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.

ST BERNARDINE MEDICAL CENTER 2101 N WATERMAN AVE SAN BERNARDINO, CA 92404 March 24, 2015
VIOLATION: NURSING SERVICES Tag No: A0385
The facility failed to ensure all nursing services were supervised to meet the needs of the patients when:


1. Oversight and supervision were not provided when the dialysis (a procedure that removes waste form the blood through a machine from a patient's body when their kidneys have stopped working) nurses preformed dialysis treatments on dialysis patients. The Dialysis nurses were mixing and administering dialysis solution to patients without obtaining individualized patient treatment orders or protocols to ensure patient safety. This failure had the potential to contribute to electrolyte imbalances (essential minerals in your body that are necessary for nerve and muscle function, body-fluid balance, and other critical processes) or metabolic imbalances (disorders that can contribute to blood pressure problems, diabetes and other disorders) which could contribute to death. (Refer to A0397)


2. Patients receiving dialysis had no individualized patient treatment orders that reflected sodium bicarbonate concentration (solution used to balance acidity in dialysis patient), which had the potential to significantly affect dialysis adequacy (the adequate waste removal from the blood) being delivered to those patients. (Refer to A0405)


3. Failing to ensure that a Policy and Procedure was in place for the Dialysis unit to guide dialysis nurses with the use of mixing the Bicarbonate and Acid Concentrates. (Refer to A 0405)



The cumulative effect of these systemic practices resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation: Nursing Services.
VIOLATION: PATIENT CARE ASSIGMENTS Tag No: A0397
Based on observation and interview, the facility failed to ensure dialysis nurses had oversight and supervision when they performed dialysis treatments (a procedure that removes waste from the blood through a machine connected to patients' when their kidneys stop working) on dialysis patients. Dialysis nurses were administering dialysis solution to patients without obtaining individualized patient treatment orders or protocols to ensure patient safety. This failure had the potential to contribute to electrolyte (essential minerals in your body that are necessary for nerve and muscle function, body-fluid balance, and other critical processes) or metabolic disorders (disorders that can contribute to blood pressure problems, diabetes and other disorders), which could contribute to death.



Findings:


During initial tour of the Dialysis Unit on March 19, 2015 at 7:30 AM, dialysis machine number 10 was prepared and primed (preparation needed for the tubing to be ready to use during dialysis), for patient use. The following electrolyte doses were observed to be set in the machine, K (Potassium - necessary for range of essential body functions such as blood pressure, muscle contractions...) = 3.0 mEq (milliequivalent - a unit of measurement)/ml (milliliters - a unit of measurement of liquid), Ca (Calcium - a mineral essential for bone, heart function and muscle contractures) = 2.5 mEq/ml, flow 500, temperature = 37.0 degrees centigrade (a unit to measure temperature) and conductivity (the degree to which a specified material conducts electricity) = 13.7.


During a concurrent interview with Dialysis Nurse 1 (DN 1), DN 1 was asked how she determined the values on the dialysis machine, DN 1 stated, "The physician only writes, either 1K, or 2K bath, then we follow what is written on the label of the container. All our machines are programmed at 35 mEq of sodium bicarbonate (mixture of solution to balance acidity in the blood) which is standard on all physician orders." DN 1 indicated that the bicarbonate solution was standard for all dialysis patients.


During an observation on March 19, 2015 at 8:30 AM, Patient 30 was taken to the Dialysis Unit. At 8:35 AM Patient 30 was connected to dialysis machine #10 through the patient's Quinton catheter (a temporary access vein for dialysis procedure). The following patient treatment settings were observed on the dialysis machine, K = 3.0 mEq (milliequivalent/milliliters), Ca = 2.5 mEq/ml, flow 500, temperature = 37.0 and conductivity = 13.7, rate - 750 ml/hr (milliliter per hour), volume = 3,000 ml (milliliter).


During an interview with the Dialysis Nurse Manager (DNM) on March 19, 2015 at 9:50 AM, the DNM was asked if they obtained the bicarbonate solution order from the physician. The DNM stated, "The Dialysis Nurses follow the manufacturer's guideline, (referring to the label of the container) in mixing the bicarbonate concentrate. The physician orders, either indicates 0K, 1K, 2K or 3K bath. There is no written protocol on how much chloride or calcium is in every bath. The dialysis nurses just know it by looking at the label of the container." DN 1 and DNM were unable to provide specific physician orders or approved protocols to guide them in preparing the dialysis solution.


During an interview with the Dialysis Medical Director (DMD - specialist in kidney diseases), on March 19, 2015 at 10:35 AM, he was asked if the nurses used a protocol or physician's orders when they prepared the dialysis solutions. DMD stated, "What the nurses do here should be the routine. I don't think there is a protocol in writing. Probably the DNM can make something in writing."


During an interview with the DNM, on March 20, 2015, at 9:50 AM, DNM stated, "The Dialysis Unit should have a policy and procedure in place for mixing the acid and bicarbonate concentrate."



The Dialysis Nurses were mixing bicarbonate and acid concentrate without any individualized specific physician treatment orders for each patient. In addition, the Dialysis nurses were following a protocol for standard solution for bicarbonate and acid concentrate, that was not approved by the hospital's Governing Body.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on observation, interview and record review, the facility, failed to ensure patients receiving dialysis (a procedure that removes waste from the blood through a machine from a patient's body when their kidneys have stopped working), had individualized patient treatment orders to reflect sodium bicarbonate concentration (a solution used to balance acidity in dialysis patient), for 8 out of thirty nine patients (Patient 26, 27, 30, 31, 32, 33, 34, and 39). This failure had the potential to increase the risk of electrolyte imbalances (essential minerals in your body that are necessary for nerve and muscle function, body-fluid balance, and other critical processes) or metabolic disorders (disorders that can contribute to blood pressure problems, diabetes and other disorders), which could contribute to death.


Findings:

During initial tour of the Dialysis Unit on March 19, 2015 at 7:30 AM, dialysis machine number 10 was prepared and primed (preparation needed for the tubing to be ready to use during dialysis) for patient use. The following electrolyte doses were observed to be set in the machine, K (Potassium - necessary for a range of essential body functions such as blood pressure, muscle contraction...) = 3.0 mEq (milliequivalent - a unit of measurement)/ml (milliliters - a unit of measurement of liquid), Ca (Calcium - a mineral essential for bone, heart function and muscle contractions) = 2.5 mEq/ml, flow 500, temperature = 37.0 degrees centigrade ( a unit to measure temperature) and conductivity (the degree to which a specified material conducts electricity) = 13.7.

During a concurrent interview with Dialysis Nurse 1 (DN 1), DN 1 was asked how she determines the values on the dialysis machine, DN 1 stated, "The physician only writes, either 1K, or 2K bath, then we follow what is written on the label of the container. All our machines are programmed at 35 mEq of sodium bicarbonate (mixture of solution to balance acidity in the blood) which is standard on all physician orders."

During an observation on March 19, 2015 at 8:30 AM, Patient 30 was taken to the Dialysis Unit. At 8:35 AM Patient 30 was connected to dialysis machine #10 through the patient's Quinton catheter (a temporary access vein for dialysis procedure). The following patient treatment settings were observed on the dialysis machine, K = 3.0 mEq (milliequivalent/milliliters), Ca = 2.5 mEq/ml, flow 500, temperature = 37.0 and conductivity = 13.7, rate - 750 ml/hr (milliliter per hour), volume - 3,000 ml (milliliter).

During an interview with the Dialysis Nurse Manager (DNM) on March 19, 2015 at 9:50 AM, the DNM was asked if they obtained the bicarbonate solution order from the physician. The DNM stated, "The Dialysis Nurses follow the manufacturer's guideline, (referring to the label of the container) in mixing the bicarbonate concentrate. The physician orders, either indicates 0K, 1K, 2K or 3K bath. There was no written protocol on how much chloride or calcium is in every bath. The dialysis nurses just know it by looking at the label of the container." DN 1 and DNM were unable to provide specific physician orders or approved protocol to guide them in preparing the dialysis solution.

During an interview with the Dialysis Medical Director (DMD - specialist in kidney diseases), on March 19, 2015 at 10:35 AM, he was asked if the nurses used a protocols or physician's orders when they prepared the dialysis solutions. DMD stated, "What the nurses do here should be the routine. I don't think there is a protocol in writing. Probably the DNM can make something in writing."

During an interview with the DNM, on March 20, 2015, at 9:50 AM, DNM stated, "The Dialysis Unit should have a policy and procedure in place for mixing the acid and bicarbonate concentrate."

During a review of the clinical record and physician orders of the patients receiving dialysis, it indicated:

1. Patient 30 was admitted to the hospital on March 6, 2015, at 11:40 PM. Admitting diagnoses included LLE (left lower extremities) cellulitis (swelling of the left lower leg), abscess (pus). The flow rate of 500 ml/hour was not included on the physician's treatment order. However, the nurses were administering a dialysis flow rate of 500 ml/hr without an individualized patient treatment order.

2. Patient 27 was admitted to the hospital on February 24, 2015 at 1:00 PM, with admitting diagnoses included aortic valve disorder (a heart problem). The flow rate of 500 ml/hour was not included on the physician's treatment order. However, the nurses were administering a dialysis flow rate of 500 ml/hr without an individualized patient treatment order.

3. Patient 26 was admitted to the hospital on March 13. 2015 at 8:27 PM. Admitting diagnosis included ESRD (end stage renal disease - the kidney is not functioning as it should). The flow rate of 500 ml/hour was not included on the physician's treatment order. However, the nurses were administering a dialysis flow rate of 500 ml/hr without an individualized patient treatment order.

4. Patient 31, was admitted to the hospital on March 18, 2015 at 8:35 PM. Admitting diagnoses included Renal Failure (kidney is not functioning as it should). The flow rate of 500 ml/hour was not included on the physician's treatment order. However, the nurses were administering a dialysis flow rate of 500 ml/hr without an individualized patient treatment order.

5. Patient 32, was admitted to the hospital on March 4, 2015 at 6:03 PM. Admitting diagnoses included cardiac arrest (heart stops beating). The flow rate of 500 ml/hour was not included on the physician's treatment order. However, the nurses were administering a dialysis flow rate of 500 ml/hr without an individualized patient treatment order.

6. Patient 33, was admitted to the hospital, on January 24, 2015 at 7:03 PM, with altered level of consciousness. The flow rate of 500 ml/hour was not included on the physician's treatment order. However, the nurses were administering a dialysis flow rate of 500 ml/hr without an individualized patient treatment order.

7. Patient 34, was admitted to the hospital, on March 18, 2015 at 3:16 PM. Admitting diagnoses included Renal Failure and CHF (congestive heart failure - when the heart is unable to do its work to pump out blood). The flow rate of 500 ml/hour was not included on the physician's treatment order. However, the nurses were administering a dialysis flow rate of 500 ml/hr without an individualized patient treatment order.

8. Patient 39, was admitted to the hospital on March 17, 2015 at 9:27 AM, with respiratory failure (difficulty breathing). The flow rate of 500 ml/hour was not included on the physician's treatment order. However, the nurses were administering a dialysis flow rate of 500 ml/hr without an individualized patient treatment order.

During a review of the policy and procedure titled, "Acid Concentrate Additives". dated 04/2000, "Purpose: To ensure safe and appropriate dialysis treatments are provided to patient and to ensure that dialysate concentrate is mixed according to the dialysis prescription. Policy statement: 6. Acceptable acid concentrate additives will include: 6.1 Potassium chloride, 6.2 Calcium Chloride...

On March 19, 2015 at 5:45 PM, an Immediate Jeopardy was called in the presence of the hospital Chief Nursing Officer due to the facility's failure to ensure patients receiving dialysis had individualized specific physician's dialysis treatment orders to reflect the amount of sodium bicarbonate concentrate and acid concentrate administered by the nurses. The Dialysis Nurses were administering bicarbonate and acid concentrate to patients without an individualized specific physician's treatment orders for each patient. The Dialysis nurses were following a protocol for standard solution for bicarbonate and acid concentrate, that was not approved by the hospital's governing body. This failure had the potential to increase the risk of electrolyte and/or metabolic imbalance, or fluid overload and death for 8 out of thirty nine patients (Patient 26, 27, 30, 31, 32, 33, 34, and 39).

On March 20, 2015 at 10:50 AM, Immediate Jeopardy was abated in the presence of the hospital President and the Chief Nursing Officer, after an acceptable corrective action plan (a plan developed by the facility to remove the immediacy of the concern) was presented to the survey team.
VIOLATION: ORDERS DATED AND SIGNED Tag No: A0454
Based on interview and record review, the facility failed to follow and implement the medical staff bylaws to ensure multiple physician orders were signed/authenticated within 48 hours by the ordering physician, for 8 out of 39 sampled patients (Patient 1, 3, 4, 35, 36, 37, 38, 39). This failure had the potential to result in physician orders not verified and authenticated as accurate and appropriate and adversely affect the overall health and safety of the patients.

Findings:

During an interview with the Clinical Quality Coordinator and a concurrent review of the clinical records on March 20, 2015 at 5 PM, he confirmed multiple physician orders were not signed/authenticated within 48 hours by the ordering physicians as follows:

1.For Patient 1
a. On December 23, 2014 at 2:30 PM, "Vasopressin (constricts blood vessels)...Administer via a central line; use peripheral only in emergency...;" was electronically signed by the physician on February 2, 2015 at 08:10:47 AM (41 days after the date it was initially ordered on December 23, 2014).

b. On December 23, 2014 at 2 PM, "Albumin (protein) 5% 250 ml IV (intravenously) x 2 prn volume;" was electronically signed by the physician on February 2, 2015 at 08:10:43 AM (41 days after the order was initiated on December 23, 2014).

c. On December 23, 2014, no time indicated, "...Cefazolin (antibiotic) 1 Gm IV...Vancomycin (antibiotic) 1 Gm (gram) IV...Bactroban (antibiotic) ointment into both nostrils BID (twice a day) x 5 days...Amiodarone (antiarrythmia)150 mg IV bolus...Morphine (narcotic analgesic-treats moderate to severe pain) 2 mg IV...Propofol (a type of anesthetic) (Diprivan) Drip infusion/drip ...Acetaminophen (Tylenol) Supp (suppository) 650 mg... Ondansetron (antiemetic-treats nausea and vomitting) (Zofran) 4 mg IV ...BLOOD GLUCOSE (sugar) CONTROL...;" was electronically signed by the physician on February 2, 2015 at 08:11:19 AM (41 days after the order was initiated on December 23, 2014).

d. On December 24, 2014 at 5:20 am, "...Epinephrine (treats severe allergic reactions) 1 mcg...Vasopressin 0.04 mcg/min...;" was electronically signed by the physician on February 2, 2015 at 08:11:04 AM (40 days after the order was initiated on December 24, 2014).

e. On December 24, 2014 at 6 AM, "Foley catheter to monitor urine output ...;" was electronically signed by the physician on February 2, 2015 at 08:11:10 AM (40 days after the order was initiated on December 24, 2014).


f. On December 25, 2014 at 11:10 AM, "Resume order prior to surgery PT/PTT/INR (a type of blood test to check blood clotting ability)...;" there was no physician signature noted.

g. On December 25, 2014 at 10:37 AM, "mednebs q 4 while on vent (ventilator - artificial respirator)...;" was electronically signed by the physician on February 2, 2015 at 02:50:17 PM (39 days after the order was initiated on December 25, 2014).

h. On December 25, 2014 at 10:05 AM, "Pre operative area with Betadine (antiseptic)5% Opth (ophthalmic - refers to the eyes) ...;" was electronically signed by the physician on February 2, 2015 at 08:11:00 AM (39 days after the order was initiated on December 25, 2014).

i. On December 28, 2014, "1000 ml D5/0.45 NS (a type of IV fluid) TKO (to keep vein open), Hespan 250 ml x 2 doses, Infuse 1 units PRBCs (packed red blood cells)...Nitroglycerin (used to treat chest pain)...Add Nitroprusside (used to treat blood pressure) (Nipride)...Nitropaste 1 inch topically...Dopamine (used to treat circulation problems) Start at 5 mcg/Kg/min ...Epinephrine Start at 1 mcg/min...;" was electronically signed by the physician on February 2, 2015 at 08:11:24 AM (36 days after the order was initiated on December 28, 2014).

j. On January 1, 2015 at 2 PM, "If pt (patient) goes AMA (against medical advice) notify ...;" was electronically signed by the physician on February 18, 2015 at 04:20:27 PM (48 days after the order was initiated on January 1, 2015).

k. On January 2, 2015, "1) D/C Home today 2) Start Levaquin (antibiotic) 500 mg po now;" was electronically signed by the physician on February 2, 2015 at 08:10:51 AM (31 days after the order was initiated ordered on January 2, 2015).

2. For Patient 3

a. On October 13, 2014 at 8:55 PM, "...Type, Screen and Crossmatch...4 Units packed Cells for open heart surgery...Vancomycin 1 Gm IVPB...Cefazolin (Ancef) 1 Gm IVPB ... Temazepam (aids in sleep) (Restoril) 30 mg ... Mupirocin (Bactroban) ointment intranasal BID x 5 days. Acetaminophen (Tylenol) 650 mg q6h, prn pain...;" was electronically signed by the physician on January 6, 2015 at 02:16:00 PM (85 days after the order was initiated on October 13, 2014).

b. On October 14, 2014 at 7 AM, "... Prep operative area with ChloraPrep...Insert Foley Catheter with monotherm...Medications to the Field Doty's 500 ml vein Graft Sol'n 250...;" was electronically signed by the physician on January 6, 2015 at 02:15:51 PM (84 days after the order was initiated on October 14, 2014).

c. On October 16, 2014 at 12:30 AM, "Amiodarone (Cordarone): (For VFib & VT)...;" was electronically signed by the physician on January 6, 2015 at 02:15:21 PM (82 days after the order it was initiated on October 16, 2014).

d. On October 17, 2014 at 9:40 AM, "Amiodarone...(no) loading dose Start at 0.5mg/min ...;" was electronically signed by the physician on January 6, 2015 at 02:14:31 PM (81 days after the order was initiated on October 17, 2014).

e. On October 17, 2014 at 9:40 AM, "1. Start Amiodarone gtt. At 0.5 mg/min, (no) boluses.2. Order clarification: D/C Metoprolol (used to treat high blood pressure and chest pain) 3. Order Clarification: Valsartan (used to treat high blood pressure and chest pain) 160 mg po daily 4 . Continue Spirolactone (used to treat high blood pressure and and fluid retention) Lasix;" was electronically signed by the physician on January 6, 2015 at 02:14:54 PM (81 days after the order was initiated on October 17, 2014).

f. On October 17, 2014 at 10:07 AM, "Turn Amiodarone gtt. (drip) off re: 5 second pause;" was electronically signed by the physician on January 6, 2015 at 02:14:36 PM (81 days after the order it was initiated on October 17, 2014).

g. On October 18, 2014 at 10 AM, "Calcium chloride (salt) 1 amp (ampule) x1 now. Call cardiologist...;" was electronically signed by the physician on November 17, 2014 at 03:18:55 PM (30 days after the order was initiated on October 18, 2014).

h. On October 24, 2014 at 5 AM, "Amiodarone (Cordarone)...;" there was no physician signature noted.

i. On October 26, 2014 at 12:00 PM, "Amiodarone (Cordarone):...;" there was no physician signature noted.

3. For Patient 4

a. On November 12, 2014 at 10:45 AM, "Keep Foley catheter for close monitoring of urine output;" there was no physician signature noted.

b. On November 12, 2014 at 12:05 PM, "Albumin 5% 250 ml (milliliter - unit of measurement)...;" was electronically signed by the physician on January 6, 2015 at 02:42:40 PM (55 days after the date it was initially ordered on November 12, 2014).

c. On November 12, 2014 at 8:45 AM, "D/C (discontinue) Tylenol # 3. Keep Norco 5/325 mg po (by mouth) 1 tab prn (as needed) pain 1-3 q (every 6 (hours) 2 tabs prn pain 4-6 q 6 (hours) per 2nd day...;" was electronically signed by the physician on January 6, 2015 at 02:42:50 PM (55 days after the order was initiated on November 12, 2014).

During an interview with the Clinical Quality Coordinator, the HIM (Health Information Management)/Coding Director and the CCU Director, and a concurrent review of the clinical records on March 20, 2015 at 5 PM, they confirmed the physician orders for Patients 1, 3 and 4, were not signed within 48 hours. The HIM/Coding Director stated the policy and procedure quidelines dictates the medication orders shall sign be signed by the ordering physician within 48 hours and all other orders as required by the regulation. She stated one of the physicians, who had signed the orders months after they were initiated, was on medical leave; "He should have signed everything before he left." The CCU Director stated it was the physician's responsibility to sign their orders.

During further interview with the Clinical Quality Coordinator and a concurrent review of the clinical records on March 23, 2015 at 2:48 PM, he confirmed multiple physician orders were not signed/authenticated promptly by the ordering physicians as follows:

4. For Patient 35

a. On March 3, 2015 at 10:45 PM, "Give patient 2 units PRBCs (packed red blood cells);" there was no physician signature noted.

b. On March 3, 2015 at 1:10 PM, "H and H (type of blood test) q 6 hrs;" there was no physician signature noted.

5. For Patient 36

a. On February 28, 2015 at 9 PM, "Morphine 3mg IM (intramuscular), Phenergan 25 mg IM, Norco 10 mg...;" there was no physician signature noted.

6. For Patient 37

a. On February 21, 2015 at 11:30 AM, "(Change neb (treatments)...;" was electronically signed by the physician on March 22, 2015 at 02:44:07 PM (29 days after the order was initiated on February 21, 2015).

b. On February 22, 2015 at 6 PM, "throat lozenge 1 lozenge...;" there was no physician signature noted.

c. On February 23, 2015 at 2 PM, "Cancel Amiodarone bolus and drip...;" there was no physician signature noted.

d. On February 26, 2015 at 1:45 PM, "Digoxin...;" was electronically signed by the physician on March 21, 2015 at 06:36:34 PM (23 days after the order was initiated on February 26, 2015).

During an interview with RN 2 on March 23, 2015 at 8 AM, he stated the process for order authentication was the physician telephone orders should be signed by the physician "within a day or two." He stated the nurses were reminded to ensure the physician signs the orders timely; during the day when the physician would be in the unit, he would take the chart and have the physician sign the orders. When asked what the process was when the orders were not signed timely, he said he was not certain if the staff were supposed to contact the utilization review department. He stated he has not seen the policy and procedure in a long time and that he would have to review it.

During an interview with RN 1 on March 23, 2015 at 8:25 AM, she state she did not know what the timeframe was for the physician were supposed to sign the orders.

During an interview with the CCU (Cardiac Care) Unit Manager and a concurrent review of the clinical record for Patient 1 on March 23, 2015 at 8:30 AM, she stated it was the physician's responsibility to ensure the orders were signed timely.

During an interview with the Director of Medical Staff on March 23, 2015 at 8:45 AM, and a concurrent review of the multiple orders that were not signed timely, he confirmed and stated the ordering physician shall sign the verbal orders within 48 hours and the medications orders within 24 hours. He acknowledged that the physician signing the orders, especially three months later, was not acceptable.

During the Quality Assurance Performance Improvement (QAPI) committee meeting on March 23, 2015 at 11:15 AM, the HIM/Coding Director stated a "random pull" audit of the patients' medical records, which included ensuring that medication orders were signed by the physician within 48 hours, was conducted monthly. She explained when the physician went on a medical leave, the physician should have signed the orders before the leave. The medical bylaws stated constituents in the same group, may sign the orders for him, but in this case, they did not. There was no formal process for nurses to be involved in ensuring the ordering physicians signed the orders timely.

During an interview with the Telemetry Unit Director and the CCU Director on March 23, 2015 at 2:05 PM, the Telemetry Unit Director stated there was no policy and procedure to follow regarding nurses following up to ensure the orders were signed by the physician timely. She stated it was hard when nurses were on a 12-hour shift; they might not be on the next day so it was up to the physician to sign the orders. The CCU Director stated it was up to the physician to come back to the unit and sign the orders.

During an interview with the Director of Medical Staff on March 23, 2015 at 2:15 PM, he confirmed multiple orders were not signed timely by the physicians. He stated they used to "flag" the orders but had stopped doing so because "it didn't make any difference."

During an interview with the HIM/Coding Director and a concurrent review of the policy and procedure on March 24, 2015 at 8 AM, she explained the audit process. She stated a minimum of 30 records were audited monthly. A random pull of the patient's medical records every 10th admission (for medical and surgical patients) would be randomly chosen and represented by all medical staff. Upon discharge, the patient's medical records would be analyzed and audited for completeness and should be completed within 48 hours. The physician's failure to sign the orders 14 days past the discharge date , would result in the physician's suspension.

A review of the facility's policy and procedure titled "MEDICAL STAFF BYLAWS December 2014 ORDERS," it revealed, "...Within 48 hours, the ordering physician shall sign all medication orders...All other verbal orders shall be signed in a timely manner unless otherwise required by regulatory statues, such as DNR or restraint orders."
VIOLATION: SURGICAL SERVICES Tag No: A0940
The facility failed to ensure that the Condition of Participation: 482.51 Surgical Services was met by failing to follow and implement its policy and procedure regarding "Surgical Counts and Sponge Accounting," for one of 39 sampled patients (Patient 1), when during a coronary bypass graft (CABG - a type of surgery done to improve blood flow to the heart) performed on Patient 1, the surgical sponge (sponges used during surgery) count (an accounting of the surgical sponges used during the surgery) was noted to be incorrect and was unaccounted for. In the event that the incorrect count of the surgical sponge was identified, the facility failed to follow and implement its policy and procedure to ensure the following:

1. The facility failed to ensure that the charge nurse/manager was notified of the incorrect sponge count. (Refer to A-0951)

2. The facility failed to ensure the surgeon was asked to performed or repeat a methodical wound examination prior to closure of the surgical operation. This failure had resulted in the second operation to locate and removed the retained sponge in the chest cavity on December 25, 2014. (Refer to A-0951)

The cumulative effect of these systemic practices resulted in the failure of the facility to deliver care in compliance with the Condition Participation for Surgical Services.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview and record review, the facility failed to ensure an accurate count of all surgical supplies was conducted for 1 of 39 sampled patients (Patient 1) as indicated in their policy and procedure regarding "Surgical Counts and Sponge Accounting,". During a coronary bypass graft (CABG - open heart surgery) performed on Patient 1, a surgical sponge (sponges used during surgery) count (an accounting of the surgical sponges used during the surgery) was noted to be incorrect and was unaccounted for. This failure resulted in Patient 1 having underwent a sternal re-exploration (the chest was reopened and re-explored) on December 25, 2014 (2 days after the CABG surgery), to search for a possible retained surgical sponge, during which the surgical sponge was found and removed.

Findings:

A review of Patient 1's clinical record revealed Patient 1 was admitted on [DATE] and had diagnoses that included [DIAGNOSES REDACTED]. Patient 1 underwent a CABG surgery and aortic valve replacement on December 23, 2014. The sponge count was incorrect during and after the surgery and was not found. A chest x-ray (a diagnostic procedure performed to visualize the chest) was done and the radiopaque sponge (a type of sponge used during surgery, that has a radiopaque marker that is detectable by x-ray) was not seen on December 23, 2014, so the incision was closed.

A CT scan (Computed Tomography-a diagnostic procedure that produces multiple images or cross sections of the body) was performed on December 24, 2014 (a day after the CABG surgery) and the radiologist did not see the retained sponge. Surgeon 1 reviewed the CT film and he stated that he saw "Suspicious squiggly lines" and scheduled Patient 1 for exploratory surgery on December 25, 2014. During the procedure, it was noted that the surgical sponge was wadded up behind the superior vena cava (a vessel found in the heart) and the aorta (main artery of the body that is found in the heart). On December 25, 2014 (two days after the CABG surgery on December 23, 2014), Patient 1 was taken back to surgery, the chest was reopened and a search of the chest cavity resulted in the sponge being located and removed.

An interview with Radiologist 1 and a concurrent review of the chest x-ray and CT scan results were conducted on March 19, 2015 at 8:40 AM, and revealed the following results:

On December 23, 2014 at 12:50 (12:50 PM), chest x-ray revealed, "IMPRESSION: No foreign body demonstrated. Intraoperative films taken during the patient's cardiac surgery."

On December 23, 2014 at 14:04 (2:04 PM), the chest x-ray result did not address presence or absence of a foreign body.

On December 23, 2014 at 14:45 (2:45 PM), the chest x-ray result did not address presence or absence of a foreign body.

On December 24, 2014 at 23:29 (11:29 PM), the CT chest scan result revealed, "IMPRESSION: 1. No definite evidence of radiopaque sponge within the chest..."

During the concurrent interview with Radiologist 1 on March 19, 2015 at 8:40 AM, he stated he remembered looking at the two chest x-ray films after the post-op (after the surgery) procedure, and that it was very difficult to see the surgical sponge. He also stated the CT chest scan results also did not reveal the surgical sponge. The Radiologist 1 stated, "In retrospect, maybe it was there." He further stated it was post-op and Patient 1 had a lot of lines (tubings) and a little CHF. The presence of the surgical sponge was not very obvious and the tag (on the sponge that is detectable with x-ray) was very faint. Radiologist 1 stated on December 23, 2014 at 12:50 PM he called the OR (Operating Room) after looking at the initial chest x-ray film that revealed there was no foreign body. The Radiologist 1 stated, "We looked back and obviously we missed it." In the CT chest scan (on December 24, 2014), it was "Kinda there in retrospect;" saw a squiggly line on the December 22, 2014 and on the December 24, 2014 chest x-ray films. He further stated, "This is something we shouldn't have missed."
During an interview with the Senior Director Perioperative Services and a concurrent review of the clinical record on March 19, 2015 at 9:10 AM, she stated the surgeon "Chose not to reopen" Patient 1 when the surgical sponge count was noted to be incorrect during the CABG surgery on December 23, 2014. The CT scan result did not show the presence of the surgical sponge. The day after the CABG surgery (December 24, 2014), the surgeon was notified that the surgical sponge was still missing and so the surgeon decided to take Patient 1 back to surgery. On December 25, 2104, Patient 1 was "Reopened" and the surgical sponge was found "Wadded" up to about the size of a "Walnut" at the notch (between the aorta [main artery found in the heart]and the superior vena cava [a large vein found in the heart]) and the radiopaque thread was there, but was full of blood.

An interview with Surgical Technician (Surgical Tech 1) and the Senior Director Perioperative Services, and a concurrent review of the nursing operative record, dated December 23, 2014, was conducted on March 19, 2015 at 9:35 AM. Surgical Tech 1 and the Senior Director Perioperative Services stated the surgical sponge count were performed as follows:

"In count," (initial/baseline count)-performed by Surgical Tech 1 and Operating Nurse (OR) Registered Nurse/Circulating Nurse at 11:15 AM; the count was noted to be "correct."

"Closing Count 1st" (before closing a cavity) - performed by Surgical Tech 1 and OR RN/Circulating Nurse; the count was noted to be "correct." (The count coincided with the time Surgical Tech 1 had to go on a lunch break.)

"Closing Count 2nd" (before wound closure begins) - performed by Surgical Tech 2 and OR RN/Circulating Nurse; the count was noted to be "incorrect."

"Final Count" (skin closure) - was performed by Surgical Tech 2 and OR RN/Circulating Nurse; the count was noted to be "incorrect."

During a concurrent interview with Surgical Tech 1 on March 19, 2015 at 9:35 AM, he stated when he got back from his lunch break (after the Closing count 2nd), he was made aware by Surgical Tech 2 and OR RN/Circulating Nurse that the surgical sponge count was noted to be "incorrect."

An interview with Surgeon 1 who performed Patient 1's CABG surgery on December 23, 2014, was conducted in the presence of Senior Director Perioperative Services, on March 19, 2015 at 1:30 PM. When Surgeon 1 was asked what his role was in ensuring that the surgical count was correct, he stated the nurses do the sponge accounting themselves. When asked at what point of the surgical procedure was he informed that the surgical sponge count was incorrect and what was done, the surgeon stated, "I was already done putting my last stitch (on the skin)."

During further interview, Surgeon 1 stated that Radiologist 1 did not see the sponge (on the Chest x-ray result dated December 23, 2014 at 12:50 PM) either. Patient 1 was then sent to Intensive Care Unit (ICU) after the surgery. The next morning, (December 24, 2014), as the surgeon was scrubbing in the OR, the nurse informed him that they (staff) still did not find the (missing) surgical sponge. At that time, Patient 1 was already intubated (had tubes inserted) and was on cardiac (pertaining to the heart) drugs. Patient 1 was extubated (had tubes removed) in the evening (of December 24, 2014) and the cardiac drugs were weaned down. Surgeon 1 ordered a CT scan on December 24, 2014. Surgeon 1 stated that Radiologist 1 endorsed that there was no evidence of any retained surgical sponge but when Surgeon 1 looked at the film, he saw a "squiggle." Patient 1 was informed by Surgeon 1 the surgical sponge count was incorrect and the Surgeon 1 wanted to take him back to surgery; Patient 1 agreed.


A review of the Operative Report, dated December 25, 2014 (2 days after the CABG surgery on December 23, 2014) revealed, "INDICATIONS FOR PROCEDURE: ... At the end of the procedure, 2 days ago, after the wires were placed, Ray-Tec sponge count was off. We obtained 2 chest x-rays, one laterally and one anteriorly with radiology assessing no evidence of any retained sponge. The patient was brought to the ICU and on x-rays and follow up, there was also no evidence of retained sponge. The OR count, however, the next day continued to be off 1 sponge, and I obtained a CT scan of the chest. The radiologist read this as no evidence of any retained sponge; however, there are some very small squiggling lines in the upper mediastinum (midway) into the right that are of concern. The patient has a prosthetic aortic valve (replaced heart valves), and for this reason, I feel it is worthwhile re-exploring him. FINDINGS AT SURGERY: There was a sponge of (in) between the aorta and the superior vena cava (large vein in the upper chest) in this extremely fat patient that was removed...."

An interview with Surgical Tech 2, in the presence of Senior Director Perioperative Services, and a concurrent review of the nursing operative record dated December 23, 2014, was conducted on March 19, 2015 at 1:40 PM. Surgical tech 2 stated she had relieved Surgical Tech 1, who went on a lunch break at 11:50 AM. Surgical Tech 2 stated she noted the surgical sponge was "Missing," during the closing count 2nd when Surgeon 1 was already "wiring" (putting wires on the sternum) and Surgeon 1 was "Ready to twist the wires." Surgical Tech 2 stated that she notified Surgeon 1 but Surgeon 1 chose to do a chest x-ray. Surgical Tech 2 stated she also informed the OR RN/Circulating Nurse, who also notified Surgeon 1. Surgical tech 2 stated the first time she notified Surgeon 1, Surgeon 1 stated he was going to do the x-ray and Surgeon 1 continued "Wiring." The second time she notified Surgeon 1, Surgeon 1 did not say anything. The third time she notified Surgeon 1, Surgeon 1 was already "Sewing" the subcutaneous (the layer under the skin). Surgeon 1 ordered the chest x-ray, which was performed after Patient 1's skin was closed.

A phone interview/conference with the OR RN/Circulating Nurse, in the presence of Senior Director Perioperative Services, was conducted on March 19, 2015 at 1:55 PM. The OR RN/Circulating Nurse stated the surgical sponge count was noted to be "Off" during the "Closing Count 2nd " with Surgical Tech 2. The OR RN/Circulating Nurse stated it happened rapidly. She stated she notified Surgeon 1 during the time when the "Wires were in and the chest was open." When she notified Surgeon 1 again, Surgeon 1 was already twisting the wires and that point, Surgeon 1 stated the missing surgical sponge "Was not in there;" Surgeon 1 did not want to reopen Patient 1, and stated he will order to have a chest x-ray taken, certain that "We could find it (missing surgical sponge)." The OR RN/Circulating Nurse stated after the operation, she notified the OR charge nurse. She then filled out an incident report through (IVOS - an electronic event reporting system), after Patient 1 went to ICU. OR RN/Circulating Nurse stated it was the nurses' responsibility to make sure the surgical sponge count was correct.

During an interview with Clinical Risk Manager on March 19, 2014 at 2:35 PM, she stated that one of the action items in response to this incident, was to re-educate the physicians of their role in methodical wound exam. This re-education was scheduled for April 10, 2015. A sponge accounting video was uploaded into the healthstream that the staff members had to complete by the end of March 2015. She stated there were no revisions made in the facility's policy and procedure because they followed their policy.

An interview with Senior Director Perioperative Services and a concurrent review of the facility's policy and procedure titled "Surgical Counts and Sponge Accounting," Number: 7420-7430-0109 Effective Date: 7/12, was conducted on March 20, 2015 at 11:30 AM. The policy revealed, "...DOCUMENTATION: ... 6.0 In the instance of an INCORRECT FINAL COUNT the charge nurse/manager will be notified...6.0 Actions to perform in the event of a missing item: 6.1 Ask the surgeon to perform or repeat a methodical wound exam .... SURGEON PROCEDURES AND SAFETY RULES ... 2.0 Performance of a methodical Wound Examination: 2.1 A methodical exploration of the operative wound must be conducted prior to closure in every operation and at any time the surgeon is informed of a missing item ....3.0 Actions to Reconcile an Incorrect Count: 3.1 If the surgeon is informed of a missing object by the circulating nurse, while the OR staff are looking for the surgical item, the surgeon should stop closing the wound and repeat the methodical wound examination."

During a concurrent interview with the Senior Director Perioperative Services on March 20, 2015 at 11:30 AM, she confirmed neither the OR charge nurse nor the RN OR manager were notified of the incorrect surgical sponge count by the OR RN/Circulating Nurse. She stated the OR RN/Circulating Nurse should have called in either the OR charge nurse or the OR manager, or Senior Director Perioperative Services, who would have walked into the OR and would have had a conversation with the surgeon that the surgical sponge count was still missing. A plan would have been discussed regarding the surgeon's decision depending on the stability of Patient 1's condition.

During an interview with the RN OR Charge Nurse and a concurrent review of the facility policy and procedure titled "Surgical Counts and Sponge Accounting," on March 20, 2014 at 2:45 PM, she confirmed she worked on December 23, 2014 when the incident happened but did not know about it until the next day (December 24, 2014). She stated she should have been notified of the incorrect surgical sponge count and she would have went into the OR to assist with the search for the missing surgical sponge, and would have persistently asked the surgeon to reexamine the wound. She confirmed the hospital management was not involved until after the fact.

During an interview with RN OR Manager and a concurrent review of the facility policy and procedure titled "Surgical Counts and Sponge Accounting," on March 20, 2014 at 3 PM, she stated she was not aware that they were missing anything until the OR RN/Circulating Nurse asked RN OR Manager to show her how to complete an incident report "Because we're missing a sponge." When the RN OR Manager asked where Patient 1 was, the OR RN/Circulating Nurse told her Patient 1 was already in the ICU. The RN OR Manager stated she should have been informed of the incorrect surgical sponge count, and she would have gone inside the OR and would have asked the surgeon to perform a methodical wound examination. She stated, "I didn't know till after the fact."

A review of the facility's policy and procedure titled "Surgical Counts and Sponge Accounting," Number: 7420-7430-0109 Effective Date: 7/12, it revealed, "RESPONSIBILITY: ... 3.0 The surgeon is responsible for performing a methodical wound exam in every case to identify and remove surgical items not intended to remain in the patient so they can be accounted for and participate with the surgical team in accounting for surgical items... "

During an interview with Senior Director Perioperative Services on March 20, 2015 at 3 PM, she stated one of the corrective actions implemented by the facility was re-education of the OR staff members (45 staff members were required to attend). She stated the facility has until the end of March 2015 to complete the re-education for the OR staff members.

A concurrent review of a copy of the February 2015 Staff Meeting segment/topic, revealed, "...IV. Sponge Accounting..." The attendance record dated February 5, 6, and 27, 2015, revealed, 24 out of 45 staff members attended the meeting. The OR RN/Circulating Nurse and Surgical Tech 1, who were involved in the surgical sponge accounting during Patient 1's CABG surgery on December 23, 2014, were not in attendance.