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Based on interview and document review the Critical Access Hospital (CAH) failed to establish a pharmacy and therapeutics committee that provides oversight for all matters relating to drugs in the hospital that meets at least quarterly. Failure of the facility to establish a pharmacy and therapeutic committee meeting at least quarterly puts all patients at risk for receiving medication therapy below the standard of care resulting in unsafe treatment and outcomes and lacks communication for patient safety between the medical staff and department of pharmacy services. Additionally, the CAH failed to provide obstetrical and newborn nursing services under the supervision of a registered professional nurse qualified by education and experience. This deficient practice puts all mother and newborn patients at risk for receiving care, medication and treatment before, during and after labor from a nurse lacking the education and experience to follow acceptable standards of practice. Also, the CAH failed to ensure a safe environment to protect newborns from abduction. This deficient practice puts all newborns at risk for abduction throughout their hospital stay.

Findings include:


Staff D, Administration interviewed in the pharmacy on 9/11/2017 at 2:03 PM acknowledged the facility has just had their first meeting for the Pharmacy and Therapeutic Committee, and plans to begin meeting at least quarterly.


- The CAH's Medical Staff By-Laws directed, " ...pharmacy and therapeutics committee ...will meet at least quarterly and send reports to the Medical Executive Committee regarding its activities ..."


KAR 28-34-10a. (d)
Pharmacy and therapeutics committee. Each hospital shall establish a pharmacy and therapeutics committee or its equivalent. The committee shall consist of at least physicians, nurses and pharmacists. This committee shall assist in the formulation of broad professional policies regarding evaluation, appraisal, selection, procurement, storage, distribution and use of drugs and safety procedures and all other matters relating to drugs in the hospital. This committee shall meet at least quarterly, record its proceedings and report to the medical staff.



Staff B, Administration interviewed in his/her office on 9/13/2017 at 12:07 PM explained the CAH failed to provide documentation of professional training and education to staff in regards to obstetrical and newborn care. Staff B explained the staff receives "on the job training" in regards to assessment of the mother throughout her labor process, fetal heart monitoring, delivery of the newborn, and post-delivery care for the mother and newborn. Staff B explained the nursing staff reviews and verbalizes understanding of set up for delivery, skills for care of the obstetric patient and newborn and use of the fetal monitor and new born warmer yearly at the nursing skills fair. Staff B further explained the nursing staff that have been hired over 1 year ago have been certified to perform Neonatal Resuscitation Program (NRP). The CAH's census for newborn deliveries in the last year is 19.


The CAH failed to provide documentation of a policy and procedure in regards to qualifications for nursing staff for the obstetric and newborn patient.


KAR 28-34-18a (b)(1)
The obstetrical and newborn nursing services, including labor, delivery, recovery, and postpartum care, shall be under the supervision of a registered professional nurse qualified by education and experience to provide nursing care to the obstetric and newborn patients.




Staff B, Administration interviewed in the Newborn Nursery on 9/13/2017 at 12:07 PM verified the facility failed to provide a system to prevent newborn abduction, and the nursery is located close to an exit door.


- The CAH's policy titled "Infant Abduction/Prevention Plan" directed, " ...immediately after birth each infant will have a name band placed on one of their extremities which includes the infants name, DOB, and Medical Record number. The mother and father/significant other will have a matching band applied to their wrist ...parents will be educated that the infant is never to be left without supervision ...education will be provided to the parents regarding the facilities infant abduction/prevention plan prior to delivery of the infant or as soon as possible following the delivery ...any employee alerted by the parent/guardian to the potential abduction of an infant will notify the charge nurse ...any staff member that notices that an infant is missing or has been notified that an infant has been taken will notify the supervisor immediately. The supervisor will notify the ward clerk and a "CODE PINK" will be announced over head. The supervisor or their designee will notify law enforcement immediately..."

There were no newborns in the CAH at the time of survey.

KAR 28-34-18a (e)(2)
Identification shall be attached to the mother and newborn infant before they are removed from the delivery room.

Based on observations and interview, the critical access hospital (CAH) failed to ensure supplies did not exceed the manufacturers' safe use date for one of one materials management supply storage room, for one of one airway cart stored in the operating room department, for one of one emergency department storage closed and in one of one physical therapy room. This deficient practice has the potential to cause harm to all patients related to the use of compromised and unsafe supplies during the care and treatment.


Findings include:


- Materials Management Supply Storage observation on 9/11/2017 at 11:03 AM revealed the following expired items:


1. Five bags of D5 ½ NS IV 1000 ml. fluid (sugar infused saline fluid given IV) with an expiration date of 7/2017, and four bags with an expiration date of 5/2017.
2. Seven bags of D5W 1000 ml. fluid (sugar infused water fluid given IV) with an expiration date of 8/2017.
3. Five female straight catheter kits (used to obtain urine from female patients) with an expiration date of 1/2017.
4. 16 IV connector caps (used to connect IV tubing) expired 6/2017.
5. 14 Penrose drains (a surgical device placed in a wound to drain fluid) with an expiration date of 8/2017.
6. 29 Sterile Disposable Marking Pens with an expiration date of 4/2017
7. One bottle of Peroxide Cleaner with an expiration date of 9/23/2010, one bottle with an expiration date of 12/22/2014, 2 bottles with an expiration date of 4/25/2013, and 3 bottles with an expiration date of 1/24/2014.
8. Two Wound vacutainers (drainage collection containers) with an expiration date of 7/2017.



Materials Management Director Staff H interview on 9/11/2017 at 11:30 acknowledged the expired supplies and removed them from use.


-Operating Room (OR) Department Hallway Airway Cart observation on 9/11/2017 at 11:57 AM revealed two King airway (breathing tubes) size 5 with an expiration date of 6/2017, and one IV start kit with an expiration date of 10/2017.


OR Director Staff M interview on 9/11/2017 at 12:00 PM acknowledged the expired items.



Emergency Department (ED) Storage Closet observation on 9/11/2017 at 2:36 PM revealed:

1. 11 Ethilon sutures size 3.0 (used to place stitches) with an expiration date of 7/2017.
2. Four packages of benzoin swabs (wound cleansing swab) with an expiration date of 6/2017 and four with an expiration date of 7/2017.




- Physical Therapy Room observation on 9/13/2017 at 1:00 PM revealed one tube of Dynatron gel (used to do ultrasounds) with an expiration date of 4/2015.


Chief Nursing Officer Staff B interview on 9/11/2017 at 3:00 PM acknowledged the items were expired.


Policy review on 9/14/2017 revealed the facility failed to provide a policy directing staff in the handling of expired supplies.

Based on medical record review, interview and document review, the facility failed to ensure a provider was on site with in 30 minutes of a patient presenting to the emergency department for 3 of 5 emergency patient records reviewed (#17, #18 and #19). This deficient practice places all emergency patients at risk for deterioration of their condition including death.



Findings include:


- Patient #17's medical record review completed on 9/14/2017 revealed the patient presented to the emergency department (ED) on 6/19/2017 at 2:10 PM for complaints of pregnancy, abdominal cramping and vaginal discharge. Patient #17 was estimated to be 12 weeks into their pregnancy by dates of their last menstrual cycle. The medical record revealed the patient was assigned a triage level (priority) of a 4, non-emergent. The provider on call was notified of the patient presenting to the ED at 2:30 PM. The medical record revealed the provider on call did not arrive on site until 4:50 PM, 2 hours and 20 minutes later, exceeding the 30-minute requirement. Record review revealed the patient received a medical screening exam including a vaginal exam, laboratory testing, an ultrasound examination, and medications during their stay. This patient was discharged at 5:10 PM later that afternoon.


Medical Records Staff S interview on 9/14/2017 at 12:44 PM reported exceeding the 30-minute requirement is a normal occurrence, "if they [provider] are in the clinic and it [emergency room case] is not deemed emergent."


- Patient #18's medical record review completed on 9/14/2017 revealed the patient presented to the ED on 7/23/2017 at 6:58 AM with a complaint of chest pain. Medical record review revealed the patient had had chest pain for one day and had attempted medications such as nitroglycerine (used to treat cardiac related chest pain) and Maalox (used to treat indigestion) with no relief. Patient #18 was assigned a triage level of 4, non-emergent. Record review revealed the provider on call was notified at 7:00 AM. Medical record review revealed the patient received a medical screening exam including laboratory, x-ray, and EKG (electrocardiogram - electrical testing of the heart) testing during their stay. Critical lab results including a critical high Troponin (specific to damage to the heart) value of 31.9 (normal range is 0.0-0.5) were called to the provider at 7:45 AM. The patient received further medications (TNkase - clot busting drug) and treatments and was subsequently transferred by ambulance to another facility due to a diagnosis of an MI (heart attack). The medical record revealed the provider did not arrive on site until 7:50 AM, 50 minutes later, exceeding the 30-minute requirement.


Medical Records Staff S interview on 9/14/2017 at 1:00 PM reports that the usual practice is for the provider to give chest pain protocol orders over the phone and then come in to see the patient.


- Patient #19's medical record review on 9/14/2017 revealed the patient presented to the ED on 8/18/2017 at 11:40 AM in the custody of county police for a complaint of needing a mental evaluation for violent behavior, threats to family and hallucinations. The patient was assigned a triage level of 2, emergent. Medical record revealed the provider on call was notified at 11:55 AM of the patient's arrival. Record review reveals the provider did not arrive on site until 2:05 PM. 2 hours and 10 minutes later, exceeding the 30-minute requirement. The patient received a medical screening exam including psychiatric assessment by the hospital's provider and a third-party mental health professional group and was deemed in need of placement in a mental health facility. Law enforcement officers were present for patient and staff security until the patient was transferred to a local mental health facility in the custody of law enforcement on 8/21/2017 (3 days after presenting to the ED).


Chief Nursing Staff B interview on 9/13/2017 at 10:35 AM communicated that for emergent patients presenting to the ED, the providers are to be here within 30 minutes, but there is not a set time for non-emergent patients.


Chief Nursing Staff B interview on 9/13/2017 at 11:17AM shared that it is not uncommon for providers to wait until lab and x-ray have finished for them to come in to see the patients. At night, when having to call lab and x-ray in, it [provider arrival] may extend past 30 minutes because staff have to wait for them [lab and x-ray] to get here, and then it takes 30 more minutes to get lab results.


Quality and Risk Staff D interview on 9/13/2014 at 11:25 AM reported the facility is not deemed a frontier facility.

- Policy titled, "Emergency Room" reviewed on 9/14/2017 directed, " ... If a patient presents during daytime hours on a week day (0700-1700) the patients regular physician/provider is called unless it is posted that physician/provider is scheduled to be out of the office or out of town ..."


-Policy titled, "ER Documentation" reviewed on 9/14/2017 directed, " ... Most patients presenting are emergent unless ER is due to convenience such as a sprained ankle 3 days ago - just could not get into clinic. Name of patient and initial screening of emergent or non-emergent must be made by the RN on duty. The RN must enter triage into the EMR (electronic medical record). Examples of emergent patients that need to be seen by physician within 30 minutes are (non-exclusive) ... new onset chest pain with symptoms ...."


- Document titled, "Article 6 Emergency Services" from the Morris County Hospital Bylaws - Rules and Regulations 2017 reviewed on 9/14/2017 directed, "Response time. On-call practitioners shall respond within 30 minutes of time after receiving a page or telephone call from emergency personnel ..."

Based on observation, interview, document, policy and procedure review the Critical Access Hospital (CAH) failed to ensure safe operating condition for the bedspread and drapes in 1 of 1 patient comfort care room, the physical therapy temperatures were corrected and safe for patient care for 1 of 1 paraffin wax bath, and Cold Packs in 1 of 1 freezer. The facility failed to ensure storage temperatures were safe in 1 of 1 Omnicell (automated dispenser for dispensing supplies or medications) freezer, 1 of 1 IV (intravenous [in the vein]) contrast dye warmer in radiology, and 1 of 1 fluid and blanket warmer in the operating room hallway. These deficient practices have the potential to expose patients to harmful conditions in the forms of burns from the paraffin wax, IV contrast, fluids and blankets, bedspread and drapes, and from unsafe care and treatments with low temperatures from the paraffin wax, and ineffective use of supplies and medications stored in the freezer.

Findings include:


- Operating Room Hallway observation on 9/11/2017 at 11:57 AM revealed one fluid warmer and one blanket warmer with an external temperature display.

Operating Room Director Staff M interview on 9/11/2017 at 11:57 AM communicated there is no daily monitoring of temperatures of either of the warmers. The machine has built in ranges, and will alarm if out of range. Staff M state the OR staff visually check the temperature periodically.

- Policy titled, "Warmed IV/Irrigation Fluids" reviewed on 9/16/2017 directed, " ...the upper cabinet is to be used for long term storage of IV and irrigation fluids. Temperature setting for this compartment will be maintained at 104 degrees Fahrenheit ..." and " ...The lower compartment is to be used for blankets and short-term storage of IV and irrigation fluids ...temperature setting for this compartment will be maintained at 140 degrees Fahrenheit."

- Omnicel Medication Dispensing station behind the nurse's desk at the main nursing desk observation on 9/11/2017 at 2:25 PM revealed an unsecured freezer containing Cervidil cream (a medicated cream used in the induction of childbirth). Freezer observation revealed it lacked a thermometer for temperature monitoring.

Quality and Risk Staff D interview on 9/11/2017 at 2:25 PM acknowledged the freezer lacked temperature monitoring.

- Document review in the Physical Therapy (PT) room of the log titled, "Bi-Weekly Equipment Temp and Cleaning Log" on 9/12/17 at 1:01 PM revealed the Paraffin Wax temperatures (temp) to be checked and maintained in a Range of 124-130 degrees Fahrenheit (F) each day before use. The temperatures were out of range for 23 of 30 days checked. The following record of dates and temperatures is as follows for 2017: 5/5 temp 123, 5/9 temp, 5/16 temp 123, 5/19 temp 123, 6/2 temp 123, 6/6/ temp 123, 6/9 temp 120, 6/13 temp 120, 6/16 temp 120, 6/20 temp 120, 6/27 temp 120, 7/7 temp 132, 7/11 temp 140, 7/14 temp 132, 7/18 temp 135, 7/28 temp 120, 8/8 temp 120, 8/16 temp 140, 8/22 temp 140, 8/25 temp 135, 8/29 temp 130, 9/1 temp 140 and 9/4 temp 140.

- Document review in the Physical Therapy room of the log titled, "Bi-Weekly Equipment Temp and Cleaning Log" on 9/12/17 at 1:01 PM revealed the cold packs stored in the freezer to be checked and maintained at 10 degrees F each day before use. The temperatures were out of ranges for 16 of 30 days. The following record of dates and temperatures is as follows for 2017: 5/9 temp 9, 5/16 temp 9, 5/23 temp 9, 6/9 temp 20, 6/13 temp 15, 6/20 temp 11, 6/23 temp 22, 6/27 temp 11, 7/7/ temp 9, 7/11 temp 18, 7/21 temp 12, 8/1 temp 12, 8/4 temp 11, 8/25 temp 11, 9/1 temp 40, and 9/4 temp 30.

Staff U from Physical Therapy interviewed while reviewing the "Bi-Weekly Equipment Temp and Cleaning Log" with the surveyor on 9/12/17 at 1:01 PM verified the Paraffin Wax and Freezer temperatures that were out of range. Staff T explained s/he adjusts the temperature for the freezer as needed.

Staff O from Physical Therapy interviewed while reviewing the "Bi-Weekly Equipment Temp and Cleaning Log" with the surveyor on 9/12/17 at 1:01 PM verified the Paraffin Wax and Freezer temperatures that were out of range.


- Radiology Department Director Staff V interview on 9/13/2017 at 9:00 AM acknowledged the warmer exceeded the recommendations for the IV contrast media. Staff V explained that the warmer was purchased from the same manufacturer so they assumed it was at the right temperature. Radiology staffs are to check to make sure that the warmer is not alarming, but they do not record a temperature reading daily. Staff V shared after confirming with the manufacturer of the warmer that the alarm will only sound if the warmer reaches 104 degrees F.


Magnavist packaging reviewed on 9/13/2017 directed, " ...store at controlled room temperature between 59-86 degrees F. Do not freeze."


Omnipaque packaging reviewed on 9/13/2017 directed, " ...store at 68-77 degrees F; excursions permitted to 59-86 degrees F. Do not freeze."


Omnipaque Manufacturer's Guidelines reviewed on 9/13/207 directed, " ...Do not freeze. Omnipaque should be stored at controlled room temperature, 68-77 degrees F; excursions permitted to 59-86 degrees Fahrenheit. Omnipaque injection in all presentations may be stored in a contrast media warmer for up to one month at 98.6 degrees F."


Policy titled, "Imaging Services" reviewed on 9/13/2017 directed, " ...Contrast warmers will be monitored daily for temperature control ..." and " ...the contrast bottles in the warmer should be discarded if it is not used at the end of 30 days ..."


- The CAH failed to provide documentation of a policy and procedure regarding temperatures for the Physical Therapy and Medication Freezers, fluid and blanket warmers, and Paraffin Wax warmers.

Based on observation, staff interview, policy/procedure review, and manufacturer's guidelines, the facility failed to: 1. Ensure safe storage for one of one portable oxygen rack containing full and empty oxygen (O2) tanks, 2. Secure medications in one of one post operative recovery room, 3. Secure medications in one of one Omnicel (an automated medication dispensing machine) freezer, 4. Secure the hallway adjoining the hospital EMS station or secure the medications at the EMS station, and 5. Date and store medications at the right temperature for one of one IV contrast media (special material injected during a computerized tomography (CT - combinations of many X-ray measurements taken from different angles to produce cross-sectional images of specific areas) to highlight structures such as blood vessels) warmer. This deficient practice puts all patients and staff at risk for harm or death due to the potential for poor security and unsafe dispensation of medications and injectables, and unsafe storage, transport and use of oxygen, potentially causing burns or explosions.



Finding include:

- Central Supply room observation on 9/11/2017 at 11:03 AM revealed a small room off the Central Supply area with a glass door and wall that went to another small room containing various boxes of delivered supplies, cardboard and a portable oxygen rack containing full and empty O2 tanks. The O2 tanks failed to be separated and labeled for which O2 tanks were full and empty.


Central Supply staff H interview in the Central Supply room on 9/11/2017 at 11:03 AM verified the empty and full portable O2 tanks failed to be separated and they were located in a room with potentially combustible items that are delivered from suppliers.


The CAH's policy titled "Oxygen, Compressed Air and CO2 Cylinders" reviewed on 9/11/2017 directed, " ...keep cylinder in a stand or cart ...always keep cylinders in a well-ventilated area ..."



- Post Operative Recovery Room observation on 9/11/2017 at 11:57AM revealed an unlocked drawer containing 13 saline (salt water solution) IV flushes unsecured.


Operating Room Director Staff M interviewed on 9/11/2017 at 12:00 PM acknowledged the unsecured medications.


- Omnicel Medication Dispensing station behind the nurse's desk at the main nursing desk observation on 9/11/2017 at 2:25 PM revealed an unsecured freezer containing Cervidil cream (a medicated cream used in the induction of childbirth).


Quality and Risk Staff D interviewed on 9/11/2017 at 2:25 PM acknowledged the medications were unsecured and replied, "I didn't think about that."


- Emergency Medical Services (EMS) station hallway adjoining the hospital observation on 9/11/2017 at 3:10 PM revealed three boxes of IV dextrose (sugar water solution) in a clear plastic tote unsecured without a locking mechanism.


Paramedic Staff T interviewed on 9/11/2017 at 3:10 PM acknowledged the medications were unsecured, and replied, "Yes, we have patients that wander back here when they try to go the ER. The door [between the hospital and the EMS station] is supposed to be locked, but its often left unlocked."



- Policy titled, "Medication Administration Policy" reviewed on 9/16/2017 directed, " ...The nurse is not to leave the medication unattended ..." and " ...No meds are to be left on the top of the COW [computer on wheels] or on any cupboard."




- Radiology Department CT scanner room observation on 9/13/2017 at 8:50 AM revealed an IV contrast-media (injected to highlight blood vessels during a CT scan) warmer reading 102 degrees Fahrenheit (F) per internal thermometer, containing 36 bottles of Omnipaque brand IV contrast and 11 vials of Magnavist brand contrast. Observation revealed the vials lacked dates when they were placed in the warmer.



- Radiology Department Director Staff V interviewed on 9/13/2017 at 9:00 AM acknowledged the warmer exceeded the recommendations for the IV contrast media. Staff V explained that the warmer was purchased from the same manufacturer so they assumed it was at the right temperature. Radiology staffs are to check to make sure that the warmer is not alarming, but they do not record a temperature reading daily. Staff V shared after confirming with the manufacturer of the warmer that the alarm will only sound if the warmer reaches 104 degrees F.


Magnavist packaging reviewed on 9/13/2017 directed, " ...store at controlled room temperature between 59-86 degrees F. Do not freeze."


Omnipaque packaging reviewed on 9/13/2017 directed, " ...store at 68-77 degrees F; excursions permitted to 59-86 degrees F. Do not freeze."


Omnipaque Manufacturer's Guidelines reviewed on 9/13/207 directed, " ...Do not freeze. Omnipaque should be stored at controlled room temperature, 68-77 degrees F; excursions permitted to 59-86 degrees Fahrenheit. Omnipaque injection in all presentations may be stored in a contrast media warmer for up to one month at 98.6 degrees F."


Policy titled, "Imaging Services" reviewed on 9/13/2017 directed, " ...Contrast warmers will be monitored daily for temperature control ..." and " ...the contrast bottles in the warmer should be discarded if it is not used at the end of 30 days ..."

Based on observation, and interview, the critical access hospital failed to ensure adequate temperature and humidity monitoring for 1 of 1 procedure room, 1 of 1 sterile processing room and 1 of 1 surgical suite. This deficient practice has the potential to place staff and patients at risk for infection, fire and bacteria during surgical procedures.


Findings include:



- Procedure Room, Central Sterilizing Room and Surgical Suite observation on 9/12/2017 revealed each room containing a digital thermometer and humidity gauge. Temperature ranges of 68-73 degrees Fahrenheit and humidity ranges of 30-60%, however a corresponding log for daily monitoring was not found.


Surgical Staff Q interviewed on 9/12/2017 at 10:35 AM communicated that there is a monitoring system for the temperature and humidity, but staff do not keep a daily log.


- Operation Room Director Staff M interviewed on 9/12/2017 at 2:05 PM shared that temperature and humidity are monitored monthly by printing a report at the end of each month, but staff do not log the temperature on a log daily. Staff M reports that air exchanges were last calculated in 2016 by himself and the environmental director. Staff M revealed there is no routine monitoring of air exchanges in the surgical suite, procedure room, or central sterilizing.


On 9/14/2017 the facility failed to provide a policy related to the monitoring of temperature, humidity and air exchanges for the surgical environment.

Based on medical staff credentialing files review, interview and document review, the facility's Governing Body failed to ensure 8 of 8 medical staff (Medical Staff G, P, W, X, Y, Z, AA, and BB) had been granted specified privileges to practice in the hospital. This deficient practice has the potential to affect the quality of patient care, and place all patients at risk for harm due to lack of qualifications and privileging oversight.


Findings include:

-Medical Staff credentialing review on 9/11/2017 revealed Medical Staff G's, P's, W's, X's, Y's, Z's, AA's, and BB's credential files lacked evidence of current reappointment approval denoting privileges with corresponding signatures from the medical staff and board of directors/governing body.


Heath Information Management Staff C interviewed on 9/11/2017 at 4:11 PM acknowledged the incomplete credentialing files.


-Document titled, "Medical Staff Bylaws" reviewed on 9/14/2017 directed, " ...the board shall give notice of its final decision to the applicant by special notice and to the chief of staff .... And notice to appoint shall include: the medical staff category to which the applicant is appointed, clinical department to which the applicant is assigned, the clinical privileges of the applicant may exercise, the length of the provisional period, and any special condition attached to the appointment ..."

Based on medical record review, interview and policy review, the facility failed to document in the medical record or transfer forms the medical condition for 3 of 5 emergency patients (#15, 18 and 19) who were transferred This deficient practice places all transferred patients at risk for inadequate care and possible death during transfers and at the receiving facility.

Findings include:

- Patient #15's medical record review on 9/14/2017 revealed the patient presented to the emergency department (ED) on 4/1/2017 with a complaint of dizziness, chest pain, diaphoresis (sweating), nausea and vomiting, and falls. Record review reveals the patient received laboratory, x-ray and EKG (electrocardiogram - electrical study of the heart), which indicated the patient was having a heart attack. The patient was subsequently transferred to a receiving hospital by way of medical helicopter. Nursing notes in the medical record reveal the patient was pain free just before transfer. The record revealed the condition of the patient was not indicated on the transfer documentation for the transport crew or for the receiving facility.


- Patient #18's medical record review completed on 9/14/2017 revealed the patient presented to the ED on 7/23/2017 at 6:58 AM with a complaint of chest pain. Medical record review reveals the patient received a medical screening exam including laboratory, x-ray, and EKG testing during their stay. The patient received further medications and treatments and was subsequently transferred by ambulance to another facility due to a diagnosis of an MI (heart attack). The record revealed the condition of the patient was not indicated on the transfer documentation for the transport crew or for the receiving facility.


- Patient #19's medical record review completed on 9/14/2017 revealed the patient presented to the ED on 8/18/2017 at 11:40 AM in the custody of county police for a complaint of needing a mental evaluation for violent behavior, threats to family and hallucinations. The patient received a medical screening exam including psychiatric assessment by the hospital's provider and a third-party mental health professional group and was deemed in need of placement in a mental health facility. Law enforcement officers were present for patient and staff security until the patient was transferred to a local mental health facility in the custody of law enforcement on 8/21/2017. The record revealed the condition of the patient was not indicated on the transfer documentation for the transporting officer or for the receiving facility.


Medical Records Staff S interviewed on 9/14/2017 at 12:50 PM acknowledged the patients' condition was not indicated.


- Policy titled, "Transfer Policy to Another Acute Facility" reviewed on 9/14/2014 directed, " ...The charge nurse will make a notation on the chart that the patient has been transferred or dismissed, the mode of transportation, and the patient's condition at the time ..."

Based on observation, staff interview, policy and procedure review the Critical Access Hospital (CAH) failed to ensure expired medications were removed from use in 1 of 1 Nursing Medication Room. This deficient practices of failing to discard expired medications puts all patients at risk for receiving medications that are ineffective and unsafe for use.


Findings include:


- Observation in the Nursing Medication Room on 9/11/2017 at 2:29 PM revealed the following expired medications: 1 bottle of Latanoprost Ophthalmic Solution (a medication to treat eye conditions that can cause blindness) with an expiration date of 7/2017, and 85 tablets of Bethanechol Chloride 25 milligrams (mg) (a medication to treat urinary and bladder problems by emptying the bladder and increasing urination) with an expiration date of 6/2017.

Staff B, Administration interviewed in the Nursing Medication room on 9/11/2017 at 2:29 PM verified 1 bottle of Latanoprost Ophthalmic Solution with an expiration date of 7/2017, and 85 tablets of Bethanechol Chloride 25 mg with an expiration date of 6/2017.

The CAH's policy titled "Outdated Medications" reviewed on 9/11/2017 directed, " ...medications in all departments are checked monthly and pulled from stock when outdated ..."

The CAH's policy titled "Medication Administration Policy" reviewed on 9/11/2017 directed, " ...expiration dates on all medications will be checked monthly ...expired medications will be removed from the shelves and replacements ordered if need ..."

Based on observation, interview and policy review, the facility failed to: 1. Ensure cleaning and disinfecting solutions did not exceed the manufacturer's expiration date for 1 of 1 materials maintenance storeroom, 2. Perform hand hygiene when completing a terminal cleaning of the procedure room (Staff R), 3. Ensure staff don appropriate attire for the procedures taking place in the room (Staff G), 4. Ensure proper cleaning procedures and handling of the colonoscopes (camera used to visualize the colon during a procedure) during 1 of 1 procedure (Staff Q), 5. Ensure expired food items were discarded for 1 of 1 food item, 6. Ensure rust and build up were removed from 1 of 1 ice machine in the staff dining room, 7. Ensure 2 of 3 Physical Therapy (PT) mats were free from exposed worn areas, and 8. Ensure items were removed from under the sink in the PT department. This deficient practice fails to provide safe therapy equipment with cleanable surfaces, fails to provide a clean and sanitary environment, and places all patients and staff at risk for infection, cross contamination, food poisoning, illnesses and pathogens.


Findings include:

- Procedure Room Observation on 9/12/2017 at 8:36 AM revealed Surgical Staff Q picking up the clean colonoscope without the use of gloves and flexing the end prior to setting it back down on the clean field.

Surgical Staff Q interviewed on 9/12/2017 at 8:36 AM replied, "its ok, its sterile." When Staff Q was reminded that his hands were not sterile, he replied, "Ok, I'm sorry, I didn't think of that."

- Scope Cleaning observation on 9/12/2017 at 10:44 AM revealed while Surgical Staff Q demonstrated steps in the drying process, Staff Q reached into the drying cabinet where cleaned scopes were hanging and grabbed one with their hands to show that they were dry.

Operating Room Director Staff M interviewed on 9/12/2017 at 2:05 PM communicated their expectations is for no "gross contamination" and that staff should "wear gloves" when touching the scope. Staff M stated, "We are not able to maintain sterility."

On 9/14/2017, the facility failed to provide a policy on the handling of the cleaned scopes.

- Procedure Room observation on 9/12/2017 at 8:37 AM revealed Physician Staff G entered the procedure room and performed the procedure wearing street clothing. Staff G donned only a plastic gown and gloves prior to performing the procedure.

Operating Room Director Staff M interview on 9/12/2017 at 2:05 PM stated, "They should wear scrubs. That is our policy."

Policy titled, " Surgical Policy and Procedure" reviewed on 9/12/2017 directed, " The surgical team shall be dressed in two-piece scrub uniforms laundered by MCH [Morris County Hospital] ..."


- Post Procedural Colonoscope Processing observation on 9/13/2017 at 9:20 AM revealed Surgical Staff Q failed to externally dry and internally dry the colonoscope by feeding air through the air and water channels, suctioning alcohol through the scope prior to hanging in the scope cabinet.

Operating Room Director Staff M interviewed on 9/12/2017 at 2:05 PM communicated that processing staff no longer perform external and internal drying process, they take the wet scope directly from the sterilizer machine to the scope hanging cabinet because the cabinet circulates air and has a HEPA filter (medical grade air purifier) inside it.

Policy titled, "Cleaning of Video Colonoscope" reviewed on 9/13/2017 directed, " ...alternately feed air through air/water channels by covering valve and depressing valve. Do this until no more retained rinse water is expelled from distal end of scope. Suction 30 cc of alcohol through the scope. Suction room air through biopsy suction channel to dry that channel. Dry all external parts of the scope .... hang scope and all accessory forceps and brushes on designated hooks in scope storage cabinet."

Document titled, "Olympus Reprocessing Manual" reviewed on 9/13/2017 directed, "using a sterile, lint-free cloth, thoroughly wipe and dry all external surfaces ..." and "Flushing the channels with 70% ethyl or isopropyl alcohol after rinsing them with sterile water facilitates drying inside the channels ..." and " ...Before storage of a high-level disinfected endoscope, thoroughly dry all parts of the endoscope (especially all internal lumens, the distal end, lenses, and electrical contacts) and accessories."

- Observation of the ice machine in the staff dining room on 9/12/2017 at 11:06 AM revealed the grill used for ice and water drainage with rust on the top left side. The ice machine also had a white hard plastic drain with slimy pink build up inside.

- Terminal Cleaning of the Procedure Room observation on 9/12/2017 at 11:51 AM revealed Surgical Staff R disconnecting a used suction container with biohazard materials inside and taking it to the biohazard trash where she pressed the item into the full biohazard container. Staff R directly resumed the terminal cleaning, failing to perform hand hygiene and change their gloves.

Surgical Staff R interviewed on 9/12/2017 at 11:51 AM acknowledged the failure to perform hand hygiene.

Staff N, Dietary Staff interviewed in the staff dining room on 9/12/17 at 11:06 AM verified the ice machine with rust on the grill and slimy pink build up in the plastic drain.

The CAH failed to provide documentation of a policy and procedure regarding maintenance of the ice machine.

- Observation of the food storage area in the facility kitchen on 9/12/2017 at 11:48 AM revealed 63 cans of Cranberry Juice (5.5 ounce) size with an expiration date of 9/11/2017.

Staff N, Dietary Staff interviewed in the food storage area in the facility kitchen on 9/12/2017 at 11:48 AM verified the 63 cans of Cranberry juice expired on 9/11/2017.

The CAH failed to ensure documentation of a policy and procedure regarding expired food for the facility kitchen.

- Observation in the Physical Therapy room on 9/13/2017 at 1:00 PM revealed 1 blue wedge pillow, and 1 black mat with worn and missing areas on all 4 corners failing to provide a cleanable surface to prevent bacteria.

- Observation in the Physical Therapy room on 9/13/2017 at 1:08 PM revealed the following items stored under the sink: 2 plastic buckets, 18 therapy cones, 3 glass vases, 3 used sponges, 1 bottle of distilled water and 1 bottle of rubbing alcohol (used to clean items).

Staff O, Physical Therapy Staff interviewed on 9/13/2017 at 1:08 PM verified the items were stored under the sink.

The CAH's policy titled "Care and Use of Clinic Equipment" reviewed on 9/13/2017 directed, " ...staff will be responsible for reporting dysfunctional or unsafe equipment to the Compliance Coordinator ...staff will remove dysfunctional equipment from the clinic area and tag it as dysfunctional, per the Compliance Coordinator's directive ..."

Based on medical record review, interview and policy review, the Critical Access Hospital (CAH) failed to complete a comprehensive care plan for 2 of 3 obstetrical (pregnant patients #1 and #3) records reviewed, and failed to initiate a care plan for 3 of 3 newborn records reviewed (#4, #5 and #6). This deficient practice places all inpatients at risk for poor, disjointed nursing care, potentially jeopardizing wellness, healing and safety.


Findings include:


- Patient #1's medical record review on 9/14/2017 revealed the patient was admitted on 1/22/2017 for symptoms of labor, and subsequently underwent an emergency cesarean section procedure (procedure to surgically remove the baby from the mother). The patient was dismissed on 1/25/2017. The medical record review revealed the care plan contained only one nursing diagnosis of pain control, lacking a comprehensive problem list.

- Patient #3's medical record review on 9/14/2017 revealed the patient was admitted on 6/7/2017 for a delivery induction procedure (using medication to start labor). The patient was dismissed on 6/8/2017. Medical record review revealed the care plan contained only one nursing diagnosis of acute pain, lacking a comprehensive problem list.


- Medical record review on 9/14/2017 revealed newborn infant patients #4, #5, and #6 lacked evidence of a care plan.


Chief Nursing Officer Staff B interviewed on 9/14/2017 at 12:04 PM acknowledged the incomplete or missing care plans, and communicated their expectation is for them to include more than one problem. Staff B shared they expected at least a care plan related to breastfeeding for the patients delivering babies.


- Policy titled, "Nursing Care Plans" reviewed on 9/14/2017 directed, " ...Nursing care plans should be made on all inpatients ..." and " ...the care plan should be individualized for each patient ..."

Based on record review, interview, and policy review, the Critical Access Hospital (CAH) failed to ensure patient records are complete. The facility failed to ensure verbal orders were signed within 24 hours for 1 of 5 emergency room patients (#18). The failure of the facility to ensure medical records are complete has the potential for incomplete patient record information necessary for continuity of care.


Findings include:


- Patient #18's medical record review completed on 9/14/2017 revealed the patient presented to the ED on 7/23/2017 at 6:58 AM with a complaint of chest pain. Medical record review reveals the patient received a medical screening exam including laboratory, x-ray, and EKG (electrocardiogram - electrical testing of the heart) testing during their stay. The patient received further medications and treatments and was subsequently transferred by ambulance to another facility due to a diagnosis of an MI (heart attack). Record review revealed document titled, "Chest Pain Standing Orders" contained checked marked and written verbal orders, lacking a provider's signature.


Medical Records Staff S interviewed on 9/14/2017 communicated their expectation is to have them signed within 24 hours.


- Document titled, "Morris County Hospital Bylaws Rules and Regulations" reviewed on 9/14/2017 directed, " ...Medical records are considered delinquent if they remain incomplete for more than thirty (30) days following the patients discharge from the hospital. Incomplete items include: missing dictation reports ... unsigned verbal orders ..."

Based on interview and document review the Critical Access Hospital (CAH) failed to ensure compliance requirements related to Periodic Evaluation and Quality Assurance Review. The facility failed to: complete a periodic evaluation of its total program on an annual basis (C-0331); provide utilization of services including the least number of patients served and volume of services (C-0332); evaluate a sample of both active and closed clinical records; to review health care policies to ensure appropriate services C-0334); ensure policies are followed with changes made as needed and assess the appropriateness of the diagnosis and treatment furnished by physicians are evaluated (C-0335).

The cumulative effect of the hospital's failure to ensure annual review of the total program, utilization of patients served, clinical record review, policies are followed and changed as needed, appropriate services are provided, and evaluations of physician services puts all patients at risk for poor quality and unsafe care.


Findings include:

Staff A, Administration interviewed in their office on 9/13/2017 at 10:40 AM acknowledged the facility failed to provide documentation of an annual evaluation of the total program for 2016.

- The CAH's Medical Staff Bylaws reviewed on 9/14/17 directed, "...participate in identifying community health needs and setting the Hospital goals and establishing plans and programs to meet those needs ..."

Based on staff interview and Medical Staff Bylaws review, the Critical Access Hospital (CAH) failed to provide documentation of an annual periodic evaluation of its total program completed for 2016. Failure to ensure an annual review of its total program put all patients at risk for unsafe and poor quality care from each department in the CAH.

Findings include:

Staff A, Administration interviewed in their office on 9/13/2017 at 10:40 AM acknowledged the facility failed to provide documentation of an annual evaluation of the total program for 2016.

- The CAH's Medical Staff Bylaws reviewed on 9/14/17 directed, "...participate in identifying community health needs and setting the Hospital goals and establishing plans and programs to meet those needs ..."

Based on interview and document review, the Critical Access Hospital (CAH) failed to ensure yearly program evaluation of all CAH services to include the number of patients served and the volume of services provided. Failure of the facility to evaluate CAH services, patients served and the volume of services puts all patients at risk for receiving care, nutrition, treatments and supportive services that are inadequate to the health and quality standards required.

Findings include:

Staff A, Administration interviewed in their office on 9/13/2017 at 10:40 AM acknowledged the facility failed to provide documentation of an annual evaluation of the total program for 2016.

- The CAH's Medical Staff Bylaws reviewed on 9/14/2017 directed, "...participate in identifying community health needs and setting the Hospital goals and establishing plans and programs to meet those needs..."

Based on interview and document review, the Critical Access Hospital (CAH) failed to ensure review of both active and closed clinical records representing services furnished under the CAH in the periodic annual review. Failure to ensure review of active and closed clinical records in the periodic review puts all patients at risk for not receiving quality, accurate and comprehensive care as chart reviews alert all staff to potential problems and issues to ensure quality of care is provided.

Findings include:

Staff A, Administration interviewed in their office on 9/13/2017 at 10:40 AM acknowledged the facility failed to provide documentation of an annual evaluation of the total program for 2016.

- The CAH's Medical Staff Bylaws reviewed on 9/14/2017 directed, "...participate in identifying community health needs and setting the Hospital goals and establishing plans and programs to meet those needs..."

Based on interview and document review, the Critical Access Hospital (CAH) failed to ensure the facility evaluated the program annually including reviewing and revising health care policies. Failure of the CAH to evaluate, review and revise health care policies puts all patients at risk for receiving care that is unsafe and below the standard of care from each profession resulting in harm and poor outcomes.

Findings include:

Staff A, Administration interviewed in their office on 9/13/2017 at 10:40 AM acknowledged the facility failed to provide documentation of an annual evaluation of the total program for 2016.

- The CAH's Medical Staff Bylaws reviewed on 9/14/2017 directed, "...participate in identifying community health needs and setting the Hospital goals and establishing plans and programs to meet those needs..."

Based on interview and document review, the Critical Access Hospital (CAH) failed to ensure results from the annual program are evaluated to determine whether utilization of services is appropriate, whether services need to be added and whether policies need to be added, deleted and/or revised to provide safe quality care for all patients served. Failure to ensure results from the annual program are evaluated puts all patients at risk for care that is unsafe and below the standard of care according to State and Federal guidelines.

Findings Include:

Staff A, Administration interviewed in their office on 9/13/2017 at 10:40 AM acknowledged the facility failed to provide documentation of an annual evaluation of the total program for 2016.

- The CAH's Medical Staff Bylaws reviewed on 9/14/2017 directed, "...participate in identifying community health needs and setting the Hospital goals and establishing plans and programs to meet those needs..."

Based on document review, and staff interview, the facility failed to include in their Swing Bed rights the right to be free from the use of restraints. Failure to notify patients of this right has the potential to place all swing bed patients at risk for injury or death related to inappropriate use of restraints.

Findings include:

- Document titled "Swing Bed Patient Rights" reviewed on 9/13/2017 revealed the document lacked the right to be free from restraints.

Medical Records Staff C interviewed on 9/14/2017 at 11:00 AM acknowledged the document lacked the right to be free from restraints.

Based on document review and staff interview, the facility failed to include in their Swing Bed rights the right to be free from abuse. Failure to notify patients of this right has the potential to place all swing bed patients at risk for abuse.

Findings include:

- Document titled "Swing Bed Patient Rights" reviewed on 9/13/2017 at revealed the document lacked the right to be free from abuse.

Medical Records Staff C interviewed on 9/14/2017 at 11:00 AM acknowledged the document lacked the right to be free from abuse.