Tuesday, August 15, 2017

Philly Hospital Cited in 4 Patient Deaths


By Walter F. Roche Jr.

A major Philadelphia hospital has been cited by state health regulators for failure to fully investigate the cause of four unexpected patient deaths in 2016, refusing to provide official records and refusing to allow state surveyors to interview key staffers involved in the incidents.
In a report recently posted on its web page, the Pennsylvania Health Department cited the 701 bed  Albert Einstein Medical Center for failure to comply with state and federal requirements in serious cases "involving the clinical care of a patient that results in death or compromises patient safety."
The report was the result of a site visit to the Einstein facility described as an unannounced complaint investigation in early May.
Einstein officials filed a plan of correction in which they promised to institute new patient safety protocols and to use those new standards for all serious events beginning on July 1.
The hospital, however, repeated the assertion that some of the records sought by state inspectors at the time of the inspection are "peer review, protected, privileged documents, entitled to protection under federal and state law."
Einstein officials did not respond to a request for comment.
In the first case cited a deceased patient who had been admitted in late July of 2016 was found looking pale and unresponsive on Aug. 7, 2016. Records examined by the surveyors attributed the death to "excessive sedative use leading to hypo-ventilation and brain anoxia."
In a second case an unidentified patient underwent a colonoscopy on Sept. 23, 2016 and returned "with worsening abdominal pain."
The patient had elected to leave after the procedure "against medical advice," the report states.
The patient, who had apparently suffered a colon rupture, did not survive.
In another case a patient reported to the emergency room on June 21, 2016 with "agitation and psychiatric symptoms."
The patient asked for something to eat and was given a sandwich. The nurse returned to find the patient choking. The patient subsequently expired.
State inspectors asked for records showing required reviews were performed following the death. "None were provided," the inspection report states.
Another death occurred following an esophageal intubation in February. When state surveyors asked for documentation and the results of a "root cause analysis," they were told the documents were confidential and "protected."
In addition, the report states, that no completion dates were included for "action items" set to be implemented as a result of the incidents.
Cited in the report was a requirement by licensed health facilities to "track medical errors and adverse patient events, analyze their causes and implement preventive actions and mechanisms."
Contact: wfrochejr999@gmail.com


Wednesday, April 13, 2016

Icing, Loss of Engine Cited in Fatal Nashville Plane Crash




By Walter F. Roche Jr.


A 2014 Nashville, Tenn. plane crash that took the lives of four members of a Kansas family was caused by the failure of the pilot to maintain airspeed after an engine failed on his third attempt to land the Gulfstream turboprop in icy conditions.
The fiery Feb. 3 crash killed Glenn Mull, 62, his wife Elaine, 63, and a child and grandchild of the couple.
In a lengthy and detailed report issued last month, investigators for the National Transportation Safety Board said that due to extensive damage they were unable to determine the cause of the engine failure, which apparently caused the aircraft to veer to the left.
A contributing factor, according to the report was ice accumulation "due to conditions conducive to icing."
The NTSB found that there were several reports of aircraft icing problem around the time of the crash although it was unclear how many of those reports were relayed to Glenn Mull, who was piloting the plane, owned by his cattle raising company, Mid-Kansas Agri Co.
The report describes in detail the anti-icing and de-icing equipment on the aircraft including a warning from a manufacturer that the system had to be activated before ice began to form.
"Warning: When icing conditions may be encountered, do not delay operation of the engine inlet heat systems. Turn the systems on before any ice accumulates. Engine inlet heat must be on if icing conditions exist or are anticipated," the NTSB report states, citing instructions from the manufacturer.
The Mulls , their daughter Amy Harter, 40,  and 16-year-old granddaughter Samantha, died from "multiple blunt force injuries," according to an autopsy report cited by the NTSB.
The twin engine turboprop first hit trees near the Bellevue YMCA outside Nashville and then slammed into the ground creating an 11-foot by 11-foot crater six-feet deep. It was attempting to land at the John C. Tune Airport.
Mull was traveling with his family to Nashville from Great Bend , Kan. to attend an agricultural convention. According to the report, the plane, built in 1982 and purchased by Mull's company in 2000, had been serviced and inspected just prior to the flight to Tennessee.
The report provides a detailed accounting of Mull's attempts to land the plane including a conversation with traffic controllers after one failed attempt in which he said he wanted "to do it again."
According to the report, Mull, at one point,  failed to follow the heading instructions radioed to him, but traffic controllers did not correct him because the difference was not consequential.
On the third landing try, the report states, "the airplane was on the final approach course when it veered to the left and began a descent... The airplane impacted trees and a field adjacent to a building (the YMCA)."
"The type and degree of damage to the left engine," the report states, "was indicative of an engine that was not operating with rotation consistent with a wind milling propeller at the time of impact," the report states.
Following the crash Mull was credited by some with steering the plane away from the nearby YMCA, packed with children, but the NTSB report states that the descent was "uncontrolled."

Tuesday, April 12, 2016

Dead Pilot Fixated on Taylor Swift


By Walter F. Roche Jr.


The pilot who crashed his plane on a fog bound Nashville, Tenn. runway in 2013 was drunk and fixated on Taylor Swift, perhaps explaining his fatal and unauthorized flight from Canada to mid-Tennessee.
A report from the National Transportation Safety Board concludes that Michael Callan, 45, of Windsor Canada crashed his rented plane while attempting to land in dense fog.
"Contributing to the accident was the pilot’s mental state, his impairment due to alcohol, and his decision to operate the airplane from Canada to the United States without the owner’s permission and without proper clearances for the flight," the brief report concludes. 
The Oct. 29, 2013 crash occurred in the early morning, but the wreckage on a Nashville International Airport runway was not discovered till hours late.
Callan's body was found among the charred and scattered remnants of the Cessna 172R aircraft, the pilot had rented from a Windsor flying club.
"This pilot was not supposed to be in the United States flying to Tennessee," an NTSB record states.
The NTSB investigation noted that Callan had apparently circled the airport for some two hours before making his final fatal approach. He had taken off from Windsor some nine hours earlier on a flight that was supposed to end on Pelee Island on Lake Erie within the Canadian border.
Noting that Callan was not qualified to make an instrument landing, the report states, "the pilot was unaware of the IFR (instrument only) conditions in Nashville until he arrived in the area and that, because he was not instrument rated, he was unable to safely land the airplane with no visual contact with the runway."
Callan's mysterious trip drew widespread attention when officials disclosed that he had listed Taylor Swift as his emergency contact person.
Records gathered by NTSB investigators show that Callan had named Swift on his application to the Windsor Flying Club, the organization that rented him the plane. Swift has stated through her publicist that she did not know Callan.
"He (Callan) had developed a significant interest in a celebrity who lived in Nashville," the NTSB report noted, adding that he also had "a history of repeated convictions for criminal activity."
 "Although the medical records did not include a specific psychiatric diagnosis, the pilot’s prior criminal actions and impulsive behavior are consistent with antisocial personality disorder, which likely led to his impetuous decision to fly to Nashville," the NTSB states.
The report cites an August 2012 mental health evaluation of Callan in which "he reported that he had developed a significant interest in a celebrity and had written several letters to her. According to the mental health evaluator, the letters 'have the flavor of stalking.' The celebrity of interest resided in Nashville, Tennessee at the time of the accident."
"Toxicological testing of the pilot’s blood revealed significantly elevated levels of ethanol, indicating that the pilot ingested alcohol before the accident. The alcohol likely further impaired the pilot’s judgment and his ability to fly the airplane safely in IFR (instrument only) conditions," the report adds.
An autopsy conducted by Tennessee authorities following the crash found that Callan's blood alcohol level was .081 percent, over the .080 percent Tennessee legal limit to drive a car. Federal regulations set a  .04 percent limit for aircaft operators.
The NTSB examination of the wreckage "found no mechanical malfunctions or failures that would have precluded normal operation."
Contact: wfrochejr999@gmail.com 
 






Thursday, April 7, 2016

Montco MH/MR Agency Cited for Overdoses



By Walter F. Roche Jr.


A Montgomery County agency providing services to the disabled has been cited by the state Health Department for dispensing methadone at  dosages of up to four times the amount prescribed by a physician.
In an inspection report recently made public, state inspectors cited two cases in which the wrong dose of methadone was dispensed to patients at Montgomery County MH/MR Emergency Services.
In one of those cases, according to the report, the patient was later discovered unresponsive, with a drastically reduced blood pressure and had to be rushed to a local hospital for emergency treatment.
Officials of the agency, located in Norristown, declined to respond to questions about the ultimate fate of the two patients.
In addition to the overdoses, state inspectors found several other violations of state and federal regulations including the presence of expired drugs and quality assurance deficiencies.
The facility failed to "properly discard expired medicines and supplies," inspectors found.
In the first of the overdoses, the report states that the patient was administered the overdose on Nov. 15 of last year at 5:50 p.m. The mistake was discovered later in the evening prompting the sounding of a crisis alarm.
After a doctor had ordered close monitoring of the patient, staffers discovered at 12:10 a.m. that he was experiencing labored breathing and his skin was discolored. After administering oxygen the patient remained unresponsive and was rushed to a local hospital.
A second patient, according to the report, who was supposed to receive a 40 milligram dose of methadone, was mistakenly given a 175 milligram dose.
Despite that discovery, the inspectors found, the patient was not administered a drug, Naxalone, to counter the effect of the overdose.
"Narcan was not administered even though Narcan was available on the code cart. Everyone is in agreement that Narcan should have been administered," the report states, citing subsequent interviews with agency personnel
Other violations cited included the apparent failure to get patients' consent prior to the administration of psychotropic drugs.
Another finding was the apparent failure to inform patients or their representatives of visitation rights. That was the case in 10 of 12 records reviewed, the report states.
In a plan of correction filed with the state, agency officials promised to implement new procedures to ensure that the proper doses of drugs were administered and steps to be taken in the event of an overdose.
They also promised to establish a monitoring procedure to avert any recurrences.
The inspection, listed as an unannounced federal complaint investigation, took place from Jan.27 to Jan. 28. The report was not made public until the county agency had the opportunity to respond.
According to its latest tax return, the Norristown agency had revenues of $17.1 million and expenses of $18.2 million in the most recent fiscal year.
Contact:wfrochejr999@gmail.com

Monday, February 29, 2016

Penn Related Facility Failed to Properly Report "Innappropriate Touching" Charges



By Walter F. Roche Jr.

A rehabilitation facility affiliated with Penn Medicine has been cited by the Pennsylvania  Health Department for failure to immediately report multiple patient complaints of improper touching.
The citation, based on complaints and a January on-site inspection, found that Good Shepherd Penn Partners failed to immediately report "situations that could seriously compromise the the quality of care and/or patient safety."
According to the report the initial complaints came from two clients who reported the improper touching occurred in November and December of 2015.
Good Shepherd, which calls itself "the official therapy provider for Penn Medicine," did not respond to requests for comment. It operates from facilities in Philadelphia and Bala Cynwyd.
State inspectors, responding to a complaint, visited the facility on Jan. 8.
According to the report, the initial complaint alleging improper touching was registered by a client on Nov. 8. A second client registered a similar complaint against the same employee on Dec. 18.
The report states that two Good Shepherd employees confirmed to the inspectors that the complaints had been registered and that they had not been reported to the state Health Department.
Although reports were filed with the state Patient Safety Authority, they were not entered properly, the report states.
They were re-entered properly at a later date.
According to the inspectors a third allegation of improper touching by the same employee was registered during a patient satisfaction survey conducted  by telephone in January.
In a plan of correction filed by Good Shepherd, administrators promised to report any future complaints to the state health agency promptly and "with sufficient detail."
They also promised to implement retraining  and monitoring programs to ensure future compliance.
The report does not identify the employee, identified only as "Employee 1," or what if any action was taken as a result of the complaints.
Contact: wfrochejr999@gmail.com












GOOD SHEPHERD PENN PARTNERS
Health Inspection Results For:

There are  34 surveys for this facility. Please select a date to view the survey results.

Surveys don't appear on this website until at least 41 days have elapsed since the exit date of the survey.



Initial Comments:

This report is the result of an unannounced, onsite complaint investigation [PSA16A59L (32540729) and PSA16A60L (32540863)] conducted on January 8, 2016, and completed on January 11, 2016, at Good Shepherd Penn Partners Penn Therapy & Fitness. It was determined the facility was not in compliance with the requirements of the Pennsylvania Department of Health's Rules and Regulations for Hospitals, 28 PA Code, Part IV, Subparts A and B, November 1987, as amended June 1998.













Plan of Correction:


51.3 (f) LICENSURE
NOTIFICATION

Name - Component - 00
51.3 Notification

(f) If a health care facility is
aware of a situation or the occurrence
of an event at the facility which
could seriously compromise quality
assurance or patient safety, the
facility shall immediately notify the
Department in writing.
The notification shall include
sufficient detail and information to
alert the Department as to the reason
for its occurrence and the steps which
the health care facility shall take to
rectify the situation.

Observations:


Based on a review of facility policy, the Pennsylvania Department of Health (DOH), Pennsylvania Patient Safety Authority Reporting System (PA-PSRS) and staff interviews (EMP), it was determined that the facility failed to notify the Department of Health immediately of situations which could seriously compromise quality of care and/or patient safety.

Findings include:

A review on January 11, 2016, of the facility's Patient Safety Plan 2015 dated February 17, 2015, revealed "...II. Scope and Components. ..Leadership guides the specific components of our patient safety program: education, reporting, analysis, and disclosure. ...Reporting...External. Depending on the severity of the event or incident, the appropriate authorities will be notified utilizing their specific required reporting format within the required time frame. Examples of external agencies may include, but are not limited to, the Pennsylvania Patient Safety Authority, Pennsylvania Department of Health...."

A review on January 11, 2016, of the facility's Patient Safety Plan 2015 dated February 17, 2015, revealed "IV. Patient Safety Committee...Structure and Reporting Relationships. The Specialty Hospital at Rittenhouse Patient Safety Committee is a separate committee that reports directly to the Professional Relations and Quality Oversight Committee, a subcommittee of the Board of Directors, and will address safety issues within each facility. It is the designated patient safety committee for The Specialty Hospital at Rittenhouse, Penn Therapy and Fitness..." The Specialty Hospital at Rittenouse Patient Safety Plan and designated patient Safety Officer shall govern patient safety matters at these sites so as to ensure a uniform standard of care at each."

A review on January 11, 2016, of PA-PSRS report 32540863 revealed patient allegations of "inappropriate touching " by EMP1 at Penn Therapy and Fitness, Bala Cynwyd. Patient #1 reported the allegations to the facility on November 8, 2015.

A review on January 11, 2016, of the PA-PSRS report 32540729 revealed patient allegations of "inappropriate touching" by EMP1 at Penn Therapy and Fitness, Bala Cynwyd. Patient #2 reported the allegations to the facility on December 18, 2015.

An interview conducted on January 11, 2016, at 2:55PM with EMP3 and EMP4 confirmed patient event 32540863 was reported to the facility on November 8, 2015, by Patient #1 and patient event 32540729 was reported to the facility on December 18, 2015, by Patient #2 to the facility. EMP3 and EMP4 also confirmed patient events 32540729 and 32540863 were not reported to DOH. Further interview with EMP3 and EMP4 revealed the patient events were entered into the Pennsylvania Patient Safety Authority Reporting System as incidents.

An interview conducted on January 11, 2016, at 3:05PM with EMP2 revealed that EMP2 received notification from the Pennsylvania Patient Safety Authority informing the facility that it had failed to enter patient events 32540729 and 32540863 appropriately into the PA-PSRS. EMP2 confirmed that the patient events were re-entered into PA-PSRS on January 5, 2016, as Infrastructure Failures.

An interview conducted on January 15, 2016, at 1:05PM with EMP2 confirmed that 21 patient satisfaction calls were placed to the patients of EMP1 on January 14, 2016, and January 15, 2016 by the facility. EMP2 stated that during the patient satisfaction call process a patient alleged that she had been "inappropriately touched" by EMP1. EMP2 also confirmed that an addendum to event 32540863 was added on January 18, 2016 to include this new event.














Plan of Correction:Effective January 28, 2016, the following action items were established for Good Shepherd Penn Partners Specialty Hospital at Rittenhouse, including its inpatient facility and outpatient sites ("Good Shepherd Penn Partner"):
* If Good Shepherd Penn Partners is aware of a situation or the occurrence of an event at its health care facility or any site which could seriously compromise quality assurance or patient safety, the facility will immediately notify the Department of Health in writing in accordance with the Medical Care Availability and Reduction of Error Act, 40 P.S. 1303.313 and 1303.314. The notification shall include sufficient detail and information to alert the Department of Health as to the reason for its occurrence, to the extent then known, and the steps which the health care facility shall take to rectify the situation.
* Events which potentially could seriously compromise patient care and/or patient safety will result in immediate notification to and/or consultation with the Department of Health.
-- The Corporate Patient Safety Officer will audit all incidents, Serious Events and Infrastructure Failures from January 1st, 2015 to present by February 19th, 2016 as a secondary validation that the proper event type and taxonomy, reporting and disclosure occurred. Any events that were not assigned the proper event type and taxonomy will be revised by February 19th, 2016.
-- On a monthly basis at each Patient Safety Committee ("Committee")meeting beginning in February, the events for the period will be reviewed with Committee members for the next six (6)months. The minutes will reflect that the events were reviewed and if event type and taxonomy were validated. Any events that are not thought to be assigned the proper event type will be noted in the meeting minutes and revised by the Patient Safety Officer.
* Any Good Shepherd Penn Partner employee who has the responsibility of reporting events to DOH through PA-PSRS will receive education and training for identification, timeframe, and reporting through the Pennsylvania Patient Safety Authority when next offered. This will include, but not be limited to PA-PSRS event types and taxonomy, reporting and disclosure.
-- The Corporate Patient Safety Officer has received all of the training and will serve as the Patient Safety Officer for Good Shepherd Penn Partners.
-- The Administrator of Good Shepherd Penn Partner will receive basic training from a representative of PA-PSRS by February 5th, 2016.
* Patient Safety Plan will be enhanced to reference alignment with 28 Pa Code 51.3 with regard to external reporting of events, as well as notification to and consultation with Department of Health germane to event; to be completed on or before March 30th, 2016. The enhancement will be communicated to employees and managers as well as mandatory training conducted by April 15th, 2016. To memorialize participation in the training, each employee will sign the participation roster and we will audit the participation roster to make sure all employees that require the training have participated.


Wednesday, February 10, 2016

Nashville General Won't Release Critical Report


By Walter F. Roche Jr.

Citing an exception in the state Open Records Act, officials of Nashville General Hospital are refusing to release a report which was used as partial justification for an emergency $10 million cash infusion from Metro Council.
In a letter sent today Marc Overlock, general counsel to the hospital authority, denied a request for the critical report from the Joint Commission.
Citing a provision in the Open Records Act, Overlock wrote "Because that law has an exception for documents that are deemed by state law to be confidential, we are not authorized to release that report."
The report was one of the major reasons given to Metro Council for the emergency cash infusion approved by the council last week.
Council members were provided only with a summary of that report given by the hospital Chief Executive Officer Joseph Webb. He told members the report included serious deficiencies in several areas including patient safety, infection control and staffing.
Webb said $2.4 million of the $10 million total would go to implement a corrective action plan covering the multiple deficiencies. He said accreditation was an absolute necessity.
In his response to the public records request, Overlock also cited a state licensing law that requires hospitals to gain accreditation from a federally recognized organization.
He said another section of that same statute states the reports "shall be maintained as a confidential record."
The $10 million in funding approved last week is in addition to regular budget funding of $35 million approved earlier.
In addition to the $2.4 million, Webb told council that the balance of the the new allocation would go to new strategic initiatives and a revenue shortfall.
Officials of the state Health Department said they do not get copies of the hospital accreditation inspection reports, nor do they regularly conduct their own inspections. The agency relies on the letters of accreditation issued by the federally recognized agencies.
The state law, however, does give the state Health Department to conduct its own inspections, if it so chooses.
"Such facilities may be subject to an inspection by the department," the statute states.
In other states, including Pennsylvania, hospitals are subject to annual state inspections and those reports are posted on the state health department web site.
The Joint Commission web site currently lists Nashville General as accredited with the last inspection in October of 2015. 
Contact:wfrochejr999@gmail.com 
















Sunday, January 17, 2016

Wills Eye Failed to Correct Multiple Deficiencies



By Walter F. Roche Jr.

A state agency has cited Philadelphia's Wills Eye Hospital for failing to correct a series of  deficiencies uncovered in a full licensure inspection more than six months ago.
According to an inspection report recently made public when state inspectors returned to Wills Eye in November, they found many of the same defciencies the facility had been cited for in an annual April licensure inspection and the hospital had failed to implement a promised plan of correction.
"It was determined that Wills Eye Hospital failed to correct the deficient practice and/or follow the plan of correction submitted and accepted by the department," the 26-page report states.
Among the repeat deficiencies cited was a failure to provide documentation that patients or their responsible parties had been notified of a serious event that occurred on July 22. Details of that "serious event" were not disclosed.
Contacted late last week a Wills Eye spokesperson said that a second plan of correction has been submitted to the state and is being implemented.
In the new plan of correction the hospital promised to set up a monitoring system to ensure that serious events were reported and proper notifications to patients were sent.
In a similar repeat finding, the state inspectors found that patient grievances were nor properly handled and there was no documentation the complaining patients were informed of the resulting action or findings.
The inspectors also found that Wills Eye had failed to appoint two community members to a patient safety committee. When cited for the same deficiency in April, Wills had promised to correct the problem and make the needed appointments by June 30.
Appointments to the patient safety panel were finally made in October, according to the latest plan filed with the state.
In yet another finding the inspectors found Wills Eye failed initiate disciplinary action against physicians who failed to submit required medical records within 30 days of a patient's discharge.
"A review on October 21, 2015, of the facility's Medical Records Discrepancy report dated June 19, 2015, revealed five physicians had missing signatures on operative reports greater that 30 days," the inspection report states.
 Wills, in its recent response, said a new notification and monitoring system already had been put in place to ensure records were completed within the 30 day time limit.
Contact: wfrochejr999@gmail.com








WILLS EYE HOSPITAL
Health Inspection Results For:

There are  4 surveys for this facility. Please select a date to view the survey results.
Surveys don't appear on this website until at least 41 days have elapsed since the exit date of the survey.



Initial Comments:

This report is the result of a revisit conducted on October 21, 2015, at Wills Eye Hospital as a result of a previous full state licensure survey that was conducted on April 13-14, 2015. It was determined that the facility was not in compliance with the requirements of the Pennsylvania Department of Health's Rules and Regulations for Hospitals, 28 Pa Code, Part IV, Subparts A and B, November 1987, as amended June 1998.








Plan of Correction:


101.111 LICENSURE
CORRECTION OF DEFICIENCY

Name - Component - 00
101.111 Policy

Whenever any hospital notifies the Department that it has completed a plan of correction and corrected its deficiencies, the Department will conduct a survey to ascertain completion of the plan of correction. Upon finding full or substantial compliance, as defined in 101.92(b), the Department may issue a regular license.

Observations:

Based on an unannounced on-site revisit survey completed on October 21, 2015, review of the facility's Plan of Correction (PoC), documents provided by the facility and interview with staff (EMP), it was determined that Wills Eye Hospital failed to correct the deficient practice and/or follow the PoC submitted to and accepted by the Department.

Findings include:

1. A review of 103.4 (3) Functions, Section 308, Patient Safety, Act 13-2002, revealed the facility continued to be out of compliance with this regulation. The deficient practice was identified during a full State Licensure survey conducted on April 13-14, 2015. The final anticipated PoC completion date for the citation was May 22, 2015.

A review conducted on October 21, 2015, of the facility's Patient Safety Plan revised May 6, 2015 revealed "...4. Written notification to the patient will be sent within 7 days of the occurrence or discovery of a serious event."

A review on October 21, 2015, of MR5, revealed that that the facility was unable to produce documentation that the patient or patient representative received notification of a serious event which occurred July 2015.

An interview conducted on October 21, 2015, at 11:10 AM with EMP1 and EMP2 confirmed that the facility had no documentation that the patient or patient representative had received notification of the serious event which occurred July 22, 2015.

An interview conducted on October 21, 2015, at 11:15 with EMP1 and EMP2 confirmed that the staff had not been inserviced on the revisions made to the patient safety plan nor the revisions to the patient safety hotline process.
________________________________

During the revisit survey conducted on October 21, 2015, 103.4 (3) Functions, Section 310. Patient Safety Committee. Composition, deficient practice related to the facility's failure to include two residents of the community served by the medical facility who are not agents, employees or contractors of the medical facility at the patient safety committee. The deficient practice was identified during the state licensure survey completed on April 13-14, 2015. The final anticipated PoC completion date for the citation was June 30, 2015.

2. A review of the facility's patient safety committee meeting minutes for June, July, August, September 2015, revealed that the facility failed to appoint two residents of the community to serve on the committee.

An interview conducted on October 21, 2015, at 11:45AM with EMP1 and EMP2 confirmed that two residents of the community had not been appointed to serve on the patient safety committee. Futher interview revealed that no residents of the community attended the patient safety committee meetings in June, July, August and September 2015.
______________________________



























Plan of Correction:Section 308

The Director of Nursing confirmed a letter was sent to the patient. The letter was scanned and attached in the electronic variance system.

Completed on 10/22/15

The CNO performed an audit of all serious events from 7/1/15 to 10/21/15. All records were found to be in compliance in accordance with ACT 13.

Completed on 11/1/15

The Patient Safety Plan was revised as of the Patient Safety Committee meeting on October 29, 2015 to include definitions for incident, infrastructure, infrastructure failure and serious event to provide additional guidance on what events must be reported as incidents and serious events under ACT 13.

Completed on 10/29/15

The WillsEye Committee, of the Board of Directors, will audit monthly the Patient Safety Committee minutes and PSO reports to ensure compliance with reporting of serious events in accordance with ACT 13.

Completed by 1/6/16

Hospital staff will be in-serviced on the patient safety plan and safety hotline. This will include a Power Point presentation, distribution of the Patient Safety Plan and a sign-in sheet with signatures. In-servicing of the Patient Safety Plan and patient safety hotline process will become a mandatory online training component conducted on an annual basis.

Completed on 11/17/15


Quality Assurance

The electronic variance system has been programmed to immediately notify the PSO and CNO of the filing of a serious event. The PSO will generate written notification to patients in accordance with the timeframe prescribed by the authority. The PSO will scan a copy of the letter into the electronic variance system beginning November 2015.

The Patient Safety Officer will provide monthly reports on serious events to include compliance with the 7 day notification period and follow-up to the Patient Safety Committee for review beginning November 2015.

The Chief Nursing Officer or designee will perform monthly audits of the reporting completed by the Patient Safety Officer, beginning November 2015, to ensure reporting of serious events within 24hrs and written notification to patients within 7 days. The CNO will provide a monthly summary of the audits to the Safety Committee beginning November 2015.

The Chief Nursing Officer or designee will immediately address non-compliance.

The Chief Nursing Officer will audit for 3 months then quarterly the Patient Safety Committee minutes to ensure event reports and follow-up are being reviewed beginning November 2015.

The WillsEye Committee, of the Board of Directors, will audit monthly for 3 months then quarterly, the Patient Safety Committee minutes and PSO reports to ensure compliance with reporting of serious events in accordance with ACT 13 beginning December 2015.

The Executive Committee will review for 3 months then quarterly the minutes of the Patient Safety Committee and recommendations to monitor the patient safety process beginning November 2015.

The Executive Committee will provide minutes for 3 months then quarterly to demonstrate approval of the Patient Safety Committee report to the Board of Directors beginning December 2015.

The Chief Nursing Officer and Patient Safety Officer are responsible for the Patient Safety Plan.


Section 310

The CEO and administrative team immediately interviewed and selected two community members to the Patient Safety Committee as evidenced by acceptance letters dated October 26, 2015.

Completed on 10/26/15

Both community members were present at the Patient Safety Committee meeting on October 29, 2015 as evidenced by the meeting sign-in sheet and minutes. One community member was present, and one community member was excused due to travel out of the country, at the Patient Safety Committee meeting on November 11, 2015 as evidenced by the meeting sign-in sheet and minutes.

Completed on 11/11/15

Quality Assurance

The Chief Nursing Officer or designee will audit monthly for 3 months then quarterly the minutes of the Patient Safety Committee to ensure the presence of two community members at the meeting. This began October 2015. The audits will be sent to the Executive Committee for review beginning November 2015.

Citation P0147 will be completed by January 19, 2016



103.4 (3) LICENSURE
FUNCTIONS

Name - Component - 00
(3) Take all reasonable steps to
conform to all applicable Federal,
State, and local laws and
regulations.

Observations:

Based on an unannounced on-site revisit survey completed on October 21, 2015, review of the facility's Plan of Correction (PoC), documents provided by the facility, and interview with staff (EMP), it was determined that Wills Eye Hospital failed to correct the deficient practice and/or follow the PoC submitted to and accepted by the Department.

Findings include:

1. A review of 103.4 (3) Functions, Section 308, Patient Safety, Act 13-2002, revealed the facility continued to be out of compliance with this regulation. The deficient practice was identified during a full State Licensure survey conducted on April 13-14, 2015. The final anticipated PoC completion date for the citation was May 22, 2015.

A review conducted on October 21, 2015, of the facility's Patient Safety Plan revised May 6, 2015 revealed "...4. Written notification to the patient will be sent within 7 days of the occurrence or discovery of a serious event."

A review on October 21, 2015, of MR5, revealed that the facility was unable to produce documentation that the patient or patient representative received notification of a serious event which occurred July 2015.

An interview conducted on October 21, 2015, at 11:10 AM with EMP1 and EMP2 confirmed that the facility had no documentation that the patient or patient representative had received notification of the serious event which occurred July 22, 2015.

An interview conducted on October 21, 2015, at 11:15 with EMP1 and EMP2 confirmed that the staff had not been inserviced on the revisions made to the patient safety plan nor the revisions to the patient safety hotline process.
____________________________________________

During the revisit survey conducted on October 21, 2015, 103.4 (3) Functions, Section 310. Patient Safety Committee. Composition, deficient practice related to the facility's failure to include two residents of the community served by the medical facility who are not agents, employees or contractors of the medical facility at the patient safety committee. The deficient practice was identified during the state licensure survey completed on April 13-14, 2015. The final anticipated PoC completion date for the citation was June 30, 2015.

2. A review of the facility's patient safety committee meeting minutes for June, July, August, September 2015, revealed that the facility failed to appoint two residents of the community to serve on the committee.

An interview conducted on October 21, 2015, at 11:45AM with EMP1 and EMP2 confirmed that two residents of the community had not been appointed to serve on the patient safety committee. Futher interview revealed that no residents of the community attended the patient safety committee meetings in June, July, August and September 2015.
_____________________________________________




















Plan of Correction:Section 308

The Director of Nursing confirmed a letter was sent to the patient. The letter was scanned and attached in the electronic variance system.

Completed on 10/22/15

The CNO performed an audit of all serious events from 7/1/15 to 10/21/15. All records were found to be in compliance in accordance with ACT 13.

Completed on 11/1/15

The Patient Safety Plan was revised as of the Patient Safety Committee meeting on October 29, 2015 to include definitions for incident, infrastructure, infrastructure failure and serious event to provide additional guidance on what events must be reported as incidents and serious events under ACT 13.

Completed on 10/29/15

The WillsEye Committee, of the Board of Directors, will audit monthly the Patient Safety Committee minutes and PSO reports to ensure compliance with reporting of serious events in accordance with ACT 13.

Completed by 1/6/16

Hospital staff will be in-serviced on the patient safety plan and safety hotline. This will include a Power Point presentation, distribution of the Patient Safety Plan and a sign-in sheet with signatures. In-servicing of the Patient Safety Plan and patient safety hotline process will become a mandatory online training component conducted on an annual basis.

Completed on 11/17/15


Quality Assurance

The electronic variance system has been programmed to immediately notify the PSO and CNO of the filing of a serious event. The PSO will generate written notification to patients in accordance with the timeframe prescribed by the authority. The PSO will scan a copy of the letter into the electronic variance system beginning November 2015.

The Patient Safety Officer will provide monthly reports on serious events to include compliance with the 7 day notification period and follow-up to the Patient Safety Committee for review beginning November 2015.

The Chief Nursing Officer or designee will perform monthly audits of the reporting completed by the Patient Safety Officer, beginning November 2015, to ensure reporting of serious events within 24hrs and written notification to patients within 7 days. The CNO will provide a monthly summary of the audits to the Safety Committee beginning November 2015.

The Chief Nursing Officer or designee will immediately address non-compliance.

The Chief Nursing Officer will audit for 3 months then quarterly the Patient Safety Committee minutes to ensure event reports and follow-up are being reviewed beginning November 2015.

The WillsEye Committee, of the Board of Directors, will audit monthly for 3 months then quarterly, the Patient Safety Committee minutes and PSO reports to ensure compliance with reporting of serious events in accordance with ACT 13 beginning December 2015.

The Executive Committee will review for 3 months then quarterly the minutes of the Patient Safety Committee and recommendations to monitor the patient safety process beginning November 2015.

The Executive Committee will provide minutes for 3 months then quarterly to demonstrate approval of the Patient Safety Committee report to the Board of Directors beginning December 2015.

The Chief Nursing Officer and Patient Safety Officer are responsible for the Patient Safety Plan.


Section 310

The CEO and administrative team immediately interviewed and selected two community members to the Patient Safety Committee as evidenced by acceptance letters dated October 26, 2015.

Completed on 10/26/15

Both community members were present at the Patient Safety Committee meeting on October 29, 2015 as evidenced by the meeting sign-in sheet and minutes. One community member was present, and one community member was excused due to travel out of the country, at the Patient Safety Committee meeting on November 11, 2015 as evidenced by the meeting sign-in sheet and minutes.

Completed on 11/11/15

Quality Assurance

The Chief Nursing Officer or designee will audit monthly for 3 months then quarterly the minutes of the Patient Safety Committee to ensure the presence of two community members at the meeting. This began October 2015. The audits will be sent to the Executive Committee for review beginning November 2015.

Citation P0317 will be completed by January 19, 2016



103.24 (2) LICENSURE
INVESTIGATION/ENFORCEMENT PROCEDURES

Name - Component - 00
103.24
(2) formal written complaints are recorded and investigated;

Observations:

Based on an unannounced on-site revisit survey, completed on October 21, 2015, review of the facility's Plan of Correction (PoC), documents provided by the facility, medical records (MR) and interview with staff (EMP), it was determined that Wills Eye Hospital failed to correct the deficient practice and/or follow the PoC submitted to and accepted by the Department.

Findings include:

1) During the revisit survey conducted October 21, 2015, 103.24 (2) Formal Written Complaints are Recorded and Investigated, deficient practice related to the Grievances was found to be uncorrected. The PoC was partially implemented by the facility. The PoC failed to correct the deficient practice. The deficient practice was identified during the state licensure survey completed on April 13-14, 2015. The final anticipated PoC completion date for the citation was May 26, 2015.

A review on October 21, 2015, of facility audit documentation for grievances in the months of July, August and September 2015 revealed that MR6 had documentation that a grievance was filed on July 22, 2015. The facility could not produce documentation that a written resolution had been sent to the patient or patient representative.

An interview conducted on October 21, 2015, at 12:45PM with EMP1 and EMP2 confirmed that the facility had no documentation that a written resolution had been sent to the patient or patient representative. EMP1 also confirmed that the grievance audit did not contain documentation that the written resolution had been sent to the patient or patient representative.













Plan of Correction:Section 103.24

The Patient Safety Officer sent a written resolution letter for the grievance filed on 7/22/15 to the patient and scanned it into the electronic grievance system.

Completed on 11/20/15

The CNO audited all hospital grievances from 7/1/15 to 10/21/15. All the grievances during this time period were resolved verbally with the patient and a confirmation letter was sent.

Completed on 11/5/15

The facility amended its policy 1.5.4, Patient Grievance Process. The policy states, The Patient Safety Officer may not mark a grievance closed until the Patient Safety Officer verifies, by visual confirmation of documentation uploaded to the Sklira grievance record that written resolution has been sent to the patient or patient representative.

Completed on 10/26/15

The WillsEye Committee, of the Board of Directors, will audit monthly for 3 months then quarterly, the Patient Safety Committee minutes and PSO reports to ensure that written resolution letters for grievances are sent to the patient or patient representative.

Completed by 1/6/16

The CNO Audit tool has been updated to confirm written resolution letters for grievances are sent to the patient or patient representative. The CNO will audit monthly for 6 months then quarterly.

Completed on 11/12/15




Quality Assurance

The PSO will receive all written, verbal and telephonic grievances beginning November 2015.

The PSO will monitor and document that a resolution was attempted within 24hrs. If not resolved within 24hrs the PSO will ensure a written reply sent is to patients within the 7 day period in accordance with policy 1.5.4, Patient Grievance Process beginning November 2015.

The Patient Safety Officer will provide a monthly summary report and accompanying documentation of all grievances to the Patient Safety Committee for review beginning November 2015.

The Patient Safety Officer will audit monthly metrics associated with patient grievances. Monitoring will include number of grievances, resolutions, outstanding items and trends and monthly report will be sent to the Patient Safety Committee for review beginning November 2015.

The CNO will audit the completion of the grievance process for each patient grievance for 3 months then quarterly and include this in the monthly audit submitted to the Patient Safety Committee beginning November 2015.

The WillsEye Committee, of the Board of Directors, will audit monthly the Patient Safety Committee minutes and PSO reports to ensure that written resolution letters for grievances are sent to the patient or patient representative beginning December 2015 for 3 months then quarterly.

Monthly reports will be sent from the Patient Safety Committee to the Executive Committee for approval beginning November 2015 for three months then quarterly.

The Patient Safety Officer and Chief Nursing Officer are responsible for the patient grievance process.

Citation P0370 will be completed by 2/29/16



111.25 LICENSURE
INFECTION CONTROL

Name - Component - 00
111.25 Infection Control.

There shall be procedures to control employes with infections and open lesions. Routine health examinations and infection control procedures shall meet at least the standards set forth in 7 Pa. Code § § 78.41-78.43 (Reserved). A dietician, dietetic technician, or dietetic assistant shall serve on any appropriate hospital infection control committees. These committees may be combined, and dietetic services infection control activities may be included among the responsibilities of the committee established pursuant to § 147.21 (relating to infection control).

Observations:

Based on an unannounced on-site revisit survey completed on October 21, 2015, review of facility's Plan of Correction (PoC), documents provided by the facility and interview with staff (EMP, it was determined that Wills Eye Hospital failed to correct the deficient practice and or/follow the PoC submitted to and accepted by the Department.

During the revisit survey conducted on October 21, 2015, 111.25, Infection Control, deficient practice was found to be uncorrected. The PoC failed to correct the deficient practice. The deficient practice was identified during the state licensure survey completed on April 13-14, 2015. The final anticipated PoC completion date for the citation was May 22, 2015

A review on October 21, 2015, of the facility document "Amendment to Agreement to Provide Consultant Services" dated July 8, 2015, revealed the facility failed to require a representative from dietary to serve on the Infection Control Committee.

An interview conducted on October 21, 2015, at 1:30PM with EMP1 confirmed the facility document "Amendment to Agreement to Provide Consultant Services" did not require a representative from dietary to attend the Infection Control Committee. Further interview with EMP1 confirmed there had been no corrective action taken to amend the document.






Plan of Correction:Section 111.25

A new contract was signed by the consulting dietician and WillsEye hospital on November 6, 2015 and includes the requirement of the dietician to attend the Infection Control Committee meetings.

Completed on 11/6/15

The electronic contract manager has been updated to include email notification of expiring contracts. The CNO will review the renewal of the dieticians contract to ensure attendance at the Infection Control Committee meeting is a requirement of the contract.

Completed on 11/6/15


Quality Assurance

The CNO or designee will monitor monthly for 3 months and then quarterly the attendance of the dietician at the Infection Control Committee beginning November 2015.

The CNO will report audit findings and corrective actions if needed to the Patient Safety Committee for review and recommendations beginning November 2015.

Quarterly reports will be sent from the Patient Safety Committee to the Executive Committee beginning November 2015.

Quarterly reports will be sent from the Executive Committee to the Board of Directors beginning November 2015.

The Chief Nursing Officer is responsible to ensure contractual obligations by the consulting dietician are met.

Citation P1121 will be completed by January 19, 2016



115.34 (b)(1) LICENSURE
MEDICAL RECORDS REVIEW

Name - Component - 00
115.34 (b) the medical records committee:

(1) shall review records for completeness and shall establish requirements regarding completion of medical records, including a system for disciplinary actions for those who do not complete records in a timely manner;

Observations:

Based on review of facility documentation, medical records (MR) and interview with staff (EMP), it was determined the facility failed to enforce disciplinary actions for physicians who failed to complete medical records within 30 days of patient discharge.

Findings include:

During the revisit survey conducted on October 21, 2015, 115.34 (b)(1) Medical Records Review, deficient practice related to the completion of Medical Records was found to be uncorrected. The facility failed to follow the PoC that was submitted and accepted by the Department. The deficient practice was identified during the state licensure survey completed on April 13-14, 2015. The final anticipated PoC completion date for the citation was June 15, 2015.
A review on October 21, 2015, of facility policy "Delinquent Records and Suspension Process" effective date August 1, 2013, revealed, "Policy. Records are delinquent 30 days after Date of Service or discharge from the hospital. Procedure. ...2. Any Physician and/or Licensed Independent Practitioner (LIP) with records that remain incomplete after 20 days will receive a pre-suspension letter notifying them of impending suspension as result of delinquent records. 3. A reminder letter will be sent on day 25. 4. A hold will be placed on their scheduling of admissions and/or procedures if the records are not current by day 30...8. At noon the suspension goes into effect if records are not completed."

A review on October 21, 2015, of the facility's Medical Records Discrepancy report dated June 19, 2015, revealed five physicians had missing signatures on operative reports greater that 30 days as follows:

EMP6, three forms from May 12, 2015.
EMP7, two forms from May 12, 2015.
EMP8, three forms from May 13, 2015.
EMP9, one form from May 14, 2015.
EMP10, two forms from May 14, 2015.

A review on October 21, 2015, of the facility's medical record discrepancy report dated July 2, 2015, revealed five physicians had missing signatures on dictated operative reports and missing signatures on forms other than operative reports greater than 30 days as follows:

EMP5, six missing signatures on dictated operative reports from May 26, 2015.
EMP11, one missing signature on dictated operative report from June 1, 2015.
EMP7, two forms missing signatures other than an operative report from May 12, 2015, (continued discrepancy from medical records discrepancy report dated June 19, 2015).
EMP10, two forms missing signatures other than an operative report from May 14, 2015, (continued discrepancy from medical records discrepancy report dated June 19, 2015).
EMP12, one form missing signature other than an operative report from May 26, 2015.

A review on October 21, 2015, of the facility's Executive Council Meeting minutes dated June 17, 2015 and September 16, 2015, and the Board of Directors of City Trusts Meeting minutes dated September 30, 2015, revealed that the Medical Records Discrepancy Reports for June 19, and July 2, 2015, had not been reported.

An interview conducted on October 21, 2015, at 2:45PM with EMP1, EMP3, and EMP4 confirmed that the physicians had medical record delinquencies greater than 30 days and had not received written notification for suspension of hospital privileges, nor had any of the physicians been suspended due to delinquent records greater than 30 days. Further interview with EMP1 and EMP4 confirmed that the Medical Records Discrepancy Report results dated June 19 and July 1, 2015, had not been reported to the Executive Council and the Board of Directors of City Trusts meetings.











Plan of Correction:Section 115.34

The CNO reviewed medical records from discrepancy reports dated 7/2/15 and 6/19/15 and found that all records are complete.

Completed on 10/22/15

Delinquent Records and Suspension Process policy 3.9.7 was amended to provide that the Medical Records Coordinator will prepare an interim Medical Records Discrepancy Report on the Friday of each week which will include a summary of 7-day reminder emails. This will be distributed to the CNO, the CEO, and the Ophthalmologist-in-Chief (OIC).

Completed on 10/26/15

Delinquent Records and Suspension Process policy 3.9.7 will be updated to include delinquency of medical records at 30 days in accordance with CMS conditions of participation.

Completed by 12/1/15

The amended Policy will be circulated to all members of the active medical staff by the Ophthalmologist-in-Chief (OIC).

Completed by 12/15/15

Chief Nursing Officer will educate the HIM staff on the amended policy to include a PowerPoint presentation and sign-in sheet with signatures from the HIM staff.

Completed by 12/15/15


The CNO audited 7 day medical records discrepancy reports from HIM to include 10/26/15, 11/2/15, 11/9/15 and 11/16/15. During this time period the delinquent medical records policy was followed. In August, 5 physicians were sent a total of 18 (7) day reminder emails and there were no 30 day delinquencies. In September a total of 9 physicians were sent 23 (7) day reminder emails and there were no 30 day delinquencies. In October, a total of 7 physicians received 11 (7) day reminder emails. At the time of the audit all records were found to be complete.

Completed on 11/19/15

The Medical Record Discrepancy Reports for August 2015, September 2015 and October 2015 were incorporated into a quarterly Medical Records Report. The Report was submitted at the Patient Safety Committee on November 11, 2015.

Completed on 11/11/15

The quarterly Medical Records Report was presented to Executive Committee on November 17, 2015. The report was delivered to the Board before Executive Committee by the CEO since there would have been a number of weeks before the Board meeting following the next meeting of Executive Council.

Completed on 11/17/15

The WillsEye Committee, of the Board of Directors, will audit monthly for 3 months then quarterly, the Medical Records Committee minutes to ensure that the medical records delinquency policy is being followed beginning December 2015.

Completed by 1/19/16

The Medical Records Report for August, September and October was submitted and reviewed in the November 2015 meeting of the Patient Safety Committee. The Patient Safety Committee submitted the report for review at the November Executive Committee meeting.

Completed on 11/18/15

June 2015 and July 2015 will be presented to the Patient Safety Committee at its next scheduled meeting in December 2015. The results will be sent for review to the Executive Committee December 2015 meeting. The Executive Committee will send their minutes, reflecting the review of the June and July medical records report, for the January 2016 WillsEye Hospital Board meeting.

Completed by 1/19/16


Quality Assurance

The Medical Records Coordinator will aggregate the interim Medical Records Discrepancy Reports for the prior month into a monthly Medical Records Discrepancy Report, which will be submitted to the Medical Records Committee each month beginning November 2015.

The revised CNO Audit tool requires confirmation of the Medical Records Discrepancy Report and has been extended for an additional 3 months beginning November 2015.

The CNO will provide the audit to the Medical Records Committee beginning December 2015.

The Medical Records Committee will provide recommendations to the HIM Coordinator and a summary report to the Patient Safety Committee beginning December 2015.

The Patient Safety Committee will approve any changes from the Medical Records Committee beginning December 2015.

The Patient Safety Committee will provide minutes to the Executive Committee beginning December 2015.

The WillsEye Committee, of the Board of Directors, will audit monthly for 3 months then quarterly, the Medical Records Committee minutes to ensure that the medical records delinquency policy is being followed beginning December 2015.

The CEO will provide quarterly compliance reports to the Board of Directors to include delinquency rates, holds and suspensions beginning November 2015.

The Ophthalmologist-In-Chief and CEO are responsible for the delinquent record process.


Citation P1539 will be completed by January 19, 2016