The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

HENRY MAYO NEWHALL HOSPITAL 23845 MCBEAN PKWY VALENCIA, CA 91355 Aug. 4, 2016
VIOLATION: MEDICAL STAFF CREDENTIALING Tag No: A0341
Based on staff interviews and document review, the Medical Staff failed to examine the credentials of mid-level, non physician practitioners who applied to the Medical Staff of the hospital for privileges to provide direct patient care in the neurosurgical (conditions of the nervous system, brain and spinal cord) service.

The qualifications, scope of practice and competencies were not reviewed prior to the granting of these privileges without Medical Staff or Governing Body approval.

This failure to ensure qualified, competent health care providers could put patients in danger of misdiagnosis or inappropriate treatment of patients managed by Physician Assistants. Findings:
An interview with the Chief Executive Officer (CEO) was conducted on 8/2/16 at 10:30 a.m. The CEO stated that the members of the Medical Staff, including the CEO, had requested criteria for appointments to the Medical Staff for the PA's. The CEO stated these requests were made in 2015 as a result of applications to the medical staff from PA's for the Neurosurgery Department. The CEO further stated no criteria for appointment to the Medical Staff of the hospital resulted, and subsequently, the Chief Medical Officer (CMO) formed an independent committee that granted privileges to designated Physician Assistants without following the credentialing process and medical staff approvals defined in the Medical Staff Bylaws.

A review of the minutes of the Governing Body meetings, dated August 31, 2015, November 31, 2015, and December 18, 2015, revealed the appointments for PA 1 and PA 2 had been placed on hold pending the recommendations of the ad hoc committee.


A review of medical records for the following 7 patients revealed the PAs had provided direct patient care and consultation from 1/2/16 - 3/22/16 without being granted Medical Staff privileges to seven of seven patients reviewed. (Patients 18, 33, 34, 35, 36, 37, 44)A review of Medical Staff documents revealed PA 1 and PA 2 received appointment to the medical staff on April 4, 2016 for the Neurosurgery Department. This appointment was made at the recommendation of an outside hired consultant with no direct input from the Department of Neurosurgery, the Medical Executive Committee or the Governing Body.

The Medical Staff Bylaws, Rules and Regulations, were not revised to reflect the addition of a mid level, non physician provider to the medical staff roster.
VIOLATION: MEDICAL STAFF BYLAWS Tag No: A0353
Based on staff interviews and document review, the General Acute Care Hospital (GACH) failed to adopt and/or enforce Medical Staff Bylaws in accordance with regulatory requirements and nationally recognized standards of practice for:

1) Required annual healthcare screening and immunizations of physicians and practitioners.
2) Appropriate and timely consultations of Emergency Department (ED) or Trauma patients by a neurosurgeon.
3) Credentialing of non-physician, mid level practitioners (Physician Assistants) prior to their being accepted to the membership of the medical staff and granted privileges.

The failure to define a mechanism for ensuring adoption and enforcement of healthcare screening and immunizations resulted in the potential for increased infection to healthcare workers and possible transmission of communicable diseases to vulnerable patients.

The failure to provide appropriate and timely consultation by a neurosurgeon resulted in a potential delay in diagnosis and treatment of serious medical conditions.

The failure to seek approval of the medical staff for the use of Physician Assistants in the patient care setting resulted in the potential for serious adverse outcomes from unqualified, unsupervised practitioners.


Findings:

1. A meeting in the Medical Staff Office was conducted on 8/2/16, at 10 a.m. with the Medical Staff Coordinator (MSC), the Chief Clinical Officer (CCO), and the Infection Control Preventionist (ICP).

The Credentials Files for Medical Doctor 1 (MD 1), MD 2, Physician Assistant 1 (PA 1), and PA 2, were reviewed. The Credentials Files for each of the medical providers failed to contain documentation of an annual healthcare questionnaire providing documentation of immunization status or current health status.

When interviewed, the ICP, the CCO, and the MSC stated the Medical Staff had refused to comply with the recommendations of nationally recognized organizations for all healthcare workers to provide evidence of annual healthcare screening and documentation of immunization status. The ICP stated the hospital followed the recommendations of the Center for Disease Control (CDC). The ICP further revealed the CDC defined healthcare workers to include physicians, nurses, emergency medical personnel, dental professionals and students, medical and nursing students, laboratory technicians, pharmacists, hospital volunteers, and administrative staff.

In a meeting with the Chief Executive Officer (CEO) on 8/2/16, at 11 a.m., he stated he was aware of the recommendation for annual healthcare worker screening to include all members of the medical staff. He stated the medical staff had refused to comply with the directive and recommendations of the CDC and had refused to submit to annual immunizations or to provide documentation for health status to the medical staff office as directed. A review of the current Medical Staff Bylaws, Rules and Regulations, dated 5/3/14, page 52-53, the following was noted as a responsibility of the Infection Control Committee: "(4) Promotion of a preventative and corrective program designed to minimize infection hazards;".

On page 46 of the current Medical Staff Bylaws, Rules and Regulations, a duty of the Executive Committee was defined (4) to implement policies of the Medical Staff..." and "to formulate Bylaws, Rules and Regulations governing the Medical Staff....". On page 41, the Chief of Staff, in coordination and cooperation with the Chief Executive Officer, was "to be responsible for the enforcement of Medical Staff Bylaws, Rules and Regulations...".


2. An interview was conducted with the Emergency Department Medical Director (MD 2) on 8/2/16, at 11:15 a.m. MD 2 stated, during Emergency (ED) and Trauma Department meetings, he had been advised by the attending staff physicians of a problem obtaining neurosurgical consultations.

MD 2 stated MD 1 had failed to respond to a request for a physician consult on Patient 18 on 1/3/16 and had instead sent a Physician Assistant (PA) in his place.

On 8/3/16 at 9:30 a.m., a conference with the Quality Assurance Performance Improvement (QAPI) committee was held. Present during the meeting were the Quality Resources Coordinator, Risk Coordinator, Vice President for Performance Management (VPPM), Infection Control Preventionist, Trauma Program Director, Director of Emergency Services, and Emergency Department Lead Clinical Coordinator. The Risk Coordinator sent a memo to the Department of Surgery, on 2/16/16. The memo revealed "during the months of August, 2015 to December 2015, 9 patients were noted to have been initially evaluated by a Physician Assistant, PA". As a result of this QAPI study, the VPPM submitted a tabulation of 60 cases representing an "Analysis of Neruosurgical PA cases". The following patients medical records (Patients 20, 21, 22, 33, 34, 35, 36, 37, 38, 39 and 40, 41, 42) were reviewed in which a Neurosurgeon was requested but the consultation was performed by a PA between 2/18/16 - 6/15/16. The QAPI study indicated the Medical Staff had failed to provide trauma and emergency neurosurgical services consultations in a manner consistent with the bylaws of the Medical Staff that had been approved by the Governing Body.

Review of the Medical Staff By Laws, Rules and Regulations, dated 5/3/14, page 23, Section 6. The Consulting Medical Staff revealed: "The members of the Consulting Medical Staff shall have the obligation of providing consultation in those cases where consultation is required by the Rules and Regulations of the Medical Staff and where such consultation is requested by a member of the Medical Staff. Consulting Staff members shall be qualified and have been granted privileges to provide consultations in their specialty". In Section 3. Definitions, the following was noted: "For the purpose of these Bylaws, the term "Medical Staff" shall be interpreted to include all physicians, dentists and podiatrists holding unlimited licenses." No where in the Medical Staff Bylaws, Rules and Regulations does it define that a Physician Assistant may provide a consultation in lieu of a physician.

3. The Chief Clinical Officer (CCO), the Chief Executive Officer (CEO) and the Vice President for Performance Management (VPPM), in an interview on 8/2/16 at 1:10 p.m. acknowledged the process for the credentialing of Physician Assistants had not been conducted according to the stipulations of the Medical Staff Bylaws with the approval of the designated medical staff committees, Medical Staff and Governing Body. The CCO< CEO and VPPM acknowledged an advisory ad hoc group had been formed and the Chief Medical Officer and chair of the Physician Assistant Advisory Committee had "signed off" on them (the Physician Assistants).

In review of the Medical Staff Bylaws, the document presented by the facility as most current at the time of the survey was dated 5/3/14, the following was noted in Article "VIII: Determination of Qualifications and Privileges:

Section 1. Classification of Privileges

Privileges granted to physicians, dentists or podiatrists who have been appointed to the Medical Staff shall be recommended by the chairman of the department to which the practitioner is assigned and after appropriate verification of information.

Section 2. Determination of Privileges

(a) Determination of initial privileges shall be based upon an applicant's training, experience and demonstrated competence....

(c) Privileges shall be determined as follows:
(3) The Executive Committee shall evaluate the privileges requested and make recommendations to the Board of Directors. [Governing Body]
(4) The Board of Directors shall make the final decision concerning the granting of privileges..."
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on observation, staff interviews, document review and hospital Policy and Procedure review, the hospital failed to ensure:

1. Medications were administered in a timely manner for 1 of 43 sampled patient (Patient 31) when there was a delay in the administration of intravenous (IV) antibiotic according to the facility's scheduled administration time;

2. Medications were stored and labeled according to hospital Policy and Procedure; and

3. Expired medications were not available for patient use.

These failures potentially delayed treatment of an infection, had the potential for mistakes in medication administration due to poor storage and labeling of medications, and the efficacy of medication could be potentially compromised with the use of expired medications. Findings: 1. During the Initial Tour of the facility's Intensive Care Unit (ICU), accompanied by the day shift ICU Charge Nurse (ICU CN), on 8/1/16 at 11 a.m., Patient 31's room was visited. An inspection of Patient 31's room revealed a 100 ml (milliliter, a unit of measurement) saline IV bag, with a vial of medication connected to it. The bag was observed hanging on an IV pole. There was no IV tubing connected to the bag nor was the medication administered to the patient. The ICU CN was asked what was in the bag that was hanging on the IV pole. The ICU CN stated that it was an IV antibiotic. The vial contained liquid solution and the ICU CN stated that the patient's nurse must have broken the seal, in between the bag and the vial, and mixed the powdered antibiotic with the saline solution. The ICU CN checked Patient 31's electronic Medication Administration Record (eMAR) and it showed that the medication should have been administered to Patient 31 at 10 a.m., one hour earlier. Review of Patient 31's medical record revealed the following: 1a. A Physician's Order, dated 7/29/16, indicated: "[name of antibiotic] 1,000 mg [milligram, a unit of measurement] vial in 100 ml Sodium Chloride 0.9% [saline solution] IV every 12 hours." The dose of the antibiotic was dependent on Patient 31's kidney function and her ability to clear waste products from the body. Patient 31's kidney function was monitored through blood samples to check the creatinine clearance (a result that measures the level of the waste product in a person's blood or urine). 1b. The eMAR indicated a scheduled time for 10 a.m. and 10 p.m. to administer the IV antibiotic. 1c. The eMAR for 7/31/16 revealed the IV antibiotic was given to the patient at 9:07 p.m. and eMAR for 8/1/16 revealed the IV antibiotic was given to the patient at 11:18 a.m. 1d. Patient 31's creatinine clearance levels for 7/30/16 at 4:30 a.m. was 0.7; for 7/31/16 at 8:25 a.m. was 0.6; and for 8/1/16 at 4:37 a.m. was 0.6. Reference that the facility used for normal range for the creatinine clearance level was 0.5 - 1.0 mg/dl (deciliter, a unit of measurement). During a concurrent interview with the ICU Director on 8/2/16 at 5 p.m., Patient 31's medical record was reviewed. The ICU Director acknowledged that there was a delay in administering of the IV antibiotic to Patient 31. A review of the facility's Policy and Procedure titled "Medication Timing," dated 12/4/15, revealed the following: 1A. "PURPOSE: To provide a method for ensuring the timely administration of medications... 1B "PROCEDURE... 3. TIME CRITICAL SCHEDULED MEDICATIONS: The following medications or classes of medications must be administered within thirty minutes before or after their scheduled dosing time, for a total window of 1 hour: a. Antibiotics; ..."





2. During a concurrent observation and interview with the Surgical Services Director (SSD) on 8/1/16, at 9:35 a.m., in the Post Anesthesia Care Unit (PACU), a 250 milliliter (ml) bag of Albumin 5% was observed lying on top of the automated medication dispensing machine. The Albumin 5% was not labeled with a patient's name, identification number or expiration date The SSD acknowledged the medication should not have been lying on top of the automated medication dispensing machine unattended.

In an interview with PACU Registered Nurse 1 (PACU RN 1) on 8/1/16, at 9:36 a.m., PACU RN 1 stated he thought the medication was supposed to be returned to pharmacy, but was not sure why the medication was lying on top of the automated medication dispensing machine, and acknowledged it should not have been left unattended.

Review of the hospital's Policy and Procedure titled, "Medication Labeling Requirements" dated 1/12/16, indicated:
2A. "Policy: All medications are appropriately labeled, including any applicable accessory or cautionary statements and expiration dates";

2B. "Procedure: ...2. All medication supplied by the Pharmacy must be properly labeled, legible, and in compliance with state and federal requirements.
The label shall include:
A. The drug name (trade, generic or both);
B. Manufacturer (if generic name is used);
C. Strength;
D. Dosage;
E. Lot number;
F. Expiration date; and
G. Dispensing persons initials".

Review of the Policy and Procedure titled, "Storage of Medication", dated 12/4/15, indicated:
2A. "Procedure: Safe Storage: Medications received by the nurse will be placed in the patient's medication cassette or in the medication room"; and

2B. "Disposition: ...4. Medications are secured so that unauthorized persons cannot obtain access to them. Housekeeping, engineering, and biomed staff may have access to [operating room] and other locked areas after hours in order to perform their designated duties".

3. During a concurrent observation and interview with the SSD on 8/2/16, at 8:45 a.m. in the Ambulatory Surgery Center (ASC), three (3) 10 ml vials of Lidocaine 1% (local anesthetic) had expired 6/16. A bottle of Monsel's solution (iron subsulfate, topical hemostatic solution used to stop bleeding) had expired 9/15. The SSD confirmed the observation and acknowledged there were expired medications available for patient use.

Review of the hospital's Policy and Procedure titled, "Storage of Medications", dated 12/4/15, indicated:
3A. "Disposition:...6. Expired, damaged, and/or contaminated medications are segregated until they are removed from the hospital. ... ."

Review of the hospital's Policy and Procedure titled, "Return of Medication" dated 1/12/16, indicated:
3A. "Procedure... All drug storage areas of the hospital will be inspected on a monthly basis by a pharmacist or pharmacist designee for outdated drugs... Nursing or other staff approved by license to administer medications, noting outdated drugs...will contact the Pharmacy Department notifying that department of the drugs existence on his or her unit."
VIOLATION: ORGANIZATION OF SURGICAL SERVICES Tag No: A0941
Based on staff interviews, medical record review and hospital policy and procedure review, the hospital failed to ensure appropriate type and number of qualified practitioners were available for open heart surgery for two (2) out of two (2) open heart surgery cases reviewed (Patients 25 and 30) when they were placed on the heart bypass machine without two (2) surgeons present inside the OR suite.

This failure placed patients at risk for injury and/or death related to lack of sufficient qualified staffing in the Operating Room (OR) during open heart surgery with bypass.

Findings:

Review of Patient 30's medical record indicated Patient 30 had a surgical procedure performed 7/28/16, at 7:08 a.m. titled, "Coronary Artery Bypass Graft X4 IMA (internal mammary artery) (one open heart arterial, 3 venous) Pump [open heart surgery], TEE (Trans-esophageal echo, a diagnostic test for the heart)". The following staff were present in the OR for this surgery:

1. Surgeon: Surgeon 1 (S 1);
2. Assisting: Registered Nurse First Assist 2 (RNFA 2, a RN with special training in surgery and surgical procedures);
3. Anesthesiologist: Anesthesiologist 1 (A 1);
4. Circulator: RN 3 and RN 4;
5. Scrub: Tech 1 (T 1); and
6. Perfusionist: (P 1) (oversees the heart lung machine during cardiac surgeries that require heart and lung bypass)

Review of Patient 25's medical record indicated the open heart surgery was performed on 2/13/16. S 1 had a RNFA as first assist during open heart surgery with bypass. There was no documented evidence another surgeon had been present during Patient 25's open heart bypass surgery.

In an interview with the Surgical Services Director (SSD) on 8/3/16, at 11:20 a.m., the SSD stated she did not know why a second surgeon was not present during the open heart surgery. The SSD acknowledged there should have been a second surgeon inside the OR suite during open heart surgeries with bypass.

In an interview with the RNFA, on 8/3/16, at 11:30 a.m., the RNFA confirmed she was the first assist for Patient 25 and 30's open heart surgeries. The RNFA confirmed there was no other surgeon inside the OR suite when Patient 25 and 30 had open heart surgery with bypass.

Review of the hospital's Policy and Procedure titled, "Assistants in Surgery", dated 8/18/15, indicated:
1. "Policy: Defines the requirement for assistants during surgery";

2. "Procedure:... The use of assistants during Cardiac [heart] Surgery at [name of hospital] is required as defined by State Law."

Review of California Code of Regulations Division 5, Title XXII (2) indicated:
1. "A minimum of three surgeons shall constitute a surgical team for the performance of all cardiovascular operative procedures which require extracorporeal bypass [circulation of blood outside of the body through a machine that temporarily assumes the heart and lung functions]. At least one surgeon must meet the requirements outlined in subparagraph (b)(1) above"; and

2. Title XXII (b)(1) indicated: A physician shall have overall responsibility for the service. This physician shall be certified or eligible for certification by the American Board of Thoracic Surgery or the American Board of Surgery with training and experience in cardiovascular surgery... ."
The hospital did maintain a program flex for the third required surgeon required by State law.

The utilization of a RNFA as a surgical first assist during open heart surgery with bypass is beyond the scope of practice for this provider designation.

A request was made for the Cardiovascular Surgery Services Policies and Procedures. The facility was unable to comply with this request.

In review of the Medical Staff Bylaws, Rules and Regulations, presented by facility staff as the most current revision of this document, dated 5/3/14, there was no section defined for Cardiovascular Services and there were no references in the Medical Staff Bylaws to policies or standards of practice for cardiovascular surgeries or care of patients with cardiovascular conditions.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on observation, staff interview, document review, and hospital Policy and Procedure review, the hospital failed to ensure:

1. The blanket warmer was functioning properly when the temperature had not been documented since 4/19/16 and the thermometer was observed to be non functioning;

2. The low temperature sterilizer air intake was free of dust and dirt which was observed covering the air intake area; and when

3. The door to the decontamination room remained closed, when the door was observed to be propped open.

These failures had the potential for patient harm from a hot blanket, compromised sterility of surgical instruments, and the spread of infection.

Findings:

1. During a concurrent observation and interview with the Surgical Services Director (SSD) in the Post Anesthesia Care Unit (PACU) on 8/1/16 at 9:40 a.m., the blanket warmer temperature gage was not registering a temperature. A "Blanket Warmer Temperature Log", located on the door of the blanket warmer, indicated the last time the temperature had been documented was on 4/19/16, as 136 degrees. The SSD stated the thermometer was broken.

Review of the hospital's Policy and Procedure titled, "Temperature of Blanket or Fluid Warmer", dated 9/4/15, indicated:
A. "Purpose: ...Define the procedure for warming blankets";

B. "Blankets will be warmed at a temperature not to exceed 130 degrees Fahrenheit or 54 degrees centigrade. ... ".

2. During a concurrent observation and interview with the Infection Control Preventionist (ICP) and the Central Supply Manager (CSM) in the Central Sterile Processing area, on 8/1/16, at 3:40 p.m., there was thick dust and dirt noted covering the low temperature sterilizers air flow intake area. The ICP and CSM stated they did not know the last time the sterilizer had been serviced. The ICP and CSM acknowledged the dust and dirt was present on the low temperature sterilizer air intake area, and it should be free of dust and dirt.

Review of the hospital's Policy and Procedure titled, "Sterilization of Supplies and Equipment", dated 8/3/15, indicated:
A. "9. A quality control program is developed and will track the following:...B. Preventative maintenance performed by engineering; ... ."

3. During a concurrent observation and interview with Quality Resources Coordinator (QRC) on 8/2/16, at 2:35 p.m., the door to the decontamination room was propped wide open. The QRC confirmed the observation and acknowledged the decontamination door should not be propped open at any time.

Review of the hospital's Policy and Procedure titled, "Decontamination Receiving and Handling", dated 9/4/15, indicated:
A. "Policy:...Door must remain closed at all times... ".
VIOLATION: INFORMED CONSENT Tag No: A0955
Based on staff interview, medical record review and hospital Policy and Procedure review, the hospital failed to properly execute an informed consent for two (2) out or 43 Patients reviewed (Patients 6 and 12).

These failures had the potential for uninformed decision making.

Findings:

Review of Patient 6's "Informed Consent", dated 7/13/16, was not timed by the Physician.

Review of Patient 12's "Informed Consent", dated 7/11/16 at 12:40, did not indicate whether Patient 12 had consented to "Taking of pictures of my medical or surgical condition or treatment, and use of the pictures for scientific, educational, or research purposes", and the "Informed Consent for Anesthesia" was not timed by Patient 12 or the Anesthesiologist.

Review of the hospital's Policy and Procedure titled, "Medical Records Physician Documentation", dated 9/4/15, indicated:
1. "General Guidelines: A. All entries must be timed, dated, and authenticated".

In an interview with the Medical Records Director (MRD) on 8/3/16, at 8 a.m., the MRD acknowledged Patient 6 and 12's Informed Consents were not timed, either by the patient or the physician. The MRD also confirmed Patient 12's consent should have either checked: "I do" or "I do not" consent to be photographed.
VIOLATION: GOVERNING BODY Tag No: A0043
Based on staff interviews, medical records review, a review of the minutes of Medical Staff and Governing Body meetings, and documents supplied by the hospital, the Governing Body (GB) failed to be effective in its legal responsibility to provide healthcare in a safe environment, to meet the needs of its patients when:

1. The GB failed to ensure the accountability of the medical staff to require annual healthcare screening and yearly immunizations for each of its healthcare workers, including physicians and physician practitioners, in accordance with its own policies and procedures and recommendations from nationally recognized authorities, to protect the healthcare worker and prevent possible transmission of communicable diseases to vulnerable patients. (Cross Reference A0353)

2. The GB failed to ensure appropriate consultations by qualified members of the Medical Staff upon request of emergency department or trauma physicians. (Cross reference A0353)

3. The GB failed to enforce its own directives to provide immediate oversight for mid-level practitioners who were providing direct patient care and consultations on patients when the mid-level practitioners had less than one year of acute hospital experience. (Cross reference A0064)

4. The GB failed to ensure that policies and procedures (P &Ps) for Cardiovascular Surgical Services had been developed and maintained. These policies and procedures are required at a minimum to include what physicians/practitioners are required to be present during a cardiovascular surgery with bypass and the qualifications of the members of the surgical team. (Cross reference A0941)

5. The GB failed to define the credentialing process for mid-level practitioners (Physician Assistants) to include the qualifications, role, scope of practice, assessment of competency and monitoring requirements (Cross reference A0341, A0353)

The cumulative effect of these deficient practices resulted in the inability of the hospital to comply with the statutorily mandated Governing Body Conditions of Participation.
VIOLATION: CARE OF PATIENTS - PRACTITIONERS Tag No: A0064
Based on staff interviews and review of selected documents and medical records supplied by the hospital, the Governing Body (GB) failed to ensure each patient was under the care of a provider qualified to provide healthcare services as specified by the Medical Staff Bylaws of the hospital when two (2) of two (2)Physician Assistants (PA 1, PA 2) with less than one year of acute care experience were allowed to provide direct patient care without physician supervision.

The failure to ensure a qualified provider to oversee the care of patients resulted in the potential for misdiagnosis or inappropriate treatment of serious medical conditions.

Findings:

Physician Assistant 2 (PA 2) was appointed to the staff of the hospital as a Neurosurgical (surgery of nervous system, brain and spinal cord) Physician Assistant (PA) on 7/05/16. The facility presented a document which stipulated "For PAs who have not yet had 1 year of acute hospital experience, immediate supervision by a Physician is required...."

Review of the medical record for Patient 20 revealed PA 2 came to the Emergency Department to evaluate and provide consultation for this patient who had sustained a fracture in the cervical spine (neck). There was no documentation of immediate supervision by a Neurosurgeon.

The facility was unable to provide any evidence of the process to be taken to ensure a PA with less than one year of experience had appropriate and adequate direct supervision for patient care. There were no protocols approved by the Medical Staff and Governing Body to determine the scope of practice of the PA or for what types of patients or procedures direct supervision would be required.

During an interview on 8/2/16, at 1:10 p.m., the Chief Clinical Officer, the Chief Executive Officer, and the Vice President for Performance Management acknowledged the PAs with less than one year documented acute care experience had been providing care without direct supervision.
VIOLATION: MEDICAL STAFF Tag No: A0338
Based on staff interviews, a review of medical records, a review of the minutes of medical staff and governing body meetings, and a review of documents supplied by the hospital, the Medical Staff failed to:

1. Ensure adequate and appropriate consultation for trauma and emergency patients coming to the hospital for urgent treatment. (Cross reference A353)

2. Provide healthcare status and immunization status upon request of the Medical Staff Coordinator. (Cross reference A0353)

3. Ensure mid-level practitioners with less than one year documented acute care experience had immediate oversight by a supervising physician. (Cross reference A064)

4. Ensure appropriate surgical assistance for patients who present to the hospital for coronary bypass surgery. (Cross reference A0941)

5. Define and implement the credentialing process for mid level practitioners (Physician Assistants) to include the evaluation of qualifications, role, scope of practice, assessment of competency and monitoring requirements prior to issuing medical staff membership and hospital privileges. (Cross reference 0341)

The cumulative effect of these systemic practices resulted in the inability of the hospital to comply with the statutorily mandated Medical Staff Conditions of Participation.
VIOLATION: POST-OPERATIVE CARE Tag No: A0957
Based on observation, staff interview, and hospital policy and procedure review, the hospital failed to maintain proper infection control practices when a licensed nurse in the Post Anesthesia Care Unit (PACU) of the Ambulatory Surgical Center (ASC) performed a finger stick blood glucose monitoring without gloves and without hand hygiene.

This failure had the potential for cross contamination and spread of infection.

Findings:

During an observation in the ASC's PACU on 8/3/16, at 9:10 a.m., Post Anesthesia Care Unit Registered Nurse 4 (PACU RN 4) performed a finger stick blood glucose monitoring on a post-operative patient. PACU RN 4 did not put gloves on prior to performing the finger stick, and did not perform hand hygiene before and after the procedure.

In an interview with PACU RN 4 on 8/3/16, at 9:40 a.m., she stated the hospital policy for performing a finger stick was to "use gloves all the time." She said, "I should've worn gloves and washed my hands."

In an interview with the Infection Control Preventionist (ICP) on 8/3/16, at 1:30 p.m., he said, "Using gloves during finger stick glucose monitoring was left to staff discretion. But they still need to wash hands."

The hospital policy and procedure titled "Diabetic Patient - Blood Glucose Monitor and Test Strip", approved on 8/7/15, indicated, "...Follow hand hygiene protocol and wear gloves for all testing..."

According to the 2015 Association of Perioperative Registered Nurses (AORN) Guidelines, "...A hand wash should be performed...before and after every patient contact, before putting gloves on and after removing gloves...Gloves must be worn when hand contact with blood or other infectious materials, mucous membranes, or non-intact skin can be reasonably anticipated..."