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5000 SAN BERNARDINO ST

MONTCLAIR, CA 91763

GOVERNING BODY

Tag No.: A0043

This CONDITION was not met as evidenced by: The hospital failed to ensure the Condition of Participation: CFR 482.12 Governing Body was met by failing to:

1. Identify lack of oversight and a defined process to ensure physicians, who were employed through a contracted service were licensed and qualified to provide the services. (Refer to A-0045, A-0083, A-0273, and A-0340)

2. Provide oversight and a defined process to ensure the confidentiality of the patients' clinical records from unauthorized individuals. (Refer to A-0057, A-0146, A-0273, and A-0441)

3. Ensure Medical Staff followed and were educated on facility policy and procedures related to massive obstetrical hemorrhage. (Refer to A-0063)

4. Ensure members of the Quality Assurance Performance Improvement Committee analyzed and investigated adverse events. (Refer to A-0286)

5. Ensure nursing staff reported change of condition status events according to facility policy and procedure. (Refer to A-0392)

6. Ensure nursing staff's documentation was complete and accurate. (Refer to A-0286 and A-0438)

7. Ensure nutritional screenings were completed per policy and procedure. (Refer to A-0450)

The cumulative effect of these systemic deficient practices resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation: Governing Body.

MEDICAL STAFF

Tag No.: A0045

Based on interview and record review, the Governing Body (GB) failed to identify the lack of oversight and or a defined process to ensure that eight out of 8 sampled physicians, who were providing services to the hospital through Contracted Service 1, were duly licensed and were qualified to provide the services.

This failure had the potential to result in physician's providing services without undergoing verification of license and qualification affecting patient's overall health and safety, in a universe of 55 patients.

Findings:

An interview with the Regional Medical Staff Director (RMSD) and the Medical Staff Coordinator (MSC) and a concurrent review of eight out of 8 sampled physicians (Physicians 5, 6, 7, 8, 9, 10, 11, and 12), under Contracted Service 1, were conducted on August 8, 2016 at 11 AM. The RMSD and the MSC confirmed that during an interview and a concurrent review of the eight sampled contracted physicians under Contracted Service 1 conducted on July 7, 2016 at 9:25 AM, there was no "file" (a folder or documentation of individuals education, experience etc.) maintained to show verification of the license and qualification of the contracted physicians. The RMSD stated, "We weren't running it because we didn't know it was in the contract." The RMSD and the MSC confirmed there was no oversight and a defined process to ensure that the physicians under Contracted Service 1, were verified as duly licensed and were qualified to provide the services, as stipulated on the contract.

A concurrent review of the "PROFESSIONAL SERVICES AGREEMENT," made and entered by the facility with Contracted Service 1 on August 1, 2010, was conducted with RMSD. It stipulated, "... Recitals: ... B. Hospital, at times, requires the services of a pediatric (pertains to medical care of infants, children and adolescents) cardiologists (pertains to doctors who treat the heart and the blood vessels) to read pediatric cardiology and echocardiogram (a test that uses sound waves to look at the structure of the heart) studies performed on its patients in order to assist the patient's treating physician in directing the care of the patient... AGREEMENT: ... 2. Professional Qualifications. Those physicians that provide the Services for Provider shall at all times be duly licensed to practice medicine in the State of California and be qualified to provide the Services."

During an interview with the RMSD and the MSC on August 8, 2016 at 11:50 AM, they presented copies of the "BreEZe" online verification (an online system that enables consumers to verify a professional license) dated July 13, 2016, for Physicians 5, 6, 7, 8, 9, 10, 11, and 12. The MSC confirmed these were ran after it was brought to their attention during a complaint investigation on July 7, 2016.

During a concurrent review of the copies of the "BreEZe" online verification, it revealed entries under "Survey Information." The document further revealed, "The following information is (in red letters) self-reported by the licensee and has not been verified by the Board." The information included, and not limited to, the physician's current training status, areas of practice, board certifications, AOA board certifications, postgraduate training years, and public record actions. The RMSD and the MSC confirmed the verification was just printed online and had not gone through the medical staff credentialing board and the GB board for review.

An interview with the Director of Cardiopulmonary (DC) was conducted on August 9, 2016 at 3:10 PM. The DC stated it was not his role but that of medical staff department to conduct verification of the contracted physicians' licenses and qualifications. The DC confirmed during an interview and a concurrent review of the contracted physicians' contract during the complaint investigation on July 7, 2016, there was no documented evidence of a "file" to show they were verified as licensed and qualified.

An interview with the representatives of the Governing Body (GB), attended by the Administrator and the Regional Administrator (RA), was conducted on August 10, 2016 at 9:15 AM. The Administrator stated she could not recall that the lack of oversight and of a defined process on the verification of the physicians under Contracted Service 1, was brought up during the GB meetings.

An interview with the RMSD and a concurrent review of the "Medical Staff Bylaws," Reviewed/Approved 9/29/2014, were conducted on August 11, 2016 at 1:15 PM. The RMSD confirmed the medical staff bylaws and the rules and regulations did not stipulate the oversight and the process on verification of the license and the qualification of the physicians who were under contracted services and non-contracted services.

The RMSD further confirmed there was no policy and procedure that had been reviewed and approved by the GB and that she had been waiting for the "2567" form (a statement of deficiencies) from the department to arrive.

During an interview on August 11, 2016 at 3:20 PM, the Administrator stated the process for "credentialing" (license verification, experience, qualifications) of the contracted physicians should have been the "same level" for both contracted and non-contracted physicians. The Administrator stated the GB oversaw the contracts, and each department should review their own contracts as well.

An interview with the Administrator and a concurrent review of the Contracted Services 1's "Annual Contract Service Evaluation Summary" dated November 2015, were conducted on August 11, 2016 at 3:45 PM. It revealed, "Scope/Nature of Service Provided by Contractor: physician viewing newborn echocardiograms." It further revealed under "Directions: Evaluate each aspect of the contract... 9. Have the Human Resources Requirements for Contract Service Personnel been met? 'NO' (was encircled)... 10 Have all requirements of the contract been met? 'NO' (was encircled)." It was signed and stamped by the Governing Board Approval as "APPROVED NOV (November) 30 2015." The administrator stated if during the evaluation the contract did not meet the criteria, the contract should have been reviewed further.

During a concurrent review of the facility's policy and procedure titled "Leases, Contracts and Agreements (Approval)," dated 07/15, the Administrator confirmed it did not stipulate a defined process on how to address whenever a contract did not meet the criteria during the evaluation.

CHIEF EXECUTIVE OFFICER

Tag No.: A0057

Based on interview and record review, the Governing Body (GB) failed to identify there was no oversight and a defined process to ensure the confidentiality of the patients' clinical records from unauthorized individuals, when six out of 6 sampled physicians who were no longer employed, continued to have access Software 1 (a software that contained the patients' clinical) .

This failure had the potential to result in unauthorized individuals having access to the patients' clinical records, in a universe of 55.

Findings:

A concurrent interview with the Regional Medical Staff Director (RMSD), the Regional IT Manager (RITM), the Information Technologist/Clinical Analyst (IT/CA), and the Medical Staff Coordinator (MSC) was conducted on August 8, 2016 at 2 PM. During the interview they confirmed there was no oversight and a defined process to ensure six out of 6 sampled physicians who were no longer employed, did not have access to the patients' clinical records in Software 1. The RSMD, RITM, IT/CA, and MSC confirmed the following:

A concurrent review of the "Monthly Updated Medical Staff Roster," from January 2016 to June 2016, had revealed a list of physicians who were no longer on staff due to "Voluntary resignation," as follows:

Physician 13 - effective May 31, 2016.

Physician 14 - effective February 29, 2016.

Physician 15 - effective January 25, 2016.

Physician 16 - effective March 25, 2016.

Physician 17 - effective November 30, 2015.

Physician 18 - effective April 25, 2016.

A review of the copies of the "MIS Provider Dictionary" revealed, Physicians 13, 14, 15, 16, and 17 continued to have access to Software 1 up to July 6, 2016 (the initial date of discovery). The IT/CA confirmed the physicians continued to remain "active" and to have access to Software 1. The IT/CA stated, the "provider type" status for these physicians should have been changed to "NOL" which meant "No Longer On Staff."

It was confirmed during an initial interview on July 6, 2016 at 3:50 PM, when asked what the facility's process was to ensure the physicians who were no longer employed, had no access to the patients' clinical records, the RMSD and MSC stated the IT (Information Technology) department would terminate the physician's access. The IT/CA stated their role was only to "build initial access" for the physicians and terminating the physician's access would be by the medical staff department. The RIHMD stated their role was to ensure the "suspended" physicians were not admitting new patients until they are in compliance with their deficiencies with medical records. The RMSD and MSC stated whenever a physician was no longer on staff, MSC would update the medical staff system to reflect the physician's status; however, they just now found out during the complaint investigation that the medical staff system "did not interface" with the IT's system thus, the physician continued to remain "active" and to have access to Software 1. The RMSD then stated, "We got a glitch; we need to come up with a system." The RMSD further stated there was a need to have a "physical double check on both sides; can't assume it went though."

The RMSD confirmed there was no defined process nor was there a policy and procedure that had been reviewed and approved by the GB to address the process of ensuring physicians who were no longer on staff, did not have access to the patients' clinical records. The RMSD stated the oversight to ensure the process was implemented "falls on medical staff."

An interview with the Administrator and the Regional Administrator (RA) members of the GB, was conducted on August 10, 2016 at 9:15 AM. The Administrator stated she could not recall if the topic of a lack of oversight or a defined process to ensure the physicians who were no longer on staff, did not have access to the patients' clinical record, was discussed at any of the GB meetings.

A review of the facility's policy and procedure titled "Confidentiality/Privacy," dated 5/13, stipulated, "PURPOSE: 1. To protect the patient's right to privacy and confidentiality pursuant to Health Insurance Portability and Accountability Act (HIPAA) and other privacy laws... I. A PATIENT'S RIGHT TO CONFIDENTIALITY... POLICY: It is the policy of the Medical Center to protect a patient's right to privacy and confidentiality, in accordance with applicable state and federal laws... E. have/his medical record read only by individuals directly involved with his/her treatment or the monitoring of the quality thereof, or by other individuals only upon his/her written authorization or that of his/her legally-authorized representative; F. expect that all communications and other records pertaining to his/her care, including the source of payment or treatment to be rendered, be treated confidentially; .. II. ACCESS AND RELEASE OF MEDICAL RECORDS... PROCEDURE: 1. Principles of Confidentiality: A. All Hospital personnel are responsible for controlling and enforcing confidentiality regarding the information contained in each medical record processed or filed by the Hospital... G. The computer access codes are considered to be confidential and, as such, are protected in the same manner as patient information. H. DHMCM personnel will safeguard the medical record against loss, defacement, tampering, use by unauthorized persons, and damage by fire or water..."

A review of the facility's policy and procedure titled "Patient Rights and Responsibilities," reviewed 6/11, stipulated, "...Addendum A Patient Bill of Rights... You have the right to:... 13. The right to the confidentiality of his or her clinical records [482.13 (d)(1)]. The right to confidential treatment of all communications and records pertaining to your care and stay in the hospital..."

CARE OF PATIENTS

Tag No.: A0063

Based on interview and record review, the Governing Body failed to ensure physicians provided care as outlined in the facility's policy and procedure "Massive Obstetric Hemorrhage." This failure created the potential for harm for 1 of 30 sampled patients (Patients 2) who hemorrhaged after giving birth, creating the potential for harm and death.

Findings:

Record review conducted on August 8, 2016, revealed Patient 2 presented to the hospital on July 2, 2016 at 4:50 AM, 36-3/7 weeks pregnant, in labor with a spontaneous rupture of membranes. Patient 2 was taken to the operating room (OR) at 5:36 AM and underwent a Caesarean section (C-section) delivering twins at approximately 6:05 AM and 6:06 AM.

Following the delivery of twins, Patient 2 developed a massive obstetric hemorrhage and became hypotensive (low {BP} blood pressure). Patient 2's BP dropped to a low of 81/55 and was transferred from the PACU (post anesthesia care unit)to the ICU (intensive care unit). Patient 2 returned to the OR on July 2, 2016, for a hysterectomy in hopes of stopping the hemorrhage. Patient 2 expired (died) on July 4, 2016 at 8:25 AM, leaving behind a spouse, a three year old child and two day old twins.

A review of the facility's "Massive Obstetric Hemorrhage," policy and procedure (P & P) dated September 2013, under the "Purpose" section, documentation revealed:

"To aid in the medical and nursing management of the patient experiencing, or at increase risk of, Obstetric Hemorrhage. Obstetric hemorrhage is a frequent cause of maternal morbidity and mortality...."

Further review of the P & P under the "Recognize Risk Factors" section revealed the following:

"I. All patients admitted to Labor and Delivery should be evaluated for their risk category:"

On August 8, 2016 at 1:40 PM during an interview with the Chief Nursing Officer (CNO), the CNO stated according to the "Massive Obstetric Hemorrhage P & P, at the time of Patient 2's admission, she was a "Level II due to current multiple gestation.

Continued review of the "Massive Obstetric Hemorrhage," documentation confirmed Patient 2 was a "Level II: Moderate Risk" due to:

"4. Current Multiple gestation"

A review of the "Level 2/Stage 2" revealed the following under "III. Patient Intervention:

G. Order Labs - DIC (disseminated intravascular coagulation-normal clotting is disrupted and severe bleeding can occur) panel (CBC {complete blood count}, PT {prothrombin time}, PTT {partial thromboplast time}, INR {international normalized ratio}, Fibrinogen)

A review of the "Surgical Case Record" dated July 2, 2016 in the "Operative Outputs" section, revealed at 6:42 AM, Patient 2 had an "Estimated Blood Loss (EBL)" totaling 1000 milliters (ml).

A review of the PACU (post anesthesia care unit) "Phase I Outputs" revealed the following:

July 2, 2016 at 6:55 AM, EBL-VAG (vaginal) 300 ml
July 2, 2016 at 7:10 AM, EBL-VAG 300 ml
July 2, 2016 at 7:30 AM, EBL-VAG 300 ml
July 2, 2016 at 7:50 AM, EBL-VAG 300 ml

Totaling 1200 ml

Documentation revealed Patient 2 experienced a total EBL of 2200 ml within 1 hour and 8 minutes.

Further review of the "Massive Obstetric Hemorrhage" P & P in the "Level 2/Stage 2" section documentation revealed:

"IT IS IMPORTANT TO STOP AND REASSESS THE PATIENTS EBL AND VITAL SIGNS
*IF EBL IS > (greater than) 1500 ml
OR
*COAGULOPATHY IS SUSPECTED
OR
*VITAL SIGNS ARE ABNORMAL

Patients should be moved to Stage 3: Significant Persistent Maternal Hemorrhage

Patient should be moved to the OR (operating room) or ICU (intensive care unit)"

A review of the "Stage 3: Modified Postpartum Care" section revealed the following

"C. Labs CBC and DIC panel @ (at) 1, 2, 4, and 6 hours"

A review of physician orders, revealed an order from Physician 1, dated July 2, 2016 at 7:36 AM for the following labs to be done on Patient 2:
PTT, PT, Fibrinogen and D-Dimer.

On August 8, 2016 at 1:35 PM, an interview was conducted with the CNO who clarified that the request lab work ordered by Physician 1 was not drawn and it was communicated to laboratory personnel to use the blood collected at the time of the patient's admission.

On August 9, 2016 at 1:23 PM, an interview was conducted with Physician 1. Physician 1 was asked if he was aware that the lab work he ordered when the patient was in the PACU was not done and the labs were run using the blood collected a the time of the patient's admission. Physician 1 stated, "No it would be inaccurate." Physician 1 confirmed no other labs were ordered on Patient 2 until after the patient returned to the ICU following her return to the OR for a hysterectomy.

No documented evidence could be located that any blood work was collected from Patient 2 on July 2, 2016 from 5:10 AM to 12:15 PM.

On August 9, 2016 at 1:45 PM, an interview was conducted with Physician 3. Physician 3 was asked if he was aware of the "Massive Obstetric Hemorrhage" P & P. Physician 3 responded, "No."

CONTRACTED SERVICES

Tag No.: A0083

Based on interview and record review, the Governing Body (GB) failed to ensure services performed under contract are provided in safe and effective manner when,there was no oversight and a defined process to ensure the eight out of 8 sampled physicians, who were under contracted services (Contracted Service 1), were verified as duly licensed and were qualified to provide the services.

This failure had the potential to result in physician providing services without undergoing verification of license and qualification that may affect patient's overall health and safety, in a universe of 55 patients.

Findings:

An interview with the Regional Medical Staff Director (RMSD) and the Medical Staff Coordinator (MSC) and a concurrent review of eight out of 8 sampled physicians (Physicians 5, 6, 7, 8, 9, 10, 11, and 12), under Contracted Service 1, were conducted on August 8, 2016 at 11 AM. The RMSD and the MSC confirmed that during an interview and a concurrent review of the contracted physicians under Contracted Service 1 conducted on July 7, 2016 at 9:25 AM, there was no "file" maintained to show verification of the license and qualification of the contracted physicians. The RMSD stated, "We weren't running it because we didn't know it was in the contract." The RMSD and the MSC confirmed there was no oversight and a defined process to ensure verification that the physicians under Contracted Service 1, were duly licensed and were qualified to provide the services, as stipulated on the contract.

A concurrent review of the "PROFESSIONAL SERVICES AGREEMENT," made and entered by the facility with Contracted Services 1 on August 1, 2010, was conducted. It stipulated, "... Recitals:... B. Hospital, at times, requires the services of a pediatric (pertains to medical care of infants, children and adolescents) cardiologists (pertains to doctors who treat the heart and the blood vessels) to read pediatric cardiology and echocardiogram (a test that uses sound waves to look at the structure of the heart) studies performed on its patients in order to assist the patient's treating physician in directing the care of the patient... AGREEMENT: ... 2. Professional Qualifications. Those physicians that provide the Services for Provider shall at all times be duly licensed to practice medicine in the State of California and be qualified to provide the Services."

During an interview with the RMSD and the MSC on August 8, 2016 at 11:50 AM, they presented copies of the "BreEZe" online verification (an online system that enables consumers to verify a professional license), dated July 13, 2016, for Physicians 5, 6, 7, 8, 9, 10, 11, and 12. The MSC confirmed these were ran after it was brought to their attention during a complaint investigation on July 7, 2016.

During a concurrent review of the copies of the "BreEZe" online verification, it revealed entries under "Survey Information." The document further revealed, "The following information is (in red letters) self-reported by the licensee and has not been verified by the Board." The information included, and not limited to, the physician's current training status, areas of practice, board certifications, AOA board certifications, postgraduate training years, and public record actions. The RMSD and the MSC confirmed the verification was just printed online and had not gone through the medical staff credentialing board and the GB board for review.

An interview with the Director of Cardiopulmonary (DC) was conducted on August 9, 2016 at 3:10 PM. The DC stated it was not his role but that of medical staff department to conduct verification of the contracted physicians' license and qualifications. The DC confirmed during an interview and a concurrent review of the contracted physicians' contract during the complaint investigation on July 7, 2016, there was no documented evidence of a "file" to show they were verified as duly licensed and were qualified to provide the services.

An interview with the representatives of the Governing Body (GB), attended by the Administrator and the Regional Administrator (RA), was conducted on August 10, 2016 at 9:15 AM. The Administrator stated she could not recall that the lack of oversight and of a defined process on the verification of the cardiologists under Contracted Service 1, was brought up during the GB meetings.

An interview with the RMSD and a concurrent review of the "Medical Staff Bylaws," Reviewed/Approved 9/29/2014, were conducted on August 11, 2016 at 1:15 PM. The RMSD confirmed the medical staff bylaws and the rules and regulations did not stipulate the oversight and the process on verification of the license and the qualification of the physicians who were under contracted services and non-contracted services. The RMSD further confirmed there was no policy and procedure that has been reviewed and approved by the GB and that she had been waiting for the "2567" form (a statement of deficiencies) to arrive.

During an interview on August 11, 2016 at 3:20 PM, the Administrator stated the process for "credentialing" (license verification, experience, qualifications) of the contracted physicians should have been the "same level" for both contracted and non-contracted physicians. The Administrator stated the GB oversaw the contracts, and each department should review their own contracts as well.

An interview with the Administrator and a concurrent review of the Contracted Services 1's "Annual Contract Service Evaluation Summary" dated November 2015, were conducted on August 11, 2016 at 3:45 PM. It revealed, "Scope/Nature of Service Provided by Contractor: physician viewing newborn echocardiograms." It further revealed under "Directions: Evaluate each aspect of the contract... 9. Have the Human Resources Requirements for Contract Service Personnel been met? 'NO' (was encircled)... 10 Have all requirements of the contract been met? 'NO' (was encircled)." It was signed and stamped by the Governing Board Approval as "APPROVED NOV (November) 30 2015." The administrator stated if during the evaluation the contract did not meet the criteria, the contract should have been reviewed further.

During a concurrent review of the facility's policy and procedure titled "Leases, Contracts and Agreements (Approval)," dated 07/15, the Administrator confirmed it did not stipulate a defined process on how to address whenever a contract did not meet the criteria during the evaluation.

PATIENT RIGHTS

Tag No.: A0115

This CONDITION was not met as evidenced by: The hospital failed to ensure the Condition of Participation: CFR 482.13 Patient Rights was met by failing to:

1. Provide oversight and a defined process to ensure the confidentiality of the patients' clinical records from unauthorized individuals. A-0146)

The cumulative effect of this systemic deficient practice resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation: Patient Rights.

PATIENT RIGHTS: CONFIDENTIALITY OF RECORDS

Tag No.: A0146

Based on interview and record review, the facility failed to ensure the confidentiality of the patients' clinical records from unauthorized individuals, when six out of 6 sampled physicians who were no longer employed, continued to have access to the patients' clinical records.

This failure had the potential to result in unauthorized individuals having access to the patients' clinical records, in a universe of 55 patients.

Findings:

A concurrent interview with the Regional Medical Staff Director (RMSD), the Regional IT Manager (RITM), the Information Technologist/Clinical Analyst (IT/CA), and the Medical Staff Coordinator (MSC) was conducted on August 8, 2016 at 2 PM. They confirmed during a concurrent interview with RMSD, RITM, IT/CA, MSC, and RHIMD conducted on July 6, 2016, there was no oversight and a defined process to ensure six out of 6 sampled physicians who were no longer employed, did not have access to the patients' clinical records to Software 1 (a computer software that contained the patients' clinical records). The RSMD, RITM, IT/CA, and MSC confirmed the following interview and concurrent review of records during the complaint investigation on July 6, 2016 as follows:

A concurrent review of the "Monthly Updated Medical Staff Roster," from January 2016 to June 2016, had revealed a list of physicians who were no longer on staff due to "Voluntary resignation," as follows:

Physician 13 - effective May 31, 2016.

Physician 14 - effective February 29, 2016.

Physician 15 - effective January 25, 2016.

Physician 16 - effective March 25, 2016.

Physician 17 - effective November 30, 2015.

Physician 18 - effective April 25, 2016.

A concurrent review of the copies of the "MIS Provider Dictionary" on July 6, 2016, revealed, Physicians 13, 14, 15, 16, and 17 continued to have access to Software 1 as of July 6, 2016. The IT/CA confirmed the physicians continued to remain "active" and to have access to Software 1. The IT/CA stated, the "provider type" status for these physicians should have been changed to "NOL" which meant "No Longer On Staff."

On August 8,, 2015 at 2 PM, when asked what the facility's process was to ensure the physicians who were no longer employed, had no access to the patients' clinical records, the RMSD and MSC stated the IT (Information Technology) department would terminate the physician's access. The IT/CA stated their role was only to"build initial access" to Software 1 for the physicians and terminating the physician's access would be done by the medical staff department. The RIHMD stated their role was to ensure the "suspended" physicians were not admitting new patients until they are in compliance with their deficiencies with medical records. The RMSD and MSC stated whenever a physician was no longer on staff, MSC would update the medical staff system to reflect the physician's status; however, they just now found out during the complaint investigation that the medical staff system did not "interface" with the IT's system thus, the physician continued to remain "active" and to have access to Software 1. The RMSD then stated, "We got a glitch; we need to come up with a system." The RMSD further stated there was a need to have a "physical double checks on both sides; can't assume it went though." The RMSD confirmed there was no defined process nor was there a policy and procedure that had been reviewed and approved by the GB to address the process of ensuring physicians who were no longer on staff, did not have access to the patients' clinical records. The RMSD stated the oversight to ensure the process was implemented "falls on medical staff."

A review of the facility's policy and procedure titled "Confidentiality/Privacy," dated 5/13, stipulated, "PURPOSE: 1. To protect the patient's right to privacy and confidentiality pursuant to Health Insurance Portability and Accountability Act (HIPAA) and other privacy laws... I. A PATIENT'S RIGHT TO CONFIDENTIALITY... POLICY: It is the policy of the Medical Center to protect a patient's right to privacy and confidentiality, in accordance with applicable state and federal laws... E. have/his medical record read only by individuals directly involved with his/her treatment or the monitoring of the quality thereof, or by other individuals only upon his/her written authorization or that of his/her legally-authorized representative; F. expect that all communications and other records pertaining to his/her care, including the source of payment or treatment to be rendered, be treated confidentially; .. II. ACCESS AND RELEASE OF MEDICAL RECORDS... PROCEDURE: 1. Principles of Confidentiality: A. All Hospital personnel are responsible for controlling and enforcing confidentiality regarding the information contained in each medical record processed or filed by the Hospital... G. The computer access codes are considered to be confidential and, as such, are protected in the same manner as patient information. H. DHMCM personnel will safeguard the medical record against loss, defacement, tampering, use by unauthorized persons, and damage by fire or water..."

A review of the facility's policy and procedure titled "Patient Rights and Responsibilities," reviewed 6/11, stipulated, "...Addendum A Patient Bill of Rights ... You have the right to:... 13. The right to the confidentiality of his or her clinical records [482.13 (d)(1)]. The right to confidential treatment of all communications and records pertaining to your care and stay in the hospital."

QAPI

Tag No.: A0263

This CONDITION was not met as evidenced by: The hospital failed to ensure the Condition of Participation: CFR 482.21 QAPI was met by failing to:

1. Identify lack of oversight and a defined process to ensure physicians, who were employed through a contracted service were licensed and qualified to provide the services. (Refer to A-0273)

2. Provide oversight and a defined process to ensure the confidentiality of the patients' clinical records from unauthorized individuals. (Refer to A-0273)

3. Ensure licensed staff notified the physician when a change of condition occurred. (Refer to A-0286)

4. Ensure medical records were complete and accurate regarding the monitoring and reporting of a patient's change in condition. (Refer to A-0286)

The cumulative effect of these systemic deficient practices resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation: QAPI.

DATA COLLECTION & ANALYSIS

Tag No.: A0273

Based on interview and record review, the facility failed to identify:

1. There was no oversight and a defined process to ensure the eight out of 8 sampled physicians, who were under contracted services (Contracted Service 1), were verified to be duly licensed and were qualified to provide the services.

This failure had the potential to result in physician providing services without undergoing verification of license and qualification that may affect patient's overall health and safety, in a universe of 55 Patients.

2. There was no oversight and a defined process to ensure the confidentiality of the patients' clinical records from unauthorized individuals, when six out of 6 sampled physicians who were no longer employed, continued to have access to the patients' clinical records.

This failure had the potential to result in unauthorized individuals having access to or altering patients' clinical records, in a universe of 55 Patients.

Findings:

1. An interview with the Regional Medical Staff Director (RMSD) and the Medical Staff Coordinator (MSC) and a concurrent review of eight out of 8 sampled physicians (Physicians 5, 6, 7, 8, 9, 10, 11, and 12), under Contracted Services 1, were conducted on August 8, 2016 at 11 AM. The RMSD and the MSC confirmed that during an interview and a concurrent review of the contracted physicians under Contracted Service 1 conducted on July 7, 2016 at 9:25 AM, there was no "file" (a folder or documentation of individuals education, experience etc.) maintained to show verification of the license and qualification of the contracted physicians. The RMSD stated, "We weren't running it because we didn't know it was in the contract." The RMSD and the MSC confirmed there was no oversight and a defined process to ensure verification that the physicians under Contracted Service 1, were verified to be duly licensed and were qualified to provide the services, as stipulated on the contract.

A concurrent review of the "PROFESSIONAL SERVICES AGREEMENT," made and entered by the facility with Contracted Services 1 on August 1, 2010, was conducted. It stipulated, "... Recitals:... B. Hospital, at times, requires the services of a pediatric (pertains to medical care of infants, children and adolescents) cardiologists (pertains to doctors who treat the heart and the blood vessels) to read pediatric cardiology and echocardiogram (a test that uses sound waves to look at the structure of the heart) studies performed on its patients in order to assist the patient's treating physician in directing the care of the patient... AGREEMENT:... 2. Professional Qualifications. Those physicians that provide the Services for Provider shall at all times be duly licensed to practice medicine in the State of California and be qualified to provide the Services."

During an interview with the RMSD and the MSC on August 8, 2016 at 11:50 AM, they presented copies of the "BreEZe" online verification (an online system that enables consumers to verify a professional license), dated July 13, 2016, for Physicians 5, 6, 7, 8, 9, 10, 11, and 12. The MSC confirmed these were ran after it was brought to their attention during a complaint investigation on July 7, 2016.

During a concurrent review of the copies of the "BreEZe" online verification, it revealed entries under "Survey Information." The document further revealed, "The following information is (in red letters) self-reported by the licensee and has not been verified by the Board." The information included, and not limited to, the physician's current training status, areas of practice, board certifications, AOA board certifications, postgraduate training years, and public record actions. The RMSD and the MSC confirmed the verification was just printed online and had not gone through the medical staff credentialing board and the GB board for review.

An interview with the Director of Cardiopulmonary (DC) was conducted on August 9, 2016 at 3:10 PM. The DC stated it was not his role but that of medical staff department to conduct verification of the contracted physicians' license and qualifications. The DC confirmed during an interview and a concurrent review of the contracted physicians' contract during the complaint investigation on July 7, 2016, there was no documented evidence of a "file" to show they were verified as duly licensed and were qualified to provide the services.

A Quality Assurance and Performance Improvement (QAPI) committee meeting was conducted on August 10, 2016 at 10:25 AM. During the meeting, the MSC confirmed the lack of oversight and of a defined process on the verification of the physicians under Contracted Service 1, was not identified by QAPI committee the until it was brought to their attention during a complaint investigation on July 10, 2016.

An interview with the RMSD and a concurrent review of the "Medical Staff Bylaws," Reviewed/Approved 9/29/2014, were conducted on August 11, 2016 at 1:15 PM. The RMSD confirmed the medical staff bylaws and the rules and regulations did not stipulate the oversight and the process on verification of the license and the qualification of the physicians who were under contracted services and non-contracted services. The RMSD further confirmed there was no policy and procedure that has been reviewed and approved by the GB and that she had been waiting for the "2567" form (a statement of deficiencies) to arrive.

During an interview on August 11, 2016 at 3:20 PM, the Administrator stated the process for "credentialing" of the contracted physicians should have been the "same level" for both contracted and non-contracted physicians. The Administrator stated the GB oversaw the contracts, and each department should review their own contracts as well.

2. A concurrent interview with the Regional Medical Staff Director (RMSD), the Regional IT Manager (RITM), the Information Technologist/Clinical Analyst (IT/CA), and the Medical Staff Coordinator (MSC) was conducted on August 8, 2016 at 2 PM. They confirmed during a concurrent interview with RMSD, RITM, IT/CA, MSC, and RHIMD conducted on July 6, 2016, there was no oversight and a defined process to ensure six out of 6 sampled physicians who were no longer employed, did not have access to the patients' clinical records to Software 1 (a computer software that contained the patients' clinical records). The RSMD, RITM, IT/CA, and MSC confirmed the following interview and concurrent review of records during the complaint investigation on July 6, 2016 as follows:

A concurrent review of the "Monthly Updated Medical Staff Roster," from January 2016 to June 2016, had revealed a list of physicians who were no longer on staff due to "Voluntary resignation," as follows:

Physician 13 - effective May 31, 2016.

Physician 14 - effective February 29, 2016.

Physician 15 - effective January 25, 2016.

Physician 16 - effective March 25, 2016.

Physician 17 - effective November 30, 2015.

Physician 18 - effective April 25, 2016.

A concurrent review of the copies of the "MIS Provider Dictionary" on July 6, 2016, revealed, Physicians 13, 14, 15, 16, and 17 continued to have access to Software 1 as of July 6, 2016. The IT/CA confirmed the physicians continued to remain "active" and to have access to Software 1. The IT/CA stated, the "provider type" status for these physicians should have been changed to "NOL" which meant "No Longer On Staff."

During the concurrent interview on July 6, 2016 at 3:50 PM, when asked what the facility's process was to ensure the physicians who were no longer employed, had no access to the patients' clinical records, the RMSD and MSC stated the IT (Information Technology) department would terminate the physician's access to Software 1. The IT/CA stated their role was only to "build initial access" to Software 1 for the physicians and terminating the physician's access would be done by the medical staff department. The RIHMD stated their role was to ensure the "suspended" physicians were not admitting new patients until they are in compliance with their deficiencies with medical records. The RMSD and MSC stated whenever a physician was no longer on staff, MSC would update the medical staff system to reflect the physician's status; however, they just now found out during the complaint investigation that the medical staff system "did not interface" with the IT's system thus, the physician continued to remain "active" and to have access to Software 1. The RMSD then stated, "We got a glitch; we need to come up with a system." The RMSD further stated there was a need to have a "physical double checks on both sides; can't assume it went though." The RMSD confirmed there was no defined process nor was there a policy and procedure that had been reviewed and approved by the GB to address the process of ensuring physicians who were no longer on staff, did not have access to the patients' clinical records. The RMSD stated the oversight to ensure the process was implemented "falls on medical staff."

A Quality Assurance and Performance Improvement (QAPI) committee meeting was conducted on August 10, 2016 at 10:25 AM. During the meeting, the MSC confirmed the lack of oversight and of a defined process to ensure the physicians who were no longer on staff, did not have access to the patients' clinical records, was not identified by QAPI committee the until it was brought to their attention during a complaint investigation conducted on July 10, 2016.

A review of the facility's policy and procedure titled "Confidentiality/Privacy," dated 5/13, stipulated, "PURPOSE: 1. To protect the patient's right to privacy and confidentiality pursuant to Health Insurance Portability and Accountability Act (HIPAA) and other privacy laws... I. A PATIENT'S RIGHT TO CONFIDENTIALITY... POLICY: It is the policy of the Medical Center to protect a patient's right to privacy and confidentiality, in accordance with applicable state and federal laws ... E. have/his medical record read only by individuals directly involved with his/her treatment or the monitoring of the quality thereof, or by other individuals only upon his/her written authorization or that of his/her legally-authorized representative; F. expect that all communications and other records pertaining to his/her care, including the source of payment or treatment to be rendered, be treated confidentially; .. II. ACCESS AND RELEASE OF MEDICAL RECORDS... PROCEDURE: 1. Principles of Confidentiality: A. All Hospital personnel are responsible for controlling and enforcing confidentiality regarding the information contained in each medical record processed or filed by the Hospital... G. The computer access codes are considered to be confidential and, as such, are protected in the same manner as patient information. H. DHMCM personnel will safeguard the medical record against loss, defacement, tampering, use by unauthorized persons, and damage by fire or water..."

A review of the facility's policy and procedure titled "Patient Rights and Responsibilities," reviewed 6/11, stipulated, "...Addendum A Patient Bill of Rights ... You have the right to:... 13. The right to the confidentiality of his or her clinical records [482.13 (d)(1)]. The right to confidential treatment of all communications and records pertaining to your care and stay in the hospital."

PATIENT SAFETY

Tag No.: A0286

Based on interview and record review, the hospital's Quality Assessment and Performance Improvement (QAPI) committee, during a root cause analysis meeting regarding the care of one of 30 sampled patients (Patient 2) failed to identify the following:

1. The lack of blood pressures were not reported to the physician.

2. The facility's "Massive Obstetric Hemorrhage" policy and procedure was not followed.

3. Lab work ordered by Patient 2's physician, was not collected as ordered.

These failures created the potential for patients to receive poor quality health care services, which may have contributed to the death of Patient 2.

Findings:

1. Record review conducted on August 8, 2016, revealed Patient 2 presented to the hospital on July 2, 2016 at 4:50 AM, 36-3/7 weeks pregnant, in labor with a spontaneous rupture of membranes. Patient 2 was taken to the operating room (OR) at 5:36 AM and underwent a Caesarean section (C-section) delivering twins at approximately 6:05 AM and 6:06 AM. Patient 2 expired (died) on July 4, 2016 at 8:25 AM.

Following the delivery of twins, Patient 2 developed a massive obstetric hemorrhage and was transferred from the PACU (post anesthesia care unit)to the ICU (intensive care unit). Patient 2 returned to the OR on July 2, 2016, for a hysterectomy in hopes of stopping the hemorrhage.

Following Patient 2's return to ICU following her hysterectomy, Patient 2 required Q (every) 15 minute vital signs, due to her critical status and having continuous intravenous (IV) medications for blood pressure management.

A review of Registered Nurse (RN) 3's nursing notes revealed Patient 2 did not have a documented BP on July 2, 2016 from 12:45 PM to 1:15 PM. No documentation could be located that any of Patient 2's physician's were made aware that the patient had no BP.

Further review of RN 3's nursing notes for July 2, 2016 revealed no documented BP for the following times:

3 PM
3:15 PM
3:45 PM
4 PM
4:45 PM
5:15 PM
5:30 PM
6 PM
6:15 PM
6:30 PM

On August 9, 2016 at 1:40 PM, an interview was conducted with Physician 3. Physician 3 was asked if nursing staff informed him that they were not able to obtain a blood pressure at times and that at times the patient had no blood pressure for hours, Physician 3 stated he was aware that the patient's blood pressure was low and stated he was "Not aware of no blood pressures."

A review of the facility's policy and procedure (P & P) titled "Notification of Physician for Unusual Events or Change in Conditions," dated September 2013, under the "Policy" section revealed the following:

"All changes in patient's condition will be reported by a licensed nurse to the admitting or consulting physician in a timely fashion.

This includes:

1. Abnormal labs/diagnostic reports
2. Changes in vital signs
3. New onset of complaints
4. Worsening signs and symptoms
5. Deterioration of condition
6. All life threatening situations
7. Patient death"

A review of RN 5's nursing notes revealed no documented BP for the following times:

8:45 PM
9:15 PM
10 PM
5:15 AM
6 AM
6:30 AM

No documentation could be located to indicate if any of Patient 2's physician's were made aware that the patient had no BP.

A review of RN 3's nursing notes for July 3, 2016 revealed no documented BP for the following times:

8:15 AM
8:30 AM
9:30 AM

Nursing notes dated July 3, 2016 at 10:08 AM by RN 3, revealed "Low BP noted. MD aware." No documentation could be located to indicate if the physician was made aware that the patient had no BP.

Nursing notes documented by RN 3, dated July 3, 2016 at 11:35 AM, revealed "Machine unable to obtain BP. MD aware." Additional documentation revealed "Physician 3 aware of the BP not registering on the monitor."

On July 3, 2016 at 12:05 PM and 12:15 PM, RN 3's nursing notes revealed Physician 3 aware of low BP status. No documentation could be located to indicate if the physician was made aware that the patient had no BP.

Continued review of RN 3's nursing notes for July 3, 2016 revealed no documented BP for the following times:

12:30 PM
12:45 PM
1 PM
1:30 PM
1:45 PM
2 PM
2:15 PM

On July 3, 2016 at 2:55 PM and 3:05 PM, RN 3's nursing notes revealed Physician 3 aware of low BP status. No documentation could be located to indicate if the physician was made aware that the patient had no BP.

Continued review of RN 3's nursing notes for July 3, 2016 revealed no documented BP for the following times:

3 PM
3:15 PM

On July 3, 2016 at 3:20 PM, RN 3's nursing notes revealed Physician 3 aware of low BP status. No documentation could be located to indicate if the physician was made aware that the patient had no BP.

Continued review of RN 3's nursing notes for July 3, 2016 revealed no documented BP for the following times:

3:30 PM
3:45 PM

On July 3, 2016 at 4 PM, RN 3's nursing notes revealed Physician 3 aware of low BP status. No documentation could be located to indicate if the physician was made aware that the patient had no BP.

A review of nursing notes for July 3, 2016 revealed no documented BP for the following times:

4:15 PM
4:30 PM
4:45 PM
5 PM
5:15 PM
5:30 PM
5:45 PM
6 PM
6:15 PM
6:30 PM

Documentation by RN 3, dated July 3, 2016 at 5:05 PM, revealed "Physician 3 aware of BP not registering on the monitor." BP cuff switched. "BP still not registering on monitor." Documentation at 5:15 PM revealed "BP still not registering on the monitor." Documentation at 5:40 PM revealed "BP still not registering on the monitor." BP cuff switched.

A review of RN 6's nursing notes for July 3, 2016 revealed no documented BP for the following times:

7 PM
7:15 PM
7:30 PM
7:45 PM

Nursing notes dated July 3, 2016 at 8 PM, documentation from RN 6 revealed, "No BP reading noted on the monitor." No documentation could be located to indicate if the physician was made aware that the patient had no BP.

Further review of RN 6's nursing notes for July 3, 2016 revealed no documented BP for the following times:

8 PM
8:15 PM
8:30 PM
8:45 PM
9 PM
9:15 PM
9:30 PM
9:45 PM
10 PM
10:15 PM
10:30 PM
10:45 PM
11:30 PM
11:45 PM

No documentation could be located to indicate if the physician was made aware that the patient had no BP.

Further review of RN 6's nursing notes for July 4, 2016 revealed no documented BP for the following times:

12 AM
12:15 AM
12:30 AM
12:45 AM
1 AM
1:15 AM

No documentation could be located to indicate if the physician was made aware that the patient had no BP.

On July 4, 2016 from 1:45 AM to 7 AM (approximately 5 hours and 15 minutes) no documentation could be located that Patient 2 had a BP. No documentation could be located that any of Patient 2's physicians had been informed.

On August 9, 2016 at 8:05 AM, an interview was conducted with ICU Charge (C) RN 1, on duty the night of July 3, 2016. ICU CRN 1 was asked if she was aware that Patient 2 did not a blood pressure multiple times and sometime hours at a time. ICU CRN 1 stated she was aware but thought the RN assigned to the patient (RN 6) had called and informed the physician.

On August 8, 2016 at 1:23 PM, an interview was conducted with the Director of Performance Improvement (DPI-a member of QAPI). The DPI was asked if during the root cause analysis (RCA) meeting regarding the care/death of Patient 2 if, the "Team Members" identified that when Patient 2 did not have a blood pressure, if the licensed staff member notified the physician. The DPI stated, "The BP's were not identified in the RCA."

2. On August 8, 2016 at 1:23 PM an interview was conducted with the Director of Performance Improvement (DPI). The DPI stated a root cause analysis (RCA) was conducted regarding the death of Patient 2.

During the interview with the DPI, the DPI was asked if the "Team Members" of the RCA had identified that the facility's policy and procedure for "Massive Obstetric Hemorrhage" had been followed and if Patient 2 had been staged according to the policy. The DPI stated, "No."

Following the delivery of twins, Patient 2 developed a massive obstetric hemorrhage and became hypotensive (low {BP} blood pressure). Patient 2's BP dropped to a low of 81/55 and was transferred from the PACU (post anesthesia care unit)to the ICU (intensive care unit). Patient 2 returned to the OR on July 2, 2016, for a hysterectomy in hopes of stopping the hemorrhage. Patient 2 expired (died) on July 4, 2016 at 8:25 AM, leaving behind a spouse, a three year old child and two day old twins.

A review of the facility's "Massive Obstetric Hemorrhage," policy and procedure (P & P) dated September 2013, under the "Purpose" section, documentation revealed:

"To aid in the medical and nursing management of the patient experiencing, or at increase risk of, Obstetric Hemorrhage. Obstetric hemorrhage is a frequent cause of maternal morbidity and mortality...."

Further review of the P & P under the "Recognize Risk Factors" section revealed the following:

"I. All patients admitted to Labor and Delivery should be evaluated for their risk category:"

On August 8, 2016 at 1:40 PM during an interview with the Chief Nursing Officer (CNO), the CNO stated according to the "Massive Obstetric Hemorrhage P & P, at the time of Patient 2's admission, she was a "Level II due to current multiple gestation.

Continued review of the "Massive Obstetric Hemorrhage," documentation confirmed Patient 2 was a "Level II: Moderate Risk" due to:

"4. Current Multiple gestation"

A review of the "Level 2/Stage 2" revealed the following under "III. Patient Intervention:

G. Order Labs - DIC (disseminated intravascular coagulation-normal clotting is disrupted and severe bleeding can occur) panel (CBC {complete blood count}, PT {prothrombin time}, PTT {partial thromboplast time}, INR {international normalized ratio}, Fibrinogen)

A review of the "Surgical Case Record" dated July 2, 2016 in the "Operative Outputs" section, revealed at 6:42 AM, Patient 2 had an "Estimated Blood Loss (EBL)" totaling 1000 milliliters (ml).

A review of the PACU (post anesthesia care unit) "Phase I Outputs" revealed the following:

July 2, 2016 at 6:55 AM, EBL-VAG (vaginal) 300 ml
July 2, 2016 at 7:10 AM, EBL-VAG 300 ml
July 2, 2016 at 7:30 AM, EBL-VAG 300 ml
July 2, 2016 at 7:50 AM, EBL-VAG 300 ml

Totaling 1200 ml

Documentation revealed Patient 2 experienced a total EBL of 2200 ml within 1 hour and 8 minutes.

Further review of the "Massive Obstetric Hemorrhage" P & P in the "Level 2/Stage 2" section documentation revealed:

"IT IS IMPORTANT TO STOP AND REASSESS THE PATIENTS EBL AND VITAL SIGNS
*IF EBL IS > (greater than) 1500 ml
OR
*COAGULOPATHY IS SUSPECTED
OR
*VITAL SIGNS ARE ABNORMAL

Patients should be moved to Stage 3: Significant Persistent Maternal Hemorrhage

Patient should be moved to the OR (operating room) or ICU (intensive care unit)"

A review of the "Stage 3: Modified Postpartum Care" section revealed the following

"C. Labs CBC and DIC panel @ (at) 1, 2, 4, and 6 hours"

No documented evidence could be located that any blood work was collected from Patient 2 on July 2, 2016 from 5:10 AM to 12:15 PM.

On August 9, 2016 at 1:23 PM an interview was conducted with Physician 1. Physician 1 confirmed no blood work was collected from Patient 2 until after the patient returned to the ICU following her return to the OR for a hysterectomy, stating, "I thought I ordered some (lab work)."

On August 9, 2016 at 1:45 PM, an interview was conducted with Physician 3. Physician 3 was asked if he was aware of the "Massive Obstetric Hemorrhage" P & P. Physician 3 responded, "No," further stating he knew nothing of the P & P.

3. A review of physician orders, revealed an order from Physician 1, dated July 2, 2016 at 7:36 AM for the following labs to be done on Patient 2:
PTT, PT, Fibrinogen and D-Dimer.

On August 8, 2016 at 1:35 PM, an interview was conducted with the Chief Nursing Officer, clarified that the requested lab work ordered by Physician 1 was not drawn and it was communicated to laboratory personnel to use the blood collected at the time of the patient's admission.

On August 9, 2016 at 1:23 PM, an interview was conducted with Physician 1. Physician 1 was asked if he was aware that the lab work he ordered when the patient was in the PACU was not done and the labs were run using the blood collected a the time of the patient's admission. Physician 1 stated, "No it would be inaccurate." Physician 1 confirmed no other labs were ordered on Patient 2 until after the patient returned to the ICU following her return to the OR for a hysterectomy.

On August 8, 2016 at 1:23 PM, an interview was conducted with the Director of Performance Improvement (DPI). The DPI was asked if the "Team Members" of the RCA (Root caused analysis) identified that a prescribed lab work, ordered during the time that Patient 2 was experiencing a "Massive Obstetric Hemorrhage" was not collected and was run using the blood that was collected prior to the patient experiencing the "Massive Obstetric Hemorrhage," the DPI, stated, "No."

MEDICAL STAFF

Tag No.: A0338

The hospital failed to ensure the Condition of Participation: CFR 482.22 Medical Staff was met by failing to:

1. Identify lack of oversight and a defined process to ensure Physicians 5, 6, 7, 8, 9, 10, 11, 12, who were employed through a contracted service were licensed and qualified to provide the services. (Refer to A-0340)

The cumulative effect of this systemic deficient practice resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation: Medical Staff.

MEDICAL STAFF PERIODIC APPRAISALS

Tag No.: A0340

Based on interview and record review, there was no oversight and a defined process to ensure the eight of 8 sampled physicians, in a universe of 8 physicians who were under contracted services (Contracted Service 1), were verified to be duly licensed and were qualified to provide the services.

This failure had the potential to result in physician providing services without undergoing verification of license and qualification, affecting patient's overall health and safety, in a universe of 55 Patients.

Findings:

An interview with the Regional Medical Staff Director (RMSD) and the Medical Staff Coordinator (MSC) and a concurrent review of eight out of 8 sampled physicians (Physicians 5, 6, 7, 8, 9, 10, 11, and 12), under Contracted Service 1, were conducted on August 8, 2016 at 11 AM. The RMSD and the MSC confirmed that during an interview and a concurrent review of the contracted physicians under Contracted Services 1 conducted on July 7, 2016 at 9:25 AM, the facility did not maintain a "file" for the contracted physicians and there was no documented evidence to show their license and qualification were verified. The RMSD stated, "We weren't running it because we didn't know it was in the contract." The RMSD and the MSC confirmed there was no oversight and a defined process to ensure the physicians under Contracted Service 1, were verified to be duly licensed and were qualified to provide the services, as stipulated on the contract.

A concurrent review of the "PROFESSIONAL SERVICES AGREEMENT," made and entered by the facility with Contracted Services 1 on August 1, 2010, was conducted. It stipulated, "... Recitals: ... B. Hospital, at times, requires the services of a pediatric (pertains to medical care of infants, children and adolescents) cardiologists (pertains to doctors who treat the heart and the blood vessels) to read pediatric cardiology and echocardiogram (a test that uses sound waves to look at the structure of the heart) studies performed on its patients in order to assist the patient's treating physician in directing the care of the patient... AGREEMENT:... 2. Professional Qualifications. Those physicians that provide the Services for Provider shall at all times be duly licensed to practice medicine in the State of California and be qualified to provide the Services."

During an interview with the RMSD and the MSC on August 8, 2016 at 11:50 AM, they presented copies of the "BreEZe" online verification (an online system that enables consumers to verify a professional license and file a consumer complaint), dated July 13, 2016, for Physicians 5, 6, 7, 8, 9, 10, 11, and 12. The MSC confirmed these were obtained after it was brought to their attention during a complaint investigation on July 7, 2016.

During a concurrent review of the copies of the "BreEZe" online verification, it revealed entries under "Survey Information." The document further revealed, "The following information is (in red letters) self-reported by the licensee and has not been verified by the Board." The information included, and not limited to, the physician's current training status, areas of practice, board certifications, AOA (American Osteopathic Association) board certifications, postgraduate training years, and public record actions. The RMSD and the MSC confirmed the verification was just printed online and had not gone through the medical staff credentialing board and the Governing Board (GB - the appointed board who governs the hospital) for review.

An interview with the Director of Cardiopulmonary (DC) was conducted on August 9, 2016 at 3:10 PM. The DC stated it was not his role but that of the medical staff department to conduct verification of the contracted physicians' license and qualifications. The DC confirmed that during an interview and a concurrent review of the contracted physicians' contract during the complaint investigation on July 7, 2016, there was no documented evidence of a "file" to show they were verified as duly licensed and qualified.

An interview with the RMSD and a concurrent review of the "Medical Staff Bylaws," Reviewed/Approved 9/29/2014, were conducted on August 11, 2016 at 1:15 PM. The RMSD confirmed the medical staff bylaws and the rules and regulations did not stipulate the oversight and the process on verification of the license and the qualification of the physicians who were under contracted services. The RMSD further confirmed there was no policy and procedure that has been reviewed and approved by the GB since the issue had been identified during the complaint investigation in July 7, 2016 since she had been waiting to receive the "2567" form (a statement of deficiencies) from the department.

During an interview on August 11, 2016 at 3:20 PM, the Administrator stated the process for "credentialing" of the contracted physicians should have been the "same level" for both contracted and non-contracted physicians.

STAFFING AND DELIVERY OF CARE

Tag No.: A0392

Based on interview and record review, the facility failed to ensure licensed staff notified the physician when a change of condition occurred for one of 30 sampled patients (Patient 2). This failure occurred when a change in the patient's vital signs occurred and the patient's physician was not notified. This failure created the potential for Patient 2's condition to deteriorate further.

Findings:

During a record review conducted on August 8, 2016, revealed Patient 2 presented to the hospital on July 2, 2016 at 4:50 AM, documented the following: 36-3/7 weeks pregnant, in labor with a spontaneous rupture of membranes. Patient 2 was taken to the operating room (OR) at 5:36 AM and underwent a Caesarean section (C-section: surgical procedure to deliver a baby through the abdomen) delivering twins at approximately 6:05 AM and 6:06 AM. Patient 2 expired (died) on July 4, 2016 at 8:25 AM.

Following the delivery of twins on July 4, 2016, Patient 2 developed a massive obstetric hemorrhage (bleeding) and was transferred from the PACU (post anesthesia care unit)to the ICU (intensive care unit). Patient 2 returned to the OR on July 2, 2016, for a hysterectomy (operation to remove reproductive organs) in hopes of stopping the hemorrhage.

On July 2, 2016, Patient 2 returned to the ICU directly from OR at 11:25 AM on the ventilator (a machine that supports breathing). At 12:34 PM, Patient 2 became hypotensive (a condition characterized by low blood pressure) with no pulse, a Code Blue (heart and breathing {one or both} functions stop) was initiated. The Code Blue ended at 12:38 PM after the patient was successfully resuscitated. A second Code Blue was called on July 2, 2016 at 1:18 PM when the patient did not have a BP (blood pressure) or pulse, At approximately 1:20 PM, the Code Blue ended successfully after the patient regained a BP and pulse.

Patient 2 required Q (every) 15 minute vital signs, due to her critical status and having continuous intravenous (IV) medications for blood pressure management.

A review of Registered Nurse (RN) 3's nursing notes revealed Patient 2 did not have a documented BP on July 2, 2016 from 12:45 PM to 1:15 PM. No documented evidence could be located to indicate if RN 3 attempted to obtain a BP manually or by any other method. No documentation could be located that any of Patient 2's physician's were made aware that the patient had no BP.

Further review of RN 3's nursing notes for July 2, 2016 revealed no documented BP for the following times:

3 PM
3:15 PM
3:45 PM
4 PM
4:45 PM
5:15 PM
5:30 PM
6 PM
6:15 PM
6:30 PM

On August 9, 2016 at 8:35 AM, an interview was conducted with RN 3. RN 3 stated, Patient 2's blood pressure fluctuated (went up and down). RN 3 was asked if she attempted to obtain a BP manually or by any other method, RN 3 stated, "No," further stating she relied on the machine for blood pressure readings.

On August 9, 2016 at 1:40 PM, an interview was conducted with Physician 3. Physician 3 was asked if nursing staff informed him that they were not able to obtain a blood pressure at times and that at times the patient had no blood pressure for hours, Physician 3 stated he was aware that the patient's blood pressure was low and stated, "Not aware of no blood pressures (meaning, physician was not aware that Patient 2 not having a blood pressure reading .... normal BP 120/20 mmHg).

A review of the facility's policy and procedure (P & P) titled "Notification of Physician for Unusual Events or Change in Conditions," dated September 2013, under the "Policy" section revealed the following:

"All changes in patient's condition will be reported by a licensed nurse to the admitting or consulting physician in a timely fashion.

This includes:

1. Abnormal labs/diagnostic reports
2. Changes in vital signs
3. New onset of complaints
4. Worsening signs and symptoms
5. Deterioration of condition
6. All life threatening situations
7. Patient death

The RN's assessment is reported to the physician."

A review of RN 5's nursing notes revealed no documented BP for the following times.

8:45 PM
9:15 PM
10 PM
5:15 AM
6 AM
6:30 AM

No documentation could be located to indicate if any physician was made aware that the patient had no BP or if other methods of obtaining a BP were attempted. Patient 2 remained a full code (full resuscitation efforts must be attempted if the heart or breathing stops).

On August 9, 2016 at 8:27 AM, an interview was conducted with RN 5, RN 5 stated the patient was on 3 vasopressors (medications that raise the blood pressure) that were maxed out (maximum dosage level was reached). As the interview continued RN 5 was asked if at any time she took a manual blood pressure or relied mainly on the machine, RN 5 stated "I did not take a manual BP. "

A review of RN 3's nursing notes for July 3, 2016 revealed no documented BP for the following times:

8:15 AM
8:30 AM
9:30 AM

Nursing notes dated July 3, 2016 at 10:08 AM by RN 3, revealed "Low BP noted. MD aware. " No documentation could be located to indicate if the physician was made aware that the patient had no BP or if other methods of obtaining a BP were attempted.

Nursing notes documented by RN 3, dated July 3, 2016 at 11:35 AM, revealed "Machine unable to obtain BP. MD aware." Additional documentation revealed "Physician 3 aware of the BP not registering on the monitor." No documentation could be located to indicate if other methods of obtaining a BP were attempted.

On July 3, 2016 at 12:05 PM and 12:15 PM, RN 3's nursing notes revealed Physician 3 aware of low BP status. No documentation could be located to indicate if the physician was made aware that the patient had no BP or if other methods of obtaining a BP were attempted.

Continued review of RN 3's nursing notes for July 3, 2016 revealed no documented BP for the following times:

12:30 PM
12:45 PM
1 PM
1:30 PM
1:45 PM
2 PM
2:15 PM

On July 3, 2016 at 2:55 PM and 3:05 PM, RN 3's nursing notes revealed Physician 3 aware of low BP status. No documentation could be located to indicate if the physician was made aware that the patient had no BP or if other methods of obtaining a BP were attempted.

Continued review of RN 3's nursing notes for July 3, 2016 revealed no documented BP for the following times:

3 PM
3:15 PM

On July 3, 2016 at 3:20 PM, RN 3's nursing notes revealed Physician 3 aware of low BP status. No documentation could be located to indicate if the physician was made aware that the patient had no BP or if other methods of obtaining a BP were attempted.

Continued review of RN 3's nursing notes for July 3, 2016 revealed no documented BP for the following times:

3:30 PM
3:45 PM

On July 3, 2016 at 4 PM, RN 3's nursing notes revealed Physician 3 aware of low BP status. No documentation could be located to indicate if the physician was made aware that the patient had no BP or if other methods of obtaining a BP were attempted.

A review of nursing notes for July 3, 2016 revealed no documented BP for the following times:

4:15 PM
4:30 PM
4:45 PM
5 PM
5:15 PM
5:30 PM
5:45 PM
6 PM
6:15 PM
6:30 PM

Documentation by RN 3, dated July 3, 2016 at 5:05 PM, revealed "Physician 3 aware of BP not registering on the monitor." BP cuff switched. "BP still not registering on monitor." Documentation at 5:15 PM revealed "BP still not registering on the monitor." Documentation at 5:40 PM revealed "BP still not registering on the monitor." BP cuff switched.

A review of RN 6's nursing notes for July 3, 2016 revealed no documented BP for the following times:

7 PM
7:15 PM
7:30 PM
7:45 PM

Nursing notes dated July 3, 2016 at 8 PM, documentation from RN 6 revealed, "No BP reading noted on the monitor." No documentation could be located to indicate if the physician was made aware that the patient had no BP or if other methods of obtaining a BP were attempted.

Further review of RN 6's nursing notes for July 3, 2016 revealed no documented BP for the following times:

8 PM
8:15 PM
8:30 PM
8:45 PM
9 PM
9:15 PM
9:30 PM
9:45 PM
10 PM
10:15 PM
10:30 PM
10:45 PM
11:30 PM
11:45 PM

No documentation could be located to indicate if the physician was made aware that the patient had no BP or if other methods of obtaining a BP were attempted.

Further review of RN 6's nursing notes for July 4, 2016 revealed no documented BP for the following times:

12 AM
12:15 AM
12:30 AM
12:45 AM
1 AM
1:15 AM

No documentation could be located to indicate if the physician was made aware that the patient had no BP or if other methods of obtaining a BP were attempted.

On July 4, 2016 from 1:45 AM to 7 AM (approximately 5 hours and 15 minutes) no documentation could be located that Patient 2 had a BP. No documentation could be located that any of Patient 2's physicians had been informed.

On August 9, 2016 at 7:35 AM, an interview was conducted with RN 6. RN 6 was asked about the patients vital signs (heart beat, blood pressure, temperature and respirations), RN 6 stated they were Q (every) 15 minutes, when asked how she obtained the patient's BP, RN 6 stated she "Relied on the machine." RN 6 was asked when the machine was unable to detect a blood pressure, if she manually checked for a BP with her stethoscope (instrument to hear lung sounds, heart beat) or any other way, RN 6 replied, "No, but I moved the cuff to other areas."

On August 9, 2016 at 8:05 AM, an interview was conducted with ICU Charge RN 1, on duty the night of July 3, 2016. ICU Charge RN 1 was asked if she was aware that Patient 2 did not a blood pressure multiple times and sometime hours at a time. ICU Charge RN 1 stated she was aware but thought the RN assigned to the patient (RN 6) had called and informed the physician. ICU Charge RN 1 further stated that "She was already on BP meds (medications to increase blood pressure)."

On July 4, 2016 at 6:50 AM, "Monitor shows asystole (no heart beat).....Code Blue called." A review of the Code Blue form revealed the patient did not have a BP or pulse, the patient was given emergency medications while CPR (cardiopulmonary resuscitation) was in progress. At 7:15 AM, the Code Blue ended successfully after the patient regained a pulse. Further, review of the 3-page Code Blue form, revealed no documentation of a blood pressure obtained during or after the Code Blue ended. Nurse's Notes on the Code Blue form revealed the patients' pupils were fixed (no reaction to light).

On July 4, 2016 at 7:25 AM, nursing notes revealed "Monitor showing asystole, called Code Blue." A review of the Code Blue form revealed the patient did not have a pulse or BP, the patient was given emergency medications while CPR was in progress. At 7:50 AM, the Code Blue ended successfully, however; no documentation of a pulse or BP were noted on the Code Blue form.

On July 4, 2016 at 7:55 AM, nursing notes revealed "Noted HR (heart rate) slowing down in the monitor. Code Blue called. A review of the Code Blue form revealed the patient did not have a pulse or BP. At 8:12 AM, the Code Blue ended unsuccessfully and the patient was pronounced dead on July 4 2016.

MEDICAL RECORD SERVICES

Tag No.: A0431

The hospital failed to ensure the Condition of Participation: CFR 482.24 Medical Record Services was met by failing to:

1. Ensure medical records were complete and accurate regarding the monitoring and reporting of a patient's change in condition. (Refer to A-0438)

2. Provide oversight and a defined process to ensure the confidentiality of all the patients' clinical records from unauthorized individuals, in a universe of 55. (Refer to A-0441)

3. Implement its policy and procedure when there was no documented evidence of nutritional screenings found in the clinical record for five of 30 sampled patients (Patients 16, 17, 18, 19, and 20). (Refer to A-0450)
The cumulative effect of these systemic deficient practices resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation: Medical Record Services

FORM AND RETENTION OF RECORDS

Tag No.: A0438

Based on interview and record review, the facility failed to ensure medical records for one of 30 sampled patients (Patient 2) were complete and accurate regarding the monitoring and reporting of a patient's change in condition. This failure created the potential for Patient 2's condition to further deteriorate.

Findings:

1. Record review conducted on August 8, 2016, revealed Patient 2 presented to the hospital on July 2, 2016 at 4:50 AM, 36-3/7 weeks pregnant, in labor with a spontaneous rupture of membranes. Patient 2 was taken to the operating room (OR) at 5:36 AM and underwent a Caesarean section (C-section) delivering twins. Patient 2 was admitted to the ICU (intensive care unit) after she developed a massive obstetric (pertains to childbirth) hemorrhage (heavy bleeding).

While in the ICU, Patient 2 required Q (every) 15 minute vital signs, due to her critical status and having continuous intravenous (IV) medications for blood pressure management.

A review of nursing notes revealed Patient 2 had no documented blood pressure multiple times and hours at a time without any of Patient 2's physicians being made aware of no (lack of) blood pressure.

Nursing notes dated July 2, 2016 revealed no documented blood pressure readings/measurements/assessments for the following times:

12:45 PM
1 PM
1:15 PM
3 PM
3:15 PM
3:45 PM
4 PM
4:45 PM
5:15 PM
5:30 PM
6 PM
6:15 PM
6:30 PM
8:45 PM
9:15 PM
10 PM

On August 9, 2016 at 1:40 PM, an interview was conducted with Physician 3. Physician 3. Physician 3 was asked if nursing staff informed him that they were not able to obtain a blood pressure at times and that at times the patient had no blood pressure for hours, Physician 3 stated he was aware that the patient's blood pressure was low and stated, "Not aware of no blood pressures."

A review of nursing notes dated July 3, 2016, revealed no documented BP for the following times.

5:15 AM
6 AM
6:30 AM
8:15 AM
8:30 AM
9:30 AM
12:30 PM
12:45 PM
1 PM
1:30 PM
1:45 PM
2 PM
2:15 PM
3 PM
3:15 PM
3:30 PM
3:45 PM
4:15 PM
4:30 PM
4:45 PM
5 PM
5:15 PM
5:30 PM
5:45 PM
6 PM
6:15 PM
6:30 PM
7 PM
7:15 PM
7:30 PM
7:45 PM
8 PM
8:15 PM
8:30 PM
8:45 PM
9 PM
9:15 PM
9:30 PM
9:45 PM
10 PM
10:15 PM
10:30 PM
10:45 PM
11:30 PM
11:45 PM

Nursing notes for July 4, 2016 revealed no documented BP for the following times:

12 AM
12:15 AM
12:30 AM
12:45 AM
1 AM
1:15 AM

On July 4, 2016 from 1:45 AM to 7 AM (approximately 5 hours and 15 minutes) no documentation could be located that Patient 2 had a BP. No documentation could be located that any of Patient 2's physicians had been informed.

2. Record review conducted on August 9, 2016 revealed on July 4, 2016 at 6:50 AM a Code Blue (emergency situation) was called due to Patient 2's cardiac monitor showed asystole (absence of heartbeat). At 7:15 AM, the Code Blue ended successfully after the patient regained a pulse, however no documentation of the patients blood pressure were noted on the Code Blue form.

On July 4, 2016 at 7:25 AM, a second Code Blue was called involving Patient 2. At 7:50 AM, the Code Blue ended successfully, however; no documentation of a pulse or BP were noted on the Code Blue form.

PROTECTING PATIENT RECORDS

Tag No.: A0441

Based on interview and record review, the facility failed to:

1. Ensure there was oversight and a defined process that ensured the confidentiality of the patients' clinical records from access by unauthorized individuals, when six out of 6 sampled physicians who were no longer employed, continued to have access to the patients' clinical records in Software 1 (a software that contained the patients' clinical records).

This failure had the potential to result in unauthorized individuals having access to the patients' clinical records, in a universe of 55 Patients.

2. Implement its policy and procedure when there was no documented evidence a "Request for Access Form" was completed and maintained when deleting employee access to the facility's information systems.

This failure had the potential to result in unauthorized access to the patient's clinical records, in a universe of 55.

Findings:

1. A concurrent interview with the Regional Medical Staff Director (RMSD), the Regional IT Manager (RITM), the Information Technologist/Clinical Analyst (IT/CA), and the Medical Staff Coordinator (MSC) was conducted on August 8, 2016 at 2 PM. They confirmed during a concurrent interview with RMSD, RITM, IT/CA, MSC, and RHIMD conducted on July 6, 2016, there was no oversight and a defined process to ensure six out of 6 sampled physicians who were no longer employed, did not have access to the patients' clinical records to Software 1. The RSMD, RITM, IT/CA, and MSC confirmed the following interview and concurrent review of records during the complaint investigation on July 6, 2016 as follows:

A concurrent review of the "Monthly Updated Medical Staff Roster," from January 2016 to June 2016, had revealed a list of physicians who were no longer on staff due to "Voluntary resignation," as follows:

Physician 13 - effective May 31, 2016.

Physician 14 - effective February 29, 2016.

Physician 15 - effective January 25, 2016.

Physician 16 - effective March 25, 2016.

Physician 17 - effective November 30, 2015.

Physician 18 - effective April 25, 2016.

A concurrent review of the copies of the "MIS Provider Dictionary" on July 6, 2016, revealed, Physicians 13, 14, 15, 16, and 17 continued to have access to Software 1 as of July 6, 2016. The IT/CA confirmed the physicians continued to remain "active" and to have access to Software 1. The IT/CA stated, the "provider type" status for these physicians should have been changed to "NOL" which meant "No Longer On Staff."

During the concurrent interview on July 6, 2016 at 3:50 PM, when asked what the facility's process was to ensure the physicians who were no longer employed, had no access to the patients' clinical records, the RMSD and MSC stated the IT department would terminate the physician's access to Software 1. The IT/CA stated their role was only to "build initial access" to Software 1 for the physicians and terminating the physician's access would be done by the medical staff department. The RIHMD stated their role was to ensure the "suspended" physicians were not admitting new patients until they are in compliance with their deficiencies with medical records. The RMSD and MSC stated whenever a physician was no longer on staff, MSC would update the medical staff system to reflect the physician's status; however, they just now found out during the complaint investigation that the medical staff system did not interface with the IT's system thus, the physician continued to remain "active" and to have access to Software 1. The RMSD then stated, "We got a glitch; we need to come up with a system." The RMSD further stated there was a need to have a "physical double checks on both sides; can't assume it went though." The RMSD confirmed there was no defined process nor was there a policy and procedure that had been reviewed and approved by the Governing Body (GB - the appointed body who governs the hospital) to address the process of ensuring physicians who were no longer on staff, did not have access to the patients' clinical records. The RMSD stated the oversight to ensure the process was implemented "falls on medical staff (department)."

A review of the facility's policy and procedure titled "Confidentiality/Privacy," dated 5/13, stipulated, "PURPOSE: 1. To protect the patient ' s right to privacy and confidentiality pursuant to Health Insurance Portability and Accountability Act (HIPAA) and other privacy laws... I. A PATIENT'S RIGHT TO CONFIDENTIALITY ... POLICY: It is the policy of the Medical Center to protect a patient's right to privacy and confidentiality, in accordance with applicable state and federal laws ... E. have/his medical record read only by individuals directly involved with his/her treatment or the monitoring of the quality thereof, or by other individuals only upon his/her written authorization or that of his/her legally-authorized representative; F. expect that all communications and other records pertaining to his/her care, including the source of payment or treatment to be rendered, be treated confidentially; .. II. ACCESS AND RELEASE OF MEDICAL RECORDS... PROCEDURE:1. Principles of Confidentiality: A. All Hospital personnel are responsible for controlling and enforcing confidentiality regarding the information contained in each medical record processed or filed by the Hospital... G. The computer access codes are considered to be confidential and, as such, are protected in the same manner as patient information. H. DHMCM personnel will safeguard the medical record against loss, defacement, tampering, use by unauthorized persons, and damage by fire or water..."

2. During a concurrent interview with the Information Technology/Clinical Analyst (ITCA) and the Supervisor of Human Resources (SHR) on August 9, 2016 at 1:20 PM, they stated whenever a the HR department received a notice of termination or resignation from an employee the SHR department would disable the employee's access to Software 1 (a software that contained the patients' clinical records). The HR department would then send the IT department a list of the "term report " (a list of terminated employees) monthly, and the IT department would confirm the employees were "termed (access to the Software 1 was terminated)." The IT/CA and the SHR confirmed their departments communicated via email.

During a concurrent review of the facility's policy and procedure titled "Information Systems Access," dated 02/14, it stipulated, "...PURPOSE: ... This policy established hospital procedures for ensuring the security of Information Systems software at (name of the facility). The policy applies to all employees of the organization, consultants, contracted service providers, vendors and auditors... PROCEDURE:... 2. The department manager must complete a "Request for Access Form" whenever it is necessary to add, modify or delete employee access to the hospital's information systems. The following outlines the procedure to be used in each instance: ... DELETE The "Request for Access Form" is completed by the manager and sent directly to Information Systems. Information Systems will delete the employee's access, sign the form and forward the original to Human Resources. Information Systems will maintain a copy of the "Request for Access Form" with a copy of the user MIS file. In the event of an involuntary termination, it is the department manager's or HR's responsibility to call I/S department, system core team leader or the on-call I/S staff to immediately delete all system access. A "Request for Access Form" should be completed within 12 hours of the termination to insure that the deletion and documentation are completed..."

During the concurrent interview with the IT/CA and the SHR, they confirmed they had not been utilizing the "Request for Access Form" but had been sending communication through the email. The IT/CA also confirmed the IT department did not maintain a copy of the "Request for Access Form" with a copy of the user MIS file (Management Information System - computer-based system that provides information).

MEDICAL RECORD SERVICES

Tag No.: A0450

Based on interview and record review, the facility failed to implement its policy and procedure when there was no documented evidence of nutritional screenings found in the clinical record for five of 30 sampled patients (Patients 16, 17, 18, 19, and 20).

This failure had the potential to result in lack of adequate communication of the patient's nutritional needs affecting the patient's overall health and safety, in a universe of 55 Patients.

Findings:

During an interview with the Director of Performance Improvement (DPI) and a concurrent review of the clinical record on August 10, 2016 at 3 PM, the DPI confirmed Patient 20 was admitted to the facility on July 1, 2016, with a chief complaint of low blood sugar.

A review of the "Nutrition Notes" revealed a Registered Dietician (RD) initial assessment was completed on July 4, 2016 (approximately three days after the admission).

During an interview with the Director Food and Nutrition Services (DFNS) and a concurrent review of Patient 20's clinical record on August 10, 2016 at 4:15 PM, the DFNS stated upon admission, the nurse would perform an initial nutritional screen on the patient and followed by the a nutritional rescreen by the RD. The DFNS stated Patient 20 was rescreened and was classified as a "moderate" nutritional risk by reviewing the "tray list." A concurrent review of the "tray list" revealed a list of multiple patients and their current diet, allergies, account number, age, sex, order date, admit date, height in centimeters, weight is kilograms, attending doctor, reason for visit, location, and the medical record number. The DFNS confirmed there was no documented evidence of the nutritional rescreen in Patient 20's clinical chart; "We don't put a note (in the patient's clinical record)."

During a concurrent review with the DFNS of the facility's policy and procedure titled "Nutritional Prioritizing Guidelines," dated 03/13, it stipulated, "PURPOSE: To ensure that the nutritional needs of the patients are being met. POLICY: Guidelines are established for prioritizing patients that need to be assessed. PROCEDURE: 1. The following parameters are used in the prioritization of patient assessments/visitations: ... MODERATE PRIORITY (2) - Patients will be seen and assessed within 3-5 days of identification. Patients on Therapeutic Diets... Patients with Supplements ... Diagnosis: Uncontrolled Diabetes or Blood Glucose. Congestive Heart Failure. Chronic Renal Failure. Pneumonia. Metabolic Problems... Geriatric Surgical Patients... Patients with Gastrointestinal Problems... Patients with a Braden Score of 13-18."

During a concurrent interview with the Registered Dietician (RD 1) and the DFNS on August 11, 2016 at 8:55 AM, RD 1 stated during the nutritional rescreens on the patients, she would review the patient's "tray list" and would look up the information such as the BRADEN scale (a scale used to assess a patient's level of risk for development of pressure sores) in the computer system." The RD stated she would input the nutritional rescreen into the computer nutritional system that served as a tracking log. A concurrent review of the computer tracking log revealed a list of patients including their acuity (classification of nutritional risk) and of the date for the next RD visit.

During an interview and a concurrent review of the clinical records with the DPI on August 11, 2016 at 9:35 AM, the DPI confirmed there were no documented evidence of a nutritional re-screens on the patients' clinical records as follows:

a. For Patient 16, admitted on July 11, 2016, with chief complaints of abdominal pain with associated nausea and vomiting.

b. For Patient 17, admitted on July 10, 2016, with chief complaints of uncontrolled diabetes (a condition of abnormal blood sugar) and chest pain.

c. For Patient 18, admitted on July 9, 2016, with chief complaints of dizziness and weakness, with a history of diabetes. Blood sugar level was 664 milligrams/deciliter (mg/dl - a unit of measurement; Normal blood sugar levels may vary but typically 80-135 mg/dl).

d. For Patient 19, admitted on July 5, 2016, with chief complaints of chest pain and lower extremity pain and swelling for three days.

A concurrent interview with the DFNS and a concurrent review of the facility ' s policy and procedure titled " Medical Record Documentation," dated 11/13, was conducted on August 11, 2016 at 4:15 PM. It stipulated, "PURPOSE: To ensure adequate communication of nutritional assessment, reassessment and education interventions and/or recommendations to physicians and the Interdisciplinary Care Team. POLICY: Documentation of nutrition services will follow established hospital guidelines. PROCEDURE: 1. A nutrition re-screen or assessment of the Admitting Patient is completed by the Clinical Dietician or Registered Diet Technician upon referral from Nursing or no later that the second day after admit. This form is located in the Dietary Section of the medical chart. Follow up documentation can be found in the progress note." The DFNS confirmed the "nutrition re-screen" refers to the nutritional screen performed by the RD on the patients that were admitted. The DFNS acknowledged there was no documented evidence of the nutritional re-screen in Patient 20's clinical record and on all the other patients' clinical records.