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Based on observation, interview and record review the hospital failed to ensure the patient received care in a safe setting by:

1) Failing to ensure telemetry alarms, which would include Lethal alarms, could be heard outside the Med/Surg nursing unit for 5 of 5 Med/Surg patients on physician ordered telemetry monitoring. (#R2, #R3, #R4, #R5, #R6)

In an interview on 12/06/10 at 2:24 with S9ADON she confirmed that an on-going alarm could not be heard beyond 15 feet away from the nursing station and that there was no dedicated telemetry tech observing the telemetry monitors at all times.

In an observation on 12/06/10 at 2:20 p.m. with S9ADON she confirmed that there were no licensed personnel, no personnel trained in basic electrocardiogram interpretation, no unit secretary to call for help, if trained to do so, should there be a telemetry alarm, nor anyone to answer the telephone if the ICU staff detected an alarm on a Med/Surg patient.

In an interview on 12/06/10 at 4:00 p.m. with S9ADON/QA, S10Risk Mgmt., and S15Med/Surg Director all stated that the current telemetry monitoring, alarm parameter settings and alarm volume on the Med/Surg unit were "not conducive to patient safety." All further confirmed that the hospital was not aware of these issues until brought to their attention during the survey.

Based on observation, interview and record review the hospital failed to ensure the Registered Nurse supervised care of all patients by:

1) Failing to ensure a re-assessment of a patient and/or notification of the physician responsible for the care of the patient was performed and documented for 1 of 6 sampled patients (#4) after routine vital signs revealed the patient had a significant change in heart rate.

Review of the medical record for patient #4 revealed he arrived at Acadian Medical Center on 09/20/10 at 1601 (4:01 p.m.). S12MD accepted patient #4 in transfer from hospital "a" .

Review of the History and Physical for patient #4, dictated by S12MD on 09/20/10 at 1811 (6:11 p.m.), read in part: " Chief Complaint: Low Heart rate. History of Present Illness: This is a 76 year-old black male with Alzheimer ' s Dementia. He is bed bound, requires PEG tube to meet his nutritional requirements. He has been combative and very aggravated and agitated at the nursing home. He was sent to (hospital " b" ) in Opelousas. From there apparently he had some low heart rates and was transferred to the emergency department at (hospital "a" ). I was called by the Emergency Room physician. He (patient #4) had a BUN (blood urea nitrogen) and creatinine, which were elevated, with creatinine above 3 and multiple blisters on his feet, which were thought to be infected ...He (#4) is in the room, a little bit lethargic. His wife says that he has not been answering questions and talkative ...Physical Examination ...Extremities: Has some blisters, possibly some mild erythema ...Assessment/Plan: 1. Cellulitis - will start Zosyn 2.25 grams IV every 8 hours ...2. Acute Renal Failure - will hydrate him with half normal saline at 150 cc an hour and repeat his labs in the morning ...3. Dementia - He is a little confused right now and either possibly sedated or having some delirium ..."

Review of the Admission Physician Order's by S12MD for patient #4 dated/timed 09/20/10 at 1:30 p.m., taken as a verbal order, revealed the following: "...Condition: Dx. (diagnosis) dehydration, cellulitis, Alzheimer's, dementia. Vital Signs: q 4 hr (hours) ...IV fluids ? NS (normal saline) 150 cc/hr ...Resume Nursing Home Diet, Zosyn 2.25 g (grams) IV every 8 hours and continue home meds."

Further review revealed S12MD wrote orders at 1800 (6:00 p.m.) on 09/20/10 that read as follows: "Bladder Scan, CBC, CMP, INR in a.m. EKG, CXR, BCX2."

Review of the EKG dated/timed 09/20/10 at 1915 (7:15 p.m.) revealed a heart rate of 78 bpm (beats per minute) and a computer generated interpretation of Sinus Rhythm with a First Degree AV (atrial - ventricular node) Block. The laboratory tests ordered for the a.m. of 09/21/10 were not done due to patient #4 having expired.

Review of the Initial Nursing Assessment performed by S21RN at Acadian Medical Center at 1630 (4:30 p.m.) on 09/20/10 revealed the following: "Vital signs: BP (blood pressure) 142/97; P (pulse) 85; R (respirations) 20; T (temperature) 96.7 oral; weight 195.6 pounds ...IV. Neurological. A. LOC: Confused, Lethargic, arouses when called. B. Speech: Garbled, Slurred ...VI. Cardiovascular. A. Rate: Regular ...E. Edema: none ...III. Physical Assessment ...Skin: A. Color: Normal. B. Temperature: Warm. C. Moisture: Dry. D. Turgor: Supple ..."

Review of vital signs taken on the 7:00 a.m. - 7:00 p.m. shift revealed:
09/20/10 at 1600 (4:00 p.m.) - BP 142/97 P 85 R 20

Review of the Nursing documentation for 09/20/10 7:00 p.m. - 7:00 a.m. shift revealed S4LPN was assigned the care of patient #4. S17RN was the RN Charge Nurse for the shift. Further review of the nursing documentation for patient #4 revealed in part: "LOC (level of consciousness): Confused, Lethargic ...Speech: Garbled ...Grips: Weak ...Breath Sounds: Diminished R/L (right and left) ... Rate (heart): Regular." The documentation also revealed patient #4 had an IV in his Right hand with ? NS (normal saline) infusing at 150 cc/hr (cubic centimeters per hour). Documentation for the "IV site check time" revealed the IV site was initialed as checked for every hour between 1600 (4:00 p.m.) - 0200 (2:00 p.m.).

Review of the Graphic Record revealed the following vital signs for patient #4 (per S12MD's admission orders of q4 (every 4 hour) vital signs) for the 7:00 p.m. - 7:00 a.m. on 09/20/10:

09/20/10 at 2000 (8:00 p.m.) - BP 144/88 P 88 R 22
09/20/10 at 2400 (midnight) - BP 144/92 P 52 R 24 (taken by S5CNA)

Review of the entire medical record revealed no documentation by the Licensed Practical Nurse (S4LPN) on duty, the Registered Nurse on duty (S17RN) or S12MD, the physician responsible for the care of patient #4, of the drop in pulse rate of patient #4 or that the physician was notified of the change in the heart rate of patient #4.

Nursing documentation for 0233 (2:33 a.m.) read as follows: "Pt. found unresponsive, VS (vital signs) unobtainable, RN notified. CPR initiated. (name, RN) .....0244 (2:44 a.m.) Dr. (S22MD) pronounced pt. deceased ..."

Review of the Discharge Summary dictated by S12MD dated/timed 09/21/10 at 12:43 p.m. read in part: "Admission Date: 09/20/10. Death Date: 09/21/10. Death Summary. Admission Diagnosis: 1. Acute Renal Failure. 2. Dehydration. 3. Cellulitis. 4. Alzheimer's dementia ... Cause of Death: Cardiac Arrest. Hospital Course: This is a 76-year-old, black male with advanced Alzheimer's dementia. He had a PEG (percutaneous endogastric tube). He was basically bed to chair bound and lived in a nursing home. He had problems with agitation behavior. He was at the psychiatric hospital (hospital "b") and being treated there for behavior problems. He was reported to have a low heart rate and was brought to the emergency department at (hospital "a"). He was evaluated there and found to be in acute renal failure and the family wanted him to come to Eunice (Acadian Medical Center). He was admitted to my service and started on IV (intravenous) fluids and IV antibiotics. Initial EKG (electrocardiogram) was sinus rhythm, heart rate of 78, no acute ischemic changes. He was waking up, talking with family and called in the middle of the night that he was unresponsive and had no vital signs. He was seen by the emergency room physician and coded per ACLS (advanced cardiac life support) protocol and did not respond and was pronounced dead at 0245 (2:45 a.m.) on September 21, 2010 secondary to cardiac arrest. The family was notified. Did see the family in the room and answered any questions they had. His body was released to the funeral home."

In an interview on 12/06/10 at 4:25 p.m. with S5CNA she stated that the CNA's (certified nursing assistants) are responsible to perform the physician ordered every four hour vital signs. S5CNA stated that she documents the vital signs in the medical record of the patient and on a sheet located at the nursing station so the nurses can review the vital signs of their patients. S5CNA further stated that vital signs would be reported directly to the nurse "if the top number (systolic) was above 190, if the bottom number (diastolic) was above 80 or if the heart rate was outside of 60 - 80 (per minute)."

S5CNA was asked if she reported any of the vital signs of patient #4 on the night shift of 09/20/10 - 09/21/10 to the nurse. S5CNA stated she reported the blood pressure of 144/92 but could not remember to which nurse. She further stated that "I do not remember if I told them (a nurse) about the heart rate."

S5CNA further stated that she did not remember the cardiac arrest of patient #4 on 09/21/10. S5CNA was asked if the hospital retains the sheet located at the nursing station where vital signs are recorded for the nurses to review and she stated she does not know.

In an interview in 12/06/10 with S15RN, Med/Surg Director, she stated that the vital signs sheets on the nursing station desk where the CNA lists the vital signs of all patients for the nurses to review are shredded. She further stated that there is no hospital policy for the CNA's to document the vital signs on a sheet at the nursing station so the nurses are aware of the vital signs of the patients.

In an interview on 16/06/10 at 4:45 with S4LPN she stated she worked the p.m. shift on 09/20/10 and was assigned the care of patient #4 by S17RN, Charge Nurse. S4LPN stated that the CNA's document the patient's vital signs in the medical record and on a clipboard at the nurse's station. She further stated that sometimes the CNA's verbally inform the nurses of patient's vital signs.

During the same interview S4LPN reviewed the vital signs graphics sheet for patient #4. S4LPN stated that the vital signs were "pretty consistent." When asked to review the vital signs and assessment documentation of patient #4 S4LPN stated she saw no reason to notify the physician. S4LPN was asked about the difference in heart rate from the 4:00 p.m., 8:00 p.m. and midnight vitals. S4LPN stated she "would check the patient's meds." S4LPN confirmed that there was no documentation of an assessment being done on patient #4 when the 12:00 midnight heart rate was documented to be 52 bpm. S4LPN further confirmed that the first narrative documentation for the entire shift regarding patient #4 was at 0233 (2:33 a.m.) when patient #4 was found unresponsive, not breathing and without a pulse.

In a telephone interview on 12/06/10 with S17RN she stated that the CNA's do the routine vital signs on patients. She further stated that the CNA's write the vital signs on a sheet of paper at the nursing station for the nurse's to review. S17RN was advised (during the telephone interview) of the heart rate of patient #4 as documented in the medical record (4:00 p.m. HR 85; 8:00 p.m. HR 88; 12:00 a.m. HR 52). S17RN stated that if the patient was sleeping the heart rate would go down. S17RN further stated that if the patient's vital signs were abnormal the patient should be assessed and this assessment should be documented.

In a face to face interview on 12/07/10 at 10:10 a.m. S17RN stated that the heart rate of patient #4 was not reported to her on the night shift of 09/20/10 - 09/21/10. S17RN stated that she was in another patient room with a patient "all night."

In an interview on 12/07/10 at 12:45 p.m. with S12MD he confirmed that he was advised of the recent history of bradycardia for patient #4 by the ER physician at hospital "a" . He further stated that he would not expect the nurses to notify him of a heart rate in the 50's. He confirmed that he did not order telemetry monitoring for patient #4. S12MD further stated that "it would have been good to have been on telemetry (patient #4) and that it takes a physician order for a patient to be on telemetry, but if the patient was assessed by the nursing staff to have a change in condition they could request a telemetry order."

In an interview on 12/06/10 at 5:15 p.m. with S9ADON, and S10 RiskMgmt. both stated that they would expect documentation of an assessment of patient #4 after his heart rate was documented to be 52 bpm.

In an interview on 12/07/10 at 8:20 a.m. with S2DON she stated that when the 12:00 a.m. vital signs were taken she would expect them to be repeated and would expect documentation of a patient assessment.

Review of a hospital policy titled "Assessment, Screening and Reassessment", no policy number, no date last revised, presented as current hospital policy, reads in part: "Purpose: To ensure that all patients receive the appropriate assessment, screening and reassessment, by qualified individuals...Policy: All patients...will have...appropriate reassessments based upon their individual needs...The goal of the assessment/reassessment process is to determine care needs and subsequently to provide the patient the best intervention possible...Reassessment/Data collection of Biophysical status. Each patient is reassessed:..acuity and/or clinical status...When a significant change occurs in a patient's condition...Documentation Procedures. Reassessments...are documented..."


2) Failing to ensure physician ordered telemetry monitoring heart rate parameters were set in accordance with hospital policy for 6 of 6 randomly selected patients on telemetry. (#R1, #R2, #R3, #R4, #R5, #R6)

Telemetry monitors are located in ICU and in the Med/Surg nursing station. Both monitors display all current hospital patients on telemetry.

In an observation made of the 6 patients on telemetry from the ICU monitor on 12/06/10 at 2:00 p.m. the following was noted:

Patient #R1: Intensive Care Unit Patient. Current heart rate was 70/regular. Alarm parameters were set as follows: High - 140, Low 40.

Patient #R2: Med/Surg patient. Current heart rate was 62/regular. Alarm parameters were set as follows: High - 120, Low 50.

Patient #R3: Med/Surg patient. Current heart rate was 63/regular. Alarm parameters were set as follows: High - 120, Low 50.

Patient #R4: Med/Surg patient. Current heart rate was 87/regular. Alarm parameters were set as follows: High - 120, Low 50.

Patient #R5: Med/Surg patient. Current heart rate was 77/regular. Alarm parameters were set as follows: High - 120, Low 50.

Patient #R5: Med/Surg patient. Current heart rate was 95/regular. Alarm parameters were set as follows: High - 120, Low 50.

In an interview on 12/06/10 at 2:20 p.m. with S3RN, ICU Charge Nurse, S14RN, Med/Surg Charge Nurse, and S9RN all stated they could not confirm the hospital policy for alarm parameters and would have to look them up.

Review of a hospital policy titled "Telemetry Monitoring", no effective date, last revised 04/01/10, presented as current hospital policy, read in part: "...Procedure...Set the high and low rates no greater than 20 above and 20 below patient's heart rate."

3) Failing to ensure telemetry alarms, which would include Lethal alarms, could be heard outside the Med/Surg nursing unit for 5 of 5 Med/Surg patients on physician ordered telemetry monitoring. (#R2, #R3, #R4, #R5, #R6)

In an interview on 12/06/10 at 2:24 with S9ADON she confirmed that an on-going alarm could not be heard outside of the nursing station and that there was no dedicated telemetry tech observing the telemetry monitors at all times.

In an observation on 12/06/10 at 2:20 p.m. with S9ADON she confirmed that there were no licensed personnel, no personnel trained in basic electrocardiogram interpretation, no unit secretary to call for help, if trained to do so, should there be a telemetry alarm, nor anyone to answer the telephone if the ICU staff detected an alarm on a Med/Surg patient.

In an interview on 12/06/10 at 4:00 p.m. with S9ADON/QA, S10Risk Mgmt., and S15Med/Surg Director all stated that the current telemetry monitoring, alarm parameter settings and alarm volume on the Med/Surg unit were "not conducive to patient safety." All further confirmed that the hospital was not aware of these issues until brought to their attention during the survey.

4) Failing to ensure Glucometer Quality checks were performed in accordance with manufacturer's guidelines by using outdated control solutions. This has the potential to affect all diabetic patients on the Med/Surg floor. (30 beds)

In an observation made on 12/06/10 at 10:33 a.m. with S14RN, Med/Surg Charge nurse and S9ADON it was discovered that there were 2 Glucometer's in use on the Med/Surg floor. Observation of the Hi and Lo control solutions revealed that both sets of control solutions were opened longer that 90 days and were still in use to perform Quality Controls on the Glucometer's.

In an interview on 12/06/10 at 10:33 a.m. with S14RN, Med/Surg Charge nurse and S9ADON they both confirmed that the control solutions were opened and in use longer than 90 days.

Review of the Precision Xceed Pro manufacturer's guidelines on page 24 read in part: "Check that the bottles of control solutions have not been opened for more than 90 days."

Review of a hospital policy titled "Precision PCx Blood Glucose System", no policy number or date of last revision, presented as current hospital policy, reads in part: "...V. Quality Control: Two levels (low and high) of control material are required to be tested every 24 hours that patient testing are performed. Once opened, quality control material is stable for 90 days and should not be used past it's open expiration date..."

Based on record review and interview the facility failed to administer medications in accordance with approved medical staff policies and procedures as evidenced by:

1) failing to administer insulin (Apidra) to 1 of 6 sampled patients (#1) as ordered by the physician on two separate occasions as evidenced by the staff not obtaining the medication from the pharmacy prior to the lunch and supper meal. Findings:

Review of the Discharge Summary dictated on 10/03/10 at 1717 (5:17 p.m.) by S12, MD, revealed patient #1 was a 57 year old female who had been admitted with hypoglycemia and hypothermia. Review of the History and Physical dictated on 10/15/10 at 16:07:47 (4:47 p.m.) by S12MD revealed patient #1 was "brought to the Emergency Room unable to keep her blood sugar up without IV fluids with glucose."She was admitted to the ICU and started on a D5 drip." Review of the physician's progress note dictated by S12MD on 10/22/10 at 0848 (8:48 a.m.) revealed the patient continued having low blood sugars. Review of the physician's progress note dictated on 9/30/10 at 1726 (5:26 p.m.) by S12MD revealed he had made rounds earlier in the morning and at 9:00 a.m., he had written an order for Aprida 5 milligrams before meals; however, at 5:30 p.m., the nurse reported to the physician that she had not received any Apidra from the pharmacy to give to patient #1. The patient's blood sugar was high and was covered with 2 units of Regular insulin per sliding scale, which had been decreased because of the patient's low blood sugars. Under Assessment/Plan, S12MD noted he had instructed the nurse responsible for the care of the patient to give the Apidra within 10 minutes of a meal. S12MD stressed the medication (Apidra) could not be given on a schedule similar to a sliding scale, but needed to be given within 10 minutes prior to a meal.

Record review of the Physician's Orders dated 9/29/10 at 1730 (5:30 p.m.), revealed S12MD ordered the patient to be transferred to telemetry. On 9/30/10 at 0900 (9:00 a.m.), S12MD had ordered Apidra 5 units subcu every AC (before meals). Change sliding scale insulin to less than 300- No insulin, 300-400 - 2 units, and over 400 - 3 units. This order was signed off by the nurse on 9/30/10 at 0930 (9:30 a.m.) and was faxed to S23, Pharmacist.

On 9/30/10 at 1700 (5:00 p.m), the physician re-wrote the order for Apidra to be given within 10 minutes of meals. This was checked off by the nurse at 1800 (6:00 p.m.) and faxed to the pharmacy.

On 10/1/10 at 1630 (4:30 p.m), the physician discontinued the Apidra/Novalog. The order was checked off by a nurse at 1630 (4:30 p.m.) and faxed to the pharmacy.

2) failing to follow the physician's order of administering insulin (Apidra) 10 minutes prior to a meal as evidenced by the nursing staff administering the insulin (Apidra) at 1800 (6:00 p.m.) and again at 2200 (8:00 p.m.). Findings:

Record review of the Medication Administration Record from 0700 (7:00 a.m.) to 1859 (6:59 p.m.) on 9/30/10, reads "Apidra 100 unit/ml solution. One dose = 5 unit = 0.05 ml Before each meal Route: Subq Subcutaneous. Under Scheduled Orders Start/Stop, it read 09/30/2010 at 1600 (4:00 p.m) 10/30/2010 at 1100 (11:00 a.m.). In the column where nursing staff sign they administered a medication, the time 1600 (4:00 p.m) was circled, a time 1800 (6:00 p.m.) was written below the 1600 (4:00 p.m.) and a line was drawn through it with the initials of "KP" under this notation. In the column dated 9/30/10 to 10/1/10 from 1900 (7:00 p.m.) to 0659 (6:59 a.m.) the time 0659 (6:59 a.m.) was circled and the time 2200 (10:00 p.m.) was written and a line drawn through this time. The initials "CC" were under this notation. Record review of the Medication Administration record from 10/01/10 to 10/01/10 from 0700 (7:00 a.m.) to 1859 (6:59 p.m.) reads "Novalog 5 units SQ 10 min AC every meal." Under the column where nursing staff sign they administered a medication, the time 1100 (11:00 a.m.) had a line through it with the initials "KP" next to the notation.

Record review of the Medication Administration Record from 0700 (7:00 a.m.) to 1859 (6:59 p.m.) on 10/1/10 reads "Levemir 100 units/ml. One dose = 5units = 0.5ml. Before each meal" "Insulin determir Route: SubQ, give within 10 min of meals" (which was handwritten). Under the column where nursing staff sign they administered a medication, the time 0750 (7:50 a.m.) had a line through it with the initials "CC" under the notation.

According to the Therapeutic Substitution Formulary provided by S23, Pharmacist, Levemir was not the substitution medication for Aprida. Levemir was a long-acting insulin.

On 12/7/10 at 8:50 a.m. in an interview with S23 Pharmacist, he stated Apidra was a substitution drug. S23, Pharmacist stated once an order was written, either the ward clerk or the nurse will fax the order to the pharmacy. The order would be entered into the computer system. If the medication can be substituted, S23, Pharmacist stated he would send in the substitution medication with a label on it explaining that the medication was being substituted.

When the pharmacist reviewed patient #1's MAR, he stated based on the Therapeutic Substitutions formulary, Humalog, Apidra (rapid acting) can be substituted using Novolog. Since Apidra could be substituted with Novolog and Novolog was a floor stock, S23 stated he did not send any insulin to the floor with a substitution label on it.

On 12/7/10 at 9:10 a.m. in an interview with S23, Pharmacist, he acknowledged the pharmacy missed the order at 0930 (9:30 a.m), which was faxed by the staff and therefore, this order was not placed in the computer. The next order written at 1700 (5:00 p.m), signed off, and faxed at 1800 (6:00 p.m) to the pharmacy, was entered into the computer. The Pharmacist confirmed it was entered because it was on the Medication Administration Record (MAR), which was generated at 1900 (7:00 p.m.) on 9/30/10.

The Apidra 0.05 ml was to be given 10 minutes before meals (0750 (7:50 a.m.)- breakfast; 1130 (11:30 a.m.)- lunch, and 1630 (4:30 p.m)-supper). On 12/7/10 at 3:30 p.m. in an interview with the DON and ADON, both confirmed patient #1 did not receive a dose of Apidra prior to lunch on 9/30/10 and prior to supper 9/30/10, and prior to breakfast 10/1/10. The DON and ADON confirmed that the patient should have received a total of 4 doses of Apidra after the physician initially ordered the medication on 9/30/10 at 0900 (9:00 a.m.). They also confirmed patient #1 received 3 doses of the Apidra, but the medication was not given 10 minutes prior to meals as ordered.

According to the Pharmacy policy titled "Dispensing: General" pg 3 of 4 under "Delivery of Medications to Patient Care Areas" reads: The pharmacy shall ensure that medications are delivered to patient care areas and are available for administration at the scheduled times. If the pharmacy is unable to provide a medication prior to the scheduled administration time, the pharmacy shall inform the nurse responsible for the area and/or the nurse responsible for the patient." Under "Comparison with Medication Administration Records" pg 4 of 4, reads: "Nurses shall compare medications supplied with the Medication Administration Record (MAR) or prescriber's order and report irregularities to the pharmacy."

According to the Pharmacy's policy titled "High-Risk Medications," Insulin was considered a high risk medication which can be error-prone or which poses a significant hazard to patients if not properly handled. Under Procedure, pg 1 of 3, reads: "For each high-risk medication identified, the organization will identify specific steps to improve safety in each of the critical medication processes: selection and procurement, storage, ordering and transcribing, preparing and dispensing, administration, and monitoring....Calculations and preparation of any high-risk medication should be double-checked, whether done in the Pharmacy or on the Nursing unit. If preparation of a high-risk medication is done on the nursing unit two nurses prior to administration must verify the calculations/preparation. Physician's orders will be verified before administering a high-risk medication to the patient."According to the policy titled "Medication Management and Administration" pg 9 of 13 "Monitoring of Patients", reads "Before a medication is administered to a patient, the medication is transcribed onto the Medication Administration Record (MAR) and verified for completeness and accuracy by a licensed nurse. The pharmacist checks the order to assure the dosage limits are within range and that it meets Formulary specifications."