HospitalInspections.org

Based on observation, interview and policy review the facility staff failed to provide personal privacy for two of two patients (#6 and #17). Patient #6 was observed exposed while sitting on a commode and Patient #17 was observed exposed while lying in bed. Patients have the right to personal privacy when toileting or when they are unable to cover themselves from public view. The facility census was 33.

Findings included:

1. Record review of the facility's policy titled "Patient Rights", revised 04/20/10, showed the following:
- The patient has the right to be treated with dignity and respect;
- The patient has the right to personal privacy.

2. Observation on 11/02/11 at 9:10 AM showed Patient #6 sitting on a commode (portable toilet) naked from the waist down and in full view of the public with the door wide open. All rooms in this unit have full glass doors and all of the patients are acutely ill; unable to ambulate, toilet themselves, etc.

During an interview on 11/02/11 at 9:10 AM, Staff A, Chief Executive Officer, stated that she also observed the patient was exposed while toileting and in public view and that the patient should not have been visible to others.

During an interview on 11/02/11 at 9:20 AM, Staff AA, Registered Nurse (RN), stated he/she knew the curtain was too short in Patient #6's room so he/she put a trash can beside the patient thinking it would block anyone from seeing the patient.



04467

3. Observation on 11/02/11 at 8:50 AM showed an exposed patient (Patient #17) in
a room with the entrance door open and privacy curtain pulled back. The patient was lying flat on the bed with eyes closed and night gown pulled up. The patient's thigh was exposed to everyone passing by from the hallway. The patient had bilateral soft wrist restraints attached to the bed and was not able to cover him/herself.

Based on interview, record review and policy review the facility failed to have physician orders for one patient (#20) of four patients with restraints. All patients must have orders written by the physician each episode restraints are applied. The facility census was 33.

Findings included:

1. Record review of the facility's policy titled "Use of Restraints and Seclusion", dated 04/09, showed the following:
-Each order for restraint used to ensure the physical safety of the non-violent or non-self-destructive patient may be renewed as authorized by hospital policy;
-A Physician renewing the original order or issuing a new order authorizes continued use of the restraint beyond the first 24 hours if restraint use continues to be clinically justified;
-The renewal or new order is issued no less often than 24 hours and is based upon an assessment of the patient by the physician. The physician documents the order on the Physician Order Form.

2. Record review of Patient #20's medical record showed the following:
-Restraint orders written on 10/28, 10/30, 10/31, 11/01;
-Nurses documented restraint checks for the days of 10/27, 10/28, 10/29, 10/30, 10/31, 11/01;
There were no physician orders for two days (10/27 and 10/29) when Patient #20 was in restraints.

During an interview on 11/02/11 at 1:45 PM, Staff BB, Director of Quality Assurance, confirmed there were no physician orders for restraints for Patient #20 on 10/27/11 and 10/29/11.

Based on observation, interview, record review and policy review facility staff failed to:
- Follow the facility's policy and procedure to document on the Medication Administration Record (MAR, a record which allows all personnel to be aware of the patient's medication administration status) why medications were held or not administered for one patient (#20) of eight patients observed and the facility failed to
-Administer the correct dosage of medication to one patient (#5) of eight patients observed. Medication doses not administered as ordered can be potentially harmful to the patient.

1. Record review of facility's policy titled "Medication Administration", 06/01/05, showed the following:
- Medication Administration Record (MAR) shall be checked for completeness and accuracy;
- Medications shall be administered as ordered. Dosages or methods of administration are not to be altered without the order of the Physician.
- Personnel administering medication must verify that the medication is being administered at the proper time, in the prescribed dose, and by the correct route.

2. Observation on 11/01/11 at 9:10 AM showed Staff Z, Registered Nurse (RN) administered Ciprofloxin (antibiotic used to treat bacterial infections) 500 milligram (mg) orally (po) one tablet to Patient #5.

Record review of Patient #5's medical record showed the following:
-A physician order dated 10/27/11 to change Ciprofloxacin to 250 mg. po q (every) 12 hours through 11/09/11;
-The MAR showed Ciprofloxacin Tab 250 mg Cipro po 0.5 tab x 500 mg/each twice a day.

During an interview on 11/02/11 at 1:45 PM, Staff BB, Director of Quality Assurance and Performance Improvement, confirmed that the medication was the incorrect dose.

3. Record review of Patient #20's MAR showed the preprinted times for medication administration were circled, indicating the medications were not administered. Further record review of the patient's medical record showed no documentation as to why the medications were not given.

During an interview on 11/1/11 at 9:15 AM, Staff Z, RN stated that the times are circled on the MAR if the mediations were not given, and Patient #20 had nothing ordered by mouth shortly after having a tube feeding tube removed. Staff Z further stated that a reason for holding a medication should be documented on the MAR or somewhere in the chart as to why the patient did not receive medications.


27029

4. During an interview on 11/02/11 at 9:44 AM, Staff BB, Director of Quality Assurance and Performance Improvement stated he/she could see the system of medication administration was broken.

During an interview on 11/02/11 at 9:15 AM, Staff Y, Doctor of Pharmacy (Pharm. D), Director of Pharmacy, stated he/she didn't know that nursing wasn't following policy and procedure for documenting if medications were held. Staff Y stated that he agreed that the system was broken if the information wasn't getting back to Pharmacy.

Based on observation, interview, record review and policy review the facility failed to have orders for restraints signed, dated and timed for one (Patient #20) of four patients with restraints. All patients must have orders written by the physician each episode restraints are applied. The facility census was 33.

Findings included:

1. Record review of the facility's policy titled "Use of Restraints and Seclusion", dated 04/09, showed the following:
-Each order for restraint used to ensure the physical safety of the non-violent or non-self-destructive patient may be renewed as authorized by hospital policy;
-A Physician renewing the original order or issuing a new order authorizes continued use of the restraint beyond the first 24 hours if restraint use continues to be clinically justified;
-The renewal or new order is issued no less often than 24 hours and is based upon an assessment of the patient by the physician. The physician documents the order on the Physician Order Form.

2. Record review of Patient #20's medical record showed the following:
-Staff documented restraint checks on 10/30/11.
-Restraint order on 10/30/11 was not signed, dated and timed by the physician.

During an interview on 11/02/11 at 1:45 PM, Staff BB, Director of Quality Assurance and Performance Improvement, confirmed that the restraint order is not signed, dated and timed on 10/30/11.

Based on observation, interview, record review and policy review the facility failed to provide proper hand washing areas for staff performing in-room dialysis for one patient (#1) of one patient observed on dialysis. The facility also failed to follow the facility's policies on hand hygiene, Personal Protective Equipment (PPE) and Acute Dialysis Services Agreement for seven (Patients #1, #2, #6, #7, #15, #20 and #21) of nine patients observed and failed to disinfect the diaphragm of four vials before withdrawing medication for one patient (#20) of one patient observed. The facility also failed to serve one patients' (#31) of seven patients' lunch meal in a sanitary manner. The facility census was 33.

Findings included:

1. Record review of the facility's policy titled "Infection Control, Hand Hygiene", revised 04/2011, showed the following:
- Hand Hygiene - a general term that applies to either handwashing, antiseptic hand wash, alcohol-based hand rub or surgical hand hygiene/antisepsis [destruction or slow growth of microorganisms (very small living substances invisible without a microscope];
- Handwashing - refers to washing hands with plain soap and water. Handwashing with soap and water remains a sensible strategy for hand hygiene and is recommended by Centers of Disease Control (CDC) and other experts;
- Hand hygiene is indicated: before donning gloves; after removing gloves; when caring for a patient diagnosed with a spore disease such as Clostridium difficile [C. diff, a a serious spore forming gastrointestinal infection that causes severe diarrhea] hand hygiene should be completed with soap and water;
- Hand hygiene must be performed between glove changes and when gloves are removed.
This policy follows the CDC's 2002 Guideline for Hand Hygiene in Health-care Settings.

2. Record review of the facility's policy titled "Infection Control, Guideline for Isolation Precautions", revised 08/11, showed the following:
- Spread of infection within a hospital requires three elements: a source of infecting microorganisms, a susceptible host and a means of transmission for the microorganism;
- Source, Human sources of the infecting microorganisms in hospitals may be patients, personnel, or, on occasion, visitors and may include persons with acute disease;
- Transmission, Contact Transmission, the most important and frequent mode of transmission of Nosocomial (acquired while in the hospital) infections, is divided into two subgroups: direct-contact transmission and in-direct-contact transmission.
- Direct-contact transmission involves a direct body surface to body surface contact and physical transfer of microorganisms between a susceptible host and an infected person;
- Indirect-contact transmission involves contact of a susceptible host with a contaminated object. Contaminated gloves that are not changed between patients;
- Isolation precautions are designed to prevent transmission of microorganisms by these routes in hospitals;
- Hand hygiene is frequently called the single most important measure for preventing spread of infection;
- Performing hand hygiene as promptly and thoroughly as possible between patient contacts and after contamination is an important component of infection control and isolation precautions. In addition to hand hygiene, gloves play an important role in the prevention of the spread of infection;
- Wearing gloves does not replace the need for hand hygiene because: Gloves may have small defects and hands can become contaminated during removal of gloves;
- Gowns and Protective Apparel, Various types of gowns and protective apparel are worn to provide barrier protection and reduce opportunities for transmission of microorganisms [infection] in hospitals;
- Gowns are also worn by personnel during the care of patients infected with epidemiologically important microorganisms to reduce the opportunity for transmission of pathogens from patients or items in their environment to other patients or environments. When gowns are worn for this purpose, they are removed before leaving the patient's environment and hand hygiene performed.
- Contact Precautions are designed to reduce the risk of transmission on epidemiologically important microorganisms by direct or indirect contact. Direct contact transmission involves skin-to-skin contact and physical transfer of microorganisms - such as direct patient care;
- Contact Precautions, in addition to wearing gloves when entering the room, during the course of providing care for a patient, change gloves after having contact with infective material. Remove gloves before leaving the patient's room and perform hand hygiene immediately;
- Source: CDC for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings.

3. Record review of the facility contract titled "ACUTE DIALYSIS SERVICES AGREEMENT, Infectious Conditions: VRE (Vancomycin-Resistant Enterococcus, Enterococci are bacteria that are naturally present in the intestinal tract of all people. Vancomycin is an antibiotic to which some strains of enterococci have become resistant. These resistant strains are referred to as VRE), MRSA (Methicillin-resistant Staphylococcus aureus is a strain of a common infection-causing bacterium that has become resistant to treatment by the antibiotic Methicillin and is therefore a hazard in places such as hospitals), Clostridium Difficile", Number: 16 dated 09/11 showed the following:
- Patients with VRE, MRSA, and /or C. diff will be dialyzed with extreme infection control precautions;
- Good hand-washing/sanitizing technique must be followed after any contact with the patient;
- Staff must assure that all personnel coming into the room are following infection control policies. This would include physicians, social workers, therapists and family members;
- Handwashing Procedure, use hospital approved soap and water.

4. The following is a direct reference from the Centers for Disease Control and Prevention Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007:
I.B.3.a.ii. Indirect contact transmission involves the transfer of an infectious agent through a contaminated intermediate object or person. In the absence of a point-source outbreak, it is difficult to determine how indirect transmission occurs. However, extensive evidence cited in the Guideline for Hand Hygiene in Health-Care Settings suggests that the contaminated hands
of healthcare personnel are important contributors to indirect contact transmission.
Examples of opportunities for indirect contact transmission include:
Clothing, uniforms, laboratory coats, or isolation gowns used as personal
protective equipment (PPE), may become contaminated with potential pathogens
after care of a patient colonized or infected with an infectious agent, (e.g., MRSA, VRE 89, and C. difficile 90.

I.C.1.a. C.difficile C. difficile is a spore-forming gram positive anaerobic bacillus
that was first isolated from stools of neonates in 1935 165 and identified as the
most commonly identified causative agent of antibiotic-associated diarrhea and
pseudomembranous colitis in 1977 166. Important factors that contribute to healthcare-associated outbreaks include environmental contamination, persistence of spores for prolonged periods of time, resistance of spores to routinely used disinfectants and antiseptics, hand carriage by healthcare personnel to other patients, and exposure of patients to frequent
courses of antimicrobial agents.

COMPONENTS OF A PROTECTIVE ENVIRONMENT
HAND HYGIENE
Perform hand hygiene immediately after removing all PPE!
Hand hygiene following glove removal further ensures that the hands will not carry potentially infectious material that might have penetrated through unrecognized tears or that could
contaminate the hands during glove removal.

5. Observation on 11/02/11 at 5:45 AM showed Staff P, Registered Nurse (RN), Contracted Dialysis Nurse, had connected the line delivering fresh water to the dialysis machine to the faucet of the hand washing sink in Patient #1's room next to the exit door. The patient had been diagnosed with C. diff and MRSA and the patient's diarrhea was so severe a fecal tube (a flexible hose placed in the anus that deposits the waste into a bag) was placed to contain the feces.

Observation on 11/02/11 at 6:04 AM showed Staff Q, Respiratory Therapist, entered Patient #1's room and donned gloves but did not wear PPE equipment as required by facility policy and CDC Guidelines for a patient with C. diff. Staff Q touched Patient #1 and adjusted the patient's Tracheostomy (surgical hole in front of neck into windpipe to help with breathing). Staff Q removed the gloves and used alcohol-based hand hygiene instead of washing his/her hands with soap and water. Alcohol-based cleanser does not kill the highly infectious spores of C. diff.

Observation on 11/02/11 from 6:10 AM to 7:00 AM showed Staff P, RN, Contract Dialysis Nurse changed gloves five times and did not perform hand hygiene before, after, or between glove changes. At 7:00 AM Staff P removed the gloves and PPE clothing and exited the room walking approximately 12 feet to the nurses' station and washed his/her hands with soap and water. The practice of leaving the patient's room to wash hands with soap and water increases the likelihood of spreading the C. diff infection.

Observation on 11/02/11 at 7:00 AM, showed Staff B, RN, Chief Clinical Officer, removed his/her PPE clothing and gloves and exited the room walking approximately 12 feet to the nurses' station to wash his/her hands with soap and water.

Document review of facility infection control policy titled "Guidelines for Isolation Precautions" dated August 2011 showed gowns and protective apparel, when worn by personnel for protection during the care of epidemiologically important microorganisms, are to be removed before leaving the patient's room and hand hygiene performed.

During an interview on 11/02/11 at 7:15 AM, Staff B, RN, Chief Clinical Officer stated that there is another sink in the patient's bathroom but it cannot be accessed by the lines of the dialysis machine because they are too short and the staff doesn't use it to wash their hands because it is so far from the patient's door.

Observation on 11/02/11 at 1:00 PM showed Patient #1 had been moved to Room 214 that provided an ante room (entry room: a subsidiary room that opens into a larger room) that contained a hand washing sink area for staff to wash hands before and after patient contact and another sink inside the room to use for a dialysis water source.

6. Observation on 10/31/11 at 2:13 PM showed Staff E, Certified Nurse Assistant (CNA), assigned to Patient #7 for one-on-one observation. Patient #7 was on contact isolation for MRSA and Staff E was wearing PPE clothing but did not tie the facial mask in place and allowed the mask to hang below his/her nose and mouth which did not provide protection.

During an interview on 10/31/11 at 2:13 PM, Staff B, RN, Chief Clinical Officer stated the facial mask should be tied securely to cover the CNA's nose and mouth.

During an interview on 10/31/11 at 3:02 PM, Staff E stated, "I should have worn it [PPE clothing] correctly and tied the mask as soon as I entered the room".

7. Observation on 10/31/11 at 2:18 PM showed family of Patient #2 in the patients contact isolation room without PPE equipment on. Patient #2 was in contact isolation for MRSA. Staff C, RN, staff nurse spoke to the family and they put on the PPE clothing but did not tie the protective gowns which did not protect their clothing.

During an interview on 10/31/11 at 2:18 PM, Staff B, RN, Chief Clinical Officer (CCO) stated that everybody does education but it is my expectation that the nurse would instruct the family to wear PPE properly.

During an interview on 10/31/11 at 2:25 PM, Staff C, RN, staff nurse, stated the family was very difficult to work with and refused to wear the PPE clothing or wear it correctly while visiting. Staff C stated that the PPE clothing should be worn by everyone visiting patients in contact isolation and should be worn correctly.

8. Observation on 10/31/11 at 2:18 PM showed Staff D, Respiratory Therapist, enter the room of Patient #1 on contact isolation for MRSA and C. diff. Staff D did not wash his/her hands before entering the room and did not put on PPE clothing or gloves while in the patients room. Staff D exited the patient's room and did not use hand hygiene.

During an interview on 10/31/11 at 2:30 PM, Staff D stated, "I crossed the boundary, I should have washed my hands and put on PPE. The organisms probably attach to your clothing".

9. Observation on 10/31/11 at 3:05 PM showed Staff C, RN, Staff Nurse and Staff E, CNA, replacing a fecal tube for Patient #1. The fecal tube had been expelled from the patient's rectum and feces were all over the patient and bed. The patient was diagnosed as having MRSA and C. diff. Staff E did not wash hands with soap and water between glove changes and the gloves were visibly contaminated with feces.

10. Observation on 11/02/11 at 6:04 AM showed Patient #1 with a fecal bag and urinary catheter bag stored and touching in a plastic wash pan under the patient's bed. The fecal bag containing feces infected with C. diff could potentially contaminate the urinary catheter bag and allow infectious organisms to infiltrate the patient's urinary tract via the catheter tubing.

During an interview on 11/02/11 at 7:00 AM, Staff B, RN, CCO, stated the bags should not be touching and should not be stored in the same container.

11. Observation on 11/02/11 at 9:15 AM showed a staff person going into Patient #6's room and putting on PPE clothing. Patient #6 was on contact isolation for MRSA. The PPE gown was not tied and when the staff leaned over the patient the gown fell forward and down the arms exposing the staff person's clothing and skin to the infectious organisms.

During an interview on 11/02/11 at 9:15 AM, Staff BB, Director of Quality Assurance and Performance Improvement identified the staff person in Patient #6's room as Staff CC, Medical Doctor (MD), Pulmonologist, and stated Staff BB did not tie the PPE gown. Staff BB stated that the facility's physicians are supposed to be champions when it comes to infection control.

12. During an interview on 11/03/11 at 9:10 AM, Staff DD, RN, Infection Control Nurse, stated that handwashing was monitored three to four times per week and stated that respiratory staff are noncompliant with hand hygiene and PPE use. Staff DD stated that handwashing, contact isolation procedures and wearing of PPE had been problems that had already been identified and they had meetings to discuss it.

Staff DD stated that the situation with the dialysis procedure where the primary sink was used as the water source and did not allow staff to wash with soap and water was the identical problem that they had before. Staff DD stated, "I wasn't aware that it was happening".


04467




29079

13. Observation on 11/01/11 at 9:45 AM showed the following:
-Staff V, Respiratory Therapist (RT) providing Tracheostomy care to Patient #21 in Contact Isolation with gown and gloves on;
-Staff V had to get supplies from down the hallway, and removed his/her gown at the patient's bedside laying it across the bedside table, got the supplies, then walked into patients room put on the gown that was laying on the bedside table and proceeded with Tracheostomy care reusing the same isolation gown;
-Staff V removed his/her gloves, put on clean gloves and cleaned the skin under the Tracheostomy Tube. He/she did not use hand hygiene between glove changes.

During an interview on 11/01/11 at 9:45 AM with Staff BB, Quality Director stated that he/she could not believe what he/she had seen Staff V doing, and stopped Staff V to tell him/her what was observed. Staff BB then mentioned that the respiratory staff will need to be reeducated on the isolation process.

14. Observation on 11/02/11 at 9:30 AM showed Staff X, RN administering Heparin 4000 units Intravenous Bolus (IVP) to Patient #20 in contact isolation. Staff X reached under his/her isolation gown, into his/her scrub pocket for an alcohol wipe to cleanse the IV port prior to injecting the medication and did not change gloves or sanitize hands.

During an interview on 11/02/11 at 9:30 AM with Staff B, Chief Clinical Officer (CCO) stated that Staff X, RN reached under his/her isolation gown and should have changed gloves before administering IVP medication.

15. Observation on 11/01/11 at 2:30 PM showed that the facilities second floor had nine contact isolation rooms (#205, #208, #209, #210, #211, #212, #214, #215, and #216) of 11 contact isolation rooms with the trash receptacle located at the foot of the patient beds in the contaminated portion of the patient room. Removal of PPE needs to be discarded out of the contaminated part of the patient room at the exit to avoid contamination of clothing.

16. Record review of the Association for Professionals in Infection Control and Epidemiology (APIC) titled "Safe Injection, Infusion, and Medication Vial Practices in Health Care", dated 04/10, showed to use aseptic technique in all aspects of medication vial use by cleansing the access diaphragm of vials using friction with an approved antiseptic swab, and allow the diaphragm to dry before inserting any device into the vial.

17. Observation on 11/02/11 at 9:15 AM showed Staff X, RN House Supervisor, drawing up Heparin (drug given to thin blood) from four small medication vials to be administered to Patient #20. Staff X flipped the protective cap off the vials and proceeded to withdraw the heparin into the syringe without scrubbing the top of the vial with alcohol.

During an interview on 11/02/11 at 9:20 AM, Staff B, RN, Chief Clinical Officer confirmed the vials of heparin should be cleansed with alcohol before withdrawing the contents, and that the rubber stopper on the vial is not considered sterile. Staff X, RN, House Supervisor was present when Staff B confirmed that the top of the vials should be cleansed prior to withdrawing the contents.











05760

18. Observations on 11/01/11 at 1:10 PM showed Staff O, CNA, in Patient #15's isolation room moving the patient's bedside table and assisting him/her to the bathroom. Staff O wore green scrubs and disposable gloves, but did not wear a disposable gown. The sign posted outside of the patient's room indicated one entering the room must wear disposable gloves and a disposable gown.

Record review of Patient #15's medical record showed patient was placed on isolation for VRE.

19. Observation on 11/02/11 at 12:53 PM showed Staff T, CNA, took Patient #31's lunch tray into the room. On the way out of the room, Staff T picked up a dirty tray off the patient's sink and put it on the cart with Patient #4 and Patient #5's clean lunch trays still on the cart. Staff T attempted to get one of the two trays left on the cart off the cart and Staff FF, Certified Dietary Manager (CDM), stopped Staff T and told him/her that he/she had just contaminated the two trays on the cart and could not serve them to the patients. Staff FF told Staff T that new trays had to be ordered for Patients #4 and #5.

20. During an interview on 11/02/11 at 12:55 PM, Staff T stated that he/she normally waited until he/she served all the trays from the cart before he/she put dirty ones back on the cart or he/she would take the dirty tray to the soiled room.





12943

21. Observation on 11/01/11 at 9:20 AM, in the room of Patient #15, showed a contact isolation room for VRE. The housekeeper, Staff R, walked out of the patient's room wearing an isolation gown and exam gloves after cleaning the patient's room. Staff R walked to his/her cleaning cart in the hall outside of the patient's room and proceeded to remove the isolation gown and gloves and discharged them in the trash container in the cleaning cart. Staff R failed to sanitize his/her hands and began touching surfaces of the cleaning cart. Contact isolation signs were present at the entrance to the patient's room in the hall.

During an interview on 11/01/11 at 9:30 AM Staff R stated that he/she should have removed the isolation gown and gloves while in the patient's room and placed them in the container for soiled isolation items and should have sanitized his/her hands.

22. During an interview on 11/02/11 at 11:30 AM, Staff S, Housekeeping Supervisor, stated that when housekeepers enter rooms listed as isolation precautions, they are required to gown and glove with PPE the same as visitors or staff must do, and reverse the process upon exit, discarding the PPE gown and gloves in the waste receptacle in the patients room before crossing the threshold out of the room.

Based on review of the Quality Assurance Performance Improvement (QAPI) program, interviews, record reviews, medication variance reviews, policy review, and risk management review, the hospital failed to track high-risk, problem-prone medication errors related to insulin, failed to investigate the severity of insulin medication errors and failed to implement improvement actions to improve the safe use of insulin in six ( #22, #23, #34,
#35, #37, #38) of seven patients reviewed. Having a blood sugar that is too low or too high can result in serious complications including damage to organs of the body, coma and death. This failure has the potential to affect all patients requiring insulin administration. The facility census was 33.

Findings included:

1. Review of the policy titled "Risk Management"; Policy Number: RM 502; Origination Date: 11/02; Revised Date 04/10; Page one, Procedure, (A) Definition: A sentinel event is defined as an unexpected occurrence involving death or serious physical or psychological injury, or risk thereof. All sentinel events must have a Root Cause Analysis completed. Serious injury specifically includes loss of limb or function. The phrase "or risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome.

Record review of the Pharmacies Services policy, titled, "Medication Safety High-Alert Medications"; Policy: PCS-10-05; Effective Date: January 2009; showed: The pharmacy will implement strategies designed to prevent the misuse of High-Risk Medications. High-Risk or High-Alert medications are those drugs involved in a high percentage of medication errors and/or sentinel events and medications that carry a higher risk for abuse, error, or other adverse outcomes. The policy identified insulin as a high risk drug.

2. Record review of the QAPI reports for 2011 showed no identification of tracking medication errors of high risk drugs such as Insulin. Medication variances (any incorrect or wrongful administration of a medication) data failed to include the type of drugs involved in the medication variances.

3. Record review of medication incident reports for dates 04/12/11 to 10/05/11 showed eight of sixty medication errors were insulin administration related as follows:

A) Incident report dated 04/12/11 for Patient #22 showed the patient received Lantus Insulin (a long-acting insulin, given once daily to help control blood sugar levels) 70 units (the number of active insulin units in each milliliter [ml] of the medication) when the physician had ordered Lantus Insulin 20 units. A review of the clinical record showed the nurse administered 50 units too much Lantus Insulin on 04/12/11 at 3:00 PM and the nurse failed to notify the prescribing physician.

During an interview on 11/02/11 at 4:17 PM Staff B, Chief Clinical Officer, stated that a review of the clinical record for Patient #22 during the survey showed:
- The staff instituted the hospital's hypoglycemic (low blood sugar) protocol after the medication error;
- The staff monitored the patient's dropping blood sugars and administered intravenous (IV) Glucose (Glucose is a type of sugar the body uses for energy) from the hospital's hypoglycemic protocol to help raise the patient's blood sugars and also administered intramuscular (IM) Glucagon (Glucagon is used to raise very low blood sugar);
-The use of the hypoglycemic protocol required a physician order. Staff B confirmed there is not a physician ordered hypoglycemic protocol for the administration of IV Glucose or the administration of IM Glucagon;
-There is no evidence the nurse notified the prescribing physician of the medication error;
-The patient's blood sugar levels were dropping on 04/13/11 after the medication error as follows:
7 AM, blood sugar of 104;
8 AM, blood sugar of 79;
9 AM, blood sugar of 75;
11 AM, blood sugar of 48;
12 PM, blood sugar of 39;
1 PM blood sugar of 44;
2 PM, blood sugar of 45;
4 PM, blood sugar of 97;
9 PM, blood sugar of 67;
11 PM, blood sugar of 50;
12 AM on 04/14/11, blood sugar of 98;
3 AM on 04/14/11, blood sugar of 44;
4 AM on 04/14/11, blood sugar of 106;
5 AM on 04/14/11, blood sugar of 63; and
6 AM on 04/14/11, blood sugar of 54.
Normal blood sugar values ranges from 70 to 99 mg/dL, (milligrams per deciliter).

Review of the clinical record for Patient #22 showed:
-on 04/12/11 at 12:30 PM the physician ordered Lantus Insulin 20 units "now" and daily;
-on 04/12/11 at 3:00 PM the nurse documented administering 70 units of Lantus Insulin;
-there are no physician orders for hypoglycemic protocol;
-on 04/13/11 at 11:30 PM the nurse documented administering 1 milligram (mg) IM Glucagon Now per hypoglycemic protocol for blood sugar of 50 at 11:15 PM;
-on 04/13/11 at 6:30 AM the nurse documented administering Dextrose (an intravenous solution of sugar) 50% IV, 50 ml, per hypoglycemic protocol for a blood sugar of 52 at 06:10 AM;
-on 04/13/11 at 6:30 PM the physician wrote in the order section, "Did they give 70 units Lantus last night instead of the 20 units I ordered? If so, please make incident report."
-on 04/14/11 at 03:30 AM the nurse documented administering Dextrose 50% IV, 50 ml, per hypoglycemic protocol for a blood sugar of 44 at 3:00 AM.

B) Review of an incident report dated 04/20/11 for Patient #22 showed a transcription error. The physician ordered 5 units of insulin before meals. Staff failed to transcribe the order onto the Medication Administration Record (MAR) from 04/17/11 to 04/20/11 and the patient did not receive the 5 units of insulin as ordered by the physician.

C) Review of an incident report dated 04/14/11 for Patient #23 showed the nurse failed to follow physician orders when the nurse failed to increase the patient's Novolog Insulin fast acting insulin) by 6 units before meals.

D) Review of an incident report dated 07/06/11 for Patient #34 showed a transcription error. The physician's insulin orders were not transferred to the MAR. The physician orders written on 07/05/11 for Novolog 4 units to be administered before lunch failed to be transcribed to the MAR. The patient missed two doses of insulin due to the errors.

E) Review of an incident report dated 08/20/11 for Patient #35 showed the nurse failed to give the patient 20 units of insulin as ordered by the physician resulting in elevated blood sugars as follows: At 7:15 AM the blood sugar was 249; at 12:15 PM the blood sugar was 233; and at 5:15 PM the blood sugar was 274. The patient missed two doses of insulin.

F) Incident report date of 08/19/11 for Patient #36 showed the Registered Nurse (RN) held the patient's insulin due to a blood sugar of 105, but the nurse failed to call the physician to report he/she did not give the insulin;

G) Review of an incident report dated 08/07/11 for Patient #37 showed the nurse failed to discontinue a previous insulin order on the MAR when a new order for Lantus Insulin was written by the physician. This resulted in two insulin orders on the MAR instead of one insulin order. This error could have resulted in the patient receiving both doses of insulin;

H) Review of an incident report of 09/12/11 for Patient #38 showed an insulin syringe was found in the patient's drawer with 25 units of clear fluid in it. The syringe had no identifying marks or labeling on the syringe.

4. Record review of the Risk Management Review dated June 2011 stated there had been no Sentinel Events to report in the second quarter of 2011 when a Sentinel Event involving 50 units too much insulin being administered did occur in the second quarter of 2011 on 04/12/11 involving Patient #22.

5. Review of the QAPI program documentation for 2011 showed the program failed to:
- Identify a trend of medication errors in insulin administration;
- Identify a sentinel event of a high risk dose of administration of insulin 50 units greater than what was ordered;
- Identify insulin medication errors as high-risk and problem-prone;
-Identify patient safety issues related to serious medication errors involving insulin;
-Identify, investigate, and develop a root cause analysis as required by the facility policy for a sentinel event.
-Identify that nurses failed to notify the prescribing physician of a high-risk medication error involving insulin;
- Identify nurses were administering IV Glucose and IM Glucagon without orders;
-Develop performance improvement actions to prevent future insulin administration errors.