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Based on findings under the Physical Environment and QAPI Conditions of Participation, it was determined that the hospital Governing Body failed to demonstrate responsibility, leadership, and accountability for the governance and day-to-day operations of the hospital in an effective, safe, and organized manner, as evidenced by:

1. Failure to ensure an establishment and maintenance of an effective, ongoing, hospitalwide, data-driven quality assessment and performance improvement program (QAPI program) which reflected the complexity of the hospital's organization and services and involved all hospital departments and services. Cross- reference to tag A-0263.

2. Failure to ensure that the hospital was in compliance with building safety standards and Plant Operations personnel qualifications. Cross-reference to tags A-0700, A-0701, A-0720, and A-0724.

The findings include:

1. The governing body did not ensure that the hospital QAPI program was ongoing and hospital-wide. During the survey on February 4-10, 2021, the hospital was unable to provide evidence of regular meetings of the Quality Management Committee, consistent quality data reporting to the Medical Executive Committee, or QAPI program oversight of other hospital departments, including Plant Operations department.

2. The governing body did not ensure that the hospital Plant Operations department arranged and maintained the hospital medical gas systems in a manner that promoted the safety and well-being of patients and was in compliance with the National Fire Protection Association (NFPA) 99 - Health Care Facilities Code - 2012 Edition. In addition, the governing body did not ensure that the personnel who performed routine and emergency maintenance on the hospital medical gas systems were qualified by training and/or certification.

Based on review of 10 medical records, hospital policy, and other pertinent documents, it was determined that the hospital failed to uphold the patients' right to make informed decisions about the care for 2 of 10 patients reviewed, as evidenced by several procedural consent forms for Patient #5 and Patient #6 being signed by family members instead of the patients and in the absence of the documented certification of incapacity for these patients.

The findings include:

The surveyors reviewed the hospital policy titled "Consent/Refusal to Consent" (dated 12/2002). Under the section "Definitions", the term "Competency" was defined as "the legal right to make one's own decision" and the term "Incapacity" was defined as "the inability to understand information presented, appreciate the consequences of acting or not acting on that information, and to make a choice". Section X of the policy stated, "The substitute consent may be given only if two physicians, after attempting to consult with the patient, certify in writing that the patient is incapable of making an informed decision". The section went on to state, "Two physicians must complete a "Physicians Certification of Incapacity to Make an Informed Decision" form within two hours of examining the patient. If the patient is unconscious, only one physician certification is needed."

Additionally, the above-mentioned policy defined "Informed Consent" as: "Informed consent is that consent which is obtained after sufficient information has been given so that the patient understands substantially the nature of the procedure to be performed, the risk and consequences associated with or without it, and the courses of action which are open to consideration other than the contemplated procedures."

Patient #5 (P5) was a 60+ year old patient who presented to the emergency department (ED) with complaints of worsening shortness of breath. P5 had recently tested positive for a respiratory infection and had been evaluated via a video visit by their primary care physician. Upon arrival to the hospital, the patient was immediately placed on supplemental oxygen due to low oxygen saturation (measurement of the amount of oxygen carried by the red blood cells). A chest x-ray and lab testing confirmed the diagnosis of the respiratory infection.

P5 was admitted to an inpatient unit and signed the general consent for treatment and a consent for a PICC (peripherally inserted central catheter: a long, thin tube that is inserted through a vein in the arm and passed through to the larger veins near the heart) to be placed. Another consent form was signed by the patient the day after the admission for permission to receive blood products.

Record review determined that approximately one month into this admission, a physician documented the following in the P5's chart, "Requesting spouses permission for an A-line." An A-line is a thin, flexible tube that is placed into an artery that allows for more accurate blood pressure assessments. Less than a week later, staff obtained consent for the second PICC line placement from the patient's spouse. The consent form was signed as, "[spouse] telephone" with reason "patient had an altered mental status". Additionally, a consent form for the third PICC line placement was noted to be signed by P5's sibling. No documentation was found to support that the necessary certification documentation was completed to show that P5 had been deemed incompetent or incapable of making their own decisions.

P6 was a 60+ year old individual who had previously been admitted to this hospital for 2 days, secondary to the diagnosis of a respiratory infection. Less than a week after the first discharge, P6 was readmitted for worsening shortness of breath, a productive cough, body aches, and a loss of appetite. P6 was evaluated in the ED and admitted to the hospital. Staff documented that P6 was "alert and oriented" on admission. Record review also determined that P6 signed consents for treatment and blood products on admission.

Throughout this admission, P6 received a PICC line, a central line (a tube that is placed in a large vein in the neck, chest, groin, or arm to give fluids, blood, or medications or to perform medical tests quickly), and a catheter for dialysis (the process of removing waste products and excess fluid from the body when the kidneys are not able to adequately filter the blood). Staff documented that the patient's spouse was the decision maker for the patient; however, P6's adult child signed multiple consent forms for P6's interventions. Eventually, staff documented that the spouse informed the hospital that the adult child was to be the main decision-maker for the patient; however, this occurred after the consent for these procedures had already been obtained. Additionally, no documentation was found to support that the necessary certification documentation was completed to show that P6 had been deemed incompetent or incapable of making their own decisions.

Without consent forms signed by the patient or a certification of the patient's incapacity signed by the physician(s), it was unclear whether P5 or P6 had the opportunity to be involved in their care, were advised of the risks and benefits of the procedures, or understood the need for the procedures that were being performed.

Based on review of 10 medical records, observations of the physical environment, hospital policies, procedures, and training documentation, and interviews with staff and other stakeholders, it was determined that the hospital failed to provide a safe environment of care to its patients, as evidenced by failure arrange and maintain its medical gas systems in such a manner that the safety and well-being of patients were assured.

The hospital's noncompliance with building safety standards and personnel qualification requirements placed all patients dependent on oxygen at risk. The non-compliance also contributed to the temporary shut off of medical oxygen on the hospital's MICU (medical intensive care unit)/SICU (surgical intensive care unit) and IMC (intermediate care unit) on January 15, 2021, when the oxygen shut off valve for MICU/SICU, and IMC units was erroneously turned off by hospital staff during troubleshooting of the medical air system. The oxygen disruption incident, which lasted approximately 15 minutes, lead to the deterioration of 2 intensive care patients (Patient #5 and Patient #8) who subsequently passed away. Cross-reference tag A-0701.

The findings include:

Patient #5 (P5) was a 60+ year old patient who presented to the emergency department (ED) with complaints of worsening shortness of breath. P5 had recently tested positive for a respiratory infection and had been evaluated via a video visit by their primary care physician. Upon arrival to the hospital, the patient was immediately placed on supplemental oxygen. P5's respiratory infection diagnosis was confirmed through a chest x-ray and laboratory testing.

P5 was admitted to the MICU/SICU with a diagnosis of "hypoxic respiratory failure due to [respiratory infection]". P5 continued to have difficulty breathing and maintaining their blood pressure in a normal range, and had a low oxygen saturation (measurement of the amount of oxygen carried by the red blood cells). The decision was made to intubate and place the patient on a ventilator to assist with breathing.

On January 15, 2021, approximately 20 minutes after the oxygen loss was identified by the hospital staff at 8.45 am, a physician documented the following note in P5's chart: "I was called that patient expired by the charge RN [registered nurse]. On exam the patient did not respond to verbal or physical stimuli. Absent heart sounds, patient intubated, no spontaneous respirations, absent peripheral pulses. Pupils are fixed and dilated. Patient was pronounced dead by me."

Patient #8 (P8) was a 70+ year old individual who presented to the Emergency Department due to having low blood oxygen levels and difficulty breathing. P8 had respiratory infection symptoms approximately 6 days prior to this hospital visit and tested positive for a respiratory infection at another facility. P8 was evaluated in the Emergency Department but had worsening respiratory status despite hospital interventions. P8 was admitted to the MICU/SICU and was placed on maximum settings of supplemental oxygen delivery via a high-flow nasal canula and still had notable difficulty breathing. P8 continued to become hypoxic (experiencing inadequate oxygen levels in tissues and cells of the body) and was intubated.

On January 15, 2021 at approximately 8.50 am, nursing staff documented that P8 was noted to be in asystole (without cardiac activity) and went into cardiac arrest. Resuscitative measures were initiated by staff for P8, and the patient regained pulse after 7 minutes. Subsequently to the incident and rescuscitation, the patient's family was notified of the cardiac event and decided to change the patient's code status to Do Not Resuscitate with "Comfort Care" measures in place. The patient was compassionately extubated and was pronounced dead a few hours after the incident.

Review of medical records for the above-mentioned patients determined that the oxygen-loss event on January 15, 2021 had a direct impact on the deterioration of the condition of P5 and P8 who were dependent on supplemental oxygen at the time of the incident. Failure of the hospital to safely and effectively maintain its medical gas systems created an unsafe environment for all hospital patients dependent on supplemental oxygen.

Based on observations of care and environment; interviews with staff and other stakeholders; and review of policies, procedures, and other pertinent documents, it was determined that the hospital failed to ensure an effective, ongoing, hospital-wide Quality Assessment Performance Improvement (QAPI) program, as evidenced by:

1) Lack of consistent meetings of the Quality Management Committee over the previous year, and lack of integration of the QAPI program staff members into the work of the program;

2) Lack of consistent reporting of the Quality Management Committee to the hospital's Medical Executive Committee;

3) Failure of the Quality Management Committee to identify, analyze, and correct the lack of required training of the Plant Operations department employees which contributed to the medical gas disruption incident on January 15, 2021.

The findings include:

On February 10, 2021, the surveyors reviewed the hospital's Quality Improvement Plan for 2021.

Under the section "Scope", the document stated: "To achieve the goal of delivering high quality care, all employees are given the responsibility and are empowered to participate in the quality improvement program: through various committee structures. The QI program includes following, but not limited to: - all direct patient care services and indirect services affecting patient health and safety..."

Under the section "Quality Management Committee", the document stated: "The Quality Management Committee (QMC) is an inter-disciplinary committee and its membership includes, but not limited to, the following individuals: Chief Medical Officer & Population Health Officer; Director of Quality/Regulatory Affairs, President of [the hospital]; Vice President of Nursing and Patient Care Services; Quality Improvement Specialists; Director of Pharmacy; Director of Risk Management; Director, Hospitalists; Chairman & Medical Director of Emergency & Observation Services; Director, Critical Care; Director, Imaging Services; Medical Director, Pathology anad Laboratory Medicine; and Director, Surgical Services among others.

The members of the QMC are responsible for following, but not limited to:

- Prioritizing issues referred to the QMC for review.
- QMC data review, benchmarking, and analysis of data.
- Appropriate plan of actions development, and follow up to ensure resolution.
- Appointing sub committees or teams to work on specific issues if necessary.
- Identifying quality indicators through various sources such as AHRQ, TJC and MHCC and incorporating best practices into the hospitals overall QI efforts;
- Reporting on ongoing findings, studies, recommendations, and trends to the Board Performance Improvement Committee (BPIC) and Medical Executive Committee (MEC) per schedule and as frequently as necessary
- Identifying educational needs of the staff an collaborating with Education Department for the provision of Education to staff as necessary.
- Advocating for the availability of necessary resources for an effective QI program."

Review of the proposed 2021 schedule for QMC meetings determined that the meetings were scheduled approximately every other month.

1) On February 4, 2021, the surveyors requested to review the quality management committee (QMC) meeting minutes for the past two years. Based on the information submitted by the hospital for review, the last meeting of QMC meeting took place on November 21, 2019. No evidence was found that any QMC meetings occurred in 2020.

On February 10, 2021, the surveyors interviewed one of the hospital's Quality Improvement Specialists (QIS1). When the surveyors asked QIS1 to describe their role within the organization, QIS1 explained that they "work a lot with COVID and sepsis". When asked to elaborate, QIS1 stated, "I come in, in the morning, I usually start my day by going through the patient charts and checking for COVID symptoms because the patients have to have certain symptoms that then get reported to the state or whoever gets the reports. I also do whatever else is listed on that organizational chart below my name." When asked what committees they were involved in, QIS1 stated, "just the director goes to the meetings." When asked how the information was disseminated among the remaining Quality Department members, QIS1 stated that "they talked throughout the day".

On February 10, 2021, the surveyors interviewed the Director of Quality/Regulatory Affairs. The above interview was discussed with the director, and the surveyors asked for further details regarding the integration of quality department members. The director stated that more emphasis needed to be placed on communication between members of the quality department and that other members should be attending committee meetings to better understand their roles and expectations of the department.

2) Review of the Medical Executive Committee (MEC) meeting minutes for October - December 2020 determined that QMC made no report to MEC during the December 2020 meeting, and the QMC report during the November 2020 meeting did not include any meaningful information on ongoing issues, quality indicators, trends, or recommendations, as outlined in the Quality Improvement Plan.

3) The hospital QAPI program failed to identify, analyze, and correct critical failures related to the lack of training of employees of the Facilities Management department. The hospital's noncompliance with personnel qualification requirements placed all patients dependent on oxygen at risk. The non-compliance also contributed to the temporary shut off of medical oxygen on the hospital's MICU (medical intensive care unit)/SICU (surgical intensive care unit) and IMC (intermediate care unit) on January 15, 2021, when the oxygen shut off valve for MICU/SICU, and IMC units was erroneously turned off by hospital staff during troubleshooting of the medical air system. The oxygen disruption incident, which lasted approximately 15 minutes, lead to the deterioration of 2 intensive care patients (Patient #5 and Patient #8) who subsequently passed away. Cross-reference tag A-0701.

Based on review of 4 open and 6 closed medical records, policies and procedures, and other pertinent documents, it was determined that the hospital failed to 1) maintain a complete medical record containing information/documentation of events and patient response to medications, services, treatments that were rendered in the time leading up to the death of Patient #5 (P5), and 2) provide details about medications and services provided during the time frame leading up to the death of Patient #6 (P6). Cross reference to tag A-0144.

The findings include:

1) Patient #5 (P5) was a 60+ year old patient who presented to the emergency department (ED) with complaints of worsening shortness of breath. P5 had recently tested positive for a respiratory infection and had been evaluated via a video visit by their primary care physician. Upon arrival to the hospital, the patient was immediately placed on supplemental oxygen. P5's respiratory infection diagnosis was confirmed through a chest x-ray and laboratory testing.

P5 was admitted to the MICU/SICU and continued to have difficulty breathing, maintaining their blood pressure in a normal range, and experiencing low oxygen saturation levels. The decision was made to intubate and place the patient on a ventilator to assist with breathing. Over the next several weeks, P5' blood pressure and oxygen saturation were controlled through medication and the ventilator; however, their kidneys were starting to fail with little to no urine output noted. Due to the patient's poor prognosis, it was determined by physicians that P5 was not a candidate for dialysis.

On January 15, 2021, the hospital MICU/SICU lost oxygen supply for approximately 15 minutes (cross-reference to tag A-0701). Approximately 20 minutes after the oxygen loss was first identified by the hospital staff, the following physician note in part was documented in the patient's chart, "I was called that patient expired by the charge RN. On exam the patient did not respond to verbal or physical stimuli. Absent heart sounds, patient intubated, no spontaneous respirations, absent peripheral pulses. Pupils are fixed and dilated. Patient was pronounced dead by me." Staff also documented that the patient's family was notified of the patient's passing and was asked to come in to the hospital.

The surveyors identified only one nursing progress note for the day in question which was time stamped approximately three hours after the event. The note stated in part, "Care and administered all due A.M meds. Patient CODE status -DNR [do not resuscitate] A1-intubate, patient became Asystole [lost pulse] @ 0907 while still vented." No other documentation was found in P5's chart related to the oxygen loss event, including the patient's response to the sudden lack of oxygen, troubleshooting of the ventilator and oxygen equipment, or any attempts to provide the patient with other sources of supplemental oxygen.

2) P6 was a 60+ year old individual who had previously been admitted to this hospital for 2 days secondary to a diagnosis of a respiratory infection. Less than a week after the discharge, P6 was readmitted for worsening shortness of breath, a productive cough, body aches, and a loss of appetite. P6 was initially admitted to a telemetry unit; however, as their condition began to worsen, the patient was admitted to the MICU/SICU and eventually intubated. Further record review determined that P6's condition continued to deteriorate during this admission and the patient eventually expired on January 15, 2021.

On the day the patient expired, a physician note titled "Death Summary" stated in part, "initially being cared in telemetry and because of increased oxygen requirement, patient was transferred to ICU and eventually intubated, developed acute renal [kidney] failure and dialysis initiated and was also on [medications] for hypotension. Carotid pulses were absent. Heart sounds are absent. [Patient] remains unresponsive. Pupils are fixed and dilated. Pronounced dead 01/15/2021 at 9:36pm."

Review of documentation leading up to the patient's death revealed the following nursing note which was written 3+ hours prior to the time of death. The note stated in part, "Pt started to desaturate down from upper 80 to 50%. [Patient] is still on the ventilator and had dialysis today. Dr. [name] was notified. Per MD, patient family was called and notified to come in." According to P6's medication administration record, new medications were administered to P6 around the time when the above-mentioned nursing note was documented; however, no documentation explaining the rationale for the new medications or the patient's response to these medications was found in P6's record.

Based on review of 10 medical records, hospital policies, and other pertinent documents, it was determined that the hospital failed to maintain complete and accurate patient records for 2 of 10 patients reviewed, as evidenced by: 1) failure to revise an identified patient name and date of birth error for Patient #1 (P1); and 2) failure to document the correct date for assessments and services provided for Patient #8 (P8).

The findings include:

1) P1 was a 25+ year old patient who was brought to the emergency department (ED) with complaints of back pain, swelling of the right lower extremity, and fatigue. P1 was evaluated in the ED and was subsequently admitted for treatment of the lower extremity infection.

Approximately 2 hours after presentation to the ED, P1 was taken to hospital Radiology Department for x-rays. An hour later, nursing staff documented in the patient's record, "Name spelled wrong and birthday are wrong in patient chart. Registration made aware to change information in medical record." During this admission, P1 underwent multiple procedures and signed multiple consent forms. It should be noted that P1 signed all forms with a different first initial than what was recorded in the medical record.

The surveyors reviewed P1's medical record one month after this admission, and the first initial throughout the record was different from the one the patient signed on the consent forms. It was unclear if registration was notified as the record provided reflected a different first name. Therefore, surveyors could not determine if the name and date of birth of P1 were appropriately corrected.

2) P8 was a 70+ year old patient who presented to the ED due to having low oxygen saturation and difficulty breathing. P8 had respiratory infection symptoms approximately six days prior to this hospital visit and tested positive for a respiratory infection at another facility. P8 was evaluated and treated in the ED, but had worsening respiratory status despite hospital interventions. P8 was admitted to the MICU (Medical Intensive Care Unit)/SICU (Surgical Intensive Care Unit) and was placed on maximum settings of high flow supplemental oxygen via nasal cannula and still had notable difficulty breathing. P8's condition continued to deteriorate and the patient was eventually intubated.

On January 15, 2021, the MICU/SICU lost oxygen supply for approximately 15 minutes, and within 20 minutes of the oxygen loss, P8's heart stopped. Hospital staff initiated cardio-pulmonary resuscitation and the patient regained pulse after seven minutes. The patient's family was notified of the cardiac event and decided to change the patient's code status to Do Not Resuscitate with "Comfort Care" measures in place. The patient was compassionately extubated and was pronounced dead a few hours after the incident.

The surveyor located the following nursing progress note in P8's chart, dated the day after the patient had died. The note stated in part, "Assumed care of the patient. Patient mechanically ventilated, hypotensive. Titration of (medication) continues to maintain a MAP > 65 mmhg. Report given to day shift Registered Nurse ..." No further provider or nursing notes were found in the medical record to provide additional explanation for this nursing care note that was written a day after the patient's death. Furthermore, no evidence was found to support that the note was reviewed and identified as a documentation error.

Based on the information reviewed, it was impossible to determine the accuracy of the documentation stated in the note or the time of when the mentioned assessments occurred.

Based on observations; interviews with staff and other stakeholders; and review of documentation, including policies, procedures, personnel files, and training records, it was determined that the facility was out of compliance with the Condition of Participation for Physical Environment.

The hospital's noncompliance with building safety standards and personnel qualification requirements placed all patients dependent on oxygen at risk. The non-compliance also contributed to the temporary shut off of medical oxygen on the hospital's MICU (medical intensive care unit), SICU (surgical intensive care unit) and IMC (intermediate care unit) on January 15, 2021, when the oxygen shut off valve for MICU, SICU, and IMC units was erroneously turned off by hospital staff during troubleshooting of the medical air system. The oxygen disruption incident, which lasted approximately 15 minutes, lead to the deterioration of 2 intensive care patients who subsequently passed away. This resulted in a finding of the immediate jeopardy. The Maryland Office of Health Care Quality (OHCQ) notified the hospital of the immediate jeopardy on 02/05/21 at approximately 5.00 pm. OHCQ received and accepted a plan to remove immediacy on 02/10/21 at approximately 4.00 pm.

The findings include:

1. Hospital failed to arrange and maintain the hospital medical gas systems in a manner that ensured the safety and well-being of patients and in compliance with the National Fire Protection Association (NFPA) 99 - Health Care Facilities Code - 2012 Edition. Cross reference to tags A-0701 and A-0720.
2. Hospital failed to ensure that the personnel who performed routine and emergency maintenance on the hospital medical gas systems were qualified by training and/or certification. Cross-reference to tag A-701.
3. Hospital failed to perform a complete routine testing of the medical gas alarm system. Cross reference to tag A-0724.

Based on observations of the physical environment, review of hospital policies, procedures, personnel files, and training documentation, and interviews with staff and other stakeholders, it was determined that the hospital failed to arrange and maintain its medical gas systems in such a manner that the safety and well-being of patients were assured, as evident by:

1. Lack of required NFPA-99 labeling on the oxygen shut off valves. Cross-reference to tag A-0720.
2. Lack of required training and/or certifications of the hospital's maintenance personnel who performed routine and emergency procedures on the medical gas systems, including oxygen valves and lines and bulk cryogenic oxygen storage.

The hospital's noncompliance with building safety standards and personnel qualification requirements placed all patients dependent on oxygen at risk. The non-compliance also contributed to the temporary shut off of medical oxygen on the hospital's MICU (medical intensive care unit), SICU (surgical intensive care unit) and IMC (intermediate care unit) on January 15, 2021, when the oxygen shut off valve for MICU, SICU, and IMC units was erroneously turned off by hospital staff during troubleshooting of the medical air system. The oxygen disruption incident, which lasted approximately 15 minutes, lead to the deterioration of 2 intensive care patients who subsequently passed away. This resulted in a finding of the immediate jeopardy. The Maryland Office of Health Care Quality (OHCQ) notified the hospital of the immediate jeopardy on 02/05/21 at approximately 5.00 pm.

OHCQ received and accepted a plan from the hospital to remove immediacy on 02/10/21 at approximately 4.00 pm. The plan included the following actions by the hospital:

1. The hospital's medical gas vendor tagged all unmarked valves with temporary tags between February 6-8, 2021.
2. The hospital's medical gas vendor zip-tied all non-locking valves in the open position between February 6-8, 2021.
3. The hospital created a Medical Gas Shut Off Procedure which outlined the steps and notifications required for the Plant Operations and clinical staff at the hospital during a routine or emergency maintenance procedures of medical gas systems.
4. The hospital completed training of all hospital's Plant Operations employees on the revised procedure for Medical Gas Shut Off Procedure between February 6-8, 2021.
5. The hospital performed training of the hospital's Nursing Directors, Nursing Educators, Administrative Nursing Supervisors, Respiratory Therapy Director and Telecommunications Leader on the hospital's Medical Gas Shut Off Procedure on February 8, 2021.
6. The hospital conducted a one-day medical gas systems training for all hospital's Plant Operations employees on February 10, 2021, led by the hospital's medical gas vendor.


The findings include:

1. The National Fire Protection Association (NFPA) 99 - Health Care Facilities Code - 2012 Edition, standard 5.1.11.2.1 states, "Shut-off Valves shall be identified with the following: 1) Name or chemical symbol for the specific medical gas or vacuum system; 2) Room or areas served; 3) Caution to not close or open valve except in emergency."

On February 4 & 5, 2021, the surveyors performed observations of medical gas piping and valves in several different areas throughout the hospital, including the valve and piping involved in the incident on January 15, 2021. The surveyors observed that that the above-mentioned oxygen valve was improperly labeled and identified. The valve was tagged with an 8.5"x 11" sheet of paper. The paper was colored white, blue, and gray, and placed in a plastic sheet protector with the word "Oxygen" marked in the center. It was attached to the valve using zip-ties. Staff reported that the labeling of this valve occurred after the incident on January 15, 2021. This tag did not comply with the above mentioned NFPA-99 standard.

On February 4 & 5, 2021, the surveyors also observed that there were 2 employees from the hospital's medical gas vendor present on-site at the hospital , who were in the process of mapping out a schematic of the hospital's medical gas distribution lines. On February 4, 2021 at 11:55 am, the surveyors interviewed both employees from the hospital's medical gas vendor. The employees reported that they had started working on this project on February 2, 2021, and had observed other areas with unlabeled valves during their mapping process.


2. The National Fire Protection Association (NFPA) 99 - Health Care Facilities Code - 2012 Edition 5.1.14.2.2.5 addresses qualifications of personnel maintaining hospital medical gas systems. The code requires, "Persons maintaining these systems shall be qualified to perform these operations". It further states, "Appropriate qualifications shall be demonstrated by any of the following: 1) Training and certification through the health care facility by which such persons are employed to work with specific equipment as installed in that facility. 2) Credentialing to the requirements of ASSE 6040, Professional Qualifications Standard for Medical Gas Maintenance Personnel. 3) Credentialing to the requirements of ASSE 6030, Professional Qualifications Standard for Medical Gas System Verifiers".

The surveyors reviewed the hospital's emergency preparedness plan on February 4, 2021. Under the section "Loss of Medical Gas/Policy", the following excerpt was found, "I. Piped medical gas shut off valves are located strategically throughout the areas served and are clearly labeled. Each department director is responsible for ensuring the department staff is trained to know the valve locations and shut off procedures."

On February 4, 2021, the surveyors reviewed the personnel files for Staff #1 and Staff #2 from the maintenance department and no evidence of qualifications and/or training related to maintenance of medical gas systems was found.

The surveyors interviewed Staff #2 and Staff #3 from the maintenance department to determine if the hospital provided medical gas system training to its maintenance staff members. Staff #2 reported that no medical gas system training was provided to maintenance staff employees and that all questions and concerns about it would be directed to the Facilities Director, Staff #3. Staff #2 also stated that maintenance department employees were instructed during the new employee orientation not to touch medical gas lines or valves. In an interview with the Facilities Director (Staff #3) on February 5, 2021 at 11:15 am, it was stated that no employees at the hospital were trained on the medical gas system, including himself.

2) The National Fire Protection Association (NFPA) 99 - Health Care Facilities Code - 2012 Edition, standard 11.5.2.1.4 states, "Equipment shall be serviced only by personnel trained in the operation and management of the equipment". In addition, the standard 11.5.2.1.5 states, "If a bulk cryogenic system is present, the supplier shall provide annual training on its operation ".

On February 4, 2021 at approximately 9.43 am, during observations of the physical environment, the surveyors inspected the bulk cryogenic oxygen storage systems outside the main hospital building. The surveyors observed ice build-up on the oxygen evaporator. The surveyors posed a question to the Facilities Director about who provided routine and emergency maintenance for the bulk cryogenic oxygen system. The Facilities Director responded that a contractor company monitored and delivered the cryogenic oxygen to the hospital, and that the hospital staff did not handle any issues related to the bulk oxygen storage. When asked about the ice build-up, the Facilities Director indicated that the hospital maintenance staff were instructed by the hospital's bulk oxygen vendor to use 180 degree Fahrenheit water to remove the ice when the build-up occurred. There was no documentation as to when or how often this de-icing procedure occurred, and if hospital maintenance staff were qualified/trained to perform it. Additional interviews with other hospital maintenance staff and review of the personnel files revealed that the hospital's bulk oxygen vendor did not provide any training on the bulk oxygen system to the hospital maintenance staff.

Based on observations of the physical environment and review of hospital policies and procedures, it was determined that the hospital failed to meet the following Building Safety standard, outlined in National Fire Protection Association (NFPA) 99 - Health Care Facilities Code - 2012 Edition. Cross-reference to tag A-0701.

The findings include:

The National Fire Protection Association (NFPA) 99 - Health Care Facilities Code - 2012 Edition 5.1.11.2.1 states, "Shut-off valves should be identified with the following: 1) name and chemical symbol for the specific medical gas or vacuum system, 2) room or areas served, 3) caution to not close or open the valve except in emergency."

On February 4 & 5, 2021, the surveyors performed observations of medical gas piping and valves in several different areas throughout the hospital, including the valve and piping involved in the incident on January 15, 2021. The surveyors observed that that the above-mentioned oxygen valve was improperly labeled and identified. The valve was tagged with an 8.5"x 11" sheet of paper. The paper was colored white, blue, and gray, and placed in a plastic sheet protector with the word "Oxygen" marked in the center. It was attached to the valve using zip-ties. Staff reported that the labeling of this valve occurred after the incident on January 15, 2021. This tag did not comply with the above mentioned NFPA-99 standard.

On February 4 & 5, 2021, the surveyors also observed that there were 2 employees from the hospital's medical gas vendor present on-site at the hospital , who were in the process of mapping out a schematic of the hospital's medical gas distribution lines. On February 4, 2021 at 11:55am, the surveyors interviewed both employees from the hospital's medical gas vendor . The employees reported that they had started working on this project on February 2, 2021, and had observed other areas with unlabeled valves during their mapping process.

Based on observations of the physical environment, review of policies and procedures, and interviews with staff, it was determined that the hospital failed to perform a complete annual testing of the medical gas system alarms in November 2020 which covered all areas of the hospital.

The findings include:

On February 4 and 5, 2021, the surveyors reviewed hospital policies, procedures, and reports related to routine testing and maintenance of medical gas systems. The most recent inspection and testing of the medical gas system was conducted by the hospital's medical gas vendor/contractor on November 28, 2020. The report from that inspection and testing had a page titled "Missed Rooms due to Covid ". The following rooms or areas were noted on that page: 5th Floor Area - Room# 504, 538, 540, 542, 548, 564, 571, 577; 3rd Floor Area - Room# 340-356; 2nd Floor Area - Entire SICU, MICU 1-4 & 6, Entire IMCU.

Based on the provided documentation, it was impossible to determine whether the medical gas system alarms worked as intended during the oxygen disruption incident on January 15, 2021.

Based on interviews with hospital staff and observations of entrance areas within the hospital, it was determined that the hospital failed to ensure that staff employed methods for preventing and controlling the transmission of SARS-CoV-2 (COVID-19) infection within the hospital, as evidenced by failure to screen patients and visitors upon entry to the facility.

The following CDC guidance was in effect at the time of the survey on 02/04-05/2021 and 02/10/2021 under "Healthcare Facilities: Managing Operations During the COVID-19 Pandemic": Limit visitors to the facility to only those essential for the patient's physical or emotional well-being and care... Assess visitors for fever and other COVID-19 symptoms before entry to the facility." (CDC, 2020)

The surveyors observed the screening process for patients and visitors at the main entrance to the hospital on February 4, 2021, February 5, 2021, and February 10, 2021 at approximately 9:00 am. The observation determined that the patients and visitors were not screened. Patients/visitors entered the hospital and presented to the information desk where hospital front desk staff inquired about the nature of the visit, and then directed patients/visitors to their requested destinations. Some patients/visitors presented to the security podium and then were directed to wait in line to receive their COVID-19 vaccine. During the 15-minute observations made by the surveyors at the main entrance, no patients/visitors were seen being screened for symptoms or exposure to COVID-19. When the surveyors presented for entry, hospital front desk staff did not ask surveyors any screening COVID-19 questions.

On February 5, 2021 at approximately 9:00 am, while the surveyors were checking in with hospital front desk staff for entry into the hospital, the surveyors interviewed the hospital front desk staff at the information desk. The surveyors asked the hospital front desk staff to explain what the screening process was for persons entering their hospital. The hospital front desk staff indicated that the hospital had the following screening process: the hospital front desk staff showed patients/visitors a screening tool/list of symptoms and asked patients/visitors about the presence of these symptoms and then the patients/visitors were asked to stand in front of a thermal temperature reader and have their temperature taken. When asked where the thermal temperature reader was located, the hospital front desk staff pointed toward a photography camera near the security podium. The surveyors observed the security podium and determined that no screening tool/list of symptoms or thermal temperature reader were present. The surveyors asked the hospital front desk staff if the screen tool/list of symptoms was available in languages, other than English, and their response was "no". Throughout this interview and check-in process, surveyors were not asked screening COVID-19 questions or showed the list which contained these questions, and did not have their temperature taken.

No evidence was found to support that the hospital had a process for screening individuals for the COVID-19 virus upon entry to the hospital, despite the testimony of staff stating how they screen individuals. Failure of hospital staff to screen patients/visitors for the COVID-19 virus upon entry to the hospital increased the risk of COVID-19 infection spread in the hospital.