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Based on policy review, document review, medical record review and interview, it was determined the facility failed to maintain an active and ongoing Quality Assessment and Performance Improvement (QAPI) program to monitor infections and the safety of services and quality of care for the patients in the dedicated emergency department (DED). Failure to have an active and ongoing QAPI program concerning infection control and the DED exposed the patients to potential for serious injury, harm and/or death resulting in IMMEDIATE JEOPARDY.

The findings included:

1. Review of the hospital's policy, "PERFORMANCE IMPROVEMENT PLAN" documented, "...The purpose of the Quality Improvement Plan is to ensure the delivery of quality patient care and to provide a means of continuously improving the quality by providing a guide for the application of Quality Assessment-Performance Improvement and Management of information...[named hospital] leaders have responsibility to actively participate in the quality improvement system...The focus of quality improvement will be on understanding and improving the processes that compose the important functions identified...Based on current knowledge and clinical experience, teams will be used to develop and select indicators for use in quality improvement activity. These indicators will be measurable, specific, objective events which will provide information useful in assessing the quality of important aspects of care or service. Departments should assure that intra-and interdepartmental indicators are developed. Actual performance evaluation measures may be directed at one or more of the dimensions of quality: appropriateness, effectiveness, what does or does not happen after a patient care function is performed or not performed, clinical criteria and/or standards of care...When the trigger is reached for evaluation, appropriate staff members or teams should evaluate care/service extensively to see if an opportunity for improvement exist...If the needed action exceeds the authority of the unit, team or committee, recommendations will be forwarded to the body having the authority to act (Quality Council)... Topics for review will include but not be limited to: Determining whether areas for improvement were identified, acted upon, and patient care and services improved..."

A. Review of the DED central logs documented Patients #8, 11, 14, 23, 24, 25, 26, 27, 28, 29, 31, 32, 33, 34, 35 and 36 were "not seen" Under the area physical exam/history/orders there was documentation of an assessment of the patient and a diagnosis which was signed by DED Physician #1 or ED Physician #2.

B. Review of the facility's "Emergency Department Staff Meeting Minutes" dated 06/27/11 documented, "...I do not know how many times I have said this, but if a Doctor or Practitioner DOES NOT see a patient, then you must document "not seen" in the space provided on the ER and logbook. We can not bill for Doctor/Practitioner if not seen. The Doctor/Practitioner is welcome to document whatever he/she wants, but we cannot bill..."

C. Review of the DED's list of indicators "ER [Emergency Room] Monitoring and Evaluation (Revised April 2000)" documented, Emergency pt [patient] is seen by a doctor and a threshold of 100%.

D. Review of the DED's "Emergency Department Monitoring & Evaluation Worksheet" dated June 2011 through November 10, 2011 contained no documentation of the indicator Emergency patient seen by a doctor.

E. Review of the facility's "Quality Council Minutes" dated 7/21/11 and dated 10/20/11 contained no documentation reflecting the 6/27/11 DED staff meeting minutes identifying the Doctor or Practitioner not seeing a patient was an opportunity for improvement.

2. Review of the hospital's policy, "Emergency Medical Treatment", documented, "Any individual who comes to the emergency department and requests examination or treatment for a medical condition is entitled to and will receive an appropriate medical screening examination (MSE) ...The medical screening examination is an ongoing process based on the patient's needs and continue until the patient is either stabilized or appropriately transferred...How to Provide the Medical Screening Examinations...The medical screening examination shall include both a generalized assessment and a focused assessment...A medical screening examination is not an isolated event. It is an on-going process. The record must reflect continued monitoring according to the patient's needs and must continue until he/she is stabilized or appropriately transferred. There should be evidence of this evaluation prior to discharge or transfer along with documentation of the process...When non-physician personnel perform the medical screening examinations, screening protocols that outline the examination and/or diagnostics workup required to determine if an emergency medical condition exits should be developed and approved by the hospital's medical staff. These protocols will normally be complaint specific and will be limited to those presented complaints that lend themselves to screening by such non-physician personnel... Emergency medical condition... A medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain and/or symptoms of substance abuse)..."

A. Review of the medical records for Patients #8, 11, 14, 23, 24, 25, 26, 27, 28, 29, 31, 32, 33, 34, 35 and 36 revealed RNs (Registered Nurse) initiated the MSE but failed to use a complaint specific protocol to determine if an emergency medical condition existed, failed to continue an ongoing assessment of the patients and failed to assess patients prior to discharge and post treatment to determine if the patients were stabilized.

B. During an interview in the conference room on 11/16/11 at 8:50 AM, the DED night supervisor stated the RN would perform an MSE on the patients presenting to the DED. The DED night supervisor stated the LPN is alone with the patients, administers medications and makes the determination when the patient is stabilized to be discharged home.

C. During an interview on 11/16/11 at 9:00 AM, the DED Supervisor stated the hospital did not have a complaint specific protocol for the RNs to use to determine if an emergency medical condition exists.

D. During an interview on 11/15/11 at 1:25 PM the DED supervisor was questioned about the DED committee meetings. The DED supervisor stated after the RN performed the medical screening examination (MSE), the RN would call the doctor that's on call in the building. If the doctor knows the patient he would prescribe medications to be given by the nurse. The ED Supervisor stated there have been times the doctor on-call does not see the patient in the DED. When asked if the DED supervisor had identified a problem with DED physician(s) not seeing patients in the DED, she stated, "Yes, I have taken it to [named Director of Clinical Services] and [named Director of Nursing], also mentioned to [named Administrative Assistant]." When questioned about the outcome of reporting her concerns, the DED supervisor stated, "It [practice] continues." The DED supervisor was asked where the physician is when the nurse calls regarding the patient, she stated, "...at night in doctors lounge, he's [physician] asleep...may come back later that shift and document..."
E. During an interview in the conference room on 11/16/11 at 10:35 AM, the DED supervisor was asked who she made aware of her concerns of patients in the DED receiving treatment and not being seen by a physician. The DED supervisor stated, "[named DON] and named [Director of Clinical Services]. When asked if she had the documentation of tracking and trending of her concerns, she stated, "No...I notice it on there [the DED record] when I do audits making sure we have not billed at a physician level. I check billing every day...I have no tracking and trending audits of that..." The DED supervisor stated the supervisors and administration had not communicated back to her regarding her concerns.
F. There was no documentation the Quality Assessment Performance Improvement committee reviewed the information regarding patients not being seen by the DED physicians and developed action plans to ensure all patients presenting to the DED seeking medical treatment were adequately examined and treated by the on-call physicians.

3. Review of the facility's Infection Control Policy and Procedure Manual documented, "...To establish preventive, surveillance, and control procedures relating to the inanimate hospital environment, including sterilization and disinfection practices...To monitor findings of any patient care evaluation studies that relate to infection control activities..."

A. Review of the facility's, "Surveillance Methods and Reporting System" policy documented, "...Infection Report Form A...initiated for any of the following conditions:...positive culture...Each month all infections reported and/or discovered and verified by the Infection Control Nurse and are compiled by site, pathogen and occurrence ..."

B. Review of the Infection Control Committee minutes dated July 2011 and October 2011 had no documentation or evidence of tracking and trending of infections for inpatients or outpatients including both healthcare associated and community acquired infections.

C. Review of the facility's Quality Council Minutes dated 7/21/11 and dated 10/20/11 contained no documentation reflecting Healthcare Associated Infections such as:
Aseptic technique practices used in invasive procedures performed outside the operating room: including sterilization of products, central line insertions,
Hand hygiene
Measures specific to prevention of infections caused by antibiotic resistance organisms,
Measures specific to prevention of infections caused by indwelling urinary catheters, tube feedings
Environment and equipment requiring disinfections, antiseptics, and germicides to be used in accordance with manufacturers instructions
Educating patients, visitors, caregivers and staff about infections and community diseases and methods to reduce transmission in the hospital and community.

D. During an interview in the conference room on 11/14/11 at 2:30 PM, the Medical Technologist/Infection Control Officer (MT/ICO) was asked if infections were being tracked and trended. The MT/ICO stated, "...No, I don't track and trend infections..." The MT/ICO was asked if the facility had an Antibiogram that shows what organisms are in the facility and the antibiotics that the organisms are susceptible to. The MT/ICO stated, "...No..." The MT/ICO confirmed a failure to mitigate risks associated with patient infections present on admission due to failure to monitor, track and trend and evaluate infections. The MT/ICO confirmed a failure to mitigate risks contributing to healthcare - associated infections such as handwashing was due to failure to monitor, track and trend and evaluate healthcare practices.

During an interview in the conference room on 11/16/11 at 2:00 PM, the DED supervisor was asked if there was an Infection Control log of DED patients that had a culture completed in the DED and follow performed. The DED supervisor stated, "...no, we do not log it or track it..."


Refer to A748, A749, A750, A0347, A1104 and A1112

Based on policy review, record review and interview, it was determined the hospital failed to ensure that employees provided pharmacy services within the scope of their practice and that drugs were being dispensed only by a licensed pharmacist or physician for 3 of 3 (Patient #23, 28 and 29) dedicated emergency department (DED) sampled patients who were dispensed medications to take home.

The findings included:

1. Review of the hospital's policy, "Prescribing, Dispensing and Administering Drugs in Emergency Room", documented, "...Drugs released from emergency room for take home use must be prepared by the pharmacist or a physician..."

2. Medical record review for Patient #23 documented the patient presented to the DED on 10/17/11 with complaints of lower back pain. The RN documented she dispensed 2 Lortab 10 milligram (mg) tablets for the patient to take home. There was no documentation from a pharmacist or physician.

3. Medical record review for Patient #28 documented the patient presented to DED on 11/6/11 for complaints of a tooth abscess. The RN documented she dispensed 3 tablets of Amoxicillin for the patient to take home. There was no documentation from a pharmacist or physician.

4. Medical record review for Patient #29 documented the patient presented to the DED on 10/13/11 with complaints of feet pain. The RN documented she dispensed 4 Lyrica 150 mg for the patient to take home. There was no documentation from a pharmacist or physician.

During an interview in the conference room on 11/15/11 at 1:25 PM, the DED supervisor was asked who dispensed the medication from the DED to the patients when discharged. The DED supervisor stated, "...Nurses under the direction of the doctor..."








19001

Based on facility policy, observations and interview, it was determined the facility failed to discard outdated medication in the pharmacy and in the dedicated emergency department (DED) for 2 of 2 medication storage areas reviewed.

The findings included:

1. Review of the facility policy, "EXPIRED MEDICATION DISPOSITION" documented, "At the beginning of each month, medications which expired the previous month are pulled off the pharmacy shelves and from the floor stock around the hospital..."

2. Observations in the hospital pharmacy on 11/14/11 at 9:00 AM revealed the following expired mediations on the pharmacy shelves:
One bottle of Theo 24 400 milligram (mg) expiration date 8/10
One bottle of Clorazepate Dipotassium 3.75 mg expiration date 8/2010
One bottle of Phoslo 667 mg expiration date 9/11
Seven single dose packets of Thioridazine hydrochloride 25 mg expiration date 10/11
Five single dose packets of Methyldopa 250 mg expiration 4/11.

3. Observations in the DED on 11/14/11 at 9:40 AM, revealed the following expired medications:
A. In the adult crash cart:
Two multi dose vials of Aminophylline 500 mg expiration date 10/11
Four vials of Verapamil HCL (HydroChloride) 5 mg expiration date 10/11
One bottle of Nitroglycerin 500 ml (milliliters) 100mcq (micrograms)/ml in D5% expiration
date 4/11
Normal Saline 500 ml bag expiration date 9/11.

B. In the courtesy box:
One bottle of Nitroglycerin 500 ml (milliliters) 100 mcq (micrograms)/ml in D5% expiration
date 1/11
Heparin 20,000 units 40 units/ml in a 500 ml bag expiration date 1/11.

C. Stock Cart:
One bottle of Pedilyte expiration date 2/11
One bottle of Pedilyte expiration date 10/11.

D. In the trauma room locked cabinets:
One opened Cetacaine topical anesthetic spray expiration date 6/11
One opened and dated 10/4/11 with an expiration date 7/11 Sensorcaine with Epi (epinephrine) .5%
One bottle of Artificial Tears ointment expiration date 4/11
One bottle of Tropicamide Opthalmic solution .5% expiration date 1/11.

4. During an interview in the pharmacy on 11/14/11 at 9:10 AM, the pharmacist stated, "I don't have a system..."

During an interview in the DED on 11/14/11 at 9:40 AM, Nurse #2 confirmed the medications on the adult crash cart, in the courtesy box and the items on the stock cart were expired.

During an interview in the DED trauma room on 11/14/11 at 9:40 AM, Pharmacy Technician #1 confirmed the medications in the locked cabinet in the trauma room were expired. The Pharmacy Technician stated, "...Yes, they opened an expired vial (Sensorcaine with Epi)..."

Based on policy review, observation and interview, it was determined the Dietary Director failed to ensure the dietary staff followed established policies and procedures for food storage and chemical storage during 3 of 3 days (11/14/11, 11/15/11 and 11/16/11) of observations of the kitchen and dietary storage areas.

The findings included:

1. Review of the facility's "RECEIVING/STORAGE" policy documented, "...PROCEDURE: 3. food will be separately stored from chemicals. 4. Opened food items and leftovers will be labeled, dated and covered to prevent contamination and ensure appropriate use within recommended times..."

Review of the facility's "CLEANING SUPPLIES/HAZARDOUS CHEMICALS" policy documented, "...3. Cleaning supplies and/or hazardous chemicals are stored separately from the food items..."

2. Observations in the kitchen on 11/14/11 at 8:55 AM, revealed the following:
A. In the walk-in refrigerator
2 glasses of orange juice and 2 glasses of milk with no dated label
A lettuce bag open to air revealing 4 heads of lettuce with no date on bag
A pail of cole slaw open with no date
A pail of pimento cheese open with no date
A pail of chicken salad open with no date.

B. In the walk-in freezer:
A bag containing hamburger patty open with no date
A container of cream potato soup open with no date
A bag containing pancakes open with no date
A bag containing fish patty open with no date
A bag containing mixed vegetables open with no date
A bag containing okra open with no date.

C. In the milk refrigerator:
2 half gallon cartons of buttermilk open with no date.

D. A can of Lysol foam cleaner stored on a shelf with the spices over the food preparation table.
A gallon bottle of Clorox liquid stored on the bottom shelf of the clean pots and pan storage rack.
An open bottle of powdered substance cleaner stored on the bottom shelf of the clean pots and pan storage rack.
2 spray bottles of Clorox liquid stored on bottom shelf of the clean pots and pan storage rack.

During an interview in the walk in refrigerator on 11/14/11 at 8:55 AM, Cook Aide #1 was asked about the open food containers not being dated. Cook Aide #1 stated, "...They were suppose to have thrown the orange juice and milk away..." Cook Aide #1 confirmed the food containers were open and not dated.

During an interview in the kitchen on 11/14/11 at 8:55 AM, Cook Aide #1 was asked about the chemicals being stored in the kitchen in the food preparation areas, next to food and clean pots and pans. Cook Aide #1 stated, "...Should not be stored there..."

3. Observations in the kitchen on 11/15/11 at 7:50 AM, revealed the following:
A. In the walk in refrigerator:
A box of citric eggs open with no date
A lettuce bag open to air revealing 4 heads of lettuce with no date on bag.

B. Stock room:
A carton of potato pearls (instant potato) open with no date
A jar of peanut butter jar opened with no date
Rice in a corrugated box with the plastic open and not sealed with no date and scoop laying on top of plastic
A box of creamy wheat hot cereal open with no date
54 corrugated outside shipping boxes on the shelves with food products stored.

C. A gallon bottle of Clorox liquid stored on the bottom shelf of the clean pots and pan storage rack.
An open bottle of powdered substance cleaner stored on the bottom shelf of the clean pots and pan storage rack.
2 spray bottles of Clorox liquid stored on bottom shelf of the clean pots and pan storage rack.

During an interview in the walk in the kitchen on 11/15/11 at 7:50 AM, Cook Aide #1 was asked about the open food containers not being dated. Cook Aide #1 confirmed the food containers were open and not dated.

During an interview in the kitchen on 11/15/11 at 7:50 AM, Cook Aide #1 was asked about the chemicals being stored in the kitchen in the food preparation areas, next to food and clean pots and pans. Cook Aide #1 stated, "...I know that bottle of Clorox is still there, my boss knows it but did not tell me to move it..."

4. Observations in the kitchen on 11/16/11 at 12:50 PM, revealed the following:
A. Stock room
A bag of macaroni open not sealed tightly and with no date
A carton of potato pearls (instant potato) open with no date

B. An open bottle of powdered substance cleaner stored on the bottom shelf of the clean pots and pan storage rack
2 spray bottles of Clorox liquid stored on bottom shelf of the clean pots and pan storage rack

During an interview in the stock room on 11/16/11 at 12:50 PM, the Dietary Manager (DM) was asked about the open food containers not being dated. The DM stated, "...Yes, I see it..." The DM was asked about the storage of chemicals in the food preparation areas and clean pot and pan area. The DM did not comment. The DM was asked about the use of corrugated shipping boxes being used to store food products in the dry stock room. The DM stated, "...I am glad I am retiring soon..."



29706

Based on policy review, document review and interview, it was determined the facility failed to ensure the therapeutic diet manual was approved by the dietitian.

The findings included:

1. Review of the facility's "DIET MANUAL" policy documented, "...The diet manual is reviewed annually and revised as necessary by the registered dietitian...will be signed and dated by the Chief of Staff and the Registered Dietitian..."

2. Review of the facility's "DIETARY MANUAL APPROVAL" signature sheet dated 7/28/11 documented signatures of the Dietary Supervisor, Administrator and Chief Of Staff. There was no documentation the dietician had reviewed and approved the dietary manual.

3. During an interview in the Dietary Manager's (DM) office on 11/14/11 at 9:15 AM, the DM stated, "...No, I don't have a signature sheet of the Registered Dietitian and Medical Staff approval..."



29706

Based on policy review, observation and interview, it was determined the facility failed to ensure food products were stored under appropriate temperature conditions and containers.

The findings included:

1. Review of the facility's "Refrigerator Temps [Temperature]" policy documented, "...To ensure safe and appropriate food temps., the refrigerators are maintained at 40 degrees - 45 degrees..."

Review of the facility's "RECEIVING/STORAGE" policy documented, "...The food items will be stored appropriately to comply with all licensure and regulatory requirements...Food and non-food supplies will be stored under safe, sanitary and secure conditions...Requirements for adequate lighting, ventilation, temperature control...will be observed to ensure compliance with all licensure and regulatory requirements..."

2. Observations in the kitchen walk in refrigerator on 11/14/11 at 8:55 AM, revealed the thermometer located in the front of the refrigerator measured 60 degrees.

During an interview in the walk in refrigerator on 11/14/11 at 8:55 AM, Cook Aide #1 was asked to verify the temperature reading on the thermometer. Cook Aide #1 stated, "Yes, the temperature reads 60 degrees...No, it should not be 60..."

Observations in the kitchen walk in refrigerator on 11/15/11 at 7:50 AM, revealed the thermometer measured 60 degrees.

During an interview in the walk in refrigerator on 11/15/11 at 7:50 AM, Cook Aide #1 confirmed the temperature reading on the thermometer was 60 degrees.

During an interview in the kitchen walk in refrigerator on 11/16/11 at 12:50 PM, the Dietary Manager (DM) stated, "...We got a different thermometer and moved it to the middle of the refrigerator, I think it is high at the door area because of staff having to come in and out to get to the freezer..."

3. Observations in the dry stock room on 11/15/11 at 7:50 AM, revealed 54 corrugated outer shipping boxes being used to store food products.

Observations in the dry stock room on 11/16/11 at 12:50 PM, revealed 54 corrugated outer shipping boxes being used to store food products.

During an interview in the dry stock room on 11/16/11 at 12:50 PM, the DM confirmed the use of corrugated outer shipping boxes were being used to store food products.



29706

Based on policy review and interview, it was determined the hospital failed to follow the Infection Control Program's policies and ensure the responsibilities of the daily functions of the Infection Control Program were assigned to a Qualified Infection Control Officer.

The findings included:

1. Review of the hospital's "INFECTION CONTROL PLAN" policy documented, "...III. The Administrator is ultimately responsible for the infection control program. Responsibility is delegated to the Infection Control Nurse to carry out the daily functions of the Infection Control Program. Those functions are described in the Infection Control Nurse job description...VIII. Evaluation of Services Service is evaluated on an on-going (daily) basis with concurrent review of problems by the Infection Control Nurse..."

2. Review of the hospital's "JOB DESCRIPTION AND PERFORMANCE EVALUATION TITLE: Infection Control Nurse" documented, "...PURPOSE: Responsible for implementing and coordinating the program of infection control, prevention, and surveillance approved by the Infection Control Committee...QUALIFICATIONS: 4. Registered Nurse..."

3. During an interview in the conference room on 11/14/11 at 2:30 PM, the Medical Technologist/Infection Control Officer was asked are you a nurse. The Medical Technologist/Infection Control Officer stated, "...No, I am a Medical Technologist...".

During an interview in the conference room on 11/15/11 at 8:28 AM, the Administrative Assistant stated, "...We don't have an Infection Control Nurse, we know we have a problem. We know we need to have a nurse...".



29706

Based on interview, it was determined the facility failed to maintain an Infection Control log of incidents related to patients who meet CDC (Centers for Disease Control) criteria for requiring isolation precautions during their hospitalization, patients identified by lab culture as colonized or infected with multi drug resistant organisms (MDRO), incidents related to infections throughout the hospital.

The findings included:

1. There was no documentation of an Infection Control log of incidents related to patients who meet the CDC criteria for requiring isolation precautions during their hospitalization. There was no documentation of a log of patients identified by lab culture as colonized or infected with multi drug resistant organisms (MDRO), incidents related to infections throughout the hospital including the dedicated emergency department patients.

2. During an interview in the conference room on 11/14/11 at 2:30 PM, the Medical Technologist/Infection Control Officer (MT/ICO) asked are infections being tracked and trended. The MT/ICO stated, "...No, I don't track and trend infections..."

During an interview in the conference room on 11/16/11 at 2:00 PM, the Dedicated Emergency Department (DED) supervisor was asked is there an Infection Control log of DED patients that have a culture completed in the DED and follow up. The DED supervisor stated, "...no, we do not log it or track it..."




29706