HospitalInspections.org

Based on medical record review, policy review, document review and staff interview, it was determined there was no evidence that 9 of 27 patients (Patient #'s 2, 4, 11, 20, 21, 22, 23, 37 and 38) in the sample were informed of their patient's rights. Findings include:

The hospital policy entitled "Patient's Rights and Responsibilities" stated, "...the hospital informs each patient of his or her rights in a language that the patient understands..."

The hospital document entitled "Patient Rights and Responsibilities" stated, "...your rights...To be informed in advance of receiving care of your rights as provided under federal and state rules and regulations..."

Medical record review revealed no evidence to support that Patient #'s 2, 4, 11, 20, 21, 22, 23, 37 and 38 were informed of their rights.

Interview with Clinical Practice Leader A on 5/3/16 between 10:25 AM and 10:35 AM confirmed these findings.

Based on policy review, document review and staff interview, it was determined that the governing body failed to ensure that the quality assessment and performance improvement (QAPI) program involved all hospital departments and services. Findings include:

The hospital policy entitled "Guidelines for the Development of Departmental Performance Plans" stated, "...The Department Director...will identify the department's: Scope of services...The Departmental Performance Improvement (PI) Plan will be developed...The Director...is responsible for...insuring that the department's activities are appropriately integrated into organization-wide priorities and processes..."

A. On 4/29/16 between 10:00 AM and 11:45 AM, the hospital's QAPI program was reviewed with Quality and Continuous Improvement Director A and Accreditation Director A. Review of QAPI documentation revealed no evidence to support performance improvement trending and analysis for the following departments:

- Materials Management
¿- Bayhealth Medical Group (physician practice group)

These findings were confirmed by Quality and Continuous Improvement Director A and Accreditation Director A on 4/29/16 at 11:45 AM.

B. On 5/2/16 at 2:05 PM, Quality and Continuous Improvement Director A and Neuroscience and Sleep Services Senior Director A were interviewed regarding the hospital's Sleep Center Service and reported the following:

- collected PI data had not been reported to or integrated into the hospital's QAPI program

Based on medical record review, policy review and staff interview, it was determined that nursing staff failed to follow physician's orders for 2 of 18 patients (Patient #'s 9 and 15) in the sample. Findings include:

The hospital policy entitled "Management of Physicians Orders" stated, "...Nursing...Review, acknowledge and complete the physician's orders..."

The hospital policy entitled "Medication Administration and Documentation of Medication Orders" stated, "...Medication Administration Record (MAR) Documentation...Any medications not administered at scheduled date and time must have reason documenting this change. Explanation must be documented on the MAR..."

The hospital policy entitled "Charting Guidelines" stated, "...Charting guidelines identify the rules of acceptable charting within the Electronic Medical Record (EMR)...Procedure...include refusals of, or omissions in care, treatments, medications, etc., with reason for refusal or omission..."

Medical record review revealed:

A. Patient #9

1. Physician order dated 4/25/16 at 10:43 PM included an order for neurological checks every 4 hours for 24 hours

2. No evidence that nursing performed a neurological check until 5:00 AM on 4/26/16 (6 hours 17 min after ordered)

Interview with Clinical Practice Leader A on 4/27/16 at 11:58 AM confirmed this finding.

B. Patient #15

1. Physician order dated 4/21/16 included an order to administer Buproprion 250 mg every morning

2. 4/26/16 MAR:
- 100 mg given instead of the ordered 250 mg

3. No documentation of why the ordered dose was not given

Interview with Nurse Manager B on 4/27/16 at 12:11 PM confirmed this finding.

Based on medical record review, policy review and staff interview, it was determined that for 3 of 18 patients (Patient #'s 3, 12 and 14) in the sample that required a plan of care, staff failed to develop and/or revise the plan of care to reflect current needs. Findings include:

The hospital policy entitled "Guidelines for Using the Plan of Care" stated, "...Documentation of a Plan of Care is required for acute inpatients and should be used in conjunction with interdisciplinary team rounding...The Plan of Care must be started within 24 hours of admission...On a daily basis the primary nurse is to identify major problems/barriers in collaboration with the Interdisciplinary team. The primary care nurse is also responsible for updating the plan of care and documenting..."

Medical record review revealed:

A. Patient #3

1. Nursing Flowsheet dated 4/23/16 documented:
- the provision of right arm wound care
- right arm wound measurements

2. Consult order dated 4/24/16
- included consult for wound nurse for wound vacuum change

3. Physician order dated 4/25/16
- included wound vacuum settings and dressing change orders to right elbow wound site

4. Plan of Care
- failed to identify/address right arm wound

Interview with Clinical Practice Leader A on 4/26/16 at 12:48 PM confirmed these findings.

B. Patient #12

1. Record of Admission dated 4/25/16 at 7:43 AM
- diagnosis of "pregnant state"

2. Nursing assessments
- dated 4/25/16: documented intermittent pain of 10 (pain scale 0 for no pain and 10 for worst pain)
- dated 4/26/16: documented pain level between 0 and 9

3. No Plan of Care developed within 24 hours of admission

Interview with registered nurse (RN) D on 4/26/16 between 10:52 AM and 11:05 AM confirmed these findings.

C. Patient #14

1. History and Physical dated 4/22/16
- documented a diagnosis of insulin dependent diabetes mellitus with hyperglycemia

2. Plan of Care
- failed to address diabetic management

Interview with Nurse Manager B on 4/26/16 at 12:32 PM confirmed this finding.

Based on observation, policy review, medical record review and staff interview, it was determined that for 2 of 8 inpatient care units, hospital staff failed to prepare, administer, secure and/or label medication according to established hospital policies and procedures. Findings include:

The hospital policy entitled "Management of Venous Access Devices" stated, "...All IV (intravenous) tubing must be labeled with start and discard dates and times...All IV bags must be labeled with the following...patient's name, room number, date, time hung, medications added, rate, nurse initials, discard time and date..."

The hospital policy entitled "Infection Prevention Guidelines for Pharmacy" stated, "...Multi-dose vials...Upon first use of a multi-dose vial, it will be dated, timed and initialed..."

The hospital policy entitled "Medication Access from Automated Distribution Cabinets" stated, "...The nurse will only remove one (1) patient's medications for one administration time. Medication removal times from ADC (automated distribution cabinets) should correspond to medication administration times within one (1) hour. Medications removed from the ADC must always be secured in the possession of the nurse authorized to administer the medications...Medications removed from the ADC and not administered to the patient...will be either returned to the ADC Return Bin or returned to the ADC pocket as prompted by the cabinet functionality...Medication not administered to the patient must be returned to the ADC within one (1) hour from the time of removal..."

A. Intensive care unit (ICU)

1. On 4/25/16 between 11:35 AM and 12:15 PM, the following multi-dose vials were observed in the medication room refrigerator:

- two (2) Humulin R U (units) 100 3 ml vials: opened and unlabeled
- one (1) Humalog U 100 3 ml vial: opened and unlabeled

Interview with Clinical Practice Leader A on 4/27/16 at 12:00 PM confirmed these findings.

2. On 4/27/16 between 10:05 AM and 10:30 AM, the following was observed in Patient #35's room:

a. The label for the infusing bag of IV D5 W (Dextrose 5% in water) solution lacked the following:
- patient room number
- time hung
- nurse initials
- discard time and date

b. The label for the IV D5 W solution tubing lacked:
- the start and discard dates and times

c. The label for IV Bactrim 400/80 milligrams (mg)/5 milliliters (ml) tubing lacked:
- the start and discard dates and times

Interview with Clinical Practice Leader A on 4/27/16 at 10:40 AM confirmed these findings.

B. 4th Floor Rehab Unit

1. Patient #14
a. Medical record review revealed:

4/24/16 - Physician's order to administer Carved 25 mg oral twice a day to be given at 8:00 AM and 5:00 PM

b. On 4/25/16 at 3:02 PM, during a tour of the medication room with Nurse Manager B, the following medication was observed in a plastic bag on the countertop, labeled with Patient #14's room number:
- one (1) 25 mg Carved tablet

c. Review of the 4/25/16 "AcuDose-Rx Station Events" report revealed:

- Carved 25 mg was dispensed to registered nurse (RN) E on 4/25/16 at 11:02 AM (4 hours 58 minutes early)

Interview with Nurse Manager B on 4/25/16 at 3:02 PM and 4/26/16 at 11:35 AM confirmed that RN E:

- failed to remove the medication Carved from the ADC no more than one hour before the medication was to be administered
- failed to secure the medication as required when he/she placed the medication in the bin on the countertop

2. Patient #15
a. Medical record review revealed:

4/19/16: Physician order for Carbidopa-Levodopa 25-250 mg one (1) tablet four times a day

4/20/16: Physician order for Bupropion HCL 150 mg oral every evening

4/25/16: the medication administration record documented that RN E administered Carbidopa-Levodopa 25-250 mg at 9:29 AM and 1:40 PM

b. On 4/25/16 at 3:02 PM, during a tour of the medication room with Nurse Manager B, two (2) medications were observed in a plastic bag on the countertop, labeled with Patient #15's room number:
- one (1) Bupropion HCL 150 mg tablet
- one (1) Carbidopa-Levodopa 25 mg/250 mg tablet

c. Review of the 4/25/16 "AcuDose-Rx Station Events" report revealed the following medications were dispensed for Patient #15 by RN E:
- one (1) Bupropion HCL 150 mg tablet at 11:05 AM
- two (2) Carbidopa-Levodopa 25-250 mg tablets at 11:06 AM

Interview with Nurse Manager B on 4/25/16 at 3:02 PM and on 4/27/16 between 10:46 AM and 12:10 PM confirmed that RN E:

- failed to remove the medications Bupropion HCL and Carbidopa-Levodopa from the ADC no more than one hour before the medication was to be administered
- failed to secure the medications as required when he/she placed the medication in the bin on the countertop

3. On 5/2/16 between 1:05 PM and 1:55 PM, the following was observed during blood product administration to Patient #36 provided by RN G:

a. The label for the infusing bag of IV 0.9 normal saline solution (NSS) lacked the following:
- patient name
- room number
- date and time hung
- rate
- nurse initials
- discard time and date

b. The label for the IV NSS tubing lacked:
- the start and discard dates and times

Interview with Clinical Practice Leader A on 5/2/16 at 1:56 PM confirmed these findings.

Based on observation, policy review, document review and staff interview, it was determined that for 1 of 1 inpatient pharmacies and 1 of 8 hospital nursing units, the hospital failed to follow accepted standards of practice for pharmaceutical services. Findings include:

The manufacturer's instructions printed on the protective/overwrap packaging for intravenous (IV) solutions 0.9% Sodium Chloride Injection solution and 5% Dextrose Injection solution stated, "...Do not remove from overwrap until ready for use...Storage: Room temperature 25 degrees C (Celsius). Avoid excessive heat. Protect from freezing..."

The hospital policy entitled "Medication Packaging" stated, "...All drugs to be repackaged must be in the original container as supplied by the manufacturer...must be repackaged by the pharmacy...labeled...The expiration date assigned shall be one year from date of re-packaging, or the manufacturer's date, if earlier...If the manufacturer's expiration date is less than one year, the assigned medication expiration date will be the last day of the month, prior to the manufacturer's expiration date...label is attached to the unit-dose package..."

Federal Drug Administration guidelines updated 3/20/15 stated, "CPG (Compliance Policy Guides) Sec. 480.200 Expiration Dating of Unit Dose Repackaged Drugs...some drugs are packaged into unit dose containers by hospital...drugs thus repacked need expiration dates based on stability data on the drugs in the unit dose containers...The Current Good Manufacturing Practice Regulations require that...drug products must bear expiration dates...The unit dose container complies with the Class A or Class B standard described in the twentieth Edition of the United States Pharmacopeia, General Tests, Single-Unit Containers and Unit-Dose Containers for Capsules and Tablets...The expiration date does not exceed six months..."

A. Observations conducted in the inpatient pharmacy on 4/25/16 between 2:30 PM and 4:30 PM revealed the following:

1. The ambient room temperature of the inpatient pharmacy's IV fluid storage room was 80 degrees Fahrenheit/26.6667 degrees Celsius and exceeded the maximum manufacturer's storage temperature of 25 degrees Celsius.
This finding was confirmed by Operations Manager/Pharmacist in Charge A on 4/28/16 at 11:45 AM.

2. All oral medications repackaged in Class B packaging material were inaccurately assigned expiration dates of twelve months, rather than 6 months.

During an interview on 4/28/16 at 12:00 PM, Operations Manager/Pharmacist in Charge A confirmed this finding.

B. During a tour of unit 2 East on 4/27/16 between 10:30 AM and 11:44 AM, the following was observed in the storage/supply room:

- one bag 5% Dextrose Injection solution 500 milliliters (ml) with overwrap removed
- one bag 5% Dextrose Injection solution 500 ml with overwrap sliced open

These findings were confirmed by Clinical Practice Leader A on 4/27/16 at 10:50 AM.

Based on observation and staff interview, it was determined that the hospital failed to maintain the building in a manner to ensure the safety for 70 of 70 inpatients on 4/25/16. The hospital failed to meet the applicable provisions of the 2000 Edition of the Life Safety Code (LSC) of the National Fire Protection Association (see the attached CMS-2567s referencing LSC deficiencies).

I. Based on observation, document review, policy review and staff interview, it was determined that for 3 of 8 inpatient care units, staff failed to ensure an acceptable level of safety and quality for emergency box and crash cart supplies. Findings include:

The hospital policy entitled "Neonatal Emergency Box" stated, "...Each day the Neonatal Emergency Box will be checked to verify the seal (lock) is still intact and the listed expiration dates on the top are not exceeded. This will be recorded on the Neonatal Emergency Box Checklist...If a seal is missing, the person will immediately contact their nurse manager, the pharmacy manager, and Central Supply so the box can be replaced..."

The hospital policy entitled "Crash Cart Daily Inspection" stated, "...done to verify presence of designated equipment...to assure that all equipment functions properly...The clinical coordinator or his/her designee will examine the crash cart daily. Document time of inspection on the check list...Document Crash Cart lock number and airway lock number on the checklist in the designated spaces...All equipment must be...without damage...(if)...Crash Cart numbers do not match to previous check list number...Notify pharmacy and complete a safety first report...Write carts new number on check list..."

A. During a tour of the fourth floor Women's Services, the following was observed:

1. On 4/25/16 at 12:25 PM:
- Crash cart in front of the nurses station contained one (1) "Baby Blue II Resuscitator": the component mask was not functional

This finding was confirmed with Clinical Nurse Specialist B on 4/25/16 at 12:28 PM.

2. On 4/27/16 at 11:02 AM:
- 1 of 2 neonatal emergency boxes in the nursery had a broken lock

This finding was confirmed with Corporate Compliance Clinical Risk Specialist A and Unit Clerk A on 4/27/16 at 11:05 AM.

B. During a tour of the third floor South Unit on 4/28/16 at 12:28 PM, the following was observed at the nurses station:

1. Staff failed to identify and document the correct serial number of the lock securing the front of the crash cart on 4/27 and 4/28/16.

2. The stand on the crash cart, holding the defibrillator, was unstable.

These findings were confirmed with Nurse Manager D on 4/28/16 between 2:18 PM and 3:21 PM.

II. Based on observation, policy review and staff interview, it was determined that for 1 of 10 patient care units, the hospital failed to ensure the integrity of upholstered patient equipment. Findings include:

The hospital policy entitled "Cleaning of Equipment" stated, "...If any staff member identifies furniture (including...upholstered furnishings of any type) whose integrity is not intact (ripped, torn, punctured)...or poses an infectious control hazard, tab the item to be taken out of service and call 7900 (Customer Support Service) to report the defective equipment/furnishing for pick-up..."

A. During an environmental tour of the outpatient physical therapy gym on 5/2/16 between 2:35 PM and 3:00 PM, the following was observed:

- two (2) mat tables (for patient exercise) with damaged vinyl
- an Upper Body Ergometer (machine for exercising the arms) with damaged upholstery

These findings were confirmed by Physical Therapist B on 5/2/16 at 2:55 PM.

I. Based on observation, medical record review, document review and staff interview, it was determined that for 6 of 15 patient care observations (Patient #'s 5, 14, 36, 39, 40 and 41), the infection control officer failed to ensure that staff adhered to infection control measures. Findings include:

The position description entitled "Infection Control Manager" stated, "...is responsible for the ongoing oversight and continuous improvement of the Bayhealth Medical Center Infection Prevention program surveillance, prevention, and clinical response regarding infectious disease exposures...Responsible for the development and implementation of a hospital-wide Infection Prevention program..."

The hospital policy entitled "Hand Hygiene" stated, "...Hand Hygiene is the single most important procedure for prevention of health-care associated infections...Hand hygiene is required in the following situations: Before, between and after patient contact...After touching any source that is likely to be contaminated with pathogens (i.e. bedrails, blood pressure cuffs, telephones, computer keyboards, common work spaces used by other providers, etc.)...Use of gloves during procedures does not eliminate the need for hand hygiene...following glove removal..."

The hospital document entitled "Hand Hygiene During Medication Administration" stated, "...Perform hand hygiene...prepare medication...Don gloves if required...Medication administration routes requiring gloves include any route which may expose the clinician to blood...such as...intramuscular and intravenous push...Administer medication...Perform hand hygiene..."

The manufacturer's guideline for preparing the Humalog KwikPen (injection pen device containing multiple doses of insulin) stated, "...Always use a new needle for each injection to help ensure sterility...pull the Pen Cap straight off...Wipe the Rubber Seal with an alcohol swab...Push the capped Needle straight onto the Pen and turn the Needle forward until it is tight..."

The manufacturer's guideline for the cleaning and disinfection of the ACCU-CHEK Inform II glucometer (machine to test blood sugar) stated, "...the meters must be properly cleaned and disinfected after every use following the guideline given in this section...Always use Clorox Germicidal Wipes...or Super Sani-Cloth Germicidal Disposable Wipes...to clean and disinfect the meter..."

The hospital policy entitled "Accucheck Inform II Glucose Meters" stated, "...Patient testing...Apply blood to the front edge of the test strip...Clean and disinfect the meter using the Clorox Germicidal wipes..."

A. Patient #5

On 4/27/16 between 12:27 PM and 12:40 PM, the following technique was observed during medication administration by registered nurse (RN) A:

- donned gloves
- cleaned intravenous (IV) port with alcohol pad
- flushed IV with normal saline solution (NSS)
- administered IV medication via syringe
- flushed IV with NSS
- picked up empty syringes
- discarded trash
- placed empty syringes in sharps container
- removed right glove
- touched computer mouse
- removed left glove
- touched oxygen flow meter
- sanitized hands

RN A failed to perform hand hygiene:
- after glove removal

Interview on 4/27/16 at 3:15 PM with Clinical Practice Leader A and Nurse Manager A, confirmed that the observed practice did not conform to the hand hygiene policy.

B. Patient #14

On 4/26/16 between 12:00 PM and 12:15 PM, the following technique was observed during medication administration by RN E:

- sanitized hands
- donned gloves
- placed needle on Humalog KwikPen
- primed pen
- set dosage
- disinfected patient's arm
- administered medication via pen

RN E failed to:
- disinfect the rubber stopper prior to attaching the needle

This finding was confirmed on 4/27/16 at 1:05 PM by Nurse Manager B.

C. Patient #36

On 5/2/16 between 1:05 PM and 1:55 PM, the following technique was observed during blood product administration by RN G:

- washed hands
- donned gloves
- touched blood tubing
- touched computer keyboard and mouse
- picked up thermometer
- touched blood pressure device
- touched IV pump machine
- removed gloves
- touched papers on computer cart
- pushed cart out of patient room

RN G failed to perform hand hygiene:
- after touching sources likely to be contaminated with pathogens
- after glove removal

Interview on 5/2/16 at 2:50 PM with Clinical Practice Leader A confirmed that the observed practice did not conform to the hand hygiene policy.

D. Patient #39

On 4/26/16 between 10:45 AM and 11:00 AM, the following technique was observed during wound care and medication administration provided by RN B:

- entered patient room
- touched tray table and other inanimate objects
- donned gloves
- retrieved syringe with medication
- injected medication from syringe into patient's arm

RN B failed to perform hand hygiene:
- before donning gloves
- before injecting medication

On 4/26/16 at 11:10 AM, Director of Emergency Services A, who witnessed the medication administration, confirmed that RN B's practice did not conform to the hand hygiene policy.

E. Patient #40

On 5/2/16 between 10:10 AM and 10:15 AM, the following was observed during IV medication administration by RN C:

- sanitized hands
- donned gloves
- hung IV medication bag on IV pump
- touched IV pump and pole while entering settings for infusion
- touched bedrail
- connected IV tubing to patient's right arm
- touched IV pump to start infusion

RN C failed to perform hand hygiene and don clean gloves:
- after touching inanimate equipment
- before direct patient contact and connection of IV tubing

On 5/2/16 at 10:15 AM, Director of Patient Services A, who witnessed the medication administration, confirmed that RN C's practice did not conform to the hand hygiene policy.

F. Patient #41

On 4/26/16 between 11:30 AM and 11:43 AM, the following was observed during glucose testing provided by RN F:

- used glucometer to test patient's blood sample
- returned glucometer to base unit in medication room

RN F failed to clean and disinfect the glucometer after use

Interview with Clinical Practice Leader A on 4/26/16 at 2:24 PM confirmed this finding.

II. Based on employee file review, policy review and staff interview, it was determined that for 1 of 17 employee files (Employee #17) in the sample, the hospital failed to test/screen for tuberculosis. Findings include:

The hospital policy entitled "Pre-Placement Health Screening and Immunization Recommendations for Heath Care Workers" stated, "Tuberculosis Screening...All employee, contractor, volunteer, and medical staff applicants will receive baseline TB (tuberculosis) screening...Procedure...T-Spot IGRA (Interferon-Gamma Release Assay) serological testing and a TB Symptom Review are completed at time of pre-placement health screening unless there is a known history of positive conversion...2-step TST (Tuberculin Skin Test)...may be ordered by Occupational Health providers if T-Spot testing is contraindicated. One of the TST...must be placed and read by Bayhealth Medical Center. A negative TST...from an outside facility within the last 12 months may be accepted as 1 of the 2 steps..."

A. Review of personnel files on 5/2/16 revealed no evidence to support that Employee #17, hired in 2003, was tested/screened for tuberculosis.

This finding was confirmed on 5/3/16 at 2:28 PM with Corporate Compliance Clinical Risk Specialist A.

III. Based on observation, policy review and staff interview, it was determined that for 32 of 32 patients in the inpatient rehabilitation unit, staff failed to follow the hospital's infection control policies. Findings include:

The hospital policy entitled "Guidelines For Infection Prevention for Physical Therapy, Occupational Therapy, Speech Pathology" stated "...Disposable Items Must be properly stored, Must be discarded after use via proper procedure for type of material..."

During a tour of the Inpatient Rehabilitation Unit on 4/29/16 at 11:45 AM, two (2) transcutaneous nerve stimulator units (TENS units -- electrical devices used for pain control) were observed:

- There was one package of single use electrodes stored with each TENS unit
- Both packages had been opened and were unlabeled
- There was no way to determine if the electrodes had been used and if so, on whom they were used

Interview with Physical Therapist A on 4/29/16 at 11:50 AM confirmed these findings.