HospitalInspections.org

Based on observation, interview, and record review, the hospital failed to ensure compliance with state regulations as follows:

1. Four of four sampled employees (Registered Nurse (RN) 5, Licensed Vocational Nurse (LVN) 1, Emergency Department Supervisor (EDS), and Operating Room Supervisor (ORS) were protected from potential aerosol (floating in air) transmissible diseases (ATD) when the hospital had no documentation in their files that the employees been offered or received all State mandated vaccines at the date of hire. ATD is defined as any disease caused by the transmission of gaseous suspensions of fine solid or liquid particles, such as sneezing and coughing. This failure had the potential to put patients at risk of transmissible diseases.

2. Two of four employees failed to have current annual evaluations of their performance documented in their files. (LVN 1 and EDS) This failure had the potential for patients to receive care by employees who were not competent.

3. The hospital failed to add a mobile MRI (magnetic resonance imaging, a type of X-ray) service to their licence. This failure had the potential to have patients treated in an unsafe manner.

Findings:

1. California Code of Regulations Title 8 (occupational health and safety requirements for aerosol transmissible diseases), Section 5199(h)(5) requires employers to make available to all susceptible healthcare workers with occupational exposure all vaccine doses listed in Appendix E. Doses listed in Appendix E include seasonal influenza vaccine, measles, mumps, and rubella (German measles) vaccine, varicella (chicken pox) vaccine, and tetanus-diphtheria-acellular pertussis (Tdap) vaccine. Tdap is a combination vaccine that protects against three potentially life-threatening bacterial diseases: tetanus (lock jaw), diphtheria (serious respiratory disease), and pertussis (whooping cough).

California Code of Regulations, Title 8, Section 5199 (a)(1)(A), applies to hospitals, skilled nursing facilities, and home health agencies, among others.

Employers are also required to ensure that employees who decline to accept a recommended and offered vaccination, sign the declination statement in Appendix C1 for each declined vaccine.

On 5/24/17 at at 11:30 am, four employee files were reviewed with the Human Resources Manager (HRM) and Administrative (Admin) Nurse 1. The employee files did not contain evidence of the following vaccinations or declinations as follows:

a. RN 5's file did not contain Hepatitis B (a serious liver infection) vaccine evidence;
b. LVN 1's file did not contain measles, mumps, and rubella vaccine, varicella, and Tdap vaccine evidence.
c. EDS's file did not contain Tdap, influenza, measles, mumps, rubella, and varicella vaccine evidence.
d. ORS's file did not contain Tdap, influenza, measles, mumps, rubella, and varicella vaccine evidence.

The hospital policy, "Communicable Disease Prevention and Control in the Workforce," dated 5/30/15, was reviewed and indicated prior to clinical activities, the hospital would ensure TB, Rubella, Hepatitis B, Varicella, Rubeola and Tdap screening and immunization were offered. Declinations of immunizations were not addressed in the policy.

In a concurrent interview, HRM and Admin Nurse 1 (responsible for employee health) stated they were unaware of the this regulation.

2. The California Code of Regulations, Title 22, Division 5, Chapter 1, Section 702013 (c) read, "Policies and procedures which contain competency standards for staff performance in the delivery of patient care shall be established, implemented, and updated as needed for each nursing unit, including standards for the application of restraints. Standards shall include the elements of competency validation for patient care personnel other than registered nurses as set forth in Section 70016, and the elements of competency validation for registered nurses as set forth in Section 70016.1. At least annually, patient care personnel shall receive a written performance evaluation. The evaluation shall include, but is not limited to, measuring individual performance against established competency standards."

On 5/24/17, EDS and LVN 1's files were reviewed and did not contain evidence of a current annual evaluation.

During an interview on 5/24/17 at 11:45 am, the Chief Nursing Officer stated the hospital practice was to conduct annual performance evaluations and believed they had been done timely.

The above performance evaluations were not found by the end of the survey.

3. California Health and Safety Code, Division 2, Chapter 9 Mobile Health Care Units, Section 1765.135. read, " (a) To qualify for a license under this chapter, an applicant shall satisfy all the requirements of this chapter, the applicable requirements of Chapter 1 (commencing with Section 1200) or of Chapter 2 (commencing with Section 1250) of Division 2, and all applicable regulations.

(b) The applicant shall file a completed application with the state department. (Effective January 1, 1994.)"

On 5/22/17 at 9 am, the hospital lobby had a posting of the mobile MRI scheduled days and hours.

Current Department licensure records were reviewed and failed to list mobile MRI as a service of the hospital.

During an interview on 5/22/17 at 10:30 am, Imaging Supervisor 1 confirmed the hospital had a mobile MRI unit. He was unaware of the above regulatory requirements.

Based on observation, interview, and record review, the hospital failed to ensure emergency equipment and supplies were available for safe use with patients when:

1. Pediatric electrode pads for defibrillation (an electric shock administered to change the hearts rhythm) on the Emergency Department (ED) and the Medical Surgical Unit (MSU) crash cart (carts stocked with life saving equipment and supplies) were expired.

2. The infant warming unit (a device used to supply supplementary heat to a newborn baby after birth) had not been checked since 11/2016 for proper functioning and temperatures.

3. Two central venous catheterization (thin flexible tube used to give medicines, fluids, nutrients, or blood products over a long period of time inserted a large vein) trays were expired.

4. An Intraosseous Vascular Access System drill (used to administer fluids into the bone if normal vein access cannot be established) had not been checked for proper functioning for over a year.

5. Expired normal saline solution bags were available on the ED crash cart.

These failures placed patients at risk of not getting safe and effective treatment in an emergency.

Findings:

1a. During an observation on 5/22/17 at 1:40 pm, the crash cart in ED Room 2 had two packages of pediatric electrode pads for defibrillation (an electric shock administered to change the hearts rhythm) which had passed the expiration date.

1b. During an observation on 5/22/17 at 11:45 am, the MSU crash cart contained two packages of pediatric electrode pads (adhesive pads placed on the skin and connected to a machine by wires that records the electrical activity of the heart) which had passed the expiration date.

During an interview on 5/24/17 at 7 am, Registered Nurse (RN) 1, an ED night shift nurse, was asked what the process for checking and replacing supplies on the crash cart, and she stated she was unsure what the process was but she would just look at what was used and replace any items she used.

During an interview on 5/22/17 at 1:40 pm, Emergency Department Supervisor (EDS) acknowledged that the pediatric pads had expired. When asked what the process for checking supplies on the crash cart, EDS stated he was unsure of the process.

The hospital policy, "Crash Cart Checks," dated 10/29/15, was reviewed and read, "All crash carts ... will be opened and completely checked on the first day of each month .... All supplies and medications are to be replaced if outdated."

2. During an observation on 5/22/17 at 11 am, the infant warming unit, located in the ED overflow room, had no evidence it had been checked for proper functioning since 11/2016.

During an interview on 5/24/17 at 7 am, RN 1 was unsure who was supposed to check the infant warming unit.

During an interview on 5/22/17 at 11:45 am, EDS stated the night shift was responsible for checking the infant warming unit and acknowledged that he had not been accountable to ensure this was done.

The hospital policy, "Crash Cart Checks," dated 10/29/15, was reviewed and read, "Monthly checks shall be performed by night shift ED RN including ... infant warmer."

This is a repeat finding from their previous recertification survey.

3. During an observation on 5/22/17 at 1:40 pm, the ED Room 2 supplies contained two expired (6/2016) central venous catheterization (a tube inserted through the skin into a large vein near the heart used to administer large amounts of fluids or blood in an emergency) trays.

4. An observation on 5/22/17 at 1:40 pm, indicated that the Intraosseous Vascular Access System drill had not been checked for proper functioning since 12/1/16.

In a concurrent interview, EDS acknowledged the supplies in ED Room 2 were expired and was unsure who was supposed to check for expiration dates.

During and interview on 5/23/17 at 8:15 am, Environmental Services Supervisor (EVS) stated she was responsible for the preventative maintenance check of the Intraosseous Vascular Access System drill and it was missed on her routine work.

5. During an observation on 5/22/17 at 1:40 pm, two expired (5/2016) normal saline (salt) solution bags were available on the ED crash cart. These items were not part of the contents list of the crash cart.

In a concurrent interview, EDS could not account for how these items were put in the crash cart or how the continued to be available after they had expired.

The hospital policy, "Crash Cart Checks," dated 10/29/15, was reviewed and read, All crash carts ... will be opened and completely checked on the first day of each month .... All supplies and medications are to be replaced if outdated."

Based on observation, interview, and facility record review, the hospital failed to ensure medications were adequately secured when:

1. The Emergency Department (ED) crash cart was unlocked.

2. The Nerve Block Black Box was unlocked.

These failures could result in medications not available for use in emergency situations and/or expired, causing an adverse patient outcome.

Findings:

1. During an observation on 5/23/17 at 9 am, the ED crash cart in Room 2 was unlocked and unattended.

In a concurrent interview, the EDS acknowledged the cart was unlocked and contained mediation that were not secured. EDS reviewed the crash cart checklist to evaluate why this might have happened. The crash cart was check on the night shift but the wrong lock number was recorded on the check list.

During an interview on 5/24/17 at 7 am, RN 1 stated she had checked the cart on that shift and when she reviewed the checklist, she acknowledged she had not done a credible check of the crash cart.

The hospital was not able to identify how or why the crash cart was not locked.

2. On 5/22/17 at 1:40 pm, a box labeled Nerve Block Box was observed without a lock on the box. This box contained two vials of dexamethasone (used to reduce inflammation).

In a concurrent interview, the EDS acknowledged that the dexamethasone was not secure in this box.

Based on interview and record review, the hospital failed to have a Governing Body that assumed full legal responsibility for determining, implementing, and monitoring policies governing the hospital operations and ensuring quality of care in a safe environment as evidenced by:

1. Failure to ensure polices and procedures were in accordance with State and Federal regulations and current standards of practice (Refer to C150, C320 and C321).

2. Failure to ensure Provision of Services was provided in a safe manner, ensuring quality of care was delivered in a safe manner (Refer to C270, C271, C274, C276, C278, C279, C297, C298, and C1000).

3. Failure to ensure care provided was adequately evaluated, to ensure hospital practices reflected by policy and procedures, Medical Staff Bylaws and Rules, federal, state, and/or standards of practice were followed for patient care services and surgical services were provided in a safe manner, provided quality of care, in accordance with national standards of practice and manufacture's guidelines (Refer to C320 and C321).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure compliance with the mandated Condition of Organizational Structure and place all patients at risk for worsening conditions, harm, or death.

Based on interview and facility document review, the hospital failed to ensure the Medical Staff Bylaws and Rules were followed for the appointment and reappointment of Medical Staff (MS) members when four of six (MS 3, 4, 5, and 6) medical staff credential files reviewed were incomplete. The medical staff files did not include:

1. Current license verification or National Practitioner Data Bank (NPDB, reports containing information adverse actions related to health providers, includes federal and state judgements, convictions, adverse licensure and privileging information) reports for MS 3;

2. Initials or signatures approving requested privileges on the Delineation of Privileges form for MS 4 and MS 5;

3. Current Drug Enforcement Administration (DEA) certificate on file for the current reappointment period 7/15 - 7/17 for MS 6.

These failures could place all patients seen by the practitioners at risk for harm if the practitioners were allowed to practice with a restricted or limited license, without the proper certificates to prescribe narcotics, and to perform procedures or privileges not approved by the Medical Staff and Governing Board.

Findings:

The facility document titled Medical Staff By-Laws, dated 2016, was reviewed and indicated, "General Qualifications" for membership include, "Be licensed in the State of California ... and, if practicing a range of clinical medicine ... have a necessary DEA number." The facility Medical Staff By-Laws further indicated, "Each application for appointment and reappointment to the Medical Staff must contain a request for the specific Clinical Privileges desired by the applicant .... Requests for Clinical Privileges shall be evaluated on the basis of the Practitioner's education, training, experience, and demonstrated professional competency and judgment, and clinical performance .... This information shall be added to and maintained in the Medical Staff file established for each Staff member."

The facility document titled Medical Staff Rules, dated 2016, was reviewed and indicated new appointment applications, "will not be deemed complete until all necessary information has been provided and verifications have been obtained, including current license, ... NPDB, DEA certification ...." "When the recommendation is favorable, the Chief Executive Officer shall promptly forward it to the Governing Body together with the application form and its accompanying information and reports and recommendations of the Medical Executive Committee of the Whole as to Staff appointment, Clinical Privileges to be granted ...." The facility's Rules document indicated for a reappointment application, "a statement of agreement to abide by Hospital and Medical Staff Bylaws and Rules; ... and a renewed request for Clinical Privileges .... The application for reappointment shall also include statements regarding the applicant's involvement in any professional liability actions, previously successful or currently pending challenges to any required licensure ... and information detailing any prior ... or pending government agency or third party payer investigation, proceedings, or litigation challenge or sanctioning ...."

During concurrent interview and facility document review with the Medical Staff Coordinator (MSC) on 5/24/17 at 8:06 am, MSC confirmed MS 3 did not have a current California license verification for the current reappointment period, 11/2016 through 11/2018. The MSC confirmed the last date the license was verified was 7/10/14, for the last reappointment period 9/2014 through 9/2016. The MSC confirmed MS 3 did not have a current NPDB report. MSC stated the last NPDB report was last ran in 2014.

The MSC further confirmed the requested privileges on the Delineation of Privileges form, did not indicate the privileges were "approved" by initials or signatures by the Medical Staff or Governing Body for MS 4 and MS 5.

The MSC also confirmed MS 6 had an expired DEA certificate in the file. The MSC confirmed the DEA certificate expired 12/31/16.

Based on observation, interview, record review and facility policy review, the hospital failed to ensure that the provision of services was being carried out in a safe manner as evidenced by the following:

1. Failure to store medications in the correct temperature range and in accordance with manufacturer's guidelines (Refer to C276).

a. Failure to store 10 of 10 acyclovir (antiviral medication) vials within the correct temperature range in accordance with manufacturer's instructions.

b. Failure to remove one of one outdated NPH insulin (medication used to manage blood sugar levels) from the medication refrigerator to ensure it was not available for patient use.

c. Failure to remove 48 of 48 outdated Marcaine® (an anesthetic medication which numbs a local area) with epinephrine (medication that narrows the blood vessels) cartridges (containers) stored in the "Dental Box" located in the Drug Room.

d. Failure to ensure that medications in one of one crash carts were stocked in accordance with the facility's approved policies and procedures.

2. Failure to ensure that "Banana Bags" (an intravenous [IV - into the patient's vein] solution, with multiple injectable ingredients), that were prepared in the facility for nine patients (Patient 9, 12, 23, 24, 25, 26, 27, 28, and 29) between 7/5/16 and 4/24/17, met criteria for "immediate-use" compounding (mixing) requirements per The United States Pharmacopeia (USP) <797> standards of practice for sterile (germ-free) compounding (Refer to C276).

3. Failure to implement policies and procedures for infection control, when the vial top of intravenous (IV - into a vein) lasix (a medication used to reduce extra fluid in the body ) was not swabbed with alcohol prior to being punctured and drawing up the the medication into a syringe (Refer to C278).

4. Failure to administer ceftriaxone (an antibiotic medication) to Patient 12 in a time window based on acceptable standards of practices (Refer to C297).

5. Failure to ensure that one of three sampled observation patients (Patient 9) had a physician order for Intake and Output (I&O) assessment (measurements to ensure proper fluid balance) implemented (Refer to C271).

6. Failure to ensure that full pediatric vital signs (temperature, pulse, respiratory rate and blood pressure) was performed for two of four pediatric patients (Patients 5 and 6), who presented to emergency department (ED) (Refer to C274).

7. Failure to ensure a registered dietitian conducted a nutrition assessment for two of 29 sampled patients (Patient 13 and 11) for "moderate nutrition risk" in accordance with the hospital's nutrition risk criteria and policy (Refer to C279).

8. Failure to ensure a nutrition care plan was developed for two of 29 sampled residents (Patients 13 and 11) (Refer to 298).

9. Failure to have policies regarding the visitation rights of patients (Refer to C1000).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of services was in compliance with the mandated Condition of Provision of Services and had the potential for worsening patient conditions, physical and psychological harm, and death.

Based on interview and record review, the hospital failed to ensure that one of three sampled observation patients (Patient 9) had their physician order for Intake and Output (I&O) assessment (measurements to ensure proper fluid balance) implemented. This failure had the potential for changes in the patient's condition to go undetected.

Findings:

On 5/23/17, Patient 9's record was reviewed. Patient 9 presented at the Emergency Department on 1/5/17 for an altered level of consciousness and was admitted to the medical surgical unit for observation and administration of intravenous (IV - through the vein) fluids. Patient 9's record contained a physician order, dated 1/5/17 at 7:24 pm to monitor I&O every shift. Patient 9's record contained no I&O assessment.

During an interview on 5/23/17 at 2:50 pm, Administrative Nurse 1 concurrently reviewed Patient 9's record and acknowledged it did not contain evidence of I&O assessment.

The National Institute for Health and Care Excellence online monograph on Intravenous Fluids, dated 12/2013, was reviewed and indicated that fluid balance measurements were clinically required to evaluate fluid and electrolyte (chemical) needs when administering IV fluids.

The hospital Registered Nurse job description, undated, was reviewed and read, "Essential duties .... Plan, provide, and evaluate nursing care recognizing and interpreting symptoms, reporting patient condition and instituting remedial measures ...."

Based on interview and record review, the hospital failed to ensure that full pediatric vital signs (temperature, pulse, respiratory rate and blood pressure) were performed for two of four pediatric patients (Patients 5 and 6) who presented to emergency department (ED). This failure had the potential for changes in condition to go undetected and negatively impact patient overall health status.

Findings:

1. On 5/23/17, Patient 5's record was reviewed. Patient 5 was a 1 year old who presented to the emergency department with a complaint of a head wound associated with a fall. Patient 5's record contained no assessment of blood pressure upon the initial set of vital signs. On discharge, Patient 5's blood pressure and temperature were not recorded.

2. On 5/23/17, Patient 6's record was reviewed. Patient 6 was a 5 month old who presented to the ED with a congested cough and respiratory insufficiency. Patient 6's record contained no assessment of blood pressure upon the initial set of vital signs. On discharge, Patient 6's blood pressure and temperature were not recorded. Patient 6 required transferred to another medical center for the stabilization of respiratory symptoms.

During an interview on 5/24/17 at 7 am, Registered Nurse 1, an ED nurse, reviewed Patient 5 and 6's record, and stated she would have obtained full vital signs on these patients both at admission and every time vital signs were taken.

During an interview on 5/24/17 at 11:30 am, the Chief Nursing Officer stated her expectation was that full vitals signs would have been obtained for Patients 5 and 6.

The American Academy of Pediatrics "Guidelines for the Care of Children in the Emergency Department," dated 2009, was reviewed and read, "Infants and children have full set of vital signs recorded in the medical record."

Based on observation, interview, record review and facility policy review, the facility failed to ensure medications were stored, prepared, compounded (mixed), dispensed, and administered in a safe manner as evidenced by:

1. Failure to store acyclovir (antiviral medication) vials within the correct temperature range in accordance with manufacturer's instructions. This occurred when ten of ten acyclovir vials were observed to be stored in the refrigerator instead of room temperature.

2. Failure to remove one of one outdated NPH insulin (medication used to manage blood sugar levels) from the medication refrigerator to ensure it was not available for patient use.

3. Failure to remove 48 of 48 outdated Marcaine® (an anesthetic medication which numbs an area of the body) with epinephrine (medication that narrows the blood vessels) cartridges (containers) stored in the "Dental Box" located in the Drug Room.

4. Failure to ensure that medications in one of one crash carts were stocked in accordance with the facility's approved policies and procedures. This occurred when the medications contained inside the crash cart did not match the medications indicated on the contents list on the outside of the crash cart.

5. Failure to ensure that "Banana Bags" (an intravenous [IV - into the patient's vein] solution with multiple injectable ingredients prepared in the facility for nine patients (Patient 9, Patient 12, Patient 23, Patient 24, Patient 25, Patient 26, Patient 27, Patient 28, and Patient 29) between 7/5/16 and 4/24/17 met criteria for "immediate-use" compounding (mixing) requirements per The United States Pharmacopeia (USP) <797> standards of practice for sterile (germ-free) compounding.

These failures had the potential to for deteriorated (reduced quality) medications to be administered to patients, to not have emergency medications available for use, and for patients to be exposed to the increased risk of infections.

Findings:

1. On 5/22/17 at 10:10 a.m., during an observation and concurrent interview in the Drug Room accompanied by Licensed Vocational Nurse A (LVN A), the medication refrigerator was opened to indicate a temperature of 43 degrees Fahrenheit (°F). Ten vials of injectable acyclovir vials from Manufacturer A were stored in the refrigerator. The acyclovir vials labeling indicated, "Store at 20° to 25°C [Celsius] (68° to 77°F) [see USP Controlled Room Temperature]." USP (United States Pharmacopeia) is a scientific nonprofit organization that sets drug standards. LVN A acknowledged the ten acyclovir vials were stored in the refrigerator and the manufacturer instructions indicated to store at room temperature.

The facility policy and procedure titled, "Medication Supplies" dated 2/25/16, was reviewed and indicated, "Solutions, drugs, supplies and equipment used to prepare or administer sterile products will be stored in accordance with manufacturer or USP requirements."

2. On 5/22/17 at 10:15 a.m., during an observation and concurrent interview in the Drug Room accompanied by LVN A, an inspection of the medication refrigerator was continued. An opened NPH vial from Manufacturer B indicated the date of 4/19/17 in black ink. The time period from the listed date on the insulin vial to the date of inspection was calculated to be 33 days. LVN A acknowledged the opened NPH vial was outdated and available for patient use.

The facility policy and procedure titled, "Medications" dated 2/25/16, was reviewed and indicated, "The 'beyond use dating or expiration date' is that date which a drug product must be removed from distribution channels, and has been deemed as having surpassing its labeled dating and no longer usable .... For manufacturers' multiple dose parenteral [drug administration does not involve digestive tract] products, such as insulin or other 'multi-dose' vial, the expiration date shall be the manufacturers' date until the vial is first punctured (first use). Upon first use, the healthcare professional using the product shall affix labeling to the product with beyond use dating not to exceed 28 days unless the manufacturer specifies otherwise (shorter or longer)."

3. On 5/22/17 at 10:41 a.m., during an observation and concurrent interview in the Drug Room accompanied by LVN A, a gray container labeled "The Dental Box" was inspected. Inside "The Dental Box", 48 cartridges of Marcaine® 0.5% (drug strength) with epinephrine 1:200,000 (drug strength) were observed with a manufacturer's expiration date of 6/2016. The time period from the listed expiration date to the date of inspection was calculated to be 326 days. LVN A acknowledged the 48 cartridges were expired.

The facility policy and procedure titled, "Medications" dated 2/25/16, was reviewed and indicated, "The 'beyond use dating or expiration date' is that date which a drug product must be removed from distribution channels, and has been deemed as having surpassing its labeled dating and no longer usable. For drugs in original manufacturers' packaging or considered as a 'loose item', but intact, and having reached its expiration date, shall be removed from Pharmacy inventory, Pyxis® [a machine that stores and tracks medications] or other storage areas and segregated [separated] in the Pharmacy in a well posted area for 'reverse distribution' or disposal via appropriate methods."

4. On 5/23/17 at 10:21 a.m., during an observation and concurrent interview in the Post-Anesthesia Care Unit (PACU) accompanied by the Consultant Pharmacist (CP), an inspection of the PACU Crash Cart was conducted. The emergency medications observed stored inside the crash cart did not match the medications indicated on the external contents list on the crash cart and the facility's policy. The CP acknowledged the emergency medications listed in the facility's policy were different from the medications observed in the PACU crash cart.

The facility policy and procedure titled, "Crash Cart Checks" dated 10/29/15 was reviewed and indicated, "[the name of the facility] shall ensure that the ... PACU Crash Carts ... are fully stocked and ready for use at the beginning of each Emergency nursing shift and monthly."

5. On 5/22/17 at 10:31 a.m., during an observation and concurrent interview in the Drug Room accompanied by LVN A, an inspection of the medication refrigerator was continued. Injectable multivitamins from Manufacturer D were observed inside the refrigerator. LVN A acknowledged the injectable multivitamins were used to prepare "Banana Bags." LVN A stated there were 11 doses of injectable multivitamins left (remaining) in the refrigerator.

On 5/22/17 at 10:50 a.m., during an interview, the Emergency Department Supervisor (EDS) acknowledged he prepared "Banana Bags" by putting each ingredient into the IV solution bag one ingredient at a time. He acknowledged the ingredients he handled previously were injectable multivitamins, magnesium (a supplement), and thiamine (a vitamin).

On 5/23/17 at 12:00 p.m., during an interview, the Chief Nursing Officer (CNO) stated the facility had no policies and procedures on "Banana Bags."

Review of USP <797> section entitled "IMMEDIATE-USE CSPs [Compounded Sterile Preparations]" indicated, "the compounding process involves simple transfer of not more than three commercially manufactured packages of sterile non-hazardous products ... and not more than two entries [punctures] into any one container or package (e.g., bag, vial) ...."

Review of "Banana Bags" ordered by prescribers from 7/5/16 to 4/24/17 indicated that nine patients (Patient 9, Patient 12, Patient 23, Patient 24, Patient 25, Patient 26, Patient 27, Patient 28, and Patient 29) were administered "Banana Bags" during this time period. The electronic clinical record was reviewed and indicated that each of these nine patients were administered IV "Banana Bags" solutions containing ingredients transferred from more than three commercially manufactured packages of sterile non-hazardous products including injectable multivitamins 10 milliliters (an unit of measurement), magnesium sulfate 1 gram (an unit of measurement), folic acid (a supplement) 1 milligram (an unit of measurement), and thiamine (a vitamin, also called vitamin B1) 100 milligrams.

Based on observation, interview, and facility policy review, the facility failed to implement policies and procedures for infection control for Patient 12. This occurred when the vial top of intravenous (IV - into a vein) lasix (a diuretic medication) was not swabbed with alcohol prior to puncture with a needle and withdrawal of the medication into a syringe.

This failure had the potential to expose Patient 12 to increased risk of infections.

Findings:

1. On 5/23/17 at 8:12 a.m., during an observation, Registered Nurse 2 (RN 2) did not swab the lasix vial top with alcohol prior to withdrawal of the medication into the syringe.

On 5/23/17 at 11:17 a.m., during an interview, RN 2 acknowledged she did not swab the lasix vial top with alcohol prior to withdrawal of the medication into the syringe which she administered to Patient 12.

The facility policy and procedure titled, "Safety" dated 2/25/16, was reviewed and indicated, "All medications withdrawn into syringes shall be done using aseptic technique [method to prevent contamination with germs] with alcohol swabbing of ampule necks and vial tops prior to entry with a needle."

Based on interview and record review, the hospital failed to ensure a registered dietitian conducted a nutrition assessment for two of 29 sampled patients (Patient 13 and 11) for "moderate nutrition risk" in accordance with the hospital's nutrition risk criteria and policy.

As a result, there was potential for the patient's nutritional needs to have been unmet which may further compromise a patient's medical status.

Findings:

1. On 5/22/17 at 2 PM, Patient 13's medical record was reviewed. Patient 13 was admitted to the hospital on 5/21/17 with an admitting diagnosis of "severe pharyngitis (inflammation of the back of the throat) with near airway obstruction" per the physician orders.

An Acute Care Nutrition Screening Form was completed by a registered nurse upon admission for Patient 13. The nutrition screening form had indicated the diagnosis of pharyngitis and had a check mark in the box for problems with swallowing. The form included an area to select a "Nutritional Priority by Diagnosis" that ranged from a priority one through a priority four, in which nutritional priority four was identified by the nurse.

Concurrently, a registered nurse (RN 1) was interviewed and stated that the hospital's nutrition policy was if a nutrition priority one or two was identified, then the nutrition screen would be faxed to the registered dietitian (RD).

During an interview on 5/23/17 at 8:52 A.M., the hospital's policy and procedure (P&P) titled Nutrition Screening And Daily Diet Roster Sheet was concurrently reviewed with RN 1. RN 1 acknowledged that dysphagia (difficulty swallowing) was listed under the priority two criteria and stated that the nurse should have selected priority two on the admission Acute Care Nutrition Screening form. RN 1 verified the correct nutrition priority had not been selected and therefore the RD was not notified, and a nutrition assessment had not been completed by the RD for Patient 13.

The hospital's P&P titled Nutrition Screening And Daily Diet Roster Sheet (dated 10/21/15), was reviewed and indicated, "Priority 2 Moderate Nutritional Risk (RD Assessment within 48 hours of receipt) ... Dysphagia (difficulty swallowing any liquid or solid material) ..."

2. On 5/23/17 at 9:05 A.M., Patient 11's medical record was reviewed. Patient 11 was admitted to the hospital on 5/18/17 "with frequent falls ..." per the history and physical dated 5/19/17.

On 5/18/17 a nurse completed an Acute Care Nutrition Screening Form upon admit in which a nutritional priority of four was identified for Patient 11.

A "Day 3 Patient Re-assessment" was conducted by a nurse as required per the hospital's nutrition screening policy and procedure. A nurse checked "Yes" next to "Eating less than 50% of meals." The area on the same form titled, "Advance Priority", in which a priority one through priority four could have been selected, was left blank. The area on the form titled "Date & Time Faxed to Registered Dietitian [RD]" was left blank.

During an interview on 5/23/17 at 9:15 A.M., a registered nurse (RN 1) concurrently reviewed the Day 3 Patient Re-assessment and acknowledged that the nurse had checked a "Yes" next to eating less than 50% of meal. RN 1 stated, "The patient triggered for a priority 2 and the nutrition screening form should have been faxed to the RD." RN 1 verified that an incorrect nutrition priority was identified for Patient 11 and therefore a nutrition assessment was not conducted by an RD for Patient 11.

The hospital's P&P titled Nutrition Screening And Daily Diet Roster Sheet (dated 10/21/15), was reviewed and indicated, "Priority 2 Moderate Nutritional Risk (RD Assessment within 48 hours of receipt) ... Inadequate intake <50% in 3 Days ..."

On 5/23/17 at 11:30 A.M., during an interview with the chief nursing officer (CNO), Patient 11's Acute Care Nutrition Screening Form and Nutrition Risk By Diagnosis Guidelines screen that was in the electronic medical record was reviewed and compared to the hospital's approved policy and procedure that was titled Nutrition Screening And Daily Diet Roster Sheet and Nutrition Risk by Diagnosis Guideline Form (last approved 10/21/2015). The electronic medical record screen titled Nutrition Risk By Diagnosis Guidelines indicated, "Inadequate Intake 25%-60% in 7 days", under the priority 2 criteria. Under the Priority 3 criteria was listed "Food Intake <50% - 75% in last 7 days." The hospital's policy and procedure titled "Nutrition Screening And Daily Diet Roster Sheet and Nutrition Risk by Diagnosis Guideline Form indicated, "Inadequate intake <50% in 3 days" under the priority 2 criteria. There was no criteria under priority three related to food intake. The CNO acknowledged the nutrition risk by diagnosis data available for the nursing staff to review located in the electronic medical record had not matched the hospital's approved policy and procedure titled "Nutrition Screening And Daily Diet Roster Sheet and Nutrition Risk by Diagnosis Guideline Form" (last approved 10/21/2015). The CNO stated the hospital would need to fix the discrepancy.

Concurrently, the CNO stated that the hospital had assigned a quality assurance project to the dietary manager in regard to timeliness and completeness of the nutrition screening and priority 1 and 2's being faxed to the RD. The CNO acknowledged that there was not a quality assurance process to review the accuracy of nutrition priority levels identified by nursing staff for patients, in order to evaluate the effectiveness of the hospital's ability to address patient nutritional needs.

The hospital's policy and procedure titled "Nutrition Screening And Daily Diet Roster Sheet and Nutrition Risk by Diagnosis Guideline Form" (dated 10/21/2015) was reviewed and included, "Patients still admitted after day 3, require the 3-day reassessment portion to be completed. Fax and phone to RD ..."

Based on observation, interview, and electronic clinical record review, the facility failed to administer ceftriaxone (an antibiotic medication) to Patient 12 in a time window based on acceptable standards of practices. This occurred when the antibiotic was administered approximately two hours after the medication's scheduled dosing time.

This failure had the potential for adverse health consequences to Patient 12 due to possible reduction of antibiotic drug level in the body.

Findings:

1. On 5/23/17 at 2:13 p.m., during an interview and concurrent electronic clinical record review accompanied by Registered Nurse 2 (RN 2), the computer screen indicated the ceftriaxone medication was highlighted green. Upon inquiry on why the medication was highlighted in a different color than the other medications, RN 2 acknowledged it was because the ceftriaxone was late with respect to the scheduled dosing time.

On 5/23/17 at 2:15 p.m., during an observation in Patient 12's room, RN 2 was observed administering the ceftriaxone antibiotic.

On 5/24/17 at 1:30 p.m., during an interview, the Chief Nursing Officer (CNO) stated the expectation regarding the timing of medication administration was one hour before or after the scheduled dosing time.
Review of Patient 12's electronic clinical record indicated that ceftriaxone 1000 milligrams (a unit of measurement) IV (intravenous - into the vein) was scheduled daily at "1200" (noon). The electronic health record indicated that ceftriaxone was administered on 5/23/17 at "1400" (2 p.m.) which was calculated to be approximately 2 hours after the scheduled dosing time.

The facility's medication administration policy was requested, but the CNO stated there was no approved policy.

Based on interview and record review, the hospital failed to ensure a nutrition care plan was developed for two of 29 sampled residents (Patients 13 and 11).

As a result of lack of a nutrition care plan there was potential for the nutritional, health and safety needs of the patient's to not have been met.

Findings:

1. On 5/22/17 at 2 P.M., Patient 13's medical record was reviewed. Patient 13 was admitted to the hospital on 5/21/17 at 11:45 P.M., with an admitting diagnosis of "severe pharyngitis [inflammation of the back of the throat] with near airway obstruction" per the physician orders.

A physician order for a regular diet was ordered on 5/21/17 at 11: 58 P.M.

A nursing physical assessment written on 5/22/17 at 12:45 A.M. included, "Pt [patient] does c/o [complain of] severe sore throat ..., Pt is taking ice water by mouth with difficulty ...."

During an interview on 5/22/17 at 2:15 P.M., a registered nurse (RN 1) concurrently reviewed Patient 13's medical record and stated that a nurse had not developed a care plan for the dysphagia (difficulty swallowing any liquid or solid material), and stated, "It was missed." In addition, RN 1 stated she would have informed the doctor that the patient had a difficult time swallowing and would have expected a swallow screen or further communication with the doctor to have occurred, and stated, "I don't see documentation in regard to that, and there was not a dysphagia care plan developed."

Further, RN 1 stated that the hospital's nutrition policy was if a nutrition priority one or two was identified, then the nutrition screen would be faxed to the registered dietitian (RD).

An Acute Care Nutrition Screening Form completed by a registered nurse upon admission for Patient 13 was also concurrently reviewed. The nutrition screening form had indicated the diagnosis of pharyngitis and had a check mark in the box for problems with swallowing. The form included an area to select a "Nutritional Priority by Diagnosis" that ranged from a priority one through a priority four, in which nutritional priority four was identified by the nurse. As a result of a priority four being selected, the RD was not notified of the swallowing problem per RN 1.

During an interview on 5/22/17 at 3:30 P.M., the chief nursing officer (CNO) stated that she would have expected to see a nursing assessment in regard to the swallowing problem, would have expected documentation that the doctor was notified and clarify whether the diet order needed to be modified. In addition, the CNO stated that the hospital had not had speech therapy, occupational therapy or swallow study capability.

During an interview on 5/23/17 at 8:52 A.M., the hospital's policy and procedure (P&P) titled Nutrition Screening And Daily Diet Roster Sheet was concurrently reviewed with RN 1. RN 1 acknowledged that dysphagia was listed under the priority two criteria and stated that the nurse should have selected priority two on the admission Acute Care Nutrition Screening form. RN 1 verified the correct nutrition priority had not been selected and therefore the RD was not notified, and a nutrition assessment had not been completed by the RD for Patient 13.

The hospital's P&P titled, "Nutrition Screening And Daily Diet Roster Sheet" (dated 10/21/15), was reviewed and indicated, "RN to complete Altered Nutrition Care Plan within 24 hours on all Priority 1 and 2 patients ..., Priority 2 Moderate Nutritional Risk (RD Assessment within 48 hours of receipt) ... Dysphagia ...."

2. On 5/23/17 at 9:05 A.M., Patient 11's medical record was reviewed. Patient 11 was admitted to the hospital on 5/18/17 "with frequent falls..." per the history and physical dated 5/19/17.

On 5/18/17' a nurse completed an Acute Care Nutrition Screening Form upon admit in which a nutritional priority of four was identified for Patient 11.

A "Day 3 Patient Re-assessment" was conducted by a nurse as required per the hospital's nutrition screening policy and procedure. A nurse checked "Yes" next to "Eating less than 50% of meals." The area on the same form titled, "Advance Priority" in which a priority one through priority four could have been selected was left blank. The area on the form titled, "Date & Time Faxed to Registered Dietitian" was left blank.

During an interview on 5/23/17 at 9:10 A.M., a registered nurse (RN 4) concurrently reviewed Patient 11's medical record and stated that a nutrition care plan had not been developed for Patient 11.

During an interview on 5/23/17 at 9:15 A.M., a registered nurse (RN 1) concurrently reviewed the Day 3 Patient Re-assessment and acknowledged that the nurse had checked a "Yes" next to eating less than 50% of meals. RN 1 reviewed the hospital's Nutrition Risk by Diagnosis Guideline Form from the hospital's approved policy and procedure, and stated, "The patient triggered for a priority 2 per the policy and the nutrition screening form should have been faxed to the RD [registered dietitian]." RN 1 verified that an incorrect nutrition priority was identified for Patient 11 and therefore a nutrition assessment was not conducted by an RD for this patient." RN 1 verified that a nutrition care plan had not been developed for Patient 11, and there should have been a nutrition care plan. RN 1 verified that there had not been any ordered nutrition interventions to address the documented poor nutritional intake, other than Zofran (medication to help prevent nausea and vomiting) was ordered on 5/19/17 to address the patient's nausea.

The hospital's P&P titled, "Nutrition Screening And Daily Diet Roster Sheet" (dated 10/21/15), was reviewed and indicated, "RN to complete Altered Nutrition Care Plan within 24 hours on all Priority 1 and 2 patients ..., Priority 2 Moderate Nutritional Risk (RD Assessment within 48 hours of receipt) ... Inadequate intake <50% in 3 Days ...."

The hospital's policy and procedure titled "Nutrition Screening And Daily Diet Roster Sheet and Nutrition Risk by Diagnosis Guideline Form" (dated 10/21/2015) was reviewed and included, "Patients still admitted after day 3, require the 3-day reassessment portion to be completed. Fax and phone to RD ...."

Based on interview and record review, the hospital failed to ensure the completion of a blood administration form to include the donor unit (tracking) number of the blood product. This failure could negatively impact a patient who might experience an adverse reaction and require immediate assistance.

Findings:

On 5/23/17, Patient 8's record was reviewed. Patient 8's record contain a physician's order for two units of packed red blood cells (PRBCs - to treat low blood cell count). The administration record of one of the PRBCs failed to contain the physician who ordered the blood product, the date of administration, the donor unit number and the type of blood product.

During an interview on 5/24/17 at 1:55 pm, Administrative Nurse 1 reviewed Patient 8's record and acknowledged the above form was not complete.

Based on observation, interview, record review and facility document review, the facility failed to ensure surgical services were provided in accordance with manufacture guidelines and nationally recognized standards of practice, ensuring safe, quality care to all patients when:

1. Endoscopes (a slender, illuminated, flexible or rigid tubular instrument used for examining an inner part of the body) were not reprocessed per manufacturer's guidelines and in accordance with current standards of practice;

2. High Level Disinfectant (HLD) was not monitored for effectiveness per manufacture's guidelines;

3. History and Physical (H&P) was not placed in the medical record prior to the start of surgery for three of four patient records reviewed (Patient 15, 17 and 18);

4. The operating room had visible black grime in and around the corners and entrance to the operating room.

5. The laryngoscope (an instrument for examining the larynx [organ forming an air passage to the lungs and holding the vocal cords; the voice box]) light source handle was corroded and nonfunctional.

6. The delineation of clinical privileges were not approved for the surgeon (refer to C321).

These failures placed patients undergoing surgical procedures at risk of exposure to infectious diseases and other adverse surgical outcomes. These cumulative effects of these systematic failures resulted in the inability of the hospital to comply with the Condition of Participation for Surgical Services.

Findings:

1. The official Olympus (endoscope manufacturer) website reviewed and offered instructions for reprocessing of the endoscopes. Each step detailed the instructions to follow when reprocessing the endoscopes (refer to website http://medical.olympusamerica.com/customer-resources/cleaning-disinfection-sterilization/cds-instructions/gi-endoscope-reprocessing);

a. Pre-Cleaning at the bedside process;
b. Leak Test - stated is necessary to "ensure there is no damage to the scope and leaking scopes present an infection control risk" potentially harboring infectious diseases, contaminating the scope and next patient;
c. Manual cleaning;
d. High Level Disinfecting (HLD) - temperature and time to be followed per manufacture guidelines;
e. Alcohol flush - promotes drying and inhibits growth of waterborne organisms.

A summary for automatic reprocessing for endoscopy was provided by the facility. The facility performs a manual HLD process. No instruction for use (IFU) for the specific manual cleaning of the endoscopes was provided.

During a concurrent interview and observation with the Endoscopy/Operating Room Technician (EDT) on 5/22/17 at 10:40 am, the EDT stated that if the endoscope was to be used for the next case, the alcohol rinse was not performed, the compressed air and alcohol flush was done at the end of the day and the endoscopes were then hung to dry. The EDT stated that the leak test was performed the day before scheduled endoscopies, not as part of the routine cleaning process immediately after each patient use.

During a concurrent interview and observation with the EDT on 5/23/17 at 8:50 am, the EDT confirmed the endoscopes were leak tested 24 hours prior to each scheduled use and the alcohol rinse was not done until after the last endoscopic procedure of the day.

The Association of periOperative Registered Nurses (AORN), 2017 Edition, "Guideline for Processing Flexible Endoscopes, Recommendation V", was reviewed and indicated, "Leak testing may decrease the risk for an infection transmitted by a flexible endoscope .... Leak testing should be performed before manual cleaning and before the endoscope is placed into cleaning solutions."

The Guidelines for Use of High-Level Disinfectant and Sterilants in the Gastroenterology (the branch of medicine that deals with disorders of the stomach and intestines) Setting, published by the Society of Gastroenterology Nurses and Associates, Inc. (SGNA), 2017 Edition, was reviewed and indicated "biofilm
(a thin, slimy film of bacteria that adheres to a surface) forms when bacteria group together on a wet surface and secrete large amounts of polysaccharide (a number of sugar molecules bonded together), which create a protective mass that cannot be removed with high-level disinfection ... meticulous manual cleaning to remove biologic material and strict adherence to reprocessing guidelines is the best approach to preventing biofilms."

The Standards for Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes published by SGNA, 2016, was reviewed and indicated the, "Leak test detects damage to the interior or exterior of the endoscope."

The Guide for Manual Reprocessing of Flexible Immersible Endoscopes, provided by Metrex HLD solution, was reviewed and indicated, "Drying: Flush all channels with 70% ... alcohol followed by air." Metrex Manual Cleaning of Scopes indicated "the entire endoscope must be dried, with each of its internal channels being flushed with 70% alcohol, followed by forced air drying, both between patient procedures and prior to storage."

The Standards for Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes published by SGNA, 2016, was reviewed and indicated' "Moisture also promotes biofilm .... Drying the endoscope after every reprocessing cycle, both between patient procedures and before storage, is a requisite practice crucial to the prevention of bacterial transmission and nosocomial infection. Drying is as important to the prevention of disease transmission and nosocomial (hospital acquired) infection as cleaning and HLD .... Alcohol flushes should be used even when sterile water is used for rinsing."

2. During a concurrent interview, observation, and facility document review with the EDT on 5/22/17 at 10:40 am, the EDT confirmed MetriCide OPA Plus Solution was used as the HLD for the endoscopes. The MetriCide OPA Plus Solution "easy step" guide indicated, for manual reprocessing, "Soak instruments in MetriCide OPA Plus Solution for 12 minutes at a minimum temperature of 20 degrees Celsius (C) (68 degrees Fahrenheit (F))." The EDT confirmed the temperature was not checked in either HLD containers prior to HLD use. Both HLD logs used to record date solution opened, date solution expired, date test strip expired, test results, etc. was reviewed with the EDT. The EDT confirmed there was no temperatures recorded on the logs.

During a concurrent interview, observation, and facility document review with the EDT and Operating Room Supervisor/Infection Control Nurse (RN) 2 on 5/23/17 at 9:15 am, the EDT stated, "each tray of HLD solution is only tested each morning and not in between scopes." The MetriCide OPA Plus Solution HLD product guide was reviewed. The product guide indicated, "Features and Benefits: Speed. Disinfects at 12 minutes at 20 degrees C in manual reprocessing." The product guide indicated, "Use of a test strip is recommended before each reprocessing cycle to ensure healthcare professionals that the disinfectant has not been compromised by excessive reuse, contamination attributed to inadequate equipment cleaning ... or misuse of the product ... which may lower the level of the solution below its Minimum Recommended Concentration (MRC) of 0.3%."

The Standards for Infection Control in Reprocessing Flexible Gastrointestinal Endoscopes published by SGNA, 2012, was reviewed and indicated to, "soak the endoscope in the high-level disinfectant/sterilant for the time/temperature required to achieve HLD."
The Guidelines for Use of High-Level Disinfectants & Sterilants in the Gastroenterology Setting, published by SGNA, 2017, was reviewed and indicated, "The efficacy of chemical sterilants and disinfectants depends on their concentration, their temperature, the physical nature of the endoscope (e.g. crevices, hinges, lumens, channels), the nature of the microorganisms on the endoscope, the size of the organic and microbial load on the endoscope, and the length of exposure of the scope to the chemical solution."

The Standards for Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes published by SGNA, 2016, was reviewed and indicated, "Test and monitor the disinfectant before each load/use by following the manufacture's instructions for testing, and keep a log of the test results."

3. The facility Medical Staff Rules, dated 2016, was reviewed and indicated, "History & Physical examination performed in manner consistent with Seneca Bylaws .... If completed within 30 days prior to the procedure, a Interval History and Physical by the surgeon prior to surgery shall confirm the History & Physical remains the same or any additions and subsequent changes are recorded in the patient's medical chart .... If not recorded, the operation shall be canceled with the exception of emergency surgery."

a. The clinical record was reviewed for Patient 17 on 5/23/17. Patient 17 was scheduled for right shoulder surgery on 1/24/17.

The Interval History and Physical Examination for Patient 17 was dated and timed by the surgeon on 1/24/17 at 8:47 am. The Operative Report was dictated on 1/24/17 at 8:32 am. The Anesthesia Record indicated the incision start time for the procedure was 1/24/17 at 7:12 am.

b. The clinical record was reviewed for Patient 15 on 5/23/17. Patient 15 was scheduled for an endoscopy (a procedure to examine the digestive tract using an endoscope) on 4/27/17. A history and physical was completed by the surgeon on 3/23/17.

During concurrent interview and record review for Patient 15 with House Supervisor (RN) 1 on 5/23/17 at 2:05 pm, RN 1 confirmed there was no Interval History and Physical Examination or updated history and physical in the medical record. RN 1 stated the surgeon completes a "History and Physical" section imbedded in the operative report, during the dictation of the operative report, after the procedure is performed. RN 1 stated the history and physical section in the operative report is not available until after the report is transcribed.

c. The clinical record was reviewed for Patient 18 on 5/23/17. Patient 18 was scheduled for a right knee surgical procedure on 2/7/17.

The Interval History and Physical Examination for Patient 18 was dated and timed by the surgeon on 2/7/17 at 10:38 am. The Operative Report was dictated by the surgeon on 2/7/17 at 10:41 am. The Anesthesia Record indicated the incision start time for the procedure was on 2/7/17 at 10:09 am.

During concurrent interview and record review for Patient 17, 15 and 18 with House Supervisor (RN) 1 on 5/23/17 at 2:05 pm, RN 1 confirmed the Interval History and Physical Examination was dated and timed after the Operative Report was dictated and would not have been in the chart prior to the patient going to surgery for Patient 17 and 18. RN 1 confirmed a Interval History and Physical Examination was not in the medical record prior to the patient going to surgery for Patient 15.

4. The Association of periOperative Registered Nurses (AORN), 2017 Edition, "Guidelines for Environmental Cleaning, Recommendation III", was reviewed and indicated, "Operating and procedure rooms must be cleaned after each patient .... The floors and walls of operating and procedure rooms should be cleaned and disinfected after each surgical or invasive procedure if soiled or potentially soiled (e.g., by splash, splatter, or spray)." "AORN Guidelines for Environmental Cleaning, Recommendation II", were reviewed and indicated, "The responsibility for verifying a clean surgical environment before the start of an operative or invasive procedure rests with perioperative nurses. The perioperative RN should visually inspect the OR for cleanliness before case carts, supplies, and equipment are brought into the room. All horizontal surfaces in the OR (e.g., furniture, surgical lights, booms, equipment) should be damp dusted before the first scheduled surgical or other invasive procedure of the day .... Damp dusting of the OR should be completed before case carts, supplies, and equipment are brought into the room. The purpose of damp dusting is to remove dust, not to perform surface disinfection, which is completed after each procedure and at terminal cleaning."

During an interview with RN 1 on 5/22/17 at 9:50 am, RN 1 stated that the Operating Room (OR) was only terminally cleaned at the end of the day when cases were performed. RN 1 stated the OR staff was responsible for cleaning the OR.

During an observation of the OR on 5/22/17 at 10:15 am, the corners and around the entrance to the OR included a black film, obscuring the details of the tile floor.

During a concurrent interview and observation with the Operating Room Supervisor, Infection Control Nurse (RN) 2 on 5/23/17 at 10:30 am, RN 2 used a paper towel moistened with water to wipe along the entrance of the OR. The paper towel had a black substance after a few wipes on the floor. RN 2 stated the floors were more than 50 years old, but the black substance should have been removed.

The facility policy and procedure titled, "Operating Room Sanitation", dated 6/29/15, was reviewed and indicated that the facility followed Association of periOperative Registered Nurses (AORN) compliance. The policy and procedure indicated, "The Surgical Suite will be cleaned between each scheduled case of the day .... Floors should be spot cleaned if necessary .... At the completion of the day's schedule or after an unscheduled procedure the Surgical Suite and Scrub/Utility areas should be terminally cleaned .... Floors should be cleaned using a clean mop head and Germicidal Disinfectant. Flooding each area while cleaning."

5. During a concurrent observation, interview and inspection of the crash cart in the pre-operative and recovery room with RN 1 on 5/23/17 at 7:40 am, RN 1 was unable to connect the laryngoscope blade to the light source handle. RN 1 confirmed, upon further inspection, that the handle appeared to have a brown corroded substance. RN 2 was unable to unscrew the light source to inspect the batteries. RN 2 retrieved a second laryngeal scope light source and removed the first light source from service. RN 1 confirmed the potential for serious harm to a patient in the event the laryngoscope blade and light source equipment were needed in an urgent and/or emergent situation.

Based on interview and facility document review, the facility failed to ensure the Medical Staff Bylaws and Rules were followed for the reappointment of one of six Medical Staff (MS) members when the medical staff credential file reviewed did not include initials or signatures approving requested privileges on the Delineation of Privileges form for MS 6.

These failures could place all patients seen by the practitioner at risk for harm if the practitioner was allowed to practice or perform procedures when privileges were not approved by the Medical Staff and Governing Board.

Findings:

The facility document titled Medical Staff By-Laws, dated 2016, was reviewed and indicated, "Each application for appointment and reappointment to the Medical Staff must contain a request for the specific Clinical Privileges desired by the applicant .... Requests for Clinical Privileges shall be evaluated on the basis of the Practitioner's education, training, experience, and demonstrated professional competency and judgment, and clinical performance .... This information shall be added to and maintained in the Medical Staff file established for each Staff member."

The facility document titled, "Medical Staff Rules", dated 2016, was reviewed and indicated, for a reappointment application, "a statement of agreement to abide by Hospital and Medical Staff Bylaws and Rules; ... and a renewed request for Clinical Privileges .... The application for reappointment shall also include statements regarding the applicant's involvement in any professional liability actions, previously successful or currently pending challenges to any required licensure ... and information detailing any prior ... or pending government agency or third party payer investigation, proceedings, or litigation challenge or sanctioning ...."

During a concurrent interview and facility document review with the Medical Staff Coordinator (MSC) on 5/24/17 at 8:06 am, the MSC confirmed the request for clinical privileges for the reappointment period 7/2015 through 7/2017 did not include initials or signatures of approval by the Medical Staff or Governing Body.

Based on observation, interview, record review, and hospital record review, the hospital failed to ensure the care provided was adequately evaluated to ensure hospital practices reflected policy and procedures, Medical Staff Bylaws and Rules, federal and state law, and/or standard of practice when:

1. Employee files for licensed staff did not include documentation they were offered or received all State mandated vaccines at the date of hire, employee files did not have current annual performance evaluations, and the hospital failed to add a mobile Magnetic Resonance Imaging (MRI - a test that uses a magnetic field and pulses of radio wave energy to make pictures of organs and structures inside the body) service to the State license (Refer to C152).

2. Provision of Services failed to ensure care was provided in a safe manner when medications were not stored, prepared, compounded, dispensed, and administered in accordance to manufacture guidelines, when care was not provided according to physician orders, vital signs were not performed according to national standards, when nutritional assessments, reassessments, and care plans were not implemented according to hospital policy and procedures, and when the hospital failed to have a visitation policy and procedure (Refer to C271, C276, C279, C297, C298, C1000).

3. Surgical Services failed to ensure endoscopes (a slender, illuminated, flexible or rigid tubular instrument used for examining an inner part of the body) were reprocessed in accordance with manufacture guidelines and national standards of practice, High Level Disinfectant (HLD - powerful chemicals used to remove all microorganisms from items such as endoscopes to make them safe for patient use) was not monitored according to manufacture guidelines, History and Physicals (documentation of medical information relevant to a patient's present condition) were not placed in the medical record prior to the start of surgery, the Operating Room had evidence of buildup on the floors, emergent medical equipment was not maintained to be available during an emergency, and delineation of clinical privileges were not approved by the Medical Staff and/or Governing Board (Refer to C320, findings 1-6 and C321).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure compliance with federal, state, and local laws, provision of services, surgical services, and in compliance with Periodic Evaluation and Quality Review. The continued systemic problems could result the potential for the problems to persist and lead to compromised patient care outcomes.

Based on interview, record review, and facility record review, the hospital failed to ensure that all patient care services affecting the health and safety of patients were evaluated.

This failure had the potential for problems to persist and compromise patient care outcomes.

Findings:

The hospital Performance Improvement Plan, dated 6/2012, was reviewed and indicated it, "Intended to provide the basis for an integrated approach to system-wide performance improvement ... will assess at least the following elements of health care: safety, access, effectiveness, appropriateness, timeliness, continuity, customer expectations, community needs, and current standards." The Plan further indicated, "[The Performance Improvement] PI committee will evaluate patient/resident care and organizational activities including, but not limited to, the continuous monitoring of the following functions:

i. Patient/resident care environment
1. Safety
2. Security
3. Sanitation ....

iv. Nutritional Services

i. Surgical and other invasive procedures ....

vii. Medical Record content and completion ....

ix. Infection Control ....

c. Medical staff accountability to the Board of Trustees

i. The Board of Trustees will ensure that the medial staff is accountable for the quality of care provided to patients/residents.

ii. The Board of Trustees QA/PI Oversight Committee shall be responsible for ensuring accountability of medical staff ....

2. The Board of Trustees will give direction and oversight to the ongoing processes of each medical staff committee."

During an interview on 5/24/17, at 2:00 pm, the quality program and plan was concurrently reviewed. The Chief Executive Officer (CEO), Chief Nursing Officer (CNO), and the House Supervisor (RN) 1, and the Medical Staff Coordinator (MSC) acknowledged lack of compliance with the following deficient practices which were not incorporated into the quality program:

Compliance with Federal, State, and Local Laws for employee files, annual reviews, immunizations, and vaccinations, licensing of new services, and the emergency log requirements;

Compliance with ensuring emergency equipment and supplies were stored appropriately, not expired, available, and ready for use;

Compliance with medical staff credentialing and privileging Bylaws, Rules, and in accordance with national standards of practice;

Compliance with medication storage, preparation, compounding, dispensing, and administration, ensuring care was delivered in a safe manner;

Compliance with following hospital policy, procedure and national standards of practice for patient assessment, reassessment, care planning for nutritional needs, following physician orders, and the documentation of vital signs;

Compliance in having a policy and procedure for visitation;

Compliance with appropriate documentation of blood products;

Compliance with national standards of practice related to the reprocessing for endoscopes (used to visual the inside of the gastrointestinal tract);

Compliance with High Level Disinfectant (HLD - powerful chemicals used to remove all microorganisms from items such as endoscopes to make them safe for patient use) use;

Compliance with general cleanliness of the Operating Room;

In the interview, the CEO, CNO, RN 1 and MSC agreed the Quality program would have to be more robust to ensure compliance with the Medicare Conditions of Participation and State Licensing requirements.

Based on interview, the hospital failed to have policies regarding the visitation rights of patients. This failure had the potential for discriminatory practices that would prevent the patient from having visitors as desired.

Findings:

On 5/24/17 at 8:40 am, the Chief Nursing Officer was interviewed and for the patient visitation policies as required in Sections 485.635(f) through Section 485.635(f)(4) (Tags C-1000 to 1002), she stated they were unaware of this requirement and did not have the required policies. No violations of these required policies were noted during the survey.

Based on interview and record review, the hospital failed to ensure that the emergency department (ED) log included the disposition and discharge date/time for all ED patients.

This failure had the potential for miscommunication that could adversely affect patient care.

Findings:

On 5/23/17, the ED log for 1/1 to 4/30/17 was reviewed. The log did not have the disposition and discharge date/time for all ED patients.

The hospital policy, "EMTALA (Emergency Medical Treatment and Labor Act)," dated 6/29/2015, was reviewed and read, "Each department of the hospital that provides medical screening examinations shall maintain a central log recording the names of patients who present for emergency services. The log shall record the name of each person who presents for emergency services and whether the person refused treatment, was refused treatment by the hospital or whether the patient was transferred , admitted and treated, stabilized and transferred or discharged. Each department shall establish its own central log, timely recording of log entries and maintenance and expedited retrieval of completed forms."

During an interview on 5/23/17 at 1:40 pm, Administrative Nurse 1 acknowledged that the hospital did not have a log that had all the elements required of an ED log and stated the hospital did not have a policy for the ED log.