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.

COMMUNITY HOSPITAL OF SAN BERNARDINO 1805 MEDICAL CENTER DRIVE SAN BERNARDINO, CA 92411 Oct. 29, 2015
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on interview, and record review, the facility failed to implement the standards acceptable of practice when the the physician failed to verify a missing surgical instrument on the x-ray as evidenced by the obstetrician failed to verify a kocher clamp (a surgical instrument with interlocking teeth on tip) and fetal scalp electrode (an electrode directly on the fetal scalp thru the cervix to evaluate fetal heart rate) with the radiologist. These failures had the potential to transmit infection and affect the health and well being of patients undergoing a C-section (a surgical procedure in which one or more incisions are made through a mother's abdomen and uterus to deliver a baby) in a universe of 2 patients.

Findings:

During an interview with the Registered Nurse (RN 1), on October 26, 2015 at 1:35 PM, when asked who placed the fetal scalp electrode (FSE) on the baby, RN1 stated the Obstetrician placed the FSE on the baby's scalp due to the baby's heart rate was decelerating (decrease in fetal heart rate) and the mother showed signs of hemmorhaging (Excessive blood loss) of a possible placenta abruptio(the separation of the placenta from it's attachment to the uterus wall before the baby is delivered. RN 1 instructed the Registered Nurse (RN 6) to get patient ready for a c-section. Before the surgery ended they noticed they were missing one Kockler clamp. The Obstetrician then ordered an x-ray. The portable x-ray technician came to the operating room and performed an x-ray on the patient. when asked if the patients incision was open or closed when the x-rays were taken, RN 1 stated she couldn't remember if the patient's incision was closed or open. RN 1 then stated she received a phone call from the x-ray tech regarding the x-ray results. The Obstetrician was instructing RN 1 to ask questions to the x-ray tech regarding if they saw a Kocher Clamp. The x-ray tech said there was ringlike object located above the bladder. When asked if the radiologist is usually the one that gives results to the physician and the RN 1 stated "yes." RN 1 stated the x-ray technician said the cavity was negative, no kocher. RN 1 stated she hung up the phone and the Obstetrician transferred the patient to post anesthesia care unit (PACU). RN 6 stated the Obstetrician orderd another x-ray to be taken.

During an interview with the Obstetrician Technologist (OBT 1), on October 26, 2015 at 4:00 PM, when asked if the Obstetrician cut the FSE and the OBT 1 stated the Obstetrician cut the FSE, cleaned the uterus, and sutured the patient. The OBT1 counted the instruments and one of the kocher was missing but it was miscounted by the central supply department. The OBT 1 stated that the Obstetrician knew that the kocher was missing but still closed the patients incision.The OBT 1 said the RN 1 was told by the x-ray tech that the x-ray was negative for the kocher clamp.

During an interview with the x-ray technician (XT 1), on October 28, 2015 at 9:00 AM, When asked was the patient in PACU (post anesthesia care unit) or the operating room when the x-rays were taken and the XT 1 stated the patient was in the operating room when he took the x-ray. The XT 1 stated he called the operating room and told the nurse he saw a string like object on the x-ray.

During an interview with the Obstetrician on October 28, 2015 at 2:30 PM, When asked why the patient had an emergency C-section; the Obstetrician stated the patient had an emergency C-section and the FSE was placed on the infant because the baby's heart was decelerating and had the potential of having a diagnosis of placenta abruptio. The Obstetrician stated she cut the electrodes to get the baby out and they noticed the kocher clamp was missing. The Obstetrician stated she was told by the scrub tech that the x-ray results were negative for the prescense of the Kocher clamp When asked was the patient's incision closed or open when they took the x-ray and the Obstetrician stated the patient was closed when the x-ray was taken in the operating room. At that time the Obstetrician received a call from one of the nurses that there was no instruments in the patient's cavity but there was a coiled wire per the x-ray results. The Obstetrician stated the second x-ray result was done in the PACU. The Obstetrician stated she transfered patient back to OR and removed the coil wire that was part of the FSE.
VIOLATION: GOVERNING BODY Tag No: A0043
Based on interview,and record review, the facility's Governing Body failed to ensure that the facility's daily operation was conducted in an effective, safe, and organized manner as evidenced by a failure to:

1) Ensure surgical services were performed in accordance with the facility policies and procedures and acceptable standards of practice when the the physician failed to verify a missing surgical instrument on the x-ray (A quick painless test that produces images of the structures inside the body) results. (refer to A-0951 ).

2) Develop, implement, and maintain an effective quality assessment and performance improvement program, involving all hospital departments, and addressing the complexity of services provided, to prevent potential adverse events, and improve patient outcomes. (refer to A-0263 ).

3) Ensure there was a defined process and procedure on provision of radiologic services, including teleradiology (transmission of digital radiographic images from one location to another, for viewing and interpretation), both by the facility and by the contracted services. (refer to A-0529)

4) Ensure Registered Nurses in labor and delivery did not deliver babies on their own without the assistance of a physician being in charge of the delivery procedure on- site. This failure resulted in an immediate jeopardy situation to patient safety on October 26, 2015. (refer to A-0049 and A-0309).

The cumulative effect of these systemic problems resulted in the failure of the hospital to deliver care in a safe setting and be in compliance with the Condition of Participation for Governing Body.
VIOLATION: MEDICAL STAFF - ACCOUNTABILITY Tag No: A0049
Based on interview, and record review the facility failed to ensure that a Medical Doctor was present at all deliveries of a pregnant patient in the hospital and that Labor and Delivery Registered Nurses do not deliver babies on their own. As evidence by:

1. Labor and delivery Registered Nurses were delivering babies without the assistance of a Medical Doctor actively participating in the delivery procedure.

2. Labor and delivery Registered Nurses were not trained regarding delivering babies on their own without the assistance of an obstetrical physician during the delivery of the fetus.

These failures had the potential to affect the health and safety of all patients requiring Obstetrical services in the hospital, in a universe of 219 patients.

On October 26, 2015 at 8:45 PM, an Immediate Jeopardy (IJ) situation was declared in the presence of the facility's Administrator,Regulatory Compliance Licensing Specialist (RCLS), and Senior Director of Quality/Infection Control (SDOQIC) they were verbally notified of the facility's failure to ensure labor and delivery nurses did not deliver babies on their own, without the assistance of a Medical Doctor being in charge during the delivery process of the fetus.

Findings:

During an interview with the Registered Nurse (RN 2) on October 26, 2015 at 4:17 PM, when asked have you ever delivered babies without an obstetrical physician onsite, RN 2 stated ,"All labor and delivery nurses deliver babies but the doctors are supposed to deliver the babies not us."

On October 26, 2015 at 5:45 PM, during a review of the declaration statement, by RN 2, explaining the incidents where Labor and Delivery Nurses were delivering babies on their own without the assistance of the Obstetrical Physician during the delivery process. RN 2 indicated "If physician is not at the bedside when placenta (An organ connects the developing baby provides oxygen and nurtrients to growing baby and removes waste products from the baby) delivers, the RN will deliver the placenta gently and start pitocin (medication used to induce labor) as usual fashion and monitor for excessive bleeding until MD arrives."

On October 26, 2015 at 5:48 PM,during a review of the declaration statement of Registered Nurse (RN 3), explaining the incident where Labor and Delivery Nurses were delivering babies on their own without the assistance of the Obstetrical Physician during the delivery process. RN 3 indicated,"If patient has an imminent delivery the physician on call is notified." The declaration statement also indicated, the Patient was delivered by RN, placenta remain intact until physician arrives unless it delivers spontaneously." The incident was written in a program called IVOS(incident reports) The report used when nurses document incidents when there is no physician present. The nurses will document the incident when the RN's deliver babies on their own.."

On October 26, 2015 at 5:50 PM during a review of the declaration statement of Registeted Nurse (RN 1), explaining the incident where Labor and Delivery Nurses were delivering babies on thier own without the assistance of the Obstetrical Physician during the delivery process. RN 1 indicated "I have delivered many babies without a physician onsite and the obstetrician physicians are not required to stay in the hospital while having patients on the floor and laboring." RN 1 also indicated she has had no training in delivering babies nor is delivering babies part of her job scope. Nurse deliveries are to be documented in a system called IVOS ( incident reports) and have been documented by all RN's and there have been no course of action has ever been addrerssed or corrected. At times she has called the emergency department physicians to assist and have been denied due to constant no show of OB physicians. She indicated they give the doctors enough ample time to get to the hospital to do their deliveries.The RN 1 indicated She does not want to ever be responsible to deliver a baby. There are too many risk factors at hand that can jeopordize their license and the safety of the patients."

During an interview with the Director of Education (DOE) on October 26, 2015 at 6:05 PM, when reviewing training records for RN 2, RN3, and RN 4 the DOE confirmed that they did not have documented evidence regarding training on delivering babie on their own.

During a review of the IVOS for Patient #10, dated Janurary 1, 2015 at 9:06 AM it documented, "NO doctor delivery. Patient delivered baby boy. MD called for delivery was informed that patient was lip and close to delivery per MD Order. MD called for delivery. MD stated she was five minutes out and delivery missed." Registered Nurse (RN 5) delivered the baby."

During a review of the IVOS for Patient #9 dated October 9, 2015 at 3:00 PM, it documented, "RN delivery, pt non-compliant, out of control. MD on OR(operating room) closing a c-section (is a surgical procedure in which one or more incisions are made through a mother's abdomen and uterus to deliver a baby). Pt had smoked heroin prior to arrival to hospital. Pt found smoking substance also in hospital bathroom during labor. Pt states it was heroin and flushed the rest down the toilet. Nurse manager, house supervisor, security, and social worker notified. Also called to CPS (children protective services). Unable to give report to them, too busy at this time. They are to call back." RN 3 delivered the baby."

On October 28, 2015, at 10:00 AM, the Immediate Jeopardy Situation was lifted in the presence of the Administrator, Regulatory Compliance Licensing Specialist (RCLS), and Senior Director Of Quality/ Infection Control (SDOQIC) when the facility's Corrective Action Plan was approved after observation, interview, and record review confirmed that the labor and delivery Registered Nurses were knowledgeable on preciptious (when delivery of baby lasts less than 3 hours or less) delivery unattended by physician. The corrective action plan included the following components:

1. The emergency department physician on duty will respond to requests for deliveries unattended by the Obstetrician (OB) physician both urgent and standard deliveries.

2. Investigate amending the OB physician emergency department call coverage agreement to include response in the event that an assigned patient's physician does respond timely.

3. The facility to evaluate implementation of a 24/7 laborist program.

4. Education to Obstetrical (relating to the care and treatment of women in childbirth) staff in the event of failure to timely respond by assigned physician and/or on-call physician and procedures to follow.

5. Policy revised to clarify guidelines for precipitous deliveries.
VIOLATION: MEDICAL STAFF Tag No: A0052
Based on interview and record review, the facility failed to ensure there was a defined process and procedure on provision of radiologic services, including teleradiology (transmission of digital radiographic images from one location to another, for viewing and interpretation), by the facility. This failure had the potential to affect overall health and safety of the patients receiving radiologic services in a universe of 219 patients.

Findings:

A concurrent interview and record review with the radiology department staff, were conducted in the presence of the Pharmacy Director on October 28, 2015.

During a concurrent interview with Radiology Manager (RM) on October 28, 2015 at 9 AM, when asked to describe the process of the provision of services in the radiology department, RM explained the "main" radiologist, Radiologist 1, was available in the facility Monday through Friday from 8am-5 PM. After 5 PM ("afterhours") when the onsite radiologist was gone, the digital images were electronically transmitted and sent online (teleradiology) to a contracted service group (Contracted Service 1), for online review and reading, for radiology imaging ordered as "STATs" (urgent), the facility radiology technicians would call and notify Contracted Services 1 of such, as soon as possible for online review and reading, for routine radiology orders, Contracted Services 1 would read the radiology digital images online as the digital images were being electronically transmitted by the facility radiology technicians.

During a concurrent interview with the Director Medical Imaging on October 28, 2015, when asked for a documented evidence of a defined process or procedure on provision of services by the radiology services department, including teleradiology, both during the day when the radiologist was onsite, and during "afterhours" when the digitally images were electronically sent to Contracted Services 1 for online review and reading, the Director Medical Imaging confirmed and verified there was none. The Director of Medical Imaging could not provide a policy and procedure for teleradiology during "after hours" for Contracted Services 1 of on-line review and readings.

During an interview with the Director Medical Imaging and the Lead Clerk Medical Imaging and a concurrent review of the on October 28, 2015 at 11:30 AM, Lead Clerk explained that Contracted Services 1 provided the facility radiologists, onsite Monday through Fridays from 7 AM, to 10 PM, and "after hours" online radiologists Monday through Friday from 10 PM to 7AM and on weekends.

During an interview with Regulatory Compliance and Licensing Specialist (RCLS) on October 28, 2015 at 4:35 PM, when asked for a documented evidence of a defined process or procedure on provision of services by the radiologic services department both during the day when the radiologist was onsite, and during "afterhours" when the digitally images were electronically sent to Contracted Services 1 for online review and reading, RCLS confirmed and verified there was none. RCLS explained, "It's all built in the contract."

There was no documented evidence of a written guideline or protocol on how radiologic services, including teleradiology (transmission of digital radiographic images from one location to another, for viewing and interpretation), would be provided between the facility and Contracted Services 1.

A review of the "ASSIGNMENT AND ASSUMPTION AGREEMENT AND CONSENT (Diagnostic and Interventional Radiology Agreement)," entered into by and between the facility and Contracted Services 1, revealed, "...ARTICLE II. GROUP'S OBLIGATIONS ...2.11 Compliance with Hospital Rules and Medical Staff Bylaws. Group shall comply and shall cause each Group Physician and Group Agent to comply, with the bylaws, rules, regulations, guidelines and policies and procedures of Hospital (the "Hospital Rules") and the bylaws, rules and regulations of the Medical Staff (the "Medical Staff Bylaws") applicable to Group, Group Physicians or Group Agents, the provision of the Services, or the obligations of Group under this Agreement, including, those Hospital Rules and medical Staff Bylaws applicable to patient relations, scheduling, billing, records, collections and other administrative matters related to the operation of the Department and/or the Hospital..."

During the meeting with the Quality Assessment and Performance Improvement committee on October 29/15 at 3 PM, the committee confirmed and verified there was no documented evidence of a defined process and procedure on provision of radiologic services, both by the facility and by the contracted services, to ensure what the facility had put in plan or had been implementing, were in place and were in compliance in the absence of a written guideline or protocol.
VIOLATION: QAPI Tag No: A0263
Based on interview, and record review, the hospital failed to ensure the Condition of Participation: CFR 482.21 Quality Assurance and Performance Improvement (QAPI) were met by failing to ensure the following:

1. Ensure surgical services were performed in accordance with the facilities policies and procedures and acceptable standards of practice when the physician failed to verify a missing surgical instrument on the x-ray ( A quick painless test that produces images of the structures inside the body) results. ( (Refer to A-0951)


2. The Governing Body (GB) and Medical Staff failed to ensure quality oversight of the hospitals's daily operations, and that they conducted in an effective, safe, and organized manner, for the management of patient care. (Refer to A-0049 and A-052).

3. Ensure there was a defined process and procedure on provision of radiologic services, including teleradiology (transmission of digital radiographic images from one location to another, for viewing and interpretation), by the facility. (Refer to A-0529).

4. Ensure Registered Nurses in labor and delivery do not deliver babies on their own without assistance of an Obstetrical Physician during the delivery process. This failure resulted in a situation of immediate jeopardy to patient safety on October 26, 2015. (refer to A-0049).

The cumulative effect of these systemic problems resulted in the failure of the hospital to deliver care in a safe setting in order to be in compliance with the Condition of Participation for Quality Assurance and Performance Improvement.
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on interview, and record review the facility failed to ensure that a Medical Doctor must be present during the delivery of babies of a pregnant patient and Delivery Registered Nurses do not deliver babies on their own without the assistance of an Obstetrical Physician being in charge during the delivery of the fetus as evidenced by:

1. Ensuring that a Medical Doctor must be present at all deliveries of a pregnant patient in the hospital who is actively participating in the delivery procedure.

2. Ensuring that Labor and delivery Registered Nurses were not delivering babies on their own without the assistance of an obstetrical physician during the delivery of the fetus.

These failures had the potential to affect the health and safety of all patients requiring Obstetrical services in the hospital, in a universe of 219 patients.

On October 26, 2015 at 8:45 PM, an Immediate Jeopardy (IJ) situation was declared in the presence of the facility's Administrator,Regulatory Compliance Licensing Specialist (RCLS), and Senior Director of Quality/Infection Control (SDOQIC) they were verbally notified of the facility's failure to ensure ensure that a Medical Doctor must be present during the delivery of babies of a pregnant patient and Delivery Registered Nurses do not deliver babies on their own without the assistance of an Obstetrical Physician/Medical Doctor being in charge during the delivery of the fetus..

Findings:

During an interview with the Registered Nurse (RN 2) on October 26, 2015 at 4:17 PM, when asked have you deliver babies without an obstetrical physician onsite, RN 2 stated,"All labor and delivery nurses deliver babies but the doctors are supposed to deliver the babies not us."

On October 26, 2015 at 5:45 PM, during a review of the declaration statement, by RN 2, explaining the incidents where Labor and Delivery Nurses were delivering babies on their own without the assistance of the Obstetrical Physician during the delivery process. RN 2 indicated "if physician is not at the bedside when placenta (An organ connects the developing baby provides oxygen and nurtrients to growing baby and removes waste products from the baby) delivers, the RN will deliver the placenta gently and start pitocin (medication used to induce labor) as usual fashion and monitor for excessive bleeding until MD arrives."

On October 26, 2015 at 5:48 PM,during a review of the declaration statement of Registered Nurse (RN 3), explaining the incident where Labor and Delivery Nurses were delivering babies on their own without the assistance of the Obstetrical Physician during the delivery process. RN 3 indicated,"if patient has an imminent delivery the physician on call is notified." The declaration statement also indicated, the Patient was delivered by RN, placenta remain intact until physician arrives unless it delivers spontaneously." The incident was written in a program called IVOS(incident reports)Nurses write when RN's deliver babies."

On October 26, 2015 at 5:50 PM during a review of the declaration statement of Registeted Nurse (RN 1), explaining the incident where Labor and Delivery Nurses were delivering babies on thier own without the assistance of the Obstetrical Physician during the delivery process. RN 1 indicated "I have delivered many babies without a physician onsite and the obstetrician physicians are not required to stay in the hospital while having patients on the floor and laboring." RN 1 also indicated she has had no training in delivering babies nor is delivering babies part of her job scope. Nurse deliveries are to be documented in a system called IVOS ( incident reports) and have been documented by all RN's and no course of action has ever been corrected. At times she has called the emergency department physicians to assist and have been denied due to constant no show of OB physicians. She indicated they give the doctors enough ample time to get to the hospital to do their deliveries.The RN 1 indicated She does not want to ever be responsible to deliver a baby. There are too many risk factors at hand that can jeopordize their license and the safety of the patients."

During an interview with the Director of Education (DOE) on October 26, 2015 at 6:05 PM, when reviewing training records for RN 2, RN3, and RN 4 the DOE confirmed that they did not have documented evidence regarding the training of L& D nurse's delivering babies without the assistance and on-site presence of a Obstetrical Physician/Medical Doctor.

During a review of the IVOS for Patient #10 dated Janurary 1, 2015 at 9:06 AM it indicated "NO doctor delivery. Patient delivered baby boy. MD called for delivery was informed that patient was lip and close to delivery per MD Order. MD called for delivery. MD stated she was five minutes out and delivery missed." Registered Nurse (RN 5) delivered the baby."

During a review of the IVOS for Patient #9 dated October 9, 2015 at 3:00 PM indicated "RN delivery, pt non-compliant, out of control. MD on OR(operating room) closing a c-section (is a surgical procedure in which one or more incisions are made through a mother's abdomen and uterus to deliver a baby). Pt had smoked heroin prior to arrival to hospital. Pt found smoking substance also in hospital bathroom during labor. Pt states it was heroin and flushed the rest down the toilet. Nurse manager, house supervisor, security, and social worker notified. Also called to CPS (children protective services). Unable to give report to them, too busy at this time. They are to call back." RN 3 delivered the baby."

On October 28, 2015, at 10:00 AM, the Immediate Jeopardy Situation was lifted in the presence of the Administrator, Regulatory Compliance Licensing Specialist (RCLS), and Senior Director Of Quality/ Infection Control (SDOQIC) when the facility's Corrective Action Plan was approved after observation, interview, and record review confirmed that the labor and delivery Registered Nurses were knowledgeable on preciptious (when delivery of baby lasts less than 3 hours or less) delivery unattended by physician. The corrective action plan included the following components:

1. The emergency department physician on duty will respond to requests for deliveries unattended by the Obstetrician (OB) physician both urgent and standard deliveries.

2. Investigate amending the OB physician emergency department call coverage agreement to include response in the event that an assigned patient's physician does respond timely.

3. The facility to evaluate implementation of a 24/7 laborist (An Obsterrician-gynecologist who is employed by the hospital whose primary role is to care for laboring patients manage obstetric emergencies program).

4. Education to Obstetrical (relating to the care and treatment of women in childbirth) staff in the event of failure to timely respond by assigned physician and/or on-call physician and procedures to follow.

5. Policy revised to clarify guidelines for precipitous deliveries.

The facility policy and procedure titled "Medical Staff Rules and Regulations"dated April 29, 2015, indicated " It is the policy of the hospital to provide on-call services for the following specialities"Gastroenterology, General Surgery, Internal Medicine, OB/GYN, Orthopedic Surgery, Pediatrics, Psychiatry, Radiology, Anesthesiology, and Urology. When an on-call physician consultation is requested, a phone response is expected within 30 minutes. Based on the phone consultation, an in person consultation will be arranged within an appropriate timeframe dependent upon the urgency of the patient's condition. It is appropriate to conclude a consultation by phone if the management is mutually agreeable by both the Emergency Department physician and the consultant. In the event that the on-call physician cannot respond because of situations beyond his or her control, the alternate covering physician will be contacted. An on-call physician may not refuse to respond to call from the Emergency Department physician and/ or refuse to examine or treat a patient on the basis of the patient's race, ethnicity, religion, national origin, citizenship, age, sex, pre-existing medical condition, physical or mental handicap, except to the extent that a circumstance such as age, sex, pre-existing condition or physician or mental handicap is medically significant to the provision of appropriate medical care to the patient; or the patient's health plan membership, insurance status, economic staturs or ability to pay."
VIOLATION: MEDICAL STAFF Tag No: A0338
Based on interview,and record review, the facility's Medical Staff failed to ensure that the facility's daily operation was conducted in an effective, safe, and organized manner as evidenced by a failure to:

1. Ensure that a Medical Doctor must be present during a delivery of a pregnant patient in the hospital that the labor and delivery Registered Nurses do not deliver babies on their own. (Refer to A-O309)

2. Ensure complete and accurate medical records for two of 31 sampled patients when the physician failed to document a full operative report for patients 20 and 22. (Refer to A-O353)


The cumulative effect of these systemic problems resulted in the failure of the hospital to deliver care in a safe setting and be in compliance with the Condition of Participation for Medical Staff.
VIOLATION: MEDICAL STAFF BYLAWS Tag No: A0353
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to ensure complete and accurate medical records for two of 31 sampled patients (Patients 20 and 22). This failure had the potential to result in lack of continuity in care, affecting the overall health and safety of the patients in a universe of 31 sampled patients.

Findings:

1. During a review of the medical record on October 29, 2015 at 7:35 AM, it revealed Patient 20 was admitted on [DATE].

A review of the "Operative Report" dated September 23, 2015 at 7:50 PM, revealed, "This is an anticipated document." There was no documented evidence of a full operative report.

During an interview with Health Information Management (HIM) Director and a concurrent review of Patient 20's medical record on October 29, 2015 at 7:35 AM, the HIM Director confirmed and verified that there was no documented evidence of a full operative report in Patient 20's medical record; it should have been completed and dictated by the surgeon immediately (24 hours) following Patient 20's surgical encounter on September 23, 2015 (37 days ago).

2. During a review of the medical records on October 29, 2015, it revealed Patient 22 was admitted to the facility on on [DATE].

A review of the "Operative Report" dated September 2, 2015 at 10:50 AM, revealed the operative report was dictated by the surgeon on September 26, 2015 (24 days after Patient 22's surgical encounter on September 2, 2015).

A review of the "Discharge Summary" dated September 2, 2015 at 12:21 PM, revealed, "This is an anticipated document."

During an interview with Health Information Management (HIM) Director and a concurrent review of Patient 22's medical record on October 29, 2015 at 8:50 AM, HIM Director confirmed and verified there was no documented evidence of a full operative report and discharge summary report in Patient 22's medical record. HIM Director stated the operative report should have been completed and dictated by the surgeon immediately (within 24 hours) after Patient 22's surgical encounter on September 2, 2015. HIM Director also stated the discharge summary should have been completed by the physician within 14 days of Patient 22's discharge.

When asked for the facility's policy and procedure on ensuring the operative report was completed accurately and timely, HIM Director stated it would be found in the Medical Staff rules and regulations.

A concurrent review of the "MEDICAL STAFF RULES AND REGULATIONS April 29, 2015, " revealed, "...B. MEDICAL RECORDS ...24. Operative reports must be dictated or written, authenticated, dated and timed by the surgeon immediately after completion of the surgical procedure and before the patient is transferred to the next level of care. When the operative report is not placed in the medical record immediately after surgery (for example, there is a transcription delay), a brief operative progress note is entered in the medical record immediately after surgery to provide pertinent information for any individual required to attend to the patient ... 27. At the time of discharge, the attending physician should record all relevant diagnoses, complications, and operative procedures performed, using acceptable disease and operative terminology; including topography and etiology where appropriate without abbreviations ... 35. A medical record will be considered complete when: ...b. A post-operative progress note is written in the medical record immediately following an operative procedure and a full operative report is written or dictated. Non-compliance will result in suspension; c. All records, including signatures, are to be completed within a period of time that in no event exceeds fourteen (14) days following discharge..."
VIOLATION: SCOPE OF RADIOLOGIC SERVICES Tag No: A0529
Based on interview, and record review, the facility failed to ensure there was a defined process and procedure on provision of radiologic services, including teleradiology (transmission of digital radiographic images from one location to another, for viewing and interpretation), both by the facility and by the contracted services. This failure had the potential to affect overall health and safety of the patients receiving radiologic services in a universe of 219 patients.


Findings:

On October 28, 2015, An inspection of the radiology department, and a concurrent interview and record review with the radiology department staff, were conducted in the presence of the Pharmacy Director.

During a concurrent interview with Radiology Manager (RM) on October 28, 2015 at 9 AM, when asked to describe the process of the provision of services in the radiology department, RM explained the "main" radiologist, Radiologist 1, was available in the facility Monday through Friday from 8am-5 PM. After 5 PM ("afterhours") when the onsite radiologist is gone, the digital images were electronically transmitted sent online (teleradiology) to a contracted service group (Contracted Service 1), for online review and reading. For radiology imaging ordered as "STATs" (urgent), the facility radiology technicians would call and notify Contracted Services 1 of such as soon as possible for online review and reading, while for routine radiology orders, Contracted Services 1 would see the radiology digital images online as the digital images were being electronically transmitted by the facility radiology technicians, for online review and reading.

During a concurrent interview with Director Medical Imaging on October 28, 2015, when asked for a documented evidence of a defined process or procedure on provision of services by the radiology services department, including teleradiology, both during the day when the radiologist was onsite, and during "afterhours" when the digitally images were electronically sent to Contracted Services 1 for online review and reading, Director Medical Imaging confirmed there was none.

During an interview with Director Medical Imaging and the Lead Clerk Medical Imaging and a concurrent review of the on October 28, 2015 at 11:30 AM, Lead Clerk explained that Contracted Services 1 provided the facility radiologists onsite Monday through Fridays from 7 AM to 10 PM, and "afterhours" online radiologists Monday through Friday from 10 PM to 7AM and on weekends.

During an interview with Regulatory Compliance and Licensing Specialist (RCLS) on October 28, 2015 at 4:35 PM, when asked for a documented evidence of a defined process or procedure on provision of services by the radiologic services department both during the day when the radiologist was onsite, and during "afterhours" when the digitally images were electronically sent to Contracted Services 1 for online review and reading, RCLS confirmed there was none. RCLS explained, "It's all built in the contract."

There was no documented evidence of a written guideline or protocol on how radiologic services, including teleradiology (transmission of digital radiographic images from one location to another, for viewing and interpretation), would be provided by the facility and Contracted Services 1.

A review of the "ASSIGNMENT AND ASSUMPTION AGREEMENT AND CONSENT (Diagnostic and Interventional Radiology Agreement)," entered into by and between the facility and Contracted Services 1, revealed, "...ARTICLE II. GROUP'S OBLIGATIONS ...2.11 Compliance with Hospital Rules and Medical Staff Bylaws. Group shall comply and shall cause each Group Physician and Group Agent to comply, with the bylaws, rules, regulations, guidelines and policies and procedures of Hospital (the "Hospital Rules") and the bylaws, rules and regulations of the Medical Staff (the "Medical Staff Bylaws") applicable to Group, Group Physicians or Group Agents, the provision of the Services, or the obligations of Group under this Agreement, including, those Hospital Rules and medical Staff Bylaws applicable to patient relations, scheduling, billing, records, collections and other administrative matters related to the operation of the Department and/or the Hospital..."

During the meeting with the Quality Assessment and Performance Improvement committee on October 29/15 at 3 PM, the committee confirmed there was no documented evidence of a defined process and procedure on provision of radiologic services, both by the facility and by the contracted services, to ensure what the facility had put in plan or had been implementing, were in place and were in compliance in the absence of a written guideline or protocol.