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1421 OAKDALE ROAD

MODESTO, CA 95355

MEDICAL STAFF - SELECTION CRITERIA

Tag No.: A0050

Based on interview and document review, the Hospital failed to ensure that its providers were selected and proctored according to its medical staff bylaws when 5 of 16 physicians whose credentialing files were reviewed (Medical Doctor [MD] 3, 6, 15, 16, 17), had their competence of procedural techniques evaluated by retrospective reviews, instead of direct observation.

This failure had the potential to put patients at risk for unsafe surgical experiences by practitioners who were not fully qualified.

Findings:

A. On 8/2/16 at 3 p.m. and 8/3/16 at 8 a.m., during concurrent interviews and document reviews with the Medical Staff Coordinator (MSC), the credentialing files of 16 medical staff were reviewed.

1. MD 3 was first granted provisional privilege in 4/2015, and became an active member of medical staff in 7/2016. MD 3's credentialing files included six proctoring forms titled, "Proctorship Report, Anesthesia Service", in which "retrospective" was checked, meaning the cases were reviewed after the procedures. On all of the six forms, under the section of "Anesthesia technique", multiple questions were listed, including; 'good IV (intravenous, into the vein) technique', 'acceptable spinal (into the spinal space) technique, intubation (insertion of tube into the airway) technique acceptable'. These questions were all checked as "Yes". When asked how those techniques were adequately evaluated during a retrospective evaluation, the MSC could not provide an explanation.

2. MD 6 was first granted provisional privilege in 1/2015, and became an active member of medical staff in 5/2016. MD 6's credentialing files included four proctoring forms titled, "Proctorship Report, Anesthesia Service", in which "retrospective" was checked. On three of the proctoring forms, under the section of "Anesthesia technique", multiple questions were listed, including; 'good IV technique', 'acceptable spinal technique, intubation technique acceptable'. These questions were all marked as "Yes". On one of the proctoring forms, the evaluations were left blank. When asked how those techniques were adequately evaluated during a retrospective evaluation, the MSC could not provide an explanation.

3. MD 15, 16, and 17 were all granted provisional privileges in 10/2015. MD 15 and 17 had three proctoring forms in their credentialing files, and MD 16 had six proctoring forms in the credentialing files. All of the proctoring forms were checked "retrospective". On these proctoring forms titled, "Proctorship Report, Gastroenterology Service", it listed 'procedural skills' under the "generic Competencies", where 'satisfactory' was checked. In addition, on MD 17's proctoring forms, the lines beside 'Diagnosis' and 'Procedure' were left blank. When asked how procedural skills were adequately evaluated during a retrospective evaluation, the MSC could not provide a clear explanation.

B. On 8/3/16 at 11:30 a.m., during a concurrent interview and document review with MD 2, also serving as Chief of Staff, and the Director of Operations (DO), the surveyor described the above findings of procedural techniques which were evaluated by retrospective reviews. The surveyor asked MD 2 how the proctors were able to evaluate the procedure technique using retrospective reviews. MD 2 acknowledged that the proctor should be present in order to adequately evaluate procedural techniques of the proctored practitioner.

Review of the hospital's Medical Staff Bylaws, approved on 9/12/11 by the Governing Body, indicated under Article V. Clinical Privileges, in the section of "5.3 Proctoring", that " ...During the proctoring, the practitioners must demonstrate they are qualified to exercise the privileges that were granted and are carrying out the duties of their Medical Staff category ...The intervention of a proctor shall be governed by the following guidelines: a. A member who is serving as a proctor does not act as a supervisor of the member or practitioner he or she is observing. His or her role is to observe and record the performance of the member or practitioner being proctored, and report his or her evaluation to the service and/or the Credentials Committee."

Both MD 2 and DO agreed that the current proctoring process in the hospital did not abide by the hospital's Medical Staff Bylaws.

C. On 8/4/16 at 9 a.m., during a concurrent interview and document review with MD 3, also serving as Chief of Anesthesia and DO, both were asked about the proctoring process in the Department of Anesthesia, MD 3 stated he would consider newly graduated physicians needed direct observation during the proctoring, while a seasoned practitioner, though newly appointed by the Medical Staff, would not need to be directly observed during the proctoring process.

Review of the hospital's policy titled, "Medical Staff Proctorship Guidelines", last revised 4/11/00, indicated that "III. The proctor shall be responsible for directly observing the procedure, and submitting a written report on the appropriate form to include evaluation of the surgical procedure for appropriateness, surgical technique, and post-operative management."

MEDICAL STAFF QUALIFICATIONS

Tag No.: A0357

Based on interview and document review, the Hospital failed to ensure that its providers were selected and proctored according to its medical staff bylaws when 5 of 16 physicians whose credentialing files were reviewed (Medical Doctor [MD] 3, 6, 15, 16, 17), had their competence of procedural techniques evaluated by retrospective reviews, instead of direct observation.

This failure had the potential to put patients at risk for unsafe surgical experiences by practitioners who were not fully qualified.

Findings:

A. On 8/2/16 at 3 p.m. and 8/3/16 at 8 a.m., during concurrent interviews and document reviews with the Medical Staff Coordinator (MSC), the credentialing files of 16 medical staff were reviewed.

1. MD 3 was first granted provisional privilege in 4/2015, and became an active member of medical staff in 7/2016. MD 3's credentialing files included six proctoring forms titled, "Proctorship Report, Anesthesia Service", in which "retrospective" was checked, meaning the cases were reviewed after the procedures. On all of the six forms, under the section of "Anesthesia technique", multiple questions were listed, including; 'good IV (intravenous, into the vein) technique', 'acceptable spinal (into the spinal space) technique, intubation (insertion of tube into the airway) technique acceptable'. These questions were all checked as "Yes". When asked how those techniques were adequately evaluated during a retrospective evaluation, the MSC could not provide an explanation.

2. MD 6 was first granted provisional privilege in 1/2015, and became an active member of medical staff in 5/2016. MD 6's credentialing files included four proctoring forms titled, "Proctorship Report, Anesthesia Service", in which "retrospective" was checked. On three of the proctoring forms, under the section of "Anesthesia technique", multiple questions were listed, including; 'good IV technique', 'acceptable spinal technique, intubation technique acceptable'. These questions were all marked as "Yes". On one of the proctoring forms, the evaluations were left blank. When asked how those techniques were adequately evaluated during a retrospective evaluation, the MSC could not provide an explanation.

3. MD 15, 16, and 17 were all granted provisional privileges in 10/2015. MD 15 and 17 had three proctoring forms in their credentialing files, and MD 16 had six proctoring forms in the credentialing files. All of the proctoring forms were checked "retrospective". On these proctoring forms titled, "Proctorship Report, Gastroenterology Service", it listed 'procedural skills' under the "generic Competencies", where 'satisfactory' was checked. In addition, on MD 17's proctoring forms, the lines beside 'Diagnosis' and 'Procedure' were left blank. When asked how procedural skills were adequately evaluated during a retrospective evaluation, the MSC could not provide a clear explanation.

B. On 8/3/16 at 11:30 a.m., during a concurrent interview and document review with MD 2, also serving as Chief of Staff, and the Director of Operations (DO), the surveyor described the above findings of procedural techniques which were evaluated by retrospective reviews. The surveyor asked MD 2 how the proctors were able to evaluate the procedure technique using retrospective reviews. MD 2 acknowledged that the proctor should be present in order to adequately evaluate procedural techniques of the proctored practitioner.

Review of the hospital's Medical Staff Bylaws, approved on 9/12/11 by the Governing Body, indicated under Article V. Clinical Privileges, in the section of "5.3 Proctoring", that " ...During the proctoring, the practitioners must demonstrate they are qualified to exercise the privileges that were granted and are carrying out the duties of their Medical Staff category ...The intervention of a proctor shall be governed by the following guidelines: a. A member who is serving as a proctor does not act as a supervisor of the member or practitioner he or she is observing. His or her role is to observe and record the performance of the member or practitioner being proctored, and report his or her evaluation to the service and/or the Credentials Committee."

Both MD 2 and DO agreed that the current proctoring process in the hospital did not abide by the hospital's Medical Staff Bylaws.

C. On 8/4/16 at 9 a.m., during a concurrent interview and document review with MD 3, also serving as Chief of Anesthesia and DO, both were asked about the proctoring process in the Department of Anesthesia, MD 3 stated he would consider newly graduated physicians needed direct observation during the proctoring, while a seasoned practitioner, though newly appointed by the Medical Staff, would not need to be directly observed during the proctoring process.

Review of the hospital's policy titled, "Medical Staff Proctorship Guidelines", last revised 4/11/00, indicated that "III. The proctor shall be responsible for directly observing the procedure, and submitting a written report on the appropriate form to include evaluation of the surgical procedure for appropriateness, surgical technique, and post-operative management."

Both MD 3 and DO concurred that the current proctoring process in the hospital did not follow their own policy.

OPERATING ROOM POLICIES

Tag No.: A0951

Based on observation, staff interview, clinical record and administrative document review, the hospital failed to ensure hospital operating room policies were followed to ensure surgical services were performed in accordance with acceptable standards of care and practice when:

1. Medical doctor (MD) 23 did not perform hand hygiene (wash hands or use an alcohol-based hand rub) prior to putting on gloves and performing a procedure and after removing gloves following the procedure for one of two tracer patients (patients observed from admission through discharge) (Patient 1) in the Pain Clinic Procedure Room.

2. Three instances of staff wearing required surgical attire incorrectly in the perioperative area (restricted and non-restricted areas requiring special attire) were observed: a) Registered Nurse (RN) 7 had exposed stud earrings when she transported Patient 1 to the Pain Clinic Procedure Room; b) MD 23 had both ears exposed when he performed a procedure on Patient 1 in the Pain Clinic Procedure Room; and (c) RN2 did not have all of her hair contained within her hat during surgery on tracer patient 2.

These failures resulted in the hospital's inability to provide patient care in a safe manner.

FINDINGS:

1. On 8/2/16 at 10:15 a.m., during an observation, MD 23 did not perform hand hygiene prior to putting on gloves and performing bilateral trochanteric bursa injections (medications inserted around both hips to relieve pain) on Patient 1 in the Pain Clinic Procedure Room and after removing gloves at the conclusion of this procedure.

On 8/2/16 at 10:33 a.m. during an interview, MD 23 stated he was aware of the facility policy to perform hand hygiene prior to putting on gloves and after removing gloves.

On 8/2/16 at 11:08 a.m., during a concurrent interview, the Director of Operations (DO) stated and the Director of Clinical Services (DCS) confirmed the facility policy stated hand hygiene was to be conducted prior to donning and after removing gloves.

The hospital policy and procedure titled, "Hand Hygiene" dated 5/18/16, indicated "Policy: A. Hand hygiene is indicated by all Medical Staff, Allied Health, and all staff at the following times: ...2. Before: ii. Donning gloves ...3. After: ii. Removing gloves ... "

The Association of periOperative Registered Nurses (AORN) publication titled, "Guideline for Hand Hygiene" 2016 Edition, indicated "Recommendation II - A standardized procedure for hand washing should be followed. ...IIa. A hand wash should be performed ...before putting gloves on and after removing gloves..."

2. Three instances of staff wearing required surgical attire incorrectly in the perioperative area were observed:

a) On 8/2/16 at 10:12 a.m., during a Tracer, RN 7 was observed with two exposed stud earrings in each ear when she transported Patient 1 to the Pain Clinic Procedure Room.

On 8/2/16 at 10:37 a.m., during an interview, RN 7 stated she was aware of the facility policy that earrings should be covered in the procedure room.

On 8/2/16 at 11:08 a.m., during a concurrent interview, the DO stated and the DCS confirmed the facility policy stated jewelry that cannot be covered should not be worn in the restricted areas.

The hospital policy and procedure titled, "Pain Clinic Dress Code" dated 5/3/16, indicated "POLICY: Staff entering the Pain Clinic semi restricted and restricted areas should wear facility approved surgical attire ... Description or Definitions: ...Restricted area: Includes the procedure rooms and staff in this area ... PROCEDURE: A.9. Jewelry including earrings ...that cannot be contained or confined within the surgical attire should not be worn ... "

The AORN publication, "Guidelines for Perioperative Practice," dated 3/9/12, indicated, "Guideline for Surgical Attire, Recommendation I... 1. j. Jewelry (e.g., earrings, necklaces, bracelets, rings) that cannot be contained or confined within the scrub attire should not be worn in... restricted areas.

b) On 8/2/16 at 10:15 a.m., during a Tracer, MD 23 was observed with both ears exposed when he performed a procedure on Patient 1 in the Pain Clinic Procedure Room.

On 8/2/16 at 10:33 a.m., during an interview, MD 23 stated he was aware of the facility policy to cover both ears in the Pain Clinic Procedure Room.

On 8/2/16 at 11:08 a.m., during a concurrent interview, the DO stated and the DCS confirmed the facility policy stated ears are to be covered in the Pain Clinic Procedure Room.

The AORN publication, "Guidelines for Perioperative Practice," dated 3/9/12, indicated, "Guideline for Surgical Attire, Recommendation III - Personnel entering the semi-restricted and restricted areas should cover the ...hair and ears ... Hair and skin can harbor bacteria that can be dispersed into the environment. The collective body of evidence supports covering the hair and ears while in the semi-restricted or restricted areas."

c) On 8/3/16 at 8:15 a.m., during an observation of tracer patient 2's surgery, RN 2's hair was falling out of the back of her hat in the operating room.

On 8/3/16 at 8:18 a.m., during an interview, the DO concurred that RN 2's hair was not contained by her hat.

The AORN publication, "Guidelines for Perioperative Practice," dated 3/9/12, indicated, "Guideline for Surgical Attire, Recommendation III - Personnel entering the semi-restricted and restricted areas should cover the ...hair and ears ... The benefit of covering the... ears and hair is the reduction of the patient's exposure to potentially pathogenic microorganisms from the perioperative team member's... hair, ears..."