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GEISINGER MEDICAL CENTER 100 NORTH ACADEMY AVENUE DANVILLE, PA 17822 June 14, 2019
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0175
Based on review of facility documents, medical record (MR) review, and staff (EMP) interview, it was determined the facility failed to monitor patients restrained for non-violent behavior in accordance with facility policy in two of three restraint medical records reviewed (MR1 and MR2).

Findings include:

Review of facility policy "Restraint/Seclusion," last revised/reviewed by the facility March 15, 2019, revealed "...Definitions: ... 7. A non-violent or non-self [sic] destructive patient is one who tries to remove lines, drains, tubes or an airway and compromises their own safety ... Procedure: ... 9. Staff will monitor patient at minimum every 2 hours by observation, interaction or direct examination for, but not limited to, readiness for discontinuation of restraints, signs of injury/circulation issues from restraint use as appropriate, respiration/ breathing issues and provide range of motion as appropriate. Safety Rounding will address hunger and/or thirst if applicable and as appropriate, meet the patients [sic] "toileting need, provide comfort by repositioning as appropriate, emotional support if needed ..."

Review of facility guidelines "Documentation Guidelines for the Use of Restraints on the Non-Violent or Non-Self [sic] Destructive Patient," last revised by the facility March 2019 revealed "... Restraint Monitoring (Group) Q [every] 2 hours: Reason for continued restraint need RN/LPN [registered nurse/licensed practical nurse] completes once in a 24 hr period. Respiration Document q 2 hours. Signs of Injury/Circulation: Document q 2 hours. Safety Rounds Documented as per Safety Rounding Policy 10.08. ROM [range of motion] Evaluate need for and/or provide and document by nursing staff as appropriate. Documentation should occur every two hours if the patient is wearing soft right/left wrist restraints, mitts, or soft right/left ankle restraints to allow movement of the extremity. Discontinuation of Restraint Discontinuation of restraint occurs when the patient meets criteria for removal. The RN will determine when the patient is no longer exhibiting the behavior requiring restraints ... "

Review of the facility policy "Purposeful Hourly Rounding 10.08," last revised/reviewed by the facility January 30, 2019, revealed "... Definitions: 1. Hourly Rounds on the awake patient are defined as a member of the healthcare team approaching the patient to ensure any issues with the following are addressed: a. Pain b. Potty (elimination) c. Position (comfort) d. Possessions (environment/belongings) Additionally, any other physiologic, environmental or psychological needs should be addressed if appropriate... 2. Hourly Rounds on the sleeping patient are defined as a member of the healthcare team visually observing the patient and can be completed without waking the patient if: a. There are no outward signs of pain (grimacing, moaning) b. The patient is continent c. The urinal is in reach d. The patient is safely positioned in the bed e. Fluids (if permitted) are in reach as well as call bell, phone and bedside table Additionally, on the sleeping patient the following should be completed: f. Observation of respiratory effort g. Observation of skin color h. Head of bed elevated to 30 degrees if the patient is obese or has a history of sleep apnea (unless the patient's condition contraindicates elevation) .... Process: Hourly Rounds are to be completed hourly on all inpatients and ED patients. Documentation of Hourly Rounds should occur in a timely manner and reflect the actual time the care provider entered the room..."

Review of MR1 with EMP7 on June 13, 2019, at 1045, revealed soft bilateral mitt restraints were ordered by the physician for non-violent behavior on April 26, 2019, at 1824; soft bilateral mitt restraints were ordered by the physician for non-violent behavior on April 27, 2019 at 1830 and soft bilateral mitt restraints were ordered by the physician for non-violent behavior on April 28, 2019 at 1722. Further review of MR1 revealed that nursing flowsheet documentation on April 27, 2019, at 1200 contained no documentation on the non-violent restraint every 2-hour assessments of continued restraint need, signs of injury/circulation, and range of motion. Further review of MR 1 revealed nursing flowsheet documentation on April 28, 2019, at 0800 contained no documentation on the non-violent restraint every 2-hour assessments of continued restraint need, signs of injury/circulation, and range of motion. Further review of MR1 revealed nursing flowsheet documentation on April 29, 2019, at 0200 contained no documentation on the non-violent restraint every 2-hour assessments of continued restraint need, signs of injury/circulation, and range of motion. Further review of MR1 revealed nursing flowsheet documentation on April 29, 2019, at 0400 and 0600 contained no documentation on the non-violent restraint every 2-hour assessments of continued restraint need, signs of injury/circulation, and range of motion.

Review of MR2 with EMP7 on June 13, 2019, at 1145, revealed soft bilateral mitt restraints were ordered by the physician assistant for non-violent behavior on May 23, 2019, at 1504 and soft bilateral mitt restraints were ordered by the physician for non-violent behavior on May 24, 2019, at 0614. Further review of MR2 revealed that nursing flowsheet documentation on May 23, 2019, at 1800 contained no documentation on the non-violent restraint every 2-hour assessments of continued restraint need, signs of injury/circulation, and range of motion. Further review of MR2 revealed that nursing flowsheet documentation on May 24, 2019, at 1800 contained no documentation on the non-violent restraint every 2-hour assessments of continued restraint need, signs of injury/circulation, and range of motion.

Interview with EMP7 on June 13, 2019, at approximately 1150, confirmed nursing assessments for non-violent restraint should be performed and documented at least every two hours. EMP7 confirmed the lack of restraint assessment documentation at a minimum of every two hours as above in MR1 and MR2.
VIOLATION: MEDICAL STAFF ACCOUNTABILITY Tag No: A0347
Based on review of facility documents, medical record (MR) review, and staff (EMP) interview, it was determined the medical staff failed to provide quality medical care by failure to establish orders for frequency of single tube tracheostomy (an incision that forms an opening into the neck for breathing) changes until after an occurrence of respiratory distress in one of one single-tube tracheostomy medical record reviewed (MR1).

Findings include:

Review of the facility's "Professional Bylaws of the Medical Staff of Geisinger Medical Center," last approved by the Board of Directors on March 20, 2019, revealed "Preamble... Whereas, it is recognized that the Medical Staff of Geisinger Medical Center is responsible, in part, for the quality of patient care in the Medical Center... and is subject to the authority of, the Medical Center's Board of Directors, and that the cooperative efforts of the Medical Center's Medical Staff, management, and Board of Directors are necessary to fulfill the Medical Center's goal of providing quality health care to its patients... Article X. Medical Staff Organization... 10.4 Functions of Departments The primary responsibility delegated to each Department is the preservation and improvement of the quality... of patient care provided in the Department. To carry out this responsibility, each Department shall: (a) establish, update on a regular basis and enforce through the efforts of the Department Chair, rules, regulations, policies and procedures that guide and support the activities of the Department; ... (f) coordinate the patient care provided by Department Members with nursing and ancillary patient care services...""

Review of the facility "Geisinger Medical Center Rules and Regulations of the Medical Staff," last approved by the Board of Directors on March 20, 2019, revealed: "Introduction These Rules and Regulations of the Medical Staff of Geisinger Medical Center are intended to be and shall at all times be considered as guidelines for the conduct of professional clinical activities at the Medical Center... The Medical Center may from time to time, establish Medical Center Policies and Procedures and Department or Division Rules and Regulations expanding upon the subject matter contained in these Rules and Regulations... Section 1.1 Admissions 1.1-1 Patients are to be admitted to the Medical Center only upon authorization by a Practitioner with admitting privileges under the Medical Staff Bylaws... Section 3.1 Consultations 3.1-1 Consultation is required on all cases where illness of the patient exceeds the severity of the admitting physician's clinical privileges..."

Review of facility policy "Tracheostomy Care Policy," last revised/reviewed by the facility on April 17, 2019, revealed "Purpose: The Tracheostomy Care policy establishes guidelines related to the care to the tracheostomy during hospitalization . Persons affected: All trained hospital and clinic Registered Nurses, Licensed Practical Nurses and Respiratory Therapists ... Tracheostomy Care: General Information: 1. GMC" [Geisinger Medical Center] Tracheostomy tubes are changed by physician at the Otolaryngology Clinic or at the bedside..." The policy does not specifically address single-tube tracheostomies and their frequency of changing the tube.

Review of MR1 on June 13, 2019, at 1045 and at 1430, revealed the patient was admitted to the hospital on April 23, 2019, with a single tube tracheostomy. Further review of MR1 revealed there were no physician admission orders relating to tracheostomy care or tracheostomy tube changes. On April 29, 2019, at 1908, a physician to nursing communication order: "In case of emergency with mucous plugging, remove laryngectomy button, clean with water, and replace" was entered. This communication order was placed after an occurrence of respiratory distress of patient of MR1 due to a mucous plug.

Interview with EMP8 on June 13, 2019, at 1030 related that just before the respiratory distress event, the patient of MR1 was breathing faster and coughing. EMP8 stated nursing did not have orders to remove the tracheostomy tube. EMP8 related that while respiratory therapy was in the room with the patient of MR1, EMP8 went immediately to the nursing station and updated the physician of the patient of MR1's change in status. EMP8 related the physician instructed EMP8 to page an ENT physician. EMP8 related they paged the ENT STAT (urgently), in the interim the patient's respiratory status declined, and a rapid response team was called.

Interview with EMP10 on June 13, 2019, at 1345 related that it is not the respiratory therapy's practice to change tracheostomy tubes. Further interview with EMP10 related that it is the physician's responsibility to change the tracheostomy tubes at this facility. EMP10 related that the respiratory therapists can suction and that in this patient's case, the respiratory therapist had attempted to suction the patient (of MR1) but had met resistance.

Interview with EMP13 on June 14, 2019, at 1140 related that hospitalists may or may not have training in the care of tracheostomies. EMP13 related in the cases where the physician has not been trained, the hospitalist should place a referral to ENT for the orders. Further interview with EMP13 related EMP13 was not aware of the event before the surveyor's conversation.
VIOLATION: RESPIRATORY CARE SERVICES POLICIES Tag No: A1160
Based on review of facility documents and staff (EMP) interview, it was determined the medical staff failed to ensure facility policy addressed the frequency of single-tube tracheostomy changes, tracheostomy care for single-tube tracheostomies and clearly define who was responsible for the care of single-tube tracheostomies.

Findings include:

Review of facility policy "Tracheostomy Care Policy," last revised/reviewed by the facility on April 17, 2019, revealed "Purpose: The Tracheostomy Care policy establishes guidelines related to the care to the tracheostomy during hospitalization . Persons affected: All trained hospital and clinic Registered Nurses, Licensed Practical Nurses and Respiratory Therapists ... Tracheostomy Care General Information: 1. GMC [Geisinger Medical Center] Tracheostomy tubes are changed by physician at the Otolaryngology Clinic or at the bedside ... 6. Trach care must be done no less frequently than Q [every] 4 - Q 8 hours (even if the tube is plugged), depending upon patient need and/or physician order... Cleaning Tracheostomy Tube- All Types ..." The policy does not specifically address single tube tracheostomies and and clearly define who was responsible for the care of single-tube tracheostomies.

Interview with EMP6 on June 13, 2019, at 0940 related the facility looked at the "Tracheostomy Care Policy" after the respiratory event occurrence and there was nothing in place on how to handle the laryngectomy buttons. EMP6 further related the laryngectomy button EMP6 was referring to a single flexible tracheostomy tube with center that was capped and when removed, there is an open stoma.

Interview with EMP5 on June 14, 2019, at 0930 related that staff do not typically see the single-tube type of tracheostomy, that it is low volume in this hospital. EMP5 related reaching out to the ENT critical resource nurse and confirmed there were no policy changes made.