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Based on review of facility documentation and personnel files (PF), as well as employee interviews (EMP), it was determined that the facility was found to be operating with no organized Governing Body, and no Chief Executive Officer, specific to the facility.

Findings include:
(Governing Body)

1. On March 7, 2018, at approximately 1:40 PM, a review of Governing Body documents provided by the facility at that time revealed, "BYLAWS OF [Out of state health system], INC. Approved: March 29, 2017/Effective: January 12, 2018." and, "BYLAWS OF (Out of state Hospital) Approved: March 29, 2017/Effective: January 12, 2018." The Governing Body documents reflected [Out of state hospital] and (Out of state health system), and were not specific to BRMC.

2. On March 7, 2018, at approximately 7:00 PM, a review of the Governing Body Membership documentation provided by the facility revealed, "[Out of state hospital] 2018 Board of Directors," and "[Out of state health system] 2018 Board of Directors." Further review of the documentation revealed no reference to BRMC membership.

3. On March 7, 2018, at approximately 4:30 PM, a review of minutes of the Governing Body, for 2017 to present, revealed no minutes for meetings occurring after the January 12, 2018, effective date of the aforementioned ByLaws and Rules and Regulations.

4. On March 7, 2018, at approximately 7:10 PM, a review of a document titled "[Out of state health system] Board of Director's Job Description" was conducted. The documentation revealed no reference to BRMC.

5. On March 7, 2018, at 11:57 AM, a review of Medical Staff Meeting Minutes for June 13, 2017, revealed, "Administrative Report ... Merger Announcement Last week the planned merger of BRMC and [Out of state Hospital] was announced. ... The two hospitals have functioned as a single organization for the past several years and share a common IT platform and share common administrative systems and functions. Additionally, as you are aware, the two hospitals have a common Board of Directors. ..."

6. On March 7, 2018, at 11:57 AM, a review of Medical Staff Meeting Minutes for December 12, 2017, revealed, "Administrative Report ... Merger Update- Management had been working for some time on the merger of Bradford Regional Medical Center (BRMC) into [Out of state hospital]. The merger is nearing completion ... First, the merger allows the new entity to operate with a with a single Medicare provider number and become a Sole Community Hospital (SCH) ... Since the advent of [Out of state health system, the two hospitals have essentially operated as a single entity. Once the merger is completed, both hospitals will retain their names and the same service arrays and offerings."

7. On March 7, 2018, at 12:45 PM, review of Medical Executive Staff meeting minutes for June 7, 2017, revealed, "Administrative Report (EMP1) provided the following updates: Merger- In 2009 Bradford Regional Medical Center and [Out of state hospital] came together under a common parent organization with the creation of [Out of state health system]. ... The initial desire of both hospitals was to formally merge but because of issues related to expediency of regulatory approval, state authorities recommended that both hospitals initially integrate under a common parent organization. This led to the formation of [Out of state health system]. This model has served both hospitals well over the last seven and a half years ... Additionally, the two hospitals, because of common boards of directors, information technology platforms and other administrative systems, function essentially as a single organization."

8. At approximately 1:50 PM on March 7, 2018, when asked if the Governing Body Bylaws provided to the survey team were individual to each facility or the same for both, EMP2, stated, "The idea is to be under one Medicare Provider Number. ... That's for both, it's for both [the Governing Body Bylaws]." When asked if the facility has a separate Governing Body Committee, or if it is combined with (Out of state hospital), EMP2 stated, "We're going to have one. ... We have one [combined Governing Body Committee]. ... We've always had one, but we did separate minutes. ... I'm not sure now [if minutes are separate], because I'm not sure if Medicare requires it [separate minutes]. ..."

9. When asked, at approximately 12:35 PM on March 8, 2018, if there is only one Governing Board for BRMC and (Out of state hospital), EMP7 stated, "There has always been only one Board ... but now since we are merged, they do just one [meeting]. ... And our Board chair, is on the Board at [Out of state health system]. ... Because Bradford Hospital no longer exists. ... We are [Out of state hospital], doing business as Bradford. ... We are one entity. ... We're just a satellite."


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Findings include:
(Chief Executive Officer)

1. On March 7, 2018, at 10:25 AM, a review of the web-pages for BRMC and (Out of state hospital) identified EMP1 as the CEO of both facilities.

2. On March 7, 2018, at 10:25 AM, a review of a document titled, "[Out of state health system] Bradford Regional Medical Center Organization Chart," revised December 2017, was conducted. The document revealed EMP1, directly reporting to the Board of Directors. The document further revealed a direct reporting line from "[Out of state health system] Services Planning, IT, HR, Finance, Communications/Mktg, Quality/Professional Affairs, Materials Management." Review of individual positions directly reporting to the (Out of state health system) Shared Services [then to EMP1], revealed the following positions: Director of Operations; Pharmacy System Director; Clinical Laboratory Director; Clinical Education; Infection Preventionist and MD recruitment.

3. When asked, at approximately 9:26 AM on March 8, 2018, for the CEO's personnel file (PF12), EMP9 stated, "I didn't bring that one. I will go get it. ... I have condensed files on executives that are not on Bradford's payroll. ..." One of the files identified as condensed/not on Bradford's payroll, was the personnel file for EMP1, President and CEO of BRMC.

4. At approximately 9:29 AM on March 8, 2018, EMP9 stated, "Obviously you can see that what I have for managers, they [personnel files] are a little thicker than the executive files. ... The executives ... on the [Out of state hospital's payroll]. ... I don't have access to their payroll information." When asked to confirm that the CEO of BRMC is not on the payroll for BRMC, EMP9 stated, "Correct. ... [Out of state hospital's] payroll. ..." While reviewing PF12, EMP9 stated, "If there's something you want to see that's not there, I can call, and they can send it over [From out of state hospital]. ..."

5. On March 8, 2018, at approximately 9:35 AM, review of PF12 revealed an enclosed resume reflecting EMP1 as the President and CEO of (Out of state health system), as well as President and CEO of (Out of state hospital) from 2009 to present. The following documents in the file were all identified as (Out of state hospital) forms not BRMC forms: New Employee Orientation Check-List, signed January 9, 2006; "Standards of Behavior", signed January 23, 2006; and "Information/Data Access Agreement and Confidentiality Statement", signed January 9, 2006. The file further contained an evaluation from the Governing Board. The evaluation had no signature and was headed, "[Out of state health system]."

6. On March 8, 2018, at 9:45 AM, when asked why the identified forms for EMP1 reflected (Out of state hospital) and not Bradford Regional Medical Center, EMP9 stated, "My understanding is if you have access to both places, it's all the same."

7. On March 8, 2018, at approximately 12:35 PM, EMP7 and EMP18, confirmed EMP1 to be the CEO of both facilities, BRMC and (Out of state hospital).

Based on review of facility documentation, facility tour, and employee interviews (EMP), it was determined that the facility failed to ensure that medical records were properly filed and retained in order to protect medical records from damage.

Findings include:

Review, at approximately 1:57 PM on March 8, 2018, of Policy 9400.016, "Security and Confidentiality of Medical Records and Health Information," revised February 28, 2018, revealed, "... 1) Statement of Policy: a) It is the legal and moral responsibility of the Bradford Regional Medical Center to maintain adequate safeguards and controls to prevent loss ... and protection from potential damage by fire and water for all medical records housed by the facility ... i) The Health Information Management employee using the storage area will be constantly aware of any problems with water leakage or potential fire hazards. ..."

1. At approximately 10:00 AM on March 8, 2018, a tour was conducted of the medical records storage area. The area was equipped with rolling shelf storage shelves that were approximately 192 feet long, seven feet high, and four feet wide, with storage capability on both sides of the shelves. Two double-sided shelves were identified as having hospital medical records stored in them. The shelves with medical records were noted to be open, and unsecured. The room was also noted to be non-sprinklered, with fluorescent lighting.

2. At approximately 10:05 AM on March 8, 2018, during the tour of the room, EMP7 confirmed that the room was non-sprinklered. When identified that if there was a fire in the room, the medical records would not be protected from loss, EMP10 stated, "Is there a reg [regulation] for that?"

Based on review of facility documentation, facility tour, and employee interviews (EMP), it was determined that the facility failed to ensure mislabeled, or otherwise unusable drugs and biologicals were not be available for patient use ten out of ten pre-filled syringes in Operating Room (OR) 3.

Findings include:

Review, at approximately 9:00 AM on March 8, 2018, of 113.203 "Labeling of Medications," revision date April 2017, revealed, "... 2. Pre-poured or Pre-drawn Medications: Medications should remain in their original containers until administered to the patient. In event that it is necessary to pre-pour a liquid or pre-draw a syringe, all medications, syringes, medication containers, and/or solutions removed from the original container must be labeled with the drug name, strength, expiration date, time, and volume when applicable. If prepared by an individual that is not the same as the individual administering the medication, then the patient's name, location, and directions for use must also be affixed to the label. ..."

Review, at approximately 2:00 PM on March 14, 2018, of "Bradford Regional Medical Center Upper Allegheny Health System: In-Service Education Attendance Record," dated March 7, 2018, revealed, "... Program/Topic: Medication Safety: Labeling Syringes ... Policy Review. Name: [EMP14], [EMP28], [EMP29], and [EMP30] ... MEDICATION SAFETY: "Labeling Syringes" ... If a Medication is drawn up into syringe, and is not going to be immediately administered: You must label the syringe! Label Must Contain: Patient Name; Drug and Amount; Prepared Date and Time; Prepared by; Expiration Date and Time ... Bradford Regional Medical Center policy 113.203 "Labeling Medications" located on Policy Medical ... Medication Safety Initiative states: "No unlabeled syringes or containers anywhere ever! ..."

1. At approximately 10:10 AM on March 7, 2018, ten out of ten syringes were found to be inadequately labeled in the OR3 Anesthesiology Cart. The following syringes were identified: three syringes labeled with only Versed; four syringes that were white in color without any labeling; and three syringes labeled with only Fentanyl.

2. EMP5, EMP7 and EMP14 confirmed the above observation, and EMP14 further stated, "The white syringe is Propofol its the only white medication that I would use. I drew them up this morning to prepare for all of my patients today. I know there is a policy on labeling syringes, but this is a complete screw up on my part."

Based on review of facility documentation, observations, and employee interviews (EMP), it was determined that the facility failed to ensure supplies and equipment were maintained to ensure an acceptable level of safety and quality.

Findings include:

(Supplies)

Review at approximately 2:50 PM on March 7, 2018, of 100.042 "Supplies Not Controlled by Materials Management- Disposals/Recalls," revised February 23, 2018, revealed, "... 1) Statement of Policy: a) All supplies used for any patient care modality that are not under the control of the Materials Management Department are monitored for outdates, contamination, or department necessity. ... c) Each department director/manager or designee will be responsible for conducting an audit of the supplies identified in #1 on a monthly basis for outdates, contamination, or necessity in the department. ... 4) Procedure: ... b) Any expired supplies will be removed from the storage room and disposed in medical waste ..."

1. At approximately 10:23 AM on March 7, 2018, the following supplies with associated expiration dates were identified within the Emergency Department's (ED) supply cart: one 6 Inch (15 cm) Approximately 1.5 mL Trifuse Ext. Set 4 Clamps - "January 2018;" one Laceration Tray Stainless Steel Instruments: Syringe and Needle - "July 2017;" two 4 inch by 4 inch gauze sponge - "10/2015," "06/2016;" one Transpac IV Monitoring Kit - August 2017; two 4 French (1.3 mm) 11 cm Super Sheath - "6/2016," "11/2015;" one 6 inch (15 cm) Approximately 1.5 mL Non-DehpTrifuse Ext. Set - "April 2016;" one 5 French (1.7 mm) 11 cm Super Sheath - "November 2015;" and one Suture Removal Kit - "January 2018."

EMP5, EMP7, and EMP13 confirmed the above findings at the time of observation, and EMP5 further stated, "There shouldn't be expired supplies in there, the nurses just checked the carts in January, but there is nothing official stating that nursing has checked the carts."

2. At approximately 10:33 AM on March 7, 2018, in the ED, there was a storage cupboard. Within the cupboard, the following supplies with associated expiration dates were identified; one Cuffed Nasal Tracheostomy Tube - "September 2017;" one Pneumothorax Set - "December 25, 2017;" and one Vaseline Petrolatum Gauze Tube Foil - "February 2018."

EMP5 and EMP7 confirmed the above findings at the time of observation.

3. At approximately 11:05 AM on March 7, 2018, the following supplies with associated expiration dates were identified within Exam Room 9 in the ED: one open Yankauert - "01/2018"; one 7.5 cm Ant/Posterior Rapid Rhino - "June 2017;" one open Xeroflo Gauze Patch - "November 2012;" one Xeroflo Gauze Patch - "November 2014;" one Tonsil Sponge - "January 2018."

EMP5 and EMP7 confirmed the above findings at the time of observation.

4. At approximately 11:14 AM on March 7, 2018, the following supplies with associated expiration dates were identified within the Intensive Care Unit: one 6 inch (15 cm) Approximately 1.5 mL Trifuse Extension Set - "January 2018;" one size 7 ½ Sterile Surgical Gloves - "March 2016;" and two size small Powder Free Vinyl Exam Gloves - "8/2014," "7/2014".

EMP5 and EMP7 confirmed the above findings at the time of observation.

5. At approximately 11:40 AM on March 7, 2018, the following supplies with associated expiration dates were identified in Central Sterile Processing: one MiniSpike Dispensing Pin - "September 2006."

EMP5 provided confirmation of the findings at the time of observation.


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(Central Sterile Processing-Equipment Preventative Maintenance)

Review, at approximately 8:10 PM on March 7, 2018, of "Subject: Sole Source- [manufacturer]," no date, revealed, "... Routine Maintenance: Steam Sterilizers - two PM inspections annually; ... Ultrasonic- Floor Models - two PM inspections annually ..."

1. Review, at approximately 8:00 PM on March 7, 2018, of sterilizer performance maintenance documentation provided by EMP5 on March 7, 2018, at approximately 12:00 PM, revealed, "[Preventative Maintenance Contractor] Report: B100592-STERILIZERS/CENTRAL PROCESSING, AMSCO, SC1224CD, STERILIZER, ULTRASONIC CLEANER," dated July 7, 2016, through December 27, 2017, revealed, that the facility failed to ensure performance maintenance checks were being completed two times annually for the 2017 calendar year.

2. When asked, at approximately 9:49 AM on March 8, 2018, if the facility could provide documentation of the second 2017 performance maintenance invoice, EMP10 stated, "EMP5 gave you all of the performance maintenance invoices that we had. We do not have documentation for July 2017."

Based on review of facility documentation, and employee interviews (EMP), it was determined that the facility failed to ensure the infection control officer identified, reported, and investigated infections and communicable diseases of patients, as defined by facility policy, for six of eight medical records (MR3, MR5, MR6, MR7, MR8, MR9).

Findings include:

Review, at approximately 1:00 PM on March 7, 2018, of 110.006 "Event (Incident) Reporting," revision dated January 26, 2018, revealed, "... 4) Procedure: Notification: A non-punitive process of relaying event information to Risk Management for follow up and process improvement of patient safety. ... e) The patient or the patient's family will be notified in writing of a serious event including health care associated infections within seven days of confirmation of the event. ..."

1. Review, at approximately 7:12 PM on March 6, 2018, of MR3, "IC Summary," revealed documentation of a positive blood culture report for K. Pneumonia (Klebsiella Pneumonia) on September 18, 2017. Further review revealed documentation of a letter being sent to the patient on October 2, 2017, fourteen days later.

EMP10 provided confirmation of this finding at approximately 9:50 AM on March 7, 2018.

2. Review, at approximately 7:13 PM on March 6, 2018, of MR6, "IC Summary," revealed documentation of a positive C.Diff result on December 25, 2017. Further review revealed documentation of a letter being sent to the patient on January 5, 2018, eleven days later.

EMP10 provided confirmation of this finding at approximately 9:50 AM on March 7, 2018.

3. Review, at approximately 7:14 PM on March 6, 2018, of MR7 "IC Summary," revealed documentation of a positive C.Diff result on August 29, 2017. Further review revealed documentation of a letter being sent to the patient on September 15, 2017, seventeen days later.

EMP10 provided confirmation of this finding at approximately 9:50 AM on March 7, 2018.

4. Review, at approximately 7:15 PM on March 6, 2018, of MR5 "IC Summary," revealed documentation of a positive Staph aureus abdominal culture on December 10, 2017. Further review revealed documentation of a letter being sent to the patient on January 5, 2018, 26 days later.

EMP10 provided confirmation of this finding at approximately 9:50 AM on March 7, 2018.

5. Review, at approximately 7:17 PM on March 6, 2018, of MR "IC Summary," revealed documentation of a MRSA positive right hip tissue and incision culture on July 13, 2017. Further review revealed documentation of letter being sent to the patient on July 21, 2017, eight days later.

EMP10 provided confirmation of this finding at approximately 9:50 AM on March 7, 2018.

6. Review, at approximately 7:18 PM on March 6, 2018, of MR9 "IC Summary," revealed documentation of a positive efoecalis knee culture on July 1, 2017. Further review revealed documentation of a letter being sent to the patient on July 11, 2017, ten days later.

EMP10 provided confirmation of this finding at approximately 9:50 AM on March 7, 2018.

7. When asked, at approximately 12:10 PM on March 7, 2018, why the identified delays between identification of a hospital-acquired infection and sending the letters to the patients occurred, EMP10 stated, "See you have to understand that it takes at least three days for me to find out about a positive healthcare associated infection; and there's a delay when I am off for the holiday or vacation. This is why it takes so long for me to get the letter to the patient and patient's family." A request was made for EMP10 to provide documentation of investigation into the hospital-acquired infection, that would lead to a confirmation date later than a positive test result date. At the time of the survey Exit, at 3:25 PM on March 8, 2018, EMP10 had not provided any additional documentation to indicate that the confirmation of positive test results were later than the Infection Control files revealed.