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Based on observation, review of facility documents and staff interview (EMP), it was determined the facility failed to ensure patient safety was maintained for four out of four multidose medication vials and one out of one antiseptic solution container.

Findings include:

Review on November 6, 2019, of facility policy "Medication Vials," last revised and reviewed November 1, 2017, revealed "Purpose: To provided parameters for appropriate use and beyond use dates for medication vials. Policy: Single dose and multiple dose vials will be used and discarded according to the provisions of the policy. Procedures: ... 5. Multiple dose vials should be labeled with a beyond use date (BUD), not to exceed 28 days, when the stopper is initially punctured."

Review on November 6, 2019, of facility policy "Medication Expiration Dates," last revised and reviewed November 1, 2017, revealed "Purpose: To define beyond use dates for opened medication containers so that drug sterility and stability will be maintained. Policy: All medications will be assigned a beyond use date when they are opened. No medication will be used after it has reached its beyond use date. Procedures: ... 5. Multi-Dose vials (injectable and inhalation agents that can be used on multiple patients) will be discarded 28 days after first use unless the manufacturer specifies a shorter date. If contamination is suspected the product should be discarded immediately. All multiple use vials will be assigned a beyond use date when the vial cap is removed or otherwise opened. The date will be the last date the product can be used. Multiple dose vials should be discarded if found to be opened and no beyond use date has been assigned. ... 9. Antiseptic Solutions (e.g. Hydrogen Peroxide, alcohol, Dakin's Solution) a) Upon first use of an antiseptic solution the container will be labeled with a beyond use date. The beyond use date will be 90 days or the manufacturer's expiration date, whichever comes first. If contamination is suspected the product should be discarded. ..."

Review on November 6, 2019, of facility policy "Medication Storage Area Inspections," last revised November 2017, revealed "Purpose: To establish parameters for inspection of drug storage areas ... 12. Storage of Insulin ... b) Insulin vials will be dated with a 28 day Beyond Use Date by nursing personnel when opened. c) Opened, dated vials may be stored at room temperature for 28 days ..."

Observation in the Emergency Department on November 4, 2019, at 9:55 AM, revealed one uncapped, vial of Lidocaine (anesthetic) and one vial of Bupivicaine (anesthetic) with no beyond use dates located in a laceration cart. Further observation in the laceration cart revealed an open container of Hydrogen Peroxide with no beyond use date

Interview with EMP7 on November 4, 2019, at 9:55 AM, confirmed the Lidocaine and Bupivicaine vials had been in the laceration cart and were uncapped and undated. EMP7 confirmed the Lidocaine and Bupivicaine were both multidose vials. EMP7 confirmed when any multidose vial is opened staff are to label the vial with the beyond use date, which is 28 days from when opened. Continued interview with EMP7 confirmed the Hydrogen Peroxide container was open and undated. EMP7 confirmed the Hydrogen Peroxide container was a multidose container. EMP7 confirmed when any multidose container is opened staff are to label the container with the beyond use date.

Observation on November 4, 2019, at 11:00 AM, revealed an uncapped vial of Lidocaine with no beyond use date located in a second laceration cart.

Interview with EMP7 on November 4, 2019, at 11:00 AM, confirmed the Lidocaine vial had been in the laceration cart and was uncapped and undated. EMP7 confirmed when any multidose vial is opened staff are to label the vial with the beyond use date, which is 28 days from when opened.

Observed during a tour of the Intensive Care Unit on November 5, 2019, revealed an opened multidose vial of insulin with no beyond use date.

Interview with EMP8 on November 5, 2019, at approximately 9:30 AM, confirmed the opened multidose vial of insulin had no beyond use date.

Based on observation and staff interview, it was determined the facility failed to ensure supply bins were 18 inches below sprinkler deflectors in the ceiling in a storage area and a clean supply area.

Findings include:

Request on November 4 and 5, 2019, for a facility policy and procedure regarding storing items on shelves under sprinklers revealed the facility had no policy regarding this. The facility provided documentation of regulations they use regarding sprinkler obstructions.

Review of "ASHE: LS.02.01.35 Sprinkler obstructions" revealed "Focus on LS.02.01.35-Sprinkler obstructions LS.02.01.35 EP 6 requires that there are 18 inches or more of open space maintained below a sprinkler deflector to the top of any storage. ... it is essential to ensure that there are not any obstructions within 18 inches of the sprinkler head to allow for proper distribution of water. ..."

Observation on November 4, 2019, at 11:10 AM, revealed a clean storage area with five bins located approximately six inches below the ceiling. Further observation at 11:30 AM, revealed a clean supply room with one bin located approximately three inches below the ceiling and four bins located approximately six inches below the ceiling.

Interview with EMP7 and EMP3 on November 4, 2019, at 11:10 AM, confirmed the clean storage area with five bins approximately six inches below the ceiling.

Interview with EMP7 and EMP3 on November 4, 2019, at 11:30 AM, confirmed the clean supply room with one bin located approximately three inches below the ceiling and four bins located approximately six inches below the ceiling.

Based on review of facility policies, observation and staff (EMP) interview, it was determined the facility failed to ensure acceptable quality supplies were available for immediate use in the pain clinic and the Emergency Department and the facility failed to have a policy to check for expiration dates on inventory supplies.

Findings include:

Review of facility policies with EMP13 on November 8, 2019, confirmed there were no policies to check for expiration dates on inventory supplies.

Review on November 6, 2019 of facility policy "Emergency Supplies," last revised on December 6, 2018, revealed "Purpose: The purpose of this policy is to outline the steps required to ensure the ready availability of adequate and appropriate supplies, equipment and drugs for emergency situations. Policy: This policy will ensure the ready availability of adequate and appropriate supplies, equipment and drugs for emergency situations. Procedures: 1. Outcome Criteria a) The Emergency Room shall check the Emergency cart twice daily. b) All other areas in the hospital shall check the Emergency Cart daily. ... e) A log shall be maintained to record daily checks ..."

Observational tour in the pain clinic with EMP2 and EMP12 on November 8, 2019, at 10:40 AM revealed approximately 15 orange-top blood collection tubes that had expiration dates of August 2019.

Interview with EMP12 on November 8, 2019, confirmed the blood collection tubes were expired and indicated the orange-top blood collection tubes were used to draw blood samples for pregnancy tests prior to the start of pain management.

Observation of the Emergency Department Ebola cart on November 4, 2019, revealed 11 out of 11 Ebola Breathable High Performance gowns with the expiration date of October 31, 2019.

Interview with EMP7 on November 4, 2019, at 11:05 AM, confirmed the Emergency Department staff are to check the Ebola cart monthly for expired items and restock as needed. Further interview with EMP 7 confirmed EMP7 was not aware of a policy and procedure on expired supplies.

Interview with EMP3 on November 4, 2019, at 11:10 AM, revealed the facility has no specific policy and procedure for expired supplies. Further interview with EMP3 on November 6, 2019, at 11:15 AM, confirmed the facility has no specific policy and procedure for expired supplies.

Review on November 4, 2019, of the Emergency Department emergency carts daily checklists for January 1, 2017 through September 30, 2019 revealed these cart checks are to be completed twice a day. Further review revealed a daily checklist for each shift, 7AM-3PM, 3PM-11PM and 11PM-7AM . The Adult Code Cart (Red Cart) South Hall checklists revealed no documentation two checks were completed on June 27, 2019. The Adult Airway Cart (Blue Cart) checklists revealed no documentation two checks were completed on December 27, 2018, March 25, 2019 and May 3, 2019. The Adult Code Cart (Red Cart) Room #17 checklists revealed no documentation two checks were completed on March 6, 2017, May 3, 2019 and July 6 and 7, 2019. The Peds Broselow Cart Room #17 checklists revealed no documentation two checks were completed on May 3, 2019.

Interview with EMP7 on November 4, 2019, at 11:00 AM, confirmed the Emergency Department emergency carts daily checklists are to be completed twice a day. The daily checklists are for each shift, 7AM-3PM, 3PM-11PM and 11PM-7AM. EMP7 confirmed each shift is to check the carts even though the policy states twice a day. EMP7 confirmed the Adult Code Cart (Red Cart) South Hall checklists had no documentation of two checks completed on June 27, 2019, the Adult Airway Cart (Blue Cart) checklists had no documentation of two checks completed on December 27, 2018, March 25, 2019 and May 3, 2019, the Adult Code Cart (Red Cart) Room #17 checklists had no documentation of two checks completed on March 6, 2017, May 3, 2019 and July 6 and 7, 2019 and the Peds Broselow Cart Room #17 checklists had no documentation of two checks completed on May 3, 2019. EMP7 confirmed each of the noted days had only one check completed on those days.

Review on November 5, 2019 of the Cardiac Lab PACU (post-anesthesia care unit) emergency code cart daily checklists for January 1-November 4, 2019 revealed these checklists had no documentation of a check completed on January 19 and 20, March 1 and 29, May 10, August 3 and September 20 in 2019. The code cart daily checklists for Cath Lab 1 had no documentation of a check completed on May 24 and September 2, 2019 and the code cart daily checklists for Cath Lab 2 had no documentation of a check completed on March 13-15, 18-21, 25-29 and April 1-5, 8-12, 15-19 and 22-23, 2019.

Interview with EMP8 on November 5, 2019, at 3:20 PM, confirmed the Cardiac Lab PACU emergency code daily checklists had no documentation of a check completed on January 19 and 20, March 1 and 29, May 10, August 3 and September 20, 2019, the Cath Lab 1 emergency code daily checklists had no documentation of a check completed on May 24 and September 2, 2019 and the Cath Lab 2 emergency code daily checklists had no documentation of a check completed on March 13-15, 18-21, 25-29 and April 1-5, 8-12, 15-19 and 22-23, 2019. Continued interview with EMP 8 confirmed the emergency code checklist is to be checked daily.

Interview with EMP8 on November 5, 2019, at 2:20 PM, revealed the defibrillator battery charge user test was not being completed unplugged as checked on the Code Cart Daily Checklist. EMP8 confirmed staff do not check the defibrillator unplugged.

Interview with EMP14 on November 5, 2019, a t 2:25 PM, confirmed the defibrillator battery unplugged test was not being completed.

Based on review of facility documents, observation and staff interview, it was determined the facility failed to ensure patient safety was maintained by monitoring patient nutrition refrigerator/freezer and blanket/fluid warmer temperatures daily on two nursing units.

Findings include:

Request on November 4, 2019, and November 6, 2019, for a facility policy and procedure regarding monitoring of patient nutrition refrigerator temperatures revealed the facility had no policy and procedure for monitoring patient nutrition refrigerator temperatures.

Review on November 6, 2019 of facility policy "Warming Cabinets for Blankets and Solutions," last reviewed May 2019, revealed "Purpose: To ensure that patient care items that are warmed prior to use meet appropriate/safe temperature standards. Policy: This policy outlines the appropriate use of warming cabinets and safe monitoring of warming cabinet temperatures to ensure their safe use in patient-care areas. Warming cabinets will only be used for blankets and appropriate fluids, and will be maintained, utilized and monitored in such a manner to minimize the risk of thermal injury to patients and staff. Procedure: 1. General Instructions: ... f) Monitoring and documenting the temperature of warming cabinets to verify that the temperature settings are maintained within specific limits including: i. Blankets: 1. Monitoring and documenting the temperature will be performed daily and recorded on the Blanket Warmer temperature log by the department. ... ii. Irrigation/IV solutions: 1. Monitoring and documenting the temperature will be performed daily and recorded on the Irrigation/IV Solutions Warmer temperature log by the department. ..."

Review of the patient nutrition refrigerator/freezer temperature logs in the Emergency Department on November 4, 2019, revealed no documentation of the refrigerator temperature on November 4 and 22, 2018; no documentation of the refrigerator temperature on January 17, 2019, March 16, 2019, March 23, 2019, and June 14, 2019; and no documentation of the freezer temperature on March 25, 2019 and June 20, 2019.

Interview with EMP7 on November 4, 2019, at 10:00 AM, confirmed the patient nutrition refrigerator and freezer temperatures are to be monitored daily. EMP7 confirmed there was no documentation of refrigerator temperatures on November 4 and 22, 2018, January 17, 2019, March 16 and 23, 2019, and June 14, 2019, and no documentation of freezer temperatures on March 25, 2019, and June 20, 2019.

Review of the patient nutrition refrigerator/freezer temperature log in the Cardiac Cath Lab on November 5, 2019, revealed the refrigerator temperature is to be monitored daily. Further review revealed no documentation of refrigerator temperatures on January 23 and 27, 2019, February 7, 18, 23 and 24, 2019, May 5 and 20, 2019, June 1, 2 and 9, 2019, September 2, 2019, and October 2, 2019.

Interview with EMP8 on November 5, 2019, at 2:00 PM, confirmed the patient nutrition refrigerator temperature is to be monitored daily. EMP8 confirmed the refrigerator temperature logs for January 23 and 27, 2019, February 7, 18, 23 and 24, 2019, May 5 and 20, 2019, June 1, 2 and 9, 2019, September 2, 2019, and October 2, 2019, had no documentation of refrigerator temperatures.

Interview with EMP3 on November 4, 2019, at 3:10 PM, and November 6, 2019, at 11:AM, confirmed the facility does not have a specific policy for monitoring the patient nutrition refrigerator and freezer temperatures.

Review of the blanket/fluid warmer temperature log in the Emergency Department on November 4, 2019, revealed no documentation of the temperature for the blanket warmer (located on the bottom of the warmer) on March 1 and 30, 2017, November 4, 2018 and April 11, June 4-10 and 24, and July 19, 2019. Further review revealed no documentation of the temperature for the fluid warmer (located on the top of the warmer) on January 6, March 1 and 30, and August 13 and 14, 2017, November 4, 2018 and April 11, June 5-10 and July 19, 2019.

Interview with EMP7 on November 4, 2019, at 11:40 AM, confirmed the blanket/fluid warmer log in the Emergency Department with no documentation of the temperature for the blanket warmer on March 1 and 30, 2017, November 4, 2018 and April 11, June 4-10 and 24, and July 19, 2019. Further interview confirmed no documentation of the temperature for the fluid warmer on January 6, March 1 and 30, and August 13 and 14, 2017, November 4, 2018 and April 11, June 5-10 and July 19, 2019. EMP7 confirmed the blanket warmer and fluid warmer temperatures are to be documented daily.

Review of the small blanket warmer temperature log in the Emergency Department on November 4, 2019, revealed no documentation of the temperature on July 30, and November 3, 4 and 23, 2018 and February 11, May 17 and 24 and June 7, 2019.

Interview with EMP7 on November 4, 2019, at 11:50 AM, confirmed the small blanket warmer log in the Emergency Department with no documentation of the temperature on July 30, and November 3, 4 and 23, 2018 and February 11, May 17 and 24 and June 7, 2019. EMP7 confirmed the small blanket warmer temperature is to be documented daily.

Review of the blanket warmer temperature log in the Cardiac Lab Unit on November 5, 2019, revealed no documentation of the blanket warmer temperature on January 6 and March 14, 2017, July 6, 20 and 26, August 17 and 31, October 31, December 27, 2018 and February 2 and 7, March 1, May 30, July 4 and 5, August 6 and 8, September 2 and 6, October 5, 6, 11 and 18, 2019.

Interview with EMP8 on November 5, 2019, at 2:10 PM, confirmed the blanket warmer temperature log in the Cardiac Lab Unit with no documentation of the blanket warmer temperature on January 6 and March 14, 2017, July 6, 20 and 26, August 17 and 31, October 31, December 27, 2018 and February 2 and 7, March 1, May 30, July 4 and 5, August 6 and 8, September 2 and 6, October 5, 6, 11 and 18, 2019. EMP8 confirmed the temperature is to be monitored daily.

Based on a review of facility policy and medical records (MR) and staff (EMP) interview, it was determined the facility failed to ensure staff followed the facility policy regarding documentation of consent for tissue and eye donation in two of two medical records (MR41 and MR42).

Findings include:

Review on November 6, 2019, of facility policy "Organ/Tissue Donation," effective December 20, 2019, revealed "Purpose: The purpose of this policy is [sic] comply with PA ACT 102 and CMS when referring deaths to the [name of organization]. ...Procedures: 1. Responsibilities: a) In accordance with PA ACT 102 and CMS, Evangelical Community Hospital must...iii. Maintain a copy, in the patient's medical record, of any document authorizing an anatomical gift...v. In absence of a document of a gift, consent from the appropriate person, as listed above must be secured prior to donation of organs, tissue or eyes. Consent may be obtained before or after death. Consent shall be obtained either in writing, telegraphic, recorded telephonic consent or through other recorded message. A copy of the consent will become part of the patient's medical record..."

Review on November 6, 2019, of facility form "Certificate of Referral/Request for Anatomical Donations" revealed "policy ...Outcome of consent...Consent Given If consent is given, a separate consent form must be signed denoting which anatomical gifts have been donated and placed in the patient's medical record..."

Review of MR41 on November 6, 2019, revealed MR41 was admitted to the Emergency Department (ED) on September 25, 2019, in cardiac arrest. Time of death was documented at 11:53 AM. MR41 was referred to [name of organization] at 12:40 PM. The patient met preliminary criteria for donation of tissue and eyes/cornea. Review of MR41's "Certificate of Referral/Request for Anatomical Donations" revealed consent was given. There was no documentation in MR41 of a separate consent form denoting which anatomical gifts had been donated.

Review of MR42 on November 6, 2019, revealed MR42 was admitted to the ED on January 19, 2019, in cardiac arrest. Time of death was documented at 2:03 PM. MR42 was referred to [name of organization] at 3:40 PM. The patient met preliminary criteria for donation of tissue and eyes/cornea. Review of MR42's "Certificate of Referral/Request for Anatomical Donations" revealed consent was given. There was no documentation in MR42 of a separate consent form denoting which anatomical gifts had been donated.

Interview with EMP11 on November 6, 2019, at approximately 2:40 PM, confirmed separate consents for anatomical donation were not present in MR41 and MR42.

Based on a review of the facility documentation, medical record (MR) review, observation and staff (EMP) interview, it was determined the facility failed to ensure a physical examination update was completed prior to surgery requiring anesthesia services in three of three medical records (MR19, MR26 and MR27).

Findings included:

Review on November 5, 2019, of the facility's "Medical Staff Bylaws Rules and Regulations", last revised March 24, 2016, revealed "...Medical Records...The required elements of an H&P are: ...2. An updated examination of the patient, including any changes in the patient's condition, when the medical history and physical examination are completed within 30 days before admission or registration. Documentation of the updated examination must be placed in the patient's medical record within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services..."

Review on November 12, 2019, of facility policy "Medical Records Requirements Policy (Inpatient, Ambulatory Surgery, & Observation)", last reviewed May 2, 2019, revealed "...Policy: It is the policy of Evangelical Community Hospital to follow the CMS Conditions of Participation, PA Code [Sections] §115.31, and §115.33, and the Medical Staff Bylaws Rules and Regulations to determine the required content of each medical record. 1. History and Physical...h) A history and physical exam that has been handwritten or completed within the electronic health record of the patient's primary care physician or in the office of the surgeon who has scheduled the procedure is acceptable if the attending physician or the surgeon documents, signs, and dates a review note indicating any changes in the physician examination. If the history and physical is updated by an allied health care practitioner it will be countersigned by the supervising physician..."

Review of MR19 on November 5, 2019, revealed a complete history and physical (H&P) was performed on October 15, 2019, by OTH1. Prior to surgery for a carotid endarterectomy on November 4, 2019, OTH2 documented at 7:30 AM the H&P was reviewed and changes were noted in the record. OTH2 did not document an updated physical examination was performed on MR19 prior to surgery.

Interview with EMP1 on November 5, 2019, at approximately 10:00 AM, confirmed there was no documentation in MR19 of an updated physical examination prior to surgery.

Review of MR26 on November 5, 2019, revealed a complete H&P was performed on October 29, 2019, by OTH3. Prior to surgery for a total knee replacement on November 5, 2019, OTH4 documented at 8:35 AM the H&P was reviewed/changes noted in the record. OTH4 did not document an updated physical examination was performed on MR26 prior to surgery.

Interview with EMP1 on November 5, 2019, at approximately 2:00 PM, confirmed there was no documentation in MR26 of an updated physical examination prior to surgery.
Review of MR27 on November 5, 2019, revealed a complete H&P was performed on October 14, 2019, by OTH5. Prior to surgery for a total hip replacement on November 4, 2019, OTH6 documented at 8:00 AM the H&P was reviewed/changes noted in the record. OTH6 did not document an updated physical examination was performed on MR27 prior to surgery.

Interview with EMP1 on November 5, 2019, at approximately 2:15 PM, confirmed there was no documentation in MR27 of an updated physical examination prior to surgery.