosion, impede sterilization surface corrosion damage ...can inhibit sterilization...Spotting, Staining, and Corrosion of Surgical InstrumentsSurgical instrument Herbert J. Kaiser, PhD; Patrick Schwab, MBA; Jason F. Tirey, MA. (October 1, 2000). Spotting, Staining, and Corrosion of Surgical Instruments. Infection Control Today. Retrieved from: spotting, staining, and corrosion are serious problems in many healthcare facilities ... Spotting, staining, and corrosion of surgical instruments can impair their function ... Spotting, staining, and corrosion also interfere with sterilization. Spores can be protected from destruction by the layers of iron oxide (rust). Corrosion can result in a shortened instrument life, which results in increased cost. Stainless Steel It is important to remember that stainless steel means stainless steel, not stain-proof steel. All types of stainless steel will eventually become corroded and stained. Also, while a surface of an instrument may look bright and shiny to the naked eye, under microscopic examination the surface is actually very rough. The rough surface allows for entrapment of impurities from soils and water ....Spotting lies loosely on the surface. Staining is integral with the surface. Corrosion penetrates the surface... Stainless steel is indeed reactive, meaning that it will corrode and become stained under certain conditions...(AORN) Recommendation IV (2009) Items to be sterilized should be packaged in a manner that facilitates sterilization and provides for an aseptic presentation of the package contents. ...Incorrect packaging may prevent sterilization from occurring. Inappropriate handling can lead to loss of package integrity. Incorrect packaging can make aseptic delivery of the contents to the sterile field difficult or impossible.. IV.c. Items to be sterilized should be positioned within packages to allow sterilant contact with all surfaces.3 Sterilant contact is necessary for sterilization to be achieved. IV.e. Instruments composed of more than one part that can be disassembled should be disassembled unless the manufacturer ' s written and validated IFU specifies that disassembly is not required.3 Sterilization of assembled instruments can prevent exposure of some areas of the device to the sterilant.3 IV.f. Items to be sterilized that have concave or convex surfaces that create potential for water retention should be positioned within packages in a manner that prevents those surfaces from retaining water.3,4 Preventing water retention can help avoid the occurrence of wet packs and sterilization failure. IV.g. Towels placed within instrument sets should be lint-free, freshly laundered, and thoroughly rinsed by a health care-accredited laundry facility. Adequate rinsing reduces the risk of leaving chemical residues that could be transferred from the towels to instruments.28 Lint left on sterile instruments may be transferred to the surgical wound and may cause a foreign-body reaction. IV.h. Items to be sterilized should be placed in the package or tray in an open or unlocked position. (AORN)

2. On 12/1/15 at 9:40 a.m., during a concurrent observation, interview and administrative document review, four of four STERIS washers located in the CSP area were found with substance build up on the front of the machines and debris in the bottom of the inside of each washer. The ICP and CSP Manager agreed the substance build up and confirmed the presence of debris in the bottom of the inside of the four washers. Review of the administrative document used to track maintenance of the washers did not indicate any dates of service. The ICP, CSP Manager, and the Clinical Director acknowledged there were no maintenance records for the washers and that there should have been.

On 12/1/15 at 3:30 p.m., during an interview, the CNO and CMO acknowledged the maintenace of the washers in the CSP should have been done according to manufacturer's guidelines and stated, " We should have done better. "

3 A. On 11/30/15 at 3:05 p.m., during a concurrent observation and staff interview, a free standing ice machine in the Labor and Delivery unit nutrition room was observed to have a drain hose connected to the back of the machine. The bottom lip of the drain hose was below the upper lip of the drain pipe so that a portion of the drain hose was in the drain pipe leading to the wall. A white substance was observed in a large patch on wall and on the floor behind and under the ice machine. The patch was the width of the ice machine and was under the ice machine approximately eight inches. Registered Nurse (RN) 4 stated she could not see an air gap. She stated the white patch was probably hard water stains. Plant Operations Manager (POM) 1 verified there was no air gap. POM 1 stated the white substance may have been caused by drainage splashing. When asked how long it would take to accumulate the amount of white substance present if it was water splashing, he stated, "A long time."

On 11/30/15 at 3:10 p.m., Supervisor of Hospitality Services stated housekeeping is responsible to clean behind the ice machine. She stated the machine could not be moved so housekeeping cleaned around it. She observed the white patch under the ice machine.

The manufacturer's instructions for the ice machine in Labor and Delivery, dated 6/18/2014, indicated " .... Separate piping to approved drain. Leave a two-inch (5 cm) vertical air gap between the end of each pipe and the drain ...."

On 11/30/15 at 3:23 p.m., during a concurrent observation and staff interview, an ice machine in the Maternity unit nutrition room, a countertop ice machine was seen with a copper pipe from the back of the machine to the sink. The lip of the copper pipe was below the upper edge of sink. RN 4 acknowledged if the sink backed up or overflowed, the drain pipe coming from the ice machine would be in the fluid in the sink.
The manufacturer's instructions for the ice machine in the Maternity unit, undated, indicated "Installing countertop dispensers ... 16 ... An air break should be provided ...."

3 B.On 12/1/14 at 9 a.m., during an inspection of the ice machines in the ED, five ice machines that supplied ice for ED patient use were found to have a white, crusty substance on the interior of the machines.

On 12/1/15 at 9:10 a.m., during an interview, Physical Plant Services stated he had cleaned all of the ice machines, just three months before.

On 12/1/15, a review of administrative documents showing when preventative maintenance was done indicated one machine had not been cleaned since 2/6/15, two others had not been cleaned since 2/11/15, one since 2/28/15, and one since 4/19/15.

On 12/2/15 at 8 a.m., during a tour of the site of the Psychiatric Unit two ice machines were found with severe build-up of yellow brownish organic substance on the interior of the machines. A slimy greenish brown glob was found in the ice dispensing chute. This led to the possibility of patients receiving contaminated ice.

On 12/2/15 at 11:30 a.m., during an interview with a plant services supervisor (PSS), the PSS stated, based on the buildup inside the machines they had not been cleaned in at least a year.

Manufacturer's recommendations for cleaning the ice machines indicate cleaning and scale removal should be performed at least every six months or sooner if the ice machine needed it.

On 12/2/15 at 10:11 a.m., during and interview, the Plant Services Director (PSD) described the process of ice machine maintenance. The PSD stated each ice machine was in a computer data base and the maintenance schedule for each ice machine was computer generated. As each ice machine needed to be serviced, the computer generated a work order for the items needing maintenance. The PSD stated the work orders were routed to two technicians for the work to be done. When asked whether the work order for the scheduled maintenance matched the instructions from the manufacturer for that ice machine, the PSD stated he did not know. When asked whether the maintenance work conducted by the technicians was followed up for for quality assurance, he stated that there was no quality assurance on the ice machine maintenance.

4. On 11/30/15 at 3 p.m., during a tour of the ED, cracks were seen in the floor along the edges of the room next to the walls of one of the rooms. The cracks were up to ½ inch wide.

On 12/1/15 at 8 a.m., during an interview, The ED Manager (EDM) stated that about half of the rooms had cracks in the floor and that the cracks had been there for "months" .

On 12/1/15, an administrative document review of the bid for fixing the floor indicated the walk through had taken place 10/27/15 and the bid submitted on 11/5/15; no estimated date of completion was documented on the form.

On 12/2/15, an administrative document from the Director for plant services indicated the bid had been accepted, but the materials had to be ordered, a shipping date received, and work scheduled for the repair. There was no estimated time for completion of the work.

5. On 12/1/15 at 9:15 a.m., during a concurrent observation and interview, the CSP area was noted to have dust and debris covering surfaces directly below an HVAC (Heating/ventilation/air-conditioning) vent. The area below the vent was a worktable used to wrap surgical trays. The CSP Manager and ICP confirmed the layer of dust and debris directly below the vent. The covering of the vent appeared dirty. The CSP Manager and ICP stated they were unsure as to whose responsibility it was to clean and maintain the exterior and interior of the vents.

The life safety portion of the survey showed the following findings related to the HVAC system and correlated with the units serving the building for CSP area (cross reference K-67):
On 12/1/15, at 1:02 p.m., the static pressure gauge for the final filters in air handler unit (AHU) 1A was reading at approximately 2 inches of water.

During an interview at 1:03 p.m., the Director of Facilities (DFS1) stated that the filters are supposed to be changed at a pressure of 1 inch of water.

At 1:08 p.m., AHU 1A was turned off and the pressure needle for the final filters went beyond 2 inches of water while the other gauges read 0 after air flow stopped.

During an interview at 1:09 p.m., the DFS1 stated that the gauge for the AHU 1A final filters was broken.

On 12/2/15, at 8:46 a.m., Plant Maintenance Mechanic (PMM5) stated that the facility does not maintain the gauges because they have a central automated system. The system did not give exact static pressure readings but instead monitored air flow. On 12/3/15, at 8:45 a.m., he stated that it was the facility's policy to change the filters when the static pressure was between 0.75 and 1.00.

On 12/3/15, at 8:30 a.m., the header on the Facility Management Filter Log stated "recommended change out is 1.0" of static pressure." The logs showed that Plant Maintenance Staff 7 was conducting monthly inspections on the air handler filters. The documentation showed that the static pressure was documented during the inspections. For AHU 2, the acronym "V.I." was documented in lieu of a static pressure since 3/27/15 for the final filters. For AHU 2B, the acronym "V.I." was documented in lieu of a static pressure since 3/24/15 for the final filters and in all the months of 2015 for the pre-filters.

During an interview at 8:39 a.m., Plant Maintenance Mechanic (PMM7) stated that when the static pressure gauges are not working, he conducts visual inspections of the filter and documents "V.I." on the logs. PMM7 stated that the gauges for AHU 2 and 2B were not working.

The facility failed to maintain the static pressure pressure gauges used by the facility as an indicator for changing the air filters.

On 12/1/15, at 1:10 p.m., the final filters for AHU 1A were observed to be dirty with an excess accumulation of dust.

On 12/2/15, at 8:36 a.m., the exterior air intakes for AHU 1 and 1A were covered with dust and debris.

During an interview at 8:37 a.m., the DFS1 stated that the intakes are not cleaned because they are difficult to reach.

On 12/2/15, at 8:58 a.m.,the pre-filters and final filters for AHU 1 were covered with an excess accumulation of dust and dirt.

On 12/2/15 at 10 a.m. the Plant Services Director stated there was no quality assurance program to ensure filters and vents were maintained in a sanitary manner and that the HVAC system was not maintained according to nationally recognized standards.

Based on observation, interview, clinical and administrative document review, the hospital failed to provide surgical services in accordance with nationally recognized standards when:

1. The processing and sterilization of surgical equipment and devices did not follow nationally accepted standards; hinged instruments were processed in closed positions, rigid trays were not loaded in a manner that allowed instruments to have maximum exposure to the sterilizing agent, and staff were not competent and trained on job specific current nationally recognized standards and policies regarding sterile processing of surgical instruments. (refer to A 951, finding 1)

Because of the serious potential harm to all patients who have surgery at the hospital related to the practice of not ensuring the sterility of surgical instruments, an Immediate Jeopardy (IJ) situation was called on 12/1/15 at 1:30 p.m. with the hospital's Chief Nursing Officer, Chief Operating Officer and Chief Medical Officer. The hospital submitted an approved written Action Plan and implementation of corrective actions that addressed the immediate jeopardy situation and led to the removal of the IJ on 12/2/15 at 4 p.m.

2. The STERIS washers and sterilizers (specialized equipment used to sterilize surgical instruments) located in the Central Sterile Processing(CSP) area were found to be visibly dirty and not maintained in accordance with manufacturer ' s instructions. (refer to A 951, finding 2)

3. The CSP area was noted to have dust and debris covering surfaces directly below a heating, ventilation and air conditioning (HVAC) vent. The area below the vent was a worktable used to wrap surgical trays. The filters associated with the HVAC system for this area of the hospital were visibly dirty. The hospital did not have a system in place to monitor and maintain the filters for the HVAC system. (refer to A 951, finding 3)

The cumulative effects of these systemic problems resulted in the hospital's inability to provide patient care in a safe manner.

Based on observation and interview, the hospital failed to ensure that surgical procedures were performed by licensed providers in all surgical locations of the hospital for 1 of 6 surgical patients observed, Patient 49, when a non-credentialed, non-privileged, and unlicensed surgical technologist (Tech) performed biopsy (taking tissue from the body for microscopic exam).

This failure put patients at risk for adverse surgical outcomes from procedures performed by non-credentialed, non-privileged, and unlicensed Tech.

Findings:

On 12/2/15, Patient 49 was observed in the GI (gastrointestinal) lab for an esophagogastroduodenoscopy (EGD, a procedure where a lighted tube is inserted into the upper digestive tract to look for abnormalities and take tissue samples). At 10:50 a.m., the GI Tech was observed opening and closing the biopsy forceps when, MD 1 said "Open, close." Four biopsies were made in the same manner. At 11 a.m., when MD 1 was informed that GI biopsies were considered surgical procedures, and the surgical tech was not privileged to perform surgical procedures, MD 1 stated, "We are not doing surgery. They are procedures."

Review of State Operations Manual Appendix A-- Survey protocol, regulations and interpretive guidelines for Hospitals, last revised 10/9/15, indicated that "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 also is the diagnostic or therapeutic treatment of conditions or disease 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 procedure are not eliminated by using a light knife or laser in place of a metal knife, or scalpel. Patient safety and quality of care are paramount and, therefore, patients should be assured that individuals who perform these types of surgery are licensed physicians ...who are working within their scope of practice, hospital privileges, and who meet appropriate professional standards."

Based on observation, staff interview, and clinical and administrative document review, the hospital failed to ensure surgical services policies, procedures, and protocols were developed, implemented, and enforced in accordance with acceptable standards of care and practice when:
1. The processing and sterilization of surgical equipment and devices did not follow nationally accepted standards; hinged instruments were processed in closed positions, rigid trays were not loaded in a manner that allowed instruments to have maximum exposure to the sterilizing agent, and staff were not competent and trained on job specific current nationally recognized standards and policies regarding sterile processing of surgical instruments.

Because of the serious potential harm to all patients who have surgery at the hospital related to the practice of not ensuring the sterility of surgical instruments, an Immediate Jeopardy (IJ) situation was called on 12/1/15 at 1:30 p.m. with the hospital's Chief Nursing Officer, Chief Operating Officer and Chief Medical Officer. The hospital submitted an approved written Action Plan and implementation of corrective actions that addressed the immediate jeopardy situation and led to the removal of the IJ on 12/2/15 at 4 p.m.

2. The STERIS washers and sterilizers (specialized equipment used to sterilize surgical instruments) located in the Central Sterile Processing (CSP) area were found to be visibly dirty and not maintained in accordance with manufacturer ' s instructions.

3. The CSP area was noted to have dust and debris covering surfaces directly below a heating, ventilation, and air conditioning (HVAC) vent. The area below the vent was a worktable used to wrap surgical trays. The filters associated with the HVAC system for this area of the hospital were visibly dirty. The hospital did not have a system in place to monitor and maintain the filters for the HVAC system.

4. The surgical technologist (Tech) failed to clean biopsy forceps (surgical instruments used to take tissue from the body for microscopic exam) according to national standards.

Findings:

1. On 11/30/15 at 3:30 p.m., during a concurrent interview and initial tour of the Central Sterile Processing (CSP), the physical environment appeared clean and uncluttered. The Director of Sterile Process (DSP) was asked if the sterile equipment and sterile trays located in the rack were ready to be used. The DSP stated that they were ready to be used in surgery that day and opened a tray for viewing. The opened surgical tray showed several instruments that were stacked on top of each other with little or no space in between them. Forceps and scissors were in the open position. One other metal tray to be used that day was opened and there were several heavier instruments that were lying on top of other small hinged instruments. This caused the smaller hinged instruments to close. Some pitting and dents were observed on several instruments in both trays.

On 12/01/2015 at 9:00 a.m., during a concurrent observation and interview with the Infection Control Preventionist ICP and CSP Manager, the decontamination process was observed with Sterile Processing Technician (SPT) 1. SPT 1 was observed to not fully submerge surgical instruments in enzymatic solution and did not brush or scrub instruments in order to mechanically decontaminate those instruments. SPT 1 failed to demonstrate and verbalize the dwell time (5 minutes) for the disinfectant used in the decontamination room. The ICP and CSP Manager confirmed the hospital base their policies on nationally recognized standards such as Association for Professionals in Infection Control and Epidemiology (APIC), Association of periOperative Registered Nurses (AORN), and Centers for Disease Control (CDC).

On 12/1/15 at 9:00 a.m., during an observation of CSP there were several wrapped trays stacked on top of each other throughout the area. CSP opened a tray for viewing. The opened tray showed there were instruments on top of each other with clamps (hinged instruments) closed. Several instruments were also noted to have a white film, scratches and dents on their surfaces. When asked about the condition of the instruments inside the trays, the DSP stated they needed to have a sheet to protect the instruments.

On 12/1/15 at 10:20 a.m., during a concurrent observation of the decontamination area and interview, a container of dirty instruments wrapped in plastic was brought into the area and placed on the sink for the decontamination process to commence. The Certified Central Service technologist (CRCST) was observed taking the container out of the plastic bag and placing the instruments into one side of a double sink. During this process the CRCST at no time changed her gloves in between the instruments she had just received and the prior instruments she had placed on the rack behind her for aeration. The CRCST took out the contents of the container and began to wash the instruments with a high pressure water spray. At no time did CRCST scrub instruments or open the hinged instruments in order to decontaminate debris on surfaces observed. At no time did the CRCST fully submerge surgical instruments in enzymatic solution. The CRCST then placed the instruments into the other side of the sink which contained an enzymatic agent, rinsed the instruments and placed them on the rack behind her for drying. The CRCST did not time the dwell time of the enzymatic solution. During the washing process several instruments were observed stacked on top of each other. The sink area had no timing device that would prompt the CRCST of the needed soaking time of 5 minutes for the instruments. CRCST described the decontamination as; the dirty instruments are brought into the area; she places them into the sink for a rough wash, then places them into the soak for two minutes, then places the instruments on the rack behind her for drying. The instruments are then placed into the washer prior to going into the sterilizing area on the clean side. CRCST failed to demonstrate and verbalize the dwell time (5 minutes) for the disinfectant used in the decontamination room.

Because of the serious potential harm related to the practice of not ensuring the sterility of surgical instruments, an Immediate Jeopardy (IJ) situation was called on 12/1/15 at 1:30 p.m. with the hospital's Chief Nursing Officer (CNO), Chief Operating Officer (COO) and Chief Medical Officer (CMO). The hospital submitted a written Action Plan that was approved on 12/1/15 at 6:35 p.m. The main components of the approved Action Plan included: 1) the stopping of all elective and non-emergent surgeries in the hospital; 2) the concurrent oversight by experienced and knowledgeable staff for the decontamination and sterilization process; 3) the training of CSP staff with return demonstration of following all policies and procedures for decontamination and sterilization process; 4) a quality assurance process that selects a sample of surgical trays for appropriate sterility; 5) the reprocessing of all surgical trays until 100% of trays are ensured to be sterile.

On 12/2/15 at 9 a.m., during an observation and concurrent interview, the decontamination and CSP area were toured with the ICP and CSP Manager. The CST Tech performing the decontamination activity was observed to not follow the 5-minute enzymatic solution immersion of the surgical instruments; the CRCST 2 estimated the time and the time was measured at less than two minutes. A prepared and sterilized surgical tray was opened for viewing. The opened surgical tray was observed to have closed hinged instruments, stacked surgical devices and debris on the surgical instruments. The ICP and the Manager confirmed the observations and agreed the process was not followed adequately to ensure the sterility of the surgical instruments.

On 12/2/15 at 3 p.m., during an observation and concurrent interview, the decontamination and CSP area was toured with the ICP and CSP Manager. The Tech conducting the decontamination area was observed to appropriately follow all steps of decontamination. The sterile processing steps were completed according to accepted standards of practice and in accordance with hospital policy and procedure. A surgical tray was opened for viewing and instruments were appropriately positioned, all hinged instruments were in the open position and no film was observed on the instruments. Because the hospital implemented the Action Plan items, the Immediate Jeopardy was removed on 12/2/15 at 4 p.m. in the presence of the CNO, COO and CMO.

On 12/2/15 at 2 p.m., during a group interview with the Quality Committee, the role of the quality committee was discussed. The interviewees included the Chief MD of the hospital Quality Committee (CMDQ), the CNO and CMO. The CMDQ and CMO agreed with the serious nature of the findings related to not ensuring the sterility of surgical instruments. The CMDQ and CMO confirmed that no data had been collected that related specifically to the quality assurance for the sterility of surgical trays. The CMDQ and CMO confirmed the Quality Committee had not established an effective monitoring process to ensure CSP staff followed accepted standards of practice for decontamination of surgical instruments in preparation for the sterile processing. The CMDQ and CMO confirmed the Quality Committee had not established an effective process to ensure CSP staff adhered to the standards of practice that would ensure proper positioning of instruments in the sterile tray. The CMDQ and the CMO confirmed the Quality Committee had not established a process to measure the quality of sterility of surgical trays in the OR by opening and examining sterile trays for effectiveness of the sterilization process.

On 12/3/15 at 10 a.m., during a group interview with the Infectious Disease Committee (IDC), the role of the Infectious Disease Committee meeting in hospital processes was discussed. The role of the IDC was explained by the Chief MD of ID. The survey findings related to the hospital failure to ensure the sterility of surgical instruments was discussed. The Chief MD of the IDC stated the committee was aware and acknowledged the serious potential harm related to not ensuring the sterility of surgical instruments. The IDC Chief acknowledged no data or surveillance had been recommended or established in order to ensure the sterility of surgical instruments.

On 12/4/15 at 11 a.m., during an interview, Governing Body (GB) representatives were aware of the serious findings related to not ensuring the sterility of surgical instruments. The GB acknowledged the potential serious harm that could result from not ensuring the sterility of surgical instruments. The GB rep agreed that more needed to be done to ensure the standards of practice and hospital policy and procedures for the decontamination and sterile process activities were strictly followed.

The AORN Recommendation IV was reviewed and indicated, "Instruments should be kept free of gross soil during surgical procedures. Blood and body fluids can cause pitting of instruments and, if left to dry, can be difficult to remove. If blood and body fluids are not removed, they can prevent adequate sterilization, which could be an avenue for transmission of other potentially infectious materials. IV.a. Instruments should be wiped as needed with sterile surgical sponges moistened with sterile water during the procedure to remove gross soil. Blood and body fluids, as well as saline, are highly corrosive. Corrosion, rusting, and pitting occur when saline, blood, and debris are allowed to dry in or on surgical instruments. Dried blood and debris can be difficult, if not impossible, to remove from all surfaces during the decontamination process; therefore, subsequent disinfection or sterilization may not be achieved. AORN, Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, 2013: Instruments should be inspected for ...corrosion, pitting, burrs, nicks, and cracks ...wear and chipping of ...plated surfaces damage[d] protective surfaces of instruments, contribute to corrosion, impede sterilization surface corrosion damage ...can inhibit sterilization...Spotting, Staining, and Corrosion of Surgical InstrumentsSurgical instrument Herbert J. Kaiser, PhD; Patrick Schwab, MBA; Jason F. Tirey, MA. (October 1, 2000). Spotting, Staining, and Corrosion of Surgical Instruments. Infection Control Today. Retrieved from: spotting, staining, and corrosion are serious problems in many healthcare facilities ... Spotting, staining, and corrosion of surgical instruments can impair their function ... Spotting, staining, and corrosion also interfere with sterilization. Spores can be protected from destruction by the layers of iron oxide (rust). Corrosion can result in a shortened instrument life, which results in increased cost. Stainless Steel It is important to remember that stainless steel means stainless steel, not stain-proof steel. All types of stainless steel will eventually become corroded and stained. Also, while a surface of an instrument may look bright and shiny to the naked eye, under microscopic examination the surface is actually very rough. The rough surface allows for entrapment of impurities from soils and water ....Spotting lies loosely on the surface. Staining is integral with the surface. Corrosion penetrates the surface... Stainless steel is indeed reactive, meaning that it will corrode and become stained under certain conditions...(AORN) Recommendation IV (2009) Items to be sterilized should be packaged in a manner that facilitates sterilization and provides for an aseptic presentation of the package contents. ...Incorrect packaging may prevent sterilization from occurring. Inappropriate handling can lead to loss of package integrity. Incorrect packaging can make aseptic delivery of the contents to the sterile field difficult or impossible.. IV.c. Items to be sterilized should be positioned within packages to allow sterilant contact with all surfaces. Sterilant contact is necessary for sterilization to be achieved. IV.e. Instruments composed of more than one part that can be disassembled should be disassembled unless the manufacturer's written and validated IFU specifies that disassembly is not required. Sterilization of assembled instruments can prevent exposure of some areas of the device to the sterilant. 3 IV.f. Items to be sterilized that have concave or convex surfaces that create potential for water retention should be positioned within packages in a manner that prevents those surfaces from retaining water. Preventing water retention can help avoid the occurrence of wet packs and sterilization failure. IV.g. Towels placed within instrument sets should be lint-free, freshly laundered, and thoroughly rinsed by a health care-accredited laundry facility. Adequate rinsing reduces the risk of leaving chemical residues that could be transferred from the towels to instruments. 28 Lint left on sterile instruments may be transferred to the surgical wound and may cause a foreign-body reaction. IV.h. Items to be sterilized should be placed in the package or tray in an open or unlocked position. AORN Recommendation IV Instruments should be kept free of gross soil during surgical procedures. Blood and body fluids can cause pitting of instruments and, if left to dry, can be difficult to remove. If blood and body fluids are not removed, they can prevent adequate sterilization, which could be an avenue for transmission of other potentially infectious materials. IV.a. Instruments should be wiped as needed with sterile surgical sponges moistened with sterile water during the procedure to remove gross soil. Blood and body fluids, as well as saline, are highly corrosive. Corrosion, rusting, and pitting occur when saline, blood, and debris are allowed to dry in or on surgical instruments. Dried blood and debris can be difficult, if not impossible, to remove from all surfaces during the decontamination process; therefore, subsequent disinfection or sterilization may not be achieved..."

2. On 12/1/15 at 9:40 a.m., during a concurrent observation, interview and administrative document review, four of four STERIS washers located in the CSP area were found with substance build up on the front of the machines and debris in the bottom of the inside of each washer. The ICP and CSP Manager agreed the substance build up and confirmed the presence of debris in the bottom of the inside of the four washers. Review of the administrative document used to track maintenance of the washers did not indicate any dates of service. The ICP, CSP Manager, and the Clinical Director acknowledged there were no maintenance records for the washers and that there should have been.

On 12/1/15 at 3:30 p.m., during an interview, the CNO and CMO acknowledged the maintenance of the washers in the CSP should have been done according to manufacturer's guidelines and stated, " We should have done better."

3. On 12/1/15 at 9:15 a.m., during a concurrent observation and interview, the CSP area was noted to have dust and debris covering surfaces directly below a HVAC (Heating/ventilation/air-conditioning) vent. The area below the vent was a worktable used to wrap surgical trays. The CSP Manager and ICP confirmed the layer of dust and debris directly below the vent. The covering of the vent appeared dirty. The CSP Manager and ICP stated they were unsure as to whose responsibility it was to clean and maintain the exterior and interior of the vents.

The life safety portion of the survey showed the following findings related to the HVAC system and correlated with the units serving the building for CSP area (cross reference K-67):
On 12/1/15, at 1:02 p.m., the static pressure gauge for the final filters in air handler unit (AHU) 1A was reading at approximately 2 inches of water.

During an interview at 1:03 p.m., the Director of Facilities (DFS1) stated that the filters are supposed to be changed at a pressure of 1 inch of water.

At 1:08 p.m., AHU 1A was turned off and the pressure needle for the final filters went beyond 2 inches of water while the other gauges read 0 after air flow stopped.

During an interview at 1:09 p.m., the DFS1 stated that the gauge for the AHU 1A final filters was broken.

On 12/2/15, at 8:46 a.m., Plant Maintenance Mechanic (PMM5) stated that the facility does not maintain the gauges because they have a central automated system. The system did not give exact static pressure readings but instead monitored air flow. On 12/3/15, at 8:45 a.m., he stated that it was the facility's policy to change the filters when the static pressure was between 0.75 and 1.00.

On 12/3/15, at 8:30 a.m., the header on the Facility Management Filter Log stated "recommended change out is 1.0" of static pressure." The logs showed that Plant Maintenance Staff 7 was conducting monthly inspections on the air handler filters. The documentation showed that the static pressure was documented during the inspections. For AHU 2, the acronym "V.I." was documented in lieu of a static pressure since 3/27/15 for the final filters. For AHU 2B, the acronym "V.I." was documented in lieu of a static pressure since 3/24/15 for the final filters and in all the months of 2015 for the pre-filters.

During an interview at 8:39 a.m., Plant Maintenance Mechanic (PMM7) stated that when the static pressure gauges are not working, he conducts visual inspections of the filter and documents "V.I." on the logs. PMM7 stated that the gauges for AHU 2 and 2B were not working.

The facility failed to maintain the static pressure pressure gauges used by the facility as an indicator for changing the air filters.

On 12/1/15, at 1:10 p.m., the final filters for AHU 1A were observed to be dirty with an excess accumulation of dust.

On 12/2/15, at 8:36 a.m., the exterior air intakes for AHU 1 and 1A were covered with dust and debris.

During an interview at 8:37 a.m., the DFS1 stated that the intakes are not cleaned because they are difficult to reach.

On 12/2/15, at 8:58 a.m., the pre-filters and final filters for AHU 1 were covered with an excess accumulation of dust and dirt.

On 12/2/15 at 10 a.m., the Plant Services Director stated there was no quality assurance program to ensure filters and vents were maintained in a sanitary manner and that the HVAC system was not maintained according to nationally recognized standards.

4. On 12/2/15, Patient 49 was observed in the GI (gastrointestinal) lab for EGD (upper endoscopy, a procedure where a lighted tube is inserted into the upper digestive tract to look for abnormalities and take tissue samples). At 10:50 a.m., the GI Tech was observed to open and close the biopsy forceps when the MD 1 said "Open, close." MD 1 withdrew the biopsy forceps with the wire, then the GI Tech released the tissue from the biopsy forceps into a tissue receptacle, filled with formalin (a solution used to fix the tissue), then rinsed the biopsy forceps with tap water. GI Tech then gave the biopsy forceps back to MD1, who introduced the wire and forceps into the lumen of endoscope. A total of 4 biopsies (taking tissue from the body for microscopic exam) were performed in the same manner.

On 12/3/15 at 1:30 p.m., during an interview, the GI Tech was asked to explain his procedures during the endoscopy. He reiterated the steps above, including rinsing the biopsy forceps and wire with tap water after each pass for biopsy, and there were no other rinses before returning the forceps and wire into the endoscope. When asked "Who taught you the biopsy?" he stated, "The previous tech." He also stated that the nurse in the GI lab had, as an evaluation for his performance, observed him perform all the steps during an endoscopy, including rinsing the wire and forceps, and he was informed that "There was nothing wrong."

Review of AORN "Guideline for Cleaning and Processing Flexible Endoscopes and Endoscope Accessories", last revised 11/2014, (http://www.aornstandards.org/content/1/SEC34.body?sid=a2c536c3-8726-4116-9a8a-914b451f1307#C3647) indicated that, "Flexible endoscope accessories (eg, water bottle, cap, water tubing, biopsy forceps, cytology brushes, cleaning brushes) should be decontaminated after use and inspected for damage." It also indicated that, "X.a. Endoscopic accessories (eg, biopsy forceps, cytology brushes) that enter sterile tissue or the vascular system should be cleaned and sterilized between use as described in the AORN "Recommended practices for cleaning and care of surgical instruments and powered equipment".

Review of AORN's "Guideline for Cleaning and Care for Surgical Instruments", last revised 11/2014, (http://www.aornstandards.org/content/1/SEC36.body?sid=520ea096-b222-4751-b067-9b8425f74150) indicated that "Recommendation VII. The type of water used for cleaning should be consistent with the manufacturers' written IFU (instruction for use) and the intended use of the equipment and cleaning product...VII.a. The final rinse should be performed with treated (eg, distilled, reverse osmosis, filtered) water of a quality that will not stain or cause damage to instruments or contribute to recontamination of the instrument."

Based on interview and document review, the hospital failed to ensure that anesthesia services were appropriately organized when general anesthetic agents were administered by unqualified staff, when the nurses in ER (emergency room) administered ketamine and propofol (both as anesthetic agents).

This failure put patients at risk for unsafe anesthesia care by persons lacking the skills to manage the effects of deep sedation (a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation, and may have impaired ability to independently maintain respiratory function) and general anesthesia (a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation, and often have impaired ability to independently maintain respiratory function).

Findings:

1. During an interview on 12/2/15 at 9:55 a.m., the surveyor asked MD* (Brandon Lew) how ketamine was administered in ER. MD * (Brandon Lew) stated that ER physician ordered ketamine, while the nurse would administer ketamine at the presence of the ER physician.

2. During an interview on 12/4/15 at 8:50 a.m., the surveyor asked MD* (Bradley Gerberich) regarding the administration of ketamine and propofol in ER. MD * (Bradley Gerberich) stated that nurse would administer ketamine and propofol at the presence of ER physician. Surveyor informed MD * (Bradley Gerberich) that ketamine and propofol were considered anesthetic agents and anesthesia can only be provided by qualified providers (anesthesiologist, certified registered nurse anesthetist, and other qualified providers) and ER nurses were not among those qualified providers.

Review of the facility's clinical policy and procedures did not indicate specific procedures regarding the use of ketamine and propofol in the ER.

Based on observation, staff interview, and administrative document review the hospital failed to ensure appropriate infection control measures When MD 5 was observed not wearing gloves when coming into contact with patient 49.

This failure could result in infection to patients.

Findings:

1. On 12/2/15 at 10:30 a.m., Patient 49 was observed in the gastrointestinal (GI) lab for EGD (upper endoscopy, a procedure where a lighted tube is inserted into the upper digestive tract to look for abnormalities and take tissue samples). MD 5 was observed positioning the patient, adjusting the patient's oxygen face mask, repositioning the oral suction tube, and administering propofol (anesthetic agent) through the Patient 49's intravenous line (a tube inserted into veins), with his bare hands. At 10:55 a.m., MD 5 was asked "Are you wearing gloves?" MD 5 stated, "I am not wearing gloves." When asked, "Why?" he stated, "No reasons. Just bad habits." When asked, "Are you supposed to wear gloves?" he stated, "I guess it's up to us." After a moment, MD 5 added, "We should [wear gloves]." This is in violation of the hospital's policy regarding hand hygiene.

Review of the hospital's "Administrative Policy & Procedure-- Hand Hygiene", last revised 11/2015, indicated that "XV. Gloves ... will be worn whenever there is a potential for contact with body fluids, mucous membrane or non-intact skin."

Based on observation, staff and patient interview and clinical and administrative document review, Five of twelve patients (Patient's 37, 40, 42, 43, and 46) did not have documentation of vital sign monitoring in accordance with hospital policy and procedure during blood transfusions.
This failure resulted in an incomplete medical record and had the potential for delay in treatment of adverse reactions to blood products.
Findings:
On 12/1/15 at 9:35 a.m., during an initial tour of the facility, Patient 12 was selected for an inpatient clinical record review. The clinical record indicated Patient 12 had received several blood transfusions.
On 12/1/15 at 9:45 a.m., an interview was conducted with Registered Nurse (RN) 8 about the hospital policy and procedure for blood products administration. She stated RN's giving blood products perform vital signs (blood pressure, temperature, respirations and pulse rate) on patients before the transfusion begins, and 15 minutes after the blood is started. RN 8 stated the nurses document on the Transfusion Record either in paper form or on the electronic medical record (EMR) and usually both. She stated if the patient exhibits any type of reaction to the blood product such as anaphylaxis (coughing, throat tightening, respiratory distress, anxiety) the blood transfusion is to be stopped immediately and the patient's doctor and blood bank are notified.
On 12/1/15 at 2:35 p.m., an interview was conducted with RN 9. She stated before administering a blood transfusion she goes over the informed consent with the patient per hospital policy. She stated she explains possible reactions (fever, chills, difficulty breathing), which could occur once the blood is started and reminds the patient to call the nurses for help, if they have a reaction to the blood.
On 12/2/15 at 2:40 p.m., during an interview, RN 10 stated the hospital policy for monitoring a patient receiving a blood transfusion included vital signs before the blood is started, and 15 minutes after. RN 10 stated she documents on the blood transfusion record and puts the information in the EMR. For patients experiencing a reaction she stated she stops the transfusion immediately, notifies the charge nurse, patients doctor and the blood bank. All the tubing and remaining blood is returned to the blood bank for testing.
On 12/2/15 at 8:20 a.m., during an interview, RN 11 stated for a blood transfusion the vital signs are performed at the start of the transfusion and 15 minutes after. She stated the hospital policy reads nurses should stay with the patient at least 15 minutes to observe for reactions.
On 12/2/15 at 1:16 p.m., a tour of the blood bank and concurrent interview was conducted with the Blood Bank Supervisor. She stated there are 22 employees working in the blood bank who type and crossmatch patients with orders for blood products. She stated on average the blood bank prepares 700 units of blood products a month. She stated any adverse reactions to blood products are handled immediately.
The facility provided a list of patients who experienced adverse reactions to blood products from January-September 2015. Of the 22 patients with reactions, Patient's 37, 40, 42, and 43 were randomly selected for a blood administration record review.
On 12/3/15 at 9 a.m., a record review and concurrent interview was conducted with RN 3 and RN 4, for Patients 37, 40, 42, and 43. Patient 37's clinical record indicated she was 64 years old and was admitted to the facility on 3/26/15 for treatment of anemia (low iron in the blood). She had a history of breast cancer and was undergoing chemotherapy. On 3/26/15 at 12:35 p.m., Patient 37's doctor ordered, "Transfuse two units of PRBC's (packed red blood cells) today over 3-4 hours each, per policy 8740.185, direct observation of patient occurs for at least the first 5-15 minutes and vital signs taken after 15-30 minutes after initiation." On 3/26/15, the hand written Transfusion Record indicated a blood transfusion was started at 3:15 p.m. There were no vital signs written at 15 minutes or post transfusion. RN 4 stated the nurses can record vital signs in two places, in the EMR or on the hand written Transfusion Record. Patient 37's EMR was accessed and navigated by RN 3. The EMR read on 3/26/15, at 2 p.m., the blood transfusion was started. Vital signs were recorded at 3 p.m., and again at 5 p.m. RN 3 stated hospital policy dictates the nurse administering blood must document a set of pre-vital signs no more than 1 hour before blood is started, 15-30 minutes after the transfusion and post-vital signs. He stated when he gives blood this is how he records the vital signs. He stated there is a lack of documentation on both the EMR and hand written Transfusion Record regarding vital signs. On 3/26/15, Patient 37 received a transfusion of platelets (a component of blood) beginning at 6:15 p.m. The Transfusion Record showed vital signs were written at the time the infusion started, (6:15 p.m.), again at 6:30 p.m. When the platelets were finished at 7:10 p.m., documentation by nursing staff read, at 1910 (7:10 p.m.) platelet pherisis (transfusion) completed and patient found shaking, dyspneic (short of breath), tachycardic (rapid heartbeat) and hypoxic (deficiency in the amount of oxygen delivered to the body tissues). Patient awake and alert. Stated she can't stop shaking. Unable to get a blood pressure and O2 saturation (reading to determine amount of oxygen in the blood, normal is greater than 94%). Rapid response (a call for designated emergency staff to assist with the patient) activated. Patient 37 was given Benadryl (antihistamine medication for allergic reactions) and stabilized. Documentation in the EMR showed vital signs were recorded at 6 p.m. There were no further vital signs recorded in the EMR. Patient 37 received the second unit of blood on 3/26/15. Written documentation on the Transfusion Record read the blood was started at 10:58 p.m. There were no written vital signs pre-transfusion. A vital sign was written in at 11:30 p.m. There were no written post-transfusion vital signs. The EMR showed one set of vital signs was recorded at 11:30 p.m., and at the completion of the transfusion on 3/27/15 at 2:40 a.m. On 3/27/15 at 10:30 a.m., written documentation on the Transfusion Record showed Patient 37 received a transfusion of platelets beginning at 10:30 a.m. A set of vital signs was written pre-transfusion at 10:15 a.m. There was no further documentation. The EMR showed vital signs were recorded at 10 a.m. and no further vital signs until 2 p.m. RN 4 stated she could see the discrepancies in documentation on both the written and recorded vital signs in Patient 37's medical record, and lack of vital signs for the platelet transfusion.
Patient 40, 25 years old was admitted to the hospital on 6/22/15 for weakness, feeling dizzy and black tarry stools. Past medical history included migraine headaches. A complete blood count (CBC) revealed she was severely anemic with a hemoglobin (protein in red blood cells that carries oxygen to organs and tissue) of six (Normal 12-15.5). On 6/22/15 at 5:59 p.m., Patient 40's doctor ordered, "Transfuse four units of PRBC's in total, Rapid Blood Loss, per policy 8740.185, direct observation of patient occurs for at least the first 5-15 minutes and vital signs taken after 15-30 minutes after initiation." On 6/22/15 at 8:08 p.m. a pre-transfusion vital sign was written on the Transfusion Record. The transfusion was documented starting at 8:30 p.m. and a vital sign was taken five minutes later at 8:35. No further vital signs were written until 10 p.m. when Patient 40 was found with a temperature of 103.1 degrees, complaints of dizziness and a witnessed fall in her room. A rapid response was called and Patient 40 was stabilized. A review of the EMR showed Patient 40 had vital signs recorded at 6:19 p.m., the blood transfusion was started at 8 p.m., and vital signs were recorded at 8:08 p.m. No further vital signs were recorded in the EMR until 10 p.m., when Patient 40 required rapid response. On 6/23/15 an infusion of blood was docume

Based on observation, staff interviews, and document review, the facility failed to ensure that outdated/unusable medications and supplies were not available for patient use.
This failure had the potential to result in patients receiving outdated drugs which may not provide the intended benefit.

Findings:
Review of the hospital's P&P titled "Expiration Guidelines" dated 12/14, read "...Definition: Expiration dating are those determined by the manufacturer and/or pharmacy which must be adhered to assure product quality ..."
Review of the hospital's P&P titled "Refrigerator/Freezer Records" dated 8/15, read "...The temperature for medication refrigerators shall be 36 - 46 degrees Fahrenheit ..."

a. Review of the manufacturer's package insert for multivitamin by intravenous infusion dated 9/07, which had been provided by the hospital read "... After the multivitamin is diluted in an intravenous infusion, the resulting solution should be refrigerated unless it is to be used immediately. The solution should be used within 24 hours after dilution ..."
Review of the manufacturer's package insert dated 10/11, provided by the hospital read "...Store famotidine injection at 2 - 8 degree Celsius (36 - 46 degree Fahrenheit) ..."

On 12/1/15 at 10:58 a.m., during a concurrent observation and interview in the 4 West medication room, Patient B's vancomycin (antibiotic) infusion bag with expiration date of 11/30/15 was observed inside the medication refrigerator. Pharmacist 2, Pharmacy Supervisor 1, Pharmacy Manager 1, and the Maternity Manager acknowledged the expired medication. Pharmacy Manager 1 stated the medication should not be in the refrigerator, it should have been returned to the pharmacy.

Also observed in the medication refrigerator was a 1000 ml bag of intravenous Dextrose 5 % in ½ sodium chloride (hydration fluid) with multivitamin (supplement), thiamine (supplement), folic acid (supplement) and magnesium sulfate (magnesium supplement) compounded on 12/1/15, with a beyond use date (BUD) of 72 hours which was contrary to manufacturer's guideline above. Pharmacy Manager 1 acknowledged above intravenous solution should be used within 24 hours after compounding.

Observed in the automated medication dispensing cabinets in the 4 West medication room were 20 vials of intravenous (IV) famotidine (used to treat condition in which the stomach acid irritates the food pipe lining) stored at room temperature without any BUD noted. Pharmacy Manager 2 stated IV famotidine was good for 8 weeks at room temperature. The hospital was unable to provide evidence their brand of famotidine IV was stable at room temperature. The Director of Pharmacy/Lab services acknowledged it was possible for a patient to receive famotidine IV stored at room temperature for over 8 weeks unknowingly.

b. Review of the manufacturer's package insert for epogen read "...store at 36 - 46 degrees Fahrenheit (2 - 8 degrees Celsius) ..."
On 12/1/15 at 1:45 p.m., during a concurrent observation and interview in the critical care unit medication room, one vial of epogen 10000 units/ml (used to treat a lack of red blood cells in the body) was observed in Patient C's cassette and another vial of epogen 4000 units/ml in Patient D's cassette stored at room temperature.
Pharmacist 1, Pharmacy Manager 2, the Director of Pharmacy/Lab services and the Maternity Manager acknowledged the epogen vials had been stored at room temperature. Pharmacist 1 was not sure how long the vials had been at room temperature, but she stated these vials were supposed to be refrigerated and not stored at room temperature.

c. Review of succinylcholine's (used to relax the muscles during surgery) manufacturer package insert dated 9/10, read "...The multi-dose vials are stable for up to 14 days at room temperature without significant loss of potency ..."
On 12/1/15 at 2:50 p.m., during a concurrent observation and interview in the operating room (OR) suite, one vial of succinylcholine 20 mg/ml 10 ml with an expiration date of 12/21/15 and the other vial with an expiration date of 12/18/15 were observed stored at room temperature in OR 12. One vial of succinylcholine with expiration date of 12/15/15 was also observed stored at room temperature in OR 1. The above succinylcholine vials were given beyond use dates (expiration dates) greater than 14 days at room temperature contrary to the above manufacturer's guideline.
One outdated vial of succinylcholine with expiration date of 11/27/15 was observed in OR 1.
Pharmacy Manager 1, Pharmacy Manager 2, the Maternity Manager and the OR Supervisor acknowledged the beyond use dates (BUD) on the succinylcholine vials. Pharmacy Manager 2 stated succinylcholine vials had been given a BUD of 30 days when stored at room temperature and expired succinylcholine vial should not be in the OR.

d. On 12/2/15 at 10:30 a.m., during a concurrent observation and interview in the Pharmacy department, one opened vial of tuberculin purified protein derivative (aid in the detection of infection with tuberculosis) with expiration date of 11/12/15 was observed in the pharmacy refrigerator. Three bags of azithromax 250 mg in 250 ml of dextrose 5 % in water (intravenous antibiotic) with expiration date of 12/1/15 were observed in refrigerator C.
Pharmacy Manager 2, the Director Pharmacy/Lab services and the Maternity Manager acknowledged the expired medications.

e. Review of the hospital's P&P titled "Unit Dose Packaging- Repackaging Oral Solids in Single Unit and Unit Dose Packages" dated 12/14, read "...Purpose: To assure the unit dose packaging of oral solids and liquid complies with requirement of federal and state laws and regulations ...Expiration date of repackaged product must not exceed 1 year or the time remaining of the expiration date..."
On 12/3/15 at 8:30 a.m., during a concurrent observation and interview in the Pediatric unit medication room, a 60 ml bottle of cherry syrup repackaged from a bulk bottle by the pharmacy was given a BUD of 12/18 (more than three years) which was contrary to above hospital's P&P.
Pharmacy Manager 1 and Pharmacy Manager 2 acknowledged the beyond use date was incorrect on this container and stated the dating should have been within the parameters in the hospital's P&P.



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Based on observation, staff interviews, administrative document review, and manufacturer's guidelines, the facility failed to ensure that outdated/unusable medications and supplies were not available for patient use.
This failure had the potential to result in patients receiving outdated drugs which may not provide the intended benefit.

Findings:

a. On 12/1/15 at 10:58 a.m., during a concurrent observation and interview in the 4 West medication room, Patient 30's vancomycin (antibiotic) infusion bag with expiration date of 11/30/15 was observed inside the medication refrigerator. Pharmacist 2, Pharmacy Supervisor 1, Pharmacy Manager 1, and the Maternity Manager acknowledged the expired medication. Pharmacy Manager 1 stated the medication should not be in the refrigerator, it should have been returned to the pharmacy.

Also observed in the medication refrigerator was a 1000 mL bag of intravenous (administered in a vein) Dextrose 5 % in ½ sodium chloride (hydration fluid) with multivitamin (supplement), thiamine (supplement), folic acid (supplement) and magnesium sulfate (magnesium supplement) compounded on 12/1/15, with a beyond use date (BUD) of 72 hours which was contrary to manufacturer's guideline below. Pharmacy Manager 1 acknowledged above intravenous solution should be used within 24 hours after compounding.

Observed in the automated medication dispensing cabinets in the 4 West medication room were 20 vials of intravenous (IV) famotidine (used to treat condition in which the stomach acid irritates the food pipe lining) stored at room temperature without any BUD noted. Pharmacy Manager 2 stated IV famotidine was good for 8 weeks at room temperature. The hospital was unable to provide evidence their brand of famotidine IV was stable at room temperature. The Director of Pharmacy/Lab services acknow

Based on observation, interview, and and record review, the hospital failed to ensure a system was in place for identifying, reporting, investigating and controlling infections and communicable diseases when:

1. The processing and sterilization of surgical equipment and devices did not follow nationally accepted standards; hinged instruments were processed in closed positions, rigid trays were not loaded in a manner that allowed instruments to have maximum exposure to the sterilizing agent, and staff were not competent and trained on job specific current national recognized standards and policies regarding sterile processing of surgical instruments.

Because of the serious potential harm to all patients who have surgery at the hospital related to the practice of not ensuring the sterility of surgical instruments, an Immediate Jeopardy (IJ) situation was called on 12/1/15 at 1:30 p.m. with the hospital's Chief Nursing Officer, Chief Operating Officer and Chief Medical Officer. The hospital submitted an approved written Action Plan and implementation of corrective actions that addressed the immediate jeopardy situation led to the removal of the IJ on 12/2/15 at 4 p.m.

2. The STERIS washers and sterilizers (specialized equipment used to sterilize surgical instruments) located in the Central Sterile Processing area were found to be visibly dirty.

3. Ten of thirty-eight ice machines located in various areas of the hospital were not maintained in a sanitary manner and hospital staff did not follow manufacturer's instructions for maintenance.

A. Ice machines (three of three) in the Labor and Delivery, Maternity, and Maternal High Risk area were found to not have an appropriate air gap (an unobstructed vertical space between the water outlet and the flood level of the drain to prevent any contaminants from flowing into the drinkable water system by siphon) between the end of the ice machine drain hose and the upper edge of the drain.

B. Five of five ice Machines in the Emergency Department (ED) and two of two in the Psychiatric Unit were found to be visibly dirty. The dirty condition of the ice machines in the Psychiatric unit required the hospital to replace the two ice machines.

4. Flooring in the Emergency Department (ED) was visibly cracked and were not maintained.

5. The CSP (Central Sterile Processing) area was noted to have dust and debris covering surfaces directly below an HVAC (Heating, Ventilation, Air Conditioning System) vent. The area below the vent was a worktable used to wrap surgical trays. The filters associated with the HVAC system for this area of the hospital were visibly dirty. The hospital did not have a system in place to monitor and maintain the filters for the HVAC system.

Findings:

1. On 11/30/15 at 3:30 p.m., during a concurrent interview and initial tour of the Central Sterile Processing (CSP), the physical environment appeared clean and uncluttered. The Director of Sterile Process (DSP) was asked if the sterile equipment and sterile trays located in the rack were ready to be used. The DSP stated that they were ready to be used in surgery that day and opened a tray for viewing. The opened surgical tray showed several instruments that were stacked on top of each other with little or no space in between them. Forceps and scissors were in the open position. One other metal tray to be used that day was opened and there were several heavier instruments that were lying on top of other small hinged instruments. This caused the smaller hinged instruments to close. Some pitting and dents were observed on several instruments in both trays.

On 12/01/2015 at 9:00 a.m., during a concurrent observation and interview with the ICP (Infection Control Preventionist) and Manager, the decontamination process was observed with Sterile Processing Technician (SPT) 1. SPT 1 was observed to not fully submerge surgical instruments in enzymatic solution (specially formulated solution used to break down and decontaminate debris and particles on surgical instruments) and did not brush or scrub instruments in order to mechanically decontaminate those instruments. SPT 1 failed to demonstrate and verbalize the dwell time (5 minutes - the amount of time required per manufacturer's instructions for the enzymatic solution to be effective) for the disinfectant used in the decontamination room. The ICP and Manager confirmed the hospital used nationally recognized standards such as APIC (Association of Professionals in Infection Control and Epidemiology), AORN (Association of periOperative Registered Nurses), and CDC (Centers for Disease Control and Prevention) to base their policies on.

On 12/1/15 at 9:00 a.m., during an observation of CSP there were several wrapped trays stacked on top of each other throughout the area. CSP opened a tray for viewing. The opened tray showed there were instruments on top of each other with clamps (hinged instruments) closed. Several instruments were also noted to have a white film, scratches and dents on their surfaces. When asked about the condition of the instruments inside the trays, the DSP stated they needed to have a sheet to protect the instruments.

On 12/1/15 at 10:20 a.m., during a concurrent observation of the decontamination area and interview, a container of instruments returned from use in the operating room wrapped in plastic was brought into the area and placed on the sink for the decontamination process to commence. The Certified Central Service technologist (CRCST) was observed taking the container out of the plastic bag and placing the instruments into one side of a double sink. During this process the CRCST at no time changed her gloves in between the instruments she had just received and the prior instruments she had placed on the rack behind her for aeration. The CRCST took out the contents of the container and began to wash the instruments with a high pressure water spray. At no time did CRCST scrub instruments or open the hinged instruments in order to decontaminate debris on surfaces observed. At no time did the CRCST fully submerge surgical instruments in enzymatic solution. The CRCST then placed the instruments into the other side of the sink which contained an enzymatic agent, rinsed the instruments and placed them on the rack behind her for drying. The CRCST did not time the dwell time of the enzymatic solution. During the washing process several instruments were observed stacked on top of each other. The sink area had no timing device that would prompt the CRCST of the needed soaking time of 5 minutes for the instruments. CRCST described the decontamination as; the dirty instruments are brought into the area; she places them into the sink for a rough wash, then places them into the soak for two minutes, then places the instruments on the rack behind her for drying. The instruments are then placed into the washer prior to going into the sterilizing area on the clean side. CRCST failed to demonstrate and verbalize the dwell time (5 minutes) for the disinfectant used in the decontamination room.

Because of the serious potential harm to all patients who have surgery at the hospital related to the practice of not ensuring the sterility of surgical instruments, an Immediate Jeopardy (IJ) situation was called on 12/1/15 at 1:30 p.m. with the hospital's Chief Nursing Officer (CNO), Chief Operating Officer (COO) and Chief Medical Officer (CMO). The hospital submitted a written Action Plan that was approved on 12/1/15 at 6:35 p.m. The main components of the approved Action Plan included: 1) the stopping of all elective and non-emergent surgeries in the hospital; 2) the concurrent oversight by experienced and knowledgeable staff for the decontamination and sterilization process; 3) the training of CSP staff with return demonstration of following all policies and procedures for decontamination and sterilization process; 4) a quality assurance process that selects a sample of surgical trays for appropriate sterility; 5) the reprocessing of all surgical trays until 100% of trays are ensured to be sterile.

On 12/2/15 at 9 a.m., during an observation a

Based on observation, staff interview, and clinical and administrative document review, the hospital failed to ensure surgical services policies, procedures, and protocols were developed, implemented, and enforced in accordance with acceptable standards of care and practice when:
1. The processing and sterilization of surgical equipment and devices did not follow nationally accepted standards; hinged instruments were processed in closed positions, rigid trays were not loaded in a manner that allowed instruments to have maximum exposure to the sterilizing agent, and staff were not competent and trained on job specific current nationally recognized standards and policies regarding sterile processing of surgical instruments.

Because of the serious potential harm to all patients who have surgery at the hospital related to the practice of not ensuring the sterility of surgical instruments, an Immediate Jeopardy (IJ) situation was called on 12/1/15 at 1:30 p.m. with the hospital's Chief Nursing Officer, Chief Operating Officer and Chief Medical Officer. The hospital submitted an approved written Action Plan and implementation of corrective actions that addressed the immediate jeopardy situation and led to the removal of the IJ on 12/2/15 at 4 p.m.

2. The STERIS washers and sterilizers (specialized equipment used to sterilize surgical instruments) located in the Central Sterile Processing (CSP) area were found to be visibly dirty and not maintained in accordance with manufacturer ' s instructions.

3. The CSP area was noted to have dust and debris covering surfaces directly below a heating, ventilation, and air conditioning (HVAC) vent. The area below the vent was a worktable used to wrap surgical trays. The filters associated with the HVAC system for this area of the hospital were visibly dirty. The hospital did not have a system in place to monitor and maintain the filters for the HVAC system.

4. The surgical technologist (Tech) failed to clean biopsy forceps (surgical instruments used to take tissue from the body for microscopic exam) according to national standards.

Findings:

1. On 11/30/15 at 3:30 p.m., during a concurrent interview and initial tour of the Central Sterile Processing (CSP), the physical environment appeared clean and uncluttered. The Director of Sterile Process (DSP) was asked if the sterile equipment and sterile trays located in the rack were ready to be used. The DSP stated that they were ready to be used in surgery that day and opened a tray for viewing. The opened surgical tray showed several instruments that were stacked on top of each other with little or no space in between them. Forceps and scissors were in the open position. One other metal tray to be used that day was opened and there were several heavier instruments that were lying on top of other small hinged instruments. This caused the smaller hinged instruments to close. Some pitting and dents were observed on several instruments in both trays.

On 12/01/2015 at 9:00 a.m., during a concurrent observation and interview with the Infection Control Preventionist ICP and CSP Manager, the decontamination process was observed with Sterile Processing Technician (SPT) 1. SPT 1 was observed to not fully submerge surgical instruments in enzymatic solution and did not brush or scrub instruments in order to mechanically decontaminate those instruments. SPT 1 failed to demonstrate and verbalize the dwell time (5 minutes) for the disinfectant used in the decontamination room. The ICP and CSP Manager confirmed the hospital base their policies on nationally recognized standards such as Association for Professionals in Infection Control and Epidemiology (APIC), Association of periOperative Registered Nurses (AORN), and Centers for Disease Control (CDC).

On 12/1/15 at 9:00 a.m., during an observation of CSP there were several wrapped trays stacked on top of each other throughout the area. CSP opened a tray for viewing. The opened tray showed there were instruments on top of each other with clamps (hinged instruments) closed. Several instruments were also noted to have a white film, scratches and dents on their surfaces. When asked about the condition of the instruments inside the trays, the DSP stated they needed to have a sheet to protect the instruments.

On 12/1/15 at 10:20 a.m., during a concurrent observation of the decontamination area and interview, a container of dirty instruments wrapped in plastic was brought into the area and placed on the sink for the decontamination process to commence. The Certified Central Service technologist (CRCST) was observed taking the container out of the plastic bag and placing the instruments into one side of a double sink. During this process the CRCST at no time changed her gloves in between the instruments she had just received and the prior instruments she had placed on the rack behind her for aeration. The CRCST took out the contents of the container and began to wash the instruments with a high pressure water spray. At no time did CRCST scrub instruments or open the hinged instruments in order to decontaminate debris on surfaces observed. At no time did the CRCST fully submerge surgical instruments in enzymatic solution. The CRCST then placed the instruments into the other side of the sink which contained an enzymatic agent, rinsed the instruments and placed them on the rack behind her for drying. The CRCST did not time the dwell time of the enzymatic solution. During the washing process several instruments were observed stacked on top of each other. The sink area had no timing device that would prompt the CRCST of the needed soaking time of 5 minutes for the instruments. CRCST described the decontamination as; the dirty instruments are brought into the area; she places them into the sink for a rough wash, then places them into the soak for two minutes, then places the instruments on the rack behind her for drying. The instruments are then placed into the washer prior to going into the sterilizing area on the clean side. CRCST failed to demonstrate and verbalize the dwell time (5 minutes) for the disinfectant used in the decontamination room.

Because of the serious potential harm related to the practice of not ensuring the sterility of surgical instruments, an Immediate Jeopardy (IJ) situation was called on 12/1/15 at 1:30 p.m. with the hospital's Chief Nursing Officer (CNO), Chief Operating Officer (COO) and Chief Medical Officer (CMO). The hospital submitted a written Action Plan that was approved on 12/1/15 at 6:35 p.m. The main components of the approved Action Plan included: 1) the stopping of all elective and non-emergent surgeries in the hospital; 2) the concurrent oversight by experienced and knowledgeable staff for the decontamination and sterilization process; 3) the training of CSP staff with return demonstration of following all policies and procedures for decontamination and sterilization process; 4) a quality assurance process that selects a sample of surgical trays for appropriate sterility; 5) the reprocessing of all surgical trays until 100% of trays are ensured to be sterile.

On 12/2/15 at 9 a.m., during an observation and concurrent interview, the decontamination and CSP area were toured with the ICP and CSP Manager. The CST Tech performing the decontamination activity was observed to not follow the 5-minute enzymatic solution immersion of the surgical instruments; the CRCST 2 estimated the time and the time was measured at less than two minutes. A prepared and sterilized surgical tray was opened for viewing. The opened surgical tray was observed to have closed hinged instruments, stacked surgical devices and debris on the surgical instruments. The ICP and the Manager confirmed the observations and agreed the process was not followed adequately to ensure the sterility of the surgical instruments.

On 12/2/15 at 3 p.m., during an observation and concurrent interview, the decontamination and CSP area was toured with the ICP and CSP Manager. The Tech conducting the decontamination area was observed to appropriately follow all steps of decontamination. The sterile processing steps were