United Memorial Medical Center, DAB CR6794 (2025)

DECISION

The Centers for Medicare & Medicaid Services (CMS) terminated United Memorial Medical Center’s (Petitioner’s) Medicare provider agreement after Petitioner was consistently out of compliance with Medicare conditions of participation.  Petitioner requested a hearing to dispute the termination.  Because I conclude that Petitioner was not in compliance with the Medicare conditions of participation applicable to hospitals, I affirm the termination of Petitioner’s Medicare provider agreement.

I.  Legal Framework

A hospital is an institution that, among other requirements, primarily engages in providing to inpatients, by or under the supervision of physicians, (A) diagnostic and therapeutic services for medical diagnosis, treatment, and care of injured, disabled, or sick persons, or (B) rehabilitation services for injured, disabled, or sick persons.  Social Security Act (Act) § 1861(e).  It may participate in the Medicare program as a provider of services, if it meets the statutory definition and complies with regulatory requirements, called conditions of participation.  Act § 1861(e); 42 C.F.R. part 482; 42 C.F.R. § 488.3.  If a provider fails to comply substantially with the provisions of section 1861 of the Act or the regulations governing its program participation, CMS, acting on behalf of the Secretary of Health and Human Services (Secretary), may terminate its provider agreement.  Act § 1866(b)(2); 42 C.F.R. § 489.53(a)(1), (3).

The Secretary promulgated regulations establishing Medicare conditions of participation

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for hospitals.  Each condition is composed of standards.  The conditions and the standards reflect both the Act’s requirements as well as those imposed by the Secretary.  See 42 C.F.R. part 482.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether hospitals meet the conditions of participation.  42 U.S.C. § 1395aa(a); 42 C.F.R. § 488.10.  “The State agency will certify that a provider or supplier is not or is no longer in compliance with the conditions of participation . . . where the deficiencies are of such character as to substantially limit the provider’s or supplier’s capacity to furnish adequate care or which adversely affect the health and safety of patients.”  42 C.F.R. § 488.24(b).  “The decision as to whether there is compliance with a particular requirement, condition of participation, or condition for coverage depends upon the manner and degree to which the provider or supplier satisfies the various standards within each condition.”  42 C.F.R. § 488.26(b).  Pursuant to 42 C.F.R. § 489.53(a)(3), a provider’s failure to meet a single condition of participation is a sufficient basis for termination.

If CMS terminates a hospital’s provider agreement, the hospital may request a hearing before an administrative law judge (ALJ) to dispute the termination.  42 U.S.C. §§ 405(b), 1395cc(h)(l)(A); 42 C.F.R. §§ 488.24(c), 489.53(e), 498.3(b)(8), 498.5(b), 498.40(a)(1).  Such an appeal is adjudicated under the provisions in 42 C.F.R. part 498. 42 C.F.R. §§ 488.24(c), 489.53(e).  In a proceeding before an ALJ under 42 C.F.R. part 498, CMS must make a prima facie case that a provider failed to comply with a condition of participation, and, if this occurs, the provider has the burden of proving compliance by a preponderance of the evidence.  Nightingale Home Healthcare, Inc., DAB No. 2784 at 11 (2017); Hillman Rehab. Ctr., DAB No. 1611 at 8 (1997); see Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004); Emerald Oaks, DAB No. 1800 (2001); Edison Med. Labs., Inc., DAB No. 1713 (1999); Cross Creek Health Care Ctr., DAB No. 1665 (1998).

II.  Background and Procedural History

Petitioner is a hospital located in Houston, Texas.  CMS Ex. 1.

On January 8, 2021, the Texas Health and Human Services Commission (state agency) concluded an onsite recertification survey of Petitioner.  CMS Ex. 4.  Following the survey, CMS notified Petitioner of condition-level noncompliance with the following requirements: 

42 C.F.R. § 482.12 Governing Body
42 C.F.R. § 482.13 Patient Rights
42 C.F.R. § 482.25 Pharmaceutical Services
42 C.F.R. § 482.42 Infection prevention and control.

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CMS Ex. 3 at 1.  CMS further notified Petitioner that, unless the deficiencies were corrected, CMS would terminate Petitioner’s provider agreement, effective June 10, 2021.  CMS Ex. 3 at 1-2.

In May 2021, state agency surveyors conducted a revisit survey at Petitioner but concluded that Petitioner continued to be out of compliance with the following Medicare conditions of participation: 

42 C.F.R. § 482.12 Governing Body
42 C.F.R. § 482.13 Patient Rights
42 C.F.R. § 482.23 Nursing Services
42 C.F.R. § 482.24 Medical Records
42 C.F.R. § 482.41 Physical Environment
42 C.F.R. § 482.42 Infection prevention and control and antibiotic stewardship programs
42 C.F.R. § 482.51 Surgical Services.

CMS Ex. 5.  The survey also identified three immediate jeopardy violations, one involving the surgical services condition and two separate violations involving the physical environment condition.  CMS Ex. 5 at 2.  On June 4, 2021, CMS sent a letter to Petitioner extending the June 10, 2021 termination date to July 30, 2021 and giving Petitioner until June 14, 2021, to submit a corrective action plan.  CMS Ex. 6 at 1-2.  The letter also informed Petitioner that if it failed to submit a corrective action plan, the termination action would proceed.  CMS Ex. 6 at 1.

On July 19, 2021, a second revisit survey was concluded.  CMS Ex. 7.  The July 2021 survey determined that two condition-level instances of noncompliance were present: 

42 C.F.R. § 482.13 Patient Rights
42 C.F.R. § 482.42 Infection prevention and control and antibiotic stewardship programs.

CMS Ex. 7 at 2.  Following the second revisit survey, Petitioner was informed that it had until August 9, 2021, to send a final plan of correction.  CMS Ex. 8.  CMS further stated that a final survey would be conducted and that failure to correct the condition-level deficiencies would result in termination of its Medicare agreement on September 13, 2021.  CMS Ex. 8 at 1.

On September 10, 2021, CMS concluded a third revisit survey.  CMS Ex. 9.  The survey found multiple condition-level noncompliance including: 

42 C.F.R. § 482.12 Governing Body
42 C.F.R. § 482.13 Patient Rights

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42 C.F.R. § 482.23 Nursing Services
42 C.F.R. § 482.42 Infection prevention and control and antibiotic stewardship programs.

CMS Ex. 9 at 8.  Two separate instances of immediate jeopardy related to patient rights were also documented.  CMS Ex. 9 at 2.  CMS then extended the termination date from September 13, 2021 to November 11, 2021, and again from November 11, 2021 to December 11, 2021.  CMS Exs. 8, 11.

On December 11, 2021, CMS extended the termination deadline one final time to January 11, 2022.  CMS Ex. 12.  CMS informed Petitioner that it would conduct a final unannounced survey to determine Petitioner’s compliance with the Medicare conditions of participation.  CMS Ex. 12.  CMS further advised Petitioner that if it was found to have condition-level noncompliance, CMS would terminate Petitioner’s Medicare provider agreement, effective January 11, 2022.  CMS Ex. 12.

On December 21, 2021, CMS concluded the final survey and found that Petitioner had the following conditional-level deficiencies: 

42 C.F.R. § 482.12 Governing Body
42 C.F.R. § 482.21 Quality Assurance and Performance Improvement (QAPI)
42 C.F.R. § 482.25 Pharmaceutical Services
42 C.F.R. § 482.42 Infection prevention and control and antibiotic stewardship programs
42 C.F.R. § 482.51 Surgical Services
42 C.F.R. § 482.55 Emergency Services.

CMS Ex. 13 at 3.  Following the December 2021 survey, CMS terminated Petitioner’s Medicare provider agreement effective January 11, 2022.  CMS Ex. 12 at 1-2.

On January 24, 2022, Petitioner requested a hearing to dispute the termination.  On March 10, 2022, Petitioner filed a second request for hearing contesting the termination.  Both cases were docketed and assigned to Judge Bill Thomas.  On January 25, 2022, Judge Thomas issued an Acknowledgment and Pre-hearing Order establishing a prehearing submission schedule.  On March 21, 2022, Judge Thomas issued an order consolidating the two cases under C-22-374.

On March 21, 2023, CMS filed its prehearing exchange and 23 exhibits.  On May 1, 2023, Petitioner filed its prehearing exchange along with five exhibits.  There were no objections filed to the exhibits and no requests to cross-examine any witnesses.  As a result, this matter can be decided on the record without an oral hearing.

The consolidated cases were transferred to me on November 1, 2024.

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III.   Issue

The general issue in this case is whether CMS had a legal basis to terminate Petitioner’s Medicare provider agreement.

IV.   Findings of Fact

My findings of fact are in italics and bold.

1. Petitioner is a hospital located in Houston, Texas.  CMS Ex. 1.
2. Prior to the termination, the hospital was authorized to receive reimbursements for medical services rendered to Medicare beneficiaries.  CMS Ex. 2.
3. The first survey concluded on January 8, 2021.  The survey found that Petitioner had multiple condition-level violations.

The initial onsite recertification survey concluded on January 8, 2021.  CMS Ex. 4.  Following the survey, CMS notified Petitioner of its condition-level noncompliance.

Petitioner was found to have a condition-level violation of 42 C.F.R. § 482.12, Governing Body.  CMS Ex. 4.  The violation was found to exist because the governing body failed to effectively discharge its oversight responsibilities when it did not ensure timely physical access to the emergency department; failed to review and approve an international medical student program; failed to ensure that nursing staff in the Covid unit had direct communication access with the attending physician; failed to obtain properly executed informed consent for procedures; failed to protect patients’ right to privacy; failed to ensure patients’ right to receive care in a safe setting by not having defibrillators readily available; failed to ensure investigational drug protocols were reviewed and approved by the facility Pharmacy & Therapeutic Committee, Medical Executive Committee, and Governing Body; failed to develop and implement policies related to investigational drugs; failed to ensure drugs and biologicals were stored per facility policy; failed to employ methods for preventing and controlling the transmission of infections per facility policies and infection prevention guidelines; and failed to ensure the implementation of Covid-19 screening for staff, visitors, and vendors per CDC recommendations.  CMS Ex. 4 at 8-10.

Petitioner was found to have a condition-level violation of 42 C.F.R. § 482.13, Patient Rights.  CMS Ex. 4 at 23.  The violation was found to exist because Petitioner failed to ensure the patients had the right to be involved in the decision-making process by failing to obtain properly executed informed consent for procedures in 10 out of 10 medical records reviewed.  The violation was further supported by Petitioner allowing media

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presence in the facility’s Covid unit to take photos and videos of patients without ensuring consent, without executing a business agreement, and without ensuring signed HIPAA agreements were in place.  CMS Ex. 4 at 32.  The condition-level violation was also found by the survey because the facility failed to have charged defibrillators; failed to ensure cardiac monitoring equipment was functioning properly; and failed to ensure that exterior access doors were closed and secure.  CMS Ex. 4 at 40.

Petitioner was found to have a condition-level violation of 42 C.F.R. § 482.25, Pharmaceutical Services.  CMS Ex. 4 at 47.  The survey found that this condition was not met because Petitioner failed to ensure investigational drug protocols were reviewed and approved by the facility pharmacy and therapeutic committee, the medical executive committee, and the governing body prior to the administration of the medications to patients.  It was also found that Petitioner failed to provide effective nursing education regarding the investigational drug protocols and failed to develop and implement policies related to investigational drugs.

Lastly, Petitioner was found to have a condition-level violation of 42 C.F.R. § 482.42, Infection prevention and control and antibiotic stewardship programs.  CMS Ex. 4 at 59.  This violation was found to exist because the facility failed to employ methods for preventing and controlling the transmission of infections pursuant to the facility’s policies and professional infection prevention guidelines.

The survey began on December 31, 2020, and concluded on January 8, 2021.  CMS Ex. 4 at 2.  Petitioner submitted a plan of correction and provided responses to the condition-level violations.  As a result, an unannounced follow-up survey was scheduled to determine whether Petitioner had attained substantial compliance with the Medicare conditions of participation.

4. The first revisit survey was conducted in May 2021.  The survey found that Petitioner continued to have multiple condition-level violations.

A follow-up survey concluded on May 14, 2021.  CMS Ex. 5.  Petitioner was found to have condition-level violations of 42 C.F.R. § 482.12, Governing Body.  CMS Ex. 5 at 8.  The violations were found because the governing body failed to ensure a physician was granted surgical privileges; failed to ensure contracted services were provided in a safe and effective manner; failed to ensure that there was a functioning nurse call system; failed to ensure that a formal complaint was documented and investigated per the facility’s grievance policy; failed to ensure a nursing program provided 24-hour care to meet patient needs; failed to ensure that medical records were stored in a secure location; and failed to secure a safe environment for staff and patients.

Petitioner was found to have condition-level violations of 42 C.F.R. § 482.13, Patient Rights.  CMS Ex. 5 at 21.  This violation was found during the survey because the facility

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failed to have a functioning nurse call system that met all Texas Administrative Code requirements and failed to investigate a complaint of neglect pursuant to the facility’s grievance policy.

Petitioner was found to have condition-level violations of 42 C.F.R. § 482.23, Nursing Services.  CMS Ex. 5 at 34.  This violation was found because Petitioner failed to verify the training and competency of its nursing staff to provide patient care.  The facility also had directors who did not meet the educational prerequisites and failed to provide adequate nursing staff in the ICU and Emergency Department.

Petitioner was found to have condition-level violations of 42 C.F.R. § 482.24, Medical Records.  CMS Ex. 5 at 60.  This violation was found because the facility failed to ensure that there was an effective medical records service that maintained physical and administrative responsibility for the records.  Id. 

Petitioner was found to have condition-level violations of 42 C.F.R. § 482.42, Infection prevention and control and antibiotic stewardship programs.  CMS Ex. 5 at 92.  The survey found that the facility failed to implement an active, system-wide program for the surveillance, prevention and control of infection.  Id. 

The survey concluded on May 14, 2021.  The termination deadline was extended to July 30, 2021.  CMS Ex. 6.  Petitioner submitted a new plan of correction and provided responses to the condition-level violations.  As a result, an additional follow-up survey was scheduled to determine whether Petitioner had attained substantial compliance with the Medicare conditions of participation.

5. The second revisit survey was conducted in July 2021.  The survey found that Petitioner continued to have multiple condition-level violations.

A second follow-up survey concluded on July 19, 2021.  CMS Ex. 7.  Petitioner was found to have condition-level violations of 42 C.F.R. § 482.13, Patient Rights.  CMS Ex. 2 at 2.  The violation was found because the facility failed to implement a process for patients to call for assistance in case of an emergency.  Petitioner was also found to have condition-level violations pursuant to 42 C.F.R. § 482.42, Infection prevention and control and antibiotic stewardship programs.  CMS Ex. 7 at 18.  The survey found this condition-level violation because the facility failed to employ methods to prevent and control infections as stated in the facility policies and professional guidelines.

The survey concluded on July 19, 2021.  The termination deadline was extended to September 13, 2021.  CMS Ex. 8.  CMS also scheduled a third follow-up survey to determine whether Petitioner had attained substantial compliance with the Medicare conditions of participation.

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6. The third revisit survey was conducted in September 2021.  The survey found that Petitioner continued to have multiple condition-level violations.

A third follow-up survey concluded on September 10, 2021.  CMS Ex. 9.  Petitioner was found to have condition-level violations of 42 C.F.R. § 482.12, Governing Body.  CMS Ex. 9 at 9-10.  The violation was found because the governing body failed to effectively discharge its oversight responsibilities in the operation of the hospital.

Petitioner was also found to have condition-level violations of 42 C.F.R. § 482.13, Patient Rights.  CMS Ex. 9 at 18.  This condition-level violation was found because the facility failed to ensure the patients received care in a safe setting.

Petitioner was found to have condition-level violations of 42 C.F.R. § 482.23, Nursing Services.  CMS Ex. 9 at 29.  This violation was found because the facility failed to put systems and processes in place to improve the previously cited failures regarding the assessment of patients in the Emergency Department.  CMS Ex. 9 at 29.

Petitioner was found to have condition-level violations of 42 C.F.R. § 482.42, Infection prevention and control and antibiotic stewardship programs.  CMS Ex. 9 at 40.  This violation was found because the facility failed to employ methods to prevent and control infections as stated in facility policies and professional guidelines.  CMS Ex. 9 at 41.

The survey concluded on September 10, 2021.  The termination deadline was extended to November 11, 2021, and again from November 11, 2021 to December 11, 2021.  CMS Exs. 10, 11.  CMS also scheduled a final follow-up survey to determine whether Petitioner had attained substantial compliance with the Medicare conditions of participation.

7. The final survey was conducted in December 2021.  The survey found that Petitioner continued to have multiple condition-level violations. 

A final survey was completed on December 21, 2021.  CMS Ex. 13.  The survey found six condition-level violations.

Petitioner was found to have a condition-level violation of 42 C.F.R. § 482.12, Governing Body.  CMS Ex. 13 at 3.  The survey found that the governing body failed to effectively provide oversight of the operation of the hospital.  CMS Ex. 13 at 3.

Petitioner was further found to have a condition-level violation of 42 C.F.R. § 482.21, Quality Assurance and Performance Improvement (QAPI).  This violation was found as a result of the hospital’s failure to implement system-wide performance improvement across all departments and services.  CMS Ex. 13 at 9.

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Petitioner was also found to have a condition-level violation of 42 C.F.R. § 482.25, Pharmaceutical Services.  CMS Ex. 13 at 29.  This violation was found because the hospital failed to ensure expired medications were stored properly; failed to ensure that medications were disposed of properly; and failed to ensure proper staff oversight.

Petitioner was also found to have a condition-level violation of 42 C.F.R. § 482.42, Infection prevention and control and antibiotic stewardship programs.  CMS Ex. 13 at 41.  This violation was cited as a result of the hospital’s failure to implement their policy related to Covid-19.

A condition-level violation was also found with regard to 42 C.F.R. § 482.51, Surgical Services.  CMS Ex. 13 at 52.  This violation was found as a result of the hospital’s failure to ensure that clinical privileges were authorized by the governing body.  CMS Ex. 13 at 52.

8. Following the December 2021 survey, Petitioner’s Medicare provider agreement was terminated effective January 11, 2022.
9. Petitioner submitted multiple plans of correction over the survey cycle. 

Petitioner submitted a plan of correction following each of the aforementioned surveys.  However, as discussed, additional condition-level violations were found at each subsequent survey.

V.  Conclusions of Law and Analysis

My conclusions of law are in italics and bold.  In this case, I conclude that Petitioner was not in compliance with the Governing Body and QAPI requirements established by 42 C.F.R. § 482.12 and 42 C.F.R. § 482.21; Petitioner’s noncompliance with 42 C.F.R. § 482.12 and 42 C.F.R. § 482.21 were at the condition level; Petitioner’s condition-level noncompliance with 42 C.F.R. § 482.12 and 42 C.F.R. § 482.21 is a basis for termination of Petitioner’s provider agreement pursuant to 42 C.F.R. § 489.53(a)(3); and therefore, it is unnecessary to discuss the remaining citations of noncompliance.1

1. Petitioner did not comply with the condition of participation at 42 C.F.R. § 482.12, Governing Body.

There must be an effective governing body that is legally responsible for the conduct of

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the hospital.  42 C.F.R. § 482.12.  In the present case, the surveyors and CMS found that Petitioner violated the Governing Body condition because Petitioner failed to provide oversight in the total operation of the hospital.  Specifically, CMS alleges numerous instances of Petitioner failing to effectively discharge its oversight responsibilities. 

As discussed below, Petitioner’s noncompliance with the requirement to ensure there was oversight in the total operation of the hospital is severe enough to put Petitioner out of compliance with the Governing Body condition of participation at 42 C.F.R. § 482.12. 

During the January 2021 survey, it was found that patient # 9 was not provided with timely access to the emergency department.  On January 5, 2021, patient # 9 was observed talking to EMS staff after she called 911 because she could not contact or otherwise access Petitioner’s emergency department.  EMS staff eventually walked patient # 9 to the emergency department.  On January 6, 2021, two calls were placed to the emergency department and it was noted that both calls rang approximately three times and then disconnected.  It was determined through interviews with staff that the emergency department was aware the phones were not working and no signs or notices were posted.  CMS Ex. 4 at 6, 8. 

The survey also found that the governing body failed to review and approve an international student medical program; failed to ensure nursing staff had direct access to the attending physician resulting in delayed treatment to patient # 18; failed to ensure that patients’ rights were protected by obtaining properly executed medical consent for procedures; failed to protect 31 patients’ right to privacy by allowing media in the Covid/ICU to take photos and videos without obtaining consent; failed to ensure readily available cardiac equipment; failed to ensure investigational drug protocols were reviewed; failed to develop and implement policies related to investigational drugs; failed to ensure that drugs were stored properly; failed to employ methods for preventing and controlling the transmission of infections; failed to ensure that Covid-19 screening processes were implemented; and failed to ensure that systems were in place to prevent the potential transmission of diseases from the use of single-use glucometers on multiple patients. 

The May 2021 survey found that the governing body failed to ensure a physician was appointed to the medical staff and was granted hospital privileges in accordance with medical staff bylaws, and the physician performed three surgeries without the official appointment and privileges.  CMS Ex. 5.  The governing body also failed to ensure services provided by a contracted dialysis company were provided in a safe and effective manner and failed to ensure a functioning nurse call system that included an audible signal at the nurse’s station, visible signal in the corridor, and two-way communication between nursing staff and patient.  CMS Ex. 5 at 8-10. 

The survey also found that the governing body failed to ensure that a formal complaint

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involving allegations of patient neglect was documented and investigated, failed to ensure that the Medical Executive Committee’s recommendation and the governing body’s appointment of a candidate included consideration of the person’s character, competence, training, experience, and judgment.  CMS Ex. 5 at 8-9, 22-23. 

It was also found that the governing body failed to ensure an effective nursing service to provide 24-hour patient care to meet patient needs.  Specifically, the governing body failed to ensure that there were adequate numbers of licensed nursing personnel to provide nursing care to two patients, T-34B and T-31A.  Patient T-34B suffered a cardiac event in the emergency department and was not transferred to inpatient ICU because of a staff shortage.  Patient T-34B spent 22 hours in the emergency department before he died.  Patient T-31A was brought to the emergency department after a suicide attempt.  A physician ordered one-on-one monitoring but it was documented that staff was not available.  Patient T-31A spent 23 hours in the emergency department before eloping. 

The survey also found that the governing body failed to ensure medical records were stored securely, that the facility’s kitchen provided food services in a sanitary environment, and its facilities met National Fire Protection Association codes. 

During the September 2021 survey, it was found that the governing body failed to ensure a physician was present on the Covid unit to supervise international medical students.  During this time, the students intubated a patient with no physician present, changed ventilator settings, wrote orders and signed the physician’s name; critical labs were relayed to the students rather than a physician; and students were seen leaving through a back door of the Covid unit when the surveyor arrived.  In an earlier corrective action plan, the governing body indicated that it was terminating its international student observer program.  However, nurses working in the Covid unit told the surveyor that there were frequently medical students on the unit at night.  CMS Ex. 9 at 15. 

During the December 2021 survey, it was found that the governing body failed to ensure that patients could enter the emergency department in a timely manner again.  Petitioner had proposed a plan following the January 2021 survey to forward calls to other departments if the emergency department phones were not answered.  However, the survey team could not access the emergency department for 42 minutes on December 17, 2021.  The surveyors tried calling the emergency department and left voicemails but were not able to gain access.  CMS Ex. 13 at 11-12. 

Therefore, the evidence clearly shows that Petitioner violated 42 C.F.R. § 482.12 and that the violations rose to the condition level because each of the violations discussed above substantially limited Petitioner’s capacity to furnish adequate care or adversely affected the health and safety of Petitioner’s patients. 

Petitioner argues in its prehearing brief that there were periods of substantial compliance

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with the Governing Body condition of participation and, therefore, it should not be used as a basis for termination.  P. Br. at 7-9.  Further, Petitioner argues that CMS incorrectly found the December 2021 governing body deficiency to be at the condition level and instead should have found a standard-level deficiency.  P. Br. at 17.  However, Petitioner has failed to provide any evidence to show that it complied with the standards of participation established by 42 C.F.R. § 482.12.

According to Petitioner, CMS improperly cited a broad range of findings to support the condition-level noncompliance with the governing body requirement; Petitioner argues that only the findings related to emergency services are related to a standard in the governing body requirement.  P. Br. at 17.  In other words, Petitioner suggests that I should limit my review of the governing body requirement to the emergency services findings only.

Contrary to Petitioner’s position, the State Operations Manual states:  “The governing body must be functioning effectively and holds the ultimate responsibility for the hospital’s compliance not only with the specific standards of the governing body CoP [conditions of participation], but also with all of the CoPs.  This is the case regardless of whether the regulatory text for a particular condition or standard within a condition specifically mentions responsibilities of the governing body.”  P. Ex. 4 at 50 (Emphasis added).  Thus, noncompliance with any conditions of participation may also support noncompliance with the governing body requirement.

Further, the findings related to the emergency services deficiency were serious enough alone to support the condition-level finding as well.  As noted, Petitioner failed to ensure patients could enter the emergency department in a timely manner as the exterior door was locked and the emergency department phones were not answered immediately.  CMS Ex. 13 at 2.  It took 42 minutes for the survey team to access the emergency department.  CMS Ex. 13 at 11-12.  A 42-minute delay would “substantially limit” the hospital’s “capacity to furnish adequate care” and therefore amounts to condition-level noncompliance.

Finally, Petitioner’s argument that it implemented its plan of correction after the September 2021 survey is also unavailing.  P. Br. at 8.  First, there is no requirement that the condition-level deficiencies cited during the December 2021 survey be the same as those cited during the prior, September 2021 survey.  Petitioner cites cases in the SNF enforcement context, which are not applicable here.  P. Br. at 5, 15 (citing Meadowbrook Manor – Naperville, DAB No. 2173 at 10-11 (2008); Oakwood Cmty. Ctr., DAB No. 2214 at 19 (2008)).  Further, the issue in this case is whether there is a basis for termination.  The regulations provide that CMS may terminate if a facility is out of compliance with a condition of participation.  42 C.F.R. § 489.53(a)(3).  Having found condition-level noncompliance at the December 2021 survey immediately before the termination, it is irrelevant whether the findings in the prior surveys were corrected.

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Therefore, I conclude that Petitioner failed to meet the Governing Body condition of participation.

2. Petitioner did not comply with the condition of participation at 42 C.F.R. § 482.21 (Quality assessment and performance improvement (QAPI) program).

Hospitals must “develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program” which “reflects the complexity of the hospital’s organization and services” and “focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors.  The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS.”  42 C.F.R. § 482.21.  The Secretary explained the purpose behind the QAPI requirement:

The fundamental purpose of the QAPI [condition of participation] is to set a clear expectation that hospitals must take a proactive approach to improve their performance and focus on improved patient care.  We stress improvement in systems in order to improve processes and patient outcomes.  This is not meant to suggest that we plan to abandon our regulatory role.  In fact, this approach reinforces our primary responsibility for assuring patient safety and protection through our delegated regulatory authority.

68 Fed. Reg. 3435, 3436 (Jan. 24, 2003) (Emphasis added).

The December statement of deficiencies and CMS assert that Petitioner failed to ensure that policies and a plan of correction related to one of Petitioner’s emergency departments were put into place and followed throughout the other facilities.  Specifically, Petitioner was cited in January 2021 for access problems to its Tidwell emergency department and then cited again for similar access problems in the December 2021 survey at its North location.  Petitioner also failed to ensure that pharmaceutical services were reviewed for quality following the previous surveys and that a plan of correction was implemented for pharmacy quality improvement indicators system wide.  Petitioner also failed to implement system-wide pharmacy policies and failed to implement performance improvements for the deficient practices found in pharmacy services.  Petitioner also did not ensure that its performance improvement plans were implemented across all facilities.  And it did not ensure that competency and clinical performance for staff were consistently evaluated.  Petitioner failed to implement performance improvements for infection control deficiencies found in prior surveys.  And, lastly, Petitioner failed to ensure that the hospital’s review of patient clinical records produced records that were maintained in a manner that provided accuracy of information and patient informed consent.  CMS Ex. 13 at 9-10.

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Petitioner does not dispute that there were unnecessary delays with getting to the emergency department at the North location, but instead attempts to argue that, despite the citation in the earlier, January 2021 survey regarding access to the Tidwell location, there was no requirement to address other emergency department locations as part of its QAPI program.  P. Br. at 19.  Petitioner adds that the plan of correction from the January 2021 survey did not specifically state that it would apply to other locations and that CMS’s acceptance of that plan of correction is binding.  P. Br. at 19.

Petitioner overlooks the regulation’s requirement that a hospital must “develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program.”  42 C.F.R. § 482.21 (Emphasis added).  As noted, the “fundamental purpose” of the QAPI is to set the clear expectation that hospitals must take a “proactive approach” to improve their performance and focus on improved patient care.  68 Fed. Reg. at 3436.  Thus, after it was specifically cited for failing to ensure timely access to one location during the January 2021 survey, Petitioner should have addressed the same issues affecting its other emergency department locations.  Contrary to Petitioner’s argument, there was no need for the first plan of correction to specifically state that it should be applied to other locations.  Petitioner’s failure to address the same issue at a second location within its hospital system constitutes a QAPI failure.

Finally, Petitioner also argues that there was no condition-level deficiency because the allegations involved only four of 20 sub-standards and there were no negative outcomes or adverse events identified.  P. Br. at 19.  I disagree with Petitioner’s position.  As noted, a hospital is no longer in compliance with the conditions of participation “where the deficiencies are of such character as to substantially limit the provider’s . . . capacity to furnish adequate care or which adversely affect the health and safety of patients.”  42 C.F.R. § 488.24(b).  In this case, failing to ensure timely access to emergency department locations alone would “substantially limit” the hospital’s capacity to furnish adequate care.  CMS Ex. 13 at 9.  Petitioner has not submitted evidence to dispute that point.

Based on the above, I conclude that Petitioner failed to meet the QAPI condition of participation.  The evidence shows that the violations rose to the condition level because the violations discussed above substantially limited Petitioner’s capacity to furnish adequate care.  42 C.F.R. § 488.24(b).  Therefore, Petitioner is deficient with that condition. 

3. Petitioner’s condition-level noncompliance with 42 C.F.R. §§ 482.12 and 482.21 furnishes a legal basis for CMS to terminate Petitioner’s Medicare provider agreement.

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CMS may terminate a hospital’s Medicare provider agreement where the hospital is not in substantial compliance with Medicare requirements.  42 U.S.C. §§ 1395cc(b)(2)(B), 1395x(e).  Failure to comply with a single condition of participation justifies terminating a hospital’s provider agreement.  42 C.F.R. § 489.53(a)(3); see, e.g., Profound Health Care, DAB No. 2371 at 3 (2011).  Petitioner argues in both its hearing request and brief that it did not have condition-level deficiencies but instead had only standard-level deficiencies.  However, as stated above, I have concluded that Petitioner had multiple condition-level deficiencies.  Therefore, CMS had the legal authority to terminate Petitioner’s Medicare provider agreement.

Petitioner also argues that it submitted plans of corrections which were accepted by CMS.  As a result, Petitioner argues that the condition-level deficiencies were corrected and termination should not have moved forward.  However, as noted above, Petitioner cites cases in the SNF enforcement context, which are not applicable here.  P. Br. at 5, 15 (citing Meadowbrook Manor – Naperville, DAB No. 2173 at 10-11 (2008); Oakwood Cmty. Ctr., DAB No. 2214 at 19 (2008)).  And during each survey, including the final survey in December 2021, additional condition-level deficiencies were found anyway.  Therefore, CMS had the legal authority to terminate Petitioner’s Medicare provider agreement.

Lastly, Petitioner argues that CMS did not follow proper procedures for a termination and that at multiple points a new termination process should have been started.  Petitioner argues that it came into substantial compliance following its plan of correction and, therefore, a new survey cycle should have begun.  However, the first survey concluded on January 8, 2021 and, as discussed above, after multiple revisits and an additional full survey, Petitioner remained out of compliance.  I find no evidence to support an allegation that CMS failed to follow proper termination procedures.  Further, to the extent that Petitioner attacks the quality of the survey, it is well-settled that the conduct of the survey is irrelevant.  Angel Kidney Care of Inglewood, Inc., DAB No. 2795 at 10-11 (2017) and cases cited therein.  Therefore, CMS had the legal authority to terminate Petitioner’s Medicare provider agreement.

VI.  Conclusion

I affirm CMS’s determination to terminate Petitioner’s Medicare provider agreement.