HospitalInspections.org

Based on review of documentation and interview, it was determined that dialysis patients were not provided care based on common standards.
Findings were:
In an article written by John R. DePalma in September 2001 it was stated "Proper control of body weight/body water, like dialysis dose, is one of the most important issues and risk factors that contribute to morbidity and mortality of ESRD patients. Without knowledge of body weight/body water, the health care giver cannot render adequate dialysis care. In a hemodialysis facility, the classic four vital signs of temperature, pulse, respirations, and blood pressure should be supplemented with the patient's actual weight both pre and post dialysis."
Facility document entitled "Acute Treatment Daily Dialysis Record" had areas that requested for pre and post patient weights, blood pressures, heart rate and temperatures. The following patients had no documented pre and post weights recorded on their dialysis treatment sheet records:
· Patient # 36
· Patient # 39
· Patient # 32
· Patient # 33
Daily weights were recorded for the following dialysis Patients # 65 and 66.
Both patients had documented weight gains of 10 kilos (22 lbs) in less than 12 days. There is no indication that the nephrologist was aware of these gains. The above lack of documentation was confirmed by the Clinical Information Specialist and the Nurse Manager of the 4th Floor on 1/4/15.
Based on a review of documentation and interview, the facility failed to ensure care in a safe setting.

Findings included:

A statement from the Association for the Advancement of Medical Instrumentation (AAMI), Accreditation Association for Ambulatory Health Care (AAAHC), Association of periOperative Registered Nurses (AORN), Association for Professionals in Infection Control and Epidemiology (APIC), ASC Quality Collaboration, Association of Surgical Technologists (AST), and International Association of Healthcare Central Service Materiel Management (IAHCSMM). Immediate-Use Steam Sterilization. Undated. Found at: , stated in part, "Instrument inventories should be sufficient to meet anticipated surgical volume and permit the time to complete all critical elements of reprocessing."

The Centers for Disease Control and Prevention (CC) website article, GUIDELINE FOR DISINFECTION AND STERILIZATION IN HEALTHCARE FACILITIES, 2008, by William A. Rutala, Ph.D., M.P.H., David J. Weber, M.D., M.P.H., and the Healthcare Infection Control Practices Advisory Committee (HICPAC), found at: , states on page 60 that "it [flash sterilization] is not recommended as a routine sterilization method because of the lack of timely biological indicators to monitor performance, absence of protective packaging following sterilization, possibility for contamination of processed items during transportation to the operating rooms, and the sterilization cycle parameters (i.e., time, temperature, pressure) are minimal...A few adverse events have been associated with flash sterilization. When evaluating an increased incidence of neurosurgical infections, the investigators noted that surgical instruments were flash sterilized between cases and 2 of 3 craniotomy infections involved plate implants that were flash sterilized849...Flash sterilization should not be used for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time817."

Review of the Immediate Use Sterilizer Logs for Sterilizers #3 and 4 for June 2015 through December 2015 revealed the following:
· In June 2015, 11 of 21 instances of immediate use sterilization (IUS) had "high demands" listed as the reason for using this sterilization method. 1 was listed as "unknown".
· In July 2015, 6 of 15 instances of immediate use sterilization (IUS) had "high demands" listed as the reason for using this sterilization method. 2 were listed as "unknown".
· In August 2015, 8 of 11 instances of immediate use sterilization (IUS) had "high demands" listed as the reason for using this sterilization method.
· In September 2015, there were 4 of 12 instances of immediate use sterilization (IUS) had "high demands" listed as the reason for using this sterilization method. 7 were listed as "unknown".
· In October 2015, 2 of 4 instances of immediate use sterilization (IUS) had "high demands" listed as the reason for using this sterilization method. 1 was listed as "unknown".
· In November 2015, 3 of 4 instances of immediate use sterilization (IUS) had "high volume" listed as the reason for using this sterilization method.
· In December 2015, 6 of 14 instances of immediate use sterilization (IUS) had "multiple cases" and "back to back cases" listed as the reason for using this sterilization method.

In an interview on 01/05/16 at 2:00 PM , staff member # 43 (Director of Surgical Services), confirmed that the facility had identified the high rates of immediate use sterilizations as an issue "during the Joint Commission visit about two months ago".

According to the staff member # 40, the facility has been ordering more instrument sets "over the past few months". The main intervention to decrease the prevalence of immediate use sterilization was "we weren't holding vendors accountable to bring instruments in early enough to complete adequate steam sterilization. We made them sign agreements that they would bring the instruments in by 4 o'clock the day before."

In an interview on 01/06/16 at 10:00 AM, staff member # 43 was asked about the prevalence of the of "high volume" and "back to back cases" documented as the reason for utilizing immediate use sterilization. He stated, "That's not because we don't have enough instruments." The staff member stated the facility utilized immediate use sterilization for approximately 2 % of the overall case loads in the past few month. This staff member was asked if the cases could be scheduled so they are not back to back to prevent immediate use sterilization of instruments. The staff member stated, "We try to reinforce to the surgeons if there are 5 scheduled cases and we only have 3 sets, to call the representative to say they need 3 or 4 more sets. They (physicians) are calling the reps the night before, and the reps can't bring them before 4 (per the agreement). Then the rep brings the instruments in the day of the procedure."


The staff member verified that surgeons schedule their procedures a week in advance. This process should allow sufficient time for the physician to arrange to have an adequate number of properly sterilized instruments available, however according to the log book, immediate use sterilization continues to be utilized due to "back to back cases". This does not meet the recommend standard to have an adequate instrument inventory available to meet the anticipated volume of surgical cases.
Based on observation, interview and record review the facility failed to provide patient care in a safe setting when:

-Four (4) of five (5) CNAs (Certified Nursing Assistants) did not demonstrate and/or verbalize the correct method of cleaning the multi patient shared Glucometers, a medical device for determining the approximate concentration of glucose in the blood. The staff were using a Red Top SaniWipe instead of the Orange top SaniWipe, which contained a 10% bleach sanitizer.(Staff #22, #23, #28, and #47)

- Staff #22, CNA removed her protective equipment in an isolated patient's room, touched the patient with C. difficile, her bare hands and did not wash her hands before leaving the room.(Clostridium difficile is a highly contagious bacteria that is shed in feces. Any surface, device, or that becomes contaminated with feces may serve as a reservoir for the Clostridium difficile spores.)

Findings Included:

Review of the facility provided policy Transmission Based Isolation Precautions Policy (last revised 2/15) reflected:
Policy: it is the policy to provide isolation precaution guidelines to prevent and control the spread of infection. Strict adherence to the guidelines contained in the policy is necessary ...
3. CONTACT PRECAUTIONS:
d. The following precautions apply:
(4) ... if dedicated equipment is not available equipment must be disinfected between patients
(5) Wash hands with soap and water when contact precautions initiated for C. difficile.

An observation on 1/5/16 at 11:30 a.m. on the 4th floor Medical Surgical Nursing unit revealed Staff #22, CNA go into patient rooms 426, 427, and 428. Staff #22 performed a blood sugar check on each of the patients using a shared glucometer. Staff #22 did not clean the glucometer between the patients. Patient room 428 had an isolation cart in front of the room and signage on the door listing the room as requiring contact isolation precautions. The patient in room 428 was on Contact precautions for C. difficile. Staff #22 was observed taking off her yellow isolation gown and gloves in the room; she proceeded to talk to the patient, touching the bedding and the patient's IV tubing and arm. Staff #22 left the isolation room, did not wash her hands and proceeded to enter room 429, the surveyor intervened.

During an interview on 1/5/16 at 11:40 a.m. on the 4th floor Medical Surgical Nursing unit Staff #22, CNA stated she wipes the glucometer off between each patient using the SaniWipes. Staff #22 showed the surveyor the Red Top SaniWipes Plus. Staff #22 confirmed she did not wash her hands and did not wipe the glucometer.

An observation on 1/5/16 at 12:00 p.m. on the 3rd floor Medical Surgical Nursing unit revealed Staff #23, CNA go into patient rooms 310, and 305. Staff #23 performed a blood sugar check on each of the patients using a shared glucometer. Staff #23 did not clean the glucometer between the patients.

During an interview on 1/5/16 at 12:15 p.m. on the 4th floor Medical Surgical Nursing unit Staff #23, CNA stated, "We don't usually wipe the glucometer between patients." "I'm not sure what to use."

During an interview on 1/5/15 at 2:45 p.m. in the Emergency Department, when the surveyor asked Staff #47 what she cleans the glucometers with, Staff #47 stated, "I use the red wipes, not the bleach". When asked to be shown the bleach wipes, the wipes were not readily available and the bleach wipes had an orange top.

During an interview on 1/5/15 at 2:49 p.m. in the Emergency Department, when the surveyor asked Staff #28 what she cleans the glucometers with, Staff #28 stated, "I use the Red Top"; "I was trained to use the Red Top".
Review of the facility provided WHOLE BLOOD GLUCOSE TEST BY NOVASTATSTRIP METER Competency Validation Tool (reviewed 2/15) reflected:
CLEANING/DISINFECTION THE METER:
1. Describes procedure for disinfection the meter.
a. Cleans with 10% bleach Sani Cloth pad and allows to air dry.
2. Lists indications for disinfection the meter
a. Disinfect the meter between each patient use
b. Disinfect the meter anytime it has become visibly soiled or contaminated.

Review of the facility provided Red Top SaniWipes technical data Bulletin reflected the product is EP
A Reg. No. 9480-6. The product Chemical Composition's active ingredients are Ammonia Chlorides; not the Bleach recommended by the manufacturer.

Review of the facility provided Nova StatStrip and StatSensor Hospital Meters, (dated December4, 2012) Customer Information Bulletin reflected:
Cleaning and Disinfection Procedure StatStrip and StatSensor
In the fall of 2010 the FDA, CDC, and CMS jointly published updated requirements for disinfection of all Point-of Care devices used at the patient bedside. In response to this new directive, Nova Biomedical developed and validated a cleaning and disinfection procedure for all StatStrip and StatSensor meters.
Validated Cleaning and Disinfection Procedure
All meter external surfaces should be cleaned and disinfected with a fresh Clorox Healthcare Bleach Germicidal Wipe EPA Reg. No. 67619-12.
Disinfect the Meter
1. Using a new, fresh germicidal wipe, thoroughly wipe the surface of the meter (top, bottom, left, and right sides) a minimum of 3 times horizontally and 3 times vertically avoiding the meter's bar code scanner and electrical connector.
2. Gently wipe the surface area of the test trip port making sure that no fluid enters the port.
3. Ensure the meter surface stays wet for 1 minute and then is allowed to air dry for an additional 1 minute. Note: To wet the meter surface again, use a new fresh germicidal wipe. Never re-use a previously soiled wipe.
4. Dispose of any used wipes and gloves in an appropriate biohazard container
5. Wash your hands thoroughly with soap and water.

During an interview on 1/6/16 at 10:30 p.m. in the Executive Conference Room, Staff # 51, the Regional Chief Nursing Officer confirmed the findings

Based on review of documentation and interview, it was determined that the facility failed to address patient needs determined by assessment and diagnosis.
Findings were:
Facility Policy entitled "Assessing/Reassessing a Patient" stated in part
"Competency -- Assessment, screening and care plan development competencies are defined by organizational policies, departmental/specialty specific scopes of assessment, licensure, certifications, applicable regulations and scope of practice requirements for the professional staff of each discipline.
The professional in a discipline is responsible for validation appropriate competency for technical and assistive personnel who assist in assessment and reassessment activities.
Initial Assessment - an assessment conducted at the first patient contact which establishes a baseline for the patient. Takes into account immediate and emerging needs and considers those needs broadly. This initial assessment is critical to patient safely as it supports staff in determining what care the patient needs as well as any further assessments.
Plan of Care - A written plan based on data gathered during assessment identifies care needs and treatment goals, describes the strategy for meeting those needs and goals, outlines the criteria for terminating any interventions, and documents progress toward meeting the plan's objectives. The plan may include care, treatment, habilitation and rehabilitation.
Care Planning (or planning for care) - Individualized planning and provision of care, treatment, or services that address the needs, safety, and well-being of the patient and may include patient's support system.. The plan, which formulates strategies, goals, and guidelines, clinical paths, care maps, or a combination of these.
Key Points
Plan of Care Process
b. A plan of care is evidenced by:
· Identification of the patient's goals, problems and desired treatment outcomes
· Assignment of priorities and timeframe's, including criteria for terminating any interventions.
· Documentation of appropriate interventions and progress related to the patient's problems
· Educational Plan/Outcomes to meet learning needs identified during assessment
· Consultations as needed
· Discharge planning process that begins on admission"
Facility Policy entitled "Individualized Interdisciplinary Plan of Care" stated in part
1. "The nursing staff develops, and keeps current, a nursing care plan for each patient. The nursing care plan may be part of an interdisciplinary care plan.
a. The attending physician shall be the primary coordinator for the medical and treatment plan of care of the patient with primary responsibility for oversight of the patient.
b. Planning of care treatment and services is individualized to meet the patient's unique needs and circumstances.
c. The patient and/or significant others shall be encouraged to be involved in the planning of care whenever possible.
Plan of Care
1. The Registered Nurse develops, and keeps current, a nursing care plan for each patient. The nursing care plan may be part of an interdisciplinary care plan. Each discipline, while maintaining awareness of the overall plan, will establish and update plans of care appropriate to their specific discipline scope of assessment and licensure."

Facility Job Description stated the following:
"Job Title: Nursing Department Supervisor
Job Family: Nursing

Responsibilities:
· Provides direction and support to unit staff. Supervises admissions, conducts assessment of patient's needs, and initiates nursing care plans. Evaluates and documents patient progress.

Job Title: RN I
Job Family: Nursing

· Implements and monitors patient care plans. Monitors, records and communicates patient condition as appropriate.
· Serves as primary coordinator of all disciplines for well-coordinated patient care.
· Notes and carries out physician and nursing orders.
· Assesses and coordinates patient's discharge planning needs with members of the healthcare team.
· Learns and applies Patient Centered Care Nursing Process including the patient / family, Evidence-Based Practices (EBP), Safety and Process Improvement for patient and unit outcomes of care processes."

Review of the following medical records revealed incomplete or missing Plans of Care:
· Patient # 27
· Patient # 29
· Patient # 34
· Patient # 38
In interviews with the Director of Maternity and Critical Care Services and the Charge Nurse of 4th Floor East on January 5, 2016 the above deficits were confirmed.

Based on observation, interview and record review the facility's director of the food and dietetic services failed to ensure staff followed the facility established safety practices for food handling.

Findings Included:

Observations on 1/4/16 at 10:40 a.m. of the facility Dietary Department revealed:
- Four (4) handwashing stations did not have waste receptacles
- Two (2) staff did not wear adequate hair restraints
- A hair was found in a container of raw sliced celery
- One (1) kitchen staff and one (1) food vendor were chewing gum in the food production areas
- Two (2) wet dirty towels were sitting out on the food counters
- Two (2) metal pans were stacked wet and not allowed to completely dry
- Two (2) dirty, wet mops were sitting on the floor
- The laminated wall above the pot washing station had a torn, unclean able, 12 inch by 12 inch
area of missing laminate.
- The stationary manual food slicer had remnants of dried lettuce on the blade.

Review of the facility provided UNIFORM DRESS CODE Policy #E004 (revised 3/11) reflected:
- Wear the approved hair restraint when on duty.
- Do no chew gum during assigned work hours.

Review of the facility provided STORAGE OF POTS, DISHES, FLATWARE, UTENSILS Policy #F017 (revised 1/14) reflected:
Pots, dishes, and flatware are stored in such a way as to prevent contamination
- Air dry all food contact surfaces, including pots ...Do not stack or store when wet.
- Moist cloths used for wiping food spills shall be clean and rinsed frequently in a sanitizing solution used for no other purpose. These cloths shall be stored in the sanitizing solution between uses.

Review of the facility provided HAND HYGIENE Policy #F007 (revised 1/14) reflected:
PROCEDURES:
- Hand wash sinks, including restroom sinks, should be clean and stocked with soap, paper towels and a covered waste receptacle.

During a tour of the Facility's kitchen, in the morning on 1/4/16, Staff # 46, the Food Service Director confirmed the Dietary findings.

Based on observation, interview and record review the facility failed to identify, develop and implement an effective infection control program to prevent communicable diseases when:

-Four (4) of five (5) CNAs (Certified Nursing Assistants) did not demonstrate and/or verbalize the correct method of cleaning the multi patient shared Glucometers, a medical device for determining the approximate concentration of glucose in the blood. The staff were using a Red Top SaniWipe instead of the Orange top SaniWipe, which contained a 10% bleach sanitizer.(Staff #22, #23, #28, and #47)

- Staff #22, CNA removed her protective equipment in an isolated patient's room, touched the patient with C. difficile, her bare hands and did not wash her hands before leaving the room.(Clostridium difficile is a highly contagious bacteria that is shed in feces. Any surface, device, or that becomes contaminated with feces may serve as a reservoir for the Clostridium difficile spores.)

Findings Included:

Review of the facility provided policy Transmission Based Isolation Precautions Policy (last revised 2/15) reflected:
Policy: it is the policy to provide isolation precaution guidelines to prevent and control the spread of infection. Strict adherence to the guidelines contained in the policy is necessary ...
3. CONTACT PRECAUTIONS:
d. The following precautions apply:
(4) ... if dedicated equipment is not available equipment must be disinfected between patients
(5) Wash hands with soap and water when contact precautions initiated for C. difficile.

An observation on 1/5/16 at 11:30 a.m. on the 4th floor Medical Surgical Nursing unit revealed Staff #22, CNA go into patient rooms 426, 427, and 428. Staff #22 performed a blood sugar check on each of the patients using a shared glucometer. Staff #22 did not clean the glucometer between the patients. Patient room 428 had an isolation cart in front of the room and signage on the door listing the room as requiring contact isolation precautions. The patient in room 428 was on Contact precautions for C. difficile. Staff #22 was observed taking off her yellow isolation gown and gloves in the room; she proceeded to talk to the patient, touching the bedding and the patient's IV tubing and arm. Staff #22 left the isolation room, did not wash her hands and proceeded to enter room 429, the surveyor intervened.

During an interview on 1/5/16 at 11:40 a.m. on the 4th floor Medical Surgical Nursing unit Staff #22, CNA stated she wipes the glucometer off between each patient using the SaniWipes. Staff #22 showed the surveyor the Red Top SaniWipes Plus. Staff #22 confirmed she did not wash her hands and did not wipe the glucometer.

An observation on 1/5/16 at 12:00 p.m. on the 3rd floor Medical Surgical Nursing unit revealed Staff #23, CNA go into patient rooms 310, and 305. Staff #23 performed a blood sugar check on each of the patients using a shared glucometer. Staff #23 did not clean the glucometer between the patients.

During an interview on 1/5/16 at 12:15 p.m. on the 4th floor Medical Surgical Nursing unit Staff #23, CNA stated, "We don't usually wipe the glucometer between patients." "I'm not sure what to use."

During an interview on 1/5/15 at 2:45 p.m. in the Emergency Department, when the surveyor asked Staff #47 what she cleans the glucometers with, Staff #47 stated, "I use the red wipes, not the bleach"
When asked to be shown the bleach wipes, the wipes were not readily available and the bleach wipes had an orange top.

During an interview on 1/5/15 at 2:49 p.m. in the Emergency Department, when the surveyor asked Staff #28 what she cleans the glucometers with, Staff #28 stated, "I use the Red Top"; "I was trained to use the Red Top".
Review of the facility provided WHOLE BLOOD GLUCOSE TEST BY NOVASTATSTRIP METER Competency Validation Tool (reviewed 2/15) reflected:
CLEANING/DISINFECTION THE METER:
1. Describes procedure for disinfection the meter.
a. Cleans with 10% bleach Sani Cloth pad and allows to air dry.
2. Lists indications for disinfection the meter
a. Disinfect the meter between each patient use
b. Disinfect the meter anytime it has become visibly soiled or contaminated.

Review of the facility provided Red Top SaniWipes technical data Bulletin reflected the product is EP
A Reg. No. 9480-6. The product Chemical Composition's active ingredients are Ammonia Chlorides; not the Bleach recommended by the manufacturer.

Review of the facility provided Nova StatStrip and StatSensor Hospital Meters, (dated December4, 2012) Customer Information Bulletin reflected:
Cleaning and Disinfection Procedure StatStrip and StatSensor
In the fall of 2010 the FDA, CDC, and CMS jointly published updated requirements for disinfection of all Point-of Care devices used at the patient bedside. In response to this new directive, Nova Biomedical developed and validated a cleaning and disinfection procedure for all StatStrip and StatSensor meters.
Validated Cleaning and Disinfection Procedure
All meter external surfaces should be cleaned and disinfected with a fresh Clorox Healthcare Bleach Germicidal Wipe EPA Reg. No. 67619-12.
Disinfect the Meter
1. Using a new, fresh germicidal wipe, thoroughly wipe the surface of the meter (top, bottom, left, and right sides) a minimum of 3 times horizontally and 3 times vertically avoiding the meter's bar code scanner and electrical connector.
2. Gently wipe the surface area of the test trip port making sure that no fluid enters the port.
3. Ensure the meter surface stays wet for 1 minute and then is allowed to air dry for an additional 1 minute. Note: To wet the meter surface again, use a new fresh germicidal wipe. Never re-use a previously soiled wipe.
4. Dispose of any used wipes and gloves in an appropriate biohazard container
5. Wash your hands thoroughly with soap and water.

During an interview on 1/6/16 at 10:30 p.m. in the Executive Conference Room, Staff # 51, the Regional Chief Nursing Officer confirmed the findings