HospitalInspections.org

Based on observations, review of medical records, policy and procedures, Medical Staff Bylaws, Alabama Board of Nursing Standards of Practice, Centers for Disease Control and Prevention, Autoclave Log Report, Defibrillator Test Log and manufacturer's directions for use and interviews, it was determined the Governing Body failed to ensure the hospital:

1. Appointed and credentialed 1 of 5 physicians to the medical staff of the hospital.

2. Maintained updated pharmacy policy and procedures and formulary.

3. Developed and implemented a policy for home medication verification.

4. Monitored refrigerature temperatures on all refrigeratures utilized for medication storage.

5. Safely stored medications scheduled for administration.

6. Pharmacist limited access to medications and dispensed all medications to be administered.

7. Staff followed policy for outdated drugs and labeling of biologicals.

8. Staff followed the manufacturer's directions for use of the "Comply SteriGage Steam Chemical Integrator" sterilizer.

9. Staff responsible for central sterilization was trained and competent to perform sterilization procedures.

10. Was constructed, arranged and maintained to ensure patient safety.

Refer to A 046, A 490, A 492, A 500, A 502,
A 701, A 749 and A 756.

This had the potential to negatively affect all patient served by the facility.

Based on observation, review of Medical Staff Bylaws and interview, it was determined, the facility failed to ensure that 1 of 5 physicians was appointed and credentialed to the medical staff of the hospital.

This affected medical record (MR) # 23 and had the potential to negatively affect all patients receiving care at this facility.

Findings Include:

Medical Staff Bylaws
Revised: 12/14

"Preamble

...To fullfill this purpose, the Hospital Board of Directors ("Board"), approves a group of practitioners who constitute the Hospital's Medical Staff....

Definitions:

...Medical Staff Appointment: Appointment to the Medical Staff, assignment to a staff category, and assignment to a clinical service. Medical Staff appointment does not automatically confer specific clinical privileges.

Clinical Privileges: Permission granted by the Board to individual practitioners to render specific types of care to patients in or under the auspices of the Hospital."

On 4/28/15 at 11:50 AM the surveyors were reviewing medical records in the room provided by the facility administration. Doctor (Dr.) ... entered the room and requested to see MR # 23's chart. Dr. ... began reviewing the MR. During this time Dr. ... stated that he was not credentialed to be on the medical staff of the hospital.

At 12:03 PM this surveyor left the room to go to the nurse's station and requested that Employee Identifier (EI) # 4, Director of Nurses (DON) be contacted. Dr. ... also proceeded to the nurse's station where he/she was observed writing a progress note and requested to review laboratory (lab) results on the computer on MR # 23. EI # 2, Registered Nurse/Quality Manager pulled up lab results on the computer and Dr. ... began reviewing.

EI # 2 was asked if Dr. ... was on medical staff at this hospital and EI # 2 responded, "He is the Medical Director for the Nursing Home."

At 12:05 PM EI # 4 came to the nurse's station and confirmed that Dr. ... did not have hospital privileges.

Review of MR # 23 revealed he/she was admitted on 4/27/15 with diagnoses including Altered Mental Status, Alzheimer's Dementia and Dehydration.

Review of the MR revealed physician orders dated 4/27/15 (not timed) were signed by Dr. ...

Review of the MR revealed a progress note dated 4/28/15 signed by Dr. ...

At 1:15 PM on 4/28/15 EI # 1, Administrator, confirmed the facility had granted emergency privileges to Dr. ...

Based on review of policies, the facilities "Defibrillator Test Log - To be completed DAILY 7A (AM)" and interview, it was determined the facility failed to assure safe operation and readiness of the facilities defibrillator's.

This affected 1 of 1 pediatric defibrillator and 1 of 1 adult defibrillator in the facility and had the potential to affect all patients receiving care in this facility.

Policy
Subject: Life Pak 9 & (and) 20 Defibrillation Testing
Revision Date: 7/9/12

"Objective: To assure The Life Pak Defibrillator is maintained and prepared for appropriate use of patient care. ...

Procedure:

The defibrillator is to be checked once every day noting the following in the log book.

Record the Date of the test.

Record the time of test (suggested at 7AM)."

During the tour of the Emergency Department (ED) Trauma Room on 4/27/15 at 8:40 AM with Employee Identifier (EI) # 2, Registered Nurse (RN) Quality Manager/Infection Control, the "Defibrillator Test Log - To be completed DAILY 7A" was reviewed for January thru April 2015. There was no documentation completed for the month of March 2015, 4/1/15 to 4/14/15, 4/16/15, 4/17/15, 4/21/15, 4/22/15 and 4/27/15.

An interview was conducted on 4/27/15 at 9:15 AM with EI # 2 who confirmed the above mentioned findings.

At 11:45 AM the surveyor and EI # 2 returned to the ED Trauma Room and the "Defibrillator Test Log - To be completed DAILY 7A" revealed it was completed on the following dates: 4/1/15, 4/7/15, 4/8/15, 4/9/15, 4/11/15, 4/12/15, 4/13/15, 4/21/15, 4/22/15 and 4/27/15.

An interview was conducted on 4/27/15 at 9:15 AM with EI # 4, Director of Nurses (DON) who confirmed the staff completed the above mentioned dates after the initial findings by the surveyor.

Based on review of medical records (MR) and interviews with administrative staff it was determined the facility failed to obtain an informed consent for patients admitted to swing beds for 2 of 2 patients and 1 of 6 patients admitted to the facility. This affected MR # 22, MR # 21, and MR # 28, and had the potential to affect all patients served by this facility.

1. MR # 22 was admitted to a swing bed on 4/15/15 with the diagnosis of Cerebrovascular Accident.

Review of the MR revealed no documentation the patient signed an informed consent for admission / or treatment to the swing bed on 4/15/15.

In an interview conducted on 4/29/15 at 2:40 PM with Employee Identifier (EI) # 4, Director of Nurses (DON) verified the patient did not sign an informed consent for admission to the swing bed on 4/15/15 and stated we don't get them to sign another consent other than the admit to hospital consent.

2. MR # 21 was admitted to a swing bed on 4/27/15 with the diagnosis of Bilateral Deep Vein Thrombosis.

Review of the MR revealed no documentation the patient signed an informed consent for admission / or treatment to the swing bed on 4/27/15.

In an interview conducted on 4/29/15 at 2:20 PM with EI # 4, and verified the patient did not sign consent for admit to swing bed.

3. MR # 28 was admitted to the facility on 1/7/15 with the diagnosis of Left Lower Lobe Pneumonia.

Review of the 1/7/15 Consent for Treatment, Notice of Privacy Practices, Your Rights as a Hospital Patient, Advance Directives, and Medicare Notice revealed documentation the patient was a nursing home patient and unable to sign the required documents.

Review of the MR revealed no documentation of contacting the patient's caregiver to obtain consent for medical treatment.

In an interview conducted on 4/29/15 at 2:48 PM with EI # 4, the aforementioned findings were verified.

Based on observation, medical record review, policy and procedure review, Alabama Board of Nursing Standards of Practice and interview, it was determined the nursing staff failed to ensure:

1. Patients received all ordered medications, treatments, and nutritional supplements.
2. Wound assessments were conducted timely.
3. Wound care was provided according to the physician's orders.
4. Physician's orders were obtained for care and maintenance of intravenous (IV) heparin (hep) lock.

This affected Medical Record (MR) # 22, MR # 21 and MR # 28, 3 of 8 admitted patient MR reviewed. And had the potential to negatively affect all patients served by the facility.

Findings include:

Facility Policy
Accuracy and Timeliness of Medical Record
Documentation
Written 1/1/14

Policy:
1. A complete, legible and accurate paper and / or electronic medical record will be maintained for every individual who is evaluated or treated as an inpatient, outpatient, or emergency patient at Greene County Hospital...

6. A patient's record is complete when the following criteria are met:
A medical history and physical examination...
Properly executed informed consent forms.
Practitioners' orders, nursing notes, reports of treatment, medication records...vital signs and other information necessary to monitor the patient's condition.

Alabama Board of Nursing Chapter 610-X-6
Standards of Nursing Practice

610-x-6-.13 Standards for Wound Assessment and Care

(1) It is within the scope of a registered nurse or licensed practical nurse practice to perform wound assessments including, but not limited to, staging of a wound and making determinations as to whether wounds are present on admission to a healthcare facility pursuant to an approved standardized procedure...

(2) The minimum training for the registered nurse or licensed practical nurse that performs selected tasks associated with wound assessment and care shall include:
(a) Anatomy, physiology and pathophysiology.
(c) Equipment and procedures used in wound assessment and care.
(d) Chronic wound differentiation.
(e) Risk identification.
(f) Measurement of wound.
(g) Stage of wound.
(h) Condition of the wound bed including:
(i) Tissues
(ii) Exudates
(iii) Edges
(iv) Infection
(i) Skin surrounding the wound...

610-X-6-.06 Documentation Standards

(1) The standards of documentation of nursing care provided to patients by registered nurses or licensed practical nurses are based on principles of documentation regardless of the documentation format.

(2) Documentation of nursing care shall be:
(a) Legible
(b) Accurate
(c) Complete. Complete documentation includes reporting and documenting on appropriate records a patient's status, including signs and symptoms, response, treatments, medications, other nursing care rendered, communication of pertinent information to other health team members, and unusual occurrences involving the patient... "


1. An observation of a medication pass was conducted on 4/28/15 at 8:00 AM. The surveyor observed Employee Identifier (EI) # 5, Licensed Practical Nurse (LPN) prepare medications for MR # 22. EI # 5 stated the following medications were at MR # 22's bedside and being administered from his/her home medications: Flonase, Valsartan and Arimidex (Chemotherapy drug). EI # 5 picked up the bottle of Arimidex and stated, "She is out of this. There are no refills".

Review of the MR revealed MR # 22 was admitted to swing bed on 4/15/15. Review of the "Progress Notes" beginning 4/16/15 revealed, "Arimidex tab (tablet) 1 mg (milligram) routine omitted absent from unit".

An interview was conducted on 4/29/15 at 1:46 PM with EI # 4, Director of Nurses (DON) who confirmed MR # 22 had not had the Arimidex since being admitted to the swing bed unit on 4/15/15. There was no documentation the physician was notified.



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2. MR # 22 was admitted to a swing bed on 4/15/15 with the diagnosis of Cerebrovascular Accident.

Review of the 4/15/15 Physician's Order revealed orders to discontinue IV (intravenous) Benadryl and accuchecks (blood glucose by fingerstick) QID (4 times a day).

Review of the MR revealed no orders for IV fluids, IV medications, or IV flushes.

Review of the 4/15/15 Patient Progress Note (PPN) for 6:00 PM revealed nursing IV documentation to include, "# 20 to right forearm. Patent. Flushes easily."

Review of the 4/16/15 PPN for 6:45 AM revealed nursing documentation to include, "IV, # 20 to LFA (left forearm); no infiltration / erythema noted."

Review of the 4/16/15 PPN for 6:15 PM revealed no documentation regarding the patient's IV.

The next PPN for 4/17/15 at 5:56 AM revealed nursing documentation of "IV, #20, to LFA, no infiltration / erythema noted."
There was no further documentation of IV found for 4/17/15.

Review of the 4/18/15 PPN revealed nursing documentation to include, "IV heplock intact in the right lower arm".

There was no documentation found the IV site was changed.

Review of the MR revealed no further documentation of the patient's IV.

Review of the MR revealed the physician treatment orders for accuchecks QID were not performed as ordered:
4/19/15 only 1 time at 11:39 AM.
4/20/15 only 3 times at 11:00 AM, 4:45 PM, and 9:44 PM.
4/22/15 only 3 times at 6:10 AM, 11:03 AM, and 4:53 PM.
4/23/15 only 2 times at 12:00 Noon and 4:30 PM.
4/24/15 only 1 time at 4:12 PM.
4/25/15 only 3 times at 7:42 AM, 10:36 AM and 8:27 PM.
4/26/15 only 3 times at 8:16 AM, 8:00 PM, and 8:45 PM.

In an interview conducted on 4/29/15 at 2:40 PM with EI # 4, it was verified the staff failed to obtain orders to flush the IV heplock, document the care of IV, obtain orders to discontinue the IV heplock, and perform the accucheck blood sugars as ordered by the physician.

3. MR # 21 was admitted to a swing bed on 4/27/15 with the diagnosis of Bilateral Deep Vein Thrombosis.

Review of the 4/27/15 and 4/28/15 Graphic Intake and Output (I & O) Record revealed documentation of the total Oral Intake as 350 milliliters (ml) for 24 hour period.

A patient interview was conducted on 4/28/15 at 8:00 AM and patient was noted to have several empty juice containers and 1/2 empty water pitcher on the overbed table.

In an interview conducted on 4/29/15 at 2:20 PM with EI # 4, verified that the patient's I & O graphic was not completed accurately.

4. MR # 28 was admitted to the facility on 1/7/15 with the diagnosis including Left Lower Lobe Pneumonia.

Review of the 1/7/15 Physician's Verbal Order at 11:13 PM revealed an order for IV fluids Normal Saline (NS) at 125 ml / hour (hr).

Review of the patient's Graphic and I & O Data reports revealed:

1/8/15- There was no IV intake documented for 11 PM to 7 AM. The patient should have received 1000 ml IV intake per physician orders.

1/10/15- There was no IV intake documented for the previous 24 hours. The patient should have received 3000 ml IV intake, per physician orders.

1/11/15- 1196 ml total IV fluid intake for the past 24 hours. The patient should have received 3000 ml for a difference of 1804 ml.

1/12/15 - 100 ml total IV fluid intake for the past 24 hours. The patient should have received 3000 ml for a difference of 2900 ml.

1/13/15 - 1125 ml total IV fluid intake for the past 24 hours. The patient should have received 3000 ml for difference of 1875 ml.

Review of the 1/10/15 6:00 PM Physician's Verbal Order revealed an order for IV fluid of Dextrose 5% and 45% NS at 100 ml/ hr.

There was no physician order found to discontinue the previous order of NS at 125 ml/ hr.

Review of the 1/8/15 Physician's Verbal Order at 3:40 AM revealed the following Skilled Nurse (SN) orders: "Wound Care
1. Clean skin tear Right trochanter with Normal Saline (NS), Pat dry.
Pack with Idioform (Iodoform), cover with dry 4 X 4 gauze. Secure with tape every day.
2. Clean decubitus to coccyx with NS, pat dry. Apply wet to dry dressing to coccyx twice a day (BID) and secure with tape.
3. Clean left buttocks with NS, dry, apply wet to dry dressing BID".

Review of 1/7/15 SN Initial Physical Assessment completed at 11:30 PM there was no documentation the patient's wounds were assessed or measured.

Review of the 1/8/15 SN Patient Progress Notes (PPN) completed at 4:00 AM, 6:58 AM, 9:41 AM, 12:04 PM, 9:25 PM, and the 1/9/15 completed at 6:54 AM revealed no documentation the patient's wounds were assessed, measured, or wound care was provided as ordered either daily or twice a day.

Review of the 1/9/15 Physician's Verbal Order at 6:54 AM revealed, "Jevity 1.5 1:00 AM, 6:00 AM, 11:00 AM, 4:00 PM, and 9:00 PM". (Jevity to be administered per tube feeding).

There was no documentation of the tube feeding Jevity 5 cans was started on 1/9/15 or that it was counted in the patient's intake.

In an interview conducted on 4/29/15 at 2:48 PM with EI # 4, it was verified the SN failed to document IV fluid intake, assess, measure, and perform wound care as ordered, or document nutritional supplement intake.

Based on review of medical records (MR), policies and procedures and interviews, it was determined the nursing staff failed to:

a) Assess vital signs per facility policy in patients receiving blood transfusion.

b) Verify and obtain physician orders for blood transfusion prior to administration.

c) Ensure blood administration documentation was completed as directed per facility policy.

This affected MR # 27, 1 of 2 patients receiving blood transfusion and had the potential to negatively affect all patients requiring blood administration in this facility.

Findings include:

Facility Policy:
Administration of Blood By Transfusion

"A. A signed order must be on the patient's chart".

Facility Policy:
Blood Transfusion

"IV. Check patient's chart for order. ...

V. Aftercare of Equipment
C. Record date, time and vital signs and signature at end of transfusion ..."

Facility Policy:
Guidelines for Blood Administration and Recipient Monitoring

"Administration and Monitoring

7. Monitor and record BP, (blood pressure) heart rate, respiratory rate and temperature ... (recommend at a minimum: prior to transfusion, after 15 minutes and at end of transfusion). Because the onset of reactions can be delayed, the patient should be observed for at least one hour after transfusion...

8. Record in the patient record ... starting and ending transfusion times".

1. MR # 27 was admitted to the facility on 2/23/15 with diagnoses including Dizziness with Weakness.

Review of the MR revealed physician orders dated 2/24/15, "T & (Type and) Cross Match 2 units PRBC (Packed Red Blood Cells)".

Review of the MR revealed a "Compatibility Report" with "Blood Unit No (number): W0416 15 003424" and a "Transfusion" record: "Date and time Began: 2/24/15 @ (at) 5:25 PM". There was no physicians order for this unit of blood.

Review of the MR revealed a "Compatibility Report" with "Blood Unit No (number): W0416 15 00 3418" and a "Transfusion" record: "Date and time Began: 2/25/15 @ (at) 4:00 AM. Time Completed:" This area was left blank.

There was no physicians order for this unit of blood. There was no documentation what time the blood transfusion was completed. There was no documentation MR # 27's vital signs were monitored at the end of transfusion or one hour post transfusion as recommended per the facility policy.

An interview was conducted on 4/29/15 at 1:50 PM with Employee Identifier (EI) # 4, Director of Nurses (DON) who confirmed the aforementioned findings.

Based on review of medical records (MR) and interview, it was determined the facility failed to obtain complete physician orders for patients admitted to swing beds in 2 of 2 MR's. This did affect MR # 22 and MR # 21, and MR # 28, 1 of 6 MR's admitted to the facility. This had the potential to negatively affect all patient's served by this facility.

1. MR # 22 was admitted to the facility with the diagnosis of Cerebrovascular Accident.

Review of the 4/15/15 Physician's Orders revealed:
"Transfer to Swing Bed.
Same Hospital Orders.
D/C (Discontinue) Benadryl IV (Intravenous)
Accucheck QID (4 times a day)."

In an interview conducted on 4/29/15 at 2:40 PM with Employee Identifier (EI) # 4, Director of Nurses (DON) verified this physician order was not complete and did not contain all medications and treatments the patient was receiving.

2. MR # 21 was admitted to a swing bed on 4/27/15 with diagnosis including Bilateral Deep Vein Thrombosis.

Review of the 4/27/15 Physician's Orders revealed, "D/C (Discontinue) Lovonox after 1:30 PM dose".

In an interview conducted on 4/29/15 at 2:20 PM with EI # 4, and verified that the Lovonox order was not complete, no dosage was indicated on the order.

3. MR # 28 was admitted to the facility on 1/7/15 with the diagnosis including Left Lower Lobe Pneumonia.

Review of the 1/9/15 Physician's Verbal Order at 6:54 AM revealed Jevity 1.5 was to be given at 1:00 AM, 6:00 AM, 11:00 AM, 4:00 PM, and 9:00 PM.

In an interview conducted on 4/29/15 at 2:48 PM with EI # 4, verified the physician failed to write complete order for route and amount of tube feeding to be administered to the patient.

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This condition level deficiency is cited based on review of the facility policies and procedures, CDC (Centers for Disease Control) safe practices for use of multi-dose vials observations, and interviews, it was determined the facility failed to ensure:


1. Pharmacy Policy and Procedure Manual is up to date. Refer to A 492

2. Hospital Formulary is current and up to date. Refer to A 492.

3. Pharmacy maintained limited access to medications and dispensed all medications ordered by the physician. Refer to A 500

4. Staff stored, dispensed, and managed medications according to the facility policy. Refer to A 502.

5. All medications and biologicals available for patients were not expired. Refer to A 505.

6. All multi-dose vials were labeled according to the facility's policy. Refer to A 505.

Refer to A 492, A500, A 502, and A 505 for additional findings.

This had the potential to negatively affect all patient served by the facility.

Based on review of policy and procedures, medical record (MR), and interview, it was determined that the facility failed to:

1. Ensure the pharmacy policies were up to date.
2. Ensure the formulary was up to date.

This affected MR # 28, 1 of 8 MR admitted to the facility and had the potential to affect all patients in the facility.

Findings include:

Facility Policy:
Pharmacy Policy and Procedure Manual and Formulary
Revised 3/2/15

Infection Control Policy

"(B) Drug Room
Area counter tops are to be cleaned daily with Hibiclens at the end of the night shift and periodically during the day as needed.

(C) I.V. Solutions...
4. Hands are to be washed with a suitable disinfectant such as Betadine prior to compounding."

1. MR # 28 was admitted to the facility on 1/7/15 with a diagnosis including Left Lower Lobe pneumonia.

Review of the 1/7/15 Physician's Order at 10:00 PM revealed an order for Levaquin 500 mg (milligrams) Intravenous Piggy Back (IVPB) Daily.

Review of the MR revealed MR # 28 was administered Levaquin 500 mg IVPB on 1/10/15 at 8:51 AM.

Review of the patient home medications and discharge medication profile revealed Norco 5/ 325 mg.

Review of the facility formulary did not contain the aforementioned medications.

Further review of the facility formulary revealed the medications Darvocet, Lortab, and Ipecac were listed as current medications. The surveyor questioned Employee Identifier (EI) # 7, Pharmacist if the above mentioned medications were still in use.

In an interview conducted on 4/29/15 at 11:00 AM with EI # 7, and it was verified:
1. That the pharmacy policies needed to be updated and stated policies would be updated with the use of the Omnicell.
2. Hibiclens / Betadine were not in use at this time for cleaning as stated per policy.
3. Darvocet, Lortab and Ipecac have been discontinued and were no longer available for patient use.

Based on review of facility policy and procedure, "Refrigerator Temp (Temperature) Log", observations and staff interview, it was determined the facility failed to:

a) Ensure refrigerator temperatures were monitored on all refrigerators utilized for medication storage.

b) Ensure medications requiring storage in a refrigerator or "in a cool place" were refrigerated as directed per policy.

c) Develop and implement a policy for home medication verification.

This had the potential to affect all patients served by the facility.

Findings include:

Policy:
Title: Storage of Medications
Reviewed: 1/08

"Purpose: To provide for the proper and safe storage of medications in clinical area.

Policy: Medications will be stored under proper conditions following manufacturer's recommendations of those of the supplier.

Procedures:

2. ...Medications requiring storage "in a cool place" are refrigerated unless otherwise directed on the label.

4. Temperatures are checked and documented every shift".

1. During the tour of the Emergency Department (ED) Trauma Room on 4/27/15 at 8:40 AM with the Employee Identifier (EI) # 2, Registered Nurse (RN) Quality Manager/Infection Control, the medication refrigerator revealed storage of Anectine and Lorazepam in locked boxes.

Review of the "Refrigerator Temp Log" for January thru April 2015 revealed there were no temperatures documented for 7AM to 7PM and 7PM to 7AM from 4/1/15 to 4/14/15.

An interview was conducted on 4/27/15 at 9:15 AM with EI # 2 who confirmed the above mentioned findings.

2. During a medication pass observation on 4/28/15 at 8:00 AM with EI # 5, the Licensed Practical Nurse (LPN), Valsartan 320 milligrams (mg) and Flonase 50 micrograms (mcg) were administered from MR # 22's home prescription bottle that was sitting on the bedside table in the patients room.

During an interview on 4/29/15 at 2:00 PM with EI # 4, Director of Nurses (DON) verified the home medications should not be left in the patient's room. EI # 4 was asked how patient home prescription medications are verified as accurate before dosing. EI # 4 stated the pharmacist is supposed to look at them.

Review of the policies and procedures submitted on 4/29/15 at 1:00 PM by EI # 4 revealed there was no policy for home medication verification.

Based on review of pharmacy policy and procedure manual, observations and interview it was determined the facility failed to:

a. safely store medications scheduled for administration.

b. ensure the Pharmacist limited access to medications and dispensed all medications to be administered.

This affected MR # 22, 1 of 8 MR's admitted to the facility and had the potential to negatively affect all patients served by this facility.

Findings include:

Department of Pharmacy
Subject: Storage of Drugs
Reviewed: 1/08

"Policy:

...Only authorized personnel on hospital business should be allowed in the drug room."


1. During a tour of the facility conducted on 4/27/15 at 8:45 AM the surveyor found the nursing medication room to be filled with wall to wall and ceiling to floor shelves filled with multi - dose containers of medications used for the patient's scheduled medications along with the Laminar Hood for IV preparation.

2. MR # 22 was admitted to a swing bed on 4/15/15 with the diagnosis including Cerebrovascular Accident.

During the observation of a medication pass on 4/27/15 at 2:55 PM with Employee Identifier (EI) # 10, Registered Nurse (RN), was observed in the nursing medication room to take a bottle of Hydralzine 25 milligrams (mg) off the shelf and put 2 tablets into a medication cup to administer to patient.

The surveyor questioned EI # 10, if the pharmacy had prepared the medications and placed in the patient's medication drawer for the staff to dispense to the patient.

EI # 10, checked the medication drawer and found the medications in a clear plastic bag, labeled by pharmacy. EI # 10 responded, "Oh yeah, that will help in the morning."

The nursing staff dispensed medications for patient administration.

In an interview conducted on 4/29/15 at 2:40 PM with EI # 4, Director of Nurses (DON), verified the above mentioned findings.

Based on review of policy and procedure, Centers for Disease Control and Prevention, observations and interview, it was determined the facility failed to ensure:

a) all biologicals in patient treatment areas were not expired.

b) all biologicals in use were correctly labeled.

This had the potential to negatively affect patients receiving care at this facility.

Findings include:

Department of Pharmacy
Subject: Storage of Drugs
Reviewed: 1/08

Policy:

"Drug storage must meet the manufacturer's recommendations as to temperature storage. The storage area must be properly locked. ...All drugs ... must be under locked storage at all times.

...Drugs requiring refrigeration must be stored in a refrigerator or a separate compartment of the refrigerator capable of maintaining a required temperature.

...Only authorized personnel on hospital business should be allowed in the drug room.

...Drugs are to be stored free from moisture and under proper sanitation, temperature, light, segregation, and security".

Department of Pharmacy
Subject: Outdated Drugs
Reviewed: 1/08

Policy:

"Drugs throughout the hospital are inspected monthly by the Consultant Pharmacist and/or his designate for outdate drugs. Drugs that are outdated or that will expire before the next inspection are pulled from stock and placed in a designated area for return for credit. Controlled drugs that are out of date or that will expire will before the next inspection are pulled from the stock and locked in the cabinet in the drug room".


Centers for Disease Control and Prevention

4. "When should multi-dose vials be discarded?

Medication vials should always be discarded whenever sterility is compromised or questionable.
In addition, the United States Pharmacopeia (USP) General Chapter 797 [16] recommends the following for multi-dose vials of sterile pharmaceuticals:
If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial."


1. During the tour of the Emergency Department (ED) Trauma Room on 4/27/15 at 8:40 AM with the Employee Identifier (EI) # 1, Registered Nurse (RN) Quality Manager/Infection Control, the following medications were found expired:

Adult Crash Cart
Phenylephrine Hydrochloride (HCL) Injection (Inj) 10 milligrams (mg)/ milliliter (ml) times (x) 10 vials expired (exp) 1/15
Lidocaine HCL 1 % 10 mg/ml (50ml) x 1 vial exp 3/15
Sodium Chloride (NACL) 0.9% 100 ml x 1 exp 9/14
5% Dextrose and 0.9% NACL1000 ml x 1 exp 3/15

Refrigerator
Anectine 200 mg/10 ml x 2 exp 3/15
Lorazepam 2 mg/ml Inj vial x 8 exp 2/15

Wall Cabinet
Nitroglycerin 25 mg in 5% Dextrose Inj 250 ml x 2 exp 3/15

An interview was conducted on 4/27/15 at 11:50 AM with EI # 1 who confirmed the above mentioned findings.



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2. A tour of the facility was conducted on 4/27/15 at 8:45 AM. The following items were found to be expired or open with no date opened labeled on the container.

Patient Nutrition Room:
15- 8 ounce (oz) cans of Jevity 1.2 Cal (Calorie) expired 4/1/15.

Storage Room beside pharmacy and nursing station:
Lantus Insulin 10 ml vial opened with no date.
Humulin R Insulin 10 ml vial opened with no date.
Humulin 70/30 Insulin 10 ml vial opened with no date.
Levemir Insulin 10 ml vial opened with no date.
Alcohol 70% 32 oz plastic bottle expired 10/20/10.
Spray bottle with written label Alcohol for cleaning hood (no date placed in the spray bottle or an expiration date).

Pharmacy:
Albuterol Sulfate 2 mg / 5 ml 16 oz bottle expired 3/15.
6- Lorazepam 20 mg / 10 ml vials expired 3/14.
7- Anectine 200 mg / 10 ml vials expired 3/15.
29- Racepinephrine Inhalation Solution 2.25 % / 0.5 ml expired 1/15.
12- Promethazine Suppositories 12.5 mg expired 2/15.
8- Bisacodyl Suppositories 10 mg expired 2/15.
Sterile Water 50 ml vial open and expired 8/14.

Nursing Medication Room Refrigerator:
2- Diltazam 25 mg / 5 ml vial open with no date.
3- Famotidine 40 mg / 4 ml vials open with no date.
Lantus insulin 10 ml vial open with no date.
Novolin 70/30 Insulin 10 ml vial open labeled with 3/26/15 and a discharged patient's name.
Levemir Insulin 10 ml vial labeled with a discharged patient's name and no date the insulin was opened.

Nursing Medication Room Narcotic Cabinet:
16- Lortab 500 mg / 5 mg tablets labeled with 2/15 expiration date.
19- Ambien 10 mg tablets labeled with 3/15 expiration date.

Room 122 - Nuclear Medicine Testing:
Sodium Chloride 0.9% 200 ml bag of IV fluid 3/4 empty.
Extension tubing open with clear liquid noted in the line.
Syringe 10 ml with 5 ml of clear fluid.
Alcohol 70% 16 oz bottle open with no date.

The above mentioned expired or open medication vials with no date labeled were verified with EI # 4 on 4/27/15 at 9:50 AM.

On 4/28/15 at 9:30 AM the surveyor observed the expired 15 cans of Jevity were still in the patient nutrition room.

This was verified with EI # 4 at the time of the tour.

Based on United States Health Public Food Code 2009 regulations, observations and interview, it was determined the hospital failed to ensure food was stored in a safe and sanitary manner.

This had the potential to negatively affect all patients.

Findings include:

United States Health Public Food Code 2009

3-501.17 Ready-to-Eat, Potentially Hazardous Food
(Time/Temperature Control for Safety Food),
Date Marking.
...commercially processed food open and hold cold
(B) Except as specified in (D) - (F) of this section, refrigerated, ready-to-eat, potentially hazardous food (time/temperature control for safety food) prepared and packaged by a food processing plant shall be clearly marked, at the time the original container is opened in a food establishment and if the food is held for more than 24 hours, to indicate the date or day by which the food shall be consumed on the premises, sold, or discarded, based on the temperature and time combinations specified in (A) of this section and: (1) The day the original container is opened in the food establishment shall be counted as Day 1; and (2) The day or date marked by the food establishment may not exceed a manufacturer's use-by date if the manufacturer determined the use-by date based on food safety...

(C) A refrigerated, ready-to-eat, potentially hazardous food (time/temperature control for safety food) ingredient or a portion of a refrigerated, ready-to-eat, potentially hazardous food (time/temperature control for safety food) that is subsequently combined with additional ingredients or portions of food shall retain the date marking of the earliest- prepared or first prepared ingredient.

(D) A date marking system that meets the criteria stated in (A) and (B) of this section may include:...
(2) Marking the date or day of preparation, with a procedure to discard the food on or before the last date or day by which the food must be consumed on the premises, sold, or discarded as specified under (A) of this section;
(3) Marking the date or day the original container is opened in a food establishment, with a procedure to discard the food on or before the last date or day by which the food must be consumed on the premises, sold, or discarded as specified under (B) of this section...


During a tour of the Dietary Department on 4/27/15 at 10:40 AM with Employee Identifier (EI) # 9, Dietary Manager, the surveyor observed opened food containers with no dates, food items which had expired and inappropriately stored food items.

The following items were opened with no date:

Plastic ziplock bag containing gallon size tea bags.
16 ounce (oz) box of Honey Nut Cheerios.
5 pound bag of grits.
32 oz container of Half & Half.
Plastic container of cubed Cantaloupe with sell by date 4/23/15.

The following expired items were found in the kitchen cooler:

Cooked grilled chicken with label 4/19/15 discard 4/20/15.
Cooked rice with label 4/23/15 discard 4/27/15.
Jelly with label 4/18/15 discard 4/21/15.
Chopped ham for omelet with label 4/20/15 discard 4/22/15.
Chopped cucumbers with label 4/22/15 discard 4/27/15.
Sliced tomatoes with label 4/23/15 discard 4/27/15.
Pickle slices with label 4/25/15 discard 4/25/15.
Chopped pork with label 4/25/15 discard 4/26/15.

Review of the cooked food temperature logs revealed no documentation the temperatures were taken of food before serving to patients for the following meal / date times:

4/13/15 Monday Dinner meal.
4/14/15 Tuesday Dinner meal.
4/15/15 Wednesday Dinner meal.
4/21/15 Tuesday Lunch meal.

In an interview conducted on 4/28/15 at 2:54 PM with EI # 9, the aforementioned findings were verified.

Based on review of medical record (MR) and interview the facility failed to perform nutritional assessment for a patient with feeding tube and decubitus ulcers. This affected MR # 28, 1 of 1 patients with a feeding tube and decubitus ulcers and had the potential to affect all patients served by this facility.

Findings include:

1. MR # 28 was admitted to the facility on 1/7/15 with the diagnosis including Left Lower Lobe Pneumonia.

Review of the 1/7/15 Initial Physical Assessment performed at 11:00 PM revealed documentation of "Dietary Consult: Consult for dehydration, Decubiti".

Further review of the MR revealed MR # 28 had a feeding tube and pressure ulcer's to the coccyx area.

Review of the MR revealed no documentation a Dietary Consult was performed for this patient with a feeding tube and multiple wounds.

In an interview conducted on 4/29/15 at 2:48 PM with Employee Identifier # 4, Director of Nurses, verified there was no documentation of consult or follow up.

Based on observations during a facility tour with hospital staff by the Fire Safety Compliance Officer and staff interviews, it was determined that the facility was not constructed, arranged and maintained to ensure patient safety.



Findings include:

Refer to Life Safety Code violations.
Refer to A 701 for additional findings.

Based on review of equipment, observations and interview it was determined the facility failed to maintain preventive maintenance (PM) on all equipment in the hospital. This had the potential to affect all patients served.

Findings include:

1. A tour of the Emergency Department (ED) was conducted by the surveyor 4/27/15 at 8:40 AM to 11:45 AM with Employee Identifier (EI) # 2, Registered Nurse (RN) Quality Manager/Infection Control, The surveyor observed the following with no PM sticker or an unreadable PM sticker:

Triage Room
Welch Allyn Otoscope and Ophthalmoscope: No PM sticker

Trauma Room
Suction Machine: an unreadable PM sticker
Glidescope: no PM sticker

Treatment Room # 2
Welch Allyn Otoscope and Ophthalmoscope: No PM sticker

Treatment Room # 4
Welch Allyn Otoscope and Ophthalmoscope: No PM sticker
PulmoAide (Compressor/Nebulizer): No PM sticker

In an interview with EI # 4, Director of Nurses (DON) at 2:30 PM on 4/29/15 confirmed the aforementioned.

Based on observations, review of facility policies and procedures, manufacturer's directions for use of the "Comply SteriGage Steam Chemical Integrator" sterilizer, Autoclave Log Report, and interviews, it was determined the staff failed to:

a) follow and perform hand hygiene and gloving per facility policy. This affected (MR) # 22 and MR # 23.

b) follow the facility policy and procedure for cleaning of equipment (blood glucose monitor) after patient use. This affected medical record (MR) # 22.

c) follow the facility policy and procedure for decontamination and assembly of instrument trays.

d) follow the manufacturer's directions for use of the "Comply SteriGage Steam Chemical Integrator" sterilizer.

This had the potential to negatively affect all patients receiving care in this faciltiy.

Findings include:

Facility Policy: Handwashing
Revised: 12/19/14

"Purpose: Handwashing is the single most important procedure for preventing the spread of infection to a patient, ... Associates are to wash their hands:
1. Before applying and after removing gloves.
2. Before and after any clean or invasive procedures.
3. After contact with blood or body fluids".

Facility Policy: Standard Universal Precautions
Revised: 12/19/14

"Procedure:

The following guidelines must be practiced as a part of routine patient care activities.
A. Handwashing:

All health care workers are expected to
wash their hands ... immediately after touching blood, body fluids ... Hands should be washed immediately after removing gloves ...

B. Gloves:
...Gloves should be promptly removed after use, before touching non-contaminated items or environmental surfaces ..."

Facility Policy: Instrument Trays, Decontamination and Assembly of

"III. Process:

All instruments and trays received from the Emergency department or other areas of the hospital will be considered contaminated when they enter the decontamination area.

2. All trays and instruments are to be placed in an enzymatic solution to aid in the cleaning.
...f. The person who is assembling the tray will place their name and date on the internal instrument count sheet, with an internal autoclave indicator and wrap in a sequential manner in the designated material or rigid container. The tray will then be placed on a rack for sterilization..."

3M Comply SteriGage
Steam Chemical Integrators

"Instructions For Use
2. Place a Comply 1243A or 1243B steam chemical integrator in each pack, peel pouch, container system or tray to be steam sterilized in the area determined to be the least accessible to steam penetration.

3. Process the load ...

4. After processing, the dark color should have entered the ACCEPT window ... IF the dark color has not entered the ACCEPT window, a REJECT result is indicated and the items in the pack, peel pouch, ... or tray were not exposed to sufficient steam sterilization conditions. These items should be returned for reprocessing."

Facility Policy: Cleaning of Equipment/Exterior
Revised: 12/12/14

"Purpose:

To ensure that patient care equipment is cleaned appropriately, routinely and managed in a safe and sanitary manner.

Policy:

Each department is responsible for cleaning all non-critical patient care equipment that may be effectively cleaned/disinfected where it is used....

Procedure:

A. Don clean gloves ...
B. With damp washcloth, thoroughly wipe down equipment until all visible matter is removed.
C. Use Sani-cloth disinfectant wipe to thoroughly clean exterior of equipment. ..."

Policy: Intravenous Infusion
Date: (No date)

"IV. Procedure:

...N. 2. Insertion of External Catheter Needles (jelco ... medicut; quick-cath)
...11. Place date, size of needle on tape and put on dressing. ...

VI. Daily Care:
A. Change IV dressing daily:
...3. Relabel dressing with date of original insertion."

1. During a medication pass observation on 4/28/15 at 8:00 AM with EI # 5, the Licensed Practical Nurse (LPN), retrieved a tray from the clean supply area which contained an accucheck monitor and supplies. EI # 5 performed hand hygiene, applied gloves and then performed a blood glucose on MR # 22 with the accucheck monitor. EI # 5 then placed the accucheck monitor inside the tray without cleaning/disinfecting after use. EI # 5 proceeded to remove his/her gloves and administered MR # 22's medications. EI # 5 did not perform hand hygiene after removing his/her gloves as directed per the facility policy.

An interview was conducted on 4/29/15 at 9:30 AM with EI # 2, Registered Nurse, Quality Manager/Infection Control and 1:42 PM EI # 4, Director of Nurses (DON) who confirmed the aforementioned findings.

2. During tour of the Central Supply area on 4/28/15 at 12:50 PM with EI # 6, Central Supply Technician and EI # 2, the surveyor observed a Comply SteriGage Steam Chemical Integrator (autoclave) in the main area of the supply room. The surveyor asked EI # 6 how often chemical and biological indicators were performed.

EI # 6 stated that a chemical indicator was performed 1 x (times) a month and a "test load with indicator" (chemical indicators placed in the autoclave and a test run performed prior to a load being ran). EI # 6 confirmed that the facility did not place a chemical indicator in the instrument packs in every load.

EI # 6 stated that the facility has biological indicator packs, "but I don't use those here." Review of the Autoclave log report revealed there was no documentation of a weekly biological indicator performed.

An interview was conducted on 4/29/15 at 10:30 AM with EI # 2 who confirmed the above mentioned findings.


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3. MR # 23 was admitted to the facility on 4/27/15 with diagnoses including Altered Mental Status, Alzheimer's Dementia, and Dehydration.

During the observation of a medication pass on 4/27/15 at 2:40 PM with EI # 10, Registered Nurse (RN), obtained the patient's antibiotic, Levaquin 500 milligrams (mg) and tubing in the nursing medication room and spiked the bag and applied label to the tubing. EI # 10 then entered the patient's room and connected the antibiotic to the pump. EI # 10 failed to perform hand hygiene before connecting the tubing to the bag of antibiotic or connecting to the patient's IV pump.

The surveyor observed the patient had Sodium Chloride 0.9% 1000 milliliter (ml) bag infusing at 75 cc / hour (hr). There was no label on the IV fluids to indicate the start date and or time.

In an interview conducted on 4/29/15 at 2:40 PM with EI # 4, DON, verified the RN failed to perform hand hygiene or correctly label the IV fluids.

4. MR # 22 was admitted to a swing bed on 4/15/15 with the diagnosis including Cerebrovascular Accident.

During the observation of a medication pass on 4/27/15 at 2:55 PM with EI # 10, RN, was observed in the medication room to take a bottle of Hydralzine 25 mg off the shelf and put 2 tablets into a medication cup to administer to patient.

EI # 10 then took the medication to the patient's room and administered the tablets. EI # 10 failed to perform hand hygiene before preparing or administering the medication to the patient.

In an interview conducted on 4/29/15 at 2:40 PM with EI # 4, verified EI # 10 failed to perform hand hygiene per policy.

Based on a review of personnel files and interview, it was determined the facility failed to ensure staff responsible for central sterilization was trained and competent to perform sterilization procedures.

This had the potential to negatively affect all patients in this facility.

Findings include:

A tour of the Central Sterilization Department on 4/28/15 at 12:50 PM was conducted with Employee Identifier (EI) # 6, the Central Supply Technician. The surveyor asked EI # 6 what type of training had been conducted with him/her regarding the sterilization process. EI # 6 replied, "just what I have gotten on my own". EI # 2, Registered Nurse, Quality Manager/Infection Control whom was also present, stated, "we have been trying to get the company to come and inservice her (EI # 6)".

Review of EI # 6's, personnel file revealed a Job Position Description dated 12/15/14 which read, "Prepares and sterilizes needed supplies as necessary. ... Operates autoclave and other patient care care equipment". There was no documentation of training or competency related to sterilization procedures and the use of the autoclave.

An interview was conducted on 4/29/15 at 10:30 AM with EI # 2 who confirmed the above mentioned findings.

Based on review of medical records (MR), agency policy, and staff interviews it was determined the agency failed to initiate or complete discharge planning for patients identified as needing home health services.

This affected MR # 24, # 25, and # 27, 3 of 8 patients admitted to the facility, and had the potential to affect all patients served.

Findings include:

Greene County Hospital
Policy : Discharge Planning
Reviewed 12/07

"Discharge planning shall be available to each patient and family...

Procedure:...
3. A discharge planning evaluation shall be initiated on each patient soon possible after admission but within 24 hours.

Post Hospital Referrals to Home Health Agencies

Procedure:
1. Identity patients that are receiving Home Health on admission.
2. Identify patients that are potential adjudicates for referral to Home Health post hospitalization.
3. Discuss with established Home Health patients the choice of returning to that agency or changing to a new agency.
5. Have the Freedom of Choice form signed indicating the patient's/family preference. This becomes a part of the medical record.
6. At discharge a copy of the discharge summary along with any other pertinent or requested information is sent to the selected agency by the discharge planner or designee."

1. MR # 24 was admitted to the facility on 2/28/15 with diagnoses including Syncope and Hypertension and discharged on 3/2/15.

Review of the 3/2/15 Initial Discharge Planning Assessment revealed the discharge assessment was not completed within 24 hours of admission.

Review of the MR revealed a Home Health referral was performed. There was no documentation a Patient's Rights Freedom of Choice Form was signed by the patient.

In an interview conducted on 4/29/15 at 12:05 PM with Employee Identifier (EI) # 11, Discharge Planner, the above mentioned findings were verified.

2. MR # 25 was admitted to the facility on 12/1/14 with diagnosis including Cellulitis and discharged on 12/6/14.

Review of the MR revealed no documentation the Initial Discharge Planning Assessment Form or a Freedom of Choice Form for Home Health was completed or signed by the patient requiring home health services.

In an interview conducted on 4/29/15 at 12:05 PM with EI # 11, the above mentioned findings were verified.

3. MR # 27 was admitted to the facility on 2/23/15 with diagnoses including Dizzy / Weakness.

Review of the MR revealed no documentation the Initial Discharge Planning Assessment Form or a Freedom of Choice Form for Home Health was completed or signed by the patient requiring home health services.

In an interview conducted on 4/29/15 at 12:05 PM with EI # 11, the above mentioned findings were verified.

Based on interviews and review of swing bed records the hospital failed to an assure activity assessment was developed for the patients and failed to follow through by providing activities to swing bed patients.

This affected Medical Record (MR) # 22, 1 of 2 swing bed MR's reviewed. This had the potential to affect all patients served in the swing bed unit.

Findings include:

1. MR # 22 was admitted to a swing bed on 4/15/15 with the diagnosis of Cerebrovascular Accident.

Review of the MR revealed there was no documentation of an activity assessment, planned activities or offer of any group activities to increase social interaction performed by Employee Identifier (EI) # 12, Activity Director.

There was no documentation or refused activities in the medical record.

In an interview conducted with the patient on 4/28/15 at 12:45 PM the surveyor asked the patient if any activities had been discussed and / or provided. The patient replied, "Not that I know of." The patient's nephew was present during the interview.

In an interview conducted on 4/29/15 at 2:40 PM with EI # 4, Director of Nurses, it was verified there was no documentation of a plan for activities.

Based on observation, medical record review, policy and procedure review, Alabama Board of Nursing Standards of Practice and interview, it was determined the nursing staff failed to ensure:

1. Patients received all ordered medications, treatments, and nutritional supplements.
2. Wound assessments were conducted timely.
3. Wound care was provided according to the physician's orders.
4. Physician's orders were obtained for care and maintenance of intravenous (IV) heparin (hep) lock.

This affected Medical Record (MR) # 22, MR # 21 and MR # 28, 3 of 8 admitted patient MR reviewed. And had the potential to negatively affect all patients served by the facility.

Findings include:

Facility Policy
Accuracy and Timeliness of Medical Record
Documentation
Written 1/1/14

Policy:
1. A complete, legible and accurate paper and / or electronic medical record will be maintained for every individual who is evaluated or treated as an inpatient, outpatient, or emergency patient at Greene County Hospital...

6. A patient's record is complete when the following criteria are met:
A medical history and physical examination...
Properly executed informed consent forms.
Practitioners' orders, nursing notes, reports of treatment, medication records...vital signs and other information necessary to monitor the patient's condition.

Alabama Board of Nursing Chapter 610-X-6
Standards of Nursing Practice

610-x-6-.13 Standards for Wound Assessment and Care

(1) It is within the scope of a registered nurse or licensed practical nurse practice to perform wound assessments including, but not limited to, staging of a wound and making determinations as to whether wounds are present on admission to a healthcare facility pursuant to an approved standardized procedure...

(2) The minimum training for the registered nurse or licensed practical nurse that performs selected tasks associated with wound assessment and care shall include:
(a) Anatomy, physiology and pathophysiology.
(c) Equipment and procedures used in wound assessment and care.
(d) Chronic wound differentiation.
(e) Risk identification.
(f) Measurement of wound.
(g) Stage of wound.
(h) Condition of the wound bed including:
(i) Tissues
(ii) Exudates
(iii) Edges
(iv) Infection
(i) Skin surrounding the wound...

610-X-6-.06 Documentation Standards

(1) The standards of documentation of nursing care provided to patients by registered nurses or licensed practical nurses are based on principles of documentation regardless of the documentation format.

(2) Documentation of nursing care shall be:
(a) Legible
(b) Accurate
(c) Complete. Complete documentation includes reporting and documenting on appropriate records a patient's status, including signs and symptoms, response, treatments, medications, other nursing care rendered, communication of pertinent information to other health team members, and unusual occurrences involving the patient... "


1. An observation of a medication pass was conducted on 4/28/15 at 8:00 AM. The surveyor observed Employee Identifier (EI) # 5, Licensed Practical Nurse (LPN) prepare medications for MR # 22. EI # 5 stated the following medications were at MR # 22's bedside and being administered from his/her home medications: Flonase, Valsartan and Arimidex (Chemotherapy drug). EI # 5 picked up the bottle of Arimidex and stated, "She is out of this. There are no refills".

Review of the MR revealed MR # 22 was admitted to swing bed on 4/15/15. Review of the "Progress Notes" beginning 4/16/15 revealed, "Arimidex tab (tablet) 1 mg (milligram) routine omitted absent from unit".

An interview was conducted on 4/29/15 at 1:46 PM with EI # 4, Director of Nurses (DON) who confirmed MR # 22 had not had the Arimidex since being admitted to the swing bed unit on 4/15/15. There was no documentation the physician was notified.



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2. MR # 22 was admitted to a swing bed on 4/15/15 with the diagnosis of Cerebrovascular Accident.

Review of the 4/15/15 Physician's Order revealed orders to discontinue IV (intravenous) Benadryl and accuchecks (blood glucose by fingerstick) QID (4 times a day).

Review of the MR revealed no orders for IV fluids, IV medications, or IV flushes.

Review of the 4/15/15 Patient Progress Note (PPN) for 6:00 PM revealed nursing IV documentation to include, "# 20 to right forearm. Patent. Flushes easily."

Review of the 4/16/15 PPN for 6:45 AM revealed nursing documentation to include, "IV, # 20 to LFA (left forearm); no infiltration / erythema noted."

Review of the 4/16/15 PPN for 6:15 PM revealed no documentation regarding the patient's IV.

The next PPN for 4/17/15 at 5:56 AM revealed nursing documentation of "IV, #20, to LFA, no infiltration / erythema noted."
There was no further documentation of IV found for 4/17/15.

Review of the 4/18/15 PPN revealed nursing documentation to include, "IV heplock intact in the right lower arm".

There was no documentation found the IV site was changed.

Review of the MR revealed no further documentation of the patient's IV.

Review of the MR revealed the physician treatment orders for accuchecks QID were not performed as ordered:
4/19/15 only 1 time at 11:39 AM.
4/20/15 only 3 times at 11:00 AM, 4:45 PM, and 9:44 PM.
4/22/15 only 3 times at 6:10 AM, 11:03 AM, and 4:53 PM.
4/23/15 only 2 times at 12:00 Noon and 4:30 PM.
4/24/15 only 1 time at 4:12 PM.
4/25/15 only 3 times at 7:42 AM, 10:36 AM and 8:27 PM.
4/26/15 only 3 times at 8:16 AM, 8:00 PM, and 8:45 PM.

In an interview conducted on 4/29/15 at 2:40 PM with EI # 4, it was verified the staff failed to obtain orders to flush the IV heplock, document the care of IV, obtain orders to discontinue the IV heplock, and perform the accucheck blood sugars as ordered by the physician.

3. MR # 21 was admitted to a swing bed on 4/27/15 with the diagnosis of Bilateral Deep Vein Thrombosis.

Review of the 4/27/15 and 4/28/15 Graphic Intake and Output (I & O) Record revealed documentation of the total Oral Intake as 350 milliliters (ml) for 24 hour period.

A patient interview was conducted on 4/28/15 at 8:00 AM and patient was noted to have several empty juice containers and 1/2 empty water pitcher on the overbed table.

In an interview conducted on 4/29/15 at 2:20 PM with EI # 4, verified that the patient's I & O graphic was not completed accurately.

4. MR # 28 was admitted to the facility on 1/7/15 with the diagnosis including Left Lower Lobe Pneumonia.

Review of the 1/7/15 Physician's Verbal Order at 11:13 PM revealed an order for IV fluids Normal Saline (NS) at 125 ml / hour (hr).

Review of the patient's Graphic and I & O Data reports revealed:

1/8/15- There was no IV intake documented for 11 PM to 7 AM. The patient should have received 1000 ml IV intake per physician orders.

1/10/15- There was no IV intake documented for the previous 24 hours. The patient should have received 3000 ml IV intake, per physician orders.

1/11/15- 1196 ml total IV fluid intake for the past 24 hours. The patient should have received 3000 ml for a difference of 1804 ml.

1/12/15 - 100 ml total IV fluid intake for the past 24 hours. The patient should have received 3000 ml for a difference of 2900 ml.

1/13/15 - 1125 ml total IV fluid intake for the past 24 hours. The patient should have received 3000 ml for difference of 1875 ml.

Review of the 1/10/15 6:00 PM Physician's Verbal Order revealed an order for IV fluid of Dextrose 5% and 45% NS at 100 ml/ hr.

There was no physician order found to discontinue the previous order of NS at 125 ml/ hr.

Review of the 1/8/15 Physician's Verbal Order at 3:40 AM revealed the following Skilled Nurse (SN) orders: "Wound Care
1. Clean skin tear Right trochanter with Normal Saline (NS), Pat dry.
Pack with Idioform (Iodoform), cover with dry 4 X 4 gauze. Secure with tape every day.
2. Clean decubitus to coccyx with NS, pat dry. Apply wet to dry dressing to coccyx twice a day (BID) and secure with tape.
3. Clean left buttocks with NS, dry, apply wet to dry dressing BID".

Review of 1/7/15 SN Initial Physical Assessment completed at 11:30 PM there was no documentation the patient's wounds were assessed or measured.

Review of the 1/8/15 SN Patient Progre

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This condition level deficiency is cited based on review of the facility policies and procedures, CDC (Centers for Disease Control) safe practices for use of multi-dose vials observations, and interviews, it was determined the facility failed to ensure:


1. Pharmacy Policy and Procedure Manual is up to date. Refer to A 492

2. Hospital Formulary is current and up to date. Refer to A 492.

3. Pharmacy maintained limited access to medications and dispensed all medications ordered by the physician. Refer to A 500

4. Staff stored, dispensed, and managed medications according to the facility policy. Refer to A 502.

5. All medications and biologicals available for patients were not expired. Refer to A 505.

6. All multi-dose vials were labeled according to the facility's policy. Refer to A 505.

Refer to A 492, A500, A 502, and A 505 for additional findings.

This had the potential to negatively affect all patient served by the facility.

Based on review of policy and procedure, Centers for Disease Control and Prevention, observations and interview, it was determined the facility failed to ensure:

a) all biologicals in patient treatment areas were not expired.

b) all biologicals in use were correctly labeled.

This had the potential to negatively affect patients receiving care at this facility.

Findings include:

Department of Pharmacy
Subject: Storage of Drugs
Reviewed: 1/08

Policy:

"Drug storage must meet the manufacturer's recommendations as to temperature storage. The storage area must be properly locked. ...All drugs ... must be under locked storage at all times.

...Drugs requiring refrigeration must be stored in a refrigerator or a separate compartment of the refrigerator capable of maintaining a required temperature.

...Only authorized personnel on hospital business should be allowed in the drug room.

...Drugs are to be stored free from moisture and under proper sanitation, temperature, light, segregation, and security".

Department of Pharmacy
Subject: Outdated Drugs
Reviewed: 1/08

Policy:

"Drugs throughout the hospital are inspected monthly by the Consultant Pharmacist and/or his designate for outdate drugs. Drugs that are outdated or that will expire before the next inspection are pulled from stock and placed in a designated area for return for credit. Controlled drugs that are out of date or that will expire will before the next inspection are pulled from the stock and locked in the cabinet in the drug room".


Centers for Disease Control and Prevention

4. "When should multi-dose vials be discarded?

Medication vials should always be discarded whenever sterility is compromised or questionable.
In addition, the United States Pharmacopeia (USP) General Chapter 797 [16] recommends the following for multi-dose vials of sterile pharmaceuticals:
If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial."


1. During the tour of the Emergency Department (ED) Trauma Room on 4/27/15 at 8:40 AM with the Employee Identifier (EI) # 1, Registered Nurse (RN) Quality Manager/Infection Control, the following medications were found expired:

Adult Crash Cart
Phenylephrine Hydrochloride (HCL) Injection (Inj) 10 milligrams (mg)/ milliliter (ml) times (x) 10 vials expired (exp) 1/15
Lidocaine HCL 1 % 10 mg/ml (50ml) x 1 vial exp 3/15
Sodium Chloride (NACL) 0.9% 100 ml x 1 exp 9/14
5% Dextrose and 0.9% NACL1000 ml x 1 exp 3/15

Refrigerator
Anectine 200 mg/10 ml x 2 exp 3/15
Lorazepam 2 mg/ml Inj vial x 8 exp 2/15

Wall Cabinet
Nitroglycerin 25 mg in 5% Dextrose Inj 250 ml x 2 exp 3/15

An interview was conducted on 4/27/15 at 11:50 AM with EI # 1 who confirmed the above mentioned findings.



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2. A tour of the facility was conducted on 4/27/15 at 8:45 AM. The following items were found to be expired or open with no date opened labeled on the container.

Patient Nutrition Room:
15- 8 ounce (oz) cans of Jevity 1.2 Cal (Calorie) expired 4/1/15.

Storage Room beside pharmacy and nursing station:
Lantus Insulin 10 ml vial opened with no date.
Humulin R Insulin 10 ml vial opened with no date.
Humulin 70/30 Insulin 10 ml vial opened with no date.
Levemir Insulin 10 ml vial opened with no date.
Alcohol 70% 32 oz plastic bottle expired 10/20/10.
Spray bottle with written label Alcohol for cleaning hood (no date placed in the spray bottle or an expiration date).

Pharmacy:
Albuterol Sulfate 2 mg / 5 ml 16 oz bottle expired 3/15.
6- Lorazepam 20 mg / 10 ml vials expired 3/14.
7- Anectine 200 mg / 10 ml vials expired 3/15.
29- Racepinephrine Inhalation Solution 2.25 % / 0.5 ml expired 1/15.
12- Promethazine Suppositories 12.5 mg expired 2/15.
8- Bisacodyl Suppositories 10 mg expired 2/15.
Sterile Water 50 ml vial open and expired 8/14.

Nursing Medication Room Refrigerator:
2- Diltazam 25 mg / 5 ml vial open with no date.
3- Famotidine 40 mg / 4 ml vials open with no date.
Lantus insulin 10 ml vial open with no date.
Novolin 70/30 Insulin 10 ml vial open labeled with 3/26/15 and a discharged patient's name.
Levemir Insulin 10 ml vial labeled with a discharged patient's name and no date the insulin was opened.

Nursing Medication Room Narcotic Cabinet:
16- Lortab 500 mg / 5 mg tablets labeled with 2/15 expiration date.
19- Ambien 10 mg tablets labeled with 3/15 expiration date.

Room 122 - Nuclear Medicine Testing:
Sodium Chloride 0.9% 200 ml bag of IV fluid 3/4 empty.
Extension tubing open with clear liquid noted in the line.
Syringe 10 ml with 5 ml of clear fluid.
Alcohol 70% 16 oz bottle open with no date.

The above mentioned expired or open medication vials with no date labeled were verified with EI # 4 on 4/27/15 at 9:50 AM.

On 4/28/15 at 9:30 AM the surveyor observed the expired 15 cans of Jevity were still in the patient nutrition room.

This was verified with EI # 4 at the time of the tour.

Based on observations, review of facility policies and procedures, manufacturer's directions for use of the "Comply SteriGage Steam Chemical Integrator" sterilizer, Autoclave Log Report, and interviews, it was determined the staff failed to:

a) follow and perform hand hygiene and gloving per facility policy. This affected (MR) # 22 and MR # 23.

b) follow the facility policy and procedure for cleaning of equipment (blood glucose monitor) after patient use. This affected medical record (MR) # 22.

c) follow the facility policy and procedure for decontamination and assembly of instrument trays.

d) follow the manufacturer's directions for use of the "Comply SteriGage Steam Chemical Integrator" sterilizer.

This had the potential to negatively affect all patients receiving care in this faciltiy.

Findings include:

Facility Policy: Handwashing
Revised: 12/19/14

"Purpose: Handwashing is the single most important procedure for preventing the spread of infection to a patient, ... Associates are to wash their hands:
1. Before applying and after removing gloves.
2. Before and after any clean or invasive procedures.
3. After contact with blood or body fluids".

Facility Policy: Standard Universal Precautions
Revised: 12/19/14

"Procedure:

The following guidelines must be practiced as a part of routine patient care activities.
A. Handwashing:

All health care workers are expected to
wash their hands ... immediately after touching blood, body fluids ... Hands should be washed immediately after removing gloves ...

B. Gloves:
...Gloves should be promptly removed after use, before touching non-contaminated items or environmental surfaces ..."

Facility Policy: Instrument Trays, Decontamination and Assembly of

"III. Process:

All instruments and trays received from the Emergency department or other areas of the hospital will be considered contaminated when they enter the decontamination area.

2. All trays and instruments are to be placed in an enzymatic solution to aid in the cleaning.
...f. The person who is assembling the tray will place their name and date on the internal instrument count sheet, with an internal autoclave indicator and wrap in a sequential manner in the designated material or rigid container. The tray will then be placed on a rack for sterilization..."

3M Comply SteriGage
Steam Chemical Integrators

"Instructions For Use
2. Place a Comply 1243A or 1243B steam chemical integrator in each pack, peel pouch, container system or tray to be steam sterilized in the area determined to be the least accessible to steam penetration.

3. Process the load ...

4. After processing, the dark color should have entered the ACCEPT window ... IF the dark color has not entered the ACCEPT window, a REJECT result is indicated and the items in the pack, peel pouch, ... or tray were not exposed to sufficient steam sterilization conditions. These items should be returned for reprocessing."

Facility Policy: Cleaning of Equipment/Exterior
Revised: 12/12/14

"Purpose:

To ensure that patient care equipment is cleaned appropriately, routinely and managed in a safe and sanitary manner.

Policy:

Each department is responsible for cleaning all non-critical patient care equipment that may be effectively cleaned/disinfected where it is used....

Procedure:

A. Don clean gloves ...
B. With damp washcloth, thoroughly wipe down equipment until all visible matter is removed.
C. Use Sani-cloth disinfectant wipe to thoroughly clean exterior of equipment. ..."

Policy: Intravenous Infusion
Date: (No date)

"IV. Procedure:

...N. 2. Insertion of External Catheter Needles (jelco ... medicut; quick-cath)
...11. Place date, size of needle on tape and put on dressing. ...

VI. Daily Care:
A. Change IV dressing daily:
...3. Relabel dressing with date of original insertion."

1. During a medication pass observation on 4/28/15 at 8:00 AM with EI # 5, the Licensed Practical Nurse (LPN), retrieved a tray from the clean supply area which contained an accucheck monitor and supplies. EI # 5 performed hand hygiene, applied gloves and then performed a blood glucose on MR # 22 with the accucheck monitor. EI # 5 then placed the accucheck monitor inside the tray without cleaning/disinfecting after use. EI # 5 proceeded to remove his/her gloves and administered MR # 22's medications. EI # 5 did not perform hand hygiene after removing his/her gloves as directed per the facility policy.

An interview was conducted on 4/29/15 at 9:30 AM with EI # 2, Registered Nurse, Quality Manager/Infection Control and 1:42 PM EI # 4, Director of Nurses (DON) who confirmed the aforementioned findings.

2. During tour of the Central Supply area on 4/28/15 at 12:50 PM with EI # 6, Central Supply Technician and EI # 2, the surveyor observed a Comply SteriGage Steam Chemical Integrator (autoclave) in the main area of the supply room. The surveyor asked EI # 6 how often chemical and biological indicators were performed.

EI # 6 stated that a chemical indicator was performed 1 x (times) a month and a "test load with indicator" (chemical indicators placed in the autoclave and a test run performed prior to a load being ran). EI # 6 confirmed that the facility did not place a chemical indicator in the instrument packs in every load.

EI # 6 stated that the facility has biological indicator packs, "but I don't use those here." Review of the Autoclave log report revealed there was no documentation of a weekly biological indicator performed.

An interview was conducted on 4/29/15 at 10:30 AM with EI # 2 who confirmed the above mentioned findings.


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3. MR # 23 was admitted to the facility on 4/27/15 with diagnoses including Altered Mental Status, Alzheimer's Dementia, and Dehydration.

During the observation of a medication pass on 4/27/15 at 2:40 PM with EI # 10, Registered Nurse (RN), obtained the patient's antibiotic, Levaquin 500 milligrams (mg) and tubing in the nursing medication room and spiked the bag and applied label to the tubing. EI # 10 then entered the patient's room and connected the antibiotic to the pump. EI # 10 failed to perform hand hygiene before connecting the tubing to the bag of antibiotic or connecting to the patient's IV pump.

The surveyor observed the patient had Sodium Chloride 0.9% 1000 milliliter (ml) bag infusing at 75 cc / hour (hr). There was no label on the IV fluids to indicate the start date and or time.

In an interview conducted on 4/29/15 at 2:40 PM with EI # 4, DON, verified the RN failed to perform hand hygiene or correctly label the IV fluids.

4. MR # 22 was admitted to a swing bed on 4/15/15 with the diagnosis including Cerebrovascular Accident.

During the observation of a medication pass on 4/27/15 at 2:55 PM with EI # 10, RN, was observed in the medication room to take a bottle of Hydralzine 25 mg off the shelf and put 2 tablets into a medication cup to administer to patient.

EI # 10 then took the medication to the patient's room and administered the tablets. EI # 10 failed to perform hand hygiene before preparing or administering the medication to the patient.

In an interview conducted on 4/29/15 at 2:40 PM with EI # 4, verified EI # 10 failed to perform hand hygiene per policy.