The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

UC SAN DIEGO HEALTH HILLCREST - HILLCREST MED CTR 200 WEST ARBOR DRIVE SAN DIEGO, CA 92103 May 12, 2015
VIOLATION: RESPIRATORY CARE SERVICES Tag No: A1151
Based on interview and document review, the hospital did not have an effective Respiratory Therapy service that maintained, organized and staffed to ensure the health and safety of patients when:

1. Failed to ensure a written process was developed and approved by the medical staff, for the delivery of oxygen therapy for the PACU and the PTU. (Tag A 1160 #1-59)


The cumulative effect of these systemic problems resulted in the hospital's failure to deliver care in compliance with the Condition of Participation for Respiratory Services and failure to provide a safe and secure environment for patients.
VIOLATION: RESPIRATORY CARE SERVICES POLICIES Tag No: A1160
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, record and document review, the hospital failed to ensure a written protocol was developed and approved by the medical staff, for the delivery of oxygen therapy for the Post Anesthesia Care Unit (PACU-an area that recovers patients after a loss of sensation with or without loss of consciousness), and the Procedural Treatment Unit (PTU-a unit that provides services to the patient population requiring, interventional, operative, and diagnostic services requiring general anesthesia [medications used to induce unconsciousness or loss of sensation] intravenous sedation) at Hospital B for 59 of 85 sampled patients (1, 2, 7, 8, 10, 11, 14, 15, 18, 19, 20, 21, 22, 23, 24, 27, 29, 32, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 46, 49, 51, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 65, 66, 67, 68, 69, 72, 73, 74, 75, 76, 77, 78, 79, 81, 82, 83, and 85).

The lack of a written protocol for respiratory care and services had the potential to affect patient stability and recovery when Registered Nurses (RNs) did not have a specific unit protocol that included, parameters for the administration of oxygen delivery device, liter flow or FiO2 (percentage of oxygen concentration participating in gas exchange in alveoli-portion of lung) in an effort to effectively monitor patients who received oxygen therapy.

Findings:

1. Patient 1 was admitted on [DATE] for a surgical procedure that included stage 3 vaginal prolapsed repair (top of the vagina falls toward the vaginal opening) per the Operative Note, dated 4/28/15.

On 4/30/15 at 10:50 A.M., an onsite investigation was conducted related to an Entity Reported Incident. The hospital reported to the Department of Public Health that on 4/29/15, it had been discovered that the oxygen outlet in room 22 of the PTU had been delivering medical air not pure oxygen.

A review of Patient 1's medical record was conducted with the Quality Compliance Specialist (QCS) 1 and the DRA. The document titled "Events", dated 4/28/15, indicated that Patient arrived in the PTU at 3:56 P.M. on a nasal canula (NC) at 3 liter per minute and with oxygen parameters that indicated "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician order dated .

On 5/5/15 at 9:15 A.M., an interview and record review was conducted with Assistant Nurse Manager (ANM) of the PTU. A review of Hospital B's "Airway Management" and the "2015-2017 Perianesthesia Nursing Standards, Practice Recommendations and Interpretive Statements-ASPAN." ANM stated that oxygen protocols implemented in the PTU, consisted of both the Airway Management and ASPAN. ANM acknowledged that both the Airway Management and ASPAN did not include unit specific protocols for the delivery of oxygen.

On 5/6/15 at 11:20 A.M., an interview was conducted with QCS 2. The QCS 2 stated that there was no specific policy related to O2 and that the nurses knew how to titrate the oxygen flow level to keep patients O2 saturation (sat-amount of oxygen in the blood) within normal (95-100%).

On 5/6/15 at 11:46 A.M., an interview with RN 5. RN 5 stated that the nurses have an oxygen protocol to maintain O2 sats at 95% and that they get report from the anesthesiologist when the patient was brought to the PTU.

Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

2. Patient 8 was admitted hospital B's PTU room 22 on 6/18/14 status post (after) a surgical procedure that included revision of cochlear implantation (medical device that provide sound signals to the brain) per the Operative Note dated 6/18/14.

Patient 8 arrived with a simple mask at 8 liter per minute of oxygen and oxygen parameters that indicated "maintain O2 (oxygen) to keep SaO2 (O2 sat, oxygen saturation-amount of oxygen in the blood) greater than or equal to 95% (normal O2 sat is 95-100%) per the physician order dated 6/18/14.

On 5/6/15 at 11:20 A.M., an interview was conducted with QCS 2. The QCS 2 stated that there was no specific policy related to O2 and that the nurses knew how to titrate the oxygen flow level to keep patients O2 saturation (sat-amount of oxygen in the blood) within normal (95-100%).

On 5/5/15 at 9:15 A.M., an interview and record review was conducted with Assistant Nurse Manager (ANM) of the PTU. A review of Hospital B's "Airway Management" and the "2015-2017 Perianesthesia Nursing Standards, Practice Recommendations and Interpretive Statements-ASPAN." ANM stated that oxygen protocols implemented in the PTU, consisted of both the Airway Management and ASPAN. ANM acknowledged that both the Airway Management and ASPAN did not include unit specific protocols for the delivery of oxygen.

On 5/6/15 at 11:20 A.M., an interview was conducted with QCS 2. The QCS 2 stated that there was no specific policy related to O2 and that the nurses knew how to titrate the oxygen flow level to keep patients O2 saturation (sat-amount of oxygen in the blood) within normal (95-100%).

On 5/6/15 at 11:46 A.M., an interview with RN 5. RN 5 stated that the nurses have an oxygen protocol to maintain O2 sats at 95% and that they get report from the anesthesiologist when the patient was brought to the PTU.

Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

3. Patient 10 was admitted hosptial B's PTU room 22 on 8/15/14 status post (after) a surgical procedure that included right neck lipoma excision (removal of soft tissue tumor) per the Operative Note dated 8/15/14.

Patient 10 arrived with a simple mask at 6 liter per minute of oxygen and with oxygen parameters that indicated "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less then 90% per the physician order dated 8/15/14.

On 5/5/15 at 9:15 A.M., an interview and record review was conducted with Assistant Nurse Manager (ANM) of the PTU. A review of Hospital B's "Airway Management" and the "2015-2017 Perianesthesia Nursing Standards, Practice Recommendations and Interpretive Statements-ASPAN." ANM stated that oxygen protocols implemented in the PTU, consisted of both the Airway Management and ASPAN. ANM acknowledged that both the Airway Management and ASPAN did not include unit specific protocols for the delivery of oxygen.

On 5/6/15 at 11:20 A.M., an interview was conducted with QCS 2. The QCS 2 stated that there was no specific policy related to O2 and that the nurses knew how to titrate the oxygen flow level to keep patients O2 saturation (sat-amount of oxygen in the blood) within normal (95-100%).

On 5/6/15 at 11:46 A.M., an interview with RN 5. RN 5 stated that the nurses have an oxygen protocol to maintain O2 sats at 95% and that they get report from the anesthesiologist when the patient was brought to the PTU.

Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

4. Patient 11 was admitted hosptial B's PTU room 22 on 8/15/14 status post (after) a surgical procedure that included infected right femoral popliteal bypass graft (replace or bypass of a blocked part of an artery) per the Operative Note dated 8/15/14.

Patient 11 arrived with a simple mask at 8 liter per minute of oxygen and with oxygen parameters that indicated, "Maintain O2 (oxygen) to keep SaO2 (O2 sat, oxygen saturation-amount of oxygen in the blood) greater than or equal to 95% (normal O2 sat is 95-100%)" and a second parameter that indicated, "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician orders dated 8/15/14.

On 5/5/15 at 9:15 A.M., an interview and record review was conducted with Assistant Nurse Manager (ANM) of the PTU. A review of Hospital B's "Airway Management" and the "2015-2017 Perianesthesia Nursing Standards, Practice Recommendations and Interpretive Statements-ASPAN." ANM stated that oxygen protocols implemented in the PTU, consisted of both the Airway Management and ASPAN. ANM acknowledged that both the Airway Management and ASPAN did not include unit specific protocols for the delivery of oxygen.

On 5/6/15 at 11:20 A.M., an interview was conducted with QCS 2. The QCS 2 stated that there was no specific policy related to O2 and that the nurses knew how to titrate the oxygen flow level to keep patients O2 saturation (sat-amount of oxygen in the blood) within normal (95-100%).

On 5/6/15 at 11:46 A.M., an interview with RN 5. RN 5 stated that the nurses have an oxygen protocol to maintain O2 sats at 95% and that they get report from the anesthesiologist when the patient was brought to the PTU.

Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

5. Patient 14 was admitted hosptial B's PTU room 22 on 9/16/14 status post (after) a surgical procedure that included pelvic organ prolapse (pelvic organs can slip out of place) per the Operative Note dated 9/16/14.

Patient 14 arrived with a simple mask at 8 liter per minute of oxygen and with oxygen parameters that indicated "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician orders dated 9/16/14.

On 5/5/15 at 9:15 A.M., an interview and record review was conducted with Assistant Nurse Manager (ANM) of the PTU. A review of Hospital B's "Airway Management" and the "2015-2017 Perianesthesia Nursing Standards, Practice Recommendations and Interpretive Statements-ASPAN." ANM stated that oxygen protocols implemented in the PTU, consisted of both the Airway Management and ASPAN. ANM acknowledged that both the Airway Management and ASPAN did not include unit specific protocols for the delivery of oxygen.

On 5/6/15 at 11:20 A.M., an interview was conducted with QCS 2. The QCS 2 stated that there was no specific policy related to O2 and that the nurses knew how to titrate the oxygen flow level to keep patients O2 saturation (sat-amount of oxygen in the blood) within normal (95-100%).

On 5/6/15 at 11:46 A.M., an interview with RN 5. RN 5 stated that the nurses have an oxygen protocol to maintain O2 sats at 95% and that they get report from the anesthesiologist when the patient was brought to the PTU.

Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

6. Patient 15 was admitted hosptial B's PTU room 22 on 9/30/14 status post (after) a surgical procedure that included abnormal uterine bleeding per the Operative Note dated 9/30/14.

Patient 15 arrived with a simple mask at 8 liter per minute of oxygen and with oxygen parameters that indicated "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician orders dated 9/30/14.

On 5/5/15 at 9:15 A.M., an interview and record review was conducted with Assistant Nurse Manager (ANM) of the PTU. A review of Hospital B's "Airway Management" and the "2015-2017 Perianesthesia Nursing Standards, Practice Recommendations and Interpretive Statements-ASPAN." ANM stated that oxygen protocols implemented in the PTU, consisted of both the Airway Management and ASPAN. ANM acknowledged that both the Airway Management and ASPAN did not include unit specific protocols for the delivery of oxygen.

On 5/6/15 at 11:20 A.M., an interview was conducted with QCS 2. The QCS 2 stated that there was no specific policy related to O2 and that the nurses knew how to titrate the oxygen flow level to keep patients O2 saturation (sat-amount of oxygen in the blood) within normal (95-100%).

On 5/6/15 at 11:46 A.M., an interview with RN 5. RN 5 stated that the nurses have an oxygen protocol to maintain O2 sats at 95% and that they get report from the anesthesiologist when the patient was brought to the PTU.

Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

7. Patient 18 was admitted hosptial B's PTU room 22 on 10/15/14 status post (after) a surgical procedure that included ulcerative colitis (inflammatory bowel disease) per the Operative Note dated 10/15/14.

Patient 18 arrived with a simple mask at 8 liter per minute of oxygen and with oxygen parameters that indicated "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician note dated 10/15/14. Patient 18 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen) and had an O2 sat that fell to 86% during the stay in the PTU room 22.

On 5/5/15 at 9:15 A.M., an interview and record review was conducted with Assistant Nurse Manager (ANM) of the PTU. A review of Hospital B's "Airway Management" and the "2015-2017 Perianesthesia Nursing Standards, Practice Recommendations and Interpretive Statements-ASPAN." ANM stated that oxygen protocols implemented in the PTU, consisted of both the Airway Management and ASPAN. ANM acknowledged that both the Airway Management and ASPAN did not include unit specific protocols for the delivery of oxygen.

On 5/6/15 at 11:20 A.M., an interview was conducted with QCS 2. The QCS 2 stated that there was no specific policy related to O2 and that the nurses knew how to titrate the oxygen flow level to keep patients O2 saturation (sat-amount of oxygen in the blood) within normal (95-100%).

On 5/6/15 at 11:46 A.M., an interview with RN 5. RN 5 stated that the nurses have an oxygen protocol to maintain O2 sats at 95% and that they get report from the anesthesiologist when the patient was brought to the PTU.

Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

8. Patient 19 was admitted hosptial B's PTU room 22 on 11/20/14 status post (after) a surgical procedure that included maxillary lymph node dissection (removal of lymph node-an important part of the immune system) per the Operative Note dated 11/20/15.

Patient 19 arrived with a simple mask at 6 liter per minute of oxygen and oxygen parameters that indicated "Respiratory rate is less less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician orders dated 11/20/14. Patient 19 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen).

On 5/5/15 at 9:15 A.M., an interview and record review was conducted with Assistant Nurse Manager (ANM) of the PTU. A review of Hospital B's "Airway Management" and the "2015-2017 Perianesthesia Nursing Standards, Practice Recommendations and Interpretive Statements-ASPAN." ANM stated that oxygen protocols implemented in the PTU, consisted of both the Airway Management and ASPAN. ANM acknowledged that both the Airway Management and ASPAN did not include unit specific protocols for the delivery of oxygen.

On 5/6/15 at 11:20 A.M., an interview was conducted with QCS 2. The QCS 2 stated that there was no specific policy related to O2 and that the nurses knew how to titrate the oxygen flow level to keep patients O2 saturation (sat-amount of oxygen in the blood) within normal (95-100%).

On 5/6/15 at 11:46 A.M., an interview with RN 5. RN 5 stated that the nurses have an oxygen protocol to maintain O2 sats at 95% and that they get report from the anesthesiologist when the patient was brought to the PTU.

Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

9. Patient 20 was admitted hosptial B's PTU room 22 on 11/21/14 status post (after) a surgical procedure that included right total hip replacement (cartilage and bone of the hip joint is surgically replaced with artificial materials) per the Operative Note dated 11/21/14.

Patient 20 arrived with a simple mask at 8 liter per minute of oxygen and oxygen parameters that indicated "Respiratory rate is less less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician orders dated 11/21/14. Patient 20 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen).

On 5/5/15 at 9:15 A.M., an interview and record review was conducted with Assistant Nurse Manager (ANM) of the PTU. A review of Hospital B's "Airway Management" and the "2015-2017 Perianesthesia Nursing Standards, Practice Recommendations and Interpretive Statements-ASPAN." ANM stated that oxygen protocols implemented in the PTU, consisted of both the Airway Management and ASPAN. ANM acknowledged that both the Airway Management and ASPAN did not include unit specific protocols for the delivery of oxygen.

On 5/6/15 at 11:20 A.M., an interview was conducted with QCS 2. The QCS 2 stated that there was no specific policy related to O2 and that the nurses knew how to titrate the oxygen flow level to keep patients O2 saturation (sat-amount of oxygen in the blood) within normal (95-100%).

On 5/6/15 at 11:46 A.M., an interview with RN 5. RN 5 stated that the nurses have an oxygen protocol to maintain O2 sats at 95% and that they get report from the anesthesiologist when the patient was brought to the PTU.

Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

10. Patient 21 was admitted hosptial B's PTU room 22 on 12/4/14 status post (after) a surgical procedure that included right and left mastectomy eradication of retained breast tissue after previous mastectomies (removal remaining breast tissue from both breasts) per the Operative Note dated 12/4/14.

Patient 21 arrived with a simple mask at 8 liter per minute of oxygen and with oxygen parameters that indicated, "Maintain O2 (oxygen) to keep SaO2 (O2 sat, oxygen saturation-amount of oxygen in the blood) greater than or equal to 95% (normal O2 sat is 95-100%)" and a second parameter that indicated, "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician orders dated 12/4/14. Patient 21 received medical gas (21 % oxygen) instead of pure oxygen (100% oxygen) and had an O2 sat that fell to 88% during the stay in the PTU room 22.

On 5/5/15 at 9:15 A.M., an interview and record review was conducted with Assistant Nurse Manager (ANM) of the PTU. A review of Hospital B's "Airway Management" and the "2015-2017 Perianesthesia Nursing Standards, Practice Recommendations and Interpretive Statements-ASPAN." ANM stated that oxygen protocols implemented in the PTU, consisted of both the Airway Management and ASPAN. ANM acknowledged that both the Airway Management and ASPAN did not include unit specific protocols for the delivery of oxygen.

On 5/6/15 at 11:20 A.M., an interview was conducted with QCS 2. The QCS 2 stated that there was no specific policy related to O2 and that the nurses knew how to titrate the oxygen flow level to keep patients O2 saturation (sat-amount of oxygen in the blood) within normal (95-100%).

On 5/6/15 at 11:46 A.M., an interview with RN 5. RN 5 stated that the nurses have an oxygen protocol to maintain O2 sats at 95% and that they get report from the anesthesiologist when the patient was brought to the PTU.

Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

11. Patient 22 was admitted hosptial B's PTU room 22 on 12/9/14 status post (after) a surgical procedure that included parathyroidectomy (removal of the parathyroid-tiny glands, located in the neck, that control the body's calcium levels.) per the Operative Note dated 12/9/14.

Patient 22 arrived with a simple mask at 6 liter per minute of oxygen and oxygen parameters that indicated "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician orders dated 12/9/14. Patient 22 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen).

On 5/5/15 at 9:15 A.M., an interview and record review was conducted with Assistant Nurse Manager (ANM) of the PTU. A review of Hospital B's "Airway Management" and the "2015-2017 Perianesthesia Nursing Standards, Practice Recommendations and Interpretive Statements-ASPAN." ANM stated that oxygen protocols implemented in the PTU, consisted of both the Airway Management and ASPAN. ANM acknowledged that both the Airway Management and ASPAN did not include unit specific protocols for the delivery of oxygen.

On 5/6/15 at 11:20 A.M., an interview was conducted with QCS 2. The QCS 2 stated that there was no specific policy related to O2 and that the nurses knew how to titrate the oxygen flow level to keep patients O2 saturation (sat-amount of oxygen in the blood) within normal (95-100%).

On 5/6/15 at 11:46 A.M., an interview with RN 5. RN 5 stated that the nurses have an oxygen protocol to maintain O2 sats at 95% and that they get report from the anesthesiologist when the patient was brought to the PTU.

Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

12. Patient 23 was admitted hosptial B's PTU room 22 on 12/9/14 status post (after) a surgical procedure that included hemorrhoidectomy (removal of hemorrhoids-swollen and inflamed veins in your anus and lower rectum) per the Operative Note dated 12/10/14.

Patient 23 arrived with a simple mask at 6 liter per minute of oxygen and with oxygen parameters that indicated, "Maintain O2 (oxygen) to keep SaO2 (O2 sat, oxygen saturation-amount of oxygen in the blood) greater than or equal to 92% (normal O2 sat is 95-100%)" and a second parameter that indicated, "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician orders dated 12/9/14. Patient 23 received medical gas (21 % oxygen) instead of pure oxygen (100% oxygen).

On 5/5/15 at 9:15 A.M., an interview and record review was conducted with Assistant Nurse Manager (ANM) of the PTU. A review of Hospital B's "Airway Management" and the "2015-2017 Perianesthesia Nursing Standards, Practice Recommendations and Interpretive Statements-ASPAN." ANM stated that oxygen protocols implemented in the PTU, consisted of both the Airway Management and ASPAN. ANM acknowledged that both the Airway Management and ASPAN did not include unit specific protocols for the delivery of oxygen.

On 5/6/15 at 11:20 A.M., an interview was conducted with QCS 2. The QCS 2 stated that there was no specific policy related to O2 and that the nurses knew how to titrate the oxygen flow level to keep patients O2 saturation (sat-amount of oxygen in the blood) within normal (95-100%).

On 5/6/15 at 11:46 A.M., an interview with RN 5. RN 5 stated that the nurses have an oxygen protocol to maintain O2 sats at 95% and that they get report from the anesthesiologist when the patient was brought to the PTU.

Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

13. Patient 24 was admitted hosptial B's PTU room 22 on 12/10/14 status post (after) a surgical procedure that included excision, right ankle soft tissue mass (tumor-abnormal mass of tissue) per the Operative Note dated 12/12/14.

Patient 24 arrived with a simple mask at 8 liter per minute of oxygen and oxygen parameters that indicated "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician orders dated 12/10/14. Patient 24 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen).

On 5/5/15 at 9:15 A.M., an interview and record review was conducted with Assistant Nurse Manager (ANM) of the PTU. A review of Hospital B's "Airway Management" and the "2015-2017 Perianesthesia Nursing Standards, Practice Recommendations and Interpretive Statements-ASPAN." ANM stated that oxygen protocols implemented in the PTU, consisted of both the Airway Management and ASPAN. ANM acknowledged that both the Airway Management and ASPAN did not include unit specific protocols for the delivery of oxygen.

On 5/6/15 at 11:20 A.M., an interview was conducted with QCS 2. The QCS 2 stated that there was no specific policy related to O2 and that the nurses knew how to titrate the oxygen flow level to keep patients O2 saturation (sat-amount of oxygen in the blood) within normal (95-100%).

On 5/6/15 at 11:46 A.M., an interview with RN 5. RN 5 stated that the nurses have an oxygen protocol to maintain O2 sats at 95% and that they get report from the anesthesiologist when the patient was brought to the PTU.

Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

14. Patient 27 was admitted hosptial B's PTU room 22 on 12/17/14 status post (after) a surgical procedure that included left inguinal hernia (soft tissue bulges through a weak point in the abdominal muscles.) per the Operative Note dated 12/17/14.

Patient 27 arrived with a simple mask at 6 liter per minute of oxygen and with oxygen parameters that indicated, "Maintain O2 (oxygen) to keep SaO2 (O2 sat, oxygen saturation-amount of oxygen in the blood) greater than or equal to 95% (normal O2 sat is 95-100%)" and a second parameter that indicated, "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician orders dated 12/17/14. Patient 27 received medical gas (21 % oxygen) instead of pure oxygen (100% oxygen).

On 5/5/15 at 9:15 A.M., an interview and record review was conducted with Assistant Nurse Manager (ANM) of the PTU. A review of Hospital B's "Airway Management" and the "2015-2017 Perianesthesia Nursing Standards, Practice Recommendations and Interpretive Statements-ASPAN." ANM stated that oxygen protocols implemented in the PTU, consisted of both the Airway Management and ASPAN. ANM acknowledged that both the Airway Management and ASPAN did not include unit specific protocols for the delivery of oxygen.

On 5/6/15 at 11:20 A.M., an interview was conducted with QCS 2. The QCS 2 stated that there was no specific policy related to O2 and that the nurses knew how to titrate the oxygen flow level to keep patients O2 saturation (sat-amount of oxygen in the blood) within normal (95-100%).

On 5/6/15 at 11:46 A.M., an interview with RN 5. RN 5 stated that the nurses have an oxygen protocol to maintain O2 sats at 95% and that they get report from the anesthesiologist when the patient was brought to the PTU.

Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen pr
VIOLATION: GOVERNING BODY Tag No: A0043
Based on interview and document review, the hospital did not have an effective governing body that carried out the functions required of a governing body as evidenced by the following:

1. Failed to ensure that contracted services related to the plumbing and testing of medical gases were performed in a safe and effective manner, when a cross connection was found (Tag A084)

2. Failed to ensure that safe care related to oxygen therapy was provided to patients in the Procedural Treatment Unit (PTU - Room 22). (Tag A144 #1-58)

3. Failed to track and monitor medication errors related to oxygen therapy in the Post-anesthesia care unit (PACU), Procedural Treatment Unit (PTU- only at Hospital B), and the Pre and Post Procedure Units (PPPU) at Hospital A and B. (Tag A286)

4. Failure to monitor or collect data related the use of electronic oxygen order sets in the PACU, PTU and PPPU. (Tag A273)

5. Failed to ensure that Registered Nurses (RNs) administered oxygen therapy in accordance with physician's orders in the PTU, PACU and PPPU at both Hospital A and B (Tag A144 #1-58)

6. Failed to administer pure oxygen to patients located in room number 22 of the PTU when the oxygen outlet delivered medical air instead of oxygen. (Tag A405 #1-63)

7. Failed to ensure written respiratory protocols were developed and approved by the medical staff, for the delivery of oxygen therapy for the PACU and the PTU. (Tag A1160 #1-58)

8. Failed to ensure that hospital B's Medical Gas Systems were in accordance with National Fire Protection Association (NFPA) related to cross connection problem with medical air and oxygen, no documented evidence of a cross connection testing, and correct labeling of the medical gas system outlet. (A tag 710 #1-3)

An interview was conducted with the representatives of the Governing Body (GB) on 5/11/15 at 3:30 P.M. The Chief Executive Officer (CEO), the Chief Medical Officer (CMO), the Chief Clinical Officer/Chief Nurse Officer (CCO/CNO), the Quality Officer, and the Associate Administrator Facilities (AA) were present. The CEO stated that the GB was responsible for the oversight of all clinical programs and the quality of the health system. The GB was aware that the hospital's facilities department was not able to provide documented evidence that the cross connection testing had been performed when the building was constructed in 2011. The AAF stated that the facilities staff were made aware of the cross connection problem in room 22 of the PTU on 4/29/15 at 12:00 P.M. He acknowledged that in room 22 of the PTU the oxygen outlet was emitting medical air (21% oxygen) and the medical air outlet was emitting pure oxygen (100%). The CMO stated that oxygen was a medication that required a physician's order prior to the delivery of it. The CMO explained that a complete physician's order for oxygen therapy included the following: oxygen delivery device, flow rate and FiO2 (fractioned inspired oxygen) in the PACU, PTU and PPPU at both Hospital A and B. She acknowledged that there were patients in the PACU, PTU and the PPPU that were administered oxygen therapy without a complete physician's order. The CMO acknowledged that there was not an oxygen protocol in place for these units (PACU, PTU and PPPU). She also acknowledged that the hospital had not collected medication error data to include errors related to oxygen therapy. In addition, the CMO acknowledged that the hospital had not monitored or collected data when the hospital transitioned to the use of electronic oxygen order sets to determine its effectiveness and to identify opportunities for improvement related to oxygen order sets and oxygen delivery in the PACU, PTU and PPPU.


The cumulative effect of these systemic problems resulted in the hospital's failure to deliver care in compliance with the Condition of Participation for Governing Body and failure to provide a safe and secure environment for patients.
VIOLATION: CONTRACTED SERVICES Tag No: A0084
Based on interview, document and record review, hospital B failed to ensure that the installation contractor (contracted service) performed cross connection testing during the initial installation of the original medical gas piping per their contract. The hospital was not able to provide documented evidence that cross connection testing had been performed during the construction of the building in 2011. A room in the Procedural Treatment Unit(PTU) was found to have oxygen (99% oxygen) emitted from the medical air outlet and medical air (21% oxygen) was emitted from the oxygen outlet.

The hospital's failure to ensure that services performed under contract, included the performance of all required testing's and the retention of the testing documents. This failure made it difficult to determine if the hospital's installation contractor performed a required cross connection test to ensure that oxygen delivery was provided in a safe and effective manner.


Findings:

On 4/30/15 at 10:50 A.M., an onsite investigation was conducted related to an Entity Reported Incident. The hospital reported to the Department of Public Health that on 4/29/15 it had been discovered that the oxygen outlet in room 22 of the PTU had been delivering medical air instead of pure oxygen.

On 4/30/15 at 11:35 A.M., an interview was conducted with the Director of Regulatory Affairs (DRA). The DRA stated that Patient (1) had not responded to oxygen until the Registered Nurse (RN) 2 removed the oxygen tubing from the wall outlet to the portable oxygen tank. Patient 1's oxygen saturation (amount of oxygen in the blood) went up to 100% once placed on the portable oxygen tank.

On 5/1/15 at 11:00 A.M., an interview was conducted with the Chief Medical Officer (CMO). The CMO stated that the hospital had discovered a medical gas cross connection problem with room number 22 in the PTU on 4/29/15. The CMO stated that the oxygen outlet had emitted medical air instead of pure oxygen. The CMO stated that the PTU room 22 was licensed as a post procedure recovery room. The CMO stated that PTU room 22 had been used primarily as a consultation room since it had been licensed and that in June of 2014 room 22 had started to be used more frequently as a post anesthesia care unit (PACU).

On 5/1/15 at 11:15 A.M., a group interview was conducted. The Director of Facility Engineering(DFE) stated that his department received a call on 4/28/15 at approximately 6:45 P.M. from RN 7 regarding room 22 in the PTU. The flow was checked and found to have proper flow. The DFE stated that on 4/29/15 at approximately 8:00-9:00 A.M., another test was conducted by the facility staff shutting off the medical air flow to all the rooms in the PTU. The medical air outlets were checked for flow, and only room 22 had flow at the medical air outlet. The DFE stated that they contacted their vendor to test room 22 for purity (gives the percentage of O2 from the outlets). The vendor found that room 22's medical air outlet had 100% oxygen and the oxygen outlet had 21%.

On 5/5/15 at 8:25 A.M., an interview with the Associate Administrator for Facility's (AAF) was conducted. The AAF stated that the final verification report for the PTU floor had indicated "everything was ok and ready for use." The other required testing reports were in boxes off site and that they would have to retrieve the boxes to find those reports.

On 5/5/15 at 1:40 A.M., an interview was conducted with the Senior Director Project Manager (SDPM) and the Director of Environmental Health and Safety (DEHS). The SDPM stated that he was not able to locate the inspection reports but was confident he could.

On 5/6/15 at 1:40 P.M., an interview was conducted with SDPM, DFE and DEHS. SDPM stated that he did not have the inspection reports related to the cross connection test for room 22 and that he had contacted the contracted company to request copies. The SDPM further stated that there were no work orders for a construction change prior to the licensing of the building and that they followed the National Fire Protection Association (NFPA-fire safety agency) regulations.

The NFPA-99, dated 1999, 4-3.1.1.1, indicated "Responsible Facility Authority 1. Shall review test records 2. Shall ensure findings and testing are completed; 4-3.4.1.2 1. Blow down test, 2. Initial pressure test and soap test 3. Cross connection test 4. Piping purge test 5. Standing pressure test; 4-3.4.1.3 3rd Party Testing 1. Cross connection test 2. Valve test 3. Outlet flow test 4. Alarm test 5. Piping purge test 6. Piping purity test...10 Medical air purity test..."

On 5/11/15 at 7:49 A.M., an interview with the DRA was conducted. The DRA stated that he had been told by the DFE that the required testing reports related to the cross connection testing, was still not found.

A portion of the construction contract agreement, dated 7/6/05, indicated "This agreement is made...between the (hospital's name) and the (name of contractor)... Article 1 work (contractor name) shall provide all work required by the Contract Documents...."

On 5/11/15 at 2:00 P.M., a group meeting with the Quality Assessment and Performance Improvement (QAPI) leadership team was conducted. The DFE stated that the SDPM had oversight and responsibility for the completion of the required items in the construction contract. The DFE further stated that SDPM was responsible for keeping all the testing reports. The DFE was able to produce reports for the cross connection testing on the 1st and 3rd floor, but was unable to provide the report for the 2nd floor, where the PTU room 22 was located.

During a previous interview on 5/4/15 at 1:30 P.M., the Senior Director of Project Management (SDPM), from the Hospital's Facility Design and Construction Department, stated that he was in charge of overseeing the contracts for the construction and that the construction project followed the provisions under the 1999 Edition of NFPA 99. He was asked to provide the cross connection inspection and testing records for PTU Room 22. The cross connection test was required testing for the Medical Gas system to determine that no cross-connection of piping systems existed. The SDPM stated that they will search for the documents.

On 5/11/15 at 3:30 P.M., a group interview with the Governing Body (GB) representatives was conducted. The Chief Executive Officer (CEO) stated that the GB had oversight over all clinical programs and health system for the hospital. The CEO stated that he was aware that the cross connection testing documents were missing.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, record and document review, Hospital B failed to provide care in a safe setting to patients in room 22 of the Procedural Treatment Unit (PTU- provides services to patients requiring, interventional, operative, and diagnostic services requiring general anesthesia [medications used to induce unconsciousness or loss of sensation] or intravenous sedation), for 58 of 85 sampled patients (1, 2, 7, 8, 10, 11, 14, 15, 18, 19, 20, 21, 22, 23, 24, 27, 29, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 46, 49, 51, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 65, 66, 67, 68, 69, 72, 73, 74, 75, 76, 77, 78, 79, 81, 82, 83, and 85) who required oxygen therapy but received medical air.

Patients who were provided with recovery care in room 22 of the PTU were at increased risk for post recovery breathing problems because the wall outlet that was thought to be delivering 100% oxygen, was actually delivering medical room air at 21% oxygen.

Findings:

1. Patient 1 was admitted on [DATE] for a surgical procedure that included stage 3 vaginal prolapsed repair (top of the vagina falls toward the vaginal opening) per the Operative Note, dated 4/28/15.

On 4/30/15 at 10:50 A.M., an onsite investigation was conducted related to an Entity Reported Incident. The hospital reported to the Department of Public Health that on 4/29/15, it had been discovered that the oxygen outlet in room 22 of the PTU had been delivering medical air not pure oxygen.

On 4/30/15 at 11:35 A.M., an interview was conducted with the Director of Regulatory Affairs (DRA). The DRA stated that Patient 1 had not responded to oxygen until the Registered Nurse (RN) 2 removed the oxygen tubing from the wall outlet to the portable oxygen tank. Patient 1's oxygen saturation (O2 sats - amount of oxygen in the blood) went up to 100% once placed on the portable oxygen tank.

A review of Patient 1's medical record was conducted with the Quality Compliance Specialist (QCS) 1 and the DRA. The document titled "Events", dated 4/28/15, indicated that Patient 1 arrived to the hospital at 5:46 A.M., was in surgery at 7:20 A.M., then in Post Anesthesia Care Unit (an area that recovers patients after a loss of sensation with or without loss of consciousness-PACU) at 1:39 P.M.. Patient 1 was transferred to the PTU at 3:56 P.M. on oxygen via a nasal canula (prongs in the nose to administer oxygen) at 3 liters per minute.

Per the same "Events" document, Patient 1's oxygen saturation while in the PACU ranged from 94-96% (normal sats 95-100%) on a simple mask and therefore was decreased to a nasal canula (NC) at 3 liter per minute. Patient 1 continued to maintain O2 sats between 93%-95% on the NC, prior to being transferred to the PTU. Patient 1's O2 sat decreased from 95% to 91% at 4:20 P.M. (24 minutes after being transferred to room 22). RN 2 placed Patient 1 back on a simple mask at 8 liters of oxygen per minute. Patient 1's O2 sat continued to decrease to 83% by 5:00 P.M. Patient 1 was placed on a non-rebreather mask (NRB- mask that covers the nose and mouth and unlike low flow nasal cannula, the NRB delivers a higher concentration of oxygen) at 8 liters of oxygen per minute by 6:00 P.M. Patient 1's O2 sats remained low for over 2-hours after arriving in the PTU.

Per the Nursing Note, dated 4/28/15 at 6:14 P.M., the Anesthesiologist (Medical Doctor/MD 2- physicians who provide medical care to patients in a wide variety of situations including airway management) arrived at Patient 1's bedside and indicated, "Pt (patient) still unable to maintain sats...."
Per the Physician Progress Note, dated 4/28/15 at 6:53 P.M., "at 6:50 P.M., pt was planning to be intubated (tube in airway to provide mechanical ventilation) and when hooked up to O2 tank on the bed, O2 sat 100%..."
On 4/30/15 at 12:12 P.M., an interview was conducted with Patient 1's primary physician (MD 1). MD 1 stated that she had not been present during Patient 1's low oxygen saturation but was informed of what had occurred. MD 1 stated that she was told that Patient 1 was going to intubated by MD 2 but prior to the intubation was placed on a portable oxygen tank and that her O2 sats increased to 100%.
On 4/30/15 at 1:15 P.M., an interview with the PTU's Assistant Nurse Manager (ANM) was conducted. The ANM stated that room 22 was known to have patients that "crashed (patients that were stable then become very unstable), needing intubation and Narcan (medication to reverse the effect of anesthesia)."
On 4/30/15 at 3:40 P.M., an interview was conducted with RN 6. RN 6 stated that she had knowledge of patients who had oxygen desaturations (decrease oxygen in blood) in room 22 of the PTU.

On 5/1/15 at 11:00 A.M., an interview was conducted with the Chief Medical Officer (CMO). The CMO stated that the hospital had discovered a medical gas cross connection problem with room 22 in the PTU on 4/29/15. The CMO stated that the oxygen outlet had released medical air instead of pure oxygen. The CMO stated that PTU room 22 was licensed as a post anesthesia care unit (PACU). The CMO stated that PTU room 22 had been used primarily as a consultation room since it had been licensed and that in June of 2014 started to be used more frequently as recovery room.

On 5/1/15 at 11:15 A.M., an interview was conducted with the Director of Facilities Engineering (DFE). The DFE stated that his department received a call on 4/28/15 at approximately 6:45 P.M. from RN 7 regarding room 22 in the PTU. The flow was checked and found to be ok. The DFE stated that on 4/29/15 at around 8:00 - 9:00 A.M., another test was conducted where the facility staff shut off the medical air flow to all the rooms in the PTU. The medical air outlets were checked for flow, and only room 22 had flow at the outlet. The DFE stated that they contacted their vendor to test room 22 for purity (gives the percentage of O2 from the outlets). The vendor found that room 22's medical air outlet had 100% oxygen and the oxygen outlet had only 21% oxygen.

On 5/4/15 at 1:30 P.M., an interview was conducted with RN 2. RN 2 stated that she took over the care of Patient 1 from Hospital B's main operating room's PACU and that Patient 1 had been stable in the PACU for three hours. RN 2 stated that Patient 1 started to have desaturations and had become anxious, but when the patient took a big breath then the O2 sats went up to the low 90's. RN 2 stated that MD 2 had arrived and ordered a chest X-ray, an ABG (arterial blood gas, test for levels of oxygen and carbon dioxide in the blood) and placed patient back on a NRB. RN 2 stated that MD 2 had planned to intubate the patient. RN 2 stated that RN 3 told her from the hallway outside room 22, that another patient had not done well in that room and that something was wrong with the O2 in the wall. RN 2 stated MD 2 had also remembered that she had intubated another patient in that room. RN 2 stated that MD 2 told her to, "humor me and lets hook her up to a tank to see what happens." RN 2 stated that within 45 seconds Patient 1's O2 sat went up and that the patient began to talk and was alert.

On 5/4/15 at 1:55 P.M., an interview was conducted with MD 2. MD 2 stated that she was the lead call anesthesiologist that day. MD 2 stated that RN 2 called and informed her of Patient 1's desaturations. MD 2 stated that she had ordered an ABG and chest X-ray due to patients O2 sats being in the low 80's. MD 2 stated that the chest X-ray came back normal and that the ABG's were normal except a low PaO2 (partial pressure of oxygen in the blood). MD 2 stated that she had another patient a couple months ago that had the same clinical symptoms and that she had to intubate that patient. MD 2 stated that Patient 1 was already on a NRB and was getting worse and desating into the 70's, she decided to hook the patient to the portable O2 prior to intubation, and once on the portable O2 that Patient 1's O2 sat "shot up".
On 5/4/15 at 2:47 P.M., an interview was conducted with RN 3. RN 3 stated that she knew about another patient in that room that had not done well. RN 3 stated that when Patient 1 had progressively worsened, that she told RN 2 to put the patient on portable O2. RN 3 stated after the patient was put on the portable O2 that her O2 sat went up.
On 5/4/15 at 3:05 P.M., an interview was conducted with RN 7. RN 7 stated that she was the charge nurse and that RN 2 and RN 3 had come to her and told her that there was something wrong with the O2 flow meter (device used to control oxygen flow delivery). RN 7 stated that she reported a problem with the flow meter to maintenance.
During a Quality Assessment and Performance Improvement (QAPI) group interview on 5/11/15 at 2:00 P.M., the Quality Officer and the DRA stated that the hospital discovered a medical gas cross connection problem in room 22 of the PTU. They acknowledged that patients recovered in room 22 of the PTU would not have had access to pure oxygen from the wall outlet labeled "oxygen".

2. During an interview and document review with the Director of Regulatory Affairs (DRA) on 5/4/15 at 7:55 A.M., a list of patient names was provided from the following timeframe of 6/18/14 - 4/28/15. The list included the names of patients who had received care in room 22 of the PTU.

Patient 8 was admitted to Hospital B's PTU room 22 on 6/18/14 status post (after) a surgical procedure that included revision of cochlear implantation (medical device that provide sound signals to the brain) per the Operative Note, dated 6/18/14.

Patient 8 arrived with a simple mask at 8 liter per minute of oxygen and oxygen parameters that indicated "maintain O2 (oxygen) to keep SaO2 (O2 sat, oxygen saturation-amount of oxygen in the blood) greater than or equal to 95% (normal O2 sat is 95-100%) per the physician order dated 6/18/14. Patient 8 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen).

During a Quality Assessment and Performance Improvement (QAPI) group interview on 5/11/15 at 2:00 P.M., the Quality Officer and the DRA stated that the hospital discovered a medical gas cross connection problem in room 22 of the PTU. They acknowledged that patients recovered in room 22 of the PTU would not have had access to pure oxygen from the wall outlet labeled "oxygen".

3. During an interview and document review with the Director of Regulatory Affairs (DRA) on 5/4/15 at 7:55 A.M., a list of patient names was provided from the following timeframe of 6/18/14 - 4/28/15. The list included the names of patients who had received care in room 22 of the PTU.

Patient 10 was admitted to Hospital B's PTU room 22 on 8/15/14 status post (after) a surgical procedure that included right neck lipoma excision (removal of soft tissue tumor) per the Operative Note, dated 8/15/14.

Patient 10 arrived with a simple mask at 6 liter per minute of oxygen and with oxygen parameters that indicated "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation- amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician's order, dated 8/15/14. Patient 8 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen).

During a Quality Assessment and Performance Improvement (QAPI) group interview on 5/11/15 at 2:00 P.M., the Quality Officer and the DRA stated that the hospital discovered a medical gas cross connection problem in room 22 of the PTU. They acknowledged that patients recovered in room 22 of the PTU would not have had access to pure oxygen from the wall outlet labeled "oxygen".

4. During an interview and document review with the Director of Regulatory Affairs (DRA) on 5/4/15 at 7:55 A.M., a list of patient names was provided from the following timeframe of 6/18/14 - 4/28/15. The list included the names of patients who had received care in room 22 of the PTU.

Patient 11 was admitted to Hospital B's PTU room 22 on 8/15/14 status post (after) a surgical procedure that included infected right femoral popliteal bypass graft (replace or bypass of a blocked part of an artery) per the Operative Note, dated 8/15/14.

Patient 11 arrived with a simple mask at 8 liter per minute of oxygen and with oxygen parameters that indicated, "Maintain O2 (oxygen) to keep SaO2 (O2 sat, oxygen saturation- amount of oxygen in the blood) greater than or equal to 95% (normal O2 sat is 95-100%)" and a second parameter that indicated, "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician's orders, dated 8/15/14. Patient 11 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen) and had an O2 sat that fell to 88% during the stay in the PTU room 22.

During a Quality Assessment and Performance Improvement (QAPI) group interview on 5/11/15 at 2:00 P.M., the Quality Officer and the DRA stated that the hospital discovered a medical gas cross connection problem in room 22 of the PTU. They acknowledged that patients recovered in room 22 of the PTU would not have had access to pure oxygen from the wall outlet labeled "oxygen".

5. During an interview and document review with the Director of Regulatory Affairs (DRA) on 5/4/15 at 7:55 A.M., a list of patient names was provided from the following timeframe of 6/18/14 - 4/28/15. The list included the names of patients who had received care in room 22 of the PTU.

Patient 14 was admitted to Hospital B's PTU room 22 on 9/16/14 status post (after) a surgical procedure that included pelvic organ prolapse (pelvic organs can slip out of place) per the Operative Note, dated 9/16/14.

Patient 14 arrived with a simple mask at 8 liter per minute of oxygen and with oxygen parameters that indicated "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician's orders, dated 9/16/14. Patient 14 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen).

During a Quality Assessment and Performance Improvement (QAPI) group interview on 5/11/15 at 2:00 P.M., the Quality Officer and the DRA stated that the hospital discovered a medical gas cross connection problem in room 22 of the PTU. They acknowledged that patients recovered in room 22 of the PTU would not have had access to pure oxygen from the wall outlet labeled "oxygen".

6. During an interview and document review with the Director of Regulatory Affairs (DRA) on 5/4/15 at 7:55 A.M., a list of patient names was provided from the following timeframe of 6/18/14 - 4/28/15. The list included the names of patients who had received care in room 22 of the PTU.

Patient 15 was admitted to Hospital B's PTU room 22 on 9/30/14 status post (after) a surgical procedure that included abnormal uterine bleeding per the Operative Note, dated 9/30/14.

Patient 15 arrived with a simple mask at 8 liter per minute of oxygen and with oxygen parameters that indicated "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of <90% per the physician orders dated 9/30/14. Patient 15 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen).

During a Quality Assessment and Performance Improvement (QAPI) group interview on 5/11/15 at 2:00 P.M., the Quality Officer and the DRA stated that the hospital discovered a medical gas cross connection problem in room 22 of the PTU. They acknowledged that patients recovered in room 22 of the PTU would not have had access to pure oxygen from the wall outlet labeled "oxygen".

7. During an interview and document review with the Director of Regulatory Affairs (DRA) on 5/4/15 at 7:55 A.M., a list of patient names was provided from the following timeframe of 6/18/14 - 4/28/15. The list included the names of patients who had received care in room 22 of the PTU.

Patient 18 was admitted hospital B's PTU room 22 on 10/15/14 status post (after) a surgical procedure that included ulcerative colitis (inflammatory bowel disease) per the Operative Note dated 10/15/14.

Patient 18 arrived with a simple mask at 8 liter per minute of oxygen and with oxygen parameters that indicated "Respiratory rate is less < 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of <90% per the physician note dated 10/15/14. Patient 18 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen) and had an O2 sat that fell to 86% during the stay in the PTU room 22.

During a Quality Assessment and Performance Improvement (QAPI) group interview on 5/11/15 at 2:00 P.M., the Quality Officer and the DRA stated that the hospital discovered a medical gas cross connection problem in room 22 of the PTU. They acknowledged that patients recovered in room 22 of the PTU would not have had access to pure oxygen from the wall outlet labeled "oxygen".

8. During an interview and document review with the Director of Regulatory Affairs (DRA) on 5/4/15 at 7:55 A.M., a list of patient names was provided from the following timeframe of 6/18/14 - 4/28/15. The list included the names of patients who had received care in room 22 of the PTU.

Patient 19 was admitted hospital B's PTU room 22 on 11/20/14 status post (after) a surgical procedure that included maxillary lymph node dissection (removal of lymph node-an important part of the immune system) per the Operative Note dated 11/20/15.

Patient 19 arrived with a simple mask at 6 liter per minute of oxygen and oxygen parameters that indicated "Respiratory rate is less < 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of <90% per the physician orders dated 11/20/14. Patient 19 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen).

During a Quality Assessment and Performance Improvement (QAPI) group interview on 5/11/15 at 2:00 P.M., the Quality Officer and the DRA stated that the hospital discovered a medical gas cross connection problem in room 22 of the PTU. They acknowledged that patients recovered in room 22 of the PTU would not have had access to pure oxygen from the wall outlet labeled "oxygen".

9. During an interview and document review with the Director of Regulatory Affairs (DRA) on 5/4/15 at 7:55 A.M., a list of patient names was provided from the following timeframe of 6/18/14 - 4/28/15. The list included the names of patients who had received care in room 22 of the PTU.

Patient 20 was admitted hosptial B's PTU room 22 on 11/21/14 status post (after) a surgical procedure that included right total hip replacement (cartilage and bone of the hip joint is surgically replaced with artificial materials) per the Operative Note dated 11/21/14.

Patient 20 arrived with a simple mask at 8 liter per minute of oxygen and oxygen parameters that indicated "Respiratory rate is less < 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of <90% per the physician orders dated 11/21/14. Patient 20 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen).

During a Quality Assessment and Performance Improvement (QAPI) group interview on 5/11/15 at 2:00 P.M., the Quality Officer and the DRA stated that the hospital discovered a medical gas cross connection problem in room 22 of the PTU. They acknowledged that patients recovered in room 22 of the PTU would not have had access to pure oxygen from the wall outlet labeled "oxygen".

10. During an interview and document review with the Director of Regulatory Affairs (DRA) on 5/4/15 at 7:55 A.M., a list of patient names was provided from the following timeframe of 6/18/14 - 4/28/15. The list included the names of patients who had received care in room 22 of the PTU.

Patient 21 was admitted hospital B's PTU room 22 on 12/4/14 status post (after) a surgical procedure that included right and left mastectomy eradication of retained breast tissue after previous mastectomies (removal remaining breast tissue from both breasts) per the Operative Note dated 12/4/14.

Patient 21 arrived with a simple mask at 8 liter per minute of oxygen and with oxygen parameters that indicated, "Maintain O2 (oxygen) to keep SaO2 (O2 sat, oxygen saturation-amount of oxygen in the blood) greater than or equal to 95% (normal O2 sat is 95-100%)" and a second parameter that indicated, "Respiratory rate is less < 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of <90% per the physician orders dated 12/4/14. Patient 21 received medical gas (21 % oxygen) instead of pure oxygen (100% oxygen) and had an O2 sat that fell to 88% during the stay in the PTU room 22.

During a Quality Assessment and Performance Improvement (QAPI) group interview on 5/11/15 at 2:00 P.M., the Quality Officer and the DRA stated that the hospital discovered a medical gas cross connection problem in room 22 of the PTU. They acknowledged that patients recovered in room 22 of the PTU would not have had access to pure oxygen from the wall outlet labeled "oxygen".

11. During an interview and document review with the Director of Regulatory Affairs (DRA) on 5/4/15 at 7:55 A.M., a list of patient names was provided from the following timeframe of 6/18/14 - 4/28/15. The list included the names of patients who had received care in room 22 of the PTU

Patient 22 was admitted hospital B's PTU room 22 on 12/9/14 status post (after) a surgical procedure that included parathyroidectomy (removal of the parathyroid-tiny glands, located in the neck, that control the body's calcium levels.) per the Operative Note dated 12/9/14.

Patient 22 arrived with a simple mask at 6 liter per minute of oxygen and oxygen parameters that indicated "Respiratory rate is less < 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of <90% per the physician orders dated 12/9/14. Patient 22 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen).

During a Quality Assessment and Performance Improvement (QAPI) group interview on 5/11/15 at 2:00 P.M., the Quality Officer and the DRA stated that the hospital discovered a medical gas cross connection problem in room 22 of the PTU. They acknowledged that patients recovered in room 22 of the PTU would not have had access to pure oxygen from the wall outlet labeled "oxygen".

12. During an interview and document review with the Director of Regulatory Affairs (DRA) on 5/4/15 at 7:55 A.M., a list of patient names was provided from the following timeframe of 6/18/14 - 4/28/15. The list included the names of patients who had received care in room 22 of the PTU

Patient 23 was admitted hospital B's PTU room 22 on 12/9/14 status post (after) a surgical procedure that included hemorrhoidectomy (removal of hemorrhoids-swollen and inflamed veins in your anus and lower rectum) per the Operative Note dated 12/10/14.

Patient 23 arrived with a simple mask at 6 liter per minute of oxygen and with oxygen parameters that indicated, "Maintain O2 (oxygen) to keep SaO2 (O2 sat, oxygen saturation-amount of oxygen in the blood) greater than or equal to 92% (normal O2 sat is 95-100%)" and a second parameter that indicated, "Respiratory rate is less < 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of <90% per the physician orders dated 12/9/14. Patient 23 received medical gas (21 % oxygen) instead of pure oxygen (100% oxygen).

During a Quality Assessment and Performance Improvement (QAPI) group interview on 5/11/15 at 2:00 P.M., the Quality Officer and the DRA stated that the hospital discovered a medical gas cross connection problem in room 22 of the PTU. They acknowledged that patients recovered in room 22 of the PTU would not have had access to pure oxygen from the wall outlet labeled "oxygen".

13. During an interview and document review with the Director of Regulatory Affairs (DRA) on 5/4/15 at 7:55 A.M., a list of patient names was provided from the following timeframe of 6/18/14 - 4/28/15. The list included the names of patients who had received care in room 22 of the PTU.

Patient 24 was admitted hospital B's PTU room 22 on 12/10/14 status post (after) a surgical procedure that included excision, right ankle soft tissue mass (tumor-abnormal mass of tissue) per the Operative Note dated 12/12/14.

Patient 24 arrived with a simple mask at 8 liter per minute of oxygen and oxygen parameters that indicated "Respiratory rate is less < 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of <90% per the physician orders dated 12/10/14. Patient 24 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen).

During a Quality Assessment and Performance Improvement (QAPI) group interview on 5/11/15 at 2:00 P.M., the Quality Officer and the DRA stated that the hospital discovered a medical gas cross connection problem in room 22 of the PTU. They acknowledged that patients recovered in room 22 of the PTU would not have had access to pure oxygen from the wall outlet labeled "oxygen".

14. During an interview and document review with the Director of Regulatory Affairs (DRA) on 5/4/15 at 7:55 A.M., a list of patient names was provided from the following timeframe of 6/18/14 - 4/28/15. The list included the names of patients who had received care in room 22 of the PTU.

Patient 27 was admitted hospital B's PTU room 22 on 12/17/14 status post (after) a surgical procedure that included left inguinal hernia (soft tissue bulges through a weak point in the abdominal muscles.) per the Operative Note dated 12/17/14.

Patient 27 arrived with a simple mask at 6 liter per minute of oxygen and with oxygen parameters that indicated, "Maintain O2 (oxygen) to keep SaO2 (O2 sat, oxygen saturation-amount of oxygen in the blood) greater than or equal to 95% (normal O2 sat is 95-100%)" and a second parameter that indicated, "Respiratory rate is less < 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of <90% per the physician orders dated 12/17/14. Patient 27 received medical gas (21 % oxygen) instead of pure oxygen (100% oxygen).

During a Quality Assessment and Performance Improvement (QAPI) group interview on 5/11/15 at 2:00 P.M., the Quality Officer and the DRA stated that the hospital discovered a medical gas cross connection problem in room 22 of the PTU. They acknowledged that patients recovered in room 22 of the PTU would not have had access to pure oxygen from the wall outlet labeled "oxygen".

15. During an interview and document review with the Director of Regulatory Affairs (DRA) on 5/4/15 at 7:55 A.M., a list of patient names was provided from the following timeframe of 6/18/14 - 4/28/15. The list included the names of patients who had received care in room 22 of the PTU.

Patient 29 was admitted hospital B's PTU room 22 on 12/19/14 status post (after) a surgical procedure that included transurethral resection of bladder tumor (surgical procedure that is used both to diagnose [DIAGNOSES REDACTED] and to remove cancerous tissue from the bladder) per the Operative Note dated 12/21/14.

Patient 29 arrived with a simple mask at 6 liter per minute of oxygen and oxygen parameters that indicated "Respiratory rate is less < 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of <90% per the physician orders dated 12/19/14. Patient 29 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen).

During a Quality Assessment and Performance Improvement (QAPI) group interview on 5/11/15 at 2:00 P.M., the Quality Officer and the DRA stated that the hospital discovered a medical gas cross connection problem in room 22 of the PTU. They acknowledged that patients recovered in room 22 of the PTU would not have had access to pure oxygen from the wall outlet labeled "oxygen".

16. During an interview and document review with the Director of Regulatory Affairs (DRA) on 5/4/15 at 7:55 A.M., a list of patient names was provided from the following timeframe of 6/18/14 - 4/28/15. The list included the names of patients who had received care in room 22 of the PTU.

Patient 34 was admitted hospital B's PTU room 22 on 1/11/15 status post (after) a surgical procedure that included cardiac catheterization(procedure used to diagnose and treat cardiovascular conditions) per the Operative Note dated 1/12/15.

Patient 34 arrived to the PTU on room air but with oxygen parameters that indicated "maintain O2 (oxygen) to keep SaO2 (O2 sat, oxygen saturation-amount of oxygen in the blood) greater than or equal to 92% (normal O2 sat is 95-100%) per the physician order dated 1/12/15. Patient 34 did require oxygen to be applied by nasal cannula (used to deliver supplemental oxygen in the nostrils) at 2 liters to maintain parameters of O2 of 92% or greater, while in the PTU. Patient 34 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen).

During a Quality Assessment and Performance Improvement (QAPI) group interview on 5/11/15 at 2:00 P.M., the Quality Officer and the DRA stated that the hospital discovered a medical gas cross connection problem in room 22 of the PTU. They acknowledged that patients recovered in room 22 of the PTU would not have had access to pure oxygen from the wall outlet labeled "oxygen".





17. During an interview on 5/1/15 at 11:00 A.M., the Chief Medical Officer (CMO) stated that the facility had discovered a medical gas cross connection problem in PTU room number 22 on 4/29/15. The CMO stated that medical air and not therapeutic pure oxygen had been emitted from the oxygen outlet.

During an interview and joint document review with the Director of Regulatory Affairs (DRA) on 5/4/15 at 7:55 A.M., a list of patient names was provided from the time frame of 6/18/14 - 4/28/15. The list included the names of patients who had received care in room 22 of the PTU.

During a joint interview and record review, initiated on 5/7/14 at 10:30 A.M., Patient 49's medical record was reviewed with the DRA. Patient 49 was admitted to the facility on [DATE] with diagnoses which included arthritis (a degenerative joint disorder) per the patient's History and Physical, dated 1/22/15. The Operative Report, dated 2/6/15, indicated that Patient 49 underwent a left medial partial knee replacement surgical procedure on 2/6/15. The DRA stated that Patient 49 was placed in PTU room 22 during the post procedure recovery period.
The DRA acknowledged that patients recovered in room 22 of the PTU would not have received pure oxygen from the wall oxygen outlet.

18. During an interview on 5/1/15 at 11:00 A.M., the Chi
VIOLATION: QAPI Tag No: A0263
Based on interview, record and document review, the hospital failed to ensure that an effective quality assessment and performance improvement program (QAPI) was implemented, when the hospital:

1. Failed to ensure that contracted services related to the plumbing and testing of medical gases were performed in a safe and effective manner, when a cross connection was found (Tag A084)

2. Failed to ensure that safe care related to oxygen therapy was provided to patients in the Procedural Treatment Unit (PTU - Room 22). (Tag A144 #1-58)

3. Failed to track and monitor medication errors related to oxygen therapy in the Post-anesthesia care unit (PACU), Procedural Treatment Unit (PTU- only at Hospital B), and the Pre and Post Procedure Units (PPPU) at Hospital A and B. (Tag A286)

4. Failure to monitor or collect data related the use of electronic oxygen order sets in the PACU, PTU and PPPU. (Tag A273)

5. Failed to ensure that Registered Nurses (RNs) administered oxygen therapy in accordance with physician's orders in the PTU, PACU and PPPU at both Hospital A and B (Tag A405 #1-63)

6. Failed to administer pure oxygen to patients located in room number 22 of the PTU when the oxygen outlet delivered medical air instead of oxygen. (Tag A 144 #1-58)

7. Failed to ensure written respiratory protocols were developed and approved by the medical staff, for the delivery of oxygen therapy for the PACU and the PTU. (Tag A 1160 #1-58)

8. Failed to ensure that hospital B's Medical Gas Systems were in accordance with National Fire Protection Association (NFPA) related to cross connection problem with medical air and oxygen, no documented evidence of a cross connection testing, and correct labeling of the medical gas system outlet. (A tag 710 #1-3)



The cumulative effect of these systemic problems resulted in the hospital's failure to deliver care in compliance with the Condition of Participation for Quality Assurance Performance Improvement (QAPI) and failure to provide a safe and secure environment for patients.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on interview and record review, the hospital's Quality Assessment and Performance Improvement (QAPI) Program failed to ensure that monitoring and data collection were performed after the implementation of the hospital's electronic oxygen order set in the Post-anesthesia care unit (PACU - an area that recovers patients after a loss of sensation with or without loss of consciousness), Procedural Treatment Unit (PTU - a unit that provides services to the patient population requiring, interventional, operative, and diagnostic services requiring general anesthesia or intravenous sedation; only at Hospital B), and the Pre and Post Procedure Units (PPPU) at Hospital A and B. Hospital A and B were not able to provide evidence to demonstrate monitoring or data collection after the implementation of their electronic oxygen order set in these units.

Failure to monitor or collect data related the use of electronic oxygen order sets impeded the hospital from assessing the effectiveness of the order sets and the identification of opportunities for improvements related to oxygen delivery in the PACU, PTU and PPPU.

Findings:

According to the hospital's Performance Improvement and Patient Safety Plan (PIPS), dated fiscal year 2014/2015, the PIPS indicated that "Leadership (including local management, senior leadership & physician leadership) directs and supports the Performance Improvement & Patient Safety (PI&PS) plan by communicating the strategic framework, prioritizing improvement activities, incorporating quality and patient safety into the management process and by assuring the allocation of resources needed to meet objectives. Per the PIPS, the Department Chairs were responsible for monitoring clinical performance within their department and implementing change when needed to improve outcomes. The Chairs were also responsible for ensuring that standards of care and services were maintained. Under methodology of the PIPS, the hospital used patient-centered, systems-focused approach for evaluating and improving processes. Under monitoring performance of the PIPS, data was compiled and analyzed in usable formats to identify changes that will lead to improvements and determine whether changes have actually improved processes and outcomes. At a minimum, the hospital collected and analyzed data to monitor performance in performance improvement priorities set by leaders. Results of measurement were aggregated and analyzed for identification of trends, variances, and opportunities to improve patient care and healthcare delivery.

On 5/6/15 at 11:20 A.M., a tour of Hospital B's PTU (post-procedure area) was conducted with the Assistant Nurse Manager (RN 11) and the Director of Regulatory Affairs (DRA).

On 5/6/15 at 4:44 P.M., a tour of Hospital B's PPPU was conducted with the Director of Nursing (DON).

On 5/6/15 at 4:53 P.M., a tour of Hospital B's PACU was conducted with the DON. At 5:00 P.M., there was a patient who came from the operating room to the PACU on oxygen therapy via a simple mask. There was no documented evidence to demonstrate that a complete physician's order related to oxygen delivery had been obtained.

On 5/7/15 at 3:15 P.M., a tour of Hospital A's PACU was conducted with the Nurse Director of Medical Surgical Services (NDMS) and the nurse manager (RN 12). There were two patients observed receiving oxygen therapy via simple mask. There was no documented evidence to demonstrate that complete physician's orders related to oxygen therapy had been obtained.

On 5/7/15 at 4:41 P.M., a tour of Hospital A's Outpatient Surgery (a pre and post procedure unit) was conducted with the NDMS and RN 12. There were two patients observed receiving oxygen therapy via nasal cannula and simple mask.

According to the Procedural Treatment Unit Scope of Service, dated 4/2015, "All procedures and care rendered in the PTU are performed under the direction of the Cardiology and Anesthesiology faculty physicians."

Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

A group interview and joint document review with the Assistant Director of Peri-Anesthesia (ADPA), the Medical Director of the PTU and the DRA was conducted on 5/6/15 at 2:17 P.M. The ADPA stated that there was a form titled "Post Anesthesia Care Unit Physician's Orders" that was used in the PACU, PTU and PPPU for the delivery of oxygen until 9/26/13 when it was discontinued. She explained that the form was discontinued because the hospital implemented their electronic oxygen order sets at that time.

On 5/11/15 at 2:00 P.M., a QAPI interview was conducted. The Inpatient Pharmacy Manager (IPM) and the Chair of Anesthesia (Physician 11) were present. The IPM stated that when the hospital's electronic medical record system team developed oxygen order sets for the PACU, PTU and PPPU, there was a pharmacy and physician champion that participated in ensuring that all required elements were in the order sets for the delivery of oxygen in these units. She acknowledged that physicians were not using the oxygen order sets, and some may not even know that the order sets were in the hospital's electronic medical record system. Physician 11 was not aware that anesthesiologists in these units were not using the correct oxygen orders sets that specified oxygen deliver device, liter flow or FIO2. He also was not aware that oxygen delivery in these units were being administered by the nursing staff without complete orders by the prescriber.

A follow-up interview was conducted with the IPM on 5/12/15 at 10:25 A.M. The IPM explained that with the last upgrade of the hospital's electronic medical record system, there was a data system that kept track of all order sets. She stated that all orders sets were reviewed annually. Per the data system, the anesthesia PACU general post operative order sets (to include oxygen order sets) were reviewed by an anesthesiologist and a pharmacist on 2/28/14. These order sets were signed off without any changes and sent to the Pharmacy and Therapeutics Committee. The IPM acknowledged that when these order sets were reviewed on 2/28/14, this was the hospital's opportunity to identify problems or concerns related to oxygen delivery and physician's orders in these units.

According to the Pharmacy and Therapeutics Committee Meeting Minutes, dated 5/21/14, the minutes indicated that "All ordersets have been reviewed."

A group interview with the Chief Medical Officer (CMO), Director of Respiratory (DOR), the Pharmacist-in-Chief (PC), Director of Pulmonary Services (DPS), the Medical Director of Respiratory Care (MDRC) and the DRA was conducted on 5/12/15 at 3:10 P.M. The CMO acknowledged that patients in the PACU, PTU and the PPPU at both Hospital A and B did not have complete physician's orders to include oxygen delivery device, liter flow or FIO2. She acknowledged that the hospital was not able to demonstrate that monitoring or data collection had been performed after the hospital's implementation of the electronic oxygen order sets. The MDRC stated that the responsibility of oxygen administration or delivery at the hospital fell under his authority and license for the inpatient units. However, he stated that the Chair of Anesthesia (Physician 11) was responsible for the administration and delivery of oxygen in the PACU, PTU and PPPU.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on interview, record and document review, the hospital failed to collect and track medication error data to include errors related to oxygen delivery in an effort to identify and reduce medical errors. Per the hospital's Medication Error Reduction Plan (MERP), the definition of a medication error was any preventable medication-related event that may lead to inappropriate medication use or cause patient harm. Such events may be related to professional practice, procedures or systems. The medication use process includes: prescribing, prescription order communication/documentation, product labeling, packaging/nomenclature, compounding, dispensing, distribution, administration, monitoring, and other use processes per the hospital's MERP.

Failure to collect and track medication error that included errors related to oxygen therapy impeded the hospital's Quality Assessment and Performance Improvement (QAPI) program from reducing medical errors and identifying opportunities for improvements related to oxygen therapy and delivery in the PACU, PTU and PPPU at Hospital A and B.

Findings:

An interview and joint document review with the Medication Safety Officer (MSO) was conducted on 5/12/15 at 9:12 A.M. The MSO stated that she had oversight over medication safety at the hospital which did not include oxygen and medical gases. She stated that errors in the oxygen delivery were not considered medication errors. She stated that the hospital's medication error rate did not include errors related to oxygen delivery. She explained that if there was an error in oxygen delivery the hospital's I-report (Incident Report - internal reporting system) would be generated and the error would be categorized as respiratory management issue. The MERP was reviewed and the definition of a medication error was read. The MSO stated that per the hospital's policies, oxygen fell into its own category which was oxygen. She explained that it was "not like our other medications". She acknowledged that when oxygen was not delivered in accordance with a physician's order, it's an error that involved an FDA (Food and Drug Administration - a federal agency responsible for protecting and promoting public health through the regulation and supervision of food and drug safety) approved drug (oxygen as a prescription drug) and that it met the medication error definition of the hospital's MERP.

The hospital was not able to provide medication error data that included errors related to oxygen therapy.

According to the hospital's Performance Improvement and Patient Safety Plan (PIPS), dated fiscal year 2014/2015, the PIPS indicated that "Leadership (including local management, senior leadership & physician leadership) directs and supports the Performance Improvement & Patient Safety (PI&PS) plan by communicating the strategic framework, prioritizing improvement activities, incorporating quality and patient safety into the management process and by assuring the allocation of resources needed to meet objectives. Under monitoring performance of the PIPS, data was compiled and analyzed in usable formats to identify changes that will lead to improvements and determine whether changes have actually improved processes and outcomes. At a minimum, the hospital collected and analyzed data to monitor performance in performance improvement priorities set by leaders. Results of measurement were aggregated and analyzed for identification of trends, variances, and opportunities to improve patient care and healthcare delivery.

On 5/12/15 at 3:10 P.M., a group interview was conducted. The Chief Medical Officer (CMO), the Director of Respiratory (on the phone), the Pharmacist in Chief (PC), the Director of Pulmonary Services (DPS) and the Medical Director of Respiratory Care (MDRC) were present. The CMO stated that oxygen was a medication that required a physician's order prior to the administration of it in the PACU, PTU and PPPU. She acknowledged that the hospital had not collected or tracked medication errors to include errors related to oxygen delivery. In addition, the CMO acknowledged that when electronic oxygen order sets were implemented, there was no monitoring or collection of data to determine its effectiveness and to identify opportunities for improvement related to oxygen delivery in an effort to reduce medical errors. The MDRC stated that oxygen administration and delivery within the hospital was under his authority and license. However, he stated that the Chair of Anesthesia was responsible for the administration and delivery of oxygen in the post-operative areas to include the PACU, PTU and PPPU.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on interview, record and document review, the hospital failed to maintain oversight and supervision for nursing services when the hospital:

1. Failed to ensure that Registered Nurses (RNs) administered oxygen therapy in accordance with physician's orders in the PTU, PACU and PPPU at both Hospital A and B (Tag A405 #1-63)

The cumulative effect of these systemic problems resulted in the hospital's failure to deliver care in compliance with the Condition of Participation for Nursing Services and failure to provide a safe and secure environment for patients.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, document and record review Hospital A and B failed to ensure that Registered Nurses (RNs) administered oxygen therapy with complete physician's orders, for 63 of 100 sampled patients (1, 2, 7, 8, 10, 11, 14, 15, 18, 19, 20, 21, 22, 23, 24, 27, 29, 32, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 46, 49, 51, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 65, 66, 67, 68, 69, 72, 73, 74, 75, 76, 77, 78, 79, 81, 82, 83, 85, 86, 87, 88, and 89) in the PTU, post anesthesia care unit (PACU- an area that recovers patients after a loss of sensation with or without loss of consciousness) and the Pre and Post Procedure Units (PPPU, same as PTU at Hospital B and outpatient surgery at Hospital A).

Failure to administer oxygen without a complete physician's order made it difficult to determine if the oxygen delivery device, liter flow or FIO2 were in accordance with the medical treatment plan. This failure had the potential to negatively impact patients who required oxygen therapy during their recovery after a procedure or surgery.

Findings:

1. Patient 1 was admitted on [DATE] for a surgical procedure that included stage 3 vaginal prolapsed repair (top of the vagina falls toward the vaginal opening) per the Operative Note, dated 4/28/15.

On 4/30/15 at 10:50 A.M., an onsite investigation was conducted related to an Entity Reported Incident. The hospital reported to the Department of Public Health that on 4/29/15, it had been discovered that the oxygen outlet in room 22 of the PTU had been delivering medical air not pure oxygen.

A review of Patient 1's medical record was conducted with the Quality Compliance Specialist (QCS) 1 and the DRA. The document titled "Events", dated 4/28/15, indicated that Patient arrived in the PTU at 3:56 P.M. on a nasal canula (NC) at 3 liter per minute and with oxygen parameters that indicated "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician order dated .

On 5/6/15 at 11:40 A.M., an interview was conducted with Registered Nurse (RN) 4. RN 4 stated that when a patient comes from home and tell her that they use O2 at home, that she will put them on that flow amount. RN 4 stated she did not get a physician order just uses "nursing judgement" to know when to call the physician. RN 4 further stated that there was a preorder from the physician to maintain O2 sat's at 92%.
On 5/12/15 at 8:40 A.M., an interview with the Assistant Director of Peri-Anesthesia (ADPA) was conducted. The ADPA stated that RNs in the PACU, PTU and the PPPU at both Hospital A and B were administering oxygen without physician's orders that included oxygen delivery device, liter flow or FIO2.

Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

2. Patient 8 was admitted hospital B's PTU room 22 on 6/18/14 status post (after) a surgical procedure that included revision of cochlear implantation (medical device that provide sound signals to the brain) per the Operative Note dated 6/18/14.

Patient 8 arrived with a simple mask at 8 liter per minute of oxygen and oxygen parameters that indicated "maintain O2 (oxygen) to keep SaO2 (O2 sat, oxygen saturation-amount of oxygen in the blood) greater than or equal to 95% (normal O2 sat is 95-100%) per the physician order dated 6/18/14.

On 5/6/15 at 11:40 A.M., an interview was conducted with Registered Nurse (RN) 4. RN 4 stated that when a patient comes from home and tell her that they use O2 at home, that she will put them on that flow amount. RN 4 stated she did not get a physician order just uses "nursing judgement" to know when to call the physician. RN 4 further stated that there was a preorder from the physician to maintain O2 sat's at 92%.
Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

On 5/12/15 at 8:40 A.M., an interview with the Assistant Director of Peri-Anesthesia (ADPA) was conducted. The ADPA stated that RNs in the PACU, PTU and the PPPU at both Hospital A and B were administering oxygen without physician's orders that included oxygen delivery device, liter flow or FIO2.

3. Patient 10 was admitted hospital B's PTU room 22 on 8/15/14 status post (after) a surgical procedure that included right neck lipoma excision (removal of soft tissue tumor) per the Operative Note dated 8/15/14.

Patient 10 arrived with a simple mask at 6 liter per minute of oxygen and with oxygen parameters that indicated "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less then 90% per the physician order dated 8/15/14.

On 5/6/15 at 11:40 A.M., an interview was conducted with Registered Nurse (RN) 4. RN 4 stated that when a patient comes from home and tell her that they use O2 at home, that she will put them on that flow amount. RN 4 stated she did not get a physician order just uses "nursing judgement" to know when to call the physician. RN 4 further stated that there was a preorder from the physician to maintain O2 sat's at 92%.
Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

On 5/12/15 at 8:40 A.M., an interview with the Assistant Director of Peri-Anesthesia (ADPA) was conducted. The ADPA stated that RNs in the PACU, PTU and the PPPU at both Hospital A and B were administering oxygen without physician's orders that included oxygen delivery device, liter flow or FIO2.

4. Patient 11 was admitted hospital B's PTU room 22 on 8/15/14 status post (after) a surgical procedure that included infected right femoral popliteal bypass graft (replace or bypass of a blocked part of an artery) per the Operative Note dated 8/15/14.

Patient 11 arrived with a simple mask at 8 liter per minute of oxygen and with oxygen parameters that indicated, "Maintain O2 (oxygen) to keep SaO2 (O2 sat, oxygen saturation-amount of oxygen in the blood) greater than or equal to 95% (normal O2 sat is 95-100%)" and a second parameter that indicated, "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician orders dated 8/15/14.

On 5/6/15 at 11:40 A.M., an interview was conducted with Registered Nurse (RN) 4. RN 4 stated that when a patient comes from home and tell her that they use O2 at home, that she will put them on that flow amount. RN 4 stated she did not get a physician order just uses "nursing judgement" to know when to call the physician. RN 4 further stated that there was a preorder from the physician to maintain O2 sat's at 92%.
Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

On 5/12/15 at 8:40 A.M., an interview with the Assistant Director of Peri-Anesthesia (ADPA) was conducted. The ADPA stated that RNs in the PACU, PTU and the PPPU at both Hospital A and B were administering oxygen without physician's orders that included oxygen delivery device, liter flow or FIO2.

5. Patient 14 was admitted hospital B's PTU room 22 on 9/16/14 status post (after) a surgical procedure that included pelvic organ prolapse (pelvic organs can slip out of place) per the Operative Note dated 9/16/14.

Patient 14 arrived with a simple mask at 8 liter per minute of oxygen and with oxygen parameters that indicated "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician orders dated 9/16/14.

On 5/6/15 at 11:40 A.M., an interview was conducted with Registered Nurse (RN) 4. RN 4 stated that when a patient comes from home and tell her that they use O2 at home, that she will put them on that flow amount. RN 4 stated she did not get a physician order just uses "nursing judgement" to know when to call the physician. RN 4 further stated that there was a preorder from the physician to maintain O2 sat's at 92%.
Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

On 5/12/15 at 8:40 A.M., an interview with the Assistant Director of Peri-Anesthesia (ADPA) was conducted. The ADPA stated that RNs in the PACU, PTU and the PPPU at both Hospital A and B were administering oxygen without physician's orders that included oxygen delivery device, liter flow or FIO2.

6. Patient 15 was admitted hospital B's PTU room 22 on 9/30/14 status post (after) a surgical procedure that included abnormal uterine bleeding per the Operative Note dated 9/30/14.

Patient 15 arrived with a simple mask at 8 liter per minute of oxygen and with oxygen parameters that indicated "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician orders dated 9/30/14.

On 5/6/15 at 11:40 A.M., an interview was conducted with Registered Nurse (RN) 4. RN 4 stated that when a patient comes from home and tell her that they use O2 at home, that she will put them on that flow amount. RN 4 stated she did not get a physician order just uses "nursing judgement" to know when to call the physician. RN 4 further stated that there was a preorder from the physician to maintain O2 sat's at 92%.
Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

On 5/12/15 at 8:40 A.M., an interview with the Assistant Director of Peri-Anesthesia (ADPA) was conducted. The ADPA stated that RNs in the PACU, PTU and the PPPU at both Hospital A and B were administering oxygen without physician's orders that included oxygen delivery device, liter flow or FIO2. She also acknowledged that an oxygen protocol had not been developed or was in place for the PACU, PTU and the PPPU that provided clear direction and guidance to the nursing staff who continued to administer oxygen without the anesthesiologist at the bedside.

7. Patient 18 was admitted hospital B's PTU room 22 on 10/15/14 status post (after) a surgical procedure that included ulcerative colitis (inflammatory bowel disease) per the Operative Note dated 10/15/14.

Patient 18 arrived with a simple mask at 8 liter per minute of oxygen and with oxygen parameters that indicated "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician note dated 10/15/14. Patient 18 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen) and had an O2 sat that fell to 86% during the stay in the PTU room 22.

On 5/6/15 at 11:40 A.M., an interview was conducted with Registered Nurse (RN) 4. RN 4 stated that when a patient comes from home and tell her that they use O2 at home, that she will put them on that flow amount. RN 4 stated she did not get a physician order just uses "nursing judgement" to know when to call the physician. RN 4 further stated that there was a preorder from the physician to maintain O2 sat's at 92%.
Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

On 5/12/15 at 8:40 A.M., an interview with the Assistant Director of Peri-Anesthesia (ADPA) was conducted. The ADPA stated that RNs in the PACU, PTU and the PPPU at both Hospital A and B were administering oxygen without physician's orders that included oxygen delivery device, liter flow or FIO2. She also acknowledged that an oxygen protocol had not been developed or was in place for the PACU, PTU and the PPPU that provided clear direction and guidance to the nursing staff who continued to administer oxygen without the anesthesiologist at the bedside.

8. Patient 19 was admitted hospital B's PTU room 22 on 11/20/14 status post (after) a surgical procedure that included maxillary lymph node dissection (removal of lymph node-an important part of the immune system) per the Operative Note dated 11/20/15.

Patient 19 arrived with a simple mask at 6 liter per minute of oxygen and oxygen parameters that indicated "Respiratory rate is less less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician orders dated 11/20/14. Patient 19 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen).

On 5/6/15 at 11:40 A.M., an interview was conducted with Registered Nurse (RN) 4. RN 4 stated that when a patient comes from home and tell her that they use O2 at home, that she will put them on that flow amount. RN 4 stated she did not get a physician order just uses "nursing judgement" to know when to call the physician. RN 4 further stated that there was a preorder from the physician to maintain O2 sat's at 92%.
Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

On 5/12/15 at 8:40 A.M., an interview with the Assistant Director of Peri-Anesthesia (ADPA) was conducted. The ADPA stated that RNs in the PACU, PTU and the PPPU at both Hospital A and B were administering oxygen without physician's orders that included oxygen delivery device, liter flow or FIO2. She also acknowledged that an oxygen protocol had not been developed or was in place for the PACU, PTU and the PPPU that provided clear direction and guidance to the nursing staff who continued to administer oxygen without the anesthesiologist at the bedside.

9. Patient 20 was admitted hospital B's PTU room 22 on 11/21/14 status post (after) a surgical procedure that included right total hip replacement (cartilage and bone of the hip joint is surgically replaced with artificial materials) per the Operative Note dated 11/21/14.

Patient 20 arrived with a simple mask at 8 liter per minute of oxygen and oxygen parameters that indicated "Respiratory rate is less less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician orders dated 11/21/14. Patient 20 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen).

On 5/6/15 at 11:40 A.M., an interview was conducted with Registered Nurse (RN) 4. RN 4 stated that when a patient comes from home and tell her that they use O2 at home, that she will put them on that flow amount. RN 4 stated she did not get a physician order just uses "nursing judgement" to know when to call the physician. RN 4 further stated that there was a preorder from the physician to maintain O2 sat's at 92%.
Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

On 5/12/15 at 8:40 A.M., an interview with the Assistant Director of Peri-Anesthesia (ADPA) was conducted. The ADPA stated that RNs in the PACU, PTU and the PPPU at both Hospital A and B were administering oxygen without physician's orders that included oxygen delivery device, liter flow or FIO2. She also acknowledged that an oxygen protocol had not been developed or was in place for the PACU, PTU and the PPPU that provided clear direction and guidance to the nursing staff who continued to administer oxygen without the anesthesiologist at the bedside.

10. Patient 21 was admitted hospital B's PTU room 22 on 12/4/14 status post (after) a surgical procedure that included right and left mastectomy eradication of retained breast tissue after previous mastectomies (removal remaining breast tissue from both breasts) per the Operative Note dated 12/4/14.

Patient 21 arrived with a simple mask at 8 liter per minute of oxygen and with oxygen parameters that indicated, "Maintain O2 (oxygen) to keep SaO2 (O2 sat, oxygen saturation-amount of oxygen in the blood) greater than or equal to 95% (normal O2 sat is 95-100%)" and a second parameter that indicated, "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician orders dated 12/4/14. Patient 21 received medical gas (21 % oxygen) instead of pure oxygen (100% oxygen) and had an O2 sat that fell to 88% during the stay in the PTU room 22.

On 5/6/15 at 11:40 A.M., an interview was conducted with Registered Nurse (RN) 4. RN 4 stated that when a patient comes from home and tell her that they use O2 at home, that she will put them on that flow amount. RN 4 stated she did not get a physician order just uses "nursing judgement" to know when to call the physician. RN 4 further stated that there was a preorder from the physician to maintain O2 sat's at 92%.

Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

On 5/12/15 at 8:40 A.M., an interview with the Assistant Director of Peri-Anesthesia (ADPA) was conducted. The ADPA stated that RNs in the PACU, PTU and the PPPU at both Hospital A and B were administering oxygen without physician's orders that included oxygen delivery device, liter flow or FIO2. She also acknowledged that an oxygen protocol had not been developed or was in place for the PACU, PTU and the PPPU that provided clear direction and guidance to the nursing staff who continued to administer oxygen without the anesthesiologist at the bedside.

11. Patient 22 was admitted hospital B's PTU room 22 on 12/9/14 status post (after) a surgical procedure that included parathyroidectomy (removal of the parathyroid-tiny glands, located in the neck, that control the body's calcium levels.) per the Operative Note dated 12/9/14.

Patient 22 arrived with a simple mask at 6 liter per minute of oxygen and oxygen parameters that indicated "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician orders dated 12/9/14. Patient 22 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen).

On 5/6/15 at 11:40 A.M., an interview was conducted with Registered Nurse (RN) 4. RN 4 stated that when a patient comes from home and tell her that they use O2 at home, that she will put them on that flow amount. RN 4 stated she did not get a physician order just uses "nursing judgement" to know when to call the physician. RN 4 further stated that there was a preorder from the physician to maintain O2 sat's at 92%.
Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

On 5/12/15 at 8:40 A.M., an interview with the Assistant Director of Peri-Anesthesia (ADPA) was conducted. The ADPA stated that RNs in the PACU, PTU and the PPPU at both Hospital A and B were administering oxygen without physician's orders that included oxygen delivery device, liter flow or FIO2. She also acknowledged that an oxygen protocol had not been developed or was in place for the PACU, PTU and the PPPU that provided clear direction and guidance to the nursing staff who continued to administer oxygen without the anesthesiologist at the bedside.

12. Patient 23 was admitted hospital B's PTU room 22 on 12/9/14 status post (after) a surgical procedure that included hemorrhoidectomy (removal of hemorrhoids-swollen and inflamed veins in your anus and lower rectum) per the Operative Note dated 12/10/14.

Patient 23 arrived with a simple mask at 6 liter per minute of oxygen and with oxygen parameters that indicated, "Maintain O2 (oxygen) to keep SaO2 (O2 sat, oxygen saturation-amount of oxygen in the blood) greater than or equal to 92% (normal O2 sat is 95-100%)" and a second parameter that indicated, "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician orders dated 12/9/14. Patient 23 received medical gas (21 % oxygen) instead of pure oxygen (100% oxygen).

On 5/6/15 at 11:40 A.M., an interview was conducted with Registered Nurse (RN) 4. RN 4 stated that when a patient comes from home and tell her that they use O2 at home, that she will put them on that flow amount. RN 4 stated she did not get a physician order just uses "nursing judgement" to know when to call the physician. RN 4 further stated that there was a preorder from the physician to maintain O2 sat's at 92%.

Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

On 5/12/15 at 8:40 A.M., an interview with the Assistant Director of Peri-Anesthesia (ADPA) was conducted. The ADPA stated that RNs in the PACU, PTU and the PPPU at both Hospital A and B were administering oxygen without physician's orders that included oxygen delivery device, liter flow or FIO2. She also acknowledged that an oxygen protocol had not been developed or was in place for the PACU, PTU and the PPPU that provided clear direction and guidance to the nursing staff who continued to administer oxygen without the anesthesiologist at the bedside.

13. Patient 24 was admitted hospital B's PTU room 22 on 12/10/14 status post (after) a surgical procedure that included excision, right ankle soft tissue mass (tumor-abnormal mass of tissue) per the Operative Note dated 12/12/14.

Patient 24 arrived with a simple mask at 8 liter per minute of oxygen and oxygen parameters that indicated "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician orders dated 12/10/14. Patient 24 received medical gas (21% oxygen) instead of pure oxygen (100% oxygen).

On 5/6/15 at 11:40 A.M., an interview was conducted with Registered Nurse (RN) 4. RN 4 stated that when a patient comes from home and tell her that they use O2 at home, that she will put them on that flow amount. RN 4 stated she did not get a physician order just uses "nursing judgement" to know when to call the physician. RN 4 further stated that there was a preorder from the physician to maintain O2 sat's at 92%.

Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

On 5/12/15 at 8:40 A.M., an interview with the Assistant Director of Peri-Anesthesia (ADPA) was conducted. The ADPA stated that RNs in the PACU, PTU and the PPPU at both Hospital A and B were administering oxygen without physician's orders that included oxygen delivery device, liter flow or FIO2. She also acknowledged that an oxygen protocol had not been developed or was in place for the PACU, PTU and the PPPU that provided clear direction and guidance to the nursing staff who continued to administer oxygen without the anesthesiologist at the bedside.

14. Patient 27 was admitted hospital B's PTU room 22 on 12/17/14 status post (after) a surgical procedure that included left inguinal hernia (soft tissue bulges through a weak point in the abdominal muscles.) per the Operative Note dated 12/17/14.

Patient 27 arrived with a simple mask at 6 liter per minute of oxygen and with oxygen parameters that indicated, "Maintain O2 (oxygen) to keep SaO2 (O2 sat, oxygen saturation-amount of oxygen in the blood) greater than or equal to 95% (normal O2 sat is 95-100%)" and a second parameter that indicated, "Respiratory rate is less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician orders dated 12/17/14. Patient 27 received medical gas (21 % oxygen) instead of pure oxygen (100% oxygen).

On 5/6/15 at 11:40 A.M., an interview was conducted with Registered Nurse (RN) 4. RN 4 stated that when a patient comes from home and tell her that they use O2 at home, that she will put them on that flow amount. RN 4 stated she did not get a physician order just uses "nursing judgement" to know when to call the physician. RN 4 further stated that there was a preorder from the physician to maintain O2 sat's at 92%.

Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

On 5/12/15 at 8:40 A.M., an interview with the Assistant Director of Peri-Anesthesia (ADPA) was conducted. The ADPA stated that RNs in the PACU, PTU and the PPPU at both Hospital A and B were administering oxygen without physician's orders that included oxygen delivery device, liter flow or FIO2. She also acknowledged that an oxygen protocol had not been developed or was in place for the PACU, PTU and the PPPU that provided clear direction and guidance to the nursing staff who continued to administer oxygen without the anesthesiologist at the bedside.

15. Patient 29 was admitted hospital B's PTU room 22 on 12/19/14 status post (after) a surgical procedure that included transurethral resection of bladder tumor (surgical procedure that is used both to diagnose [DIAGNOSES REDACTED] and to remove cancerous tissue from the bladder) per the Operative Note dated 12/21/14.

Patient 29 arrived with a simple mask at 6 liter per minute of oxygen and oxygen parameters that indicated "Respiratory rate is less less than or equal to 8 breaths per minute AND oxygen saturation (O2 sat, oxygen saturation-amount of oxygen in the blood) is below 90% (normal O2 sat is 95-100%) or decreased by more than 5% from baseline in patients with a baseline oxygen saturation of less than 90% per the physician orders dated 12/19/14.

On 5/6/15 at 11:40 A.M., an interview was conducted with Registered Nurse (RN) 4. RN 4 stated that when a patient comes from home and tell her that they use O2 at home, that she will put them on that flow amount. RN 4 stated she did not get a physician order just uses "nursing judgement" to know when to call the physician. RN 4 further stated that there was a preorder from the physician to maintain O2 sat's at 92%.

Per the hospital's Oxygen Protocol, dated 2014, it indicated that "... the Oxygen Protocol may be ordered in forms other than specified by this protocol by entering an order that specifies the type of oxygen delivery device, liter flow or FIO2 (fraction of inspired oxygen value). There was no oxygen protocol in place for the PACU, PTU and the PPPU at both Hospital A and B.

On 5/12/15 at 8:40 A.M., an interview with the Assistant Director of Peri-Anesthesia (ADPA) was conducted. The ADPA stated that RNs in the PACU, PTU and the PPPU at both Hospital A and B were administering oxygen without physician's orders that included oxygen delivery device, liter flow or FIO2.

16. Patient 34 was admitted hospital B's PTU room 22 on 1/11/15 status post (after) a surgical procedure that included cardiac catheterization(procedure used to diagnose and treat cardiovascular conditions) per the Operative Note dated 1/12/15.

Patient 34 arrived to the PTU on room air but with oxygen parameters that indicated "maintain O2 (oxygen) to keep SaO2 (O2 sat, oxygen saturation-amount of oxygen in the blood)
VIOLATION: PHYSICAL ENVIRONMENT Tag No: A0700
Based on observations, interviews and document reviews the hospital failed to ensure a safe physical environment for patients, visitors and staff by the following:


1. Failed to ensure that hospital B's Medical Gas Systems were in accordance with National Fire Protection Association (NFPA) related to cross connection problem with medical air and oxygen, no documented evidence of a cross connection testing, and correct labeling of the medical gas system outlet. (A tag 710 #1-3)


The cumulative effect of these systemic problems resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation for Physical Environment to ensure that a safe environment was provided to all patients, visitors, and staff.
VIOLATION: LIFE SAFETY FROM FIRE Tag No: A0710
Based on observation, record review, and interview, the hospital failed to ensure that their Medical Gas Systems were in accordance with National Fire Protection Association (NFPA) 101, 2000 Edition and NFPA 99, Health Care Facilities 1999 Edition.
This was evidenced by:

1. The hospital's failure to provide the correct labeling on the medical gas system's outlet in the Procedural Treatment Unit (PTU) room 22.

2. The hospital failed to provide cross connection inspection and testing records from all required parties for the medical gas piping in the (PTU) room 22.

3. The hospital failed to provide the approved plan location and design detail of the pre-manufactured head wall containing the piped medical gas for PTU room 22.

These failures had the potential to negatively impact all patients in PTU room 22 requiring oxygen therapy.

NFPA 101, Life Safety Code, 2000 Edition
5.1.7* Maintenance of Design Features. The design features required for the building to continue to meet the performance goals and objectives of this Code shall be maintained for the life of the building. Such performance goals and objectives shall include complying with all documented assumptions and design specifications. Any variations shall require the approval of the authority having jurisdiction prior to the actual change.
(See also 4.6.9.2.)
5.4.7* Post-construction Conditions. Design characteristics or other conditions related to activities during the life of building that affect the ability of the building to meet the stated goals and objectives shall be specified, estimated, or characterized sufficiently for evaluation of the design.
5.8.3 Building Design Specifications. All details of the proposed building design that affect the ability of the building to meet the stated goals and objectives shall be documented.

18.3.2.4 Medical Gas. Medical gas storage and administration areas shall be protected in accordance with NFPA 99, Standard for Health Care Facilities.

NFPA 99 Health Care Facilities, 1999 Edition
4-3.5.3 Gas Systems Recordkeeping-Level 1. Prior to the use of any medical gas piping system for patient care, the responsible authority of the facility shall ensure that all tests required in 4-3.4.1 have been successfully conducted and permanent records of the test maintained in the facility files.
4-3.4.1 Piped Gas Systems-Level 1.
4-3.4.1.2 Installer Performance Testing. The following tests shall be conducted by the installer or representative prior to those tests listed in 4-3.4.1.3, System Verification. Test gas shall be oil-free, dry nitrogen.
Where manufactured assemblies are to be installed, tests required under this section shall be performed at all station outlets after completion of the pipeline and after installation prior to installation of any manufactured assemblies employing flexible hoses or tubing.
(c) Cross-Connection Test.
1. It shall be determined that no cross-connection of piping systems exists. All medical gas systems shall be reduced to atmospheric pressure. All sources of test gas shall be disconnected from all of the medical gas systems with the exception of the one system to be checked. This system shall be pressurized with oil-free nitrogen (see Section 2-2, Definitions) to 50 psig (350 kPa gauge). With appropriate adapters matching outlet labels, each individual station outlet of all medical gas systems installed shall be checked to determine that test gas is being dispensed only from the outlets of the medical gas system being tested .
a. The source of test gas shall be disconnected and the system tested shall be reduced to atmospheric pressure. Each additional piping system shall then be tested in accordance with 4-3.4.1.2(e)1.
b. Where a medical vacuum piping system is installed, the cross-connection testing shall include that piped vacuum system with all medical gas piping systems.
c. All medical-surgical vacuum systems shall be in operation so that these vacuum systems are tested at the same time the medical gas systems are tested .
d. Each station outlet shall be identified by label (and color marking, if used).
2. The presence and correctness of labeling required by this standard for all components (e.g., station outlets, shutoff valves, and signal panels) shall be verified.
4-3.4.1.3 System Verification. The following tests shall be performed after those listed in 4-3.4.1.2, Installer Performance Testing. The test gas shall be oil-free, dry nitrogen.
This testing shall be conducted by a party technically competent and experienced in the field of medical gas pipeline testing. Such testing shall be performed by a party other than the installing contractor.
When systems have been installed by in-house personnel, testing shall be permitted by personnel of that organization who meet the requirements of 4-3.4.1.
All tests required under 4-3.4.1.3 shall be performed after installation of any manufactured assemblies employing flexible hoses or tubing. Where there are multiple possible connection points for terminals, each possible position shall be tested independently.
(a) Cross-Connection Test. After closing of walls and completion of requirements of 4-3.4.1.2, it shall be determined that no cross-connection of piping systems exists by either of the following methods:
1. All medical gas systems shall be reduced to atmospheric pressure. All sources of test gas from all of the medical gas systems, with the exception of the one system to be checked, shall be disconnected. This system shall be pressurized with oil-free, dry nitrogen (see Section 2-2, Definitions) to 50 psig (350 kPa gauge). With appropriate adapters matching outlet labels, each individual station outlet of all medical gas systems installed shall be checked to determine that test gas is being dispensed only from the outlets of the medical gas system being tested .
a. The source of test gas shall be disconnected and the system tested reduced to atmospheric pressure. Proceed to test each additional piping system in accordance with 4-3.4.1.3(a)1.
b. Where a medical vacuum piping system is installed, the cross-connection testing shall include that piped vacuum system with all medical gas piping systems.
2. An alternate method of testing to ensure that no cross-connections to other piping systems exist follows:
a. Reduce the pressure in all medical gas systems to atmospheric.
b. Increase the test gas pressure in all medical gas piping systems to the values indicated in Table 4-3.4.1.3(a)2. Simultaneously maintain these nominal pressures throughout the test.
c. Any medical-surgical vacuum systems shall be in operation so that these vacuum systems are tested at the same time the medical gas systems are tested .
d. Following the adjustment of pressures in accordance with 4-3.4.1.3(a)2b and c, each station outlet for each medical gas system shall be tested using the gas-specific connection for each system with a pressure (vacuum) gauge attached. Each pressure gauge used in performing this test shall be calibrated with the line pressure regulator gauge used to provide the source pressure.
e. Each station outlet shall be identified by label (and color marking, if used), and the pressure indicated on the test gauge shall be that listed in 4-3.4.1.3(a)2b for the system being tested .
(g)* Final Tie-in Test. Prior to the connection of any work or any extension or addition to an existing piping system, tests in 4-3.4.1.3(a) through 4-3.4.1.3(f) shall be successfully performed. After connection to the existing system and before use of the addition for patient care, the tests in 4-3.4.1.3(h) through 4-3.4.1.3(j) shall be completed. Permanent records of these tests shall be maintained in accordance with 4-3.5.3.

Findings:

1. On 4/30/15, an entity reported incident was investigated regarding a patient room at the Sulpizio Cardiovascular Center with a medical gas outlet delivering medical air and not oxygen.
At 3:45 P.M., the Medical Gas System outlets were observed in the Procedural Treatment Unit (PTU) Room 22, located on the 2nd floor of the Sulpizio Cardiovascular Center. The medical gas outlets were located in the back wall on the right side of the room. The green colored outlet was labeled oxygen, the yellow colored outlet was labeled medical air and the white colored outlet was labeled medical vacuum.

On 5/4/15 to 5/12/15, the records for the inspection and testing of the piped in medical gas were requested and the hospital staff were interviewed.

On 5/4/15, at 10:30 A.M., the hospital provided reports from a medical gas company that confirmed that the PTU Room 22, located on the 2nd Floor in the Sulpizio Cardiovascular Center (SCVC), had cross connected the medical air and oxygen outlets. The reports, dated 4/29/15 and 5/2/15, indicated that the outlet labeled for oxygen had purity test that measured 21% (instead of greater than 99%) and the outlet labeled for medical air had purity test that measured greater than 99%. The report noted that the medical air and oxygen lines were cross connected and not labeled correctly in PTU Room 22.

2. On 5/4/15, at 1:30 P.M., the Senior Director of Project Management (SDPM) from the Hospital's Facility Design and Construction Department was interviewed. He stated that he was in charge of overseeing the contracts for the construction of the SCVC and that the construction project followed the provisions under the 1999 Edition of NFPA 99. He was asked to provide the cross connection inspection and testing records for PTU Room 22 (also known by Door #2-122 and Building Plan Room #2B60). The cross connection test was required testing for the Medical Gas system to determine that no cross-connection of piping systems existed. The SDPM stated that they will search for the documents.

On 5/5/15 at 8:35 A.M., the hospital's Associate Administrator of Facilities (AAF) was interviewed and he stated that the signed certificate of occupancy and the signed verified compliance reports were maintained by the Facility and that the field inspection reports were maintained by the Facility Design and Construction Department. He stated that the inspection reports were archived. The AAF stated that they were working on trying to locate the cross connection inspection and testing records for PTU Room 22.

On 5/6/15, at 3:00 P.M., the SDPM from the hospital's Facility Design and Construction Department presented a package of field inspection reports. The package did not include the cross connection inspection and testing records for PTU Room 22. The SDPM stated that he would make a call out to his installer to see if they could send over a copy of the cross connection test record.

On 5/12/15 at 9:00 A.M., the SDPM was interviewed and stated that he was unable to locate the cross connection inspection and testing records for PTU Room 22.

3. On 5/12/15 at 9:15 A.M., the SDPM was asked to provide the approved building plans that included the location of the pre-manufactured head wall in PTU Room 22 and the design detail of the pre-manufactured head wall containing the piped medical gas. The Director of Facilities Engineering (DFE) was present during the interview and he stated that the records requested shall be channeled through the hospital's regulatory affairs.

On 5/12/15 at 5:00 P.M., the Associate Administrator of Facilities, the Director of Regulatory Affairs, and the DFE stated that they were unable to provide the previously requested records.