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280 MIDDLETOWN ROAD

LANGHORNE, PA null

CONSULTATION WITH MEDICAL STAFF

Tag No.: A0053

Based on review of facility documents and interviews with staff (EMP), it was determined the facility failed to ensure the governing body consulted directly with the individual assigned the responsibility for the organization and conduct of the hospital's medical staff.

Findings include:

A request was made on October 9, 2018, to EMP2, for documented evidence that the governing body consulted directly with the individual assigned the responsibility for the organization and conduct of the hospital's medical staff. None was provided.

Interview with EMP1, on October 9, 2018, at 11:41 AM confirmed there was no documented evidence the governing body consulted directly with the individual assigned the responsibility for the organization and conduct of the hospital's medical staff. EMP1 further confirmed the facility did not have a policy for the governing body to consult directly with the individual assigned the responsibility for the organization and conduct of the hospital's medical staff.

PATIENT RIGHTS: ADMISSION STATUS NOTIFICATION

Tag No.: A0133

Based on review of facility policy and procedures, review of medical records (MR) review of documents and interview with staff (EMP), it was determined the facility failed to document in the medical record if the patient requested or declined notification to a family member or representative of his or her choice and his or her own physician of the hospital admission for 22 of 22 medical records reviewed (MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8, MR9, MR10, MR11, MR12, MR13, MR14, MR15, MR16, MR17, MR18, MR19, MR20, MR21, and MR22).

Findings include:

A request was made to EMP1 on October 10, 2018, of the facility's policy regarding notification to a family member or representative of the patient's choice and his or her own physician of the hospital admission. None was provided.

Review on October 10, 2018, of MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8, MR9, MR10, MR11, MR12, MR13, MR14, MR15, MR16, MR17, MR18, MR19, MR20, MR21, and MR22 revealed these patients were admitted to the hospital between September 30, 2018. Further review of these medical records revealed there was no documented evidence the patient requested or declined notification to a family member or representative of his or her choice and his or her own physician of the hospital admission.

Interview with EMP1, on October 10, 2018, at 2:40 PM, confirmed there was no facility policy regarding notification to a family member or representative of the patient's choice and his or her own physician of the hospital admission. Further interviewed confirmed there was no documented evidence in the medical records (MR1-MR22) that the patient requested or declined notification to a family member or representative of his or her choice and his or her own physician of the hospital admission.

MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY

Tag No.: A0347

Based on review of facility documents and interviews with staff (EMP), it was determined the facility failed to have quarterly Medical Executive Committee meetings as required by its established Medical Staff bylaws.

Findings include:

Review on October 11, 2018, of the facility's "Medical Staff Bylaws", dated June 17, 2010, revealed "B. Medical Executive Committee ... 3. Meetings of the Medical Executive Committee shall be: (a) conducted at least quarterly, or more frequently as necessary."

Review on October 11, 2018, of the Medical Executive Committee (MEC) meeting minutes revealed there was no documented evidence the MEC committee met in 2016. Further review revealed there was no documented evidence the MEC committee met in second, third, and fourth quarters of 2017, and second quarter of 2018.

Interview with EMP1 on October 11, 2018, at 11:15 AM, confirmed the Medical Staff Bylaws required the MEC to meet at least quarterly. Further interview with EMP1 confirmed there was no documented evidence the MEC committee met in 2016, there was no documented evidence the MEC committee met in second, third, and fourth quarters of 2017, and second quarter of 2018.

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Based on review of facility documents and interviews with staff (EMP), it was determined the facility failed to ensure its Medical Executive Committee fulfilled its duties as required by its established Medical Staff bylaws.

Findings include:

Review on October 11, 2018, of the facility's "Medical Staff Bylaws", dated June 17, 2010, revealed "B. Medical Executive Committee ... 2. The duties of the Medical Executive Committee shall be: ... c. To receive and act upon reports and recommendations of the committees appointed by the President of the Medical Staff concerning the quality assessment and improvement activities ... d. To receive and act upon reports and recommendations from Medical Staff committees, Department Heads, and assigned activity groups.

Review on October 11, 2018, of the Medical Executive Committee (MEC) meeting minutes dated March 28, 2017, March 20, 2018, and September 20, 2018, revealed there was no documented evidence the MEC committee received and acted upon reports and recommendations of the committees appointed by the President of the Medical Staff concerning the quality assessment and improvement activities and received and acted upon reports and recommendations from Medical Staff committees, Department Heads, and assigned activity groups.

Interview with EMP1 on October 11, 2018, at 11:22 AM, confirmed the Medical Staff Bylaws required the MEC committee to receive and act upon reports and recommendations of the committees appointed by the President of the Medical Staff concerning the quality assessment and improvement activities and to receive and act upon reports and recommendations from Medical Staff committees, Department Heads, and assigned activity groups. Further interview with EMP1 confirmed there was no documented evidence the MEC committee received and acted upon reports and recommendations of the committees appointed by the President of the Medical Staff concerning the quality assessment and improvement activities and received and acted upon reports and recommendations from Medical Staff committees, Department Heads, and assigned activity groups.

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Based on review of facility documents and interviews with staff (EMP), it was determined the facility failed to ensure its Pharmacy and Therapeutics Committee consisted of at least two representatives of the Medical Staff as required by its established Medical Staff bylaws.

Findings include:

Review on October 11, 2018, of the facility's "Medical Staff Bylaws", dated June 17, 2010, revealed "C. Pharmacy and Therapeutic Committee. 1. The Pharmacy and Therapeutics Committee shall consist of at least two (2) representatives of the Medical Staff ..."

Review on October 11, 2018, of the Pharmacy and Therapeutics Committee meeting minutes, dated from July 2017 through July 2018, revealed there was no documented evidence that at least two representatives of the Medical Staff were on the Pharmacy and Therapeutics Committee or attended these meetings.

Interview with EMP1 on October 11, 2018, at 11:15 AM, confirmed the Medical Staff Bylaws required at least two representatives of the Medical Staff were on the Pharmacy and Therapeutics Committee or attended these meetings. Further interview with EMP1 confirmed there was no documented evidence that at least two representatives of the Medical Staff were on the Pharmacy and Therapeutics Committee or attended these meetings from July 2017 through July 2018.

DIRECTOR OF DIETARY SERVICES

Tag No.: A0620

Based on review of facility documents, personnel files (PF) and interview with staff (EMP), it was determined the facility failed to employ a full-time Food and Dietetic Services Director.

Findings include:

Review on October 12, 2018, of facility document "Job Description ... Job Title: Dietician ..." date [unknown], revealed "The Dietician supervises the nutritional aspects of patient care through nutritional assessments, planning, counseling and recommendation of therapeutic diets, as well as enteral and parenteral feedings and documentation of care ... Participates in the development of policies, procedures, and standards as they apply to the clinical nutrition area; interprets and maintains compliance to ensure effective patient care ...".

Review on October 12, 2018, of PF2 revealed documented evidence of PF2 designated as the Dietician-Nutritionist. Further review revealed no documented evidence of PF2 designated as the full-time Director of Food and Dietetic Services.

Interview on October 9, 2018, with EMP1 at 1:20PM, confirmed the designation of PF2 as the Dietician-Nutritionist. Further interview confirmed no full-time employment or designation as Director of Food and Dietetic Services for PF2.

SCOPE AND FREQUENCY OF REVIEW

Tag No.: A0655

Based on a review of facility documentation and staff interviews(EMP), it was determined the facility failed to ensure its Utilization Review plan provided for review of drugs and biologicals.

Findings include:

Review on October 10, 2018, of the facility's "Utilization Review Plan 2018", revealed there was no provision in the plan to provide for a review of drugs and biologicals.

Review on October 10, 2018, of the "Utilization Review, Tissue and Transfusion Committee" meeting minutes from January 2018 through September 2018 revealed there was no documented evidence the Utilization Review committee reviewed drugs and biologicals provided by the facility.

Interview with EMP1, on October 10, 2018, at 11:30 AM, confirmed there was no provision in the plan to provide for a review of drugs and biologicals and there was no documented evidence the Utilization Review committee reviewed drugs and biologicals.

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on facility policy and procedures, observation, and interview with staff (EMP), it was determined the facility failed to ensure efficient management of sterile supplies were maintained to ensure an acceptable level of safety and quality.
Findings include:
Review on October 12, 2018, of facility policy, "Inventory, Ordering, Receiving, and Storage of Supplies, Monitoring Expired Supplies" dated September 1, 2018, revealed "... Purpose ... 4. To monitor for expiration of supplies on a regular basis and use whenever possible those items nearing the expiration date first, if it is impossible to use prior to the expiration date then Central Supply will make arrangements to return or dispose of expired items. Under any circumstances, any item which has reached an expiration date or is damages or compromised in any way must be immediately removed from stock and placed where it cannot be accidentally used ... Central Supply personnel will assist any department in disposing of expired stock or stock about to be expired ...".
Observation on October 11, 2018, of the Operating Room Corridor, at 11:36AM, revealed an unlocked Airway Exchange Cart. Further observation of the Airway Exchange Cart revealed one Multi-Lumen Central Venous Catherization Kit, expiration date 2016-01-21; one Sheridan/CF Endotracheal Tube, expiration date 11-2017; five 14 gauge, Instye Autoguard Shielded IV Catheter Single Use Only, expiration date 11-2017; and one Laryngeal Mask Airway Size 3 30-50kg, expiration date 05-28-2018.
Interview on October 11, 2018, with EMP3 at 11:36AM confirmed the sterile supplies specified above were expired. Further interview confirmed the Airway Exchange Cart should have been locked.
Observation on October 11, 2018, of the Postanesthesia care unit (PACU) supply closet revealed three purple top, BD Vacutainer K2 EPTA 7.2mg , expiration date 2018-09-30; two pink top, BD Vacutainer K2 EPTA 7.2mg, expiration date 2018-8-31; and two pink top, BD Vacutainer K2 EPTA 10.8mg, expiration date 2018-8-31.
Interview on October 11, 2018, with EMP3 at 12:00PM, confirmed the Blood Vacutainer Blood Collection Tubes specified above were expired.

VENTILATION, LIGHT, TEMPERATURE CONTROLS

Tag No.: A0726

Based on review of facility policy and procedures, facility document, and interview with staff (EMP), it was determined the facility failed to maintain a log for temperature and humidity levels for four of four Operating Rooms (OR1, OR2, OR3 and OR4).

Findings include:

Review on October 12, 2018, of facility policy, "Surgical Services ... Temperature and Humidity Monitoring" date [unknown], revealed "Purpose ... To provide appropriate methods of monitoring and adjusting Surgical Suite temperature and relative humidity levels ... Although there are design criteria for operating room heating, ventilation and air conditioning ("HVAC") systems related to temperature and humidity, the actual temperature and humidity within each operating room is mostly affected by the clinical requirements of the procedure and the heat and humidity load added by the operating team and equipment ... A relative humidity that is too high can result in damp or moist supplies with added opportunity for mold growth ... A relative low humidity that is to low can result in excessive bacteria-carrying dust within the surgical environment ...".

A request was made to EMP2 for the 2018 Temperature and Humidity Log for the Operating Rooms. None was provided.

Interview on October 12, 2018, with EMP2 at approximately 2:15PM, confirmed no documented evidence of a Temperature and Humidity Log maintained for OR1, OR2, OR3 and OR4, for January 1, 2018, to October 10, 2018.

POST-ANESTHESIA EVALUATION

Tag No.: A1005

Based on review of policies and procedures, and medical records (MR), and interviews with staff (EMP), it was determined the facility failed to ensure a post-anesthesia evaluation was completed and documented in the medical record no later than 48 hours after surgery in 22 of 22 medical records reviewed (MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8, MR9, MR10, MR11, MR12, MR13, MR14, MR15, MR16, MR17, MR18, MR19, MR20, MR21, and MR22).

Findings include:

Review on October 10, 2018, of facility policy "Medical Record Content and Completion Guidelines", dated January 2017, revealed "H. Pre and Post Anesthesia Evaluations ... 3. The anesthesiologist or other practitioners with appropriate privileges must document a post-anesthesia note, within 48 hours of surgery, showing the condition of the patient post-anesthesia."

Review on October 10 through October 12, 2018, of MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8, MR9, MR10, MR11, MR12, MR13, MR14, MR15, MR16, MR17, MR18, MR19, MR20, MR21, and MR22, revealed these patients had surgical procedures that required anesthesia between September 1, 2017, and September 30, 2018. Further review of these medical records revealed there was no documented evidence that a post-anesthesia evaluation was completed and documented in the patients' medical records no later than 48 hours after surgery.

Interview with EMP1 on October 12, 2018, at 11:35 AM, confirmed the patients in MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8, MR9, MR10, MR11, MR12, MR13, MR14, MR15, MR16, MR17, MR18, MR19, MR20, MR21, and MR22 had surgical procedures that required anesthesia. Further interview with EMP1 confirmed there was no documented evidence that a post-anesthesia evaluation was completed and documented in the patients' medical records no later than 48 hours after surgery.