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Based on observation, interview, record review and policy review, the facility failed to ensure that respiratory care services was staffed adequately to meet the patient needs for five (#3, #4, #7, #11 and #12) of five patients who received respiratory care (A-1154). The facility also failed to provide Respiratory Therapy (RT) medications and care according to physician's orders or standard of care, for five (#3, #4, #7, #11 and #12) of five patients reviewed who received respiratory care (A-1160). These failures had the potential to lead to negative patient outcomes, and could affect all patients who required respiratory care.

The severity and cumulative effect of these failures resulted in the facility being out of compliance with 42 CFR 482.57 Condition of Participation: Respiratory Services.

Based on observation, interview, record review and policy review, the facility failed to ensure that respiratory care services was staffed adequately to meet the patient needs for five (#3, #4, #7, #11 and #12) of five patients reviewed. This had the potential to affect the health outcomes of all patients with respiratory care needs in the facility. There were 17 patients who received respiratory services in the facility. The facility census was 19.

Findings included:

1. Record review of the facility's policy titled, "Cardiopulmonary (specific to heart, lungs and circulation) Scope and Complexity of Services," dated 03/2014, showed that:
- The number of Respiratory Therapist (RT) staff per shift would vary according to the workload;
- The workload will be monitored by each shift for the next shift as workloads vary;
- Staffing ratios are developed using projected workload units based on the Patient Treatment Point System; and
- Increased staffing needs will be met by staff as needed or by supervisory staff.

Record review of the facility's policy titled, "Administration of Drugs," dated 04/27/17, showed that unless the prescriber orders otherwise, drugs shall be administered at standard time, and doses are considered "on time" if administered within one hour before or one hour after scheduled time.

2. Record review of a History and Physical (H&P) dated 05/09/17, showed that Patient #3 had a history of smoking and Chronic Obstructive Pulmonary Disease (COPD, a group of lung diseases that block airflow and make it difficult to breathe). The patient's physical examination showed decreased breath sounds in both lower lungs and chest X-ray results showed possible pneumonia and bilateral pleural effusions (buildup of fluid between the tissues that line the lungs and the chest). The medical plan for the patient's respiratory care was to treat with steroids (medication used to decrease inflammation in the lungs) and bronchodilators (medication that widens the air passages into the lungs to allow free movement of air).

Record review of a Physician order dated 05/08/17 at 11:57 PM, showed that Patient #3 was to receive a DuoNeb (combination of medications, administered through inhalation to allow improved air exchange in the lungs) four times daily.

Record review of the DuoNeb Administration History for Patient #3, showed that between 05/09/17 and 05/17/17, the patient received 10 doses outside of the scheduled administration times of 9:00 AM, 1:00 PM, 5:00 PM and 9:00 PM (includes the one hour before or after allotment, per facility policy), and five doses were missed completely. Documentation showed that the reasons the DuoNebs were not administered were due to staffing one RT, and the RT was not available.

3. Record review of a Medication Administration Record (MAR) Report for Patient #4, showed the following missed RT medications or cares:
- On 05/02/17 at 1:00 PM, DuoNeb;
- On 05/07/17 at 9:00 PM, Brovana (medication used to treat breathing problems) Nebulizer (RT administered inhalation of medication through a mist);
- On 05/07/17 at 9:00 PM, Pulmicort (medication used to prevent breathing problems); and
- On 05/11/17 at 4:00 PM, 05/12/17 at 12:00 PM, and 05/15/17 at 12:00 PM and 4:00 PM, oral care (to cleanse the mouth of bacteria, which can prevent hospital acquired pneumonia).
There was no documentation related to why the medications or cares were missed by RT.

4. Record review of a H&P dated 05/06/17, showed that Patient #7 had a history of pneumonia, with a respiratory plan to administer DuoNeb treatments and oxygen by nasal cannula (plastic tubing which carries oxygen into the nose).

Record review of a Physician order dated 05/06/17 at 12:40 PM, showed that Patient #7 was to receive a DuoNeb three times daily.

Record review of the DuoNeb Administration History for Patient #7, showed that between 05/06/17 and 05/17/17, the patient received eight doses outside of the scheduled administration times of 10:00 AM, 4:00 PM and 10:00 PM (includes the one hour before or after allotment, per facility policy), and seven doses were missed completely. Documentation showed that the reasons the DuoNebs were not administered were due to staffing one RT, and the RT was either too busy or unavailable.

5. Record review of Patient #11's medical record showed that he was admitted to the facility on 05/10/17 with complaints of acute respiratory failure with high oxygen requirements needing titration (controlled amount of oxygen delivery) of high flow oxygen respiratory treatments for COPD.

Record review of the patient's Physician Order showed an order for DuoNeb respiratory treatments QID (four times daily.)

Record review of the patient's MAR showed that the patient's DuoNeb treatments were scheduled for 9:00 AM; 1:00 PM; 5:00 PM and 9:00 PM.

Record review of the patient's MAR dated from 05/10/17 to 05/17/17 showed the following:
-The patient received his 1:00 PM DuoNeb treatment too late one out of six opportunities and too early two out of six opportunities (the patient did not receive his treatments within the scheduled timeframe three times out of six).
-The patient received his 5:00 PM DuoNeb treatment too early two out of six opportunities (the patient did not receive his treatments within the scheduled timeframe two times out of six).
-The patient received his 9:00 PM DuoNeb treatment too late one out of seven opportunities (the patient did not receive his treatment within the scheduled timeframe one time out of seven).
Staff administered the patient's DuoNeb treatment either too early or too late six times out of 26 opportunities.

6. Record review of Patient #12's medical record showed she was admitted to the facility on 04/17/17 with complaints of needing ventilator (machine used to support breathing) and tracheotomy (trach, a surgically created opening through the neck into the trachea [windpipe] to assist with breathing) weaning and respiratory treatments four times daily.

Record review of the patient's Physician Order showed an order for DuoNeb respiratory treatments QID, at 9:00 AM; 1:00 PM; 5:00 PM and 9:00 PM.

Record review of the patient's MAR dated from 05/11/17 to 05/17/17 showed the following information:
-The patient received her 1:00 PM DuoNeb treatment too early two out of six opportunities (the patient did not receive his treatments within the scheduled timeframe two times out of six).
-The patient received her 5:00 PM DuoNeb treatment too early four out of six opportunities (the patient did not receive his treatments within the scheduled timeframe four times out of six).
Staff administered the patient's DuoNeb treatment too early six times out of 26 opportunities.

Record review of the patient's Respiratory Treatment Flowsheet showed that staff did not document the patient's respiratory treatment pre and post respiratory or heart rate from 05/12/17 to 05/17/17 for 9:00 AM, 1:00 PM, 5:00 PM and 9:00 PM.

During an interview on 05/17/17 at 12:30 PM, Staff K, Licensed Practical Nurse (LPN), Charge Nurse stated that staff did not document the patient's pre and post respiratory treatment assessment for respiratory and heart rate from 05/12/17 to 05/17/17.

7. Observation and concurrent interview on 05/15/17 at 9:31 PM, showed Staff B, RT, was the only RT on duty. Staff B stated that of the 19 inpatients, 13 of them were scheduled to have respiratory treatments (respiratory medications administered through inhalation) administered at 8:00 PM. Staff B stated that she had not completed three of the scheduled treatments, and had not assessed or cared for two patients' artificial airways (used to maintain airway patency, which include tracheostomy, a temporary or permanent surgically created hole in the neck), which according to policy were considered late at 9:00 PM. Staff B stated she was late with respiratory care because the facility had decreased RT night shift (7:00 PM through 7:00 AM) staff from two RTs to one.

During an interview on 05/16/17 at 10:31 AM, Staff H, Chief Clinical Officer (CCO), stated that she was responsible for the scheduled staffing of the RT Department. She discussed staffing with Staff J, RT Manager or the Charge Nurse on a day to day basis, which included her calling in on the weekends to discuss the RT needs of the patients.

During an interview on 05/16/17 at 1:40 PM, Staff I, RT, stated that RT staffing changed two week ago (around 05/01/17) when they decreased staffing on days and nights. Staff I stated that day shift decreased from two-12 hour RT staff to one-12 hour and one- eight hour, and night shift decreased from two-12 hour RT staff to one-12 hour RT staff.

8. Record review of daily staffing sheets from 05/15/17 through 06/03/17, showed that two RTs were scheduled to work day shifts (7 AM through 7:00 PM) and two RTs were scheduled to work night shifts. Each day, one of the RT staff was marked through, and rewritten to work only eight of the 12 originally scheduled hours, and one of the 12 hour night shift RT staff was marked through completely, which indicated that the staff member was off. This was verified by Staff B, Charge Nurse.
This indicated that future staffing was based on a set number of hours allotted to be staffed, and not on respiratory needs or acuity of the patients.

During an interview on 05/16/17 at 10:31 AM, Staff G, Chief Executive Officer (CEO), stated that:
- The standard for RT staffing was one RT to four or five respiratory patients, for day shift and/or night shift.
- 19 respiratory patients (for example) should be doable (to provide RT medication and cares in a timely manner) by one RT (contradicted previous statement.)
- The facility's staffing for RT was expected to be 1.8 hours per patient day (HPPD, a consistent measurement used to determine the amount of staff hours needed to provide care based on census. Example of 1.8 HPPD staffing: 10 inpatients require 18 staffed RT hours in a 24 hour day.)
- The expected RT HPPD did not account for patient acuity (intensity or degree of hospital care each patient's needs.)

9. Record review of an RT census tracking report, showed the following daily averages for 04/2017:
- Patient census 19;
- Artificial airways 4.5;
- Nebulizer treatments (RT administered inhalation of medication through a mist) 39.1; and
- RT staffed 2.75 HPPD (equals four-12 hour and one-four hour staff shifts)

Record review of an RT census tracking report showed the following daily averages for 05/2017;
- Patient census 18;
- Artificial airways 5.3;
- Nebulizer treatments 43.5; and
- RT staffed 2.0 HPPD (equals three-12 hour staffed shifts).
This showed that the facility decreased staffing by an average of 16 hours per day, even though the RT work load increased.

10. Interview with concurrent observation on 05/16/17 at approximately 11:15 AM, Staff T, Agency RT, and Staff I, RT, stated upon observation of the RT patient census board (white board maintained in the RT Department of all current patients, room numbers, and RT medication administration and cares needed), that they could not complete the patient RT medication administration and cares, consistent with policies and procedures based on the current patient needs, if they were staffed with only one RT. Staff G, CEO, was present during the interview.

During an interview on 05/17/17 at 2:11 PM, Staff I, RT, stated the following occurred when only one RT was staffed:
- It was dangerous and put patients' safety at risk.
- She had voiced her concerns about patient safety to Staff J, RT Manager, who stated he would speak with Staff G, CEO about the patient safety concerns.
- A patient coded (code blue event, a medical response to death or near death of a patient), on 05/10/17 while she staffed RT alone, and some RT medications and cares were late or missed completely.
- She was required to respond to all code blue events, which left no other respiratory staff to provide RT medication or cares to patients.
- She was required to respond to all rapid responses (deterioration of a formerly stable patient), which left no other RT staff to provide RT medication or cares to patients.
- In attempts to complete patient care, RT treatments were administered early or late (outside of the one hour time allotted time frame), which caused the treatment to be too close to the previous treatment, or following treatment.
- RT treatments were missed.
Staff I added that of the 19 current patients, 17 of them required some type of respiratory care or treatments. There were seven artificial airways with two of those patients on ventilators. Staff I stated that RT staffing was decreased approximately two weeks ago, and that when the RT department previously determined staffing needs, the manager considered the census, acuity and RT needs of the patients. Staff I added that staffing needs were currently based only on the number of patients with artificial airways and ventilators, not overall RT needs.

During an interview on 05/17/17 at 9:37 AM, Staff J, RT Manager, stated that:
- As of the first part of 05/2017, day shift RT staffing was changed from two-12 hour RT staff to one-12 hour and one-eight hour RT staff, and nights from two-12 hour RT staff to one-12 hour RT staff.
- Administration, specifically Staff H, Chief Clinical Officer, looked at the total number of ventilated (breathing assisted or controlled by the use of a machine) and artificial airway patients for RT staffing, and did not take into consideration the amount of respiratory medications or cares that patients would need.
- Staffing ratios using projected workload units based on the Patient Treatment Point System (per policy) were not used.
- When staffing was decreased, he voiced concerns about patient safety to Staff G, CEO, and Staff H, CCO.
- Staff M, Pulmonologist, was "very upset" when RT staff was decreased, and per report, discussed his concerns with the Founder and Chairman of the hospital corporation.

During a telephone interview on 05/17/17 at 3:25 PM, Staff M, Pulmonologist stated that:
- He had concerns with the decreased RT staffing;
- He did not feel that it is safe to only have one RT on duty;
- Staff G, CEO, would not speak with him about his concerns, so he voiced his concerns to Staff H, CCO;
- His medical partner, Staff U, Pulmonologist, spoke with Staff G, CEO, about her concerns with the decreased RT staffing; and
- He left employment with the facility due to downstaffing of RT.

During an interview on 05/16/17 at 10:31 AM, Staff H, CCO, stated that there had been no patient safety concerns related to the RT staffing brought to her attention.

During an interview on 05/17/17 at 3:47 PM, Staff G, CEO stated that neither Staff M, nor Staff U brought concerns to him related to RT staffing or any RT related concerns. Staff G added that he had no idea RT staff had late or missed RT treatments.

11. Record review of Quality Reports for RT missed medications showed:
- March had one missed RT medication;
- April had no missed RT medications; and
- May 9th through May 15th (seven days) had 30 missed RT medications.

During an interview on 05/16/17 at 3:50 PM, Staff F, Chief Quality Officer, stated that Staff J, RT Manager, had informed her that RT staff had trouble "getting stuff done" (RT medication administration and cares), when the staffing changed for their department.

During an interview on 05/17/17 at 8:20 AM, Staff G, CEO, stated that when the RT staffing decreased, they (administration) were unaware of the magnitude of the problem.

During an interview on 05/16/17 at 2:31 PM, Staff G, CEO, stated, "I took a step back and looked at it [RT staffing], I realized it needed to be revisited. I will take 50% of the blame".

During an interview on 05/17/17 at 4:50 PM, Staff J, Director of Respiratory, stated that:
-He has been the RT manager at the facility for two years.
-When patient census dropped that is when RT staffing changed.
-He had made a suggestion to have at least two RT staff scheduled until 1:00 AM but was told no because of low patient census.
-He explained to the CEO that RT should not be scheduled according to patient census because of the required tasks administered by RT staff.
-The RT office had a board that listed the various respiratory cares each patient required by staff. Staff J denied administrative staff ever visiting the RT office to visualize what services RT provided to patients, for example, the number respiratory treatments, trach care, ventilator checks and oxygen titration.
-He had not been informed that an incident report needed to be filled out for missed RT medications or treatments.
-RT missed medications and treatments just started in May since the reduction in RT staffing.



18018

Based on interview, record review and policy review, the facility failed to provide Respiratory Therapy (RT) medications and care according to physician order or standard of care, for five patients (#3, #4, #7, #11 and #12) of five patients reviewed. This had the potential to affect the health outcomes of all patients receiving RT medications in the facility. There were 17 patients who received respiratory services in the hospital. The facility census was 19.

Findings included:

1. Record review of the facility's policy titled, "Administration of Drugs," dated 04/27/17, showed that unless the prescriber orders otherwise, drugs shall be administered at standard time, and doses are considered "on time" if administered within one hour before or one hour after scheduled time.

2. Record review of a History and Physical (H&P) dated 05/09/17, showed that Patient #3 had a history of smoking and Chronic Obstructive Pulmonary Disease (COPD, a group of lung diseases that block airflow and make it difficult to breathe). The patient's physical examination showed decreased breath sounds in both lower lungs and chest X-ray results showed possible pneumonia and bilateral pleural effusions (buildup of fluid between the tissues that line the lungs and the chest). The medical plan for the patient's respiratory care was to treat with steroids (medication used to decrease inflammation in the lungs) and bronchodilators (medication that widens the air passages into the lungs to allow free movement of air).

Record review of a Physician order dated 05/08/17 at 11:57 PM, showed that Patient #3 was to receive a DuoNeb (combination of medications, administered through inhalation to allow improved air exchange in the lungs) four times daily.

Record review of the DuoNeb Administration History for Patient #3, showed that between 05/09/17 and 05/17/17, the patient received 10 doses outside of the scheduled administration times of 9:00 AM, 1:00 PM, 5:00 PM and 9:00 PM (includes the one hour before or after allotment, per facility policy), and five doses were missed completely.

3. Record review of a Medication Administration Record Report (MAR) for Patient #4, showed the following missed ordered and scheduled RT medications or cares:
- On 05/02/17 at 1:00 PM, DuoNeb;
- On 05/07/17 at 9:00 PM, Brovana (medication used to treat breathing problems) Nebulizer (RT administered inhalation of medication through a mist);
- On 05/07/17 at 9:00 PM, Pulmicort (medication used to prevent breathing problems); and
- On 05/11/17 at 4:00 PM, 05/12/17 at 12:00 PM, and 05/15/17 at 12:00 PM and 4:00 PM, oral care (to cleanse the mouth of bacteria, which can prevent pneumonia).

4. Record review of a H&P dated 05/06/17, showed that Patient #7 had a history of pneumonia, with a respiratory plan to administer DuoNeb treatments and oxygen by nasal cannula (plastic tubing which carries oxygen into the nose).

Record review of a Physician order dated 05/06/17 at 12:40 PM, showed that Patient #7 was to receive a DuoNeb (combination of medications, administered through inhalation, to allow improved air exchange in the lungs) three times daily.

Record review of the DuoNeb Administration History for Patient #7, showed that between 05/06/17 and 05/17/17, the patient received eight doses outside of the scheduled administration times of 10:00 AM, 4:00 PM and 10:00 PM (includes the one hour before or after allotment, per facility policy), and seven doses were missed completely.

5. Record review of Patient #11's medical record showed that he was admitted to the facility on 05/10/17 with complaints of acute respiratory failure with high oxygen requirements needing titration (controlled amount of oxygen delivery) of high flow oxygen respiratory treatments for COPD.

Record review of the patient's Physician Order showed an order for DuoNeb respiratory treatments QID (four times daily).

Record review of the patient's MAR showed that the patient's DuoNeb treatments were scheduled at 9:00 AM; 1:00 PM; 5:00 PM and 9:00 PM.

Record review of the patient's MAR dated from 05/10/17 to 05/17/17 showed the following:
-The patient received his 1:00 PM DuoNeb treatment too late one out six opportunities and too early two out of six opportunities (the patient did not receive his treatments within the scheduled timeframe three times out of six).
-The patient received his 5:00 PM DuoNeb treatment too early two out of six opportunities (the patient did not receive his treatments within the scheduled timeframe two times out of six).
-The patient received his 9:00 PM DuoNeb treatment too late one out of seven opportunities (the patient did not receive his treatment within the scheduled timeframe one time out of seven).
Staff administered the patient's DuoNeb treatment either too early or too late six times out of 26 opportunities.

6. Record review of Patient #12's medical record showed she was admitted to the facility on 04/17/17 with complaints of needing ventilator (machine used to support breathing) and tracheotomy (trach, a surgically created opening through the neck into the trachea [windpipe] to assist with breathing) weaning and respiratory treatments four times daily.

Record review of the patient's Physician Order showed an order for DuoNeb respiratory treatments QID.

Record review of the patient's MAR showed that the patient's DuoNeb treatments were scheduled at 9:00 AM; 1:00 PM; 5:00 PM and 9:00 PM.

Record review of the patient's MAR dated from 05/11/17 to 05/17/17 showed the following information:
-The patient received her 1:00 PM DuoNeb treatment too early two out six opportunities (the patient did not receive his treatments within the scheduled timeframe two times out of six).
-The patient received her 5:00 PM DuoNeb treatment too early four out of six opportunities (the patient did not receive his treatments within the scheduled timeframe four times out of six).
Staff administered the patient's DuoNeb treatment too early six times out of 26 opportunities.

Record review of the patient's Respiratory Treatment Flowsheet showed that staff did not document the patient's respiratory treatment pre and post respiratory or heart rate from 05/12/17 to 05/17/17 for 9:00 AM, 1:00 PM, 5:00 PM and 9:00 PM.

During an interview on 05/17/17 at 12:30 PM, Staff K, Licensed Practical Nurse (LPN), Charge Nurse stated that staff did not document the patient's pre and post respiratory treatment assessment for respiratory and heart rate from 05/12/17 to 05/17/17.

During an interview on 05/15/17 at 9:31 PM, Staff B, RT, stated that of the 19 inpatients, 13 of them were scheduled to have respiratory treatments (respiratory medications administered through inhalation) administered at 8:00 PM. Staff B stated that she had not completed three of the scheduled treatments, which according to policy were considered late at 9:00 PM.

During an interview on 05/17/17 at 2:11 PM, Staff I, RT, stated the following related to RT medication administration:
- RT Staffing was recently decreased which resulted in early, late or missed RT medication administration;
- RT treatments administered early or late (outside of the one hour time allotted time frame), caused the treatment to be too close to the previous treatment, or following treatment;
- She had concerns about the RT workload, and voiced her concerns to Staff J, RT Manager, who stated that he would speak with Staff G, CEO about the concerns.

7. Interview with concurrent observation on 05/16/17 at approximately 11:15 AM, Staff T, Agency RT, and Staff I, RT, stated upon observation of the RT patient census board (white board maintained in the RT Department of all current patients, room numbers, and RT medication administration and cares needed), that they could not complete the patient RT medication administration, consistent with policies and procedures based on the current patient needs, if they were staffed with only one RT, which occurred on (partial) day shifts and night shifts (12 hour shifts). Staff G, CEO, was present during the interview.

8. Record review of Quality Reports for RT missed medications showed:
- March had one missed RT medication;
- April had no missing RT medications; and
- May 9th through May 15th (seven days) had 30 missed RT medications.

During an interview on 05/16/17 at 3:50 PM, Staff F, Chief Quality Officer, stated that Staff J, RT Manager, had informed her that RT staff had trouble "getting stuff done" (RT medication administration).

During an interview on 05/17/17 at 3:25 PM, Staff M, Pulmonologist stated that he had concerns with the lack of care provided by the RT Department, and shared those concerns with Staff H, Chief Clinical Officer (CCO.)

During an interview on 05/16/17 at 10:31 AM, Staff H, CCO, stated that there were no RT related concerns brought to her attention.

During an interview on 05/17/17 at 8:20 AM, Staff G, CEO, stated that they (administration) were unaware of the magnitude of the problem (missed or late RT medication administration).


18018