The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

SETON MEDICAL CENTER 1900 SULLIVAN AVENUE DALY CITY, CA 94015 Dec. 11, 2015
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation, interview and document review, the hospital failed to ensure that drugs and biologicals were distributed in accordance with State law and hospital policy an procedures as evidence by:

1. high risk medications were not distributed in accordance with hospital policy and procedures to minimize medication errors. High risk medications were distributed to various patient care area with no safeguards in place to prevent medication errors associated with such high risk medications.

2. failure to maintain a system to ensure that nobody other than a pharmacist or an individual under the direct supervision of a pharmacist was allowed to dispense medications beyond the immediate needs of patients as required by State regulation. Medications in the medication trays inside the anesthesia carts for use during surgical procedures, which included numerous high-risk medications, were dispensed by anesthesia technicians not under the direct supervision of a hospital pharmacist.

3. medications were not stored at appropriate temperatures to ensue integrity and effectiveness. The medication storage refrigerator in the emergency department was not maintained at the proper temperature range of between 36F and 46F.

Findings:

1a. During a tour of the pharmacy at approximately 10:55 a.m. on 12/9/15, three 1-liter bags of cardioplegic solution were observed on the bottom shelf of the medication storage refrigerator.

Cardioplegic solution is a solution used to perfuse the heart during heart surgery to induce arrest (stopping) of the heart.

During an interview at approximately 11:10 a.m. on 12/9/15, Staff 46, a hospital pharmacy technician, stated that he prepared cardioplegic solution for use during cardiac surgeries. Staff 46 explained how he would prepare a high potassium concentration cardioplegic solution by adding 120 mEq of potassium chloride to the base cardioplegic solution. Staff 46 further stated that bags of cardioplegic solution were then delivered to the surgery department with other medications. Staff 46 added that the only cautionary label that he fixed on the bags of cardioplegic solution was "contains insulin".

During an interview at approximately 11:15 a.m. on 12/9/15, Staff 18, the hospital Director of Pharmacy, stated that because of the high potassium content of the cardioplegic solution, the product should be distributed with cautionary labeling to alert hospital staff to minimize the risk of inadvertent administration of the solution to patients.

1b. During an inspection of the emergency drug supply cart in the surgery department with Staff 18 at approximately 11:55 a.m. on 12/10/15, one 1-liter bag of sterile water for injection was observed among the drug supply for the management of [DIAGNOSES REDACTED]. The solution looked similar to other 1-liter bags of fluid to be administered intravenously. No cautionary labeling alerting staff that the product should not be used for direct intravenous administration was noted on the packaging of the product. Staff 18 stated that the 1-liter bag of sterile water for injection was supplied by the pharmacy and was for the reconstitution of dantrolene (a drug for the management of [DIAGNOSES REDACTED]).

Inadvertent intravenous administration of sterile water may cause hemolysis (rupture of red blood cells) and death.

1c. During an inspection of the medication cart in Operating Room Suite 11 with Staff 40, a surgery department staff at approximately 9:35 a.m. on 12/11/15, a number of medications identified by the hospital as high risk/high alert medications were observed among the drug supply including 10-ml (milliliters, volume unit) and 30-ml vials heparin ( a blood thinning agent) 1000 units/ml (unit per milliliter, concentration units), oxytocin (a medication for induction of labor) 10 units/ml vials, succinylcholine (a neuromuscular blocking agent for tracheal intubation) 20mg/ml. There were no special labeling on the identified high risk/high alert medications and in the designated compartments they were stored.

A review of the hospital policy and procedure on high-risk medications, last revised 2/14, indicated that cardioplegic solution, heparin, oxytocin and succylcholine where identified by the hospital as high alert medications which bore a heightened risk of causing significant patient farm when they were used inappropriately. The policy also indicated that all pharmacy storage areas (including nursing units) for high risk medications would be flagged.

Cardioplegic solution, heparin, oxytocin, succinylcholine and sterile water for injection (in container of 100 milliliters or more) were identified by the Institute for Safe Medication Practices (ISMP), a nonprofit organization devoted to medication error prevention and safe medication use, as high-alert medications. High alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients.

2. During a tour of the hospital surgery department with Staff 18, the hospital Director of Pharmacy, Staff 41, Operating Room charge nurse, at approximately 12:00 noon on 12/10/15, two mobile carts containing medications were inspected. Medications for use during surgical procedures were observed in the cart. Staff 41 stated that one cart was an anesthesia cart and the other cart was a nerve block kit. Staff 41 further stated that the medications stored within those carts were stocked by anesthesia technicians. Staff 41 explained that drugs were first removed by an operating room registered nurse from the automated drug dispensing cabinet (ADDC) located in the department to an anesthesia technician who would then stock and restock all drugs in medication trays excluding controlled substances used in all operating rooms. Staff 18 stated that the ADDC in the surgery department was stocked by a pharmacy technician under the supervision of a pharmacist but pharmacy was not involved in the preparing, stocking and restocking of medications in the medication trays of the anesthesia carts in the operating room suites.

During a tour of the Operating Room Suite 11 with Staff 40 and Staff 42,operating room staff, at approximately 10:10 a.m. on 12/11/15, medications identified by the hospital as high-risk medications including heparin (a blood thinning agent), lidocaine (a local anesthetic for injection), succylcholine (a skeletal muscle relaxant to facilitate tracheal intubation) and pancuronium (an adjunct to general anesthesia to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery). The identified high-risk medications and their respective storage compartments were not flagged or labeled to alert staff of their high risk status. In addition, one vial of pancuronium were observed in a compartment labelled "Rocuronium", and a 30-ml (milliliters, volume unit) vial of heparin 1000 units/ml was observed in the medication tray. Staff 42 stated that drugs in the medication tray were stocked by anesthesia technicians.

A review of the hospital policy and procedure on high-risk medications, last revised 2/14, indicated that heparin, lidocaine and succylcholine and other neuromuscular blocking agents were identified by the hospital as high alert medications which bore a heightened risk of causing significant patient harm when they were used inappropriately. The policy also indicated that all pharmacy storage areas (including nursing units) for high risk medications would be flagged.

Pancuronium and Rocuronium are both neuromuscular blocking agents for the induction of skeletal muscle relaxation during surgery. According to Lexi-Comp, a recognized drug information provider for health care professionals, Pancuronium and Rocuronium differ in their duration of action (the length of time that the effect of a drug persists). Pancuronium has a duration of action of 60 to 110 minutes while Rocuronium has a duration of action of 30 minutes. An error in administering Pancuronium instead of Rocuronium may result in delay in clinical recovery in surgical patients.

During an interview at approximately 11:00 a.m. on 12/11/15, Staff 40 stated that the hospital did not have a medication list that the anesthesia technician would follow to stock or restock drug supply in the anesthesia carts. Staff 40 presented a document with a heading of " Operating Room Drugs Charge/Replenishment Document " and stated that anesthesia technicians went by the list to restock drugs in the OR medication trays.

A review of the Operating Room Drugs Charge/Replenishment Document showed that there were a total 70 drugs listed. There were more drugs on the list than the number of drugs that were observed in the medication tray located in OR Suite 11. Heparin 1000 units/ml in a 30-ml vial, a medication that was observed in the medication tray in OR Suite 11 was not listed on the document. The list also did not indicate how many units of each drugs should be stocked in each medication tray.

California Code of Regulations, Title 22 Section (d) stipulates that there shall be a system maintained in the hospital whereby no persons other than a pharmacist or an individual under the direct supervision of a pharmacist shall dispense medications for use beyond the immediate needs of the patients.

The failure of the hospital to ensure that a system was maintained whereby nobody other than a pharmacist or an individual under the direct supervision of a pharmacist was allowed to dispense medications beyond the immediate needs of patients resulted in inconsistencies and an identified error in the stocking/restocking of medication tray used in the operating room.

3. During an inspection of the medication storage refrigerator located in the emergency room department with Staff 18, the hospital Director of Pharmacy and Staff 44 at approximately 11:30 AM on 12/10/15, approximately 20 different drugs were observed inside the refrigerator including sodium chloride 0.9% for injection in 250 ml (milliliters, volume unit) bags, diltiazem (a medication for the management of the regular heart rate or heart rhythm) solution for injection, succinylcholine (a drug to induce skeletal muscle relaxation to facilitate tracheal intubation) solution for injection and tetanus vaccines. The refrigerator internal temperature was displayed as at 36F by an electronic temperature monitoring device while a dial thermometer placed at the back of the top shelf of the refrigerator reported a temperature of 50F. The drugs stored on the top shelf felt cool and slightly colder than room temperature to the touch while medications stored on the bottom shelves felt cold and at refrigerated temperature to the touch. Staff 18 placed her hand on the different shelves inside the refrigerator and confirmed that the drugs stored on the top shelves were significantly warmer than the drugs stored on the bottom shelves. Staff 18 stated that the temperature difference was likely due to lack of air circulation inside the refrigerator. The DOP added that the type of refrigerator used in the emergency department was not appropriate for medication storage and she was going to replace the refrigerator with a medication storage-grade refrigerator.

A review of the hospital medication storage policy and procedure titled "Medication: Refrigerator/Warmer /Room temps; General Storage and Security", last revised 1/2014, indicated that all pharmaceuticals would be stored within appropriate temperature ranges recommended by manufacturers. Medication storage refrigerators should be maintained at a temperature range of between 36F and 46F.
VIOLATION: GOVERNING BODY Tag No: A0043
Based on observation, interview, and record review, the hospital failed to provide governing body oversight when:

1. The four hemodialysis machines ( a machine used to provide a Hemodialysis treatment - a therapy that uses hemodialysis machine and a dialyzer [artificial kidney] to remove extra fluids and waste products from the blood which the kidneys could not excrete) and four Reverse Osmosis (RO - process of water purification to remove contaminants like chloramine [Chlorine/Chloramine - a disinfectant added to community water supplies for public health protection] from the water in order for the water to be safe for patient use during hemodialysis) machines were not maintained and monitored to ensure patients on hemodialysis treatment were not potentially exposed to unsafe water and dialysate (fluids used in hemodialysis to remove waste material from the blood and keep useful material from leaving the blood), and excessive fluid removal which could cause serious injury and death. (Refer to A-0724).

2. The Infection Control Program was not implemented in Perioperative (surgical) area, Cardiac Catheterization Lab (area where invasive procedures were done to check how well the heart was working), hemodialysis, dietary and various patient care areas. (Refer to A-0747).

3. The Medical Director responsible of the hemodialysis (also called dialysis) unit did not provide quality care and services to hemodialysis patient when an on-going problem with leaking dialysis equipment was not brought to the governing body for assessment as a capital expenditure need. The deficient practice resulted in continued use of equipments that repeatedly malfunctioned, and potentially exposed hemodialysis patients to unsafe water and dialysate and excessive fluid removal which could cause serious injury and death.(Refer to A-0049).

4. Registered Nurses did not supervise and evaluate the individualized patient Plan of Care for six of thirty four sampled patients (Refer to A-0395);

5. The Biomedical (Biomed) Manager (Biomedical Engineering -
the application of engineering principles and design concepts to medicine and
biology for healthcare purposes (e.g. diagnostic or therapeutic equipment]) lacked the required years of work experience to provide the clinical engineering services that included: repair, inspection, and maintenance of the four hemodialysis and reverse osmosis (RO) machines. This failure resulted in the continued use of the four, liquid-leaking hemodialysis machines and RO machines for seven patients which placed them at risk of contracting hospital-acquired infection and other health conditions including hemolysis (the breakage of, or damage to the membrane of red blood cells that results in leakage of hemoglobin into the surrounding fluid (Refer to A-0724)

6. The Biomed Technician and Hemodialysis Registered Nurses did not follow manufacturer's directions for use for maintenance, monitoring and recognizing machine malfunctions when four RO machines and four hemodialysis machine were leaking fluids but were not taken out of service. The defective machines were used for patients' hemodialysis treatment, potentially exposing patients to unsafe water and dialysate and excessive fluid removal which could cause serious injury and death. (Refer to A-0724).

7. The Board of Directors Minutes dated 5/14/15 through 10/6/15 do not indicate any awareness that the contracted Emergency Physician Services for the Emergency Department had been cited for violations of the EMTALA (Emergency Medical Treatment Ad Labor Act) regulations.

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment.
VIOLATION: MEDICAL STAFF - ACCOUNTABILITY Tag No: A0049
Based on interview and record review, the hospital's governing body failed to ensure the medical staff (Staff 50) responsible of the hemodialysis (therapy that uses hemodialysis machine and a dialyzer [artificial kidney] to remove extra fluids and waste products from the blood which the kidneys could not excrete) unit provided quality care and services to hemodialysis patients when on-going problems with leaking hemodialysis equipments were not brought to the governing body for assessment of its compliance to all Conditions of Participation. The deficient practice resulted in continued use of equipments that repeatedly malfunctioned, and potentially exposed hemodialysis patients to unsafe water and dialysate and excessive fluid removal which could cause serious injury and death.

Findings:

During an interview on 12/7/15 at 2:00 PM, Staff 12 stated he was aware of the water leaking out of all four of the hemodialysis and RO (Reverse Osmosis) machines in use, and the problem had been ongoing. Staff 12 stated the RO machines were refurbished but had been maintained by an outside company.

During an interview on 12/8/15 at 11:20 PM, Staff 11 stated it was incorrect for licensed nurses to use the machines if there were leaks. Staff 11 stated he made multiple requests to Administration to change the machines because of on-going problems with fluid leaks, however, his request had not been processed. Staff 11 stated Staff 50 was aware of the problems with the hemodialysis equipment.

During an interview on 12/9/15 at 11:55 AM, Staff 50 stated he was aware of the on-going problems with leaking hemodialysis equipment. Staff 50 stated the hemo dialysis equipment had been in its suboptimal state for a while and patient sfety was at risk.

Review of the governing body minutes for 2015 did not include the problem with leaking dialysis equipments and that these problems were brought to the attention of the governing body. The hospital provided a copy of the Capital Expenditure Request (CER) List for the last three years (2013-2015), and none of the years include consideration of purchasing new hemodialysis equipment despite its suboptimal state.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on observation, interview, and record review, the facility to ensure an organized nursing services were provided to patients when:

1. Registered Nurses did not provide supervision and evaluation of nursing care when six of the 34 sampled patients did not have individualized patient Care Plans with measurable goals for treatment. (Refer to A-0395);

2. Registered Nurses did not administer medications as ordered by the physicians and according to professional standard of practice. (Refer to A-0405).

3. Registered Nurses did not follow manufacturer's directions for use for maintenance, monitoring and recognizing machine malfunctions when four reverse osmosis (RO - process of water purification to remove contaminants like chloramine [Chlorine/Chloramine - a disinfectant added to community water supplies for public health protection] from the water in order for the water to be safe for patient use during hemodialysis) machines and four hemodialysis (Hemodialysis treatment - a therapy that uses hemodialysis machine and a dialyzer [artificial kidney] to remove extra fluids and waste products from the blood which the kidneys could not excrete) machine were leaking fluids but were not taken out of service. The defective machines were used for patients' hemodialysis treatment, potentially exposing patients to unsafe water and dialysate (fluids used in hemodialysis to remove waste material from the blood and keep useful material from leaving the blood), and excessive fluid removal which could cause serious injury and death. (Refer to A-0724).

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality nursing care in a safe environment.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, observation, and record review, the hospital failed to ensure a Registered Nurse supervised and evaluated the nursing care of each patient when comprehensive, individualized Plans of Care were not developed for six out of the 34 sampled patients (Patients 3, 4, 5, 9, 11, and 12) when:

1. For Patient 3, no evidence Care Plans were developed to address wound care of (a) his open chest wound, (b) his progressive sacral and buttock pressure ulcers, and (c) his need for Contact Precaution isolation (gowns and gloves when touching the patient and any dressings and other surfaces which are touched by the patient);

2. For Patient 4, no evidence of Care Plans were developed to address the wound care of (a) her enterocutaneous abdominal fistula, (b) her right knee cellulitis, and (c) her need for Contact Precaution isolation.

3. For Patient 5, no evidence Care Plan was developed to address the use of hemodialysis (an artificial kidney);

4. For Patient 9, there was no Care Plan developed when Patient 9 was placed on a Droplet Isolation (one of the three types of transmission- based precautions used for diseases that are spread by large particles in the air. This type of precaution is used for patients that have an infection that can be spread through close respiratory or mucous membrane contact with respiratory secretions);

5. For Patient 11, no Care Plan was developed that addressed both hemodialysis and peritoneal dialysis (PD is a treatment for patients with severe chronic kidney disease that uses the patient's peritoneum in the abdomen as a membrane across which fluids and dissolved substances are exchanged from the blood);

6. For Patient 12, no Care Plan was developed to address the use of hemodialysis.

The hospital policy and procedure "Nursing Process, Plan of Care and Documentation" dated 4/11, stated that the hospitals "utilize the nursing process (assessment, analyzing data, planning or intervention, and evaluation) to guide in the planning of care for each patient. The Plan of Care is individualized for each patient based on the information gathered through the nursing process."

Failure to develop a comprehensive Care Plans had the potential to negatively impact the care and services rendered to patients.

Finding:

1. Patient 3 was admitted to the hospital 11/12/15 for diagnoses which included a mediastinal (middle area of the chest which contains the heart and its blood vessels, the esophagus, the trachea, and other smaller organs) infection following cardiopulmonary (heart and lung) surgery, lung cancer, diabetes, and renal disease. Patient 3 was receiving acute hemodialysis treatments three times per week. He was also being followed by a wound specialist for an open, draining chest wound. During the course of his hospitalization , Patient 3 developed pressure ulcers of his sacrococcygeal area (tailbone) and both buttocks.

Record review of Patient 3's chart indicated pictures of the chest wound taken on 11/20/15 and 11/27/15. There were additional pictures labeled as the chest wound and dated 11/22/15 and 12/11/15 but these photographs were clearly from Patient 3's sacral and buttock areas.

Record review of Patient 3's chart indicated picture of the sacrococcygeal and buttocks pressure ulcers dated 11/22/15 in which the skin of this area appeared to be intact. Subsequent pictures taken on 11/27/15, 12/1/15, 12/4/15, 12/8/15 which show evolving tissue damage to the epithelium (top layer of skin).

During an interview with the charge nurse on 12/8/15 at approximately 1:40 PM, this Registered Nurse (Staff 30) reviewed Patient 3's Care Plans and stated that there were no individualized Wound Care Plans developed for either the chest wound or the sacrococcygeal and buttocks pressure ulcers. Staff 30 explained that physician orders for treatments do appear on the computerized treatment plan but this is not a substitute for developing a written Plan of Care for the patient.

2. Patient 4 was admitted on [DATE] with diagnoses which included cellulitis (bacterial infection of the skin and the underlying fat layer) of the right knee, an enterocutaneous fistula (abnormal communication between the small or large bowel and the skin), and end stage renal disease. Patient 4 had acute hemodialysis three times per week. With a written physician's order, Patient 4 did her own dressing changes of her enterocutaneous fistula.

During an interview on 12/9/15 at approximately 11:00 AM, the Registered Nurse (Staff 31) stated that Patient 4 did her own dressing changes of her fistula. Staff 31 said that, except for the picture taken on admission, none of the staff was allowed to see her fistula and none of the staff were permitted to assist with the dressing changes.

Staff 31 reviewed Patient 4's medical record and confirmed that there were no Plans of Care for wound care of the enterocutaneous abdominal fistula or the right knee cellulitis.






3. Patient 5 was admitted on [DATE] with diagnoses that included chronic kidney disease, (CKD - a condition characterized by a gradual loss of kidney function over time).
Review of the physician order dated 11/27/15, indicated: "R (right ) IJ (Internal jugular- the deeper of the two jugular veins in the neck that drain blood from the head, brain, face and neck and convey it toward the heart) Temp (temporary) HD (hemodialysis) cath (catheter ) ready to use", signed and dated by the physician on 11/27/15 and a written order on 11/27/15 to start hemodialysis.

Review of the clinical record showed no evidence that a Care Plan (CP) was developed for the use of the hemodialysis.

In an interview on 12/10/15 at 10:10 AM, a Registered Nurse (Staff 32) stated Patient 5 had dialysis treatments four times during his hospitalization . When asked to show evidence for a CP, Staff 32 searched the entire clinical record with the help of another Registered Nurse (Staff 33). Both Staff 32 and 33 acknowledged the CP was not developed. They stated, "there should be a Care Plan".

4. Review of the History and Physical Report (HPR) dated 12/3/15 indicated Patient 9 was admitted on [DATE] with the chief complaint of "productive cough with yellowish sputum and shortness of breath, and bloody sputum." The Assessment section of the HPR document indicated the diagnosis of acute respiratory failure secondary to chronic obstructive pulmonary disease (COPD - a Chronic Obstructive Pulmonary Disease that caused obstructed airflow from the lungs.)

Review of the Physician Order dated 12/2/15 indicated an order to place Patient on Droplet Precaution Isolation.

In an interview on 12/9/15 at 10:30 a.m. Staff 33 was asked what the staff would do when an there was an order for droplet precautions. Staff 33 stated an isolation cart would be placed outside the door of patient's room, a sign would be place outside indicating the kind of precaution, mask and gown would be required when going inside the room.

Review of the clinical record did not show evidence that a Care Plan was developed for the Droplet Precautions.

In a concurrent review and interview on 12/9/15 at 10:40 a.m., Staff 33 searched the entire clinical record and acknowledged there was no CP developed. Staff 33 stated Patient 9 was no longer on isolation, it was discontinued on 12/5/15, but, "there should have been a Care Plan for it". When asked what was the importance of having Care Plan, Staff 33 stated, "so, we have a basis on how care is given and how far we are on the care of the patient."

5. Review of the History and Physical Report dated 12/6/15 indicated Patient 11 was admitted to the hospital with the diagnoses that included altered mental status and end-stage renal disease (ESRD-is the last stage of chronic kidney disease when the kidneys can no longer support the body's needs). The HPR document also indicated Patient 11 had a peritoneal catheter in the left upper chest.

During the initial tour of the Intensive Care Unit (ICU) on 12/7/15 at 11:07 a.m., accompanied by a Registered Nurse (Staff 34) Patient 11 was observed receiving dialysis.

Review of the clinical record showed no evidence that a Care Plan was developed for dialysis.

In an interview in 12/9/15 at 2:20 p.m., with a Registered Nurse (Staff 35) she stated Patient 11 was re- admitted back to the ICU from the Telemetry Unit today (12/9/15) at 5:30 a.m. When asked to show evidence of CP for dialysis, Staff 35 and Staff 36 searched the entire clinical record but did not find evidence of CP for hemodialysis or peritoneal dialysis. Staff 36 stated, "I do not see one for dialysis. She should have one." Staff 35 stated Patient 11 was scheduled to have peritoneal dialysis "this afternoon" instead, because of some "issues" with the hemodialysis machine.

6. Review of the History and Physical Report (HPR) dated 12/1/15 indicated Patient 12 was admitted on [DATE] with the diagnoses that included end-stage renal disease, hemodialysis dependent.

Review of the clinical record showed no evidence Care Plan was developed for the renal disease and the use of the hemodialysis.

In an interview on 12/ 9/15 at 11:20 a.m. Staff 36 searched the entire record but did not find a CP for renal disease and use of hemodialysis. Staff 36 stated, " I am not seeing it here. I can have one added".
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interviews and document reviews, the hospital nurses failed to ensure medications were administered in accordance to physician's orders and professional standards of practice for 7 of 34 sampled patients as evidence by:

1. The hospital failed to ensure medications were administered as ordered when four of four patients (patient 10, 31, 32, and 33) on intravenous Norepinephrine and Phenylephrine (medications used for critically low blood pressure) continuous infusions were not administered in accordance to physician orders and hospital protocol putting patients at risk for serious complications, possible end organ damage and death, due to incorrect dosing of high risk/alert medications (Norepinephrine and Phenylephrine).

2. The hospital failed to administer Fentanyl patches in accordance to professional standards of practice. A system was not in place to prevent non-opioid tolerant patients, patients that had not received 60mg/day for 7 days of Morphine (pain medication) or equivalent, from receiving Fentanyl patch (medication used for pain) which could result in serious or life-threatening hypoventilation (inadequate breathing). Patient 8 received Fentanyl patch without demonstrating opioid tolerance (60mg/day morphine or equivalent for 7 days) and was at risk for serious adverse consequences, including but not limited to respiratory depression and possibly death.

3. Failure to administer medications accordance with physicians' orders and physician ordered protocols. Patient 27 and Patient 28's heparin (a blood thinning agent) infusion therapy was not titrated (adjustment based on response) in accordance with the hospital heparin drip protocol. In addition, Patient 27 was administered heparin continuous infusion at 1400 units/hour (infusion rate) instead of the physician ordered dose of 1000 units/hour for over 6 hours which resulted in Patient 27 developing an over-anticoagulated (excessive thinning of blood) state as indicated by a critically high Anti-factor Xa (a laboratory test to measure heparin levels in the blood to monitor anticoagulant (blood thinning) therapy) level of >1.3 (therapeutic range 0.3 to 0.7).
4. Failure to ensure that compounded sterile preparations for intravenous administration were assigned beyond-use dates in accordance with current professional standards of practice. Compounded sterile (free of bacteria and other living organisms) preparations of medium risk level, as defined by USP <797>, United States Pharmacopeia Chapter 797, a professional standards of practice for the compounding of CSPs, were assigned beyond use dates of 10 days, exceeding the beyond-use date of 9 days for such products for storage under refrigeration according to USP <797>.
Beyond-use date is the date after which a compounded preparation should not to be used as determined from the date the preparation is compounded.
Findings:

1. During an interview 12/10/15 at 2:18 PM Staff 18 stated the hospital policy indicated that when physician's wrote orders for Norepinephrine and Phenylephrine that did not specify the initial rate and titrations then the hospital intravenous (IV) Drip Titration Protocol would be followed.

A review on 12/10/15 of the undated hospital policy entitled Medications: Intravenous Medication Administration Guidelines and Standard Concentration of Critical Care Drugs Appendix 1 indicated the IV Drip Titration Protocol as followed:
*Norepinephrine Initial Dose-1mcg/min
*Norepinephrine Titration-1 mcg/min every 5 minutes until desired response. When weaning decrease by 1 mcg/min every 10 minutes as tolerated.
*Phenylephrine Initial Dose-20 mcg/min
*Phenylephrine Titration-20 mcg/min every 10 minutes to desired response. When weaning decrease by 10 mcg/min every 10 minutes as tolerated.

1a. A review on 12/07/15 of the clinical record indicated Patient 10 was admitted to the hospital with Septic Shock (severe infection that can cause multiple organ failure and death). There were physician's orders for IV Norepinephrine infusion per hospital protocol titrate for mean arterial pressure (MAP-average blood pressure) greater than 65. The clinical record documented how much the nurses titrated the IV Norepinephrine infusion (The IV Norepinepherine protocol rates are in parenthesis):
*12/07/15
12:31 PM-5 mcg/min (4 mcg/min higher than protocol)
06:00 PM-4 mcg/min
08:25 PM-3 mcg/min
10:19 PM-5 mcg/min (1 mcg/min higher than protocol)

During an interview on 12/07/15 at 2:25 PM, Staff 9 stated that she was the nurse who administered Patient 10's IV Norepinephrine. She also stated she did not have physician orders for starting Patient 10 on 5 mcg/min (5 times the ordered initial rate). She said she did not use the protocol when infusing Patient 10 ' s IV Norepinephrine. She also said she was not aware of the protocol.

During an interview on 12/08/15 at 11:59 AM Staff 27 stated that she was the physician who prescribed Patient 10's IV Norepinephrine. She also stated she expected the nurses to follow the hospital protocol. She said she had not read the protocol, however she did expect the nurses to follow the protocol.

1b. A review on 12/09/15 of the clinical record indicated Patient 31 was admitted to the hospital with Septic Shock. There were physician's orders for IV Norepinephrine infusion per hospital protocol titrate for systolic blood pressure (SBP-blood pressure of the cardiac cycle when the ventricles contract) greater than 100. The clinical record documented how much the nurses titrated the IV Norepinephrine infusion (The IV Norepinephrine protocol rates are in parenthesis):
*11/30/15
03:00 AM-10 mcg/min (1 mcg/min starting rate-9 mcg/min higher than protocol)
04:00 AM-10 mcg/min
06:00 AM-15 mcg/min (4 mcg/min higher than protocol)
08:15 PM-10 mcg/min (4 mcg/min lower than protocol)
02:00 PM-10 mcg/min
07:32 PM-8 mcg/min (1 mcg/min lower than protocol)
09:54 PM-5 mcg/min (2 mcg/min lower than protocol)

During an interview on 12/09/15 at 2:28 PM, Staff 15 stated that she was the nurse who administered Patient 31's IV Norepinephrine. She also stated she did not document physician orders for starting Patient 31 on 10 mcg/min (10 times the ordered initial rate). She said she should have followed the protocol when infusing Patient 31's IV Norepinephrine.

1c. A review on 12/09/15 of the clinical record indicated Patient 32was admitted to the hospital with Septic Shock. There were physician's orders for IV Norepinephrine infusion per hospital protocol titrate for MAP greater or equal to 65. There were also physician's orders for IV Phenylephrine (medication used to increase blood pressure) infusion per hospital protocol titrate for MAP greater or equal to 65. The clinical record documented how much the nurses titrated the Norepinephrine and Phenylephrine infusions(The IV Norepinephrine protocol rates are in parenthesis):
*Phenylephrine 11/07/15
07:58 AM-100 mcg/min (20 mcg/min starting rate-80 mcg higher than protocol)
09:47 AM-150 mcg/min (30 mcg/min higher than protocol)
11:27 AM-100 mcg/min (30 mcg/min lower than protocol)
*Norepinephrine 11/09/15
04:07 AM 3 mcg/min (1 mcg/min starting rate-2 mcg higher than protocol)
08:30 AM 3 mcg/min
09:10 AM 5 mcg/min (1 mcg/min higher than protocol)
10:09 AM 3 mcg/min (1 mcg/min lower than protocol)
12:24 PM 5 mcg/min (1 mcg/min higher than protocol)
*11/21/15
Patient Expires

During an interview on 12/09/15 at 4:05 PM, Staff 16 stated that he was the nurse who administered Patient 32's IV Norepinephrine and Phenylepherine. He also stated that there was no documented physician orders for starting Patient 32 on Phenylepherine 100 mcg/min (5 times the ordered initial rate)and Norepinephrine 3 mcg/min (3 times the ordered initial rate). He said he should have followed the 2protocol when infusing these IVs for Patient 32.

1d. A review on 12/09/15 of the clinical record indicated Patient 33 was admitted to the hospital with Septic Shock. There were physician's orders for IV Norepinephrine infusion per hospital protocol titrate for SBP greater than or equal to 90. The clinical record documented how much the nurses titrated the IV Norepinephrine infusion(The IV Norepinephrine protocol rates are in parenthesis):
*11/29/15
09:50 AM-5 mcg/min (1 mcg/min starting rate-4 mcg higher than protocol)
10:00 AM-10 mcg/min (4 mcg/min higher than protocol)
10:30 AM-15 mcg/min (4 mcg/min higher than protocol)
10:40 AM-20 mcg/min (4 mcg/min higher than protocol)
10:50 AM-22 mcg/min (1 mcg/min higher than protocol)
10:55 AM-25 mcg/min (2 mcg/min higher than protocol)
12:00 PM-23 mcg/min (1 mcg/min lower than protocol)
12:15 PM-22 mcg/min
12:45 PM-20 mcg/min (1 mcg/min lower than protocol)
01:00 PM-15 mcg/min (4 mcg/min lower than protocol)
01:15 PM-10 mcg/min (4 mcg/min lower than protocol)
*12/02/15
Patient Expires

During an interview on 12/09/15 at 4:33 PM, Staff 17 stated that she was the nurse who administered Patient 33's IV Norepinephrine. She also stated she did not have physician orders for starting Patient 33 on 5 mcg/min (5 times the ordered initial rate). She said she did not use the protocol when infusing Patient 33's IV Norepinephrine. She also said that she never looked at the protocol.

During an interview on 12/09/15 at 1:00 PM Staff 12 stated that he managed the nurses that had administered the IV Norepinephrine and Phenylephrine. He also stated he was not aware that the nurses were not following physician's orders and hospital protocol. He said it was the expectation that if the physician's orders do not specify the initial rate and subsequent titrations then to follow the hospital protocol.

During an interview on 12/10/15 at 3:23 PM Staff 19 stated that he was the Medical Director and it was his expectation that when physician orders do not specify the initial rate and subsequent titrations the nurses would then follow hospital protocol. He stated that there are significant risks when inappropriately dosing Norepinephrine and Phenylephrine such as end organ damage and death. He said it is important to accurately dose Norepinephrine and Phenylephrine.

According to the Institute of Safe Medication Practice (ISMP), a nationally recognized medication resource which focuses on medication error prevention and safe medication use, indicates in the entitled document ISMP's List of High Alert Medications "High-alert medications [referring to Norepinephrine and Phenylephrine] are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients."

2. According to the U.S Food and Drug Administration (FDA) issued a Public Health Advisory in July 2005 emphasizing the safe use of fentanyl transdermal (route of administration where medications are delivered across the skin) system, also known as the fentanyl patch. Despite the advisory issued in July 2005, FDA continued to receive reports of death and life-threatening side effects in patients who were prescribed fentanyl patches. On 12/21/2007, FDA again issued a Public Health Advisory on the safe use of fentanyl patch. This warning also known as a black box warning is the strongest FDA warning for drugs that carry a significant risk of serious or life threatening adverse effects.

The FDA black box warning indicates "FOR USE IN OPIOID-TOLERANT PATIENTS ONLY ...Fentanyl transdermal system contains a high concentration of a potent ...opioid agonist [chemical that decreases pain and can have side effects of sedation and respiratory depression], fentanyl ...Fentanyl transdermal system should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance ...Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily ...or an equianalgesic dose of another opioid. Because serious or life-threatening hypoventilation [inadequate ventilation/breathing] could occur, fentanyl transdermal system is contraindicated ...in patients who are not opioid-tolerant ...Fentanyl transdermal system is ONLY for use in patients who are already tolerant to opioid therapy of comparable potency. Use in non-opioid-tolerant patients may lead to fatal respiratory depression."

According to the Fentanyl patch manufacturer's package insert indicates "Respiratory depression is the chief hazard in elderly or debilitated patients ...in non-tolerant patients ...Fentanyl transdermal system should be used with caution in elderly ...patients as they may have altered pharmacokinetics due to poor fat stores, muscle wasting or altered clearance ...In post-marketing experience, deaths from hypoventilation due to inappropriate use of fentanyl transdermal system have been reported ...Fentanyl transdermal system is only for adults ...with persistent, moderate to severe chronic pain and who are already using another strong opioid narcotic pain medicine around-the-clock, and have been using the medicine regularly for a week or longer. This is called being opioid-tolerant "

A review on 12/11/15 of the clinical record indicated Patient 8 was [AGE] years old and had a history of metastatic cancer. Patient 8 had Physician orders for Fentanyl patch 12 mcg every 72 hours to treat her pain. Patient 8 was on Hydrocodone-Acetaminophen (combination opioid and analgesic) as needed prior to starting the Fentanyl Patch. The clinical record did not specify a dose or how long Patient 8 was on the Hydrocodone-Acetaminophen. A review of Lexicomp Online, a nationally recognized drug information resource, indicated that the maximum dose would be dependent upon the content of Acetaminophen (max 4 gm/day); which would be about 8 tablets (approximately 40 mg of Hydrocodone=approximately equal to 40 mg of Morphine).

During an interview on 12/11/15 at 11:42 AM Staff 21 stated that she was proficient in the use of the computerized clinical record. She also stated that after a thorough review of Patient 8 ' s clinical record she did not find any documentation or evidence of the Nurse evaluating for opioid tolerance prior to the administration of the Fentanyl patch.

During an interview on 12/11/15 at 1:16 PM Staff 18 stated that the Pharmacy Technician and the Nurse would complete a medication reconciliation (process of identifying patient ' s medications prior to admission) for newly admitted patients. A review on 12/11/15 of the hospital policy entitled Medications: High Risk Medications indicated " Based on dosing equivalence, fentanyl patches will be approved by pharmacy prior to administration."

During an interview on 12/11/15 at 1:30 PM Staff 26 stated that he was the Pharmacy Technician who would complete the medication reconciliation for newly admitted patients. He also stated that after the medication reconciliation was completed it would be reviewed by the Pharmacist and Physician. He said that medication reconciliation does not always occur with all newly admitted patients. He also said that less than half of newly admitted patients would have a completed medication reconciliation, he did not do the medication reconciliation for Patient 8.

During an interview on 12/11/15 at 3:15 PM Staff 22 stated that he was the Pharmacist that reviewed the Fentanyl patch order for Patient 8. He also stated that as long as the patient was on some opioid he would dispense the Fentanyl patch. He then said that opioid tolerance was equivalent to Morphine 30mg/day for 5 days (Black box warning: Morphine 60mg/day for 7 days or more). After being corrected, he said that he did not know that the patient needed to be on Morphine 60 mg/day for 7 days. He expressed that he did not evaluate for opioid tolerance correctly for Patient 8. He concluded " I guess I should not have sent it."

During an interview on 12/11/15 at 3:40 PM Staff 25 stated she was the nurse that administered Patient 8 ' s Fentanyl patch. She also stated that the patient was on Hydrocodone-Acetaminophen before starting the Fentanyl patch. She said she thought that was ok. She also said she did not know what opioid tolerance was or what it meant. She did not know how to evaluate for opioid tolerance.

During an interview on 12/11/15 at 3:30 PM Staff 23 stated she was the Hospitalist (Physician whose activities are performed chiefly within a hospital). She also stated that a small dose of Hydrocodone-Acetaminophen, if the patient tolerated it, would be enough to start administering a Fentanyl patch. She was not aware of the black box warning or the manufacturer recommendations that patients must be on Morphine 60 mg/day for 7 days or equivalent prior to starting the Fentanyl patch.

During an interview on 12/11/15 at 1:16 PM Staff 18 stated that we really need a hospital policy evaluating for opioid tolerance for patients starting on a Fentanyl patch. During an interview on 12/11/15 at 3:40 PM Staff 25 also stated that we need a specific hospital policy for evaluating for opioid tolerance.

According to the Institute for Safe Medication Practices (ISMP), a nationally recognized medication safety resource, in an ISMP publication Medication Safety Alert June 28, 2007 entitled Ongoing, Preventable Fatal Events with Fentanyl Transdermal Patches Are Alarming! indicated "Despite warning from the FDA, manufacturers, and various patient safety agencies, fentanyl transdermal patches continue to be prescribed inappropriately ...in opiate-nave [not opioid tolerant] patients, sometimes in large doses or in combination with oral or intravenous opiates ...Unfortunately, pharmacists have often filled these prescriptions without question, and nurses caring for patients have applied the patches without recognizing the prescribing error. ISMP is deeply troubled by these practices and alarmed by what appears to be a steady stream of reports of adverse events with fentanyl patches-including fatalities-caused by inappropriate prescribing, dispensing, and administration of the drug."






3a. A review of Patient 27's clinical record with Staff 20, a clinical educator, at approximately 2:40 p.m. on 12/9/15 showed that the patient was ordered heparin continuous infusion for acute coronary syndrome on 11/20/15. The order was written as:

**** General heparin protocol ****

Start at 15 units/kilogram (weight unit)/hour. Max dose: 1000 units/hour (units per hour, rate of infusion).

A review of the hospital approved (last approved 9/2012) general heparin drip protocol for venous thromboembolism and acute coronary syndrome showed the following protocol on heparin dose adjustment and procedures for laboratory test monitoring:

Anti-Xa level <0.2: Rebolus (Repeat as a single dose) 2000 units, increase by 200 units/hour

Anti-Xa level 0.2 - 0.29: Rebolus 2000 units, increase by 140 units/hour

Anti-Xa level 0.3 - 0.7: Therapeutic range, no change

Anti-Xa level 0.71 - 0.8: Decrease infusion rate by 70 units/hour

Anti-Xa level 0.2 - 0.29: Decrease infusion rate by 140 units/hour

Anti-Xa level = or > 1: Hold the infusion for 1 hour, then decrease infusion by 140 units/hour

Anti-Xa level = / > 1.3: STOP infusion and call MD for further orders. Anti-Xa level in 2 hours

After any new adjustments in the rate, draw Anti-Xa in 6 hours from the adjustment time.

If the drip rate is changed, indicate new rate on the heparin drip flow sheet.

Anti-factor Xa assay is a laboratory test to measure plasma heparin levels to monitor anticoagulant (blood thinning) therapy.

Acute coronary syndrome is a condition of decreased blood flow in the blood vessel(s) of the heart causing reduced perfusion and damage to heart muscle.

Patient 27's clinical record indicated that the patient had a documented weight of 93 kg (kilograms, weight unit) on admission. Patient 27's heparin continuous infusion was started at 7:07 p.m. on 11/20/15 at the rate of 1200 units/hour. At 7:23 p.m., the heparin infusion rate was adjusted to 1000 units/hour. One minute after the adjustment, at 7:24 p.m., the patient's heparin infusion rate was adjusted again to 1400 units/hour. A critical anti-factor Xa level of > (greater than) 1.3 was reported by the laboratory at 1:38 a.m. on 11/21/15. Staff 20 confirmed that there was no documentation of physician notification of the critical laboratory results by any nursing staff.

Patient 27's clinical record also indicated that at 12:49 a.m. on 11/22/15, a subtherapeutic (below therapy level) anti-factor Xa result of 0.26 was reported. Patient 27's heparin drip was increased to 1540 units/hour at 1:51 a.m. on 11/22/15 but there was no documentation of a bolus dose of heparin being given. According to the heparin drip protocol, Patient 27 should be administered a bolus dose of heparin 2000 units in addition to increasing the infusion rate 140 units/hour.

During an interview at approximately 3:00 p.m. on 12/9/15, Staff 20 stated that Patient 27 was ordered heparin continuous infusion at a starting rate of 1000 units/hour. There was no physician order to change the heparin infusion rate to 1400 units/hour. Staff 20 confirmed that Patient 27's heparin infusion was erroneously administered at 1400 units when the prescribed dose was 1000 units per hour. Staff 20 added that the patient's heparin infusion was not properly titrated when a subtherapeutic Anti-factor Xa level was reported on 11/22/15.

During an interview at approximately 3:45 p.m. on 12/9/15, Staff 18, the hospital Director of Pharmacy stated that the administration of heparin continuous infusion at 1400 units per hour to Patient 27 was a medication error.

3b. A review of Patient's 28's clinical record with Staff 20 at approximately 3:05 p.m.. on 12/9/15 showed that Patient 28 was ordered heparin continuous infusion at 10:08 p.m. on 6/25/15 for deep vein thrombosis of right leg (blood clot in the blood vessel of the leg). The physician order was written as:

**** General heparin protocol ****

Start at 18 units/kg/hour. Max dose: 1400 units/hour.

On 6/29/15 at 10:30 a.m., a subtherapeutic level of Anti factor Xa level of 0.26 was reported when Patient 28 was receiving heparin continuous infusion at 1250 units/hour. According to the heparin drip protocol, Patient 28 should receive a bolus dose of 2000 units and an increase in infusion rate by 140 units/hour. Patient 28's clinical record indicated that the patient's heparin infusion rate was not adjusted and was kept at 1250 units/hour after the subtherapeutic level of Anti Xa was reported.

At 6:46 p.m. on 6/29/15, a critical Anti factor Xa level of >1.10 was reported for Patient 28 by the laboratory. According to the heparin drip protocol, Patient 28's heparin infusion should be held for 1 hour and then reduced by 140 units/hour. Patient 28's clinical record showed that there was no documentation of holding of Patient 28's heparin infusion by 1 hour and the heparin infusion rate was not reduced but was kept at 1250 units/hour.

During an interview at approximately 3:30 p.m. on 12/9/15, Staff 20 confirmed that Patient 28's heparin infusion therapy was not titrated and in accordance with the physician's order and the hospital approved heparin drip protocol.

A review of the hospital policy and procedure on high-risk/high-alert medications, last revised 2/2014, indicated that anticoagulants (blood thinning agents) including heparin were identified by the hospital as high-risk/high-alert medications. The policy indicated that caregivers were to double-check high-alert medications as follow:
1. Independently comparing the label and product contents in hand versus the written order or Medication Administration Record.
2. Independently verifying any calculations for dose that required preparation (any time the medication was not dispensed in the exact patient-specific unit)
3. Assuring the accuracy of infusion pump programming for continuous intravenous infusions of medications.
4. Review lab values as appropriate.

Heparin is a blood thinning agent for the management of thromboembolic (blood clots within blood vessels) events and prevention of blood clot formation. Overdosing of heparin may cause over-anticoagulation (excessive thinning of blood) which may lead to bleeding complications including excessive blood loss from bleeding, gastrointestinal (within stomach and intestines) bleeding and hemorrhagic stroke (bleeding within the brain). Heparin is identified by the Institute for Safe Medication Practices (ISMP), a nonprofit organization devoted to medication error prevention and safe medication use, as high-alert medications. High alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error.

4. A review of the hospital batch compounding record indicated the following intravenous drugs were prepared by the pharmacy:

One batch of 3 bags of Vancomycin (an antibiotic for management of bacterial infection of susceptible microorganisms) 1500 mg (milligrams, weight units) was prepared by the hospital pharmacy on 12/4/15 with an assigned beyond use date of 10 days.

One batch of 6 bags of Vancomycin 1500 mg was prepared by the hospital pharmacy on 12/4/15 with an assigned beyond use date of 10 days.

One batch of 4 bags of Vancomycin 1250 mg, 3 bags of Vancomycin 1500 mg and 1 bag of Vancomycin 500 mg was prepared by the hospital pharmacy on 12/1/15 with an assigned beyond use date of 10 days.

One batch of 4 bags of Vancomycin 1500 mg and 3 bags of Vancomycin 1250 was prepared by the hospital pharmacy on 12/1/15 with an assigned beyond use date of 10 days.

A review of the hospital Intravenous Admixtures Services policy and procedures, last revised 5/2015, showed that the hospitals had not developed any procedures and guidelines on the assignment of beyond-use dates to compounded sterile preparations to ensure the safety and quality of the CSPs prepared by the pharmacy for patient use.

A review of USP <797> published in 2008 indicated that the compounding of medications in batches by the hospital is considered medium risk level compounding and such preparations should be assigned beyond-use dates of 30 hours for room temperature storage, 9 days for storage under refrigeration and 45 days for storage at frozen state.

During an interview at approximately 11:20 a.m. on 12/9/15, Staff 18, the hospital Director of Pharmacy stated that the hospital followed USP <797> for compounding of intravenous drugs but the hospital had mistaken the practice of batch compounding as low risk level compounding and hence had been assigning beyond-use dates to such batch compounded preparations based on that misunderstanding. Staff 18 further stated that the compounding records indicated the identified products were not assigned beyond use dates in accordance with current professional standards of practice and such products should have been assigned beyond-use date of 9 days for storage under refrigeration.
VIOLATION: PHARMACIST SUPERVISION OF SERVICES Tag No: A0501
Based on observation, interview and document review, the hospital failed to ensure that compounding of drugs was performed consistent with State law. Compounded sterile preparations were not labeled in accordance with state regulations. Cardioplegic solution prepared by the pharmacy was not labeled with the correct concentration of potassium chloride (an electrolyte) in the solution.

Cardioplegic solution is a solution used to perfuse the heart during heart surgery to induce arrest of the heart.

Findings:

During an inspection of the hospital pharmacy at approximately 11:00 a.m. on 12/9/15 with Staff 18, the hospital Director of Pharmacy, three one-liter bags of cardioplegic solution were observed in the medication storage refrigerator. Staff 18 stated that the hospital pharmacy technician would use the products to prepare cardioplegic solution of the appropriate potassium concentrations for the surgery department for cardiac (heart) surgeries.

During an interview at approximately 11:10 a.m. on 12/9/15, Staff 46, a hospital pharmacy technician, explained that he prepared cardioplegic solution of 2 different concentrations for use in cardiac surgeries, a high concentration which contained 120 mEq (milliequvalents, weight unit) of potassium chloride per 1 liter and a low concentration which contained 60 mEq of potassium chloride in 1 liter. Staff 46 stated that to prepare a high potassium concentration cardioplegic solution, he would first withdraw 150 mL of cardioplegic solution from the bag taking into consideration the overfill volume in the bag as well as the additional potassium chloride (120 mEq in 60ml) and other drugs that he would need to add to the solution. Staff 46 also stated that he followed the same procedures to prepare the low potassium concentration cardioplegic solution except that he would add 60 mEq of potassium chloride into the bag intead of 120 mEq. Staff 46 presented preprinted labels of the cardioplegic solution that he would affix on the compounded cardioplegic solution which read:

**** High K+ (potassium) cardioplegic solution ****

Potassium chloride 120 mEq/L (concentration unit)

Regular insulin 25 units per liter added: ____
NaHCO3 (sodium bicarbonate) checked by: ____



Another label read:

**** Low K+ (potassium) cardioplegic solution ****

Cardioplegic solution 1000 ml
Potassium chloride 60 mEq
Sodium bicarbonate 10 mEq
Regular insulin 25 units


A review of the hospital's Master Formula for the preparation of cardioplegic solution showed that 150 mL was to be discarded from the cardioplegic solution bag prior to adding other electrolytes and drugs. For high potassium concentration cardioplegic solution, 120 mEq (60ml) of potassium chloride was to be added to the bag. For low potassium concentration cardioplegic solution, 60 mEq (30ml) of potassium chloride was to be added to the bag.

A review of the product labeling by the manufacturer of the cardioplegic solution indicated that the product already contained 16 mEq a potassium in each 1 liter bag.

According to the compounding procedures explained by Staff 46 and the master formula for cardioplegic solution, the removal of 150 mL of the solution during preparation would leave a total of 13.6 mEq of potassium chloride in the bag of base solution. The addition of 120 mEq of potassium chloride to the bag would yield a final product which contained 133.6 mEq of potassium chloride for the high potassium concentration cardioplegic solution. The addition of 60 mEq of potassium chloride to the bag for the low potassium concentration cardioplegic solution would yield a final product which contained 73.6 mEq of potassium chloride in the solution. The labeling concentration of potassium chloride 120 mEq per liter for the high potassium cardioplegic solution which contained 133.6 mEq of potassium and the labeling of 60 mEq per liter for low potassium cardioplegic solution which contained 73.6 mEq of potassium was an inaccurate labeling of the concentration of potassium chloride in the products.

During an interview at approximately 11:20 a.m. on 12/9/15, Staff 18 stated that she was not aware of the 16 mEq of potassium chloride contained in the base cardioplegic solution from the manufacturer.

Potassium is an important electrolyte in controlling the contraction of heart muscle.

Division 17 of Title 16 California Code of Regulations 1751.2 (b) stipulates that a pharmacy which compounds sterile product shall include the name and concentrations of ingredients contained in the sterile injectable products on the label for such products.

The hospital failed to be in compliance with current state regulation on the accurate labeling of compounded sterile preparations.
VIOLATION: DIRECTOR OF DIETARY SERVICES Tag No: A0620
Based on observation, interview, and record review, the hospital Nutrition Services Director failed to ensure safe food handling in a sanitary environment when:

1. A counter in the food preparation area was used for slicing meat while the ready to eat salad was being prepared, staff personal items(computer tablet with earbuds), and bags of sliced bread were in the counter;

2. The food production and dishwashing areas had dirty fans, and a space between the deep frying unit and a metal counter was dirty;

3. The back splash metal surface in the dishwashing area had dark stained caulking; and,

4. A ceiling light fixture above the dishwasher was uncovered, with no light bulbs and showing areas of corrosion.

This had the potential for the hospital to serve food to patients which was contaminated by food-borne organisms or debris from dirty equipment that may result to food- borne illness.

Findings:

1. During a 12/9/15 10:50 AM tour of the kitchen escorted by the Food and Nutrition Services Director (Staff 38), a dietary staff was slicing raw meat on a counter shared by another dietary staff preparing salads. Between the two staff working areas three plastic bags of sliced bread were on the counter. A computer tablet with earbuds and two more sliced bread bags were noted on a shelf that run across the counter area.
When asked about the proximity between meat slicing and the ready to eat salad preparation, as well as the personal items on the shelf, Staff 38 stated: "Well they are careful...but I understand, they should not be in the proximity...yes, cross contamination risk...", and added about the personal items: "...he is not using them while working...but it should not be in the food area...".
Record review of a 3/14 dated hospital provided copy of a policy titled "Food Safety Standards" states under "Policy: To ensure that the food safety standards used in the food and nutrition services department meets or exceeds those established by the Food Code, U.S. Public Health Service FDA 1997..."
The FDA Food Code 2013 (The U. S. Food and Drug Administration, FDA, publishes the Food Code providing scientifically sound technical and legal basis for regulating the retail and food service segment of the industry like restaurants, grocery stores and health institutions); states under: "Preventing Food and Ingredient Contamination 3-302.11 : Food shall be protected from cross contamination by: ... separating raw animal foods during storage, preparation, holding, and display from: (a) Raw ready-to-eat food, including other raw animal food such as fish for sushi or mollusk shellfish, or other raw ready-to-eat food such as fruits and vegetables,..."

2. During the same 12/9/15 10:50 AM tour of the kitchen escorted by the Food and Nutrition Services Director, Staff 38, a wall fan in front of the food production area and another fan in the dishwashing area, were observed with blades and grill covered by a dark colored dust like material. Staff 38 stated: " We clean them often...but I see they need to be cleaned...".
A space of about three inches wide next to the deep frying unit and a small metal counter had thick dried layers of grease splashes along the sides and the floor was covered with old food and grease particles up to two inches high. When asked about the finding, a cook, Staff 39 stated: "yes it is pretty dirty there...I wish they could put something to cover this gap...". Staff 38 added: "We have Environmental Services cleaning these area about once a year...but we'll take care of this...it has to be cleaned...".
Record review of a 3/14 dated hospital provided copy of a policy titled "Food Safety Standards" stated under "Service Standards: 4. Fans will be cleaned on a monthly basis to ensure that they are free of dust particles."
3. During a 12/9/15 10:50 AM tour of the kitchen escorted by the Food and Nutrition Services Director, Staff 38, the dishwashing counter area had sections of the back splash metal surface with black colored caulking at the wall joint behind. When asked about the observation, Staff 38 stated: " Yes, caulking is not black...we'll report to the engineers...".
A ceiling three tubes light fixture above the dishwasher was observed uncovered, with no light bulbs and with brown rust like stains in the metal frame. Asked about the observation Staff 38 stated: "I can see it is rusty...it's been out for a while...I need to call the engineers for this...".
VIOLATION: PHYSICAL ENVIRONMENT Tag No: A0700
Based on observation, interview and record review, the facility failed to ensure machines used by seven of 34 sampled patients (Patient 1, 2, 3, 4, 11,12 and 14) were maintained and monitored to ensure patient safety as demonstrated by the following:

1. Four of four hemodialysis machines and four of four reverse osmosis machines were leaking fluids from the water connections, drainage connections, bottom of the hemodialysis machines and reverse osmosis machines, and onto the floor during hemodialysis treatment of Patient 1, 2, 3, and 4 on the 10th Floor. The defective machines were also used by Patient 11 and 12 on the Intensive Care Unit on 12/7/15. The leaking of fluids could be an indication the machines were not functioning correctly and could be unsafe for patients' use. (Refer to A-0724).

2. Four of four reverse osmosis (RO) machines were not monitored for chloramine according to the manufacturer's instructions for use before every patient treatment. (Chlorine/Chloramine - a disinfectant added to community water supplies for public health protection).The high level of chloramine when undetected could potentially expose four patients (Patient 1, 2, 3 and 4) to unsafe water, which could result to death due to hemolysis. (Hemolysis - premature destruction of red blood cells causing release of potassium in the bloodstream and decreased capacity of the red blood cells to carry oxygen to vital organs and different parts of the body. Hemolysis could cause shortness of breath, chest pain and cardiac arrest). (Refer to A-0724)

An Immediate Jeopardy was announced on 12/07/15 at 4:15 PM regarding 4 of 4 reverse osmosis machines that were leaking fluid onto the floors from the water connections, drainage connections, and the bottom of the hemodialysis machines during hemodialysis treatment of Patients 1, 2, 3, and 4 on the 10th floor unit. These same defective machines were also used on Patients 11 and 12 in the Intensive Care Unit on 12/7/15. The leaking of fluids could be an indication that the machines were not functioning correctly and could be unsafe for patient use. After six revisions of the POC (Plan of Correction) the IJ was removed on 12/10/15 at 5:57 PM.

3. Patient 14 had a hemodialysis treatment on Machine #4 without providing documentation to the Department that Machine #4 was repaired and deemed safe for patient use. The decision was made by licensed staff to use Machine # 4 after Machine #3 was found to be leaking fluids. Machine #3 was identified by the facility as not leaking and in good working condition according to the Plan of Correction (POC) submitted on 12/7/15 for the Immediate Jeopardy. The deficient practices put patients at high risk of exposure to unsafe water and dialysate, (Dialysate - fluids used in hemodialysis to remove waste material from the blood and keep useful material from leaving the blood), and excessive fluid removal which could result in serious injury and death. (Refer to A-0724).

4. One contractual personnel (Staff 2) lack the required years of work experience to provide the clinical engineering services that included: repair, inspection, and maintenance of the four hemodialysis machines. This failure resulted in the continued use of the four, liquid-leaking hemodialysis machines and RO machines for seven patients which placed them at risk of contracting a hospital-acquired infection and other health conditions including hemolysis. (Refer to A-0724).

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment.
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and record review, the facility failed to ensure machines used by seven of 34 sampled patients (Patient 1, 2, 3, 4, 11,12 and 14) were maintained and monitored to ensure patient safety when:

1. Four of four hemodialysis machines and four of four reverse osmosis machines were leaking fluids from the water connections, drainage connections, bottom of the hemodialysis machines and reverse osmosis machines, and into the floor during hemodialysis treatment of Patient 1, 2, 3, and 4 on 10th Floor. The defective machines were also used by Patient 11 and 12 on Intensive Care Unit on 12/7/15. The leaking of fluids could be indications the machines were not functioning correctly and could be unsafe for patients' use.

2. Four of four reverse osmosis (RO) machines were not monitored for chloramine according to manufacturer's instructions for use before every patient treatment. The high level of chloramine when undetected could potentially expose four patients (Patient 1, 2, 3 and 4) to unsafe water, which could result to death due to hemolysis.

3. Patient 14 had hemodialysis treatment on Machine #4 without providing documentation to the Department that Machine #4 was repaired and deemed safe for patient use. The decision was made by licensed staff to use Machine # 4 after Machine #3 was found to be leaking fluids. Machine #3 was identified by the facility as not leaking and in good working condition according to Plan of Correction (POC) submitted on 12/7/15 for the Immediate Jeopardy.

4. One contractual personnel (Staff 2) lack the required years of work experience to provide the clinical engineering services that included: repair, inspection, and maintenance of the four hemodialysis machine. This failure resulted in the continued use of the four, liquid-leaking hemodialysis machines and RO machines for seven patients which placed them at risk of contracting hospital-acquired infection and other health conditions including hemolysis (the breakage of, or damage to the membrane of red blood cells that results in leakage of hemoglobin into the surrounding fluid).

The deficient practices put patients at high risk of exposure to unsafe water and dialysate, and excessive fluid removal which could result to serious injury and death.

Hemodialysis treatment - a therapy that uses hemodialysis machine and a dialyzer (artificial kidney) to remove extra fluids and waste products from the blood which the kidneys could not excrete.

Hemolysis - premature destruction of red blood cells causing release of potassium in the bloodstream and decreased capacity of the red blood cells to carry oxygen to vital organs and different parts of the body. Hemolysis could cause shortness of breath, chest pain and cardiac arrest.

Chlorine/Chloramine - a disinfectant added to community water supplies for public health protection.

Reverse Osmosis (RO) - process of water purification to remove contaminants like chloramine from the water in order for the water to be safe for patient use during hemodialysis.

Acceptable Chloramine level - 0.0 - 0.1 milligrams/Liter (AAMI - Association for the Advancement of Medical Instrumentation standard).

Dialysate - fluids used in hemodialysis to remove waste material from the blood and keep useful material from leaving the blood.

On 12/7/15 at 4:15 PM, an Immediate Jeopardy was declared based on failure to maintain, monitor and follow manufacturer's instructions for use of the RO and hemodialysis machines which put four patients (Patient 1, 2, 3, 4, 11 and 12) at high risk of exposure to unsafe water and dialysate and excessive fluid removal which could lead to life-threatening complications like hemolysis. The Chief Executive Officer, Chief Financial Officer, Chief Nursing Executive, Quality Director and Infection Control Nurse were present. The facility submitted an acceptable plan of correction (POC) on 12/7/15 at 7:17 PM. The POC included: All hemodialysis was completed for the day at 4:40 PM. All defective equipment has been removed from service. The machines would remain out of service until repaired and deemed appropriate for use. Currently one dialysis machine (Machine # 3) was confirmed as not leaking and in good working order. This machine will be re-checked before use by Company 1. The facility was arranging for temporary use of dialysis equipment should a patient need to be dialyzed in the immediate future. This equipment would be checked by Company 3 prior to its use. The dialysis nurses would be reeducated regarding the maintenance process for the equipment as outlined in the equipment repair policy entitled "Reporting Equipment Malfunction." The policy would be reviewed with the staff and inservice records maintained. The Biomed staff would also be re-educated regarding the process. The Hemodialysis Nursing Director would be responsible for ongoing monitoring of the equipment maintenance and repair process in the Hemodialysis Unit to ensure the process is followed. The physicians of the six patients (Patient 1, 2, 3, 4 11 and 13) affected would be notified of the potentially defective machines for determination of additional follow-up. The physicians would also be involved in conversations/notifications of patients. Capital Equipment Request (CER) to purchase 4 new dialysis machines has been requested and is in process for approval by the Corporate Office. The Immediate Jeopardy was not removed on 12/7/15.

On 12/8/15, the facility was not able to provide documentation of repair and maintenance of Machine #3 which was identified by the facility as the only machine in good working condition and deemed safe for patient use. The facility was not able to provide repair and maintenance of the other two machines, Machine #1 and 4 which were repaired and deemed safe for patient use. During an observation and interview on 12/8/15 at 2:00 PM, Patient 14 was observed having hemodialysis treatment on Machine # 4 because Machine # 3 was leaking fluids according to Staff 11. The four hemodialysis machines and RO machines had been malfunctioning for three years according to Staff 11, and despite the facility's efforts to repair it, Machine # 3 leaked again. The Immediate Jeopardy was not removed on 12/8/15, based on the facility's failure to implement the POC.

On 12/9/15, the facility was made aware the POC accepted on 12/7/15 was rejected and the facility was required to submit a revised POC which would not include four of four hemodialysis machines and four of four RO machines. The staff present on the meeting to request a new POC were Chief Executive Officer, Chief Nursing Officer, Quality Director, Hemodialysis Supervisor, Hemodialysis Director, Infection Control Nurse, Environmental Services Supervisor and Chief Nephrology. The Immediate Jeopardy was not removed on 12/9/15.

On 12/10/15, the facility submitted a revised POC which included: All defective equipment was removed from service on 12/8/15 and had been retired. All dialysis and RO equipment had been removed from the department and completed on 12/9/15. The dialysis unit was thoroughly cleaned, including floor stripping and rewaxing. The cleanliness of the dialysis unit would be monitored daily. The facility had obtained dialysis equipment for temporary use. The equipment was checked on 12/9/15 by a technician from outside company and deemed in good working condition. Arrangements were made to provide education to all dialysis nurses on the use of the equipment by an outside educator. Components of the service will include pre, intra and post dialysis procedures prior to providing dialysis. As an additional option, the facility would attempt to obtain outside dialysis nurses experienced in using the new equipment to provide dialysis. Licensure, competencies health records of the outside nurses will be verified. The facility had standing contract with chronic dialysis unit and would transfer patients to provide emergent dialysis that could not be met by the facility. Patients who can tolerate the procedure at the chronic dialysis center will be transported by ambulance in the accompaniment of a facility nurse. The nurse will remain with the patient throughout the dialysis and accompany the patient back to the hospital. All other patients will be discharged from the facility and transferred to another acute care facility in conjunction with the patient's physician. The physicians of patients needing dialysis will inform patients of the change in schedule and transportation. The Chief Nephrology will be involved in all discussions outlined in the POC. The facility had obtained three loaner Fresenius machines (same model as previous machines) and three ROs from their sister hospital. The equipment was transported overnight and a Fresenius certified technician will be onsite to prepare the equipment for use according to manufacturer's requirements and facility policy. The equipment user and maintenance manual will be kept onsite. The equipments would have records of preventative maintenance, disinfection log, culture and endotoxin results (test for bacterial growth) and history of problems and/or repairs. Education for the nurses and technicians required for the new RO machines will be provided by an outside technician experienced in the use, maintenance and repair. The policy and procedure for Start-Up Log (monitoring log for RO machine) will be revised for any required changes using the manufacturer's guidelines. Nurses will complete in-service prior to providing dialysis. A Capital Equipment Request to purchase four new dialysis machines and four new RO machines was approved by the Corporate Office and the equipment had been ordered on [DATE]. Prior to utilization of the newly purchased machines, the machines will be brought into service according to manufacturer's recommendations, will develop policies and procedures, educate all dialysis staff by an outside educator, all dialysis nurses will demonstrate competencies prior to using the new machines, biomedical staff who will provide preventative maintenance will receive in-service by an outside educator, course contents and attendance will be maintained and all manuals will be maintained. The POC was accepted and the Immediate Jeopardy was removed on 12/10/15 at 5:57 PM.

Findings:

1. During the 12/7/15 1:30 PM initial tour of the Dialysis unit on the 10th floor, four patients (Patients 1, 2, 3, & 4) were undergoing hemodialysis while lying on their beds, each connected to a dialysis machine and a reverse osmosis machine.

Observations of the area indicated privacy curtains were not drawn for the four patients, sets of towels were placed at the base of each of the four hemodialysis and reverse osmosis machines, as well as water dripping from some of the hose connections in those machines and onto the floor underneath. The four machines showed different significant degrees of rust and corrosion at the base. A wall behind the machines showed two hose outlets dripping water into plastic basins placed on the floor.

A Registered Nurse (Staff 6) overseeing the dialysis of the four patients was asked about the towels and the water dripping on the floor. Staff 6 stated: "It's been an ongoing problem for a long time....we have had this problem for at least three years....we requested to have these machines replaced..."






2. During an observation and interview on 12/7/15 at 1:50 PM, Staff 6 stated the problem was reported last Friday (12/4/15) to Staff 1 who came and looked at the machines (hemodialysis and RO) and said he (Staff 1) will fix the machines on Monday (12/7/15). Staff 6 stated when she came this morning, there were no notes on the four hemodialysis and four RO machines "not to be used", so she and Staff 7 used it for patients' hemodialysis treatment. When asked what was done when the machines started to leak again, Staff 6 stated, she called Staff 1 who said the machines were okay to use. Staff 6 stated she could not identify if the leaks were coming from the hemodialysis machines, RO machines or connection ports. Staff 6 moved the machine and there was pool of water on the floor behind the machine. There was water on the two plastic basins placed on the connection ports on the wall and approximately 15 large towels were placed to catch the fluids around the machine and on the floor.

During an interview on 12/7/15 at 2:00 PM, Staff 12 stated he was aware of the water leaks on the hemodialysis machines and RO machines and the problem had been an ongoing problem. Staff 12 stated the RO machines were refurbished but had been maintained by an outside company. Staff 12 stated he had a capital equipment request for new RO and hemodialysis machines dated 12/7/15.

During an interview on 12/7/15 at 2:15 PM, Staff 51 stated the company who was maintaining the RO machines came and fixed it on 12/6/15, however, the machines leaked again today.

During an interview on 12/7/15 at 2:50 PM, Staff 2 stated he called the company maintaining the RO machines and the company stated, "If there's a problem like any leaks, don't use the machines."

During an observation and interview on 12/7/15 at 3:35 PM, Staff 6 stated chloramine tests were done from the collection sample port between the two carbon tanks near the nursing station. When asked if there were chlorine/chloramine tests done on the four RO machines, Staff 6 stated, "No." Staff 6 was asked why the decision was made to start hemodialysis treatment even if the machines were leaking, Staff 6 stated, "RO machines and the hemodialysis machines passed tests and I thought the machines were safe to use for patient treatment." When it was pointed out to Staff 6 the magnitude of leaks by the amount of towels around the machines and on the floor (approximately more than 15 large towels), Staff 6 stated, "We didn't have any machines to use." When asked if she knew where the leaks were coming from, Staff 6 stated, "I don't know."

Review of the facility's Reporting Equipment Malfunction policy and procedure, revised 4/21/14, indicated, "Purpose: To set up process to identify and arrange for repair of broken or inoperable equipment... 3. A. When a malfunction is evident, the following steps shall be taken: 1) Double-check procedure techniques to ascertain whether there is a true malfunction or a procedural error. 2) If malfunction continues to occur remove the equipment from service."

Review of the hemodialysis machine Problem Report stated the following:
Hemodialysis Machine Number 1
10/26/15 - leaking water
10/6/15 - request stat (immediately), leaking

Hemodialysis Machine Number 3
2/23/15 - leaking at back, not sure if machine or water

Hemodialysis Machine Number 4
9/16/15 - no water, filter dirty, patient waiting
7/2/15 - flow error
4/18/15 water system won't turn on

Hemodialysis Machine Number 5
11/4/15 - giving flow error
11/2/15 - flow error
10/26/15 - leaking water
8/5/15 - showing no water
3/19/15 - leaking

Review of the Fresenius 2008K Operator's Manual indicated, "Warning! The dialysate path is a closed fluidics system. Discontinue use immediately if a fluid leak is detected. Do not attempt to administer or continue dialysis treatment with a machine which has a fluid leak, this could result in excessive fluid removal from the patient leading to serious injury or death. System leaks may also pose a slip-and-fall hazard. Clean up spills immediately."

Review of Company 1 RO Machine Maintenance Log dated 12/6/15, indicated, Company 1 did maintenance works on four of four RO machines. The Service Report indicated all necessary maintenance was done.

Review of Company 2 RO Machine Service Report dated 12/7/15, indicated, "Emergency services call to address report of multiple leaking machines - RO # 1, only RO found to have visible leaks..."

Review of the facility's RO machine Operation Manual with Revision date 10/22/01, indicated, "Section 2, Operation 2. 1 CAUTION... The following operating or water supply conditions could cause an accident or the RO+ system to fail: ...6. Incoming tap water should be between 41 F and 77 F... It is not recommended to use water temperatures below 41F because it will reduce the membrane performance.... Never use water warmer than 77F... 8. The RO system is equipped with a pretreatment system to remove chlorine. It is important to test chlorine at the Chloramines Test Port before each use of the system. Chlorine will deteriorate the membrane and cause system failure. 9. Incoming tap water pH (test for acidity and alkalinity) should be within EPA (Environmental Protection Agency) National Secondary Drinking Water Regulations of 6.5 - 8.5. If the water changes drastically, the membrane will be harder to clean. Periodically check the pH of Incoming Tap Water to verify that is within the specified range... 15. Always maintain water flow and pressure to avoid damage to the pump. 16. Minimum feed pressure is 20 psi (pounds per square inch). Maximum feed pressure is 90 psi."

During an interview and record review on 12/7/15 at 3:40 PM, the log hanging on the four machines entitled 2008K Dialysis Machine & Reverse Osmosis Machine Maintenance Log, indicated the parameters monitored for the RO were total chlorine, TDS (Total Dissolved Solids combined content of contaminants in the water) and percent rejection rate (below 90% is an indication of poor quality of water). Staff 6 and Staff 7 verified the total chlorine was not monitored on four of four RO machines. Staff 6 stated the total chlorine written on the four RO machine logs were the result of chloramine tests between the two big carbon tanks near the nursing station. Staff 6 verified the TDS was not measure on four RO machines, however, the log indicated, "Passed", because the RO machine had no alarm. Staff 6 verified there was no visible number for percent rejection rate on the RO machines so the licensed nurses documented, "Passed", on the log.

Review of the RO Machine Directions for Completing the Startup Log, indicated, "The log must be completed every time the system is used. RO+ Performance - temperature, product water flow, pump pressure, Incoming Tap Water pressure, hour reading meter, chloramine, Good Quality Light Green.

The Startup log was not implemented by the facility as part of RO monitoring to ensure quality and safe water for patient use.

During an observation and interview on 12/7/15 from 1:50 PM thru 3:45 PM, the facility's hemodialysis unit was observed to have pools of water at the bases of machine, signs of leaks from the RO and hemodialysis machines and connection ports and multiple towels on the machines and on the floor which were all indications of dialysis equipment malfunctions, verified by Staff 6. The bases of the RO and hemodialysis machines had signs of heavy corrosion which were indications of on-going problems with fluid leaks, verified by Staff 6. The facility staff were not able to provide documentation for four of four RO machines performance monitoring according to the manufacturer's directions for use, specifically monitoring of the chloramine level which could cause hemolysis, a serious and fatal hemodialysis complications. Additionally, the facility staff were not able to provide documentation which indicated the four of four hemodialysis machines were used according to the manufacturer's user manual. Staff 6 and Staff 7 did not follow the "Warning!" for leaks when Patients 1, 2, 3 and 4, had hemodialysis treatment on 12/7/15 with the unidentified leaks on the RO and hemodialysis machines, potentially exposing patients to unsafe water and dialysate and excessive fluid removal.

3. During an observation and interview on 12/8/15 at 11:15 AM, the hemodialysis unit had four machines. Machine #5 had a yellow label which indicated not to use the machine. Machines # 1, 3 and 4 had no labels and there were no patients connected on the machines. Staff 1 stated the machines had been checked and ready for use. When asked to provide documentation of maintenance and repair of Machines # 1, 3 and 4, Staff 1 stated he would provide it later. Staff 1 verified Machine # 3 was the machine identified in the POC to have been in good working condition and deemed appropriate for use, however, Machine # 1 and 4 had been repaired for leaks and were also in good working condition. Staff 13 and 14 were requested to turn on Machines # 1, 3 and 4 to check if the machines would show any leaks or malfunction.

During an interview on 12/8/15 at 11:20 PM, Staff 11 stated it was incorrect for licensed nurses to use the machines if there were leaks. Staff 11 stated he made multiple requests to Administration to change the machines because of on-going problems with fluid leaks, however, his request had not been processed. Staff 11 stated Staff 50 was aware of the problems with the dialysis equipment.

During an interview 12/8/15 at 12:00 PM, Staff 1, Staff 11 and Staff 12 stated they will provide RO and hemodialysis machine endotoxin results, culture results, documentation of recent maintenance and repair for Machines # 1, 3 and 4. Staff 11 and 12 were informed by the surveyors to provide the documents as soon as possible for review of implementation of the submitted POC on 12/7/15 for the Immediate Jeopardy. Staff 11 and Staff 12 were informed by the surveyors NOT to start patients' treatment until all documents pertaining to Machines # 1, 3 and 4 had been reviewed and verified with Staff 1 who was in-charge of the repair and maintenance.

During an observation and interview on 12/8/15 at 2:00 PM, Patient 14 was having hemodialysis treatment on Machine # 4. When Staff 11 was asked why Machine # 3 was not used, (which was the machine identified on the POC as in good working condition), Staff 11 stated, "Machine # 3 leaked so they had to dialyze Patient 14 on Machine # 4. Staff 11 was informed by the surveyors Staff 1 had not provided proof of maintenance and repairs of Machine # 1, 3 and 4, therefore the surveyors were not able to verify Machine # 1, 3 and 4 were in good working condition and deemed safe for patient use. Staff 11 stated Patient 14's hemodialysis treatment would be terminated and dialysis staff would not provide treatment until a solution to the problem on leaks have been resolved.

On 12/9/15, the facility was made aware the POC accepted on 12/7/15 was rejected and the facility was required to submit a revised POC which would not include four of four hemodialysis machines and four of four RO machines. The staff present on the meeting to request a new POC were Chief Executive Officer, Chief Nursing Officer, Quality Director, Hemodialysis Supervisor, Hemodialysis Director, Infection Control Nurse, Environmental Services Supervisor. The Immediate Jeopardy was not removed on 12/9/15.

On 12/10/15, the revised POC was accepted. The four hemodialysis machines and four RO machines were removed from service on 12/8/15 and had been retired. The Immediate Jeopardy was removed on 12/10/15 at 5:57 PM.





4. Review of the document titled: Agreement for Clinical Engineering Services (an agreement between the hospital and the outside contracting company) dated 2/21/13, indicated: "... 2. Obligations of (Name of the contractual company). 2.1 Clinical Engineering Services shall include inspection of Covered Equipment, as well as ensuring that Covered Equipment meets applicable quality control standards and calibration requirements. Clinical Engineering Services shall also include the documentation of service work and management of a Covered Equipment. ... 2.1.1 Management of Service Operations: (Name of the contractual company) will provide management and service of imaging ...., and biomedical equipment. 2.1.2. Repair,, Maintenance and Performance Assurance: (Name of the outside company) will be responsible for the repair, inspection, and maintenance on all Covered Equipment. ... ."

During the 12/7/15 1:30 PM initial tour of the Dialysis unit on the 10th floor, four patients (Patients 1, 2, 3, & 4) were undergoing hemodialysis while lying on their beds, each connected to a dialysis machine and a reverse osmosis machine.

Observations of the area indicated privacy curtains were not drawn for the four patients, sets of towels were placed at the base of each of the four hemodialysis and reverse osmosis machines, as well as water dripping from some of the hose connections in those machines and on the floor underneath. The four machines showed different significant degrees of rust and corrosion at the base. A wall behind the machines showed two hose outlets dripping water into plastic basins placed on the floor.

A Registered Nurse (Staff 6) overseeing the dialysis of the four patients was asked about the towels and the water dripping on the floor. Staff 6 stated: "It's been an ongoing problem for a long time....we have had this problem for at least three years....we requested to have these machines replaced..."

In an interview on 12/7/15 at 2:00 PM, Staff 2 stated he was a hired contractual personnel who manages day to day operation of hospital equipment including the hemodialysis machine.

Review of the document titled: Success Profile Clinical Engineering Manager 1 Job Summary, (outside company's job description for the Clinical Engineering Manager 1 position ), updated 12/29/14, indicated the job description for the MBM position that included: "hands on service component in general biomedical support". The section on: "Education and Work Experience" indicated: "... Technical certification such as: A+ (means Information Technology), CBET (Certified Biomedical Technologist), CRES (Certified Radiology Equipment Services), CLES (Certified Laboratory Equipment Specialist), CCE (Certified Clinical Engineer), preferred. Minimum of 3 (three) years experience managing in a clinical engineering environment."

In an interview on 12/11/15 at 1:55 PM, Staff 2 stated he did not have any of the certifications as stated above, but, was "working" on getting "CCE".

In another interview on 12/11/15 @ 2:40 PM, Staff 2 explained his years of work experience as a Clinical Engineer were when he was a student getting his Masters Degree in Clinical Engineering.

In a document review titled: "Employment Verification" (VE) done by an outside consulting firm for the contracting company, dated 10/20/14, indicated that Staff 2 worked in a hospital in Boston, Massachusetts from 1/14 to 5/14 as an "intern". Further review of the document VE indicated: "(Name of a company in Toronto, Canada and Name of the Human Resource Counselor), verified applicant's dates of employment as September 2012 to September 2014' which do not match dates listed on application of September 2012 to January 2014. Applicant was a Clinical Engineering Masters student." Continued review of the VE document indicated: "Canadian Forces Army, Toronto, Ontario, Canada, (Name of the Human Resource Staff), verified applicant's dates of employment as May, 2008 to February, 2014 which do not match date listed on the application of May, 1, 2007 to December 1, 2013. Applicant was employed as Medic."

In a concurrent review of the Employment Verification (VE) document and interview on 12/11/15 at 2:25 p.m. the hospital Human Resource Coordinator (HRC), HRC read the VE document. When asked if Staff 2 met the required "minimum 3 years" work experience, HRC stated, "No, He was an "intern" (a student or trainee)" in a hospital. When asked if the BMM was qualified, HRC stated, "I don't know. I was not involved in hiring contractual. I don't have an answer. I am not a recruiter." HRC stated the VP (Vice President) for Human Resource was not available for comment at that time.
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation, interview, and record review, the hospital failed to implement it's Infection Control Program when it did not:

1. Implement Infection Control measures intended to mitigate cross-contamination (transfer of disease-causing microorganism from one patient to another) between patients when two (Patients 3 & 4) of the thirty three sampled patients were not placed on Contact Precautions (gowns and gloves when in contact with any surfaces that may have been contaminated by the patient and their wound drainage) isolation despite their having infected draining wounds (Refer to A-0749).

2. Ensure Cardiac Catheterization (area where invasive procedures were done to check how well the heart was working) staff practiced infection control measures in separation of dirty and clean supplies, traffic patterns and cleanliness in the area, and aseptic technique to prevent cross-contamination. (Refer to A-0749).

3. Ensure hemodialysis (a therapy that uses hemodialysis machine and a dialyzer [an artificial kidney] to remove extra fluids and waste products from the blood which the kidneys could not excrete) unit staff implement infection control policies and procedures to prevent cross-contamination. (Refer to A-0749).

4. Ensure Operating Room staff used appropriate personal protective equipment (PPE - protective clothing like gowns, gloves, mask etc.), practiced hand hygiene, and maintained environmental cleanliness in the operating room area to prevent cross-contamination. (Refer to A-0749).

5. Ensure safe food handling in a sanitary environment (Refer to A-0620);

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observations, staff interviews, and document reviews the infection control officer failed to develop effective systems for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel in accordance with facility policy and nationally recognized infection control guidelines as evidenced by the failure to ensure:

1. Infection Control measures intended to mitigate cross-contamination between patients when two (Patients 3 & 4) of the 34 sampled patients were not placed on Contact Precautions (staff to wear gowns and gloves when in contact with any surfaces that may have been contaminated by the patient and their wound drainage) isolation despite having infected draining wounds.

This had the potential for cross-contamination (transfer of disease-causing microorganism from one patient to another) of patients on the Oncology Service (10th Floor), the Medical/Surgical Service (9th Floor), the Hemodialysis Service, Radiology, and CT (Computer assisted Tomography) Scanning when these two patients traveled to these areas.

2. Cardiac Catheterization staff practiced infection control measures in separation of dirty and clean supplies, traffic patterns and cleanliness in the area, and aseptic (sterile) technique to prevent cross-contamination.

3. Ensure hemodialysis (a therapy that uses hemodialysis machine and a dialyzer [an artificial kidney] to remove extra fluids and waste products from the blood which the kidneys could not excrete) unit staff implement infection control policies and procedures to prevent cross-contamination.

4. Perioperative staff wore appropriate personal protective equipment (PPE), practiced hand hygiene, maintained environmental cleanliness in the operating room area and sterile reprocessing area (area where instruments were cleaned, decontaminated and sterilized) to prevent cross-contamination, and ensure staff in the sterile reprocessing area was aware of Creutzfeldt-Jakob Disease (CJD) to prevent transmission of prion (infectious agent) to personnel, other patients or the community.

5. Ensure safe food handling in a sanitary environment.

Findings:

1. Patient 3 was admitted to the hospital 11/12/15 for diagnoses which included a mediastinal (middle area of the chest which contains the heart and its blood vessels, the esophagus, the trachea, and other smaller organs) infection following cardiopulmonary (heart and lung) surgery, lung cancer, diabetes, and renal disease. Patient 3 was receiving acute dialysis treatments three times per week. He was also being followed by a wound specialist for an open, draining chest wound. During the course of his hospitalization , Patient 3 developed pressure ulcers of his sacrococcygeal area (tailbone) and both buttocks.

Record review of Patient 3's chart indicated pictures of the chest wound taken on 11/20/15 and 11/27/15. There were additional pictures labeled as the chest wound and dated 11/22/15 and 12/11/15 but these photographs were clearly from Patient 3's sacral and buttock areas.

During an observation on 12/7/15 at 1:30 PM, Patient 3 was lying in bed in the Hemodialysis Unit and was attached to a hemodialysis machine. Patient 3 was wearing a surgical mask and he appeared to be sleeping.
The privacy curtain was not drawn and there was no indication that Patient 3 was on isolation other than his mask.

The Registered Nurse (Staff 6) stated Patient 3 was on "reverse isolation" because his white blood count was low.

Record review of Patient 3's chart indicated a Consultation Report, dated 11/23/15, by a specialist in infectious disease. The consultant identified the sternal wound infection organism as Pseudomonas aeruginosa. He changed the antibiotic treatments Patient 3 was receiving and recommended changing the existing central line catheter and sending a culture of the line tip.

The Nephrologist's Progress Notes, dated 12/9/15 at 10:12 AM, indicated that Patient 3 had a "staph bacteremia" (blood infection with the organism Staphylococcus aureus).

During an interview on 12/8/15 at approximately 1:40 PM, the Registered Nurse (Staff 30) reviewed Patient 3's chart and acknowledged that he had a draining chest wound and stated that Patient 3 was not on "Contact Precaution" isolation (use of gowns and gloves when coming in contact with any surfaces which might have been in contact with the wound and/or the drainage from the chest wound). Staff 30 also stated that there was no Care Plan for Contact Precautions.

During an interview on 12/9/15 at 11:25 PM, the hospital's Infection Control Coordinator (Staff 10) stated that the nursing staff had never asked her to consult on Patient 3.

During an interview on 12/9/15 at 1:40 PM, Staff 10 stated she had reviewed Patient 3's chart and she thought Patient 3 should be on Contact Precaution isolation. Staff 10 said the nursing staff should have contacted her about Patient 3 when he was first admitted to the hospital. Staff 10 said that there was an easy to use drop-down screen in the computer system to request and Infection Control Consultation.

Patient 4 was admitted on [DATE] with diagnoses which included cellulitis (bacterial infection of the skin and the underlying fat layer) of the right knee, an enterocutaneous abdominal fistula (abnormal communication between the small or large bowel and the skin of the abdomen), and end stage renal disease. Patient 4 had acute hemodialysis three times per week. With a written physician's order, Patient 4 did her own dressing changes of her enterocutaneous fistula.

During an observation on 12/7/15 at 1:30 PM, Patient 4 was lying in bed in the Hemodialysis Unit and was attached to a hemodialysis machine. Patient 4 was wearing a surgical mask and she appeared to be sleeping. The privacy curtain was not drawn and there was no indication that Patient 4 was on isolation other than her mask.

The Registered Nurse (Staff 6) stated Patient 4 was not on isolation but rather she preferred to leave the mask partially on (only covering her mouth) during her hemodialysis treatment.

During an interview on 12/9/15 at approximately 11:00 AM, the Registered Nurse (Staff 31) stated that Patient 4 did her own dressing changes of her fistula. Staff 31 said that, except for the picture taken on admission, none of the staff was allowed to see her fistula and none of the staff were permitted to assist with the dressing changes. Staff 31 said Patient 4 was on bedrest and she did not recall seeing a bottle of hand sanitizer on Patient 4's overbed table.

Staff 31 acknowledged that Patient 4's abdominal wound was draining material from her bowel and, since the staff did not observe the actual dressing changes, nursing personnel could not determine what she might have contaminated.

Staff 31 reviewed Patient 4's medical record and confirmed that there was no Plan of Care for Contact Precaution isolation.

During an interview on 12/9/15 at 11:25 PM, the hospital's Infection Control Coordinator (Staff 10) stated that the nursing staff had never asked her to consult on Patient 4.

During an interview on 12/9/15 at 1:40 PM, Staff 10 stated she had reviewed Patient 4's chart and she thought Patient 4 should be on Contact Precaution isolation. Staff 10 said the nursing staff should have contacted her about Patient 4 when he was first admitted to the hospital.







2 a. During an environmental tour on 12/7/15 at 11:02 AM, the following were observed in the Cardiac Catheterization area (area where invasive procedures were done to check how well the heart was working):

1) a big plastic bag with trash was stored under the sink in the clean supply room

2) a used coffee mug was on the work area inside Room 1

3) there were white marks on the biohazard bins and a magazine inside the biohazard bin in Room 1.

4) medication cups on Room 1 was on top of the cabinet opened to all elements like dust

5) dirty supply room had big bags of sterile supplies which were for "medical mission donation" according to staff

6) Room 2 had an uncovered oxygen tubing with no label and ready for use

7) Room 2's table base was rusted and had dust, black matter and pieces of cloth fiber and paper

8) Room 2's equipment light handle (frequently touched surface)was covered with tape which would make it difficult to clean the surface and for disinfectant to have sufficient contact time to kill bacteria and viruses

9) Room 2's patient armrest had multiple tape residue on the surface which would make it difficult to clean the surface and for disinfectant to have sufficient contact time to kill bacteria and viruses

10) nursing stations on Room 1, 2 and 3 had opened supplies like blue towels, fluid lines (intravenous tubing), syringes, gauze, gloves, shoe covers, surgical scissors and clamps which were available for staff use.

During an interview on 12/7/15 at 11:20 AM, Staff 5 verified the observed infection control practices had the potential for cross-contamination and would be addressed with the Supervisor.

During an interview on 12/7/15 at 11:45 AM, EVS(environmental services) Supervisor verified catheterization lab Room 1, 2 and 3 table bases, biohazard bins, surfaces with tapes needed repeat cleaning and disinfection.

2 b. During an observation on 12/7/15 and 12/9/15 at 9:00 AM, facility staff and visitors were allowed to go inside and out cath lab Room 1, 2 and 3 without changing to surgical attire. There was no visible sign for semi-restricted and restricted areas.

During an interview on 12/7/15 at 11:30 AM, Staff 5 stated there was no restricted areas in the cath lab if there was no patient. Staff 5 stated the movement of staff and visitors were restricted only if a procedure was on-going.

Review of the facility's policy and procedure entitled Traffic Patterns in Surgical Services, dated 8/11, indicated, "Restricted: Includes Operating and Procedure rooms and clean core areas. Traffic in this area is required to wear full surgical attire and cover all head and facial hair, including sideburns. When in this area, non-scrubbed personnel attire to include long-sleeved jackets (should be worn, buttoned or snapped during the use in restricted areas). Masks are required where sterile supplies or scrubbed-in personnel are located. Persons from other departments entering the semi-restricted areas or restricted areas for a brief time for a specific ancillary purpose may either change and wear surgical attire or don a single-use disposable coverall jump suit (jumpsuit) designed to totally cover outside apparel. All head and facial hair shall be covered by a surgical cap and/or hood."

2 c. During an observation on 12/9/15 at 2:30 PM, Staff 5 was observed opening a long packaged sterile supply during an invasive procedure in the cath lab. Staff 5 added it to the sterile field by holding the supply under his elbow and peeled off the packaging and laid it on top of the sterile supply horizontally to the sterile field.

Review of the facility's policy and procedure entitled Aseptic Principles in Cath Lab Procedures, revised 2/11, indicated, "4. Circulators must avoid reaching over sterile field." This was part of staff training.

3. During an observation on 12/7/15 at 1:30 PM thru 3:45 PM, the following infection control practices were observed in the hemodialysis unit which could create cross-contamination:

a) hemodialysis staff was observed eating a banana in the nursing station

b) bag of saline, bloodlines and dialyzer were on top of each hemodialysis machine and ready for use for the next patient, while the current patients were having hemodialysis treatment

c) oxygen masks, oxygen tubings, Yankaeur suction tip were behind each hemodialysis machine and had the potential to be contaminated by blood and body fluids from splashes

d) the bases of four hemodialysis machines and RO (reverse osmosis) machines were heavily corroded and paints were chipped off. These areas could not be cleaned appropriately and chipped paint and corrosion could harbor bacteria and viruses and spread to hemodialysis patients

e) hemodialysis unit floor had black matter stain and orange stain from corrosion

f) hemodialysis unit floor was wet with fluids and bases of dialysis equipment (4 machines) were covered in multiple towels to dry the fluids. The wet towels could be a medium for bacterial growth and other blood-borne pathogens from the leaking fluids

g) Staff 6 was observed taking off a patient from the hemodialysis machine without a gown and faceshield. This put staff at risk of exposure to blood and body fluids

h) alcohol dispenser near the nursing station was dusty and had brown stain

i) nursing station had used paper towel on the floor and the counter was dusty

During an interview on 12/7/15 at 2:00 PM, the Infection Control Nurse verified the towels, corrosion and chipped paint on the machines could be medium for bacterial growth. Infection Control Nurse stated the state of the hemodialysis unit was not acceptable with regards to infection control.

During an interview on 12/7/15 at 2:02 PM, the EVS Supervisor verified the hemodialysis unit floor was dirty and in need of cleaning, and would be done immediately.

Review of the facility's policy and procedure entitled Infection Control - Renal Dialysis Service, revised 7/14, indicated, "1. Associates shall follow Standard Precautions and Transmission Based Precautions as outlined in the hospital Control Manual and shall integrate these precautionary measures when providing patient care to prevent acquisition and transmission of potentially infectious organisms... 3. Personal protective equipment shall be worn to prevent potential skin and mucous membrane exposure when contact with blood, tissue and body fluid is anticipated or the likelihood of splash exist.... 13. Eating, drinking or smoking are not allowed in the dialysis unit."






4. a. During an observation of patient surgery on 12/10/15 at 10:30 AM, Staff 53, 54, 55, 56, 57 were all wearing short sleeve scrubs. Staff 52 was wearing a jacket with sleeves rolled up to his elbow showing hair on his arms throughout the surgical procedure . Staff 54 remained without long sleeve jacket throughout the surgical procedure while he moved around to give supplies to Staff 55.

Review of the facility's policy and procedure entitled Dress Code - Surgery dated 8/11, indicated, "Restricted: ... When in this area, non-scrubbed personnel; attire include long-sleeved jackets (should be worn buttoned, or snapped during use in restricted areas)."

4. b. During an observation of patient surgery on 12/10/15 at 10:30 AM, Staff 52, 53, 54, 56, 57 were wearing caps with hair visible on the sideburns and neck. Staff 55 was wearing a personal cap with garment still visible throughout the surgical procedure.

Review of the facility's policy and procedure entitled Dress Code - Surgery dated 8/11, indicated, "2. All head and facial hair, including sideburns and neckline hair, must be covered by a cap or hood while in the restricted area of the surgical suite."

4.c. During an interview on 12/10/15 at 11:05 AM, Staff 54 stated wedding bands may be worn when in the surgery suite as long as the surfaces were smooth.

Review of the facility's policy and procedure entitled Dress Code - Surgery dated 8/11, indicated, "5. Jewelry must be kept to a minimum in the surgery suite. A. Wedding bands may be worn; i.e. smooth surfaced, NO gemstones or irregular surfaces rings are allowed if not scrubbing."

Review of the AORN 2014 Perioperative (care that is given before, during and after surgery) Standards and Recommended Practices, Guidelines for Surgical Attire stated that all personnel entering the semirestricted and restricted areas of the surgical suite should confine or remove all jewelry and watches. Rings should be removed from hands. These items may harbor organisms that cannot be removed during handwashing. Higher bacterial count have been noted when jewelry is worn.

4.d. During an observation on 12/10/15 at 11:45 AM, the kick bucket (medical receptacle mounted on wheels) had multiple gauze with small blood stain. Staff 55 stooped down and counted the gauze with bare hands. Staff 55 did not disinfect hands after touching the blood-stained gauze, then touched the light panel on the wall, and adjusted the surgical light on the surgical table.

Review of the facility's policy and procedure entitled Dress Code - Surgery dated 8/11, indicated, "7. Protective personal equipment will be made available to reduce the risk of exposure to potentially infectious materials."

Review of the facility's policy and procedure entitled Infection Control - Surgical Services, revised 7/14, indicated, "Associate Protection 5. Hands shall be washed as soon as possible following unanticipated contact with blood or body fluids and after removing gloves.

The World Health Organization Guidelines for Hand Hygiene in Health Care: A Summary (2009) states to perform hand hygiene: a) before and after touching the patient B) before handling an invasive device for patient care, regardless of whether or not gloves are used ac) after contact with body fluids or excretions, mucous membranes, non-intact skin, or wound dressings d) if moving from a contaminated body site to another body site during care of the same patient e) after contact with inanimate surfaces and objects (including medical equipment) in the immediate vicinity of the patient f) after removing sterile or non-sterile gloves .

4.e. During an observation and interview on 12/10/15 at 12:00 PM, the surgical procedure was done and Staff 52 and Staff 57 took off their surgical attire and put them on the hamper located near the clean supplies. The used surgical attires touched the clean supplies on the shelves. Staff 58 stated the hamper will be relocated to prevent cross-contamination.

During an interview on 12/10/15 at 12:15 PM, Staff 58 stated it was a work in progress to have Operating Room staff follow infection control policies and procedures. Staff 58 verified the practices of staff during the surgical procedure with PPE, hand hygiene and separation of dirty and clean could create cross-contamination, and it would be addressed.

4.f. During an observation of Operating Room and interview on 12/10/15 at 12:20 PM, Room 3 and Room 5 Environmental Services (EVS) closet's floor mop sink had black matter all over it and the walls looked tattered and had blackish tint. Staff 59 stated the rooms were cleaned after every shift. Staff 58 stated she would follow-up with the EVS Supervisor about the two rooms.

4.g. During an observation on 12/10/15 at 12:25 PM, the OR Biohazard Room (medical waste storage) had a EVS cart with a mop head immersed in water. Staff 59 stated the EVS cart belonged to PM shift.

Review of the facility's policy and procedure entitled Infection Control - Surgical Services, revised 7/14, indicated, "Environmental Protection - 11. Mops and reusable cloths used for environmental cleaning shall be discarded or placed into laundry bags following the cleaning of each room."

4.h. During an observation and interview on 12/11/15 at 2:05 PM, Staff 60 verified the decontamination room (area for cleansing, rinsing and/or removing contaminated materials) had black matter on the wall, black matter on the bottom of eyewash station and shower and the floor was dirty. Staff 60 stated the building was old but the room would be cleaned by EVS staff.

4.i. During an interview and record review on 12/11/15 at 2:15 PM, Staff 60 was asked what sterilization procedures were done after surgery of a patient who had a Creutzfeldt-Jakob Disease (CJD), Staff 60 stated he was not aware of the disease CJD.

Review of the facility's policy and procedure entitled Infection control for Patients with Prion Diseases Creutzfeldt-Jakob Disease, revised 7/14, stated, "Objectives: 1. To prevent transmission of prions to personnel, other patients or the community. 2. To confine, contain, and safely handle the contaminated materials generated during the course of the hospitalization . 3. To define contaminated materials and tissues and describe the appropriate disposal.... Creutzfeldt-Jakob Disease (CJD) is a rare, fatal neurodegenerative (incurable and debilitating conditions that result in progressive degeneration and/or death of nerve cells) disorder characterized by a rapid, progressive dementia, sensory disturbances and myclonus (muscle twitching). CJD is one of a group of neuro-degenerative diseases termed transmissible spongiform encephalophaties (are a group of rare degenerative brain disorders characterized by tiny holes that give the brain a "spongy" appearance. These holes can be seen when brain tissue is viewed under a microscope). A unique biologic agent termed prion, which stands for proteinaceous infectious particle, causes these diseases. Prions do not contain DNA (deoxyribonucleic acid - a molecule that carries most of the genetic instructions used in the development, functioning and reproduction of all known living organisms) or RNA (Ribonucleic acid - a polymeric molecule implicated in various biological roles in coding, decoding, regulation, and expression of genes) are not considered alive and are not inactivated by standard disinfective agents and procedures... 4. Surgical Procedures - Before admission to Seton Medical Center, the infection control team should be informed of the intention to perform surgical procedure on any person...Directions for Handling Surgical Equipment (Sterilization)- A. The safest and most unambiguous (clear) method for ensuring that there is no risk of residual infectivity on contaminated instruments and other materials is to discard and destroy them by incineration (waste destruction using high temperature). B. Any and all instruments used for the invasive or surgical procedures in patients with confirmed or suspected prion disease will be handled as follows: high infectivity - destroy by incineration... medium or low infectivity - destroy by incineration if status of patient is definite; and clean quarantine (isolation) pending final diagnosis...F. Cleaning Process (Sterilization): ... The instruments are to be stored in a leak proof puncture proof resistant, sealed container and labeled "Biohazardous - Possible CJD" until the diagnosis is confirmed. G. Flash sterilization (method of sterilizing an instrument designed for use in the OR for emergent and immediate use of a forgotten or unanticipated instrument or one that was accidentally dropped on the floor) of contaminated instruments during the case is prohibited. H. Frozen Sections (rapid microscopic analysis of a specimen) will not be performed."







5.a. During a 12/9/15 10:50 AM tour of the kitchen escorted by the Food and Nutrition Services Director (Staff 38), a dietary staff was slicing raw meat on a counter shared by another dietary staff preparing salads. Between the two staff working areas three plastic bags of sliced bread were on the counter. A computer tablet with earbuds and two more sliced bread bags were noted on a shelf that run across the counter area.
When asked about the proximity between meat slicing and the ready to eat salad preparation, as well as the personal items on the shelf, Staff 38 stated: "Well they are careful...but I understand, they should not be in the proximity...yes, cross contamination risk...", and added about the personal items: "...he is not using them while working...but it should not be in the food area...".
Record review of a 3/14 dated hospital policy titled "Food Safety Standards" states under "Policy: To ensure that the food safety standards used in the food and nutrition services department meets or exceeds those established by the Food Code, U.S. Public Health Service FDA (Food and Drug Administration)1997..."
The FDA Food Code 2013 (The U. S. Food and Drug Administration(FDA), publishes the Food Code providing scientifically sound technical and legal basis for regulating the retail and food service segment of the industry like restaurants, grocery stores and health institutions); states under: "Preventing Food and Ingredient Contamination 3-302.11 : Food shall be protected from cross contamination by: ... separating raw animal foods during storage, preparation, holding, and display from: (a) Raw ready-to-eat food, including other raw animal food such as fish for sushi or mollusk shellfish, or other raw ready-to-eat food such as fruits and vegetables,..."

5.b. During the same 12/9/15 10:50 AM tour of the kitchen escorted by the Food and Nutrition Services Director, Staff 38, a wall fan in front of the food production area and another fan in the dishwashing area, were observed with blades and grill covered by a dark colored dust like material. Staff 38 stated: " We clean them often...but I see they need to be cleaned...".
A space of about three inches wide next to the deep frying unit and a small metal counter had thick dried layers of grease splashes along the sides and the floor was covered with old food and grease particles up to two inches high. When asked about the finding, a cook, Staff 39 stated: "yes it is pretty dirty there...I wish they could put something to cover this gap...". Staff 38 added: "We have Environmental Services cleaning these area about once a year...but we'll take care of this...it has to be cleaned...".
Record review of a 3/14 dated hospital provided copy of a policy titled "Food Safety Standards" states under "Service Standards: 4. Fans will be cleaned on a monthly basis to ensure that they are free of dust particles."
5.c. During a 12/9/15 10:50 AM tour of the kitchen escorted by the Food and Nutrition Services Director, Staff 38, the dishwashing counter area had sections of the back splash metal surface with black colored caulking at the wall joint behind. When asked about the observation, Staff 38 stated: " Yes, caulking is not black...we'll report to the engineers...".
A ceiling three tubes light fixture above the dishwasher was observed uncovered, with no light bulbs and with brown rust like stains in the metal frame. Asked about the observation Staff 38 stated: "I can see it is rusty...it's been out for a while...I need to call the engineers for this...".