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a two- to four-page paper on hospital deficiencies. The hospital is : Kaiser Foundation Hospital- South San Francisco What organization oversees this hospital? a paragraph explaining why the hospital was tagged with deficiencies. Develop an effective compliance plan for this issue to include the components of an effective plan and steps back to compliance. Add a summary or conclusion. Use in-text citations and add a corresponding reference list. Use this references and other one as needed Quality, Safety & Oversight – enforcement. CMS.gov. (2025, April 21). https://www.cms.gov/medicare/health-safety-standards/certification-compliance/enforcement III, G.B. M. (2013). Managing Legal Compliance in the Health Care Industry. Jones & Bartlett Learning. https://online.vitalsource.com/books/9781284075533 Hospitals. CMS.gov. (2025, June 20). https://www.cms.gov/medicare/health-safety-standards/certification-compliance/hospitals EL CENTRO REGIONAL MEDICAL CENTER Short – Term 050045 1415 ROSS AVENUE EL CENTRO CA 1 2/2/2017 6N5511 Survey not available EL CENTRO REGIONAL MEDICAL CENTER Short Term 050045 1415 ROSS AVENUE EL CENTRO CA 0043 GOVERNING BODY A ######## 7LW611 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 to provide a safe and secure environment for patients by the following: 1. The Governing Body failed to ensure that operating room (OR) staff maintained a safe environment in the OR when a power strip that did not have a back cover and had live electrical conductors exposed, was used. This posed a risk of equipment failure, electrical shock and fire in an oxygen rich environment. A Tag 144 and A Tag 724 2. The Governing Body failed to ensure that Quality Assessment and Performance Improvement (QAPI) had oversight for the implementation and provision of surgical services utilizing a sophisticated robotic surgical device, impeded the hospital from identifying outcomes (such as infections and surgical complications) and opportunities for improvement related to this potentially high risk surgical device. A Tag 263 3. There was no documented evidence that operating room nursing staff and technicians had job-specific training and competencies regarding the da Vinci Robotic surgical device. A Tag 941 4. There was no documented evidence of their written process related to the training and competency evaluation of Registered Nurses (RNs) and Certified Surgical Technicians (CSTs) in the Operating Room (OR) related to the use of the hospital’s robotic surgical device. A Tag 951 5. The Governing Body failed to ensure that the Director of Facilities obtained California Office of Statewide Health Planning and Development (OSHPD) permits prior to construction projects and approvals. These buildings did not contain audible and visual fire detection devices which had the potential to cause injury to all. A Tag 710 K 56, K 52 (3), K 62 (5) and K 67 (1) 6. Failure to substantially comply with 42 CFR (Code of Federal Regulations) 482.41 (B) (1) for General Acute Care Hospitals. This was evidenced by the facility failing to meet provisions under the NFPA (National Fire Protection Association) 101, Life Safety Code 2000 Edition. As a result, this increased the risk of injury to the patients, staff, and visitors in the event of a fire or disaster. A Tag 710 (refer to K tags) A review of the bylaws for the board of trustees was conducted on 11/22/13 at 1:00 P.M. The bylaws specified the Governing Body ultimate responsibility under powers and duties section 3.01-7 : “The making, adopting, and modifying as necessary and appropriate, from time to time, rules and regulations governing the activities and programs of the Hospital, including its educational and medical activities and programs; the organization of services; choice of staff; appointment of physicians and other health care professionals; admission or exclusion of patients; and, in general, the governing of all internal activities at the Hospital and its activities and programs.” An interview was conducted with representatives of the Governing Body on 11/22/13 at 4:00 P.M., the members of the board stated that they were not informed that the OR staff were using a power strip that did not have a back cover which exposed live electrical conductors in the OR. They stated they were not aware that the da Vinci robotic surgical device had been installed without OSHPD approval. In addition, they were not aware that documented evidence of job-specific training and competency evaluations on the da Vinci device for nursing staff and technicians were not obtained. They stated they were not aware that the Facilities Director had completed construction of buildings without OSHPD permits. They acknowledged that they had not validated the Facilities Director’s job-specific roles and responsibilities, or his adherence to OSHPD requirements for permits, in an effort to ensure that he was following all requirements necessary for installations of devices and construction. The cumulative effect of these systemic problems resulted in the facility’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. EL CENTRO REGIONAL MEDICAL CENTER Short Term 050045 1415 ROSS AVENUE EL CENTRO CA 0085 CONTRACTED SERVICES A ######## 7LW611 Based on interview and document review, the hospital failed to ensure that it’s lease agreement (contract) with a vendor to rent a building for the storage of records and equipment, contained details and specifications related to ensuring the protection and safe storage of records from damage, flood and fire. The lack of specific details in vendor contracts impedes the hospital from ensuring the integrity of medical records and the implementation of safe storage requirements. Findings: An interview with the interim Health Information Management manager (HIM 1) was conducted on 11/20/13 at 8:30 A.M. HIM 1 stated that the hospital stored medical records in two locations: the “barn” (a fixed trailer located on hospital property) and offsite storage facility 1 (OSF 1). On 11/20/13 at 1:43 P.M., a tour of the hospital’s older storage facility located on 2nd Street (OSF 2) was conducted with the Chief Operating Officer (COO), Chief Financial Officer (CFO), the Director of Quality and Risk Management (DQRM) and the interim Health Information Management manager (HIM 1). Multiple boxes were found stored with medical equipment in a building that was dirty, disorganized, poor lighting and no temperature control. The boxes were dusty, dirty and difficult to reach as there were several medical equipment and other obstacles that impeded direct access to all of them. A review of a document entitled “Agreement For Offsite Record Storage Services” for OSF 1, dated 10/2007, was conducted on 11/20/13 at 9:54 A.M. The contract contained detailed and clear storage area responsibilities and requirements for the storage of records and materials. Per the same contract, it stipulated that “Storage areas must be kept clean, free of debris and rodents, heat and moisture.” An interview with the Director of Quality and Risk Management (DQRM) was conducted on 11/22/13 at 4:03 P.M. The DQRM had confirmed that the hospital had two offsite medical storage locations: OSF 1 and an older storage facility located on 2nd Street (OSF 2). She stated that the hospital had a lease agreement (vendor contract) to rent the building at OSF 2, for the storage of medical records and medical equipment. She acknowledged that the OSF 2 vendor contract did not contain details of required services to ensure the safe storage and protection of medical records from damage, flood and fire. A review of all the copies of the lease agreements (contract) with OSF 2, dated 6/16/93, 7/1/94 and 6/30/03, was conducted on 11/22/13, there was no documented evidence to show that clear and specific details were listed to ensure the safe storage and protection of medical records from damage, flood and fire. EL CENTRO REGIONAL MEDICAL CENTER Short Term 050045 1415 ROSS AVENUE EL CENTRO CA 0115 PATIENT RIGHTS A ######## 7LW611 Based on observation, interview, and document review, the hospital failed to protect and promote each patients’ rights when patient care was not provided in a safe environment for patients by the following: 1. Failure to ensure that care was provided in a safe setting when medical devices (auxiliary equipment) in the Operating Room (OR) were plugged into a 6-plug multiple outlet adapter (power strip). The back cover of the outlet adapter was missing which exposed live electrical conductors to an oxygen-enriched environment. This had the potential to cause equipment failure during a surgical procedure, electrical shock and fire. A Tag 144 2. The Governing Body failed to ensure that the Director of Facilities obtained California Office of Statewide Health Planning and Development (OSHPD) permits prior to construction projects and approvals. These buildings did not contain audible and visual fire detection devices which had the potential to cause injury to all. A Tag 710 K 56, K 52 (3), K 62 (5) and K 67 (1) 3. Failure to substantially comply with 42 CFR (Code of Federal Regulations) 482.41 (B) (1) for General Acute Care Hospitals. This was evidenced by the facility failing to meet provisions under the NFPA (National Fire Protection Association) 101, Life Safety Code 2000 Edition. As a result, this increased the risk of injury to the patients, staff, and visitors in the event of a fire or disaster. A Tag 710 (refer to K tags) The cumulative effect of these systemic problems resulted in the hospital’s failure to deliver care in compliance with the Condition of Participation for Patient’s Rights and failure to provide patient care in a safe and secure environment. EL CENTRO REGIONAL MEDICAL CENTER Short Term 050045 1415 ROSS AVENUE EL CENTRO CA 0144 PATIENT RIGHTS: CARE IN SAFE SETTING A ######## 7LW611 Based on observation, interview and document review, the hospital failed to ensure that care was provided in a safe setting when medical devices (auxillary equipment) in the Operating Room (OR) were plugged into a 6-plug multiple outlet adapter (power strip). The back cover of the outlet adapter was missing which exposed live electrical conductors to an oxygen-enriched environment. Medical devices used during surgical procedures in the OR that were plugged into an outlet adapter with exposed live electrical conductors in an oxygen-rich environment had the potential to cause equipment failure, electrical shock and an electrical fire. The hospital’s failure to provide care in a safe setting had the potential to affect all the patients, staff and visitors in the OR. On 11/19/13 at 2:55 P.M., a situation of Immediate Jeopardy was determined to be present due to that finding. (Reference A Tag 724 as well). The Chief Executive Officer, the Chief Operating Officer, the Chief Nursing Officer, and the Director of Quality and Risk Management were present. The Immediate Jeopardy was abated on 11/22/13 at 4:30 P.M. after an acceptable corrective action plan was implemented. Findings: On 11/19/13 beginning at 1:29 P.M., a group observation of the hospital’s da Vinci “Si” HD surgical system (a sophisticated surgical robot designed to enable complex surgery using a minimally invasive approach. The robot consists of three components: surgeon console; patient cart, which holds specialized instruments; and the vision cart) located in OR #4, was conducted with the Director of Surgical Services (DSS) and the Director of Quality and Risk Management (DQRM). The Vision Cart contained auxillary equipment which included a digital device (used in the OR; has the ability to capture images in high definition and record video in multiple formats), insufflator (a device that blows gas into a body cavity) and an electrical surgical unit (a surgical device that uses high-frequency electric current for cutting or destroying tissue, as in cauterization). The auxillary equipment were plugged into a 6-plug mutiple outlet adapter (a power strip). The back cover of the outlet adapter was missing, exposing the live electrical conductors. The outlet adapter was plugged into a 20-Amp (amperage) circuit and the circuit was observed to be in the “ON” position. An interview with the DSS was conducted on 11/19/13 at 3:30 P.M. He acknowledged that there were 3 medical devices (the digital device, the insufflator and an electrical surgical unit) that were plugged into a power strip. He confirmed that the power strip did not have a back cover which led to the exposure of live electrical conductors to an oxygen-enriched environment. He acknowledged that auxillary equipment plugged into a power strip that had exposed live electrical conductors had the potential to cause equipment failure, electrical shock and an electrical fire. He also stated that he was not aware that the general use of power strips, even when they were marked hospital-grade and were intact, was not allowed in the OR. According to the hospital’s Chief Operating Officer (COO), robotic surgeries had been performed since 2010. A list of patients who had robotic surgery performed from 6/7/10 – 11/18/13 was reviewed. There were a total of 576 patients who had robotic surgery performed. The hospital verbalized that they were unable to determine the length of time the multiple outlet adapter with the missing cover was used in the OR during surgical procedures, and the unknown number of patients and staff that were placed at risk for potential equipment failure, electrical shock and fire due to the exposed live electrical conductors. EL CENTRO REGIONAL MEDICAL CENTER Short Term 050045 1415 ROSS AVENUE EL CENTRO CA 0263 QAPI A ######## 7LW611 Based on interview and document review, the hospital failed to ensure that it’s Performance Improvement Program was implemented and maintained in an on-going manner to evaluate the quality and appropriateness of services provided related to robotic surgery. Findings: A review of the hospital’s “Organizational Quality Assessment and Performance Improvement (QAPI) Plan” dated 2013 was conducted on 11/21/13. The objectives and goals indicated that: “This QAPI plan describes the organizational procedures to be utilized in process design, performance measurement, and performance assessment and performance improvement activities. It is the intent of the organization’s leaders to develop a quality assessment and performance improvement (QAPI) program that allows all departments and services collaboratively to evaluate the provision of patient care and perform improvement activities. This plan describes communication and coordination of all organizational activities directed toward improving patient care services. As described in this plan, “departments” refers to all medical staff departments and “services” refer to all clinical and non-clinical Medical Center support services.” Per the same plan entitled “Structure of Organizational QAPI Activities”, it stipulated that “The CEO/COO (Chief Executive Officer/Chief Operating Officer) shall oversee the development and implementation of QAPI activities for all [Hospital Name] support services and assure the integration and coordination of department-specific activities into the organization-wide QAPI program. Results of QAPI activities will be reported to Quality Council, the Medical Executive Committee (MEC), the Board of Quality Committee, and the Board of Trustees at least quarterly….” The Framework for Performance Improvement indicated that “In determining organizational measures, the organization considers the dimensions of performance including efficacy, appropriateness, availability, timeliness, effectiveness, continuity of care, safety, efficiency, and respect and caring as may be appropriate in the measurement of any specific process. Also, included are high volume, high risk and problem prone processes.” The hospital’s QAPI plan defined the following: ” A performance improvement model is a formal description of the thinking and analysis process adopted by an organization to consider potential improvement opportunities. The performance improvement model adopted by [Hospital name/acronym] is FOCUS-PDCA which is the acronym for: Find a process to improve Organize a team that knows the process Clarify current knowledge of the process Understand causes of process variation Select the process to improve Plan (collect data) Do (analysis of data) Check (did it work?) Act (continue to improve)” A group interview was conducted with the Director of Quality and Risk Management (DQRM) and the Assistant Director of Quality and Risk Management (ADQRM) on 11/22/13 at 11:05 A.M. The DQRM stated that she had only been in her role as the Director of Quality and Risk Management since the end of September 2013. She did not have access to the previous Director’s data and work related to the hospital’s robotic surgery QAPI activities. She acknowledged that she could not validate if any QAPI activities related to the robotic surgery services were performed and what data was collected, in effort to ensure patient safety, improve health outcomes, prevention and reduction of medical errors. The hospital’s QAPI program failed to monitor and maintain oversight of the implementation and provision of surgical services utilizing a sophisticated robotic surgical device. The lack of oversight impeded the hospital from identifying outcomes (such as infections and surgical complications) and opportunities for improvement related to this potentially high risk surgical device. The cumulative effect of these systemic problems resulted in the facility’s failure to deliver care in compliance with the Condition for Quality Assessment and Performance Improvement and failure to provide robotic surgical care to their patients in a safe environment. EL CENTRO REGIONAL MEDICAL CENTER Short Term 050045 1415 ROSS AVENUE EL CENTRO CA 0396 NURSING CARE PLAN A ######## 7LW611 **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, interview and record review, the hospital failed to ensure that Registered Nurses (RNs) developed a written nursing care plan when an infection was identified through a diagnostic test, in accordance with the hospital’s policy, for 1 of 33 sampled patients (1). Patient 1 had a positive Methicillin-Resistant Staphylococcus Aureus (MRSA – an infection caused by a strain of staph bacteria that’s become resistant to the antibiotics commonly used to treat ordinary staph infections) test result in the urine on 11/13/13, there was no documented evidence to show that a nursing care plan had been developed related to the infection. Failure to establish a written care plan, related to an identified patient problem (an infection), had the potential to impede the hospital’s goal of ensuring that the nursing staff were consistent in providing nursing care to meet the needs of the patient. In addition, failure to establish a written plan of care did not provide a means to determine when and if the plan of care was revised or updated as needed. Findings: On 11/21/13 beginning at 1:15 P.M., a tour of the medical-surgical nursing floor was conducted with the Director of Quality and Risk Management (DQRM) and the clinical nurse manager (RN 1). Patient 1’s room had a contact isolation sign posted. A review of Patient 1’s medical record was conducted 11/21/13 at 1:33 P.M. Patient 1 was admitted on [DATE] with a diagnosis that included urinary tract infection per the the Facesheet. A Microbiology Report, dated 11/11/13, indicated that a urine culture had been collected and received. Patient 1’s urine culture tested positive for MRSA and the lab result was released to the nursing staff on 11/13/13 at 7:38 A.M. According to a Nursing Note, dated 11/13/13 at 11:58 A.M., RN 2 was aware of Patient 1’s positive MRSA result in the urine and had placed the patient on contact isolation. There was no documented evidence to show that the nursing staff had developed a written nursing care plan related to Patient 1’s identified infection. An interview and joint record review was conducted with RN 3 on 11/21/13 at 1:50 P.M. RN 3 stated that she was the nurse caring for Patient 1 on 11/21/13. She stated that Patient 1 was on contact isolation for MRSA in the urine. When RN 3 was asked to show Patient 1’s nursing care plan related to the identified infection on 11/13/13, she confirmed that a written care plan had not been developed, in accordance with the hospital’s policy. She stated that nursing care plans were developed when problems were identified. She acknowledged that 8 days had passed and a writtne care plan had not been developed for Patient 1’s MRSA in the urine (infection). A review of the hospital’s policy entitled “Care Plan; Patient”, last review date of 8/22/12, was conducted on 8/22/13. The policy indicated that “… the RN will identify the patient problems (actual/potential), and initiate the Patient Care Plan based on diagnostic test results and assessment information gathered….” Per the same policy, it stipulated that “The careplan will be updated and reviewed daily, on an ongoing basis, and whenever a patient condition changes.” An interview with RN 1 was conducted on 11/21/13 at 2:10 P.M. RN 1 acknowledged that there was no documented evidence that a written care plan had been developed when Patient 1’s MRSA in the urine was identified in accordance with the hospital’s policy. An interview with the Infection Control Coordinator (ICC) was conducted on 11/22/13 at 11:18 A.M. The ICC stated that the hospital had identified problems with nursing care plans and were working on correcting the problem. However, she stated that there should have been documented evidence in Patient 1’s medical record to show that a care plan had been developed when the patient’s urine culture tested positive for MRSA. EL CENTRO REGIONAL MEDICAL CENTER Short Term 050045 1415 ROSS AVENUE EL CENTRO CA 0405 ADMINISTRATION OF DRUGS A ######## 7LW611 **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on interview and document review, the hospital failed to ensure that a pre-printed medication order form provided clear and specific medication orders as to which medication was to be used first for the management of nausea and vomiting for 7 of 33 sampled patients (5, 14, 17, 23, 27, 28 and 32). Furthermore, there was no documentation of nursing clarification of the order. Lack of clear and specific medication orders made it difficult for the nursing staff to determine which medication was to be administered first. Findings: 1. A review of patients’ 5, 14, 17, 23, 27, 28 and 32’s medical records was conducted on 11/20/13 at 11:00 A.M. Patient 5 was admitted on [DATE] with a diagnosis of [DIAGNOSES REDACTED] vomiting). There was no documentation to specify which anti-nausea medication to use and in what order. There was no documentation in the medical records that the registered nurse (RN) clarified the orders for nausea and vomiting medication. A review of the hospital’s policy entitled “Medication Orders, Resolving Questionable Physician”, indicated that “clarification of orders with the physician occurs when there may
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