HospitalInspections.org

Based on a review of facility documents, medical records (MR) and interview with staff (EMP) it was determined that Conemaugh Miners Medical Center Medical Staff failed to be accountable to the Governing Body by admitting a patient on a ventilator to the service of a physician who was not granted privileges in ventilator management in one of one patients.


Findings:

Board of Trustee Bylaws of Conemaugh Miners Medical Center, dated October 2017, " ... Article VIII - Medical Care Evaluation. ... 8.3 Professional Accountability to the Board. The Medical Staff and other health care professional staffs providing patient care services shall conduct, and be accountable to the Board for conducting activities that contribute to the preservation and improvement of the quality and efficiency of patient care provided in the Hospital. These activities shall include these functions: 8.3(a) Providing effective mechanisms to monitor and evaluate the quality of patient care and the clinical performance of individuals with delineated clinical privileges within the Hospital; 8.3(b) Ongoing review, evaluation and monitoring of patient care practices through a systematic process of overall quality assessment and improvement: 8.3(c) Delineation of clinical privileges for Medical Staff members, commensurate with individual credentials and demonstrated ability and judgment, and assignment of patient care responsibilities to other health care professionals consistent with individual qualification and demonstrated ability; ... ."

Conemaugh Miners Medical Staff Bylaws, Board approved April 25, 2017. " ... Article VII - Determination of Clinical Privileges. ... 7.2 Delineation of Privileges in General. 7.2 (a) Requests. Each application for appointment and reappointment tot he Medical Staff must contain a request for the specific clinical privileges desired by the applicant. The request for specific privileges must be supported by documentation demonstrating the practitioner's qualifications to exercise the privileges requested. ... Article XI - Services. ... 11.2 Service Functions. ... 11.2 (b) Establish guidelines for the granting of clinical privileges with in the service and submit the recommendations as required under these bylaws regarding the specific clinical privileges for applicants and reapplicants for clinical privileges; ... 11.2)f) Coordinate the patient care provided by the service's members with nursing, administrative, and other non-Medical Staff services; ... ."

Conemaugh Miners Medical Center Medical Staff Rules and Regulations, Approved by the Board of Trustees on March 28, 2017. " ... Article II Admission. Section 1: Who may admit patients. A patient may be admitted to the hospital only by medical staff appointees who have privileges to do so. Patients shall be admitted for the treatment of any and all conditions and diseases for which the hospital has facilities and personnel. When the hospital does not provide the services required by a patient or a person seeking necessary medical care, or for any reason cannot be admitted to the hospital, the hospital or the attending physician, or both, shall assist the patient in making arrangements for care in an alternate facility so as not to jeopardize the health and safety of the patient, ... Article VI - Intensive Care Unit. Section 1: Who May be Admitted. ... 2. Medical/Surgical admissions to the ICU will be made by physician's order on a bed-available basis. Any appointee of the medical staff may admit patients to ICU on a bed-available basis consistent with his delineation of clinical privileges ... Medical/Surgical patients who may be eligible for admission to the ICU include: ... b. Patients who required mechanical ventilation; ... d. patients with tracheostomies who remain at high risk; ... ."


A review of MR1 Physician Documentation " ... ED Provider Notes at 12/04/18 1510 ... Patient Active Problem List: ALS (amyotrophic lateral sclerosis) ... Muscular atrophy, Acute on chronic respiratory failure with hypoxia ... Dependence on home ventilator, Pneumonia of left lower lobe due to infectious organism ... Chief Complaint: Cough; Ventilator chronic dependence; ... History of present illness: ... has a very advanced neurological deficit which has left them on a ventilator as well as ongoing aggressive care with recurrent pneumonia and upper respiratory tract infections.... is on a ventilator 24 hour a day. ... Review of systems: All systems are reviewed with positive findings chronic ventilator patient with ... recurrent bronchitis and upper respiratory tract infections ... Plan: ... was then started on IV Rocephin. Patient also was aggressively managed with nebulizer treatment marked improvement in cough. ... Patient was continued on aggressive management with tube feedings, mouth care management of thrush and ongoing follow-up. ... ."

Admit to Inpatient (Order 32000151) ... Admitting Physician: EMP3 ... Estimated Length of Stay. Greater than or equal to 2 midnights ... ."

H & P signed by EMP3 at 12/05/18. ... Service: General Medicine ... Admission Date: 12/04/2018. Chief Complaint: Patient does not feel well. History of Present Illness: Patient has ALS and has had progression of the disease to the point they have a trach and is on a vent off and on. ... it was felt should be admitted for IV antibiotics, etc. ... The ALS has been exhausting for the family and patient. ... Diagnosis: 1, Acute respiratory failure with pneumonia. ... had been Cipro for pseudomonas isolated from culture, strep was negative. ... There is a question whether the patient should stay here though because they are on a home vent and to change to hospital vent, we would have to have ICU present and open. So, at this point in time, will see how patient does. So, will continue aggressive care as is. ... ."

MR1 Ventilator orders - Auto released daily.
Ventilator Settings - VC; 400; 12; 5; 2-31/min; 95% (Order 32004254)
Respiratory Care Date: 12/5/2018 Department Miners Medical Center Med Surg Ordering/Authorizing: EMP3 , MD ...
Ventilator Settings - VC; 400; 12; 5: ...
Vent Mode: VC Tidal Volume (ml): 400 Resp. Rate (b/min) 12 PEEP (cmH2O): 5 FIO2 (5) 2-31/min Keep O2 sat Above 95%
Comments Goal: ph of 7.35 - 7.45 mm Hg and PCO2 35-45 Suspected CO2 retainers: maintain ph of 7.35 - 7.45 (Do Not normalize PCO2) ... ."


An interview was conducted with EMP5, RT, at approximately 1:30 PM. Normally the practice at this hospital has been to transfer any vent dependent patient out. We don't keep them here, the ICU has been closed for years. ... EMP3 told us to find out what the home settings were for the vent and to keep the patient on their home settings, That's the only order we got. These are full blown vent settings and the patient doesn't need that, but we don't have a Pulmonologist to write an order to change the settings. ... ."

A review of the Credential File for the attending physician for this ventilated patient revealed that the physician had privileges as Active Staff in Family Medicine. It was noted that this physician had not requested nor were they granted privileges in ventilator management.

An interview was conducted with EMP8 on December 13, 2018, at approximately 11:00 AM. EMP8 confirmed that the attending physician did not have ventilator management privileges.

Cross Reference:
482.22(a)(2) Medical Staff Credentialing

Based on a review of facility documents, medical records (MR) and interview with staff (EMP), it was determined that Conemaugh Miners Medical Center failed to provide a safe setting by failing to follow their adopted policy regarding patient owned/leased equipment being used while an inpatient status for a one of one patients, by failing to admit the patient to a physician who is privileged to manage a ventilator, and by failing to provide ventilator competencies to the nursing staff assigned to the care of the patient. (MR1)

Findings:

Conemaugh Miners Medical Center, PolicyStat ID:4622701, revised 04/2017. Respiratory Equipment Maintenance. Purpose: This policy provides guidelines to ensure the reliability and proper function of the respiratory equipment. The Respiratory Therapy Department participates in an effective maintenance Operation in cooperation the Memorial Medical Center's Clinical Engineering Department and per established manufacturer maintenance agreements. 2. Preventive maintenance schedule on required equipment is maintained by Memorial Medical Center's Clinical Engineering Department. 3. Any equipment that is not properly functioning will be removed for service and tagged as such until it can be repaired, and proper function be verified by a qualified service technician. 4. Prior to the placement in service of any new respiratory therapy equipment, the clinical engineering department shall be notified to perform electrical safety and specified performance verifications. They will also place this equipment on their routine maintenance schedule. 5. Per Clinical Engineering, Miners Environment of Care and Acute Care Committees, the following guidance applies to patient owned/rented medical equipment that may be brought to our facility for clinical use: All equipment used must conform to facility clinical standards, with regards to maintenance checks and operational verification. This is to be verified by DME documentation or equipment labeling. The clinical standard for Respiratory Therapy Equipment, whether hospital or patient owned/rented is documented operational/periodic maintenance with 1 year. It is the responsibility of hospital clinical staff implementing this patient equipment to verify this documentation prior to its use in our facility. If the patient/family is unable to provide this documentation, hospital owned equipment must be used. Hospital owned equipment will be preferred for use and will always be used if in the Respiratory Therapist's judgment, the home equipment is not properly or adequately functioning based on the patient's current condition. It is the responsibility of the patient/family to operate their owned/rented equipment, as they are most familiar with its functional characteristics, i.e.. On/off button, humidifier adjustment, etc. Hospital staff may operate/assist in implementation of the device if they have been deemed competent in its use. After Respiratory Therapy's scheduled operating hours, the nursing supervisor is to contact the on-call RT, for any equipment brought to our facility that doesn't conform to the aforementioned standards, or for any questions regarding clinical functionality, as hospital owned equipment may then need to be implemented. ... ."

Conemaugh Miners Medical Center, PolicyStat ID: 4709943, revised 11/2017. Ventilator Management-Respiratory Care. Purpose: To outline the procedure for Respiratory Therapists to follow when caring got (sic) mechanically ventilated patients. Level of Personnel: Registered Respiratory Therapist, Certified Respiratory Therapist, Special Duty Registered Nurse (see policy #640-620). Policy: All Respiratory Therapy personnel shall adhere to the following procedure and shall be responsible for management of mechanical ventilation under the supervision of the attending physician, the consulted pulmonologist, and or the Respiratory Therapy Medical Director. Procedure: Ventilators will be initiated in accordance with specific physician orders to include: Tidal Volume, Rate, FOI2, Mode of Ventilation, and any ordered PEEP, PSV. The Respiratory Therapist on duty will be responsible for operation of the ventilator. ... Nursing staff will be properly trained in mechanical ventilation a sufficient level to allow them to manage the ventilator when Respiratory Therapy staff is not available. Respiratory Therapy Duties: Initiate mechanical ventilation, Maintain ventilator care when on duty, Make necessary adjustments to the ventilator as ordered or necessary, Replace ventilator equipment per policy, Weaning the patient from the ventilator as ordered. Respiratory Therapy will be on-call after departmental hours and be available to assist with any ventilator issues: troubleshooting, setup, setting changes as required by Nursing. ... Ventilators will only be used in the ICU, Emergency Room or PACU unless otherwise specified.


MR1 Respiratory Therapy Notes by EMP13, RRT at 12/04/18 1830 ... Late entry. Spoke with EMP14, Supervisor and EMP12, Supervisor, separately about concerns of having pt. on Med Surg floor and following hospital policy and procedures. They were made aware that RT is only in hospital till 7 pm. and nursing not properly trained on ventilator care. I did place an AMBU bag in pt room, RN and Supervisor aware. Checked pts home ventilator. Pt's parent at bedside, pt. resting comfortably. ...
" RT Notes by EMP6, RRT at 12/05/18 0933 ... Pt. rcvd on home vent. Vent has humidification that is not supported by MH vent. SpO2 mid 80's 2 l/M )2 bled in to vent SpO2 92%. Bs bilat sl course. Vent settings/alarms checked. Home settings - alarms inactive. Alarms set for hospital stay. Parent at Bed Side and aware. # 6 cuffed trach patent and secure. Cont. to monitor. ...
" RT Note by EMP5, RRT at 12/05/18 1051 ... Had meeting with EMP11 About my concerns with home equipment being used on Med Surg when our policy says that we are not able to use it due to Biomed and Maintenance not being able to check and monitor it properly. Also, my concern with nursing staff not being properly oriented to this particular vent in case of an emergency, and Respiratory not being in the hospital after 7 pm should a problem arise. Also spoke with EMP3 with my concern about not following hospital procedures ... ."

An interview was condcuted with EMP5 on December 14, 2018, at approximately 1:30 PM, "I asked the parent when was the last time the trach was changed and they said like May. ... I asked the parent what supplies they had at home and to bring them in because the patient is a special order size, which we don't have. I asked EMP3 about changing it, they weren't comfortable doing that so I asked the ED doc to help me. I tried and felt resistance, then EMP15 tried and they met resistance. We have a surgeon here today and asked them to look at it when finished in the OR. They checked it out and said they believe that is is being held by scar tissue and are not comfortable changing it out at this small of a facility because there will be bleeding in to the airway and we just don't have the resources here if the patient loses their airway. The patient is not on a monitor and or any oxygen saturation monitoring. ... ."

MR1 did not contain any documented evidence that facility staff reviewed any documented operational/periodic maintenance with 1 year for the ventilator that the patient uses at home as per their adopted policy


A review of the Credential File for the attending physician for this ventilated patient revealed that the physician had privileges as Active Staff in Family Medicine. It was noted that this physician had not requested nor were they granted privileges in ventilator management.

An interview was conducted with EMP8 on December 13, 2018, at approximately 11:00 AM. EMP8 confirmed that the attending physician did not have ventilator management privileges.

A review of Personnel Files (PF) of Registered Nurses who were assigned the care of this patient were reviewed. It was noted that none of the PFs contained documented evidence of any type of training or competency for ventilators or ventilated patients.

Based on a review of facility documents and staff interview (EMP), it was determined that Conemaugh Miners Medical Center failed to follow their adopted Medical Staff Bylaws and Rules and Regulations by admitting a patient on a ventilator to the service of a physician who was not granted privileges in ventilator management in one of one patients.

Findings

Conemaugh Miners Medical Staff Bylaws, Board approved April 25, 2017. " ... Article VII - Determination of Clinical Privileges. ... 7.2 Delineation of Privileges in General. 7.2 (a) Requests. Each application for appointment and reappointment to the Medical Staff must contain a request for the specific clinical privileges desired by the applicant. The request for specific privileges must be supported by documentation demonstrating the practitioner's qualifications to exercise the privileges requested. In addition to meeting the general requirements of these Bylaws for medical staff membership, each practitioner must provide documentation establishing that he/she meets the requirements for training, education and current competence set forth in any specific credentialing criteria applicable to the privileges requested, ... 7.2(d) The delineation of an individual's clinical privileges shall include the limitations, if any, on an individual's prerogatives to admit and treat patients or direct the course of treatment for any conditions for which the patients were admitted. ... ."

Conemaugh Miners Medical Center Medical Staff Rules and Regulations, Approved by the Board of Trustees on March 28, 2017. " ... Article II Admission. Section 1: Who may admit patients. A patient may be admitted to the hospital only by medical staff appointees who have privileges to do so. Patients shall be admitted for the treatment of any and all conditions and diseases for which the hospital has facilities and personnel. When the hospital does not provide the services required by a patient or a person seeking necessary medical care, or for any reason cannot be admitted to the hospital, the hospital or the attending physician, or both, shall assist the patient in making arrangements for care in an alternate facility so as not to jeopardize the health and safety of the patient, ... ."

A review of MR1 Physician Documentation " ... ED Provider Notes at 12/04/18 1510 ... Patient Active Problem List: ALS (amyotrophic lateral sclerosis) ... Muscular atrophy, Acute on chronic respiratory failure with hypoxia ... Dependence on home ventilator, Pneumonia of left lower lobe due to infectious organism ... Chief Complaint: Cough; Ventilator chronic dependence; ... History of present illness: ... has a very advanced neurological deficit which has left them on a ventilator as well as ongoing aggressive care with recurrent pneumonia and upper respiratory tract infections.... is on a ventilator 24 hour a day. ... ."

An interview was conducted with EMP5, RT, at approximately 1:30 PM. Normally the practice at this hospital has been to transfer any vent dependent patient out. We don't keep them here, the ICU has been closed for years. ... EMP3 told us to find out what the home settings were for the vent and to keep the patient on their home settings, That's the only order we got. These are full blown vent settings and the patient doesn't need that, but we don't have a Pulmonologist to write an order to change the settings.

A review of the Credential File for the attending physician for this ventilated patient revealed that the physician had privileges as Active Staff in Family Medicine. It was noted that this physician had not requested nor were they granted privileges in ventilator management.


An interview was conducted with EMP8 on December 13, 2018, at approximately 11:00 AM. EMP8 confirmed that the attending physician did not have ventilator management privileges.

Cross Reference:
482.12(a)(5) Medical Staff Accountability

Based on a review of medical record (MR), facility documents and interviews with staff (EMP) it was determined that Conemaugh Miners Medical Center failed to assign nursing personnel with specialized qualifications to provide nursing care for a patient on a ventilator for one of one patients (MR1) and failed to maintain staffing assignment sheets.

Findings:

MR1 ED Provider Notes ... at 12/04/18 1510 ... Patient Active Problem List: ALS (amyotrophic lateral sclerosis) ... Muscular atrophy, Bulbar weakness, ... Acute on chronic respiratory failure with hypoxia ... Dependence on home ventilator, Pneumonia of left lower lobe due to infectious organism ... Chief Complaint: Cough: Ventilator chronic dependence; sore throat; chronic cough with wheezing. History of present illness: ... has a very advanced neurological deficit which has left patient on a ventilator as well as ongoing aggressive care with recurrent pneumonia and upper respiratory tract infections. Has been complaining of a sore throat or difficulty with some type of mucus in the posterior pharynx as well as wheezing and coughing. Is on a ventilator 24 hour a day. ... Review of systems: All systems are reviewed with positive findings chronic ventilator patient ... Diagnosis: Acute respiratory distress; acute respiratory failure; chronic ventilator patient; oral thrush. Plan: ... then started on IV Rocephin. Also was aggressively managed with nebulizer treatment marked improvement in cough. ... Patient was continued on aggressive management with tube feedings, mouth care management of thrush and ongoing follow-up. Chest x-ray reveals a left basilar flat infiltrate with laboratory results revealing a hemoglobin of 10 and hematocrit of 32. Did discuss this with the parent as well as with Dr. ... Patient is on and off the ventilator sometimes 2-3 hours a day only. Patient will be placed in the hospital for aggressive IV antibiotics and ongoing care. ... ."


MR1 Nursing Note at 12/04/18 2350 ... Upon receiving verbal report from preceeding shift, I was informed that this pt has a trach and is on a vent (brought in from home), and that while nursing has not been trained or experienced in the use of ventilators, hospital staff will not be operating or interacting with the equipment. I was told that the pt's family was informed that Miner's Med Surg Department is not equipped or trained to accept pt's that require a ventilator and that the parent insisted that someone from the family would be present at all times to operate the equipment and take care of the pt's needs associated with the ventilator and that he will be at the hospital "just to receive IV antibiotics". The pt's family has agreed to be present with the pt at all times during his hospitalization and will assume responsibility for all aspects of its use. At the start of my shift at 1900, a caregiver was present with pt and did monitor and operate the equipment, until leaving at approximately 2130. At that time caregiver stated that the pt's sibling would be coming in "at some point" but they did not know when. Upon asking if the sibling was planning to stay with the pt over night, they replied "I have no idea". When, still no one had arrived by 2215, the Nursing Supervisor was notified and did contact the pt's parent via telephone and informed parent that no one was present with the pt. The pt's parent seemed to be confused as to why this would be a problem but did reluctantly agree to have someone come to the hospital. At approximately 2330 the pt's sibling did arrive and stated that they did not know why they had to be present, I did attempt to explain that the nursing staff are not trained on the pt's equipment and are unable to operate the machine and require someone who is familiar with it to be present at all times. The pt's sibling stated "well, I don't know how to run it either".


Conemaugh Miners Medical Center, PolicyStat ID: 4709943, revised 11/2017. Ventilator Management-Respiratory Care. Purpose: To outline the procedure for Respiratory Therapists to follow when caring got (sic) mechanically ventilated patients. Level of Personnel: Registered Respiratory Therapist, Certified Respiratory Therapist, Special Duty Registered Nurse (see policy #640-620). Policy: All Respiratory Therapy personnel shall adhere to the following procedure and shall be responsible for management of mechanical ventilation under the supervision of the attending physician, the consulted pulmonologist, and or the Respiratory Therapy Medical Director. Procedure: Ventilators will be initiated in accordance with specific physician orders to include: Tidal Volume, Rate, FOI2, Mode of Ventilation, and any ordered PEEP, PSV. The Respiratory Therapist on duty will be responsible for operation of the ventilator. The ventilator will be checked Q 1 hour for the 1st 24 hours, and then Q2 hour afterwards. All checks will be documented on the ventilator flow sheet. Nursing will be apprised of any changes made. Nursing staff will be properly trained in mechanical ventilation a sufficient level to allow them to manage the ventilator when Respiratory Therapy staff is not available. Respiratory Therapy Duties: Initiate mechanical ventilation, Maintain ventilator care when on duty, Make necessary adjustments to the ventilator as ordered or necessary, Replace ventilator equipment per policy, Weaning the patient from the ventilator as ordered. Respiratory Therapy will be on-call after departmental hours and be available to assist with any ventilator issues: troubleshooting, setup, setting changes as required by Nursing. The Respiratory Therapy Medical Director will intervene when an issue regarding ventilation arises that cannot be solved by the staff therapist or Manager of Respiratory Therapy. Ventilators will only be used in the ICU, Emergency Room or PACU unless otherwise specified. ... ."

A sample of Personnel Files (PF) of Registered Nurses who were assigned the care of this patient were reviewed. It was noted that none of the PF contained documented evidence of any type of training or competency for ventilated patients.

An interview was conducted with EMP2 at approximately 9:00 AM. "The patient is in their 30's with ALS. Patient is taken care of at home by their parents and sibling. They brought the patient to the ED on Tuesday because they seemed to be having more secretions than normal and felt like something was wrong in their throat. They are only on vent for approximately 3 hours a day at home, patient is not vent dependent, and the ED doctor wanted to keep the patient overnight for IV antibiotics. I thought that since the family has all had training and patient is not vent dependent, that the family could stay overnight with patient. I arranged for the nurses to have vent training for next week, December 18th. The patient is on a Phillips vent, the same one we have here. My Nursing Supervisors all have vent competencies. The patient was only supposed to be here overnight and yes, they are still here. We have huddles everyday to discuss their care. Respiratory manages the vent during the day and the family takes care of it at night. We did have the patient very close to the Nurses Station but the family wanted to move to a bigger room with 2 beds since they were staying overnight. We do have a vent protocol and we do have policies, yes it says a vent needs to be in ED, PACU, ICU, but it also says "unless otherwise specified."

An interview was conducted with EMP5, RT, at approximately 1:30 PM. Normally the practice at this hospital has been to transfer any vent dependent patient out. We don't keep them here, our ICU has been closed for years. We will keep an acute patient who was just placed on a ventilator in the ED long enough to get them stable for transfer. This young patient is a full code and I had concerns from day one as the nurses have not had any training, and Respiratory staff is only here from 7A - 7P. I looked at the policy and it doesn't say we can do vent management on Med/Surg. I felt bad that the nurses are without proper training and we've tried to reassure them the best we could, if the patient ran into a problem after hours, to take them off the vent and bag them until we can get here, and we have a half an hour to get here. We went right to Administration because none of us feel that the patient should be here. It's a dangerous situation. Administration was not happy. The patient was already on their vent from home when they arrived in our ED, or we would have used our vent. It is similar to our vent here, except for the oxygen source. The attending physician told us to find out what the home settings were for the vent and to keep the patient on their home settings. That's the only order we got. These are full blown vent settings and the patient doesn't need that, but we don't have a Pulmonologist to write an order to change the settings. I just got the patient off the vent this morning, they have been on 24/7 for the past 7 day, so now we have to wean them off. The patient is scared, they can barely speak above a whisper, they are paralyzed from the neck down, they doesn't have a call bell that they can ring, and they are as far away from Respiratory and from Nursing as they can be. The family insisted on being in a double bed room, because they were told they had to stay and take care of the vent from 7P - 7A. They had to be called in the to stay the very first night. The nurses can't understand what the patient is saying - it's not a good situation, there is a big potential for things to go wrong."


Conemaugh Miners Medical Center, PolicyStat ID:4622701, revised 04/2017. Respiratory Equipment Maintenance. Purpose: This policy provides guidelines to ensure the reliability and proper function of the respiratory equipment. The Respiratory Therapy Department participates in an effective maintenance Operation in cooperation the Memorial Medical Center's Clinical Engineering Department and per established manufacturer maintenance agreements. 2. Preventive maintenance schedule on required equipment is maintained by Memorial Medical Center's Clinical Engineering Department. 3. Any equipment that is not properly functioning will be removed for service and tagged as such until it can be repaired, and proper function be verified by a qualified service technician. 4. Prior to the placement in service of any new respiratory therapy equipment, the clinical engineering department shall be notified to perform electrical safety and specified performance verifications. They will also place this equipment on their routine maintenance schedule. 5. Per Clinical Engineering, Miners Environment of Care and Acute Care Committees, the following guidance applies to patient owned/rented medical equipment that may be brought to our facility for clinical use: All equipment used must conform to facility clinical standards, with regards to maintenance checks and operational verification. This is to be verified by DME documentation or equipment labeling. The clinical standard for Respiratory Therapy Equipment, whether hospital or patient owned/rented is documented operational/periodic maintenance with 1 year. It is the responsibility of hospital clinical staff implementing this patient equipment to verify this documentation prior to its use in our facility. If the patient/family is unable to provide this documentation, hospital owned equipment must be used. Hospital owned equipment will be preferred for use and will always be used if in the Respiratory Therapist's judgment, the home equipment is not properly or adequately functioning based on the patient's current condition. It is the responsibility of the patient/family to operate their owned/rented equipment, as they are most familiar with its functional characteristics, i.e.. On/off button, humidifier adjustment, etc. Hospital staff may operate/assist in implementation of the device if they have been deemed competent in its use. After Respiratory Therapy's scheduled operating hours, the nursing supervisor is to contact the on-call RT, for any equipment brought to our facility that doesn't conform to the aforementioned standards, or for any questions regarding clinical functionality, as hospital owned equipment may then need to be implemented. ... ."

On December 21, 2018, at approximately 10:30 AM, a request was made to review staffing assignment sheets for Medical/Surgical Unit for the timeframe of December 2 through December 15, 2018. EMP2 stated, "Our assignment sheets are in EPIC. I requested them but we are having difficulty retrieving them. Some staff still do the handwritten ones, too." Handwritten assignment sheets were reviewed and it was noted that there were no assignment sheets for December 2, 3, 4, 5, or December 10, 2018.
As of December 31, 2018, 9:00 AM, the facility has not provided the requested documentation.


Handwritten assignment sheets dated December 6, 7, 8, 9, 11, 12, 13, 14, 15, 2018, were reviewed but failed to show a complete 24 hour schedule.
There were no handwritten assignment sheets provided for December 2, 3, 4, 5,10, 2018.

Based on a review of facility documents and staff interview (EMP) it was determined that Conemaugh Miners Medical Center failed to have documented evidence that their policies and procedures for the delivery of respiratory care services were reviewed by the Medical Director of Respiratory Care Services and that they were approved by the Medical Staff, and failed to follow their adopted ventilator management policies by admitting a ventilated patient to their Medical/Surgical Unit, and by assigning nursing staff who did not have competencies in ventilator management to a patient on a ventilator, and by failing to document that a patient owned/leased ventilator met the clinical standards as per their policy.


Findings:

Respiratory Care Services 2019 Quality Assurance Plan. Scope of Care Provided. Respiratory Care shall be provided, under the medical direction of a physician, to all persons seeking care at Miners Hospital. This includes both pediatric and adult care. The scope of care for the Respiratory Care Department includes as inventory of all the therapeutic and diagnostic services provided by Respiratory Care Staff, the type of patient served and the setting in which care is provided. ... ."

A review of Respiratory Care policies and procedures lacked documented evidence that they were reviewed by the Medical Director of Respiratory Care Services, and approved by the Medical Staff.

EMP3 confirmed that the Medical Director for Respiratory Care does not have a formal process to approve their policies and procedures.

MR1 documentation revealed 59 entries related to the patient's oxygen delivery method. 53 entries revealed that the patient was receiving supplemental oxygen via the ventilator. Six entries revealed that the patient was receiving supplemental oxygen via the trach mask.

Conemaugh Miners Medical Center, PolicyStat ID: 4709943, revised 11/2017. Ventilator Management-Respiratory Care. Purpose: To outline the procedure for Respiratory Therapists to follow when caring got (sic) mechanically ventilated patients. Level of Personnel: Registered Respiratory Therapist, Certified Respiratory Therapist, Special Duty Registered Nurse (see policy #640-620). Policy: All Respiratory Therapy personnel shall adhere to the following procedure and shall be responsible for management of mechanical ventilation under the supervision of the attending physician, the consulted pulmonologist, and or the Respiratory Therapy Medical Director. Procedure: Ventilators will be initiated in accordance with specific physician orders to include: Tidal Volume, Rate, FOI2, Mode of Ventilation, and any ordered PEEP, PSV. The Respiratory Therapist on duty will be responsible for operation of the ventilator. The ventilator will be checked Q 1 hour for the 1st 24 hours, and then Q2 hour afterwards. All checks will be documented on the ventilator flow sheet. Nursing will be apprised of any changes made. Nursing staff will be properly trained in mechanical ventilation a sufficient level to allow them to manage the ventilator when Respiratory Therapy staff is not available. Respiratory Therapy Duties: Initiate mechanical ventilation, Maintain ventilator care when on duty, Make necessary adjustments to the ventilator as ordered or necessary, Replace ventilator equipment per policy, Weaning the patient from the ventilator as ordered. Respiratory Therapy will be on-call after departmental hours and be available to assist with any ventilator issues: troubleshooting, setup, setting changes as required by Nursing. The Respiratory Therapy Medical Director will intervene when an issue regarding ventilation arises that cannot be solved by the staff therapist or Manager of Respiratory Therapy. Ventilators will only be used in the ICU, Emergency Room or PACU unless otherwise specified.


Policy #640-620 as referenced in this policy was requested.(Conemaugh Miners Medical Center, PolicyStat ID: 4709943, revised 11/2017. Ventilator Management-Respiratory Care.) ... Level of Personnel: ... Special Duty Registered Nurse (see policy #640-620). EMP1 confirmed that this policy #640-620 related to special duty RNs is no longer valid and should have been removed as a reference.


Conemaugh Miners Medical Center, PolicyStat ID:4622701, revised 04/2017. Respiratory Equipment Maintenance. Purpose: This policy provides guidelines to ensure the reliability and proper function of the respiratory equipment. ... 4. Prior to the placement in service of any new respiratory therapy equipment, the clinical engineering department shall be notified to perform electrical safety and specified performance verifications. They will also place this equipment on their routine maintenance schedule. 5. Per Clinical Engineering, Miners Environment of Care and Acute Care Committees, the following guidance applies to patient owned/rented medical equipment that may be brought to our facility for clinical use: All equipment used must conform to facility clinical standards, with regards to maintenance checks and operational verification. This is to be verified by DME documentation or equipment labeling. The clinical standard for Respiratory Therapy Equipment, whether hospital or patient owned/rented is documented operational/periodic maintenance with 1 year. It is the responsibility of hospital clinical staff implementing this patient equipment to verify this documentation prior to its use in our facility. If the patient/family is unable to provide this documentation, hospital owned equipment must be used. Hospital owned equipment will be preferred for use and will always be used if in the Respiratory Therapist's judgment, the home equipment is not properly or adequately functioning based on the patient's current condition. It is the responsibility of the patient/family to operate their owned/rented equipment, as they are most familiar with its functional characteristics, i.e.. On/off button, humidifier adjustment, etc. Hospital staff may operate/assist in implementation of the device if they have been deemed competent in its use. After Respiratory Therapy's scheduled operating hours, the nursing supervisor is to contact the on-call RT, for any equipment brought to our facility that doesn't conform to the aforementioned standards, or for any questions regarding clinical functionality, as hospital owned equipment may then need to be implemented. ... ."


MR1 did not contain any documented evidence that facility staff reviewed any documented operational/periodic maintenance with 1 year for the ventilator that the patient uses at home as per their adopted policy.

Based on a review of facility documents, medical records (MR) and interview with staff (EMP), it was determined that Conemaugh Miners Medical Center failed to admit a mechanically ventilated patient to a physician who is privileged to manage a ventilator. (MR1)

Findings:

Conemaugh Miners Medical Center, PolicyStat ID: 4709943, revised 11/2017. Ventilator Management-Respiratory Care. Purpose: To outline the procedure for Respiratory Therapists to follow when caring got (sic) mechanically ventilated patients ... Policy: All Respiratory Therapy personnel shall adhere to the following procedure and shall be responsible for management of mechanical ventilation under the supervision of the attending physician, the consulted Pulmonologist, and or the Respiratory Therapy Medical Director. Procedure: Ventilators will be initiated in accordance with specific physician orders to include: Tidal Volume, Rate, FOI2, Mode of Ventilation, and any ordered PEEP, PSV. The Respiratory Therapist on duty will be responsible for operation of the ventilator. ... Respiratory Therapy Duties: Initiate mechanical ventilation, Maintain ventilator care when on duty, Make necessary adjustments to the ventilator as ordered or necessary, Replace ventilator equipment per policy, Weaning the patient from the ventilator as ordered. ... ."


Conemaugh Miners Medical Center Medical Staff Rules and Regulations, Approved by the Board of Trustees on March 28, 2017. " ... Article II Admission. Section 1: Who may admit patients. A patient may be admitted to the hospital only by medical staff appointees who have privileges to do so. Patients shall be admitted for the treatment of any and all conditions and diseases for which the hospital has facilities and personnel. When the hospital does not provide the services required by a patient or a person seeking necessary medical care, or for any reason cannot be admitted to the hospital, the hospital or the attending physician, or both, shall assist the patient in making arrangements for care in an alternate facility so as not to jeopardize the health and safety of the patient, ... Article VI - Intensive Care Unit. Section 1: Who May be Admitted. ... 2. Medical/Surgical admissions to the ICU will be made by physician's order on a bed-available basis. Any appointee of the medical staff may admit patients to ICU on a bed-available basis consistent with his delineation of clinical privileges ... Medical/Surgical patients who may be eligible for admission to the ICU include: ... b. Patients who required mechanical ventilation; ... d. patients with tracheostomies who remain at high risk; ... ."

A review of MR1 Physician Documentation " ... ED Provider Notes at 12/04/18 1510 ... Patient Active Problem List: ALS (amyotrophic lateral sclerosis) ... Muscular atrophy, Acute on chronic respiratory failure with hypoxia ... Dependence on home ventilator, Pneumonia of left lower lobe due to infectious organism ... Chief Complaint: Cough; Ventilator chronic dependence; ... History of present illness: ... has a very advanced neurological deficit which has left them on a ventilator as well as ongoing aggressive care with recurrent pneumonia and upper respiratory tract infections.... is on a ventilator 24 hour a day. ... ."

MR1 Ventilator orders - Auto released daily.
Ventilator Settings - VC; 400; 12; 5; 2-31/min; 95% (Order 32004254)
Respiratory Care Date: 12/5/2018 Department Miners Medical Center Med Surg Ordering/Authorizing: EMP3 , MD ...
Ventilator Settings - VC; 400; 12; 5: ...
Vent Mode: VC Tidal Volume (ml): 400 Resp. Rate (b/min) 12 PEEP (cmH2O): 5 FIO2 (5) 2-31/min Keep O2 sat Above 95%
Comments Goal: ph of 7.35 - 7.45 mm Hg and PCO2 35-45 Suspected CO2 retainers: maintain ph of 7.35 - 7.45 (Do Not normalize PCO2) ... ."

An interview was conducted with EMP5, RT, at approximately 1:30 PM. Normally the practice at this hospital has been to transfer any vent dependent patient out. We don't keep them here, the ICU has been closed for years. ... EMP3 told us to find out what the home settings were for the vent and to keep the patient on their home settings, That's the only order we got. These are full blown vent settings and the patient doesn't need that, but we don't have a Pulmonologist to write an order to change the settings. ... ."


A review of the Credential File for the attending physician for this ventilated patient revealed that the physician had privileges as Active Staff in Family Medicine. It was noted that this physician had not requested nor were they granted privileges in ventilator management.

An interview was conducted with EMP8 on December 13, 2018, at approximately 11:00 AM. EMP8 confirmed that the attending physician did not have ventilator management privileges.