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Based on observation, interview and document review, the Governing Body failed to ensure that the Medical Staff enforced their Bylaws. Members of the Medical Staff were not suspended for delinquent medical records as required in the Bylaws. As a result over 3000 medical records were incomplete because the facility did not enforce their own bylaws. The Governing Body failed to ensure the confidentiality of patient records. Log books containing patient information were not able to be accounted for. X-ray films were available to employees of the Biomedical Department. This resulted in the potential for the confidentiality of protected patient information to be compromised. The Governing Body did not ensure that the hospital's Quality Assessment Performance (QAPI) Improvement Program was comprehensive and reached all areas of the hospital. The QAPI Program had not identified issues regarding enforcement of Medical Staff Bylaws or confidentiality of patient records. This resulted in the Governing Body being unable to identify areas of improvement in those areas.

Findings:

1. The Governing Body did not ensure that the Medical Staff Bylaws were enforced. The Medical Staff did not enforce suspensions for physicians with delinquent records longer than 30 days as required by policy. See A-0047 and A-353.

2. The Governing Body did not ensure the confidentiality of patient records. See A-0441

3. The Governing Body did not ensure that the QAPI program was comprehensive and reached all areas of the hospital. See A-263

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment.

Based on interview and document review, the Governing Body failed to ensure that the Medical Staff enforced the bylaws regarding timeliness of completion of Medical records. Over 3000 medical records were missing either dictation or a physician signature. As a result over 3000 medical records were incomplete because the facility did not enforce their own bylaws.

Findings:

1. A list of patient records that were incomplete was provided to the survey team in a printed document. The report was dated 9/23/14. The listing for "Pending Signature" showed there to be 2,994 signatures pending at that time. Fifty-five [55] records were pending dictation. According to a Medical Staff Policy "Delinquency Status," dated 7/01, "Signatures not completed within 30 days of notification were identified as delinquent." All 2,994 signature delinquencies were at least 30 days old.

2. The Director of Health Information was interviewed on 9/24/14 at 12:00 PM. She stated that there were instances when members of the Medical Staff were fined for delinquent medical records, however, Medical Staff members were never "taken out of the system." She nodded that "taken out of the system " meant suspension.

3. The Chief of Staff Elect (or incoming COS) was interviewed on 9/24/14 at 2:10 PM. He stated that the Medical Staff Record Delinquency Report was reviewed every month at the meeting of the Medical Executive Committee. The Chief of Staff Elect was aware that letters were sent to Medical Staff Members who had delinquent records. However, he was not aware of the rest of the process. The Chief of Staff Elect concurred that the process needed improvement.

4. The Director of Regulatory Affairs (DRA) stated that several years ago there had been a more detailed process for the handling of delinquent medical records. The DRA recounted that physicians who had delinquencies over a certain time limit would be unable to admit patients or do procedures until they had taken care of delinquent records. These records would be pulled and ready so that the provider could finish them without canceling surgery or admission or compromising patient safety.

According to the Medical Staff Policy Manual, Delinquency Status, policy number 8710-519, last approved 9/09, "It is the policy of (the facility) to ensure that all medical records are completed in a timely manner and reflects the care provided to the patient." The policy also states, "Dictations not completed within 14 days of notification are identified as Delinquent. Signatures not completed within 30 days of notification are identified as Delinquent."

Based on observation, interview and document review, the hospital's Quality Assurance and Performance Improvement (QAPI) program failed to ensure that all confidential patient information was stored appropriately to maintain the highest level of confidentiality. Log books containing patient information could not be accounted for resulting in an inability of the hospital to ensure that they were properly retained and stored. X-ray films and reports were stored in an area accessible to biomedical staff that did not have a valid need to have such access. The QAPI Program did not ensure that the Medical Staff followed and enforced policy regarding the completion of medical records. As a result over 3000 medical records were incomplete because the facility did not enforce their own bylaws.

Findings:

1. The QAPI program did not ensure that policies regarding completion of medical records were followed and were consistent with community practice. (See A-0047 and A-0353)

2. The QAPI program was not aware of serious issues regarding the storage and confidentiality of patient health information. (See A-0441)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment.

Based on interview and document review, the Governing Body failed to ensure that the Medical Staff enforced the bylaws regarding timeliness of completion of Medical records. Over 3000 medical records were missing either dictation or a physician signature. As a result over 3000 medical records were incomplete because the facility did not enforce their own bylaws.

Findings:

1. A list of patient records that were incomplete was provided to the survey team in a printed document. The report was dated 9/23/14. The listing for "Pending Signature" showed there to be 2,994 signatures pending at that time. Fifty-five [55] records were pending dictation. According to a Medical Staff Policy "Delinquency Status," dated 7/01, "Signatures not completed within 30 days of notification were identified as delinquent." All 2,994 signature delinquencies were at least 30 days old.

2. The Director of Health Information was interviewed on 9/24/14 at 12:00 PM. She stated that there were instances when members of the Medical Staff were fined for delinquent medical records, however, Medical Staff members were never "taken out of the system." She nodded that "taken out of the system " meant suspension.

3. The Chief of Staff Elect (or incoming COS) was interviewed on 9/24/14 at 2:10 PM. He stated that the Medical Staff Record Delinquency Report was reviewed every month at the meeting of the Medical Executive Committee. The Chief of Staff Elect was aware that letters were sent to Medical Staff Members who had delinquent records. However, he was not aware of the rest of the process. The Chief of Staff Elect concurred that the process needed improvement.

4. The Director of Regulatory Affairs (DRA) stated that several years ago there had been a more detailed process for the handling of delinquent medical records. The DRA recounted that physicians who had delinquencies over a certain time limit would be unable to admit patients or do procedures until they had taken care of delinquent records. These records would be pulled and ready so that the provider could finish them without canceling surgery or admission or compromising patient safety.

According to the Medical Staff Policy Manual, Delinquency Status, policy number 8710-519, last approved 9/09, "It is the policy of (the facility) to ensure that all medical records are completed in a timely manner and reflects the care provided to the patient." The policy also states, "Dictations not completed within 14 days of notification are identified as Delinquent. Signatures not completed within 30 days of notification are identified as Delinquent."

The facility failed to have a medical record service that has administrative responsibility for all medical records, as evidenced by:

1. The facility failed to have health information department leadership that was fully aware of, and responsible for, all medical records and protected health information (PHI) of patients. (See A-0432)
2. The facility failed to ensure that medical records are accurately written, promptly completed, properly filed, and retained and accessible. This failure had the potential to result in medical records not containing complete and accurate data. (See A-0438)

3. The facility failed to ensure the medical record storage room was secured, and that patient radiology records were not accessible by unauthorized persons. As a result, an unknown number of patient medical records that contained protected health information (PHI) were accessible to the public. The facility also failed to ensure there was a system in place for the accountability of Emergency Department (ED) patient transfer logs and 4 types of patient logs in the Labor and Delivery (L&D) unit. (See A-0441)

4. The facility failed to ensure the Conditions of Admission (patient's consent to treatment) form was signed for 3 of 3 medical records (Patients 2, 14, 28) during the patients' entire length of stay. (See A-0466)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment.

Based on observation, interview and record review, the facility failed to ensure that the leadership in the health information department was fully aware of the status and location all medical records and protected health information (PHI) of patients within the facility. As a result, the leadership was unable to provide an accurate inventory or accounting of patient logs within the facility, stored offsite, or if patient records were missing.

1. On 9/23/14 at 11 A.M., a tour of the Radiology cage (RC), next to the Medical Records cage (MRC), was conducted with the Director of Medical Records (DMR) and the Director of Ancillary Services (DAS). The RC was a large room with 5 double-sided rows, and 2 walls, containing an unknown number of radiology films and reports.

On 9/23/14 at 11:10 A.M., the DMR stated she does not have access to that area, only radiology staff has access. However, the DMR did not know who, or how many, staff had access. The DMR stated she does not run reports of the badge access transactions to the RC either. The DMR stated she is also the Privacy Officer, and that "All PHI is under me." She further stated, "As Privacy Officer, I should have knowledge of who has access and run reports of who and when an area is accessed."

The DAS stated during an interview on 9/23/14 at 11:20 A.M. that he oversees the Radiology Department. According to the DAS, clerical and filing staff from radiology had badge access to the RC area. The DAS stated he does not routinely run reports of the badge access transactions.

2. On 9/24/14 at 10:30 A.M., a tour of the L&D unit was conducted with the Director of Women's and Newborn Services (DWN). In the secretary's office near the overflow NICU, there was a large file drawer cabinet. Inside the drawers were stacks of numerous hard-cover ledger log books. There were surgery log books going back to 2010, delivery log books going back to 2008, and placenta log books going back to 2008. Also in the drawers were log books of patient admissions to L&D, as well as paper copies of the admission log books going back to 2008. All the log books contained patient information, including, name, date of birth, and diagnosis.

When interviewed on 9/24/14 at 10:45 A.M., the Unit Secretary (US 1) stated she was responsible for the inventory of log books in the file drawers. However, US 1 did not know exactly what log books, or how many, were in the drawers.

The DWN stated that everything in the drawers should be shredded "after one month," however she was unable to explain why there were log books from 2008. The DWN did not know exactly what log books, or how many, were in the drawers.

On 9/24/14 at 2:40 P.M., the DMR was interviewed regarding patient logs containing PHI from the Labor and Delivery Unit (L&D). The DMR was not aware of the patient logs kept on the L&D unit, including surgery logs, delivery logs, placenta logs, newborn screening logs, or admission logs. She stated there was no policy or system in place to account for patient logs. The DMR was also unable to provide an accurate inventory or account of patient logs within the facility or stored offsite.

When interviewed on 9/24/14 at 3:20 P.M., the Director of Regulatory Affairs (DRA) stated that there was no job description for the Privacy Officer. The DRA also stated there was no policy or procedure for the tracking or accountability of patient logs.

The facility was unable to provide an itemized list or accurate inventory of the 4 types of L&D patient log books

Based on document review and staff interview, the facility failed to ensure that medical records are accurately written, promptly completed, properly filed, and retained and accessible. As a result, over 3000 medical records were incomplete or not in compliance with the facility's own policy and procedures.

Findings:

On 9/23/14 at 1:35 PM, review of the facility's Medical Center Rules and Regulations, dated August, 2013, Page 98, #12, stipulated the following: "The attending member shall be held responsible for the preparation of a complete medical record for each patient as defined by the Medical Record Committee. An abbreviated form, for transient admissions not exceeding 48 hours for minor procedures, may be used. For all other patients, a complete medical record shall include a discharge summary, which shall be completed within two weeks following the patient's discharge."

Review of the "Medical Staff Policy-Issue Date: 7/01-Subject: Delinquency Status-Policy Number: 8710-519(B)" on 9/24/14 at 10:30 AM revealed the following: "1. It is the policy of the facility to ensure that all medical records are completed in a timely manner and reflects the care provided to the patient. 2. Dictations not completed within 14 days of notification are identified as Delinquent. 3. Signatures not completed within 30 days of notification are identified as Delinquent."

On 9/24/14 at 2:00 PM, analysis of the printed document "Medical Staff Deficiency Report for 9/23/14" showed that there were 2,994 reports awaiting completion by the signature of the dictating physician. All of these reports were identified as delinquent over 30 days of notification. In addition, there were 55 reports awaiting dictation by the attending physician and they were identified as not completed within 14 days of notification and therefore, delinquent. Subsequent review of the "Medical Staff Deficiency Report of 9/23/14" revealed that 151 physicians had records that were delinquent, and not in compliance with the facility's Rules and Regulations. This information was verified by Staff Member #A on 9/24/14 at 2:30 PM.

Based on observation, interview and record review, the facility failed to ensure the medical record storage room was secured, and that patient radiology records were not accessible by unauthorized persons. As a result, an unknown number of patient medical records that contained protected health information (PHI) were accessible to the public. The facility also failed to ensure there was a system in place for the accountability of Emergency Department (ED) patient transfer logs.

Findings:

1. On 8/14/14 at 9 A.M., the Department entered the facility to conduct a complaint investigation related to unsecured Medical Records.

At 9:10 A.M., a tour of the Medical Records Department, located on the basement floor of the facility, was conducted with the Director of Regulatory Compliance, Interim Manager for Security and the Director of Medical Records.

The door to the Medical Records cage (MRC) which was the storage room for medical records was unlocked and un-manned. The MRC was located in a hallway in which unauthorized persons were able to access.

The Director of Medical Records stated during the tour, "It (door) is generally locked. It should be locked 24/7." She further said, the keys to MRC were kept in the Medical Records Department and staff were to unlock, lock, and return the key to Medical Records.

According to the Interim Manager for Security, who was also present during the tour, stated that the MRC room measured 21 feet 5 inches by 30 feet, a total of 645 square feet.

Upon entry into MRC, the entire right wall had floor to ceiling metal shelves which held patient medical records. In addition, there were 42 large storage boxes which also contained patient medical records. To the left of the room were 6 large metal filing cabinets with thousands of patient micro-fiche records that were dated from 1983 to 2011.

The Director of Medical Records, who was also present during the tour, stated that on the right wall there were 116,449 Emergency Department patient discharged records from 2009 through 2010. The information in the medical records included: Patient's names, address, reason for the visit, condition of admission, emergency department triage, original involuntary legal holds, and discharge instructions.

In addition to the above Emergency Department records, the Director of Medical Records acknowledged there were 42 boxes which included: fetal monitor strips, transplant surgery, outpatient surgery, birth defect monitoring records, and billing records. There were also, 6 large filing cabinets that contained thousands of X-ray and imaging micro-fiche.

Due to the volume of patient medical records, the facility could not provide an accurate number of patient medical records stored in the unsecured MRC.

The facility's policy and procedure, Medical Records/Health Information, revised 9/03, was reviewed on 8/14/14. The Director of Medical Records acknowledged that the policy did not address security procedures for the MRC.

2. On 8/11/14, the Department of Public Health received 6 of the facility's Emergency Department patient transfer logs (December 2013 through May 2014) from an anonymous source.

On 8/14/14 at 10:10 A.M. an interview was conducted with the Director of Regulatory Compliance, regarding the Emergency Department patient transfer logs. The Director of Regulatory Compliance said that on 8/7/14, she retrieved 4 emergency department transfer log books from the Emergency Department. The logs were then taken to the Quality Assurance Department, then to the Performance Improvement office, then to the Administrative conference room. The last known location of the logs was on 8/8/14 inside the front door of the Facilities Department building.

On 8/14/14 at 11:30 A.M., the Facilities Department building was observed with the Interim Security Manager, Director of Regulatory Compliance, and the Senior Vice President of Medical Services. The Facilities Department building was located outside the facility entrance, across the facility's drive way, through a large patient parking lot, down a small hill to the right of the hospital, and in a detached building. The Facilities Department building door was unlocked.

The Director of Regulatory Compliance, during the tour, stated she was not notified the Emergency Department transfer logs were missing until late evening on 8/13/14. She also said the facility believed only a total of 4 Emergency Department patient transfer logs were missing. The Director of Regulatory Compliance acknowledged there was no chain of custody procedure for the possession of the Emergency Department patient transfer logs.

The Director of Emergency Services stated on 8/14/14 at 10:30 A.M., "There is no process for checking out the logs." She said the facility would not know if logs were missing. She further stated, "I know it is a flimsy process." The Director of Emergency Services said the logs were collected annually in January and stored with a contracted storage company.

The itemized list of Emergency Department transfer logs that were sent to an offsite storage company was requested. The facility was unable to produce an itemized list of the Emergency Department logs that were sent offsite for storage.

3. On 9/23/14 at 11 A.M., during a tour of the medical records storage room, additional storage areas were observed, in the same room separated by chain link fences, contained radiology films in radiology jackets (envelopes). During the tour, the Medical Records Director stated, "That's the Radiology Department storage area. I don't have anything to do with that."

On 9/23/14 at 11:30 A.M., during a tour of the radiology storage area, numerous storage shelves with radiology jackets were observed adjacent to a chain-link fence separating the area with another area. During the tour, the Director of Radiology stated, "The adjacent areas are engineering areas."

On 9/23/14 at 11:45 A.M., during a tour of the facility engineering area, a 5 foot tall chain-link fence was observed, separating the radiology storage area with the engineering area. Shelving, containing radiology related patient records, were observed adjacent to the chain link fence and immediately readily available to anyone on the engineering side of the fence.

During the tour, The Director of Engineering stated, "We sometimes have visitors and vendors in our area." The Director of Engineering acknowledged that anyone in the engineering area had immediate unsupervised access to all the patient records stored on the radiology shelves placed adjacent to the 5 foot tall chain link fence. The Director of Engineering also stated, "The general hospital key opens the door of the engineering area, and anyone with that key has access to this area."

On 9/24/14 at 9:40 A.M., during an observation and interview, the Director of Radiology acknowledged that there were 6 shelving units of approximately 6 feet in length and 7 feet tall, filled with radiology jackets containing patient medical records that were placed against the chain link fence, allowing access from anyone in the engineering area. The Director of Radiology stated, "There are well over three thousand records that were accessible on the shelves, and over ten thousand records in the area."

Based on closed electronic record review, staff interview, and document review, the facility failed to ensure that the Conditions of Admission (patient's consent to treatment) form was signed and in the patient's record for 3 of 3 patients (2, 14, 28). The consent had a page for a signature, however the forms were never signed during the patient's entire length of stay.

Findings:

1. The medical record for Patient 2 was reviewed 9/23/14 at 10:55 AM. The electronic record contained a page for a signature of the patient or representative giving consent for the hospital's Conditions of Admission. In the place for patient (or other) signature dated 7/13/14, was handwritten "patient unable to sign due to MC (medical condition)." The patient was in the hospital for over 48 hours with no documentation that any other attempt was made to obtain the patient's signature. The patient was discharged without a signature on the consent. The patient was admitted on 7/13/14 through the Emergency Department (ED) with a gastrointestinal (GI) bleed.

The Director of Health Information was also identified as the Director of Registration Services. She was interviewed on 9/24/14 at 1:35 PM. She stated that her expectation would be that another attempt would be made to obtain a signature within 24 hours of arriving to an inpatient unit or before discharge. She stated there was no system to attempt to obtain a signature at the earliest possible opportunity, which is the community standard. She was unable to provide information on the process for obtaining a signature on the consent if one was not obtained initially.

A policy entitled, Conditions for Admissions Signature Requirements, dated 3/2011, was reviewed on 9/24/14 at 1:45 PM.

The policy stated, "If the patient is unstable...at the time of registration...the chart will be flagged 'Need COA.' The face of the chart will be flagged, 'Patient not cleared for discharge." The policy further described how a nurse admitting, transferring or discharging a patient will notify the ED unit secretary who will then respond in person to that nursing station. There was no documentation of any of this occurring.

2. Patient 14 was admitted to the facility on 7/21/14 with a diagnosis of status-post hip replacement, per the Face Sheet. The patient was a prisoner with the State Corrections and was admitted to the facility's Forensics Unit.

The Electronic Medical Record (EMR) was reviewed on 9/23/14 at 1:30 P.M. with the Nursing Quality & Outcome Coordinator (NQOC). The consent for Conditions of Admission (COA) was not located in the record.

During an interview on 9/23/14 at 3:20 P.M., the DRA stated that, "Everybody signs a COA, even Forensics patients." The DRA acknowledged there was no COA in Patient A's record. She further stated, "It should've been there but it wasn't."

3. Review of the medical record for Patient 28 on 9/25/14 at 9:30 AM, revealed that she was admitted on 9/8/14. The signature page on the Conditions of Admission form stated "Patient unable to sign." Subsequent review of the record revealed there was no documentation to show that any attempt was made to follow up to obtain a signature of the patient or her representative. This patient did have a "Durable Power of Attorney" representative. She was discharged on 9/17/14 with no evidence of a signed "Conditions of Admission form.