The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.
| UNIVERSITY OF TEXAS M D ANDERSON CANCER CENTER,THE | 1515 HOLCOMBE BLVD HOUSTON, TX | Aug. 23, 2019 |
| VIOLATION: MEDICAL STAFF - APPOINTMENTS | Tag No: A0046 | |
| Based on record review and interview, the Governing Body failed to ensure that members of the hospital medical staff are appointed only by the Governing Body. Findings: Review of the Medical Staff Bylaws, Article IV, Section 4.3, shows, " Temporary Privileges. The Governing Body, the Chief Medical Executive, or the Chief Medical Officer, on written request of the appropriate Department Chair or Division Head, shall have the authority to grant temporary privileges to an appropriately licensed Practitioner with documented current clinical competence as set forth below and as detailed in written policy..." Further, it shows, "...Any grant of temporary privileges shall be reviewed by the CCMS at its next meeting. Temporary privileges may be terminated at anytime by the President, Chief Medical Executive, or Chief Medical Officer on recommendation of the CCMS, the ECMS, the Practitioner's Division Head, or the Department Chair responsible for supervision of the Practitioner..." Interviews with the Chief Medical Executive and the Chief Operating Officer confirmed that any of the individuals mentioned in the provision of the bylaws can grant or terminate temporary privileges which is contrary to the requirement of the regulation. |
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| VIOLATION: MEDICAL STAFF - ACCOUNTABILITY | Tag No: A0049 | |
| Based on review of records, the Governing Body failed to ensure that the medical staff was accountable to the Governing Body for the quality of care provided to patients. The Governing Body was responsible for the conduct of the hospital which includes the quality of care provided to patients. Findings: Review of the Medical staff bylaws, Article II, Section 2.2, shows, "The Medical staff is accountable to the Governing Body through the Chief Medical Executive and Chief Medical Officer, for the fulfillment of its purposes and responsibilities and for assuring that all patient care activities are conducted consistent with accepted professional standards and legal and accreditation requirements." This finding is contrary to the requirement of the regulation. Review of laboratory's policies, patient emergency release records for blood products, and in interview with staff, the laboratory failed to ensure signatures of the requesting physicians were obtained before or after emergency release of blood products [21 CFR 606.160(b)(3)(v)] for 7 of 10 patients in 2018 and 2019. Cross refer to CLIA Tag D5553. Review of patient record DG_Blood1 revealed that patient was admitted on June 26, 2019, with diagnoses of hepatitis, rhabadomyolysis, chronic kidney disease, hip pain, and proximal muscle weakness. The patient was transfused with 5 units of PRBC on July 9, 2019, via rapid infusion. However, the medical record failed to show documentation of the need for the 5-units of PRBC. This was confirmed by a transfusion physician on 8/19/19 @ 11:00 AM. Review of patient record DG_Blood2 revealed that patient received multiple units of platelets (2 unites on 5/26/19, 3 units on 5/27/19, 1 unit on 5/28/19, and 2 units on 5/29/10). The patient was pronounced dead at 16:00 on 6/5/19. The ICU physician documented TRALI vs. TACO vs. PNA, however, there was no workup done. This was confirmed by a transfusion physician on 8/19/19 @ 11:00 AM. Review of patient DG_Blood3 revealed that patient received multiple units of blood products (on 6/26/19, 2 units of PRBC and 1 unit of platelet; on 6/27/19, 2 units of PRBC, 1 unit of platelet, 4 units of FFP; on 6/28/19, 1 unit of PRBC, 2 units of platelets; on 6/29/19, 2 units of PRBC and 1 unit of platelet). The patient condition deteriorated and pronounced dead at 12:57 on 6/30/19. There was no transfusion workup done. This was confirmed by a transfusion physician on 8/19/19 @ 11:00 AM. |
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| VIOLATION: CONTRACTED SERVICES | Tag No: A0084 | |
| **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, interview, and record review, the facility failed to ensure staff who conduct testing of the facility's water treatment system using quantitative tests that can detect color meets the requirement of identifying colors; failed to assess staff competency in 2 of 6 staff observed. Contract Registered Nurse #s 118 and 65 Findings: Review on 08/21/2019 of Contract Registered Nurse #118's personnel and training record revealed he was hired to the facility on [DATE] as a contract registered nurse for hemodialysis. Review of his personnel and training record revealed a color recognition test dated April 2014, which indicated the staff was color blind. Review of a letter from an ophthalmologist dated May 23, 2019, revealed the following recommendation, "I would suggest testing MR #118 with water samples at work under various conditions to determine how well he is able to perform the tests. His past work performance related to water testing would be valuable." Review of Contract Registered Nurse (#118's) training record revealed no documentation that the ophthalmologist's recommendation was followed. Interview on 08/21/2019, at 9:30 a.m., with Contract Registered Nurse Manager ( #157) revealed he had done the test but it was not documented. Registered Nurse 65 Review of Contract Registered Nurse # 65's annual competency check list revealed she was hired to the facility on [DATE] as a Registered Nurse providing hemodialysis treatment to patients at the hospital. Review of a Dialysate Concentrate Adjustment Competency Assessment (Changing the concentrate value by adding electrolyte to the solution) dated 8/05/2019, revealed the competency was evaluated by verbalization only. There was no documentation that the staff was observed performing the task. During an interview on 08/21/2019 at 10:00 a.m. with the Hospital Dialysis Nurse Manger revealed, the registered nurse changes the composition of the dialysate solution by adding electrolyte to the concentrate solution at times, but she did not observe staff performing the task. Based on review of contracts and interview, the Governing Body failed to ensure that the services provided under contract were provided in a safe and effective manner. Findings: Review of 8 contracts for patient care related services showed no metrics or indicators to evaluate the quality of services being provided. Example: 1. The contract for laundry services with the Texas Medical Center Hospital Laundry Cooperative Association failed to ensure that linens delivered to the hospital were protected from environmental contaminants and failed to ensure that sterile linens/gowns were kept sterile during transport from the laundry facility to the hospital Operating Rooms. 2. The contract with Brainlab for clinical consultation showed that the "onsite support facilitated by Brainlab engineer; stationed onsite for instant technical response in order to provide optimal technical support for surgical team..." Interview with the Director of Perioperative Services, Chief Operating Officer, Chief Medical Executive, and the Associate Vice President of Supply Chain stated that there was no Brainlab engineer onsite but there are Brainlab Technicians onsite in the Operating Room during surgical procedures. Further, the contract shows that the onsite Brainlab engineer "direct MR and radiology staff in performing necessary scans prior to surgery..." An engineer is not a physician as defined in the Act and/or the regulations and therefore cannot direct what diagnostic tests are done on a patient in a Medicare participating hospital. Review of a list of contracted services revealed there was a total of 249 contracted services. Review of the list revealed some of the following missing information in relation to performance improvements Leica Bond RX service agreement used for auto-staining (lab testing) expired on [DATE] (12 days prior to date of survey). "According to documentation the performance indicators in the contract were insufficient. The corrective action was, Appropriate KPIs (key performance indicators) will be identified by Sourcing and contract stakeholder. KPIs will go through clinical review for insufficiency. Sourcing will incorporate KPIs into purchase orders until an amendment or new agreement is executed, if applicable. Scorecard will be developed by Sourcing and implemented for tracking KPIs. Contract stakeholder will track and collect supporting documentation." Best Care EMS (Emergency Medical service) - Ambulance Transport which was the ambulance service for patient care. According to documentation the metrics for the contract was pending clinical review. Cross Country Staffing which was for temporary nurse staffing and allied services. According to documentation the metrics for the contract was pending clinical review. Abbott f/k/a St Jude Medical/service which was capital equipment service agreement. According to documentation the performance indicators in the contract were insufficient. The corrective action was, "Appropriate KPIs will be identified by Sourcing and contract stakeholder. KPIs will go through clinical review for insufficiency. Sourcing will incorporate KPIs into purchase orders until an amendment or new agreement is executed, if applicable. Scorecard will be developed by Sourcing and implemented for tracking KPIs. Contract stakeholder will track and collect supporting documentation." Belimed OR Single Sterilizer Full Service Agreement revealed the performance indicators were insufficient and not tracked. The corrective action was, "Appropriate KPIs will be identified by Sourcing and contract stakeholder. KPIs will go through clinical review for insufficiency. Sourcing will incorporate KPIs into purchase orders until an amendment or new agreement is executed, if applicable. Scorecard will be developed by Sourcing and implemented for tracking KPIs. Contract stakeholder will track and collect supporting documentation." Gulf Coast Testing was used for blood testing services for infectious disease prior to uploading into the National Marrow Donor Program registry revealed the performance indicators were insufficient and not tracked. " Appropriate KPIs will be identified by Sourcing and contract stakeholder. KPIs will go through clinical review for insufficiency. Sourcing will incorporate KPIs into purchase orders until an amendment or new agreement is executed, if applicable. Scorecard will be developed by Sourcing and implemented for tracking KPIs. Contract stakeholder will track and collect supporting documentation." National Children's Hospital Laboratory Services Contract used for laboratory service agreement for targeted B-ALL Fusion Analysis in pediatric patients. Documentation revealed the performance indicators were insufficient. " Appropriate KPIs will be identified by Sourcing and contract stakeholder. KPIs will go through clinical review for insufficiency. Sourcing will incorporate KPIs into purchase orders until an amendment or new agreement is executed, if applicable. Scorecard will be developed by Sourcing and implemented for tracking KPIs. Contract stakeholder will track and collect supporting documentation." Viracor-IBT / Eurofins Clinical Diagnostic used for clinical laboratory services revealed the performance indicators were insufficient. " Appropriate KPIs will be identified by Sourcing and contract stakeholder. KPIs will go through clinical review for insufficiency. Sourcing will incorporate KPIs into purchase orders until an amendment or new agreement is executed, if applicable. Scorecard will be developed by Sourcing and implemented for tracking KPIs. Contract stakeholder will track and collect supporting documentation." Castle Bioscience-Molecular Genetics Test used for Molecular Genetic Testing Services revealed the performance indicators were insufficient. " Appropriate KPIs will be identified by Sourcing and contract stakeholder. KPIs will go through clinical review for insufficiency. Sourcing will incorporate KPIs into purchase orders until an amendment or new agreement is executed, if applicable. Scorecard will be developed by Sourcing and implemented for tracking KPIs. Contract stakeholder will track and collect supporting documentation." Carefusion -support and maintenance agreement for Pyxis Equipment revealed the performance indicators were insufficient. " Appropriate KPIs will be identified by Sourcing and contract stakeholder. KPIs will go through clinical review for insufficiency. Sourcing will incorporate KPIs into purchase orders until an amendment or new agreement is executed, if applicable. Scorecard will be developed by Sourcing and implemented for tracking KPIs. Contract stakeholder will track and collect supporting documentation." |
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| VIOLATION: OFF-CAMPUS EMERGENCY POLICIES AND PROCEDURES | Tag No: A0094 | |
| Based on observation, review of documentation and interview, it was determined that the hospital failed to ensure that there were emergency supplies (crash carts) in 14 of 14 off campus outpatient locations available for emergency medical situations involving staff, patients and visitors at these hospital outpatient locations. Findings were: The hospital failed to ensure that there were emergency supplies (crash carts) in 14 of 14 off campus outpatient locations available for emergency medical situations involving staff, patients and visitors at hospital off campus outpatient locations. During onsite observations at off campus hospital outpatient locations (which are departments of the hospital) on the week of 8/12/2019 to 8/16/2019 and 8/19/2019 to 8/22/2019, as well as interviews with senior hospital outpatient administrative staff, it was determined that there were off campus outpatient locations with no crash cart. In an interview on 8/14/2019 with staff member#26, the survey team was told that the hospital outpatient sites were "911 facilities" and although there were AEDs (automatic external defibrillator) at these sites there were not crash carts or code blue teams at all these locations. In the event of an emergency, 911 would be called. Staff member #26 commented that it was a JCAHO (Joint Commission on Accreditation for Healthcare Organizations) recommendation not to have crash carts at the outpatient site locations. In an interview on the morning of 8/19/2019 with senior hospital outpatient administrative staff members #1, #26, #261 (and #285, #286 who attended telephonically) the survey team was informed that the only outpatient location that has a crash cart onsite is the MD Anderson West Houston location at Katy Freeway, Houston, Texas, . Review of document provided to survey team stated: "Response to Request for removal of Crash Carts from HALs (Houston Area Locations)" stated: "Unable to location any other documentation notating recommendation from Joint Commission to remove Crash Carts from HALs other than what was provided in the CPR sub-committee meeting minutes." Review of hospital document provided to team listing hospital outpatient locations included: 1.) MD Anderson Holly Hall Blood Donor Center located at 2555 Holly Hall Street, Houston, Texas, , (approximately 2 miles from the main hospital location). 2.) MD Anderson Diagnostic Imaging - Bellaire located at: 6602 Mapleridge, Houston, Texas, , (approximately 4.9 miles from main hospital location). 3.) MD Anderson Diagnostic Imaging - West Houston located at: Katy Freeway, Suite 100, Houston, Texas, , (approximately 23 miles from the main hospital location). 4.) MD Anderson Diagnostic Imaging- West Houston located at Katy Fwy, Suite 100, Houston, Texas (approximately 19.7 miles from the main hospital location). Note: onsite survey team visit found this location had a crash cart. 5.) MD Anderson League City site located at: 2280 Gulf Freeway South, League City, Tx, , (approximately 19.7 miles from the main hospital location). 6.) MD Anderson Memorial City located at: 925 Gessner Road, Medical Plaza 4, Houston, Texas, , (approximately 15 miles from the main hospital location). 7.) MD Anderson Sugar Land site located at: 1327 Lake Pointe Parkway, Sugar Land, Tx, , (approximately 17.3 miles from the main hospital location). 8.) MD Anderson The Center for Advanced Biomedical Imaging located at 1881 East Road, Houston, Texas, , (approximately 2 miles from main hospital). 9.) MD Anderson The Woodlands MAC I site located at St. Luke's Way, The Woodlands, Texas, , (approximately 37.7 miles from the main hospital location). 10.) MD Anderson The Woodlands MAC III site located at St. Luke's Way, The Woodlands, Texas, , (approximately 37.7 miles from the main hospital location). 11.) MD Anderson Woman's Hospital located at 1700 Fannin, Houston, TX, , (approximately 1 mile from the main hospital location). Note: this location is for consultation only and physician practice. 12.) Mohs and Dermasurgery Center located at 6655 Travis, Houston, Texas, , (approximately 1 mile from the main hospital location). Note: onsite survey team visit found this location had a crash cart. 13.) Radiology Outpatient Clinic located at 1700 Holcombe Blvd, Houston, Texas, , (approximately 0.2 miles from the main hospital location). 14.) The Proton Therapy Center located at 1840 Old Spanish Trail, Houston, Texas, , (approximately 1 mile from the main hospital location). Note: onsite survey team found this location had a crash cart. On the late morning of 8/16/2019 staff member #26 provided the survey team with a document listing the date and location of 911 calls to hospital outpatient sites in response to an emergency medical situation. This document listed that the League City location had contacted EMS on 2/20/2019, 4/17/2019, 5/31/2019, 6/6/2019, and 7/1/2019. The Sugarland location had contacted EMS on 4/15/2019 and 8/9/201. The West Houston location had contacted EMS on 5/1/2019 and 7/29/2019. The Woodlands location had contacted EMS on 4/3/2019, 5/15/2019, 7/16/2019. Twelve (12) activations for medical 911 emergencies. Review of hospital policy CLN0506, entitled: "Cardiopulmonary Resuscitation (CPR) Services & Emergency Medical Response (Code Blue) Policy" stated under the purpose section: "This policy outlines the processes for the provision of cardiopulmonary resuscitation (CPR) services and emergency medical response at The University of Texas MD Anderson Cancer Center (MD Anderson)." The policy statement stated: "It is the policy of MD Anderson to provide emergency medical care to patients, visitors and other workforce members as appropriate." The scope section of the policy stated: "Compliance with this policy is the responsibility of all faculty, trainees/students, and other members of MD Anderson's workforce." The definitions section of the policy stated: "Code Blue Team: Staff who immediately respond when a Code Blue is called and provide advanced cardiopulmonary life support." Also listed under the definitions section was: "Houston Area Locations (HALS): MD Anderson facilities in the community that provide outpatients services to MD Anderson patients." (Note these "HAL" locations are the outpatient locations referred to above). The general procedure portion stated: "1.2 The Code Blue Team should be activated by any workforce member for medical emergencies, including cardiopulmonary arrest, that involves an individual (including a patient, visitor, volunteer, or workforce member) experiencing any of the following conditions: A. Unresponsiveness, B. Not breathing, C. No pulse, D. Is in apparent physical distress, E. Requests help for difficulty breathing." "1.3 For applicable medical emergencies that occur on the Main Campus (including the immediate grounds of these locations), activate the Code Blue Team by calling 713-792-7099 (see MD Anderson Code Blue Map)." "1.4 For medical emergencies in all other locations, including MOHS Clinic, parking garages, Proton Therapy Center, Radiation Oncology Center (ROC), South Campus Research Buildings 1MC, the Zayed Building, and Holly Hall Blood Center, call 911." In the 4.0 Code Blue Responsibilities section: "4.2 As expansion occurs in the Houston Area Locations (HALS), there may be an indication for internal Code Blue Teams. Determination of need will occur on the type of services being offered at that location and should be reviewed and approved by the CPR Subcommittee of the Medical Staff." Review of hospital document: "CPR Subcommittee April 18, 2019" meeting minutes revealed comments concerning "Code Blue Operations Update." These comments included: "The HALS emergency plan comes through Code Blue Ops and CPR Subcommittee. Issue is how to manage medical emergencies, 911 response area, until EMS arrives or anesthesia for procedures." The follow up column listed a N/A. Review of document entitled: "Houston Area Location League City Emergency Response" stated: "The first responder should delegate additional respondents to call 911." Review of document entitled: "The Woodlands HAL Departmental Emergency Operations Plan" for "MAC 1" and "MAC 3" (dated 12/20/2018) stated on page 23: Medical Emergencies." "Call Code Blue Team for all clinical locations at the Main Campus and Mays Clinic." "Call 9-1-1 for all other locations." Review of document entitled: "West Houston HAL Departmental Emergency Operations Plan" for Katy Freeway, Houston, TX, , stated on page 24: Medical Emergencies." "Call Code Blue Team for all clinical locations at the Main Campus and Mays Clinic." "Call 9-1-1 for all other locations." Review of document entitled: "MD Anderson Cancer Center Sugar Land Departmental Emergency Operations Plan 2019" for 1327 Lake Pointe Parkway Sugar Land, TX, Suite 100, Suite 200, Suite 201, Suite 400", stated on page 22: Medical Emergencies." "Call Code Blue Team for all clinical locations at the Main Campus and Mays Clinic." "Call 9-1-1 for all other locations." Review of document entitled: "MD Anderson League City Departmental Emergency Operations Plan 2019" for 2280 Gulf Freeway League City, Texas, " stated on page 23: Medical Emergencies." "Call Code Blue Team for all clinical locations at the Main Campus and Mays Clinic." "Call 9-1-1 for all other locations." The hospital could provide no documented evidence, that the Medical Staff had assessed the need, at each off campus outpatient service location, for an emergency response protocol, other than dialing 9-1-1. The Medical Staff had not assessed staff training or supplies that might be required to maintain a patient in an emergency situation, until Emergency Medical Staff could arrive and take over the care of the patient. |
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| VIOLATION: GOVERNING BODY | Tag No: A0043 | |
| Based on review of documents and interviews, this hospital failed to ensure that it has an effective Governing Body to oversee the total operation of the hospital. This hospital is a State government entity that falls under the University of Texas System, as such subject to the Texas Education Code (TEC). This hospital is focused on research of causes, treatments, and prevention of cancer, as well as a degree granting institution of the University of Texas System. Findings: Review of the TEC, Chapter 65, Section 65.11 shows that, "The government of the university system is vested in a board of nine regents appointed by the governor with the advice and consent of the senate. The board may provide for the administration, organization, and names of the institutions and entities in The University of Texas System in such a way as will achieve the maximum operating efficiency of such institutions and entities, provided, however, that no institution or entity of The University of Texas System not authorized by specific legislative act to offer a four-year undergraduate program as of the effective date of this Act shall offer any such four-year undergraduate program without prior recommendation and approval by a two-thirds vote of the Texas Higher Education Coordinating Board and a specific act of the Legislature." Section Sec. 65.31, shows that, "(a)The board is authorized and directed to govern, operate, support, and maintain each of the component institutions that are now or may hereafter be included in a part of The University of Texas System...(g)The board by rule may delegate a power or duty of the board to a committee, officer, employee, or other agent of the board." Section 73.103 shows that, "The board of regents shall appoint a president of the institution..." Section 52.352 shows that, "(d) In addition to powers and duties specifically granted by this code or other law, each governing board shall: ...(3) appoint the president or other chief executive officer of each institution under the boards control and management and evaluate the chief executive officer of each component institution and assist the officer in the achievement of performance goals..." Review of the "Governing Body Charter for The University of Texas MD Anderson Cancer Center" dated June 18, 2019, showed that it was approved by the President of the hospital and not by the Board of Regents. The Charter showed that "In accordance with Texas education code and consistent with the authority of the Board of Regents, the President of The University of Texas MD Anderson Cancer Center serves as the Governing Body of the Hospital..." There was no Board of Regents signatory in the Charter to indicate the appointment of the President as the Governing Body for the hospital. There was no Board of Regents meeting minutes to show such appointment. Further, review of documents presented for review during the survey failed to show clear indication that the Governing Body was discharging its oversight responsibilities on the total operation of the hospital in that the meeting minutes since June 20, 2019, showed commingling of functions of the Executive Leadership Team and the Governing Body. The June 20, 2019 meeting was called to order by the Chief Medical Officer. The minutes showed approval of revisions to the Medical Staff Bylaws, Fair Hearing Manual, Organizational Manual, Rules and Regulation, and policy changes. The President was not present during the meeting. Interview with the President, Chief Operating Officer, and Chief Medical Executive confirmed the above findings. Based on record review and interview, the Governing Body failed to effectively discharge its oversight responsibilities in the total operation of the hospital. Findings: 1. Failed to ensure that medical staff privileges are only granted by the Governing Body. Cross refer to Tag A0046 2. Failed to ensure that Medical Staff are accountable to the Governing Body for the quality of care provided to patients. Cross refer to Tag A0049 3. Failed to ensure the quality of services provided under contract and services provided allows the hospital to meet all applicable Conditions of Participation. Cross refer to Tag A0084. 4. A. ensure patient's safety before, during, and after receiving Ketamine (a Schedule III controlled substance approved by the FDA as an anesthetic agent) Infusions in the Pain Management Outpatient Clinic located on the 4th floor at 1515 Holcombe Boulevard in 4 (Patient #250, #251, #252, and #262) of 5 patient records reviewed. B. ensure that a policy was in place that was approved by the Medical Staff for outpatient Ketamine infusions in the outpatient setting. C. ensure patients were monitored and assessed by a Registered Nurse (RN) before, during, and after receiving Ketamine Infusions in the outpatient clinic. D. ensure the RN's were educated and trained to monitor patients who received Ketamine infusions. E. ensure the RN's were competent and trained in administering and monitoring patients that received conscious sedation. F. ensure patients were monitored and assessed by a RN before, during, and after receiving conscious sedation. G. ensure hemodialysis machines in use for hemodialysis treatment of patients were calibrated as to the dialysate concentrate prescribed by the physician in 1 of 1 observation. Hemodialysis machine #5. H. administer enteral feeding and post feed flushes as prescribed by patient's physician. Patient #36. I. implement patient's physician's orders for pulmonary function test, VRE culture, and daily weight . Patient #212. J. ensure acid and bicarb (bicarbonate) wands were secured to the acid and bicarb jugs during dialysis. Also, 1 of 1 peritoneal dialysis patients did not have daily weights recorded as ordered by the physician. K. protect 1 of 1 patients and follow their own policy to contain and decontaminate a chemotherapy spill. Cross Refer to Tag A0144 L. ensure 7 of 20 patient visits reviewed revealed evidence of documentation of explanation of patient's rights. Cross Refer to Tag A0117 M. obtain adequate informed consent for anesthesia services provided during proton therapy (a type of radiation therapy) as only one anesthesia consent form was signed when proton therapy was initiated and anesthesia services were provided with a series of proton therapy treatments in 2 of 2 proton therapy patient records reviewed. Cross Refer to Tag A0131 N. provide privacy to its patients by monitoring patients in their surgical suites without fully disclosed consent, displaying electronic monitoring of surgical areas on monitors in the anesthesia work room in POD A and POD B of the surgical area. Cross Refer to Tag A0143 O. ensure patient confidentiality. The facility failed to follow their own policies regarding safeguarding patient health information and controlling visibility of patient information on computer screens. Cross Refer to Tag A0146 P. ensure restraints were implemented in accordance with safe and appropriate techniques as determined by hospital policy for 6 of 6 (#265, 266, 267, 269, 270, and 206) patients reviewed. Cross Refer to Tag A0167 5. Failed to ensure that this hospital develop and maintain an effective and ongoing quality assessment and performance improvement (QAPI)program in 8 of 13 departments that were reviewed (Contracted services, Nursing, Dialysis, Lab, Surgical services, Nursing, Infection control and Outpatient services). Cross refer to Tags A0283 and A0286 6. Failed to: A. provide patient care and treatment per facility policy, per physician orders, and/or notify physician of changes of condition for 29 patients of 29 patients reviewed (Patients # 18, 67, 171, 172, 177, 218, 225, 228, 230, 231, 233, 285, 286, 288, 290, 291, 293, 311, 312, 316, 317, 318, 319, 322, 323, 324, 325, 326, and 327). Cross Refer to Tag A0392 B. evaluate 1 (#307) of 1 patient's care needs and patient's health status by unnecessarily withholding clear liquids for six hours while waiting for a computed tomography (CT) scan. Per hospital protocol, the patient could have consumed a clear liquid diet for six of the nine hours the patient waited for completion of scan. This hospital failure placed the patient at risk for dehydration. Cross Refer to Tag A0395 C. ensure that nursing care plans include interventions regarding all patient diagnoses. Twenty four (24) (#13, #14, #17, #18, #20, #21, #24, #29, #45, #69, #70, #71, #76, #79, #109, #110, #111, #112, #225, #289, #313, #314, #315, and #326) of 44 medical records reviewed had incomplete plans of care. Cross Refer to Tag A0396 D. 1. administer medication as prescribed by the patient's physician in 1 of 7 sampled patients. (Patient #48) 2. follow the facility's policy for documentation of treatment and interventions in 6 ( #271, #39, #276, #277, #278, and #279) of 7 patients reviewed. Cross Refer to Tag A0405 7. Failed to: A) 1) ensure 5 out of 5 contracted transportation couriers (Staff #304, #305, #367, #368, and #369) were transporting hazardous drugs (chemotherapy medications) in a safe manner. Courier staff were not trained on how to contain and clean a chemotherapy spill and did not possess the proper equipment for containing and cleaning of a chemotherapy spill during transport. 2) ensure safe disposal of medications. Drugs were being disposed of in sharps containers (plastic containers used for the disposal of used needles and glass) at two of the outpatient facilities (West Houston and Katy locations). Cross Refer to Tag A0491 B) develop accountability procedures to ensure controlled medications, such as narcotics, that were dispensed as a continuous intravenous (IV) infusion (medication delivered into a vein at a constant rate) were not diverted by unauthorized persons. Cross Refer to Tag A0494 8. Failed to provide dietary services in a sanitary manner to prevent the cross contamination of food products: A. The two portable freezer units and a multi-use food truck were located on the facility's loading dock adjacent to where construction debris and the facility's unsealed, contaminated linens were being off loaded and on loaded. The freezer unit's inside doors, floors, ceilings, and walls were noted with dark debris. B. Multiple kitchen equipment and counters were soiled with old dried food debris. C. Multiple staff were observed in the kitchen and handling food trays without the use of hair restraints. Cross refer to Tags A0618 and A0724 9. provide a sanitary environment to avoid sources and transmission of infectious and communicable diseases. The facility failed to: A.) Ensure that clean linens were not contaminated by soiled linens, soiled equipment, and/or soiled staff uniforms. B.) Ensure that sterile surgical linens were handled and stored appropriately to prevent contamination by dust, soiled linens, soiled equipment, and/or soiled staff uniforms. C.) Ensure that durable medical equipment, which was removed from isolation rooms, was sanitized using the appropriate disinfectant for the organism being isolated and stored under appropriately clean conditions after disinfection. D.) Ensure that nursing staff were educated in and used the appropriate disinfectant for the organism being isolated when disinfecting equipment coming out of patient isolation rooms. E.) Ensure that patient transportation staff cleaned and disinfected wheelchairs and stretchers between patient use, as well as stored said equipment under appropriately clean conditions. F.) Ensure Environmental Services/Housekeeping maintained isolation precautions to prevent cross contamination while conducting housekeeping services. G.) Ensure policies were developed and implemented for the proper use of the Trophon High Level Disinfectant System for ultrasound probes. H.) Ensure staff were utilizing the required protective equipment when entering isolation rooms. The facility also failed to include the protective equipment required for isolation in the facility policy. I.) Ensure staff wash/sanitize hands between touching contaminated items and performing central venous catheter and vascular access care during initiation and termination of hemodialysis treatment on 2 of 2 patients observed. Patients #49 and 36. J.) Know the Hepatitis B antibody status or administer the immunization for 5 of 10 non-immune surgical staff health records reviewed. (Staff #267, #272, #288, #289, and #291). The facility failed to follow the CDC guidelines and the facility policy on Hepatitis B monitoring and follow-up guidance. K.) To maintain a sanitary environment in 10 of 10 departments throughout the facility system. (Pain Management Clinic at 1515 Holcombe Blvd, MOHS and Dermasurgery Center, Main Campus Pharmacy, La Maistre Building, Mays Clinic Building, Main Campus, League City, West Houston, Sugar Land, and Diagnostic Imaging.) Cross Refer to Tag A0749 10. Failed to: A. ensure sterile surgical linen packs that contained surgical gowns, drapes, and towels were sterilized according to manufacturer recommendations. B. ensure sterile surgical linen packs that contained surgical gowns, drapes, and towels were transported in a manner that would protect the sterile items from moisture, excessive humidity, and condensation caused by temperature extremes. C. ensure there was a process in place to monitor the sterilization and transport of sterile linen packs from an outside contracted vendor to the surgery department. D. ensure that surgical instruments were transported to an offsite surgery center in a manner that would protect the sterile instruments from moisture, excessive humidity, and condensation caused by temperature extremes. E. ensure that an instrument loaner set that contained surgical implants (Zimmer/Biomet Plates) was sterilized according to the manufacturer recommendations. Cross refer to Tag 0940 11. Failed to ensure that outpatient services were provided in a safe manner as multiple issues were found during the onsite survey. Cross refer to Tags A1076 |
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| VIOLATION: PATIENT RIGHTS | Tag No: A0115 | |
| Based upon observation, record review, and interview, the facility failed to A. ensure patient's safety before, during, and after receiving Ketamine (a Schedule III controlled substance approved by the FDA as an anesthetic agent) Infusions in the Pain Management Outpatient Clinic located on the 4th floor at 1515 Holcombe Boulevard in 4 (Patient #250, #251, #252, and #262) of 5 patient records reviewed. B. ensure that a policy was in place that was approved by the Medical Staff for outpatient Ketamine infusions in the outpatient setting. C. ensure patients were monitored and assessed by a Registered Nurse (RN) before, during, and after receiving Ketamine Infusions inthe outpatient clinic. D. ensure the RN's were educated and trained to monitor patients who received Ketamine infusions. E. ensure the RN's were competent and trained in administering and monitoring patients that received conscious sedation. F. ensure patients were monitored and assessed by a RN before, during, and after receiving conscious sedation. It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety, and placed all patients at risk for the likelihood of harm, serious injury, impairment, and /or subsequent death. G. ensure hemodialysis machines in use for hemodialysis treatment of patients were calibrated as to the dialysate concentrate prescribed by the physician in 1 of 1 observation. Hemodialysis machine #5. H. administer enteral feeding and post feed flushes as prescribed by patient's physician. Patient #36. I. implement patient's physician's orders for pulmonary function test, VRE culture, and daily weight . Patient #212. J. ensure acid and bicarb (bicarbonate) wands were secured to the acid and bicarb jugs during dialysis. Also, 1 of 1 peritoneal dialysis patients did not have daily weights recorded as ordered by the physician. K. protect 1 of 1 patients and follow their own policy to contain and decontaminate a chemotherapy spill. Cross Refer to Tag A0144 L. ensure 7 of 20 patient visits reviewed revealed evidence of documentation of explanation of patient's rights. Cross Refer to Tag A0117 M. obtain adequate informed consent for anesthesia services provided during proton therapy (a type of radiation therapy) as only one anesthesia consent form was signed when proton therapy was initiated and anesthesia services were provided with a series of proton therapy treatments in 2 of 2 proton therapy patient records reviewed. Cross Refer to Tag A0131 N. provide privacy to its patients by monitoring patients in their surgical suites without fully disclosed consent, displaying electronic monitoring of surgical areas on monitors in the anesthesia work room in POD A and POD B of the surgical area. Cross Refer to Tag A0143 O. ensure patient confidentiality. The facility failed to follow their own policies regarding safeguarding patient health information and controlling visibility of patient information on computer screens. Cross Refer to Tag A0146 P. ensure restraints were implemented in accordance with safe and appropriate techniques as determined by hospital policy for 6 of 6 (#265, 266, 267, 269, 270, and 206) patients reviewed. Cross Refer to Tag A0167 |
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| VIOLATION: PATIENT RIGHTS: NOTICE OF RIGHTS | Tag No: A0117 | |
| Based on review of medical records and interview, it was determined that there was not always documented evidence of the teaching of patient's rights being provided to every patient with each visit. 7 of 20 patient visits (Patients # 148 thru 153 and patient # 162) reviewed revealed no evidence of documentation of explanation of patient's rights. Findings: Patient Education document entitled "Patient Rights and Responsibilities" stated in part "At the University of Texas MD Anderson Cancer Center, we respect you as an individual with unique health care needs. We want you to know about your rights as a patient, as well as what your responsibilities are to yourself, your health care team and to other patients." Review of medical records during the week of 8/12/19 revealed 7 of 20 records (Patients # 148 thru 153 and patient # 162) lacked documented evidence that patient rights had been discussed with patients during each admission. These findings were confirmed by Representative for Patient Advocacy on 8/16/19. Further on 8/15/19, the Manager of Business Services from the West Houston location admitted that 3 staff members there had not been trained to document teaching of patient rights at each admission. |
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| VIOLATION: PATIENT RIGHTS: INFORMED CONSENT | Tag No: A0131 | |
| **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on review of documentation and interviews with facility staff, the facility failed to obtain adequate informed consent for anesthesia services provided during proton therapy (a type of radiation therapy) as only one anesthesia consent form was signed when proton therapy was initiated and anesthesia services were provided with a series of proton therapy treatments in 2 of 2 proton therapy patient records reviewed. The anesthesia services were provided by different anesthesia providers from the provider who obtained informed consent in 2 of 2 proton therapy patient records reviewed. The anesthesia consent form did not specify that the consent was for any other dates of service other than the date the consent was executed. This resulted in a potential lack of informed consent for anesthesia services as the proton therapy progressed over a period of time. The facility policies did not specify that a single anesthesia consent could be used for multiple episodes of anesthesia services. Findings: The electronic medical record of patient #293 was reviewed on 8/20/19 with the assistance of RN staff #295. The record reflected patient #293 was a 3 year and [AGE] year old boy with high risk neuro[DIAGNOSES REDACTED] who was receiving "consolidative radiation to the primary site of disease, 21.6 Gy in 12 fx...Start 8/12/19 ...The patient's last scheduled treatment is Tuesday, August 27, 2019." The record contained a "Disclosure and Consent Anesthesia and/or Perioperative/Peri-procedure Pain Management (Analgesia)" dated 7/31/19. The form reflected in part "You have the right, as a patient, to be informed about your condition and the recommended anesthesia/analgesia to be used so that you may make the decision whether or not to receive the anesthesia/analgesia after knowing the risks and hazards involved. This disclosure is not meant to scare or alarm you; it is simply an effort to make you better informed so you may give or withhold your consent to the anesthesia/analgesia." "I (we) voluntarily request that anesthesia and/or perioperative pain management care (analgesia) as indicated below be administered to me (the patient). I (we) understand it will be administered by an anesthesia provider and/or the operating practitioner, and such other health care providers as necessary. Perioperative means the period shortly before, during and shortly after the procedure." "I (we) understand that anesthesia/analgesia involves additional risks and hazards but I (we) request the use of anesthetics/analgesia for the relief and protection from pain or anxiety during the planned and additional procedures. I (we) realize the type of anesthesia/analgesic may have to be changed possibly without explanation to me (us)." "I (we) understand that serious, but rare, complications can occur with all anesthetic/analgesic methods. Some of these risks are breathing and heart problems, drug reactions, nerve damage, cardiac arrest, brain damage, paralysis, or death." "I (we) also understand that other complications may occur. Those complications include but are not limited to: GENERAL ANESTHESIA - injury to vocal cords, teeth, lips, eyes; awareness during the procedure; memory dysfunction/memory loss; permanent organ damage; brain damage." The consent form was signed by the patient's mother on 7/31/19 0940 and by anesthesiologist staff #350 on 7/31/19 at 0940. The consent form did not indicate that the patient's authorized representative gave consent for anesthesia services on any other date than 7/31/19. The record reflected that patient #293 received anesthesia services as follows: 7/31/19. Procedure: Initial CT Simulation. Anesthesia Type: General - Spontaneous Breathing. Providers: Anesthesiologist, staff #350, CRNA, staff #305. 8/12/19. Procedure: PTC - Proton TX Intermediate. Anesthesia Type: General - Spontaneous Breathing. Providers: Anesthesiologist, staff #351, CRNA, staff #304. 8/13/19. Procedure: PTC - Proton TX Intermediate. Anesthesia Type: General - Spontaneous Breathing. Providers: Anesthesiologist, staff #348, CRNA, staff #304. 8/14/19. Procedure: PTC - Proton TX Intermediate. Anesthesia Type: General - Spontaneous Breathing. Providers: Anesthesiologist, staff #352, CRNA, staff #304. 8/15/19. Procedure: PTC - Proton TX Intermediate. Anesthesia Type: General - Spontaneous Breathing. Providers: Anesthesiologist, staff #353, CRNA, staff #304. 8/16/19. Procedure: PTC - Proton TX Intermediate. Anesthesia Type: TIVA (Total IV Anesthesia). Providers: Anesthesiologist, staff #349, CRNA, staff #304 . 8/19/19. Procedure: PTC - Proton TX Intermediate. Anesthesia Type: TIVA. Providers: Anesthesiologist, staff #354, CRNA, staff #303. 8/20/19. Procedure: PTC - Proton TX Intermediate. Anesthesia Type: TIVA. Providers: Anesthesiologist, staff #346, CRNA, staff #303. RN, staff #295 was asked if the record of patient #293 contained any other anesthesia consent forms for the period from 7/31/19 to 8/20/19 and after checking, staff #295 stated there were no other anesthesia consent forms other than the one dated 7/31/19. The electronic medical record of patient #294 was reviewed on 8/21/19 with the assistance of RN staff #295. The record reflected patient #294 was a 2 year and [AGE] year old boy diagnosed with [DIAGNOSES REDACTED]"plan for definitive concurrent chemoradiation, L skull base b. neck 1800 cGy, start 7/30/19, last 8/12/19; L skull base neck 2 Proton cGyRBE start 8/13/19. The patient's last scheduled treatment is Friday, September 6, 2019." The "Disclosure and Consent Anesthesia and/or Perioperative/Peri-procedure Pain Management (Analgesia)" form as outlined above was signed by patient #294's father on 7/17/19 1039 and by anesthesiologist, staff #344 on 7/17/19 1038. The consent form did not indicate that the patient's authorized representative gave consent for anesthesia services on any other date than 7/17/19. The record reflected that patient #294 received anesthesia services as follows. 7/17/19. Procedure: Initial CT Simulation. Anesthesia Type: TIVA, General - Spontaneous Breathing. Providers: Anesthesiologist, staff #344, CRNA, staff #306. 7/30/19. Procedure: XRT IMRT TX Delivery Complex. Anesthesia Type: TIVA. Anesthesiologist, staff #345, CRNA, staff # 307. 7/31/19. Procedure: XRT IMRT TX Delivery Complex. Anesthesia Type: TIVA. Anesthesiologist, staff #350, CRNA, staff #305. 8/1/19. Procedure: XRT IMRT TX Delivery Complex. Anesthesia Type: TIVA, General - Spontaneous Breathing. Providers: Anesthesiologist, staff #350, CRNA, staff #308. 8/2/19. Procedure: XRT IMRT TX Delivery Complex. Anesthesia Type: TIVA. Anesthesiologist, staff #346, CRNA, staff #309. 8/5/19. Procedure: XRT IMRT TX Delivery Complex. Anesthesia Type: TIVA. Anesthesiologist, staff #347, CRNA, staff #310. 8/6/19. Procedure: XRT IMRT TX Delivery Complex. Anesthesia Type: TIVA. Anesthesiologist, staff #347, CRNA, staff #310. 8/7/19. Procedure: XRT IMRT TX Delivery Complex. Anesthesia Type: TIVA. Anesthesiologist, staff #347, CRNA, staff #310. 8/8/19. Procedure: XRT IMRT TX Delivery Complex. Anesthesia Type: TIVA. Anesthesiologist, staff #347, CRNA, staff #311. 8/9/19. Procedure: XRT IMRT TX Delivery Complex. Anesthesia Type: TIVA. Anesthesiologist, staff #347, CRNA, staff #309. 8/12/19. Procedure: XRT IMRT TX Delivery Complex. Anesthesia Type: TIVA. Anesthesiologist, staff #345, CRNA, staff #312. 8/13/19. Procedure: PTC - Proton TX Intermediate. Anesthesia Type: General - Spontaneous Breathing. Anesthesiologist, staff #348, CRNA, staff #304. 8/14/19. Procedure: PTC - Proton TX Intermediate. Anesthesia Type: General - Spontaneous Breathing. Anesthesiologist, staff #352, CRNA, staff #312. 8/15/19. Procedure: PTC - Proton TX Intermediate. Anesthesia Type: General - Spontaneous Breathing. Anesthesiologist, staff #353, CRNA, staff #304. 8/16/19. Procedure: PTC - Proton TX Intermediate. Anesthesia Type: TIVA. Anesthesiologist, staff #349, CRNA, staff #304. 8/19/19. Procedure: PTC - Proton TX Intermediate. Anesthesia Type: TIVA. Anesthesiologist, staff #354, CRNA, staff #303. 8/20/19. Procedure: PTC - Proton TX Intermediate. Anesthesia Type: TIVA. Anesthesiologist, staff #346, CRNA, staff #303. RN, staff #295 was asked if the record of patient #294 contained any other anesthesia consent forms for the period from 7/17/19 to 8/20/19 and after checking, staff #295 stated there were no other anesthesia consent forms other than the one dated 7/17/19. The facility policy # CLN0547 titled "Informed Consent Policy" dated 1/18/19 stated in part, "1.0 Patient Consent: Consent Required 1.1 Informed Consent should be obtained by the Attending Physician or Physician Designee for all applicable care, treatment, services, medications, interventions, or procedures, including major and minor surgeries, anesthesia, radiation therapy, chemotherapy, and bioimmunotherapy, before proceeding with such care, treatment, services, medications, interventions, or procedures ... 1.2 The Informed Consent process should include all applicable aspects of the Elements of Informed Consent ... for the duration of the treatment plan and should be documented in accordance with this policy. 1.3 Disclosure of information related to Informed Consent should be provided by appropriate members of the health care team and should involve an opportunity for the patient or Patient Representative to ask questions of the clinician ultimately responsible for the care, treatment, services, medications, interventions, or procedures being consented to (typically, a Physician or a Physician Designee). ...1.6 A separate Informed Consent for intravenous sedation, anesthesia and/or perioperative/peri-procedure pain management should be obtained before proceeding with such services. ...9.0 Multiphasic Intervention, Treatment, or Procedure 9.1 Treatments, interventions, or procedures that are multiphasic, or those that involve several known steps and are performed at subsequent intervals may be included into a single Informed Consent process. 9.2 Documentation in the Informed Consent form and the Physician or Physician's Designee's note should include what has been discussed with the patient or the Patient Representative. 10.0 Re-Consenting 10.1 Following a patient reassessment, the Informed Consent process should be repeated and a new Informed Consent form signed if any of the following circumstances occurs: A. The patient's condition has changed since the Informed Consent was received such that the likely risks, hazards, limitations, side effects, or benefits may have changed significantly ... B. The patient or Patient Representative has additional questions that may substantially affect decisions about the proposed treatment, care, services, intervention, or procedure. C. Any outstanding indications that the patient or Patient Representative does not understand the care, treatment, services, medications, interventions, or procedure for which Informed Consent was previously provided. D. Information regarding new significant risks, hazards, limitations, side effects, or benefits relating to all the applicable treatment, care, services, intervention, or procedure becomes available after the Informed Consent was received. E. Information regarding new alternatives to the applicable care, treatment, services, intervention, or procedure becomes available after Informed Consent was received, which may substantially affect decisions about the proposed treatment, care, services, intervention, or procedure. F. The patient was consented as a Minor and has now reached adulthood ... G. There is an error in the previously signed consent form ... 10.2 Re-consenting may not be required for the following circumstances: A. Treatments with pre-planned, sequential procedures that have been discussed with, and consented by, the patient or Patient Representative during the Informed Consent process for the procedure, and none of the indications listed above in 10.1 have occurred. Refer to Re-Consenting for Treatment or Procedure for examples. B. A change in the person(s) who is identified on the Informed Consent form as the person who will conduct the care, treatment, services, medications, interventions, or procedures, or who will administer any anesthesia. The newly identified provider should have a discussion with the patient or Patient Representative, about the change in the previously identified provider on the Informed Consent form, and document this discussion and the agreement, or lack of agreement, with this change in the patient's medical record." Facility-based policy attachment # ATT1920 titled "Re-consenting for Treatment or Procedure" dated 1/9/15 stated in part, "1.0 Treatments or Procedures Not Requiring Re-consenting Re-consenting may not be required for certain pre-planned repeated treatments or procedures that are discussed with, and consented by, the patient or Patient Representative during the original consenting process. Examples of pre-planned repeated treatments or procedures include, but are not limited to, the following: 1.1 Radiation therapy. 1.2 Chemotherapy administration by either intravenous, intrathecal, intra-arterial or other routes. 1.3 Interventional Radiology procedures. 1.4 Endoscopy procedures that require sequential therapeutic interventions. 1.5 Blood transfusions. 1.6 Sedation/anesthesia administration or perioperative or peri-procedural drug administration for pain management. 1.7 Bone marrow aspiration." In an interview with the Chief Nurse Anesthetist, staff #313 on 8/22/19 at approximately 10:00 am in the 11th floor consultation room, the above findings were reviewed with staff #313. Staff #313 acknowledged that there was a single anesthesia consent for patient #293 and #294 who both had multiple episodes of anesthesia services provided by various anesthesia providers. |
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| VIOLATION: PATIENT RIGHTS: PERSONAL PRIVACY | Tag No: A0143 | |
| Based on observation and interview, it was determined that the facility failed to provide privacy to its patients by monitoring patients in their surgical suites without fully disclosed consent, displaying electronic monitoring of surgical areas on monitors in the anesthesia work room in POD A and POD B of the surgical area. Findings: A tour of the operating rooms on 8/20/2019 revealed cameras and video equipment in each of the operating rooms. During the tour upon entering the anesthesia work room for POD A and POD B, the computer screens were displaying live video of patients and was visible to anyone who had access to the room to view the patients in the operating rooms. Also, during the tour, surveyor entered the anesthesia work room and observed that the door had no locking mechanism, and anyone had access to view the patient in the operating room. During an interview with Staff #366 on 8/19/2019, at 10:41 AM, she was asked what the process for privacy was for the computers that were displaying pictures of the patients in operating rooms. Staff #366 stated, "We are supposed to minimize the screen when we leave." Surveyor stated, "So, if someone unauthorized entered the room like housekeeping or materials management they could click the mouse and pictures would appear." Staff #366 stated, "Yes". A review of the hospital's record titled, "Patient Rights and Responsibilities" revealed no consent about cameras and videos being used for monitoring in the operating room and the patient giving permission. A review of the hospital's record titled, "Informed Consent Policy" revealed no consent about cameras and videos being used for monitoring in the operating rooms and the patient giving permission. A review of the hospital's record titled, "Disclosure and Consent Anesthesia and/or Perioperative/Perioperative -procedure Pain Management (Analgesia)" revealed no consent about cameras and videos being used for monitoring in the operating rooms and the patient giving permission. A review of the hospital's record titled, "Consent to Diagnosis & Treatment" revealed no consent about cameras and videos being used for monitoring in the operating rooms and the patient giving permission. A review of the hospital's record titled, "Disclosure and Consent Medical & Surgical procedures" revealed no consent about cameras and videos being used for monitoring in the operating rooms and the patient giving permission. A review of the hospital's record titled, "Acceptance of financial Responsibility and Assignment of Benefits" revealed no consent about cameras and videos being used for monitoring in the operating rooms and the patient giving permission. An interview with Staff #11 on the afternoon of 8/19/2019 confirmed the above findings. |
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| VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING | Tag No: A0144 | |
| **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, document review, and interview, the facility failed to: A. ensure patient's safety before, during, and after receiving Ketamine (a Schedule III controlled substance approved by the FDA as an anesthetic agent) Infusions in the Pain Management Outpatient Clinic located on the 4th floor at 1515 Holcombe Boulevard in 4 (Patient #250, #251, #252, and #262) of 5 patient records reviewed. B. ensure that a policy was in place that was approved by the Medical Staff for outpatient Ketamine infusions in the outpatient setting. C. ensure patients were monitored and assessed by a Registered Nurse (RN) before, during, and after receiving Ketamine Infusions inthe outpatient clinic. D. ensure the RN's were educated and trained to monitor patients who received Ketamine infusions. E. ensure the RN's were competent and trained in administering and monitoring patients that received conscious sedation. F. ensure patients were monitored and assessed by a RN before, during, and after receiving conscious sedation. It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety, and placed all patients at risk for the likelihood of harm, serious injury, impairment, and /or subsequent death. G. ensure hemodialysis machines in use for hemodialysis treatment of patients were calibrated as to the dialysate concentrate prescribed by the physician in 1 of 1 observation. Hemodialysis machine #5. H. administer enteral feeding and post feed flushes as prescribed by patient's physician. Patient #36. I. implement patient's physician's orders for pulmonary function test, VRE culture, and daily weight . Patient #212. J. ensure acid and bicarb (bicarbonate) wands were secured to the acid and bicarb jugs during dialysis. Also, 1 of 1 peritoneal dialysis patients did not have daily weights recorded as ordered by the physician. K. protect 1 of 1 patients and follow their own policy to contain and decontaminate a chemotherapy spill. Findings: PATIENT #250 Patient #250 was admitted for an outpatient Ketamine Infusion on 7/18/2019. Review of the Physician medication order revealed, "Ketamine 25 mg in 100 ml sodium chloride once over 1 hour." The Ketamine Infusion was started at 2:47 PM and completed at 3:58 PM per documentation by Staff #262. The last vital sign was taken at 4:19 PM. Physician #375's documentation revealed patient received 2 mg Versed IV (a sedative medication used to help patients feel relaxed before a procedure given Intravenous) prior to the start of the infusion. No physician order, documentation of time given, or who administered the medication could be located within the medical record. No pre or post infusion assessment by a Registered Nurse was documented in the medical record. Physician #375's documentation revealed patient's disposition was "Home". There was no documentation of what time the patient left the facility. No further documentation was located throughout the medical record regarding a responsible driver or to whom discharge instructions were given to. PATIENT #251 Patient #251 was admitted for an outpatient Ketamine Infusion on 8/12/2019. Review of the Physician medication order revealed, "Ketamine 50 mg in 100 ml sodium chloride once over 1 hour." The Ketamine Infusion was started at 2:42 PM and completed at 3:42 PM per documentation by Staff #263. The last vital sign taken was at 3:10 PM. This was 32 minutes prior to the completion of the Ketamine infusion. Physician #374's documentation revealed patient received 2 mg of Versed IV prior to the start of the infusion. No physician order, documentation of time given, or who administered the medication could be located within the medical record. No pre or post infusion assessment by a Registered Nurse was documented in the medical record. No documentation of vital signs or monitoring post infusion could be located within the record. There was no documentation of what time the patient left the facility. Physician #374's documentation revealed patient's disposition was "Home". No further documentation could be located throughout the medical record regarding a responsible driver or to whom discharge instructions were given to. Staff #188 confirmed the above findings. PATIENT #252 Patient #252 was admitted for an outpatient Ketamine Infusion on 8/8/2019. Review of the Physician medication order revealed, "Ketamine 50 mg in 100 ml sodium chloride once over 1 hour." The Ketamine Infusion was started at 11:32 AM and completed at 12:45 PM per documentation by Staff #263. The last vital sign taken was at 12:45 PM. A pre infusion-pain score was documented at "8" (a numeric pain scale used to indicate a patient's pain level, 1-10 with 10 being the worse pain.) and no documentation of post infusion assessment was noted in the record. Physician #373 documented Patient #252 " ...was monitored for approximately 30 minutes afterward in the post procedure area. The patient was discharged home as per protocol..." No pre-assessment or post assessment was documented by the Registered Nurse. No documentation of the discharge time or if the patient was accompanied by a responsible adult. A Review of the "AFTER VISIT SUMMARY" revealed, Versed was administered at 11:31 AM. No dose was documented. Further review of the medical record did not reveal an order was written by the provider or who administered the medication. Staff #188 confirmed the above findings. PATIENT #262 Patient #262 was admitted for an outpatient Ketamine Infusion on 8/7/2019. Review of the Physician medication order revealed, "Ketamine 70 mg in 100 ml sodium chloride once over 2 hours." The Ketamine Infusion was started at 11:25 AM and completed at 3:00 PM per documentation by Staff #264. The last vital sign was recorded at 1:00 PM and the infusion was completed at 3:00 PM. Physician #374 documentation revealed, patient received 2 mg of Versed IV prior to the start of infusion. No physician order, documentation of time given, or who administered the medication could be located within the medical record. No documentation of a nursing assessment prior to the start of the infusion was in the medical record. There was a post infusion progress note documented by Staff #264 dated 8/7/2019 at 8:51 AM and read, " ...Procedure completed. Patient re-evaluated by fell ow and/or attending physician and discharged in stable condition ..." This progress note documented by Staff #264 was timed 2 hours and 34 minutes before the start of the infusion. There was no documentation of what time the patient left the facility and if they were released with a responsible adult. Staff #188 and #295 confirmed the above findings. PATIENT #262 (Date of Service 7/24/2019) Patient #262 was admitted for an outpatient Ketamine Infusion on 7/24/2019. Review of the Physician medication order revealed, "Ketamine 50 mg in 100 ml sodium chloride once over 1 hour." The Ketamine Infusion was started at 11:44 AM and completed at 1:20 PM per documentation by Staff #263. Physician #374 documentation revealed patient received 2 mg of Versed IV prior to the start of infusion and an additional 2 doses of 1 mg Versed was given for anxiety. No physician order, documentation of time given, or who administered the medication could be located within the medical record. No documentation of a nursing assessment prior to the start of the infusion was in the medical record. There was a post infusion progress note documented by Staff #263 dated 7/24/2019 at 10:00 AM and read, " ...Procedure completed. Patient re-evaluated by fell ow and/or attending physician and discharged in stable condition ..." The progress note documented by Staff #263 was timed 1 hour and 44 minutes before the start of the infusion. There was no documentation of what time the patient left the facility and if they were released with a responsible adult. Staff #188 and #295 confirmed the above findings. A review of the document titled, "LOW DOSE KETAMINE (INTRAVENOUS) ADMINISTRATION FOR PAIN MANAGEMENT IN THE hospitalized ADULT PATIENT" revealed the policy was written and approved for inpatients only. No further documentation, policy, or protocol was provided for review. A Review of the drug information for Ketamine (Ketalar) on the FDA.com website, Reference ID: 09 revealed the following: " ...Emergence reactions have occurred in approximately 12 percent of patients. The physiological manifestations vary in severity between pleasant dream-like states, vivid imagery, hallucinations, and emergence delirium. In some cases, these states have been accompanied with confusion, delirium, excitement, and irrational behavior. When Ketalar is used on an outpatient basis, the patient should not be released until recovery from anesthesia is completed and then should be accompanied by a responsible adult. Warnings Cardiac function should be continually monitored. Respiratory depression may occur with over dosage or too rapid a rate of administration of Ketalar, in which case supportive ventilation should be employed. Mechanical support of respiration is preferred to administration of analeptics. Risk of Drowsiness The patients should be cautioned that driving an automobile, operating hazardous machinery, or engaging in hazardous activities should not be undertaken for 24 hours or more (depending upon the dosage of Ketalar and consideration of other drugs employed) after anesthesia ..." Ketalar (Ketamine) is a CIII non-barbiturate general anesthetic. A review of Policy # CLN0596 titled, "Sedation/Analgesia for Procedures Policy (Policy Related to Universal Protocol)" revealed the following: " ...2.0 Medication Administration 2.4 RN's assisting in administration of Sedation/Analgesia are responsible for documenting the drug, dose, route, site, time, and effects all medications including oxygen therapy on the institutionally approved Sedation Record. 2.5 All drugs administered for the Sedation/Analgesia shall have dose and time of administration documented in the patient's medical record. 6.0 Patient/Caregiver Teaching & Discharge Planning 6.2 Outpatients must have a responsible adult who will be available to provide transportation arrangements prior to the procedure. Before discharge, the patient and/or the accompanying adult must verbalize an understanding of the above instructions and will verify the he/she has received a written copy of the instructions by signing the appropriate discharge instructions. 7.0 Equipment and Plan of Care 7.1. During the procedure, a minimum of two available licensed Personnel will be required: A. Physician Operator, who must order the sedative medication and Supervise its administration, including additional doses and titration. B. RN Monitor, who has the primary duty to: Continuously monitor the appropriate physiologic variables from the time of the administration of the sedative medication until discharge criteria are met; or until the patient is discharged ..." Further review of this policy did not reveal any specific training or competencies that were required for a Registered Nurse to safely administer and/or monitor a patient receiving conscious sedation. On 8/20/2019 after 1:00 PM, a review of employee files for Staff #263 and #187 was conducted with the Human Resources Department. Staff #263 and #187 did not have documentation of competencies or training to give or monitor patients receiving conscious/moderate sedation in their files. This was verified by the Human Resources Representative. An interview was conducted on 8/16/2019 at 8:50 AM with Staff #187 and Staff #188. Staff #187 was asked which patients received Versed (a medication that helps patients relax or feel sleepy before a medical procedure) prior to procedures. Staff #187 stated, the only patients that receive Versed are the Ketamine infusions and that is based on the patients' needs at the time of their visit. Staff #188 stated, also stated if any of the other pain procedures require Versed they are taken to the Main Operating Room. An interview with Physician #372 was conducted on 8/16/2019 after 9:30 AM. Physician #372 was asked if patients receiving Ketamine infusions were given any type of sedation prior to the start of the infusion. Physician #372 stated, "All Ketamine Infusions are pre-medicated with Versed." An interview was conducted on 8/20/2019 at 9:20 with Staff #263. Staff #263 was asked if any sedation medication was given to patients that were given Ketamine infusions for their chronic or acute pain. Staff #263 stated, "Yes, they usually do get Versed before the infusion starts and the nurse gives it and we stay with the patient. If they have a family member they stay in the room also." Staff #263 was asked if she had education and training on giving and monitoring a patient receiving Conscious Sedation. Staff #263 stated, "No." Staff #263 was asked if the provider stayed in the room during the infusion. Staff #263 stated, they don't always stay in the room but they never leave the clinic. Staff #263 was asked if she knew the maximum dose of Ketamine a patient could receive safely before it became and anesthetic dose. Staff #263 replied, "No but we never give over 50 mg or less than 25 mg." Staff #263 was then asked how long the patient was monitored before they could be released from the clinic. Staff #263 said, "We will monitor them in the post procedure room, next to the nurse's station for about 45 minutes." An interview was conducted on 8/20/2019 at 9:20 AM with Staff #187. Staff #187 was asked if any sedation medication was given to out patients that were receiving Ketamine infusions for their chronic or acute pain. Staff #187 stated, "Yes, they usually get Versed before the infusion starts and the nurse gives it IV push (intravenously pushed through IV tubing) and we stay with the patient. If they have a family member they stay in the room too." Staff #187 was asked if she had any education or training on giving and monitoring a patient receiving Conscious Sedation. Staff #187 stated, "No." Staff #187 was asked if the provider stayed in the room during the infusion. Staff #187 stated, they don't always stay in the room. Staff #187 was asked if she knew the maximum dose of Ketamine a patient could receive safely before it became an anesthetic dose. Staff #187 replied, "No." Staff #187 was then asked how long the patient was monitored before they could be released from the clinic. Staff #187 said, "We will monitor them for 45 minutes after the infusion is completed." An interview was conducted with Physician #320 on 8/20/2019 at 10:05 AM. Physician #320 was asked how the patients were monitored during a ketamine infusion. Physician #320 stated the nurse stays with the patient and monitors the vital signs during the infusion and then they are kept post infusion for 1 hour for monitoring and they are always released with a responsible person. Staff #188 confirmed the above findings. Review of the Operators Manual, Page 44, for 2008 K hemodialysis machine directs staff as follows: "Verify that the concentrate type displayed near the top of the screen correctly matches the prescribed concentrate type, and that the acid bicarbonate or acetate concentrates connected to the machine match the type selected. If an incorrect concentrate type is displayed, the correct concentrate must be entered." On 08/12/2019, at 10:32 a.m., Patient # 36 was observed on the hemodialysis unit in room #1979. The Patient was receiving hemodialysis treatment at a blood flow rate of 300 mls/minute and a dialysate flow rate of 600 mls/minute. The Patient was utilizing a Fresenius 2008K hemodialysis machine #5. Observation of the setting on the hemodialysis machine revealed, the hemodialysis machine was set to mix a dialysate concentrate of 2.5 potassium and 2.5 calcium. Review of the Patient's prescription revealed a Physician's order dated 08/12/2019 for a dialysate concentrate of "2.5 mEq/L potassium and 1.5 mEq/L calcium first 2 hours and calcium 2.00 mEq/L remaining two hours." Review of the setting on the hemodialysis machine revealed the hemodialysis machine was not calibrated to mix the dialysate concentrate of calcium 1.5 mEq/liter. The Surveyor immediately notified hemodialysis Unit Manager #62 that the hemodialysis machine was not calibrated to mix the prescribed dialysate concentrate for the Patient's hemodialysis treatment. The Facility's Hemodialysis Unit Manager said, there were 9 hemodialysis machines in use in the facility and that they were not calibrated to mix dialysate concentrate of calcium 1.5 mEq. Patient #36 On 08/14/2019 at 9:15 a.m. Patient #36 was observed on the hemodialysis unit in room 1979. The Patient had a PEG tube (percutaneous endoscopic gastrostomy) in place with a bag and tubing attached. The bag was empty, and feeding was observed partially in the tubing. The tube was not flushed after administration of the feeding. The Surveyor notified the hemodialysis nurse of her observation of feeding partially in the tubing while the bag is empty. Review on 08/14/2019 of the Patient's clinical record revealed a physician's order dated (8/10/2019 for Novasource Renal (renal dialysis TF low electrolyte content) half can X 4 feeding. Water flush before each feed 60 and water flush after each feeding 120. Review of the patient's clinical record revealed a physician order dated 08/12/2019 for Novasource Renal (renal dialysis TF low electrolyte content) I can X 4 feeding. Water flush before each feed 60 and water flush after each feeding 120. Review of the Patient's clinical record for the following dates revealed no documentation that the Patient's (PEG) was flushed after administration of the Patient's nutritional feed and that the required amount of formula (4 cans daily) was administered to the Patient on the following days: 08/11/2019: Feed administered at 18:00 and discontinued at 22:00. review of the record revealed Post flush water was not administered to the patient. 08/14/2019: Feed administered at 20:00. review of the record revealed Post flush water was not administered to the Patient. Documentation indicated prescribed formula was administered at the following times: 0900, 1800 and 2000. Review of the Patient's clinical record revealed the Patient was administered 3 cans of feed on 08/14/2019 instead of the prescribed 4 cans. 08/15/2019: PEG tube feed administered at 20:30. Review of the record revealed post flush water was not administered to the Patient. Documentation indicated prescribed formula was administered on the following times: 0959, 1635 and 2030. Review of the Patient's clinical record revealed the Patient was administered 3 cans of feed on 08/15/2019 instead of prescribed 4 cans. Review of the Patient's laboratory results dated [DATE] revealed an albumin level of 2.5 L gm/dl (facility's reference range 5.5 -5.2 gm/dl), sodium 133 L MEq/L (facility's reference range 136-145), and Chloride 93 L MEq/L (facility's reference range 98-107). Review of a Registered Dietician's progress notes dated 08/13/2019 revealed the following entry "Severe Protein Calorie Malnutrition." Patient # 212 On 08/20/2019 at 11:07 a.m. Patient #212 was observed in the intensive care unit at room # 723. The Patient was receiving oxygen via a nasal cannula at 2 liters/per minutes. Review on 08/20/2019 of the Patient's clinical record located in the electronic medical record, revealed a physician's order dated 08/06/2019 for PFT (pulmonary function test). Review of the Patient's medical record revealed there was no indication in the record that the test was performed. Review of the Patient's clinical record (chest x-ray result) dated 08/20/2019 revealed the following result: "Impression interval decrease of bilateral lung opacities that may represent pulmonary edema or pneumonia." Interview on 08/20/2019 at 2:30 p.m. with Informatic Clinical Analysis staff who reviewed the record with the Surveyor revealed, "the order is still active". She further stated, she could not find the result that the test was done." Review of the Patient's clinical record revealed a Physician's order dated 08/09/2019 for "VRE culture every Sunday." Review of the Patient's clinical record revealed no indication that the VRE culture was done on Sunday 8/11/2019. Review of the Patient's clinical record revealed physician's orders dated 08/04/2019, 08/08/2019, and 08/10/2019 for daily weight. Review of the Patient's clinical record located in the electronic Medical Record revealed no indication that daily weight was done as ordered by the physician on 08/11/2019, 08/12/2019, 08/13/2019, 08/14/2019, 08/15/2019, and 08/16/2019. During a tour of the inpatient dialysis area on 8/13/2019, at 9:35 AM, observed the acid and bicarb wands not secured to the acid and bicarb jugs during the dialysis treatment. The wands were hanging from the jugs making them susceptible to being knocked out of the jugs and for contaminates to enter the jugs. This could also allow for acid or bicarb spills if the jug was knocked over due to the wands not being secured on the jugs. An interview with Staff #57 on 8/13/2019, at 9:45 AM, confirmed the acid and bicarb wands do not fit securely on any of the acid and bicarb jugs in the dialysis unit. Patient 281 A review of the medical records for peritoneal dialysis patient #281 revealed, daily weights were not completed as ordered. Peritoneal dialysis was ordered on [DATE] to run nightly for 6 exchanges. Daily weights were ordered by the physician on admission 8/16/2019 at 10:46 PM. In review of the medical record for patient #281 weights were documented as follows: 8/16/19 - 67 kg 8/17/19 - 67.9 kg 8/18/19 - 69 kg 9/19/19 - no weight documented 8/20/19 - 69 kg An interview with Staff #57 on 8/22/2019 at 9:30 AM confirmed weights should have been done daily before peritoneal dialysis and there was no weight documented on 8/20/2019. Facility policy entitled "Chemotherapy Spills and Surface Contamination Policy" stated under 'Small Spills (500cc or Less): ... 7.2 Spills on Non-Carpeted Surface with Chemotherapy Spill Kit: If spill is on a non-carpeted surface, locate a Chemotherapy Spill Kit available in the area, locate additional supplies (e.g., soap, water, a 10% bleach solution such as Dispatch, and absorbent material), and follow the steps below: A. Take out contents of the Chemotherapy Spill Kit. Display the sign that warns others about the spill. Don the PPE following the procedure outlined in Section 3.1. B. Contain spill by laying the Chemosorb pads over the spill. The pads will absorb the liquid and transform it into a gel to assist with disposal. C. Caution: Chemosorb gel is extremely slippery when wet. Avoid skin and eye contact, and do not inhale. D. Cuff both yellow biohazard bags and place on the floor adjacent to spill site. E. Detach scoop from scraper and use both to pick up the Chemosorb gel, being careful not to contaminate gloves. Place the gel in one of the waste bags. If there is any broken glass, use the scoop to place it in a sharps container. F. Use absorbent pad, soap, and water to pick up any remaining gel. Place the absorbent pad in the same bag. G. During cleanup, use only one hand to directly clean the spill area and exposed surfaces. H. Use the other hand to touch non-contaminated areas and supplies. I. Using the contaminated hand, wipe the area with soap-dampened absorbent pad using an inward, circular motion, cleaning from least contaminated to the most contaminated areas. Use water-dampened absorbent pad to rinse the area. J. Repeat the process three times. K. Spray a 10% bleach solution (such as Dispatch) on absorbent pad and, using the same inward, circular motion, use it to clean area. Discard contaminated absorbent pad in yellow bag. L. Allow the area to air dry for fifteen minutes. M. Seal the yellow bag, place it inside the second yellow bag, and seal it. N. Place sealed bags in a biohazard receptacle for disposal. O. Following cleanup for all spills, remove PPE following the procedure in Section 3.2. P. Coordinate final cleaning with Environmental Services. 7.3 Spills on Non-Carpeted Surface without Chemotherapy Spill Kit: If Chemotherapy Spill Kits are not available in the immediate area, follow the steps below to clean up the spill: A. Don PPE following procedure outlined in Section 3.1. B. Place blue absorbent pads over the spill area to absorb the bulk of the spill and place the used pads in a biohazard container. C. Dampen absorbent pad with warm water and small amounts of soap. Wipe down the contaminated area starting from the outer area of the spill, then working inward to the center of the spill. The used absorbent pad should be placed into a biohazard container. Used water dampened absorbent pad to rinse the area. D. Repeat this process three times. E. Spray a 10% bleach solution (such as Dispatch) on absorbent pad and wipe the spill area. Discard the contaminated pads in a biohazard container. F. Allow the area to air dry for fifteen minutes. G. Place spill debris in a biohazard receptacle for disposal. H. Follow the clean-up for all spills, remove PPE following the procedure in Section 3.2. I. Coordinate final cleaning with Environmental Services, if required." Patient Grievance dated 6/4/19 stated "On June 2nd, the patient's chemo was hung and started at midnight. Around 0330, the patient woke up wet and called the RN. The patient's clothing and bedding were wet and there was a large spill on the floor along with some blood. The RN cleaned the floor with bath towels, changed the bed linens, and changed the patient. The towels, linens and patient's personal clothing were all thrown in the regular trash. The patient showered. The RN advised his Charge Nurse that the spill was less than 100cc and he cleaned it up. The next night, the patient and the spouse told the assigned RN and the CN that the spill was almost to the door and they were concerned about exposure. They stated that they asked several people about it throughout the day, but nobody addressed it. Additionally, they are concerned that the patient did not receive his full dose (or potentially any of the dose) of chemo." Review of facility self-investigation revealed incorrect attachment of tubing and chemotherapeutic medications at the IV infusion pump which caused the leak. Apparently, the nurse only evaluated the fluid on the floor and not on the patient's linens and clothing so incorrect spillage was calculated. The spill was not cleaned according to policy nor documented in the patient medical record. Further, the remaining chemotherapeutic medication was not returned to the pharmacy for evaluation. Because of the lack of documentation and reporting, Environmental Services did not complete terminal cleaning of the room for 20 hours. In an interview with the Representative for Patient Advocacy on 8/19/19, it was acknowledged that they incorrectly cleaned and reported chemotherapeutic spill that caused staff and patients exposure to toxic materials. |
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| VIOLATION: PATIENT RIGHTS: CONFIDENTIALITY OF RECORDS | Tag No: A0146 | |
| Based on observation and interview, the facility failed to ensure patient confidentiality. Findings: Facility policy entitled: "Patient Privacy: Safeguarding Paper PHI Policy" stated in part, "It is the policy of The University of Texas MD Anderson Cancer (MD Anderson) to comply with state and federal laws governing the protection and confidentiality of PHI." "The Health Insurance Portability and Accountability Act of 1996 (HIPPA) requires that certain protections be applied to PHI, including PHI contained in paper form. It is MD Anderson's policy to comply with HIPPA and other applicable guidance by implementing appropriate safeguards for the use, storage, transport, transmission and disposal of paper PHI." Page 2 of 6 stated: "Paper PHI should not be left unattended on photocopiers, printers, fax machines, or in other common areas (such as conference rooms)." Page 4 of 6 stated: "5.1 In General: Paper PHI should be stored in secure locations (e.g., locked file cabinets or access-controlled rooms or areas)." Tour of patient floor G10NW on 8/14/19 revealed a specimen collection container on a counter accessible to patients and visitors. Next to the collection container was a book where nursing staff wrote the patient name and specimen type. The unsecured patient information was confirmed during the tour on the same day by the Associate Director of the Department of Nursing. Portions of medical records as well as identifying patient information were found unsecured and thus potentially accessible by unauthorized individuals in various outpatient clinics: During a tour on 8/12/19 of the Fifth floor of the Mays Clinic Reconstructive Surgery Unit, room 5.2408 (note: this area had no door and thus there was no way to secure the area from unauthorized individuals who may have chosen to enter), the surveyors found that there were portions of medical records which were unsecured on top of a wooden shelving unit and thus, potentially accessible by unauthorized individuals. When the surveyors entered this area, there were no staff observed to be working in the room. The survey team found a hard copy 2-page discharge summary and a hard copy 3-page pre-operative note for Patient # 37. Also found was a hard copy 2-page operative note for Patient # 184. In addition, the surveyors observed a printed hard copy listing of the clinic schedule for 8/12/2019, which listed 6 patients including the two referenced above. In interviews with the RN Nurse Manager and the RN, Executive Director on the afternoon of 8/12/2019, it was confirmed that portions of medical records were found unsecured. During a tour of the 6th floor Mays building Gynecologic Oncology Center on the afternoon of 8/12/2019, the surveyors found that the door to the "Camellia Room" was not lockable and inside this room in an unlocked wall-mounted cabinet there were what appeared to be daily patient schedules, listing the names of patients who were to be seen on that particular day. These sheets ranged in date from 2016 to 2018. When the surveyors entered this area, there were no staff observed to be working in the room. The surveyors asked the RN Clinical Director to estimate approximately how many of these patient schedule sheets there were. She responded that there were approximately 400 of the daily schedule sheets. During a tour on 8/14/19 of the LaMaistre building 11th floor Bone Marrow Aspiration clinic, the following was found: on the lobby/registration area counter there was black plastic bin found which contained 2 Bone Marrow Aspiration Clinic Patient Arrival Forms. These forms were for patient # 188. This form contained patient medical record numbers that contained a patient name. The form was lying face down in the plastic tray and beside the plastic tray was an 'out to lunch' sign, which prompted patients to place their arrival forms in the bin. When the surveyors initially approached the registration desk area, there was no staff member observed in the area. In an interview in the early afternoon of 8/14/2019 with staff members # 301 and #26, it was confirmed that these forms containing patient information were found unsecured. In the unlocked Specimen room there was an unlocked wall mounted cabinet containing a binder as well as loose sheets which were labeled "Specimen Log In Sheets". There were approximately 200 of these sheets. Each of the sheets contained six separate lines where specimens could be logged-in, as well as a patient name, medical record number, and diagnosis. The area where the patient name was recorded contained a sticker, listing the patient name. During an interview in the early afternoon of 8/14/2019 with the RN Nurse Manager it was confirmed the specimen log book and loose specimen sheets were not secured. During a tour of the LaMaistre building 10th floor, the surveyors turned the door handle to the Audiologists office and it was found to be unlocked; no staff were inside. (note: this office is immediately adjacent to a patient lobby/waiting area). As the surveyors stepped inside the office they observed that one of the large desk mounted computer monitors was on, and a closer examination of the monitor revealed that there was what appeared to be a patient schedule, listing the names of individual patients. Also observed in the office were hard copies of unsecured patient schedule sheets with names of individual patients, and there were also unsecured file folders on the desk for what appeared to be hearing aid orders which again, contained the names of patients. In an interview on the early afternoon of 8/14/2019 with the Nurse Manager, it was confirmed the door to the audiologist office was not locked and that the patient information inside the office, to include the computer screen as well as the hard copies on the desk, were not secured. During a tour on 8/14/19 of the LaMaistre building 10th floor Head and Neck Center workroom, it was observed that there was no door or physical barrier preventing people from entering this area. When the surveyors entered the room, there were no staff present. Inside the room there was an unlocked small filing cabinet and inside this cabinet were portions of 6 patient records to include radiation treatment records. Some of these documents were dated from 2013. In an interview on the early afternoon of 8/14/2019 with the Nurse Manager it was confirmed the patient medical record documents found in the workroom were unsecured. During a tour of building G floor 22 on 8/21/2019, the following observation was made. A tech, identified as Staff #381, was near the nurses station and the surveyor requested to speak with a nurse. Staff #381 exited the area of nurses station and left to locate a nurse. The computer screen was visible and did not time out. The surveyor walked into the nurses station and viewed 48 patients by first and last name, date of admission, room number and physician. Staff #66, the Registered Nurse returned, after a short discussion she left the nurses station. She entering the hallway, then returned and disabled the viewing of the patient list on the computer screen. |
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| VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION | Tag No: A0167 | |
| Based on review of facility policy, review of medical records and interview, the facility failed to ensure restraints were implemented in accordance with safe and appropriate techniques as determined by hospital policy for 6 of 6 (#265, 266, 267, 269, 270, 206) patients reviewed. Findings: Facility policy entitled "Restraint Policy" stated in part, "It is the policy of The University of Texas MD Anderson Cancer Center (MD Anderson) that restraint(s) be used only in appropriate circumstances to ensure the immediate physical safety of all patients, staff, or others. MD Anderson promotes an environment that protects the health and safety of all patients, limits the use of restraint(s) to clinically appropriate situations, and discontinues restraint(s) as soon as appropriate and possible ... A Physician order is required for all Restraints. The type of Restraint(s) is to be the least restrictive intervention that will effectively protect from harm (1) the patient, (2) faculty members, trainees/students, and other members of MD Anderson's workforce, or (3) others ... A. If Non-Violent Restraint(s) is applied, a telephone or written order must be obtained either during the emergency application of the Restraint(s) or immediately (within 30 minutes) after application of Restraint(s). A Physician must evaluate the patient in person within 24 hours of initiating the Restraint(s) and authenticate the telephone order, if applicable. B. If Violent or Self-Destructive Behavior Restraint(s) are applied, a telephone or written order must be obtained either during the emergency application of the Restraint(s) or immediately (within 30 minutes) after the application of the Restraint(s). A Physician must evaluate the patient in person within one hour of initiating the Restraint(s) and authenticate the telephone order, if applicable." Patient # 265 had an order for "Violent/Self-Destructive" restraint at 0450 on 5/24/19. There was no documented evidence of the restraint or Q15 minute checks of the patient. The reason for the restraint was "Imminent danger to others." The order was discontinued at 0654 and a new order was written for "Non-Violent" 2-point restraint. Patient # 266 was put into 2-point "Violent" restraint on 7/5/19 at 1820. The physician did not complete a face to face assessment until 2113. Patient # 267 had an order for "Violent/Self-Destructive" restraint at 0451 on 5/24/19. There was no documented evidence of the restraint or Q15 minute checks of the patient. The reason for the restraint was "Imminent danger to others." The order was discontinued at 0652 and a new order was written for "Non-Violent" 2-point restraint. Patient # 206 was put into 2-point restraint at 7/26/19 at 0012. The order for restraint was not entered until 10:59 am. The order was discontinued at 0457 on 7/27/19. On 8/6/19, this same patient was put into a 2-point "Violent" restraint at 2153. No face to face was completed within one hour by a physician. The patient received emergency medications Haldol and Ativan. There was no nursing documentation to evaluate the effectiveness of the medications. Patient # 269 was transferred from the ED on 5/12/19 at 0511 in restraints. No order for restraint was made until an order for a "Violent" restraint was entered on 5/12/19 at 1332. There were no documented Q15 minute checks for this order. At 1424, there is documentation that bilateral wrist restraints were applied, and a new order was written for "non-violent" restraint. On 7/12/19 at 1940, Patient # 270 received Thorazine 25 mg IVPB for "agitation." There was no documented re-evaluation of the medication's effectiveness. On that same day at 2054, patient was put into bilateral "non-violent/medical" restraint. The nurse's note prior to restraint stated that patient was unable to receive his radiation treatment due to agitation. He also tried to kick and hit his sitter and the nurse. Patient was restrained until 7/13/19 at 1130. This restraint was ordered as a non-violent restraint when it is apparent that the restraint was "Violent." A violent restraint required a one-hour assessment by a physician and should have lasted no longer than 4 hours. The above restraint errors were confirmed by the unit Psychiatrist, the Director of Psychiatry, the Director of Specialty and the Representative for Patient Advocacy during chart review on 8/22/19. |
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| VIOLATION: QAPI | Tag No: A0263 | |
| Based on observation, interview, and record review, the facility failed to develop and maintain an effective and ongoing quality assessment and performance improvement program in 7 of 13 departments that were reviewed (Contracted services, Nursing, Dialysis, Lab, Surgical services, Infection control, and Outpatient services). The facility failed to: A. ensure they identified opportunities for improvement with data that was being collected. The facility failed to ensure contracted services were assessed and quality improvement projects were developed. B. to set performance improvement activities that affected health outcomes, patient safety, and quality of care. The facility failed to provide documentation of performance improvement projects that were implemented as a result of incidents involving harm to patients. The facility failed to provide documentation of performance improvement projects being implemented after incidents involving quality of care on patients. C. to measures it's success and track performance to ensure that improvements were sustained. The facility failed to provide documentation of tracking of performance improvement projects that were implemented as a result of incidents involving harm to patients. D. to ensure Quality improvement projects being escalated to the Quality Council, Executive leadership team and Governing body (local and institutional). Refer to A tag 0283 for additional information. E. ensure the facility's Governing Body and Medical Staff provided clear expectations for safety program on escalation of sentinel events through Quality. They failed to ensure a clear process was established for reporting serious sentinel events, and monitoring restraints and seclusions. Refer to A tag 0286 for additional information. |
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| VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES | Tag No: A0283 | |
| **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, interview, and record review, the facility failed to: A.ensure they identified opportunities for improvement with data that was being collected. The facility failed to ensure contracted services were assessed and quality improvement projects were developed. B. to set performance improvement activities that affected health outcomes, patient safety, and quality of care. The facility failed to provide documentation of performance improvement projects that were implemented as a result of incidents involving harm to patients. The facility failed to provide documentation of performance improvement projects being implemented after incidents involving quality of care on patients. C. to measures it's success and track performance to ensure that improvements were sustained. The facility failed to provide documentation of tracking of performance improvement projects that were implemented as a result of incidents involving harm to patients. D. to ensure Quality improvement projects being escalated to the Quality Council, Executive leadership team and Governing body (local and institutional). This deficient practice was found in 7 of 13 departments that were reviewed (Contracted services, Nursing, Dialysis, Lab, Surgical services, Infection control and Outpatient services). Findings: CONTRACTED SERVICES Review of a list of contracted services revealed there was a total of 249 contracted services. Review of the list revealed some of the following missing information in relation to performance improvements Leica Bond RX service agreement used for auto-staining (lab testing) expired on [DATE] (12 days prior to date of survey). "According to documentation the performance indicators in the contract were insufficient. The corrective action was, Appropriate KPIs (key performance indicators) will be identified by Sourcing and contract stakeholder. KPIs will go through clinical review for insufficiency. Sourcing will incorporate KPIs into purchase orders until an amendment or new agreement is executed, if applicable. Scorecard will be developed by Sourcing and implemented for tracking KPIs. Contract stakeholder will track and collect supporting documentation." Best Care EMS (Emergency Medical service) - Ambulance Transport which was the ambulance service for patient care. According to documentation the metrics for the contract was pending clinical review. Cross Country Staffing which was for temporary nurse staffing and allied services. According to documentation the metrics for the contract was pending clinical review. Abbott f/k/a St Jude Medical/service which was capital equipment service agreement. According to documentation the performance indicators in the contract were insufficient. The corrective action was, "Appropriate KPIs will be identified by Sourcing and contract stakeholder. KPIs will go through clinical review for insufficiency. Sourcing will incorporate KPIs into purchase orders until an amendment or new agreement is executed, if applicable. Scorecard will be developed by Sourcing and implemented for tracking KPIs. Contract stakeholder will track and collect supporting documentation." Belimed OR Single Sterilizer Full Service Agreement revealed the performance indicators were insufficient and not tracked. The corrective action was, "Appropriate KPIs will be identified by Sourcing and contract stakeholder. KPIs will go through clinical review for insufficiency. Sourcing will incorporate KPIs into purchase orders until an amendment or new agreement is executed, if applicable. Scorecard will be developed by Sourcing and implemented for tracking KPIs. Contract stakeholder will track and collect supporting documentation." Gulf Coast Testing was used for blood testing services for infectious disease prior to uploading into the National Marrow Donor Program registry revealed the performance indicators were insufficient and not tracked. " Appropriate KPIs will be identified by Sourcing and contract stakeholder. KPIs will go through clinical review for insufficiency. Sourcing will incorporate KPIs into purchase orders until an amendment or new agreement is executed, if applicable. Scorecard will be developed by Sourcing and implemented for tracking KPIs. Contract stakeholder will track and collect supporting documentation." National Children's Hospital Laboratory Services Contract used for laboratory service agreement for targeted B-ALL Fusion Analysis in pediatric patients. Documentation revealed the performance indicators were insufficient. " Appropriate KPIs will be identified by Sourcing and contract stakeholder. KPIs will go through clinical review for insufficiency. Sourcing will incorporate KPIs into purchase orders until an amendment or new agreement is executed, if applicable. Scorecard will be developed by Sourcing and implemented for tracking KPIs. Contract stakeholder will track and collect supporting documentation." Viracor-IBT / Eurofins Clinical Diagnostic used for clinical laboratory services revealed the performance indicators were insufficient. " Appropriate KPIs will be identified by Sourcing and contract stakeholder. KPIs will go through clinical review for insufficiency. Sourcing will incorporate KPIs into purchase orders until an amendment or new agreement is executed, if applicable. Scorecard will be developed by Sourcing and implemented for tracking KPIs. Contract stakeholder will track and collect supporting documentation." Castle Bioscience-Molecular Genetics Test used for Molecular Genetic Testing Services revealed the performance indicators were insufficient. " Appropriate KPIs will be identified by Sourcing and contract stakeholder. KPIs will go through clinical review for insufficiency. Sourcing will incorporate KPIs into purchase orders until an amendment or new agreement is executed, if applicable. Scorecard will be developed by Sourcing and implemented for tracking KPIs. Contract stakeholder will track and collect supporting documentation." Carefusion -support and maintenance agreement for Pyxis Equipment revealed the performance indicators were insufficient. " Appropriate KPIs will be identified by Sourcing and contract stakeholder. KPIs will go through clinical review for insufficiency. Sourcing will incorporate KPIs into purchase orders until an amendment or new agreement is executed, if applicable. Scorecard will be developed by Sourcing and implemented for tracking KPIs. Contract stakeholder will track and collect supporting documentation." TMC Hospital Laundry Coop Association which was used for Hospital Laundry and Linen Services revealed that the metrics were pending review. During an interview on 08/14/2019, after 8:30 a.m, Staff #'s 121 and 122 said that the servicers were responsible for keeping their own metrics. A dashboard was being created and they are trying to create a committee. They were bringing in a company to help categorize their contacts. Staff #61 said the program was being designed right now for contracted services and it will feed into the main quality dashboard. Staff #'s 61, 121 and 122 confirmed contracted services had not been evaluated, metrics identified or monitored. NURSING During an observation on 08/13/2019, after 1:00 p.m., Quality improvement project boards were observed on G12. The board listed current projects for the unit. During an interview on 08/13/2019, after 1:00 p.m., RN #55 showed the surveyor a list of improvement projects that they were currently working on for the unit. The list was more extensive than the projects listed on the board. RN #55 explained that some of the projects were completed and some were still in process. During an interview on 08/13/2019, after 2:20 p.m., RN #'s 50 and 56, said that some of the project improvements that they were working on were K-card rounding, enhanced recovery, femoral catheters, stem cell, medication purpose/side effects, and sleep experience. A request was made to see a list of the current improvement projects for nursing with the information that was analyzed. RN #50 provided 13 studies that they were working on under the umbrella of nursing. There was no documentation of when some were started and the goals for how long they were going to continue before reevaluation. Review of the Quality Assessment and Improvement Programs for 2019 and 2020 did not outline all of the local and institutional projects. RN #'s 50 and 51 said that some of the metrics that staff had on a local level were not being reported up to Quality and Governing Body. If there was a policy change that affected the entire institution the improvement project would be sent to the Quality council, Executive leadership, and Governing body. SURGERY Review of Patient Safety Committee Minutes dated 05/28/2019 revealed the following: "Patient Death While on Heparin: [AGE] year old female with secondary malignant neoplasm of the brain with a scheduled placement of stereotactic head frame for gamma knife radiosurgery. Patient had an untoward reaction to Bupivacaine and Lidocaine injection into scalp frame pin sites due to overdosages." Underneath action items the following was listed: "Conduct a medication use evaluation of 0.75 % Bupivacaine usage at MDA and determine if it is being used according to FDA approved indications. Post evaluation, determine if P& T Committee intervention is warranted. Provide education to EC, Neurosurgery, and Gamma Knife staff on the s/s of Bupivacaine toxicity and use of intralipids in treatment. Develop a process for areas that use Bupivacaine without anesthesia service support and EC to have access to intralipids for possible Bupivacaine toxicity. Review the ordering tool to evaluate the oral agents used for pain control and present case study to in neurosurgery staff meeting." All were due by 05/17/2019 and follow-up action planning meeting scheduled. Review of the root cause analysis information revealed a new "Surgical Safety Checklist" which was dated 06/27/2019. There was documentation of future changes in order sets for the Bupivacaine starting in August 2019 Review of Quality Assessment and Performance Improvement and Executive Leadership meeting minutes that were provided for the timeframe of June - August 2019 made no mention of the improvement projects that had been implemented in relation to this root cause analysis. During an interview on 08/19/2019, after 8:40 a.m., Physician #79 said that the incident occurred because of an overdose of Bupivacaine. To correct the problem an order set was developed to adjust the medication based on weights. Training was provided to surgeons. The timeout procedure was changed. DIALYSIS Review of Quality Assurance Performance Improvement (QAPI) documentation revealed the following events from May - June 2019: May Safety Intelligence Reports Harm Score 5 (meaning moderate temporary harm) Early termination due to chest pain Harm Score 4 (meaning severe temporary harm) Catheter Malfunction Wrong dose of Zosyn prescribed, patient was on CRRT (continuous renal replacement therapy) medication was prescribed after initiating CRRT, because of that BPA (bisphenol-A) didn't fire) June Safety Intelligence Reports Harm Score 5 Early termination due to hypertension and chest pain Acute change during IHD (in-center hemodialysis)- Muscle cramps and tachycardia Harm Score 4 Catheter access issue -no blood return Delay in transportation Review of quality minutes dated 07/15/2019 revealed that "Nursing Dialysis Metrics - deferred to the next meetings." Review of Patient Safety minutes dated 07/23/2019 revealed there were two root cause analysis in May and two in June 2019. There was no mention of the events from dialysis. Review of quality minutes dated 07/29/2019 revealed the dialysis department gave a presentation, but there was no documentation of the events that were listed for dialysis. Review of the quality minutes agenda dated 08/12/2019 revealed no mention of dialysis. During an interview on 08/16/2019 after 11:12 a.m., RN #63 said, all the evidence for the safety events were in the information provided to the surveyors. RN #63 said they implemented new procedures because of the problems with the catheters. The problem with transportation of the patients had been identified, but the problems with late medications were not addressed. During an interview on 08/20/2019 after 2:00 p.m.., Staff #'s 61, 62 and 64 confirmed that not all quality improvement projects were taken to the Quality council. Review of Patient #48's clinical record revealed a physician's order dated 07/31/2019 for "Midodrine 10 mgs via gastrostomy tube three times daily before meal. Hold if SBP greater than 150 mm/Hg in addition, Monday, Wednesday, and Friday when he receives dialysis. Please give a dose 30 minutes BEFORE dialysis (not additional dose but mid-day dose). Avoid administering after the evening meal, or within 4 hours of bedtime." Review of the Patient's medication administration record and hemodialysis treatment record for the following days revealed, Medication Midodrine 10 mgs was not administered 30 minutes prior to hemodialysis treatment as prescribed: 08/09/2019: Medication Midodrine 10 mgs administered at 8:43 a.m. and hemodialysis treatment initiated at 10:00 a.m. 08/07/2019: Medication Midodrine 10 mgs administered at 8:01 a.m. and hemodialysis treatment initiated at 11:00 a.m. 08/05/2019: Medication Midodrine 10 mgs administered at 9:29 a.m. and hemodialysis treatment initiated at 10:20 a.m. 08/02/2019: Medication Midodrine 10 mgs administered at 9:10 a.m. and hemodialysis treatment initiated at 10:00 a.m. The Surveyor reviewed the Patient's clinical record with the Unit's Manager who confirmed that the medication was not administered as prescribed because at times transportation is late in transferring the Patient to hemodialysis for hemodialysis treatment. Review of the Dialysis Quality Assessment Performance Improvement Meeting Minutes for July 2019 revealed documentation which indicated there was a problem transporting patients to the hemodialysis unit. Interview on 08/19/2019 at 9:35 a.m. with the Facility's Dialysis Nursing Director revealed, she had identified that patients were not transported timely to the hemodialysis unit, but she had not done a root cause analysis or a plan implemented to address the transportation problem with patients. She said, she met with personnel from transportation and spoke with the contract staff manager they would to use the contract nurses to pick up their patients but this was not implemented. LABORATORY Review of the "Division of Pathology and Laboratory Medicine CLIA Laboratory Quality Plan" date 8/9/19 revealed an algorithm for reporting Quality Assessment Performance Improvement (QAPI). All divisions will report to the Quality Executive Council then to Division Head and ultimately Quality Assurance Performance Improvement Council. Review of the Pathology and Laboratory Medicine Quality Council Report for the second quarter of 2019 revealed data was collected. The laboratory had comments on the data sheet concerning actions taken on an issue or goals but there was no defined approach to the continuous study and improvement of the processes of providing healthcare services to meet the needs of patients. Review of the Executive Leadership Team Meeting Minutes for 7/2/19 and 7/9/19 revealed there was no documentation found concerning the Laboratory data, findings, actions, or process improvements. INFECTION CONTROL Review of the Infection Control Quality initiatives revealed an Annual Infection Program Risk Assessment and Analysis. The program assessment and analysis had an Infection Control Risk Assessment Plan attached for 2019. The plan included the following: Hand Hygiene Emergency Mgmt Plan ICU Associated Infection Disinfection/Sterilization/Low level Clean- Patient Care Equipment Clostridium difficile CRBSI/CLABSI Dialysis Environmental Cleaning Respiratory Viruses [DIAGNOSES REDACTED] Antimicrobial Stewardship (AMS) Use of Isolation Precautions Surgical Site Infections Temperature and Humidity (OR and SPD areas) PICU (PICS) Duodenoscopy Re-processing Legionella/Waterborne Fungal Invasive Procedures Outside the OR CAUTI Multi-resistant Organisms Blood Borne pathogens Pharmacy-compounding Food and Nutrition Services IR Pavilion Patient Care Supply Storage Communicable Diseases [DIAGNOSES REDACTED] turberculosis Construction/Renovation An interview was conducted on 8/14/19, at 11:00AM, with Staff #40, #137, and #138. Staff #40 spoke to infection control and the QAPI projects they are looking at. Staff #137 reported they are focusing on[DIAGNOSES REDACTED] and the high rate of infection in CA patients. They had purchased UV lights to use in surgery and in patient's rooms to help eliminate infections. Staff #138 stated, they were not sure where they will fall in reporting to quality at this time. Staff #138 was asked how they are reporting regularly to QAPI and medical staff? Staff #138 stated, they are having meetings and following issues on the infection control committee level and will be taking up the information when it is their time to report. Staff #138 was not sure of the date. Isolation was discussed. Staff #40 reported that the facility has an isolation module for the nurses to follow and environmental care rounding was performed every day. Staff #40 reported that they are focusing on CLABSI/CAUTI and reporting that information monthly to the Infection Control Committee. Staff #40 and #137 stated they would bring documentation of the QAPI for Infection Control. Staff #40, 137, and 138 did not have any evidence to provide the surveyors with at that time. The only information provided to the surveyors after multiple request was a Outcomes Report on "Decreasing CLABSI with Daily CHG Bathing." There was no other information provided. Review of the QAPI Council Meeting minutes for 7/29/19 revealed that Infection Control had not participated or reported to QAPI. Review of the Medical Quality Planning Committee revealed the committee was canceled for June and July. Review of the minutes of the ELT on 7/30/19, 8/1/19, 8/8/19 revealed there was no infection control information discussed or presented to the ELT. Review of the minutes of the Governing Board Executive Leadership Team Meeting Minutes for 7/2/19 and 8/1/19 revealed there was no infection control information discussed or presented. An interview with Staff #61 and #62 was conducted on 8/19/19. Staff #62 reported that the departments would be reporting to QAPI, GB, ELT, and would be put on a schedule on when they will be reporting their information and data. Staff #62 stated that he was working with the teams on how to present. At this time there was no further data, analysis, monitoring or implementation of Infection Control provided. Outpatient Services: The hospital failed to ensure that: 1.) There was documentation of results related to specific quality assurance process improvement initiatives for the endoscopy center. 2.) There was documentation of a performance initiative for the melanoma skin center. 3.) There was corrective action when monthly metrics were not met for West HAL (Houston Area Location). The surveyors were presented with a 4-page document entitled: "Ambulatory Operations + Access Quality Assurance Process Improvement Initiatives (6/18-8/19)." Staff member #1 informed the surveyor that this document was compiled in response to surveyor request for examples of PI initiatives. Review of this document listed 32 separate hospital centers and improvement initiatives for each of the centers. At the bottom of each page was the statement: "Blue = attendee lists, agendas and minutes available". Of the 139 improvement initiatives listed 47 were blue. Specific examples included: 1.) The Endoscopy Center. Among the improvement initiatives for the Endoscopy Center were: Revision of HLD (high level disinfection) process. In interviews with staff member #26 on 8/20/2019 and 8/21/2019, it was confirmed that there was no documentation available for the Revision of HLD process improvement initiative. 2.) Performance initiative for The Melanoma/Skin Center was listed as: "Review and streamlining of instruments." The survey team was presented with an undated document entitled: "Quality Improvement Initiatives". This document contained a section entitled: "Review and streamlining of instruments." The comments for this section stated: "Problem: Providers feedback that the instruments in trays are not appropriate and are not used and have to open individual packs. Also, out dated." "Intervention: Created a team with faculty (derm), MA and AA to go through all trays, visually check, discard, create a new tray, order and bundle new trays for procedures. From 11 instruments down to 7 instruments per tray. Decreased use of individual packs and replacements, saving not only dollars but increased efficient by not running out of room while procedure is ongoing to grab additional or appropriate individual instruments." No documentation was found by or provided to the surveyor regarding the outcome or status of this performance initiative. In an interview with staff members #1 and #26 on 8/20/2019 it was confirmed that there was no documentation available for this performance initiative. 3.) Review of document for West Houston HAL (Houston Area Location) regarding "Nursing Audit Tool: Standardize reporting of monthly metrics." This document stated: "Improve and maintain patient education documentation rates above 95% for new patients and consults." A corresponding document showing monthly percentages achieved for this metric revealed that "Education Documentation: New" the percentages for Apr-19 were: 93%, for May-19: 91%, for Jun-19: 89% and for Jul-19: 92%. When the surveyor asked for documentation as to what the West Houston HAL was doing in regard to not meeting the identified metric of 95% an email was provided by staff member #18 for review. This email which was dated August 20, 2019 from staff #286 stated: For the four months (April '19-July' 19) that were below 95% target, the corrective action plan will be as follows." Among the actions listed was: "1. Identify the instances where the documentation is lacking." The email concluded by stating: "The concentration of these errors was mainly due to a lot of newer staff getting used to the process. Growing pains." No other documentation was found by or provided to the surveyor addressing that the metric was not met for four consecutive months. |
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| VIOLATION: PATIENT SAFETY | Tag No: A0286 | |
| **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on record review and interview, the facility's Governing Body and Medical Staff failed to ensure that clear expectations for safety were established by implementing a clear process of reporting serious sentinel events, and monitoring restraints and seclusions. Review of the Patient Safety Committee Meeting minutes dated 7/23/19 revealed the committee met and discussed 2 Root Cause Analysis (RCA) cases. Harm and potential for harm occurred in the RCA and changes were implemented. The Patient Safety Committee minutes revealed the following: A change was made in the fall policy and procedure. Develop standards of practice guidelines, template, algorithms for CNS [DIAGNOSES REDACTED] patient with ICP and educate staff and explore the ability for One Connect to flag the Glasgow scores for providers who can't see nursing documentation. Plans were discussed in how the committee was going to move forward in identifying events using the present consulting company's model. Three presentations were given on the Sentinel Event with the medication Bupivacaine, Patient Safety Skin presentation, the continuous Quality Assessment and Performance Improvement Program. Review of the Quality Assessment Performance Improvement (QAPI) meeting minutes for 7/29/19 revealed that Staff #79 had not presented any of the RCA information. There was no written evidence the patient safety committee presented the changes made to the policy and procedures, the development of guidelines, templates, algorithms, or staff education to be developed. Review of the QAPI Medical Committee meeting minutes revealed there was no meeting for June, July, and August. Staff #61 confirmed the findings on 8/20/19. Staff #61 stated, "They cancelled their meetings so there would be no minutes." Review of the Executive Committee of Medical Staff (ECMS) meeting minutes on 7/30/19 revealed Patient Safety Report from 5/28/19 was presented and Occupational Health. There was no documentation of the RCAs or the outcomes. Review of the Executive Leadership Team (ELT) meeting minutes on 7/9/19 revealed no minutes for patient safety. The meeting minutes for 7/2/19 revealed patient safety was addressed in generality and discussions were made on the metrics they would be following in the future. There was no discussion noted on Patient Safety Events/RCAs and outcomes to the ELT or Governing Body. On 8/1/19 the Governing Body Executive Leadership Team minutes describe Staff #79 reporting SI events data and two RCAs but no mention of which RCAs reported or outcomes. An interview was conducted with Staff #79 in the morning of 8/19/19. Staff #79 reported about two years ago the facility started daily patient safety meetings Monday - Friday. At 8:00 AM each morning they would discuss what had happened in the last 24 hours. After that meeting they would have a safety team meeting and decide if those incidents could be handled at the Patient Safety Team level or if they needed to be escalated up the chain of command. Staff #79 explained, there was a numbering system to patient safety events from 1-9. 1 being minimal and 9 being death. Staff #79 stated that if the incident received a score higher than 8 then an email would be sent up the leadership chain and a decision would be made if an RCA was needed. All other events would be followed at the level of the Patient Safety Director and committee for analysis. Staff #79 confirmed not all information had been taken to ELT or Governing Body. Review of restraints and seclusions revealed there was only data presented for non-violent: violent or self-destructive behavior restraint Adult. The data had no measure, analysis, tracking or monitoring in place for the data. There was no data for chemical restraints. Staff #79 confirmed that Restraints and Seclusions had not been reported or followed in Patient Safety. |
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| VIOLATION: NURSING SERVICES | Tag No: A0385 | |
| Based upon observation, record review, and interview, the facility nursing staff failed to: A. provide patient care and treatment per facility policy, per physician orders, and/or notify physician of changes of condition for 29 of 29 patients reviewed (Patients # 18, 67, 171, 172, 177, 218, 225, 228, 230, 231, 233, 285, 286, 288, 290, 291, 293, 311, 312, 316, 317, 318, 319, 322, 323, 324, 325, 326, and 327). Cross Refer to Tag A392 B. evaluate 1 (#307) of 1 patient's care needs and patient's health status by unnecessarily withholding clear liquids for six hours while waiting for a computed tomography (CT) scan. Per hospital protocol, the patient could have consumed a clear liquid diet for six of the nine hours the patient waited for completion of scan. This hospital failure placed the patient at risk for dehydration. Cross Refer to Tag A0395 C. ensure that nursing care plans include interventions regarding all patient diagnoses. Twenty four (24) (#13, #14, #17, #18, #20, #21, #24, #29, #45, #69, #70, #71, #76, #79, #109, #110, #111, #112, #225, #289, #313, #314, #315, and #326) of 44 medical records reviewed had incomplete plans of care. Cross Refer to Tag A0396 D. 1. administer medication as prescribed by the patient's physician in 1 of 7 sampled patients. (Patient #48) 2. follow the facility's policy for documentation of treatment and interventions in 6 ( #271, #39, #276, #277, #278, and #279) of 7 patients reviewed. Cross Refer to Tag A0405 |
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| VIOLATION: STAFFING AND DELIVERY OF CARE | Tag No: A0392 | |
| **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on record review and interviews, the hospital failed to have adequate numbers of licensed registered nurses and other personnel to provide care to all patients to meet their needs. Lack of staffing resulted in inability to provide care that was ordered for the patient. Nursing staff failed to provide patient care and treatment per facility policy, per physician orders, and/or notify physician of changes of condition for 29 patients of 29 patients reviewed (Patients # 18, 67, 171, 172, 177, 218, 225, 228, 230, 231, 233, 285, 286, 288, 290, 291, 293, 311, 312, 316, 317, 318, 319, 322, 323, 324, 325, 326, and 327). Findings: Review of incident reports documented the following: 1. Pt. #288 failed to receive "his immunotherapy Ipi/Nivo at the time requested because they are understaffed in the evening." 2. Pt #293 failed to receive "his chemotherapy (chemo) that was due at 10 AM. Pharmacy emphasized that the drug is short-stable and expensive and pharmacy would only prepare the dose close to the time it's due. Pharmacy delivered the drug at 9:55 and notified 2 nurses. At 11:21, the pharmacy received a message saying that the drug was expired. The pharmacy prepared the drug, but it will be later than 30 minutes due to the amount of time it takes to prepare the drug...They will bring the drug around 12:55 due to the limited number of staff the floor has on the weekend during lunch time." 3. Pt #317 failed to receive "the appropriate dose of chemotherapy due to the PCT not documenting a correct weight and overriding the EPIC alert...Not reported to the RN...The RN noticed on the third day that the weight was a discrepancy. The RN reported to the Pharmacy and the physician immediately and the dose was adjusted." 4. Pt.#318 failed to "...receive the amicar drip due to the pump being off. RN that was caring of the patient did not know. (IV pumps are suppose to be checked every two hours during "5 P rounding." (5 P rounding: Potty, Pumps, periphery, position and pain). 5. Pt. #319 "...fell while going to the bathroom. There were three nurses assigned to the Pod and all 3 were involved with a Code in another room. The patient felt weak and lowered herself to the floor and did not sustain an injury." 6. "Nurses were float nurses to the floor. The patient care tech went to the other floor without notifying the nurses. No help answering the call lights...They had a confused patient who was jumping in and out of bed...Nurses were not able to go on break or supper because it was not safe for just one nurse left on the pod. The resource RN was also full load and said she did not have a lunch break either." 7. Pt.#321 "...was cleared for chemo at 1556 but chemo was not started on the day shift...When questioned about why chemo wasn't started the dayshift nurse stated that she wasn't able to do chemo and the charge nurse told her to admit the patient and the night shift could administer the chemo." 8. Pt. #316 "...Pt had chemo due at 2230. A change of assignment occurred at 2230 due to preceptor being sent to ED. Event occurred after preceptor left. Patient assignments were changed in the middle of the shift due to staffing and acuity considerations." (This is just a random sample of the numerous incidents that are all similar to those listed) A confidential interview was conducted with an employee on 8/13/2019, documented ":...the nursing staff feels that they are not adequately staffed. The staff feels that all the nurses feel the same way. Nurses learn how to do short cuts to take care of patients. Most of the time they are staffed at 4:1 but you cannot do a good job of patient care with that ratio. 3:1 patient to nurse ratio is what they are shooting for. This floor is very busy and if you have 'Q1 hour flap checks' on more than one patient you are too busy to make sure that everything is done on time. A few nurses have left he hospital due to staffing. When asked if the Charge Nurse or the Clinical Nurse Leaders take patients or help out, the staff stated that the Charge Nurse sometimes is assigned a patient. The Clinical Nurse Leaders (CNL) will come and try to help if you beg them or if you can find them, but they are not up on their education and keeping up with what is going on and they usually do not know what to do once they come to help you. Staff states that she goes home after her shift and wonders if she missed anything on her patient or if she did everything for her patient that was ordered. The staff states that it is stressful because our patients are so critical and have so much going on that you have to stay on top of things and double check that you have done everything for the patient. She states that the patients are the ones effected by the short staffing. They are not getting the care they deserve." An interview with Personnel #328 on 8/13/2019, the surveyors asked about staffing. Personnel #328 stated that they staff via budget. On the floor, we were on the ratio is 4:1 (4 patients to 1 RN). This was an extremely busy floor and the nurses were busy with patient care. When asked if there was anyway they can get additional nurses to help when they have new surgeries for admit, blood administration, chemo administration, etc.. Personnel #328 stated, they do not consider acuity when staffing. Personnel #328 stated, "it really works out, the only floor that have a different nurse to patient ratio is ICU, Pedi ICU, and the [DIAGNOSES REDACTED] floor. They have a charge nurse, clinical nurse leaders, and the Associate Nurse Director who can lend a hand when they need extra help." The nurses were very busy and rushing around the unit working. It was approximately 2:00 PM and the charge nurse was asking nurses if they had received a lunch break. Personnel #328 stated ..."the nurses go to each other and offer breaks as they have time." On 8/12/2019, Personnel #24 and Personnel #256 were asked to test the defibrillator. After fumbling around for a few minutes and trying to figure out how to do the testing of the defibrillator, Personnel #24 and Personnel #256 pulled out the instructions to the defibrillator and test fired the defibrillator. Personnel #328 stated, "Personnel #24 and Personnel #256 are not the usual personnel that test the defibrillator." The surveyor asked if that is not a skill that all nurses should know how to perform and Personnel #328 stated, "yes." The surveyor asked if the nurses on the floors were not ACLS certified and Personnel #328 stated... "ACLS is not required except in ICU." On 8/14/2019, Personnel #302, Personnel #42, and Personnel #291 were asked to test the defibrillator. The personnel were having trouble test firing the defibrillator. The Personnel fired the defibrillator but got a message on the screen that did not confirm the firing. The Personnel were confused and stated they would call Bio-Med department to come and check the defibrillator. Personnel #328 stated, "...Not sure if that is a warning or if that comes up every time you fire the defibrillator, but they will have it checked out." The surveyor told Personnel #328 that it should be a daily event on their unit and out of 3 Personnel that might have to use the defibrillator at anytime, they are not sure the defibrillator is working properly or not. What would the Personnel do if they were in a code and did not know for sure if the defibrillator was working properly or not. On 8/12/2019, interview with RN #332 revealed "staffing is a rollercoaster", it can be difficult to retain nurses on the unit and registered nurses cannot be hired if there is no opening. Interview with RN#331 was completed on 8/14/2019. The nurse stated concerns with increase in patient falls possibly linked to not enough nurses staffed on unit. Patient #311 was hospitalized [DATE] - 8/16/2019 at the facility with diagnoses of [DIAGNOSES REDACTED] On 8/21/2019 patient #311 EHR was reviewed. It was noted the purposeful rounding (5 P's) was documented only for the following dates/time: 8/16/2019- 2 PM, 12 PM, 8 AM, 2:00 AM, (patient was discharged [DATE]) 8/15/2019- 12 PM, 8 AM, 4:00 AM, 12:30 AM 8/14/2019- 7:00 PM, 5:00 AM 8/13/2019- 9:30 PM, 7 PM, 4 PM, 2 PM, 12 PM, 10 AM, 9 AM, 8 AM, 5 AM, 8/12/2019- 7 PM-7 AM, 6:30 AM. Patient #312 was hospitalized [DATE] - 8/13/2019 at the facility with a diagnosis of [DIAGNOSES REDACTED] On 8/21/2019 patient #312 EHR was reviewed. It was noted the purposeful rounding (5 P's) was documented only for the following dates/time: 8/13/2019- 4 PM, 2 PM, 7:30 AM, 5 AM, 4 AM, 1 AM (patient was discharged [DATE]). 8/12/2019- 9 PM, 7 PM, 5 PM, 4:30 AM, 12 AM. 8/11/2019- 8:30 PM, 7 PM, 5 PM, 2 PM, 11 AM, 10 AM, 8 AM, 4 AM 12 AM 8/10/2019- 8 PM, 6 PM-7 AM, 4 AM, 8/9/2019- 11 PM, 10 PM, 5:30 PM On 8/13/2019 RN#325 verbalized purposeful rounding is to be completed by nursing staff, every hour and every two hours at night for all patients On 8/21/2019 RN#259 confirmed purposeful rounding is to be completed by nursing staff every hour and every two hours at night while the patient is hospitalized The "Inpatient Nursing Documentation of Patient Care Policy" dated 7/18/2019 states the following: ...."4.0 Shift Documentation. 4.1 The following must be documented every shift or more frequently, if ordered or applicable: .... I. Purposeful Rounding." The policy contained a list of definitions that included the definition for purposeful rounding: "For the purpose of this policy, refers to intentional nursing staff rounding to ensure the key elements for patient safety are in place, including but not limited to the 5Ps (Pain, Position, Possession, Potty, and Pump) and visual safety checks. Purposeful rounding will occur hourly from 0700 - 2100 and every 2 hours from 2200 - 0600. Purposeful Rounding may be performed more frequently, as needed." Nursing failed to implement physician orders for daily weights, incentive spirometry, sitz bath, TED (anti-embolism/compression) hose, and sequential compression devices (SCD). Findings: Review of facility policy titled "Inpatient Nursing Documentation of Patient Care Policy," dated 7/18/19, showed that it was the policy of the facility for nursing to record patient interventions in the medical record in a timely, accurate, and complete manner. Record review of eight (8) current & five (5) discharged patients' clinical records showed 12 patients had physician orders for the following nursing interventions: I. Daily weights: Patient #231: seven (7) weights missed Patient #230: six (6) weights missed Patient #225: six (6) weights missed Patient #326: four (4) weights missed Patient #324: three (3) weights missed Patient #218: two (2) weights missed Patient #233: two (2) weights missed Patient #228: two (2) weights missed Patient #325: two (2) weights missed Patient #323: two (2) weights missed Patient #327: two (2) weights missed Patient #322: two (2) weights missed II. TED Hose: Patient #230: Physician order dated 08/08/19 for TED hose. There was no nursing documentation that TED hose were ever applied. The patient was discharged on [DATE]. Patient #233: Physician order dated 05/06/19 for TED hose. This was an active order for 15 days, only four (4) nursing entries related to TED hose during that time period. Patient # 322: Physician order dated 02/04/19 for TED hose. There was no nursing documentation that TED hose applied for nine days (02/4 through 02/13/19). During an interview on 08/19/19, at 10:15 AM, with RN Navigator # 335, she stated that if TED hose were ordered by physician, nursing was required to document TED hose every shift as: "on, off, or patient refused, or other related comments." III. SCD : Patient #326 : Physician order dated 08/10/19 for SCD. There was no nursing documentation that SCD was ever applied. Patient #323: Physician order, dated 08/08/19 for SCD. There was no nursing documentation that SCD was ever applied. IV. Incentive Spirometry (IS) : Patient #322: Physician order dated 02/04/19 for "Incentive Spirometry 10 x daily while awake." There was no documentation of incentive spirometry (IS) for 18 days, only two entries of IS were recorded for 26 days of the active order (Feb. 23 & 24, 2019). Patient #327: Physician order dated 01/30/10 for incentive spirometry. There were only 4 nursing entries related to IS, the order was active for twenty days. This patient was discharged [DATE]. During an interview on 08/20/19, at 11:30 AM, with RN Navigator #335, she stated that respiratory therapy would often provide the initial IS patient education but nursing was responsible for recording the actual IS use by the patient. V. Sitz bath: Patient # 231: Physician order dated 07/29/19 for "sitz bath three times a day." There was no nursing documentation sitz baths were ever provided. The medical records were reviewed on a series of dates between 8/13/19 and 08/22/19. All electronic records were reviewed each time with RN Navigator #335. RN Navigator #335 was unable to locate the documentation to verify the physician orders had been implemented for the 12 patients listed above Nursing failed to: A. Acquire physician's orders for the treatment of wounds present on admission. B. During a wound dressing change a nurse did not discard her dirty gloves, wash her hands and apply clean gloves before handling a clean gauze dressing. C. The nurses were inconsistent in following the wound care nurse's recommendations. D. The facility did not develop a policy for Dating and Labeling of wound dressing changes. Findings: Review of Patient #67's medical records reflected a 74-year-old-male, admitted on [DATE] with a left elbow surgical wound. The patient was seen by the wound care nurse on 8/9/19 when she made recommendation for the treatment of the patient's left elbow and left lateral knee wounds. The left elbow treatment recommendations included cleansing the wound and changing the dressing every other day and as needed for soilage [sic] or saturation, and to assess under foam dressing at least once per day. The Left lateral knee treatment recommendations included cleansing the wound and changing the dressing every other day and as needed for soilage [sic] or saturation. The wound care nurse did not obtain a physician's order for the wound treatments. During an interview on the morning of 8/22/19, in the facility INR room, Staff #42 stated, "It's up to the provider to put the recommendations into an order ... Physicians should write an order to get a wound consult ... the recommendation is not a physician's order." An observation on the morning of 8/16/19, in patient room G1243, with Staff #54 present revealed Patient #67 receiving wound care to a left lower leg wound. Staff #82 removed the old dressing, a small amount of blood was noted on the dressing. Staff #82 cleaned the wound with a saline soaked gauze, then dried the wound with a clean dry gauze, and applied a clean dressing over the wound. Staff #82 did not perform hand hygiene and change her gloves after removing the dirty dressing and prior to cleaning of the wound, possibly contaminating the wound, and did not document the date the dressing was changed on the dressing. Patient #67's left elbow dressing did not have a date to indicate when the dressing had been changed last. Review of the facility provided document Skills: Dressing (undated) reflected, " ... 16. Remove the old dressing by slowly pulling back across the wound in the direction of hair growth ... 17. Dispose of the soiled dressing in the wastebasket or waterproof bag, following the organization's practice for infection control. 19. Prepare the dressing supplies using aseptic technique. 20. Pour sterile saline or the prescribed solution over sterile 4 X 4-in gauze pads or use an organization-approved spray wound cleanser. 21. Perform hand hygiene and don gloves. Don sterile gloves if the practitioner orders sterile dressing changes, such as for sharp debridement ..." C.) Review of the Wound Care Nurse's assessment dated [DATE] reflected, Recommend to discontinue [sic]the wound VAC and change dressing recommendations to a Collagen dressing to further aide in the healing process. For the skin tears on the left lateral knee, would recommend using a non-adherent dressing such as Mepilex Lite or Xeroform. Review of physician's orders dated 8/16/19 reflected, "For the left Elbow: 1. Cleanse wound using pressurized saline (Lawson# - order from Materials Management via fax), pat dry. 2. Cut and apply Hydrofera Blue Ready to cover the wound bed (Lawson #9806) 3. Secure wound with Medipore or paper tape 4. Change dressing every other day and PRN if soiled, displaced or saturated. 5. May assess under dressing at least once per day" Review of the Left Elbow daily assessments reflected no documented wound assessments on 8/10/19, 8/11/19, 8/12/19, and 8/17/19. The dressing changes were missed, per the wound care nurse's recommendations on 8/11/19, 8/15/19, and 8/18/19. The nurses had been treating the wounds without a physician's order for 8 days. D.) Review of the facility provided Skills: Dressing document (Undated) reflected, " ...27. Label the dressing per the organization's practice ..." The facility was unable to provide the organization's practice. During an interview on the morning of 8/20/19, in an Administrative Conference room, Staff #314, stated, " ...We do not have a policy on the labeling of dressing changes." During an interview on the morning of 8/20/19, in an Administrative Conference room, Staff #290 stated, "Best practice is, the dressings should be dated when the dressing was changed." Record review on 8/21/19, of Pt #172's medical records showed doctor's orders for a blood transfusion to be given on 5/10/19. Further review of orders stated for vital signs to be taken 15 minutes after initiation of transfusion, then every hour until finished. Review of vital sign documentation showed the first vital sign was taken 20 minutes after initiation (5 minutes late) and there were no vital signs taken until two hours after initiation, completely missing the one-hour post initiation. In an interview on 8/21/19, at 11:00 AM, Staff #144 stated that the nurse giving the blood transfusion was late five minutes to obtain the first vital signs and the one-hour post initiation of transfusion vital signs were completely missed and should have been done per doctor's orders. Record review on 8/21/19, of Patient #177's medical records showed an order for a blood transfusion to be given on 8/15/19 with vital signs to be taken every 15 minutes for one hour, then every 30 minutes for one hour, then every hour until completed. Further review revealed the initiation of infusion started at 10:15 AM, and the vital signs were not taken at 12:15, nor again at 1:15. In an interview on 8/21/19, at 11:45 AM, Staff #141 stated that the two vital signs were not done per doctor's orders. Record review on 8/21/19, of Patient #171's medical records showed, he received an infusion of chemotherapy on 8/16/19. Doctor's orders stated to take vital signs prior to infusion. Further review revealed the infusion initiation was 10:23 AM, but there were no vital signs taken prior to this. In an interview on 8/21/19, at 12:00 PM, Staff #141 stated " ...the nurse didn't do it [the vital signs prior to infusion]". Record review of facility policy #CLN1115 titled "Blood Component Administration and Transfusion Reaction Policy" stated to obtain vital signs 30 minutes prior to starting a blood transfusion, and also every hour after 15 minutes after the initiation, then hourly from start of transfusion through completion. Review of medical records on 08/19/2019, 8/20/2019, and 08/21/2019 revealed the following: Patient #18 was admitted on [DATE], for complications related to [DIAGNOSES REDACTED] to include bilateral pulmonary embolisms, acute kidney injury, diabetes, dehydration, and [DIAGNOSES REDACTED]. The patient was ordered Thrombo-Embolic Deterrent (TED) hose on 08/09/19 at 7:09 p.m. There was no documentation in the patient's medical record to show the patient ever received the TED hose. There is no documentation to show that the doctor was notified that the order was not carried out by the nurses. Further review of the record revealed there were four incidents when the patient's vital signs were out of the physician set parameters of "Notify Team when O2 sat is less than 90, systolic blood pressure (top number) greater than 150 and/or diastolic blood pressure (bottom number) greater than 90." 08/10/19 0000 - O2 Sat 89% 08/11/19 0500 - O2 sat 89% 08/12/19 1800 - O2 sat 87% 08/13/19 1955 - Blood Pressure 176/91 An interview with staff # 330 on 08/20/19, at approximately 10:45 a.m., revealed that nursing staff should have followed all physician orders and should have notified the physician when doctors' orders are not followed. Staff # 330 confirmed the vital signs were outside of the physician set parameters. Staff # 330 stated the nurse should have notified the physician. Patient #285 was admitted on [DATE], with a new diagnosis of [DIAGNOSES REDACTED]. There was no documentation that this order was carried out or that the physician had been notified that the order had not been carried out. Documentation on 08/13/19, at 8:00 p.m., revealed the patient refused "Anti-Embolism Intervention." There was also no documentation that showed the nurse notified the physician. An interview with staff # 330 on 08/20/19, at approximately 3:21 p.m., revealed that nursing staff should have followed all physician orders and should have notified the physician when doctors' orders are not followed. Staff # 330 confirmed documentation that the patient refused "Anti-Embolism Intervention" on 08/12/19 at 8:00 p.m., and there was no documentation to show the nurse notified the physician of the patient's refusal. Patient #286 was admitted on [DATE], for chemotherapy. Review of medical record revealed on 7/15/19, the physician entered vital sign parameter orders on when the physician is to be notified if they vital signs fall above or below what the doctor had set. The physician ordered to be notified if patient's respiration rate is greater than 25 or less than 12, if the systolic blood pressure is greater than 150 or less than 90, and diastolic blood pressure is greater than 90 or less than 50. There were 6 instances when the nurse did not notify the physician of vital signs outside the set parameters. 08/12/19 1400 - respirations 28 08/12/19 1458 - respirations 28 08/12/19 1558 - respirations 26 08/12/19 1658 - respirations 26, blood pressure 152/74 08/12/19 2251- blood pressure 154/77 08/13/19 0051 - blood pressure 154/75 Further review of the medical record, revealed, the patient became unresponsive on 08/16/19, at 10:44 p.m., per an entry written by a nurse practitioner. A nurse note dated 08/17/19, at 6:38 a.m., described an event when the patient became unresponsive around the above noted time. However, the note was not identified as a late entry. It is noted this patient expired on [DATE]. An interview on 08/20/19, at approximately 1:50 p.m., with staff # 330, confirmed the vital signs were outside physician ordered parameters and the nurse did not notify the physician. Staff # 330 stated nursing staff should have followed all physician orders and should have notified the physician regarding the vital signs outside of parameters. Staff # 330 also confirmed the entry from 08/17/19 should have been noted as a late entry. Patient #288 was admitted on [DATE], for a craniotomy due to brain cancer. On 06/19/19 at 7:43 p.m., the physician entered an order for hourly neurovascular checks. Review of the medical record revealed the following: 06/19/19 2000 - start 06/19/19 2105 - 5 minutes late 06/19/19 2305 - 5 minutes late 06/20/19 - 0600 - No Glasgow Coma Scale Documented 06/20/19 - 0700 - No neuro check documented 06/20/19 - 0800 - No Glasgow Coma Scale Documented 06/20/19 - 0900-1100 - No neuro check documented, and no documentation found to explain why the neuro checks were not completed for 3 hours. 06/20/19 - 1130 - restarted 06/20/19 - 1200 - no Glasgow Coma Scale Documented 06/20/19 - 1300 - No Glasgow Coma Scale Documented 06/20/19 - 1445 - 15 minutes late, no Glasgow Coma Scale Documented 06/21/19 - 0814 - Physician order entered to stop hourly neurovascular checks. Further review revealed a physician's order for SCD's on 06/19/19, at 7:45 p.m., was not documented as being completed. All findings were confirmed by staff # 330 on 08/20/19, at approximately 2:00 p.m. Patient #290 was admitted on [DATE], at 7:41 p.m., for complications related to [DIAGNOSES REDACTED]. The patient received multiple blood transfusions beginning 08/20/19 at 12:43 a.m. Documentation revealed on 08/20/19, at 6:39 a.m., the patient had a critical Hemoglobin value of 6.4. There was no documentation to show the nurse notified the physician in a timely manner. Further review revealed a verbal order by a nurse on 08/20/19, at 8:51 a.m., an order was received to redraw the hemoglobin and on 08/20/19, at 9:10 a.m., a critical hemoglobin values of 6.5 was recorded in the medical record. There was no documentation found in the medical record that the nurse notified the physician of the critical laboratory value. Further review of the medical record revealed that the patient was not administered a medication as ordered by the physician. On 08/20/19, the 10:00 p.m., dose of Sodium-bicarb mouthwash was not administered to the patient as ordered. An interview was conducted with staff # 54 on 08/21/19, at 10:00 a.m.. When asked what the procedure for addressing critical lab values were, she responded that the nurse is to notify the physician within 30 minutes of receipt of the lab. She also stated the nurse is supposed to document the notification and action in the medical record. Staff # 54 was also asked about medication documentation. She stated, the nurse is to scan the medication when it is given, and it is entered into the medical record. When asked what the nurse would do if the medication was not given, she stated there should be a comment entered and the physician should be notified. Staff # 54 confirmed the above findings. Patient #291 was admitted on [DATE], with pain related to his cancer diagnosis. Review of the medical record revealed the patient's vital signs were outside of the following parameters (pulse >100, systolic blood pressure greater than 160 or less than 90, diastolic blood pressure greater than 90, or less than 40) 16 times between the 08/03/19 and 08/09/19. Further review revealed the physician did not set patient specific vital signs for this patient. 08/03/19 0009 - blood pressure 144/92 08/03/19 0410 - blood pressure 151/100 08/03/19 0939 - blood pressure 152/92 08/03/19 1514 - blood pressure 152/91 08/03/19 1852 - blood pressure 152/94 08/03/19 2109 - blood pressure 147/93 08/03/19 2228 - blood pressure 154/96 08/04/19 1917 - blood pressure 160/88 08/05/19 1519 - blood pressure 150/91 08/06/19 1122 - blood pressure 146/91 08/06/19 1532 - blood pressure 151/95 08/06/19 1532 - pulse 125 08/06/19 1945 - blood pressure 141/95 08/08/19 1414 - blood pressure 151/90 08/08/19 2044 - blood pressure 150/90 08/09/19 1325 - blood pressure 137/93 There was no documentation to show the nursing staff ever notified the physician regarding the vital signs out of parameters. Further review revealed the patient refused vital signs 6 times: 08/04/19 0500 - patient refused to have vital signs taken 08/04/19 0730 - patient refused to have vital signs taken 08/04/19 0815 - patient refused to have vital signs taken 08/09/19 0820 - patient refused to have vital signs taken 08/09/19 1301 - patient refused to have vital signs taken 08/11/19 1500 - patient refused to have vital signs taken An interview was conducted with staff # 100 at the time of review. Staff # 100 was asked what the expectation of reporting abnormal vital signs when the physician has not set patient specific vital signs. Staff # 100 stated the nurse was to report abnormal vital signs based on parameters set by the charting system if the physician had not ordered patient specific parameters. Staff # 100 further stated the nurse should have notified the physician of the patient's refusal to have vital signs taken. There was no documentation that the nursing staff notified the physician of the abnormal vital signs or the patient's refusal of vital signs. The above findings were confirmed on 08/12/19 by staff # 100 and # 101. Review of the facility's policy CLN0647 titled "Inpatient Nursing Documentation of Patient Care" dated 07/18/2019, revealed the following: Section 1.0 General Information and Collection of Information: 1.1 - The Registered Nurse (RN), in collaboration with other health care providers and the patient/caregiver, is responsible for reviewing the patient's Assessment data, formulating a plan of care and evaluating patient response and outcomes as well as identifying the learning needs and or barriers to learning. The nursing staff failed to follow this policy by not reviewing the assessment data and physician orders were not followed on multiple occasions. 1.4 "When documenting a late entry, indicate 'Late Entry' with a comment of note in the patient's medical record. The nurse failed to identify a late entry in a patient's medical record as a late entry after the patient had expired." Section 4.0 Shift Documentation: 4.2 Document medication administration. The nurse failed to document administration of a medication in the patient's medical record, or any reason for the medication not being administered as well as not documenting the provider was notified the medication was not given. Section 9.0 Critical Results 9.1 - "Critical results will be communicated to the Physician or Advanced Practice Provider (APP) as soon as possible and documented with 60 minutes from the time the results are available." The nurse failed to document the notification of the physician or APP in the medical record. |
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| VIOLATION: RN SUPERVISION OF NURSING CARE | Tag No: A0395 | |
| **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on interviews and records review, the hospital failed to evaluate 1 (#307) of 1 patient's care needs and patient's health status by unnecessarily withholding clear liquids for six hours while waiting for a computed tomography (CT) scan. Per hospital protocol, the patient could have consumed a clear liquid diet for six of the nine hours the patient waited for completion of the scan. This hospital failure placed the patient at risk for dehydration. Patient #307 was admitted [DATE], with active diagnoses of [DIAGNOSES REDACTED]. The patient care plan did not include the risk for dehydration. On 8/18/2019, 1:47 PM, a CT scan of abdomen with contrast was ordered by Physician #380. The scan was not performed until 8/18/2019 at 11:29 PM. This test requires the patient to drink an oral contrast - for better imaging of the abdominal cavity. During an Electronic Health Record (EHR) review on 8/22/2019, the hospital order set for CT abdomen with contrast was noted. The following was included in the order set: "Diet: Clear liquids only, three hours prior to scheduled CT examination." On 8/21/2019, an interview occurred with patient #307 and next of kin. The interview revealed, the patient ate breakfast on 8/18/2019 and did not eat for the rest of the day due to pending CT scan on that day. On 8/21/2019, at 11:25 AM, an interview was conducted with RN #380, who was assigned to patient on 8/18/2019 from approximately 6:45 AM-7:15 PM. The RN alleged that he called the CT department multiple times throughout the day to see when he could prepare for CT scan/have patient drink oral contrast prior to scan. According to the RN, he was not notified to start preparing for CT scan until 7:30 PM and the patient was scheduled for scan at 8:30 PM. RN #380 confirmed patient food and fluids by mouth was withheld (NPO) after CT ordered. On 8/21/2019, at 2:15 PM, an interview with the Diagnostic Radiology Manager, Diagnostic Radiology Supervisor, Diagnostic Radiology Nursing Supervisor, and Diagnostic Radiology Nursing Assistant Supervisor was held. The interview revealed Patient #307 CT scan was ordered, the radiologist reviewed the patient's kidney function lab result and recommended giving intravenous fluids (IV fluids) before and after CT scan. An order was placed by provider to administer intravenous fluids for four hours before scan and six hours after scan. This staff stated it is the responsibility of the diagnostic radiology nurse and inpatient nurse to coordinate scan time. STAT and urgent scheduled orders and critical care patients have a high priority and may delay completing scans routine scheduled orders. If oral contrast is ordered the goal is to have patient scanned within two hours of drinking. However, the patient still can be scanned if oral contrast was completed greater than two hours. The patient is allowed clear liquids up to three hours of scheduled scan, afterwards the patient should be NPO until scheduled scan. The staff was able to show documentation of diagnostic radiology nurse from 8/18/2019. The note stated the diagnostic radiology nurse and inpatient nurse coordinating the start time for oral contrast on 8/18/2019 at 7:30 PM and tentative scheduled CT scan at 8:30 PM. EHR review of Patient #307 showed an order for IV fluids "100 ml/hr for 4 hours prior to and 6 hours following CT". This order was from Physician #380 on 8/18/2019 at 1:47 PM On 8/18/2019, at 2:45 PM, intravenous fluids was started and completed 8/18/2019 at 6:45 PM by RN #326. Records review of EHR showed Patient #307 drank the oral contrast on 8/18/2019, at approximately 7:16 PM. There were three routine CT scans performed prior to Patient #307 scan. One of the three CT scans was ordered after Patient #307 order date/time. On 8/22/2019 RN #54 was interviewed. It was asked if it is standard for a patient to be NPO for a CT abdomen with contrast. RN #54 stated she was unsure. Policy titled "Adult/Pediatric Oral Contrast Administration on Inpatient Units and the Emergency Center" dated 1/5/2018 states the following: " ....2.2 Radiology Nursing Staff Responsibility .... B. Confirmation that the oral contrast order set has been received by the inpatient RN. The inpatient nurse will coordinate the patient's appointment time, contrast administration times, initial report, and transportation needs. C. Coordination of the oral contrast administration time with the inpatient RN" Policy titled "Administration of Iodinated Contrast Material" dated February 2019 state the following: "2.9 Inpatient hydration should be addressed pre and post procedure by the floor nurse." |
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| VIOLATION: NURSING CARE PLAN | Tag No: A0396 | |
| **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on review of documentation and interview, it was determined that nursing care plans failed to include interventions regarding all patient diagnoses. Twenty-four (24) (#13, #14, #17, #18, #20, #21, #24, #29, #45, #69, #70, #71, #76, #79, #109, #110, #111, #112, #225, #289, #313, #314, #315, #326) of 44 medical records reviewed had incomplete plans of care. Findings: Facility policy entitled "Interdisciplinary Inpatient Care Plan and Education Record Policy" stated in part, "The Care Plan process begins at the first point of contact upon inpatient admission and is ongoing throughout the hospital stay. Inpatients should have a plan of care initiated within 24 hours of admission and documented in the medical record. Appropriate clinical practice guidelines (CPG) should be added by the licensed health care provider (LHP) to each patient's Care Plan based on the patient's condition and/or needs. The CPG provides a list of topics that the LHP can select to individualize the Care Plan and provide education. The individualized Care Plan and Education Record are documented in the medical record." Patient # 21 had no nursing plan of care initiated for Altered Mental Status. Patient # 29 had no nursing plan of care initiated for Acute Kidney Injury or Hemoptysis. Patient # 20 had no nursing plan of care initiated for Tachycardia or Fever and Chills. Patient # 13 had no nursing plan of care initiated for Anticoagulation Therapy. Patient # 17 had no nursing plan of care initiated for Prevention of DVTs (pt. had history). Patient # 14 had no nursing plan of care initiated for Hearing Loss. Patient # 69 had no nursing plan of care initiated for anticoagulation therapy or Anemia (Hgb 7.3-8.2). Patient # 70 had no nursing plan of care initiated for Pleural Effusion or Dyspnea. Patient # 71 had no nursing plan of care initiated for Acute Renal Failure Syndrome or Dehydration. Patient # 76 had no nursing plan of care initiated for Altered Nutrition for hypoalbuminemia (albumin was 2.8 and decreasing). 10 of 15 medical records reviewed had incomplete plans of care. This was confirmed by nursing staff and the Representative for Patient Advocacy on 8/13 and 8/14/2019. Record review of the facility policy "Inpatient Nursing Documentation of Patient Care Policy", dated 07/18/2019 stated: Shift documentation: The following must be documented every shift or more frequently, if ordered or applicable. Document individualized care plans, interventions and outcomes. Reassess learning needs as appropriate. Patient # 24 had no care plan initiated for addressing deep vein thrombus. Patient # 109 had no nursing care plan initiated to address the Whipple procedure. Patient # 110 had no nursing care plan initiated to address the an ileostomy. Patient # 111 had no nurse care plan initiated to address the ileostomy. Patient # 112 had no nursing care plan initiated to address a total hysterectomy. Interview on 08/13/2019 at 1100 with the clinical nurse leader who stated "I see what you mean". Patient #326 Record review on 08/20/19, of the current patient census for Unit G-22 showed Patient #326 was admitted on [DATE] with a diagnosis of [DIAGNOSES REDACTED] Interview on 08/20/19, at 10:30 AM, with his bedside nurse RN # 337, she stated Patient #326 had a pelvic abscess and a prior colostomy, and was admitted for increased weakness and pain. She said physical therapy staff ordered a trapeze bar yesterday to help with his markedly decreased mobility. Review of Patient #326's electronic medical record failed to show "impaired mobility" and "colostomy" as topics addressed in his care plan. Interview on 08/20/19, at 1:30 PM, with RN Navigator #335, she said both of these issues should have been updated in the care plan. Patient # 225 Record review on 08/14/19, of the electronic medical record of Patient # 225 showed, she was admitted on [DATE], with history of metastatic [DIAGNOSES REDACTED]. Patient #225 was noted upon admission to have a Stage III pressure ulcer to her sacrum. Review of Patient # 225's care plan failed to show wound care as a topic addressed in her care plan. Interview on 08/14/19 at 11:45 AM with RN Navigator #335, she said "wound care" should have been listed in the care plan. Patient # 18 was admitted for complications related to [DIAGNOSES REDACTED], dehydration, bilateral pulmonary embolisms, [DIAGNOSES REDACTED], and acute kidney injury. The patient had no nursing plan of care initiated for bilateral pulmonary embolisms, [DIAGNOSES REDACTED], and acute kidney injury. An interview was conducted with RN # 330 regarding the nurses' responsibility to initiate a patient specific care plan. The staff member stated the care plans should be specific to the patient. The staff member demonstrated how the nurse can add items to the care plan and how they can be changed to specifically meet the patients if it is not included in the preloaded database. RN # 330 confirmed the care plan for patient # 18 was not complete or patient specific. Patient # 45 was admitted with a diagnosis of [DIAGNOSES REDACTED]. Patient #79 was admitted with with a diagnosis of [DIAGNOSES REDACTED]. Patient #289 was admitted with a diagnosis of [DIAGNOSES REDACTED]], infiltrating duct [DIAGNOSES REDACTED] of female breast, pain due to neoplastic disease malignant neoplasm of chest wall, and generalized acute body pains. The care plan did not address the problem with change of body image, knowledge deficit, recurrence of cancer. Patient #313 was admitted for surgery for a malignant neoplasm of the right kidney, except renal pelvis. The care plan did not address the problem of knowledge deficit due to new cancer diagnosis with surgery, anxiety related to new diagnosis and change of appetite. Patient #314 was admitted with a diagnosis of [DIAGNOSES REDACTED]. Patient #315 was admitted with right extremity sarcoma, hemorrhage, and abdominal pain. The care plan did not address his recurrence of cancer, surgery with change of body image, change of appetite with abdominal pain. An interview with Personnel #327 on 8/21/2019 confirmed that there were changes in the patients condition or needs and that they should have been addressed on the Care Plan. Facility policy entitled "Interdisciplinary Inpatient Care Plan and Education Record Policy" stated in part "The Care Plan process begins at the first point of contact upon inpatient admission and is ongoing throughout the hospital stay. Inpatients should have a plan of care initiated within 24 hours of admission and documented in the medical record. Appropriate clinical practice guidelines (CPG) should be added by the licensed health care provider (LHP) to each patient's Care Plan based on the patient's condition and/or needs. The CPG provides a list of topics that the LHP can select to individualize the Care Plan and provide education. The individualized Care Plan and Education Record are documented in the medical record...4.2 The RN should evaluate the progress and achievement of the Care Plan goals and revise as appropriate prior to bedside shift report and permanent hand-off communication." |
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| VIOLATION: ADMINISTRATION OF DRUGS | Tag No: A0405 | |
| Based on observation, interview, and record review, the facility's nursing staff failed to: A. administer medication as prescribed by the patient's physician in 1 of 7 sampled patients. (Patient #48) B. follow the facility's policy for documentation of treatment and interventions in 6 ( #271, #39, #276, #277, #278, and #279) of 7 patients reviewed. Findings: A. Review of Patient #48's clinical record revealed a physician's order dated 07/31/2019 for "Midodrine 10 mg via gastrostomy tube three times daily before meal. Hold if SBP greater than 150 mm/Hg. In addition, Monday, Wednesday, and Friday when he receives dialysis. Please give a dose 30 minutes BEFORE dialysis (not additional dose but mid-day- dose). Avoid administering after the evening meal or within 4 hours of bedtime." Review of the Patient's medication administration record and hemodialysis treatment record for the following days revealed Medication Midodrine 10 mg was not administered 30 minutes prior to hemodialysis treatment as prescribed: 08/09/2019: Medication Midodrine 10 mg administered at 8:43 a.m. and hemodialysis treatment initiated at 10:00 a.m. 08/07/2019: Medication Midodrine 10 mg administered at 8:01 a.m. and hemodialysis treatment initiated at 11:00 a.m. 08/05/2019: Medication Midodrine 10 mg administered at 9:29 a.m. and hemodialysis treatment initiated at 10:20 a.m. 08/02/2019: Medication Midodrine 10 mg administered at 9:10 a.m. and hemodialysis treatment initiated at 10:00 a.m. The surveyor reviewed the Patient's clinical record with the Unit's Manager who confirmed that the medication was not administered as prescribed because at times transportation is late in transferring the Patient to hemodialysis for hemodialysis treatment. Facility policy titled "Medication Administration Record" stated in part "The following will be indicated on the electronic MAR: ...I. Indication for a medication." Facility policy titled "Inpatient Nursing Documentation of Patient Care Policy" stated in part "It is the policy of The University of Texas MD Anderson Cancer Center (MD Anderson) that: "Documentation of assessment, interventions, evaluation, and patient/caregiver education in the inpatient setting (including the Emergency Center (EC), Clinical Decision Unit (CDU), and Transitional Post-Anesthesia Unit (TPACU) is recorded in the patient's medical record." The policy continued under "Patient Assessment and Reassessment": "Reassessment of a patient will be documented: A. Prior to, during, and after a procedure or treatment, as indicated. B. Within an appropriate timeframe, for the evaluation of effectiveness and patient's response to the intervention. C. If clinically indicated (e.g., change in the patient's status/condition), ordered or applicable." Review of the following medical records on 8/21/19 revealed the following: Patient # 271 received Ativan 0.5 mg IM (indicated for anxiety) on 8/5/19 at 0450. There was no documentation by the nurse who administered the medication with rational for giving the medication nor evaluation for the medication's effectiveness. Patient # 39 received Ativan 0.5 mg on 7/30/19 (indicated for nausea and vomiting). There is no nursing documentation to explain why the medication was given nor was there a documented evaluation of its effectiveness. Patient # 276 received Ativan 1 mg on 5/22/19 STAT at 1357 and 1534. There was no indication on the order why the medication was ordered. Patient # 277 received Ativan IV on 7/22/19 at 1539 and again on 7/24/19 at 0834. There is no indication for use on the MD order. Patient # 278 received PRN Ativan and Haldol IV on 7/8/19. There was no indication why these medications were given by the nurse. Patient # 279 received a onetime dose of Ativan and Dilaudid. The ordering MD had no indication for prescribing the medication. In interviews with the unit Psychiatrist, the Director of Psychiatry, the Director of Specialty and the Representative for Patient Advocacy on 8/22/19, the above medication documentation errors were confirmed. |
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| VIOLATION: Condition of Participation: Pharmaceutical Se | Tag No: A0489 | |
| Based on observation, review of records, and interview, the hospital failed to: A) 1) ensure 5 out of 5 contracted transportation couriers (Staff #304, #305, #367, #368, and #369) were transporting hazardous drugs (chemotherapy medications) in a safe manner. Courier staff were not trained on how to contain and clean a chemotherapy spill and did not possess the proper equipment for containing and cleaning of a chemotherapy spill during transport. No evidence was provided to verify that courier staff were aware of the potential for occupational exposure to chemotherapy agents and risks associated with it. This unsafe condition placed staff, patients, and the public at risk of potential harm by unknowingly coming in contact with a hazardous drug that had not been properly contained and cleaned. 2) ensure safe disposal of medications. Drugs were being disposed of in sharps containers (plastic containers used for the disposal of used needles and glass) at two of the outpatient facilities (West Houston and Katy locations). This unsafe condition allowed for the possible unauthorized retrieval of medications (to include narcotics) by unathorized persons. Cross Refer to Tag A0491 B) develop accountability procedures to ensure controlled medications, such as narcotics, that were dispensed as a continuous intravenous (IV) infusion (medication delivered into a vein at a constant rate) were not diverted by unauthorized persons. This unsafe condition placed patients at risk of not receiving the amount of prescribed medications and potentially being cared for by an impaired staff member who could have diverted medication intended for the patient. Cross Refer to Tag A0494 |
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| VIOLATION: PHARMACY ADMINISTRATION | Tag No: A0491 | |
| Based on observation, review of records, and interview, the hospital failed to ensure: A. 5 out of 5 contracted transportation couriers (Staff #304, #305, #367, #368, and #369) were transporting hazardous drugs (chemotherapy medications) in a safe manner. Courier staff were not trained on how to contain and clean a chemotherapy spill and did not possess the proper equipment for containing and cleaning of a chemotherapy spill during transport. No evidence was provided to verify that courier staff were aware of the potential for occupational exposure to chemotherapy agents and risks associated with it. This unsafe condition placed staff, patients, and the public at risk of potential harm by unknowingly coming in contact with a hazardous drug that had not been properly contained and cleaned. B. safe disposal of medications. Drugs were being disposed of in sharps containers (plastic containers used for the disposal of used needles and glass) at two of the outpatient facilities (West Houston and Katy locations). This unsafe condition allowed for the possible unauthorized retrieval of medications (to include narcotics) by unauthorized persons. Findings: A. On the morning of 8-12-2019, a tour of the Inventory Control area of pharmacy was made with Staff #49, #50, #139, and #336 present. A shelf with the four off-site pharmacy locations (League City, Sugarland, Woodland, and Katy) was observed. When asked if chemotherapy agents were transported to the off-site pharmacies, Staff #139 advised that chemotherapy was transported to the off-site pharmacies for use at the infusion centers. Transportation was provided by contracted couriers. Review of the contract between the hospital and the courier service was made. A Statement of Work (SOW) between the Institution-Wide Courier Service and the hospital was included in the contract. Per the SOW, under item "2. Description of Requested Service" the following was noted: "Dedicated Route Services Contractor will be responsible for the timely pick-up and delivery of different items to/from various departments/locations within the TMC and other clinical research facilities in the Houston-metropolitan area. Items to be transported may be, but not limited to: envelopes and documents (including time sensitive and confidential), supplies (medical, office patient nutrition, etc.) perishable supplies, blood products, bodily fluids, biohazards, laboratory and pathology samples, surgical instruments, computer equipment, monitors, printers, and miscellaneous items such as: medical graphics materials, posters, balloons for employee recognition events, etc. Some of the times will require proper storage at regulated temperature. By Request Services Contractor will be responsible for the timely pick-up/delivery of laboratory specimens, including but not limited to the following categories: anatomical/surgical pathology, chemistry, cytology, blood bank, coagulation, cytogenetics/molecular genetics, hematology, immunology (sic)/serology, immunocytology, microbiology, and virology; patient prescriptions; pharmaceutical supplies; and stock medication. Other items include reports, supplies and other materials (e.g., specimen containers, x-ray films, pre-packaged regimens, medical records, etc.) to and from designated locations within the scope of the contract. Contractors shall ensure the appropriate transport conditions to guarantee specimen integrity and the security and confidentiality of all documents, laboratory reports, medical records and comply with HIPPA (sic) regulations. ... 3. Minimum Contractor Specifications, Certifications, Experience and Requirements ... Contractors shall ensure that all drivers: 1) maintain an acceptable driving records. 2) have a valid Texas driver's license (not suspended or revoked). 3) are trained in bio-hazardous materials handling, blood borne pathogens exposure, spill cleanup in compliance with DOT, CDC Transportation regulations, and applicable State, federal, local agency regulations. 4) trained in applicable Health Insurance Portability and Accountability (HIPPA) (sic) regulations." While the SOW specified that drivers would be handling biohazardous materials and were at risk for blood borne pathogen exposure that required specialized training to include spill cleanup, no mention was found of couriers transporting chemotherapy agents that required specialized training and specialized equipment for spill containment and cleanup. On 8-13-2019, training records for all contracted couriers were requested. Records were received for Staff #304, #305, #367, #368, and #369. Each courier had two certificates from "Integrity Medical Courier Training for the following: " ...satisfactory completion of required annual HIPAA Awareness Training for Medical Couriers in observance of the Health Insurance Portability and Accountability Action of 1996. (HIPAA)" " ...satisfactory completion of Automated Bloodborne Pathogen Awareness class on Bloodborne Pathogens, Exposure Control, Transportation & Specimen Integrity Best Practice Industry Standards (as based on OSHA 29 CFR 1910.1030)" No records for training on the containment and cleanup of chemotherapy spills was alleged or provided. On 8-15-2019 after 10:00 AM, in interview was conducted with Staff #303. Staff #303 demonstrated how the chemotherapy was packaged for transport. The containers used to transport chemotherapy did not contain markings on the outside of the container warning that hazardous drugs were inside. The packaging inventory sheet was placed on the inside of the container. The packaging labels placed on the inventory sheet for the drugs being transported contained the drug name and destination, but did not indicate that the drug was a hazardous drug. Staff #303 was asked why there were no markings as to the type of drug being placed in the transport container for the couriers to know they were transporting hazardous drugs (chemotherapy). Staff #303 explained that contents of the container were not listed so that couriers would not be tempted to take the drugs. Staff #303 was asked how couriers were supposed to know that the package contained hazardous drugs that required special precautions, Staff #303 stated that "they signed contracts stating they know they are carrying hazardous drugs." No such contract was provided. The only contract that was provided was the contract reviewed above. On 8-15-2019 at approximately 1:45 PM, couriers Staff #304 and Staff #305 were interviewed. Both couriers explained that they were certified in HIPAA and Blood Borne Pathogens. They both confirmed this was the only training required. They stated that they did not drive commercial courier vehicles. They drove their own private vehicles. They both verified that they did not have Commercial Driver's Licenses (CDL) that would have required additional training other than what had been provided already. Staff #305 had an Occupational Safety and Health Administration (OSHA) approved Blood Borne Pathogen spill kit in a cooler bag she used to transport biohazardous specimens. Staff #304 stated her spill kit was in her private automobile. Staff #304 was observed to remove a Blood Borne Pathogen spill kit from under the driver's seat of her private automobile. Staff #305 stated she had the same kit in her private automobile. When asked if she would use this kit to contain and clean up any liquids leaking from the blue container she had just picked up from the pharmacy, Staff #304 stated, "I sure would". Staff #305 agreed and stated she would use that kit also. Blood Borne Pathogen spill kits and OSHA approved Chemotherapy spill kits and procedures are not interchangeable. Review of MD Anderson Institutional Policy #ADM0171, Chemotherapy Spills and Surface Contamination Policy, was made as follows: "Purpose The purpose of this policy is to ensure personal and environmental protection to faculty, trainees/students, and other members of The University of Texas MD Anderson Cancer Center's (MD Anderson's) workforce involved in handling cleanup operations for Chemotherapy agents. Faculty, trainees/students, and other members of the MD Anderson's workforce who are planning to have children or who are pregnant will also reduce their likelihood of Exposure to the lowest possible level by following all of the requirements contained in this policy. ... 2.0 Education 2.1 Faculty, trainees/students, and other members of MD Anderson's workforce will receive appropriate instructions on (1) the management of Chemotherapy agents, (2) overall protection of faculty, trainees/students, and other member of MD Anderson's workforce, and (3) care of the patient receiving Chemotherapy agents according to Position Description. 2.2 Strict adherence to the standard operating procedures and correct use of PPE within the intended purpose statement of this policy provides overall personal protection of faculty, trainees/students, and other members of MD Anderson's workforce. 2.3 Disclosure for the potential of occupational Exposure to Chemotherapy agents shall be made to all faculty, trainees/students, and other members of MD Anderson's workforce and documented in personnel records. 2.4 All private duty, temporary, and contract workforce members will be given information by their respective agency explaining the potential for occupational Exposure to Chemotherapy agents prior to working at MD Anderson." No evidence was alleged or provided that demonstrated the hospital verified requirement 2.4, listed above, was completed by the contracted agency prior to allowing contracted couriers to transport chemotherapy medications. B. During a tour of the West Houston outpatient facility on 8/14/2019, an interview was conducted with staff #123. The surveyor asked staff #123 about the drug disposal process at the facility. Staff #123 said the nurses dispose of medications in the sharps containers. The surveyor asked staff #122, how do you dispose of drugs? Staff #122 said, drugs are disposed of in the sharps containers. During a tour of the Katy outpatient facility on 8/15/2019 an interview was conducted with staff # 171. The surveyor asked staff #171 how do you dispose of drugs? Staff #171 said drugs are disposed of in the sharps container. An interview was conducted with staff #166, staff #166 said drugs are disposed of in the sharps containers. During the interviews with staff #123, 122, 171 and 166 the findings were confirmed. |
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| VIOLATION: PHARMACY DRUG RECORDS | Tag No: A0494 | |
| Based on observation, review of record, and interview, the facility failed to develop accountability procedures to ensure controlled medications that were dispensed as a continuous intravenous (IV) infusion (medication delivered into a vein at a constant rate) were not diverted by unauthorized persons. This unsafe condition placed patients at risk of not receiving the actual amount of prescribed medications and potentially being cared for by an impaired staff member who could have diverted medication intended for the patient. On 8-13-2019, after 1:00 PM, a tour of the ICU on G-7 was conducted with Registered Nurses (RN) #317, #318, and #319 present. In ICU room 24, a continuous intravenous infusion of Fentanyl, a narcotic drug, was observed to be running through a standard infusion pump that could be used for all types of medications. The IV bag of medication was not in a secured, locked box. The tubing used to connect the bag to the infusion pump and connect the infusion pump to the patient's IV site was observed to be standard IV tubing. This tubing was observed to have a port where a needle and syringe could be used to withdraw or add medications between the medication bag and the pump. It also had the same type of access port on the tubing between the pump and the patient. This unsecured set-up has the likelihood to allow for unauthorized persons to access and withdraw narcotics without detection. RN #317, #318, and #319 confirmed that the only time the medication was measured was when the bag was completed. The medication remaining in the bag and in the tubing was measured and recorded as waste by two RN's. RN #317 and #318 confirmed that the amount of drug wasted was not compared to the documented administration on the nursing flow sheet to verify that the total amount of Fentanyl in the bag was accounted for. An interview was conducted with Staff #139 on 8-13-2019. Staff #139 stated that the Medication Diversion Committee had been aware that the bags of controlled medications were unsecure. Staff #139 stated, the committee was looking into different types of lock boxes for the bags but were still investigating the different types. Staff #139 stated, he was not aware of the problem with the tubing having port access above and below the pump. Staff #139 stated, there was an initiative being studied to replace the pump tubing and that the port-less tubing would be included in that initiative. Staff #139 stated that initiative would take approximately one year. Staff #139 stated that nursing documented the amount of Fentanyl given on the nursing flow sheet. Staff #139 stated that currently, pharmacy staff did not reconcile the amount of documented medication administration from the nursing flow sheet with the amount of wasted medication to ensure the documented amounts matched the dispensed medication amount. Records were reviewed for Patient #257 and #258 on 8-19-2019. Review of the flow sheets found that the documented milliliters of Fentanyl administered did not add up to the total amount dispensed for the patient. Patient #257 had received Fentanyl through continuous IV infusion between 6-10-2019 through 7-2-2019. IV tubing was required to be changed every 72 hours. The tubing change and medication bag change were not at the same time. Tubing changes were a set time, every 72 hours. Medication bag changes depended on the patient condition and how fast the rate of medication administration was set. This rate varied based on patient condition. Per interview with Staff #306, approximately 15 to 20 milliliters of fluid were required to fill the tubing. When the tubing was changed, no documentation of the waste of the medication that was left in the tubing at the time of tubing change was found. From the start of the IV infusion of Fentanyl for Patient #257, to the stop of the infusion, at least 7 tubing changes should have occurred with a potential for unaccounted waste of Fentanyl of approximately 105 to 140 milliliters. On 8-20-2019, Staff #139 was again interviewed. Staff #139 confirmed that pharmacy staff were not able to reconcile Patient #257's record of medication dispensed with record of medication administered and/or wasted. |
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| VIOLATION: SAFETY FOR PATIENTS AND PERSONNEL | Tag No: A0536 | |
| Based on a tour, interview, and a review of documentation, the facility failed to ensure that proper safety precautions must be maintained against radiation hazards. This includes adequate shielding for patients, personnel, and facilities, as well as appropriate storage, use and disposal of radioactive materials. Finding: Facility policy ADM3264 entitled, "Radioactive Apparel" stated in part, "4.0 Caring for Radioprotective Apparel ... 4.2 Each department shall have procedure for care and cleaning of radioprotective apparel according to manufacturer's guidelines or accepted standards." Per interview and observations, the facility mainly utilizes Sani-Wipes to clean all lead aprons. There were no department specific procedures to identify appropriate manufacturer guidelines for cleaning aprons indicating what products are approved for cleaning these aprons. During a tour of the Main Campus Diagnostic Imaging area on 08/12/19, staff was asked what product was utilized to clean lead aprons. Staff member # 113 replied that the aprons were cleaned with Sani-Wipes. During a tour of the West Houston on 08/15/19 facility surveyors asked what product was utilized to clean lead aprons. The staff member interviewed replied Sani-Wipes. The staff member was asked what the manufacturer recommendations were for cleaning that brand of lead apron which was Universal Medical. On 08/16/19, the facility provided information from the Universal Medical website regarding cleaning of their aprons. The website stated in part, "Approved disinfectants for vinyl and weblon materials: Galahad, LPH, Amphyl, One-Stroke, Vesphene II, Viro-Check, Alcide LD." In interview on 08/17/19 staff member # 105 stated that they were contacting Universal Medical to clarify if the use of Sani-Wipes is approved by the company. This staff member stated that facility was also in the process of contacting all vendors they had purchased aprons for to see if Sani-Wipes are acceptable to use on their lead aprons. As of 08/22/19 the facility provided this surveyor a list of lead apron vendors and their response to inquiries regarding if the use of Sani-Wipes is approved. The facility had over 20 vendors they utilize for lead aprons. 7 vendors indicated the use of Sani-Wipes or QAT wipes was approved for their products. 13 of the vendors had not responded and/or they could not locate contact information for the vendors. 1 vendor specified, "Use only warm water and mild detergent on our specially formulated Clorox apron cleaner." Based on the above findings there was no standardized procedure, approved cleaner, or system for cleaning the lead aprons. This was confirmed in an interview with staff members #40 and 105 on 08/22/19. |
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| VIOLATION: QUALIFIED STAFF | Tag No: A0547 | |
| Based on review of facility documents, review of personnel files, and staff interview, the facility failed to ensure only personnel designated as qualified by the medical staff may use the radiologic equipment and administer procedures. Findings: Review of the facility 2017 Radiation Safety Manual stated in part, "2.3 Radiation Safety Training ...Training is required annually for: *Personnel who care for patients ... that are being treated with unsealed radioactive material and that do not meet the requirements to be released immediately from radiation safety isolation." Review of the personnel file for staff # 228 on 8/21/19, a radiology technician, revealed radiation safety training was dated 3/22/18, 17 months overdue. This was verified by their direct supervisor, during review. On 8/22/19, documentation was provided that staff # 228 completed the training on 8/21/19. Review of the credentialing file for staff # 214, with radiation oncology, revealed they were approved for Gamma Knife Privileges which stated in part, "Additional Training: ...Training by the vendor on the specific device ..." No training for the Gamma Knife by the vendor was provided. Staff #105 verified staff # 214 should not have Gamma Knife privileges. The above was verified in an interview with staff # 105 on the morning of 8/22/19. |
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| VIOLATION: FOOD AND DIETETIC SERVICES | Tag No: A0618 | |
| Based on observation, interview, and record review, the facility failed to provide dietary services in a sanitary manner to prevent the cross contamination of food products when: A. The two portable freezer units and a multi-use food truck were located on the facility's dock area adjacent to where construction debris and the facility's unsealed, contaminated linens were being off loaded and on loaded. The freezer unit's inside doors, floors, ceilings, and walls were noted with dark debris. B. Multiple kitchen equipment and counters were soiled with old dried food debris. C. Multiple staff were observed in the kitchen and handling food trays without the use of hair restraints. Findings: A.) An observation on morning of 8/15/19, on the facility's dock receiving area, revealed a large, open construction container with discarded construction debris inside, including fiberglass, dirty stained ceiling tiles, and wall board. The Sysco food delivery truck was making a food delivery and was sitting adjacent to the construction container. An observation on the morning of 8/19/19, on the facility's dock receiving area revealed the facility's contracted linen service truck being loaded with large containers of soiled linens. The containers were uncovered and the linen was stacked over the top. The linen truck was parked adjacent to the Sysco delivery truck making a food delivery. Review of the facility provided Isolation Policy MD Anderson Institutional Policy #CNN0432 reflected, " ...All Soiled linen should be treated the same regardless of whether or not a patient is on isolation .... B.) Observations on the morning of 8/12/19 in the facilities kitchen, accompanied by Staff #60, RD, LD, Director of Nutritional Services, revealed the following: - Three plastic cutting boards with deep gouges cut into the material leaving visible dried food debris in the grooves. -The facility's soup dispensing machine had multiple parts with dried-on food debris, with the likelihood of debris falling back into the soup. - The underside of shelving in the bakery was dirty with dried food debris that could fall into the food being prepared. - The large round cooking kettle had visible food residue and a piece of paper was noted sitting in the bottom of the kettle's inside drain. Review of the facility policy Cleaning and Sanitizing #7-08 Department of Dining Services (last reviewed January 2018) reflected, "Introduction To outline the procedures for cleaning and sanitizing in order to prevent contamination of food products ... Scheduled: The areas occupied by Production, the cafeteria and Catering will be kept clean and free of dust, dirt and grease. These areas and all equipment will be cleaned on a scheduled basis ... Non-Food: All non-food contact surfaces of equipment will be cleaned as often as necessary to keep the equipment free of dust, dirt, grease and food particles. Sanitized: Kitchenware, utensils, food preparation surfaces and food contact surfaces of equipment will be washed, rinsed and sanitized after each use or interruption of operation ... C.) Observations while being accompanied by Staff #314 on the morning of 8/13/19 revealed, - On the G11 inpatient unit revealed, Staff #58, room service staff with a beard, was not wearing a beard guard to cover the facial hair. Staff #58 stated, "I should be covering my beard." - On the G11 inpatient unit revealed, Staff #146, room service staff with a beard and moustache, the beard was covered but not the moustache. Staff #146 stated, "I don't have to cover the moustache." - In the facility's kitchen, revealed Staff #313, Refrigeration contractor, in the facility's food preparation area without a hair restraint and a beard guard for his beard. During an interview on the morning of 8/13/19, Staff #60, RD, LD, Director of Nutritional Services stated, "They need to be wearing hairnets and the beard and moustache need to be covered ... Anyone coming into the kitchen needs to be wearing a hair restraint." |
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| VIOLATION: MAINTENANCE OF PHYSICAL PLANT | Tag No: A0701 | |
| **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, record review, and interview, the facility failed to ensure that the hospital environment was maintained in a safe manner. Findings: 1. Emergency Communication in Restrooms in Corridors: a. During tours throughout the facility (Lutheran and Alkek building as well as outpatient clinics Mays, League City and West Houston) it was observed that there was no standardized emergency pull cords in patient designated bathroom in corridors to inpatient units and throughout the facility. If a patient or a visitor who use these bathrooms in the corridors were to fall and could not get up there was no means of communication for calling staff for help. There was no standardization of signage identifying a patient bathroom from staff bathrooms throughout facility. Some areas had signage and locks preventing patients from entering staff bathroom, others did not have signage or means of preventing patients from entering staff designated bathrooms. b. Observation: During tours of MD Anderson Diagnostic Imaging -West Houston which is an outpatient department, it was observed that on the Mammography imaging side of the suite bathroom had emergency stop buttons 4 - 5 feet from the floor. If pressed, a light would come on outside of the bathroom. There were no audible alarms. No emergency pull cords that a patient could reach 6 inches from the floor to access for patients who could fall on the floor could not get up while in these bathrooms. c. Observation on 8/15/2019 at 1:30 PM at the Diagnostic Imaging West Houston Bone imaging area showed four (4) patient bathrooms. Two (2) of the bathrooms had a red call button about 2 feet from the floor adjacent to the toilet and tissue dispenser. A red light on the ceiling outside the bathroom came on when the red call button was pushed in bathroom ECB1.3187. There was no audible alarm when the red button was pushed. No staff member came to bathroom ECB1.3187 when the red light came on in the hallway. In the other two (2) patient bathrooms, there was a red button and a white button. The red button was on the wall and the white button was on the tissue dispenser. The red button in bathroom EDB1.3135 controlled the red light outside the bathroom and the white button made a doorbell sound at the nurse's station when pushed by the surveyor. There was no signage in any of the bathrooms that identified the buttons as emergency call buttons. d. Interviewed staff # 43 throughout the tours of the facility [DATE] - 22, 2019 at various times who also witnessed, took pictures, and confirmed that patient/visitor bathrooms in the corridors to the inpatient units and the outpatient clinics visited did not have emergency pull cords or any form of emergency call system for patient or visitors who collapse on the floor. Staff #43 also observed there were no standardization of signage delineating staff restrooms from patient restroom. If a restroom in corridor had "staff use" signage there were no standardization of preventing patients from going into staff bathrooms. e. In an interview with Staff 176 on 8/15/2019 at 1:30 PM at Diagnostic Imaging Bone Imaging suite, she stated that the bathrooms with just the red button do not alarm at the nurse's station, adding that if the red button was pushed, a staff member would need to be in the area to notice it. She also stated that there was no signage in any of the bathrooms that instructed patients to push the red or white emergency buttons (red or white) in case of an emergency f. Interview with nursing staff # 367 at G21 floor on 08/19/19 at 02:15 p.m. revealed, patient restroom G21.3605 in corridor outside of nursing unit an emergency pull cord alarm was not installed. She stated "we're using this unit temporarily." g. Interview on 08/20/19 at 09:28 a.m. with staff #368 on G18 floor revealed that patients in therapy would use the restroom in corridor G18.3605. He confirmed the restroom had no emergency pull cord alarm in place. h. Review of National Fire Protection Association 99 which refers to healthcare facilities states "Under NFPA 99, each patient bed and bath is required to have a call station. Call stations in the bathroom must be accessible to someone lying on the floor ...." i. American with Disability Act Requirement (ADA) states "The ADA mandates that an accessible element, such as a nurse call system, must be mounted no higher than 48 inches from the ground for spaces that only allow forward reach" j. Guideline for Designs and Construction of Health Care Facilities (FGI Guidelines): States:" 10.3.8.3 Emergency call system- Specific locations in the hospital (a)Patient toilet and bathing facilities. A nurse emergency call system shall be provided at each inpatient toilet, bath, sitz bath, and shower room. A nurse emergency call shall be accessible to a collapsed patient lying on the floor. Inclusion of a pull cord will satisfy this standard. (b) Outpatient and treatment areas. Provisions for emergency calls shall be provided in outpatient and treatment areas where patients may be subject to incapacitation." 2. Based on observation, interview, and record review, the facility failed to ensure the safety of patients and staff by maintaining the ceiling tiles in 2 of 2 areas: Janitor's Closet WTC2.10.10 and G7 hallway at room G7.3220C. Failure to maintain the complete membrane formed by the ceiling can compromise the operation of the sprinklers or detectors. a. Observation on 8/14/2019, at 11:00 AM, of the Medical Arts Center in The Woodlands showed that a ceiling tile was cocked sideways in a Janitor's Closet WTC2.10.10, located on the second floor. A sprinkler head had been installed in ceiling. b. Observation on 8/21/2019, at 11:30 AM, of a hallway in G7 showed that a ceiling tile just outside room G7.3220C was missing. The hallway had ceiling sprinkler heads. c. In an interview with Staff 43 on 8/21/2019 at 11:30 AM, he stated the ceiling tiles should be in place. d. Record review of Maintenance Infection Control Risk Assessment (not dated or timed) revealed: "Table C - Description of Infection Control Precautions by Class ... Class II ... 5. Immediately replace ceiling tile(s) displaced for visual inspection." e. Observed on 8/21/19 at 8:45am Baseboards in Alkek building 1st floor near elevator dinged and bent, floors dirty from heavy traffic in area near elevators |
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| VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE | Tag No: A0724 | |
| Based on observation, interview, and review of policy, the facility failed to: 1. Ensure facility equipment was on a Preventive Maintenance Program and had stickers on equipment to show equipment they had been inspected. 2. Maintain facilities and supplies to ensure an acceptable level of safety and quality as expired medical supplies were found in patient care areas available for use which potentially could have resulted in unsafe or ineffective medical supplies being used. Finding: 1. During tour of facility equipment there were random equipment found in facility that was either not on a preventive maintenance program or did not have a safety Preventive maintenance sticker on the equipment a. During a tour of the hospital Acute Palliative Care Unit on 08/20/19 in the company of staff #97 revealed two Hoyer lifts had no inspection sticker indicating they had been inspected for safety. Interview with staff #97 during the tour, confirmed that the two Hoyer lifts had no inspection sticker. b. Interview with staff #366 on 08/21/19 at 09:35 a.m., revealed the hospital had not inspected the two Hoyer lifts. Staff #366 stated, "we're in the process of developing a PM (Preventive maintenance) procedures for the hospital Hoyer lifts." c. Observation of Mays Clinic at Cancer prevention unit on 08/13/19 at 09:25 a.m., revealed the specialized mammography assist chair used in the unit had not been inspected. d. Interview with nursing staff # 39 on 08/13/19 at 09:26 a.m. at Mays clinic who confirmed the mammography chair had no inspection sticker. Personnel #1 stated "I didn't know it was not inspected. It's supposed to have an inspection sticker." e. Observed Preventive maintenance stickers missing from some of the equipment in random facilities toured example room P716 in Lutheran building automated vital sign monitor with no preventive maintenance stickers, Alkek Operation room suite missing preventive maintenance stickers on Storz CMAC Anesthesia monitor as evidence of preventive maintenance being done on equipment. f. Interview with nursing staff #9 on August 21, 2019 at 10:23am during tour of main OR at the Alkek building, witnessed and confirmed Storz CMAC Anesthesia Monitor was missing PM stickers. Interviewed staff # 367 on August 13, 2019 at 11:15am am during tour of unit on floor P7 Lutheran building who witnessed and confirmed preventive maintenance sticker was missing and should have been on equipment. g. Review of Instruction manual for both mammography, total lift chair and Hoyer lift. The Hoyer lift instruction manual state that "daily checks, yearly service, inspections, and tests will ensure a lift is kept in optimum safety working condition. The Ultralift manual states "daily, monthly and yearly inspections and adjustments are to be done by a qualified technician .... inspection should be recorded and include but not be limited to, date, model, serial number, findings, corrective measures ..." h. Review of facility policy titled "Medical Equipment Management Plan" with last revision date of 02/24/18, reflected the following purpose: " ...involves the promotion of safe environment for patients and staff, which meet regulatory, operational and financial requirements." 2. a. A bottle of isopropyl alcohol found in the Holly Hall Blood Donor Center that had been transferred from the original container was not properly labeled which potentially caused it to be kept beyond the expiration date. b. Emergency call cords in dressing rooms in the Radiology Outpatient Clinic were rendered inoperable by the cords being wrapped around plastic wall signs which potentially could cause a patient in distress not being able to get help readily. c. During a tour of the Respiratory Department on the morning of 8/12/19 in the company of staff #34 the following expired supplies were found. 1. Found in the Dirty Equipment Room: Bleach Germicidal Wipes, 1 lb. 10 oz. container, expired 8/17; Hydrogen Peroxide spray, 2 oz. bottle, 6 expired 8/12 and a 4 oz. bottle expired 4/10. 2. Found in the MICU RT Storage Room in a bronchoscopy cart, Cytology Brush, expired 9/17. d. In an interview with staff #34 during the tour on the morning of 8/12/19, staff #34 confirmed that the above listed supplies were expired. e. During a tour of the Cardiopulmonary Center on the morning of 8/19/19 in the company of staff #296, PDI Sani-Cloth Bleach Wipes, package of 75, expired 6/19 were found in PFT Room #3. In an interview with staff #296 during the tour on the morning of 8/19/19, staff #296 confirmed that the Sani-Cloth Bleach Wipes were expired. f. During a tour of the Thoracic and Orthopedic Treatment Center on the afternoon of 8/19/19 in the company of staff #299 the following expired supplies were found in the Cast Room: BD Eclipse Needle, 30 gauge x ", 3 expired 9/17; BD Eclipse Needle, 27 gauge x ", 30 expired 1/19; and Xeroform 5" x 9", 2 expired 3/19. In an interview with staff #299 during the tour on the afternoon of 8/19/19, staff #299 confirmed that the above listed supplies were expired. g. During a tour of the Holly Hall Blood Donation Center located at 2555 Holly Hall St. Houston, TX on the morning of 8/20/19 in the company of staff #331, an approximately 4 oz. plastic bottle containing a clear solution was found in the refrigerator in the collection area lab. The bottle had a hand written label which reflected "91% Isopropyl Alcohol 7/20/16." There was no expiration date recorded on the label. In an interview with staff #331 during the tour on the morning of 8/20/19, staff #331 stated that the bottle should have been labeled with the expiration date. h. The facility policy entitled "Beyond Use Dating and Labeling of Medications, Disinfectants and Antiseptics in Patient Care, Perioperative and Procedural Areas Policy" #CLN0438 dated 12/13/17 reflected in part "1.3 C. Disinfectants and Antiseptics should be discarded by the Expiration Date indicated by the manufacturer on the label." i. The facility policy entitled "Reagents - Labeling, Preparation, and Storage" # DIV QIP 0613 dated 7/23/09 reflected in part "3.0 Reagents, calibrators, controls, stains, chemicals and solutions are properly labeled, as applicable and appropriate, with the following elements: Name, content quantity, concentration or titer; Storage requirements; Date prepared, filtered or reconstituted by laboratory; Expiration date or new expiration date if opening the container changes the expiration date, storage requirements, etc.; Lot number if applicable; Cautionary information, if applicable." j. In a tour of the Radiology Outpatient Clinic located at 1700 Holcombe Blvd., Houston, TX on the morning of 8/15/19 in the company of staff #195 , the emergency call cords in 2 of 4 dressing rooms were observed to be wrapped around a plastic sign mounted on the back wall of the room so if the cord was pulled, the emergency call would not activate. The cord was also shortened by being wrapped around the sign so it could not be reached if a patient was on the floor. In an interview with staff #195 during the tour on the morning of 8/15/19, staff #195 acknowledged that the emergency call cords were wrapped around the signs in the two dressing rooms. k. During observation of the Breast Center Outpatient Clinic on floor 5 in the late morning on 8/12/19, it was revealed that Treatment Room #3 contained 16 expired 6.0 sutures, the 'Chart Room' contained 12 expired 7.0 sutures, and Room #10 contained an expired Mediplex Transfer Dressing. In an interview on 8/12/19 at the time of these findings with Staff #29 Nurse Manager, she stated the expired supplies should not have been in the rooms. l. During observation of the Genitourinary Outpatient Center's Clean Utility Room on floor #7 on the morning of 8/13/19, it was revealed that the dermatology "Padget" machine contained 16 expired disposable blades (expired 9/07). In an interview on 8/13/19 at 10:00 AM with Staff #32-Nurse Manager, he stated the 16 expired disposable blades should have been discarded and not have been available for use. m. During observation of the 11th floor Bone Marrow Aspiration outpatient clinic in the early afternoon on 8/14/19, there were expired 'Sanicloth' wipes used for cleaning in rooms #13 (expiration 4/19) and #14 (expiration 6/19). In an interview on 8/14/19 at the time of these findings with Staff #185, he stated the expired Sanicloths should not have been in the rooms. n. During observation of the Head and Neck outpatient center workroom on the 10th floor in the late afternoon on 8/14/19, there was one full box of expired Hemoccult slides (expiration 7/18). In an interview with Staff #184 during the time of observation, she stated the Hemoccult slides should not have been available for patient use and promptly discarded the entire box. o. Review of hospital "employee notes" dated Friday, August 5, 2016 stated: "Here are seven ways to maintain the cleanliness of patient-care items in clean supply/storage rooms.: ...4. Discard expired supplies by regularly checking supplies ..." p. Review of hospital "Focus of the Week | July 1, 2019" stated: "Monitor expiration dates of supplies/medications". Among the areas listed was: "Crash cart medications and supplies (e.g., pads)." "Medical supplies, including disinfectants and antiseptics". |
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| VIOLATION: INFECTION CONTROL | Tag No: A0747 | |
| Based on observations, interviews, and records review, the facility failed to provide a sanitary environment to avoid sources and transmission of infectious and communicable diseases. The facility failed to: 1.) Ensure that clean linens were not contaminated by soiled linens, soiled equipment and/or soiled staff uniforms. 2.) Ensure that sterile surgical linens were handled and stored to prevent contamination by dust, soiled linens, soiled equipment and/or soiled staff uniforms. 3.) Ensure that durable medical equipment which was removed from isolation rooms was sanitized using the appropriate disinfectant for the organism being isolated and stored under appropriately clean conditions after disinfection. 4.) Ensure that nursing staff were educated in and used the appropriate disinfectant for the organism being isolated when disinfecting equipment coming out of patient isolation rooms. 5.) Ensure that patient transportation staff cleaned and disinfected wheelchairs and stretchers between patient uses, as well as stored said equipment under appropriately clean conditions. 6.) Ensure Environmental Services/Housekeeping maintained isolation precautions to prevent cross contamination while conducting housekeeping services. It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients in the facility at risk for the likelihood of harm, serious injury, and possibly subsequently death. 7.) Ensure policies were developed and implemented for the proper use of the Trophon High Level Disinfectant System for ultrasound probes. 8.) Ensure staff were utilizing the required protective equipment when entering isolation rooms. The facility also failed to include the protective equipment required for isolation in the facility policy. 9.) Ensure staff wash/sanitize hands between touching contaminated items and performing entral venous catheter and vascular access care during initiation and termination of hemodialysis treatment on 2 of 2 patients observed. Patients #49 and 36. 10.) Know the Hepatitis B antibody status or administer the immunization for 5 of 10 non-immune surgical staff health records reviewed. (Staff #267, #272, #288, #289, and #291). The facility failed to follow the CDC guidelines and the facility policy on Hepatitis B monitoring and follow-up guidance. 11.) To maintain a sanitary environment in 10 of 10 departments throughout the facility system. (Pain Management Clinic at 1515 Holcombe Blvd, MOHS and Dermasurgery Center, Main Campus Pharmacy, La Maistre Building, Mays Clinic Building, Main Campus, League City, West Houston, Sugar Land, and Diagnostic Imaging.) Cross Refer to Tag A0749 |
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| VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES | Tag No: A0749 | |
| **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observations, interviews, and records review, the facility failed to provide a sanitary environment to avoid sources and transmission of infectious and communicable diseases. The facility failed to: 1.) Ensure that clean linens were not contaminated by soiled linens, soiled equipment, and/or soiled staff uniforms. 2.) Ensure that sterile surgical linens were handled and stored to prevent contamination by dust, soiled linens, soiled equipment, and/or soiled staff uniforms. 3.) Ensure that durable medical equipment, which was removed from isolation rooms, was sanitized using the appropriate disinfectant for the organism being isolated and stored under appropriately clean conditions after disinfection. 4.) Ensure that nursing staff were educated in and used the appropriate disinfectant for the organism being isolated when disinfecting equipment coming out of patient isolation rooms. 5.) Ensure that patient transportation staff cleaned and disinfected wheelchairs and stretchers between patient use, as well as stored said equipment under sanitary conditions. 6.) Ensure Environmental Services/Housekeeping maintained isolation precautions to prevent cross contamination while conducting housekeeping services. It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety, and placed all patients in the facility at risk for the likelihood of harm, serious injury, and possibly subsequent death. Findings: 1.) Observations conducted on 8/14/19, from 1:30 p.m. to 2:30 p.m., of the main laundry staging areas for the hospital revealed the following information: -Soiled Linen area (the pit): Both sets of double doors leading into the soiled linen area were being maintained in an open fashion. At the back of the soiled linen room was another set of double doors which were partially pushed open. Clean linen could be viewed through the door. The surveyor asked the Director of Materials Management what area was behind the double doors located at the back of the soiled linen room. The director stated that it (the doors) lead directly into the clean linen area and that the door should remain shut. The director then closed the doors. However, a crack remained between the doors which was large enough to fully see the clean linen. -Clean Linen area: Observation of the clean linen carts containing the operating room (OR) scrubs revealed that they were being stored in directly in front of the double doors which lead into the soiled linen area. The surveyor could feel air flow coming from the soiled linen area into the clean linen carts which had a foul odor. The plastic covering of the carts was ripped and torn and was being blown by the air flowing through the door. Continued observations revealed sterile surgical linens were being stored on wire racks in the same room with basic linens. The sterile linens were not wrapped in a manner to ensure sterility and the cart itself was only partially covered by a torn plastic sheet. Dust and other debris were observed on the sterile linens. On the other side of the same room was located the employee's personal lockers as well as lockers marked for the deposit of employees soiled work clothing. On the adjoining the wall where the work lockers were located was another set of double doors with a sign marked "soiled equipment." In an interview conducted on 8/14/19 at the time of observation, the Director of Materials Management, stated that the sterile linen being stored in the main linen area was back up for surgery and that materials staff were just waiting for the surgery staff to request the sterile linens so it could be sent up. During continued interview, the surveyor asked about the adjoining room marked "soiled equipment". The director stated, "no one is to be exiting with dirty equipment through that door." During another interview conducted on 8/15/19, at 9:00 a.m., with the Director of Material Management regarding the sterile linen observed by the surveyors on 8/14/19, The director stated he had a conversation with the Operating Room (OR) supervisor prior to the surveyor's arrival the morning of 8/15/19. The OR supervisor informed him that the sterile linens observed the previous day should be sent back to the laundry due to dating/labeling concerns on the packaging. Prior to his conversation with the OR director, he was not aware that there was anything wrong with the sterile linens. He further revealed that he thought the packaging of the sterile linens looked appropriate. However, the sterile linens should have been sent to the dirty (soiled) laundry area for reprocessing. 2.) Continued observations conducted on 8/15/19, from 9:15 a.m. to 10:30 a.m., of the main clean linen storage area revealed the following: -Two linen carts were observed to contain sterile surgical linens. The sterile surgical linens were not wrapped in a manner to ensure sterility and were soiled with dust and unidentified debris. These carts were being stored directly across from the staff lockers and the doors leading to the soiled equipment area. While the surveyors were observing the sterile surgical linens, hospital staff were observed to open the soiled equipment room doors and removed 2 equipment carts from the soiled area, wheeling them through the clean linen area. In an interview conducted on 8/15/19 at the time of observation, the Director of Materials Management stated that he was not aware that the other 2 carts of sterile linens were down in the clean linen storage area. In an interview conducted on 8/15/19, at 3:50 p.m., the director of Infection Control revealed that the main soiled linen storage area (the pit) was a "negative pressure" room. In an interview conducted on 8/16/19, at 10:00 a.m., the Director of Operations and Maintenance and Heating Ventilation and Air Conditioning (HVAC) Technician #209 stated that prior to the evening of 8/15/19 the hospital's main soiled linen storage area was a "positive pressure" room. The HVAC technician also stated that the main clean linen room was supposed to be a "positive pressure" area, but the system was not functional. He further stated that he was not certain how long it had been broken. Record review of the facility policy entitled: Infection Control for Patient Care Areas, dated 4/11/19, Version #46.0 revealed in part the following information: Section 4.6) Patient care linen should be stored in a way as to assure cleanliness and to prevent contamination. -M.) Package, transport, and store clean linens by methods that should ensure their cleanliness and protect them from dust and soil during intra-facility and inter-facility loading, transport, and unloading. Record review of the facility policy entitled: Isolation Policy, dated 3/31/16, Version# 49.0, revealed in part the following information: Section 16.0) Soiled Linen -All soiled linen should be treated the same regardless of whether or not a patient is on isolation. Record review of the facility policy entitled: Instrument and Equipment: Cleaning, Disinfection & Sterilization, dated 7/31/19, Version# 50.0, revealed in part the following information: 4.8) Storage of Sterile Items: E.) Factors that Compromise the Bacterial Barrier Efficiency of a Package Material: -Airborne bacteria may be forced into the package by incorrect or excessive handling, poor storage facilities, or improper techniques. -Dust may be forced into the package by incorrect or excessive handling, poor storage facilities, or improper techniques. F.) Appropriate Storage Conditions for Sterile Packs: Per AAMI recommendations, including: -Limited Access to storage area and/or closed cabinets. -Store soiled/dirty supplies separately from clean or sterile supplies. -Area must be clean, dry, and dust free. -Temperature and relative humidity per AAMI recommendations. -Controlled area signs posted. 3.) Observation conducted on 8/15/19 at 10:10 a.m. of the facility Soiled Equipment room, located adjacent to the clean linen area, revealed the following information: -Areas marked "Clean" and "Dirty" were demarcated by a roughly taped red line on the floor. -Equipment carts located on the "clean" side of the room were observed to have peeling tape, dust, unidentified debris, and stains/spills on them. -Wire racks used to store clean equipment had debris and an unidentified dried brown substance on them. -Wooden shelves used to store clean equipment were observed to have large amounts of accumulated dust and unidentified debris on them. -Medical equipment identified as clean, and ready for patient use, were observed to have dust and debris on the surface of the machines. -An IV pump which was on the "clean" side of the room was noted to have a substance that resembled dry blood splatter on the side, with accumulated dust and debris on top of the machine. In an interview conducted on 8/15/19, at the time of discovery, the director of Infection Control confirmed the above findings. Record review of the facility policy entitled: Infection Control for Patient Care Areas, dated 4/11/19, Version# 46.0 revealed in part the following information: Section 4.14) Clean or sterile items should be separated from dirty equipment and dirty areas. In an interview conducted on 8/15/19, at 10:20 a.m., Materials Management Staff #339 stated that equipment that comes from isolation rooms comes down to the soiled equipment room bagged. When asked by the surveyor if materials management staff are informed what type of organism was in the isolation room where the equipment was located, he stated, "no, they don't tell us. We just know it came from isolation because it is bagged." When asked what type of disinfectant is used to clean equipment from isolation rooms, the staff stated that materials management staff use Super Sani Wipes (Purple) (QUAT Type) to clean all equipment. Even equipment from isolation rooms. In an interview conducted on 8/15/19, at 3:50 p.m., the Director of Infection Control revealed that the the soiled equipment area, which is adjacent to the main clean linen storage, is used to store equipment from patient isolation rooms. She further stated that IV pumps, from isolation rooms, are disinfected twice. Once by materials management staff, then a second time by pharmacy staff. In an interview conducted on 8/19/19, at 2:10 PM, the Assistant Manager of Pharmacy confirmed that pharmacy does a second wipe down of the IV pumps with Super Sani Wipes (QUAT) which come from the "clean" side of the equipment room in materials management. When asked by the surveyor why pharmacy staff felt it was necessary to perform a secondary cleaning of the pumps, the assistant manager stated, "for our own piece of mind." The surveyor then asked if pharmacy personnel were informed what type of organism was in the isolation room in which the IV pumps were removed. He stated, "no, we aren't told what type of isolation the patient is on." Record review of the facility policy entitled: Isolation Policy, dated 3/31/19, Version# 49.0, revealed in part the following information: 15.0) Environmental Measures: 15.3) Cleaning and disinfecting non-critical surfaces in patient care areas are part of standard precautions. In general, these procedures do not need to be changed for patients on isolation precautions, except for C. Difficile, cluster, or outbreak in which 1:10 dilution of sodium hypochlorite (bleach) may be used. 4.) Observations conducted on 8/13/19, at 11:25 am, of Room # G 1248 (patient 42) revealed there was an isolation cart located outside his room. A sign which stated the patient was on contact isolation was hung on the door. An open box containing individually wrapped Super Sani Wipes (QUAT type) was located on the cart. The package information located on the Sani wipe box stated that the box held 50 individually packaged wipes. The surveyor opened the top of the box and observed only 13 packages of wipes were left. In an interview conducted on 8/13/19, at the time of observation, with Associate Director of the palliative care unit revealed that patient # 42 was on isolation precautions for C. Difficile (C-Diff) toxin. When asked what disinfectant was to be used for patients on isolation for C-Diff infection, the Associate Director stated that staff were supposed to be using bleach wipes for the disinfection of C-Diff isolation rooms. In an interview conducted on 8/13/19, at 11:32 am, Registered Nurse (RN) #98 revealed that she was the primary nurse for patient #42 . She further stated that the Super Sani Wipe Box, which was observed on the isolation cart, came with the cart and that she was the one that opened the box to use it (the wipes). When asked by the surveyor what she used the Super Sani wipes (QUAT) to disinfect, RN#98 would not tell the surveyor. Observation conducted on 11:38 am of the garbage can outside of patient #42's isolation room revealed numerous open used packages of Super Sani wipes, which had been discarded in the garbage can. Record review of the Physician's progress notes for Patient #42 revealed that he was a [AGE]-year-old male, admitted on [DATE], with diagnosis of advanced metastatic pancreatic cancer. Further review of the clinical record revealed that the patient had a consult with the Infectious Diseases Physician due to Klebsiella pneumonia bacteremia and C. Difficile, for which the patient was placed on contact isolation. Record review of the facility policy entitled: Isolation Policy, dated 3/31/19, Version# 49.0, revealed in part the following information: 15.0) Environmental Measures: 15.3) Cleaning and disinfecting non-critical surfaces in patient care areas are part of standard precautions. In general, these procedures do not need to be changed for patients on isolation precautions, except for C. Difficile, cluster, or outbreak in which 1:10 dilution of sodium hypochlorite (bleach) may be used. 5.) Observations conducted on 8/21/19 from 10:00 am to 11:08 am of the facility wheelchair storage areas revealed the following: - The floors in the patient transportation storage rooms, where wheelchairs were stored, were observed to have dust, food wrappers, screws, unidentified debris, as well as a black substance throughout the floor. -Base boards were falling off the walls. -Large holes were observed in the sheetrock. -Large bins of soiled linens were being stored in the same room with the wheelchairs. IV poles were being stored behind the soiled laundry bin. One IV pole had become entangled in the top of the bin and was stuck. In an interview conducted on 8/21/19, at 10:32 am, the Associate Director of Patient Resources confirmed the above findings. She further stated that the wheelchair storage room was not on a routine housekeeping schedule, and that patient transportation staff were responsible for notifying housekeeping when the storage room needed cleaning. During continued observations conducted on 8/21/19, at 10:55 am, patient escort staff #357 was observed to be cleaning a wheelchair for patient transport. As staff was getting ready to leave the storage area, the surveyor asked patient escort staff #357 if the wheelchair was now "clean" and ready for patient use. The staff stated "yes." Upon the surveyor's further observations, the "clean" wheelchair was noted to have a white splattered substance on the inside of the wheelchair arms, chewed bubble gum stuck between the top portion of the seat and arm rest, and human hair stuck to the connection where the foot rest attaches to the main body of the wheelchair. Observations conducted on 8/21/19, from 11:15 a.m. to 11:45 a.m., of the patient transportation stretcher storage area revealed the following: - The bottoms of the stretchers throughout the storage area were noted to be soiled with dust, unidentified debris, and a black substance. - 3 stretchers were observed to have a dried brownish red substance on the wheels which resembled dried blood. - 2 mortuary tables were observed to have candy wrappers shoved in the openings of the metal frames. - 6 stretchers were observed to have used rubber gloves, candy wrappers, and other unidentified debris shoved down inside of the integrated oxygen tank holders. - The stretchers throughout the storage area had a black substance located on the inside of the integrated oxygen tank holders. - 4 stretchers had ripped/torn pads and were still in circulation for patient use. During the above observations, staff were observed cleaning stretchers in preparation for patient use. The surveyors noted staff were only wiping down the top of the mattress pad and the siderails of the stretchers. At no time were staff observed to clean underneath the mattress pads, look inside the oxygen tank holders, or clean the bottom and wheels of the stretchers. In an interview conducted on 8/21/19, at 11:35 am, patient escort staff #358 stated that staff only clean the top portion of the mattress pad and the siderails of the stretchers. In an interview conducted on 8/21/19, at 11:39 am, the Director of Patient Transportation confirmed the above findings and revealed that staff only clean the areas of the stretcher that the patient is likely to touch. Record review of the facility policy entitled: Instrument and Equipment: Cleaning, Disinfection & Sterilization, dated 7/31/19, Version# 50.0, revealed in part the following information: Section 2.2) Steps for Cleaning Reusable Instruments, Equipment, and Items in the Environment: -B.) Equipment: -Remove any organic or inorganic debris by manually cleaning. -C.) Environmental Items (e.g. door handles, phones, counters, nurse call devices, bedside tables, workstations on wheels, beds, stretchers, patient care furniture, keyboards and floors). -Patient care furniture, e.g. stretcher pads, mattresses, sleeper sofas, reclining chairs, should be free of tears, rips of damage that could prevent appropriate cleaning or disinfection. -Remove any organic or inorganic debris by manually cleaning. Based on observations, review of facility documents, and staff interview, the facility failed to develop and implement policies governing control of infections and communicable diseases. Findings: *Facility-based policy titled "Instrument and Equipment: Cleaning, Disinfection & Sterilization Policy" stated in part, "3.5 High-Level Disinfection (Semi-Critical Items) A. New Instrument and Equipment manufacturer requirements for High-Level Disinfection must be determined prior to purchase, and Infection Control, Environmental Health and Safety (EH&S) and Facilities should be notified to assure best practice guidelines for Disinfection can be met." ...J. Policies and procedures for High-Level Disinfection will be developed using the validated instructions provided by the medical device manufacturers, reviewed at regular intervals, revised as necessary, and readily available in the practice setting." Observations of the Radiology Department in the main campus and West Houston Diagnostic Imaging throughout the survey (8/12/19 through 8/21/19) revealed staff were using a Trophon High-Level Disinfection system for ultrasound probes. In an interview on 8/16/19 at 10:35 am, when asked for a policy regarding the system, staff # 105 stated there was no policy regarding the specific Trophon system. *The waterbath manual in the CT simulator area of the Sugarland site stated in part, "Reprocessing: Warning: Users of this product have an obligation and responsibility to provide the highest degree of infection control to patients, co-workers and themselves. To avoid cross-contamination, follow infection control policies established by your facility. Note: Drain and clean waterbath periodically." The facility "Civco Water Bath Cleaning Procedure" stated in part, "This procedure should be performed monthly." Review of the facility water bath cleaning schedule for the Sugarland site on 8/15/19 revealed the following months were missing for the last two years: 10/17, 2/18, 5/18, 9/18 and 12/18. The above was verified in an interview with staff # 105 on the morning of 8/22/19. Based on observation, interview, and record review, the facility failed to provide care in a sanitary environment when staffs were going into isolation rooms without the required protective equipment and the facility's isolation policies did not include the protective equipment required for Protective isolation and the appropriate sanitizing product for C-Difficile. Findings: Review of the facility policy, Infection Control for Patient Care Areas Policy (Published Date: 4/11/2019) reflected, "The purpose of this policy is to minimize the risk of the transmission of infections from patient to patient and between patients and faculty, trainees/students, and other members of MD Anderson's workforce ....3.2 Once a patient has been identified as requiring isolation ... the isolation status should then appear in the patient medical record .... Once the isolation status of the patient is determined, appropriate action should be taken ..." Review of the facility policy, Isolation Policy (Published Date: 3/31/2016) reflected, "The purpose of this policy is to prevent transmission of microorganisms from infected or Colonized patients to other patients, family members, visitors, ... 2.0 Protective Isolation 2.1 Protective isolation is the practice of protecting a susceptible patient from acquiring an infection from other sources, either directly or indirectly. 2.2 Although protective isolation is no longer recommended by the CDC, protective isolation may be instituted for patients on the Hematology Services and the Pediatric Service at the discretion of the Physician. The services utilizing protective isolation are responsible for providing education on this issue to the nursing units caring for their patients ... 5.0 Contact Isolation ... D. Clostridium Difficile (wash hands with soap/water only) ... 15.3 Cleaning and disinfecting non-critical surfaces in patient care areas are part of standard precautions. In general, these procedures do not need to be changed for patients on isolation precautions, except for C. Difficile, cluster, or outbreak in which 1:10 dilution of sodium hypochlorite (bleach) may be used ..." An observation on the morning of 8/12/19, on the G10 unit, revealed Staff #202 and Staff #47 go into room G10.70 without donning an isolation mask or gloves. The nurses turned off the IV machine that was beeping and lowered the bed. The sign on the patient's door reflect the patient was on Contact Isolation Precautions. During an interview on the morning of 8/12/19, Staff #47 when asked if she was aware the patient was on Contact Isolation stated, "I didn't see the sign, this isn't my patient ..." During an interview on the morning of 8/12/19, Staff #47 stated, "The patient is on protective Isolation, gloves and masks need to be worn .... They put the wrong sign on the door." During an interview and observation on the morning of 8/13/19, Room G10.70 with a Contact Isolation sign on the door, when asked what she was on isolation for, Staff #47 stated, "C-diff ... it's the wrong sign. A 'Contact Isolation with soap and water' sign was placed on the door." Review of the patient's medical records revealed Patient #187 was not at risk for contracting an infectious disease and did not require Protective Isolation. During an interview on the morning of 8/14/19, in the facility conference room, Staff #40 confirmed the facility's Protective Isolation policy did not reflect the protective equipment needed or detail the exclusions for a person on Protective Isolation such as no fresh plants and that the wording 'may' to 'must' for the Section 15.3, related to use of beach with patient on C. Difficile Isolation, needed to be changed. Based on observation, interview, and record review, the facility's staff failed to maintain a sanitary environment by ensuring staff wash/sanitize hands between touching contaminated items and performing central venous catheter and vascular access care during initiation and termination of hemodialysis treatment on patients. Patient #s 49 and 36 Findings: Patient #49 On 08/12/2019, at 12:04 p.m., contract Registered Nurse #59 was observed on the 11th floor Hemodialysis suite. The Registered Nurse was observed terminating hemodialysis treatment on Patient #49 who had a right double lumen subclavian central venous catheter, by which he had received hemodialysis treatment. Observation revealed the Registered Nurse created a clean field which she stored syringes with normal saline for flushing of the Patient's central venous catheter and swabs. The Registered Nurse donned a pair of clean gloves, picked up the garbage bin with her gloved hands then touched the clean field with her contaminated hand used to remove the garbage bin. The Registered Nurse did not wash/sanitize her contaminated hands after touching the contaminated garbage bin. Subsequent observation revealed the nurse was observed wearing a face shield with a mask attached. During rinse back of the Patient's blood and termination of the limbs of the central venous catheter from the external blood line revealed, the mask was observed under Registered Nurse #49's nostrils which created the potential for harmful pathogen from the nurses' nostrils contaminating the Patient's central venous catheter. On 08/12/2019, at 12:18 p.m., the surveyor notified Registered Nurse#49 of her observation of break in infection control technique while discontinuing the patient's hemodialysis treatment. Registered Nurse #49 stated "ok." Patient #36 On 08/14/2019, at 9:15 a.m., Registered Nurse #118 was observed in the hemodialysis unit in room 1979. The Registered Nurse was initiating hemodialysis treatment on Patient #36. The Patient had a left arm vascular access via which he receives hemodialysis treatment. Observation revealed Registered Nurse (118) donned a pair of clean gloves, removed the soiled dressing from the patient's vascular access site, assessed the patient by checking the patient's blood pressure and feet, reset the cardiac monitor attached to the patient, picked up a face shield from the computer station and applied it to his face. After completing the various tasks, the Registered nurse cleaned the Patient's vascular access site and inserted the hemodialysis needles with his contaminated gloved hands. Subsequent observation revealed the Registered Nurse washed his hands and applied a pair of clean gloves. He then flushed the patient's lines and attached the external blood lines to the needles he had inserted. After attaching the blood lines, Registered Nurse #118 applied alcohol jell to the contaminated gloves he was wearing then picked up the patient's prescription sheet from the computer station. During an interview on 08/14/2019, at 9:45 a.m., in the presence of the Facility's Hemodialysis Nurse Manager and Registered Nurse #118, the surveyors notified Registered Nurse #118 that he had used the same gloves to examine the patient and touched various objects in the room and his face while applying the face shield, then used his contaminated gloved hands to cannulate the patient's vascular access. Registered Nurse #118 stated, "I thought I changed my gloves twice." The Surveyor then informed him that he had applied alcohol jell to the pair of gloves while being worm by him. Registered Nurse (118) stated, "I was nervous." Review on 08/14/2019 of Patient # 36's Clinical record revealed a laboratory result dated 08/12/2019 which indicated the patient was positive for (Escherichia coli). Review of the facility's contracted service current Policy and Procedure on Treatment Initiation Utilizing Dialysis Catheter: Policy # A-TI-0090 directs staff as follows: " To avoid possible catheter contamination or undue injury to patient , the key is to properly access and de-access the dialysis catheter using aseptic technique." Review of the facility's current policy and procedure on Hand Hygiene Published 3/22/2019 version #35 directs staff as follows: "Standard precautions include: "Hand Hygiene -Perform hand hygiene: (a) After touching blood, body fluids, secretions, excretions and contaminated items - weather or not gloves are worn. (B) After removing gloves (c) Between patient contacts (d) Any time to avoid transfer of microorganisms to other patients or the environment. (e) Between tasks and procedures on the same patient to prevent cross contamination of different body sites. (5) Change gloves between tasks and procedures on the same patient after contact with material that may contain a high concentration of microorganisms." Based on observation, interview, and record review, the facility failed to ensure adherence to its policy regarding appropriate use of personal protective equipment (PPE) and hand hygiene. Two (2) of six (6) nurses observed providing direct patient care failed to change gloves and sanitize their hands per policy (registered nurse [RN] # 98 & # 65). Findings: Review of facility policy titled "Hand Hygiene Policy", dated 3/22/19," showed that when hand washing was not indicated , antiseptic hand rub could be used. Indications for antiseptic hand rub included: before donning and after removing sterile or non-sterile gloves; before handling medication; and after coming in contact with inanimate surfaces in the patient environment. RN #98 Observation on 08/14/19, at 10:30 AM, showed RN # 98 prepared to change the intravenous tubing (IV), change the IV "manifold,"and administer IV medications to Patient # 215. RN # 98 gathered the medication and equipment, washed her hands, and donned appropriate PPE. She stated, she was going to administer IV Thorazine 50 milligrams (mg) in a 50 milliliter (ml) fluid "piggyback." She said, she was also going to give the patient some Robinul IV push. During the changing of the IV tubing, RN # 98 dropped something on the floor and picked it up with her gloved hand, which touched the floor. While wearing the same contaminated glove, she returned to connecting the IV medication and programmed the IV pump. After RN #98 finished hanging the IV Thorazine, she again dropped something on the floor and picked it up wearing the same gloves. She failed to change her gloves and sanitize her hands. While wearing the same contaminated glove, RN # 98 administered Robinul IV push to a peripheral IV line in Patient # 215's lower left forearm. During an interview immediately following the medication administration, RN # 98 stated that she should have changed her gloves and sanitized her hands both times she touched the glove to the floor. She verified it was an infection control issue. RN # 265: Observation on 08/15/19, at 10:10 A.M., showed RN # 265 prepared to change Patient # 227's dressing covering her peripherally inserted central catheter (PICC). In addition, the RN was administering medication to this patient. RN # 265 gathered the needed supplies, disinfected the overbed table, washed her hands, and donned appropriate PPE. She sanitized her hands after removing the old dressing to the PICC site and donned sterile gloves. Following the PICC dressing change, RN # 265 removed her sterile gloves but failed to sanitize her hands between glove changes. She proceeded to administer Patient # 227's medication. Based on review of personnel files and interview, the facility failed to know the Hepatitis B antibody status or administer the immunization for non-immune staff for 5 (#267, #272, #288, #289, and #291) of 10 surgical staff health records reviewed. Also, the facility failed to follow the CDC guideline and the facility policy on Hepatitis B monitoring and follow-up guidance. A review of Staff #267's health record revealed Hepatitis B titer was not drawn. The declination was signed by Staff #267 and marked, "I do not need the Hepatitis B vaccination series; because already had it." There was no evidence the staff member had taken the Hepatitis B series. The facility failed to offer the Hepatitis B vaccine series or draw a titer. A review of Staff #272's health record revealed Hepatitis B titer was not drawn. The declination was signed by Staff #272 and marked, "I do not wish to receive the Hepatitis B vaccine at this time." There was no evidence the staff member had taken the Hepatitis b series. |
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| VIOLATION: SURGICAL SERVICES | Tag No: A0940 | |
| **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, record review, and interview the facility failed to: A. ensure sterile surgical linen packs that contained surgical gowns, drapes, and towels were sterilized according to manufacturer recommendations. B. ensure sterile surgical linen packs that contained surgical gowns, drapes, and towels were transported in a manner that would protect the sterile items from moisture, excessive humidity, and condensation caused by temperature extremes. C. ensure there was a process in place to monitor the sterilization and transport of sterile linen packs from an outside contracted vendor to the surgery department. D. ensure that surgical instruments were transported to an offsite surgery center in a manner that would protect the sterile instruments from moisture, excessive humidity, and condensation caused by temperature extremes. E. ensure that an instrument loaner set that contained surgical implants (Zimmer/Biomet Plates) was sterilized according to the manufacturer recommendations. It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients having endoscopy procedures and/or surgery in the facility at risk for the likelihood of harm, serious injury, and possibly subsequently death. F. ensure that perioperative staff (operating room and Pre/Post anesthesia) had current competencies that were specific to the job they were performing in the facility in 4 (Staff #'s 84, 267, 273, and 288) of 10 personnel records reviewed. G. ensure a sanitary environment for the provision of surgical services in sixteen ( Mays ASC- Pre-Op Supply Room, Anesthesia Supply room, OR3, Interventional Radiology/Cath Lab PACU, Interventional Radiology, Cath Lab, Endoscopy Center, Main OR -Supply Core A&B, OR1, OR16, OR21, OR22, storage room in main OR hallway, Pre-Operative room P503, and Pavilion tower core supply room) of sixteen areas observed. Findings: During a tour on August 15, 2019, at 9:00 a.m. the following observations were made: A. STERILIZATION OF LINEN PACKS In the clean laundry room there were sterile surgical linen packs stored on a permanent wire rack lined on the wall and in transport racks. The transport racks were plastic and wire racks. Clean/unsterile laundry was stored in the same room on the opposite side. There was no barrier to separate the linens. The portable wire racks that contained the sterile linen was coated in rust, dust, dirt, and debris on the bottom shelf. There was a pack identification label on the front of the sterile packs. Some of the labels did not have a load number or date of sterilization noted. On one of the portable wire racks used to transport the sterile linen packs from the outside truck to the surgery department, the shrink wrap was torn and did not cover the cart completely. The linen was exposed to outside contaminates (dust, dirt, insects, and microorganisms) when unloaded from the transport truck. Staff #277 was asked if the external wraps used in the sterilization of the surgical linen packs were impervious. Staff #277 stated, "yes." Staff #277 was asked to open one of the sterile linen packs for observation. At 9:12 a.m., the outside wrapper was placed in a sink and water was turned on to check the impermeability of the drape. Observation of the drape after approximately 10 seconds of water running revealed water seeped through the drape. During a tour of the materials management department on August 15, 2019, at 10:00 a.m., observed sterile linen packs stored on a wire rack. There were several packs noted with a sterilization date of 2014; over 5 years ago. During an interview on August 15, 2019, after 2:00 P.M. Staff #10 was asked if the surgical staff were aware of the grid on the inside of the surgical linen packs indicating the number of sterilizations. Staff #10 said, she was aware of the grid and the parameters of sterilization. Review of several of the surgical linen pack grids on the outer sterilization wrap revealed that the grids were not dated with the start day of the sterilization cycle. The grids were marked with 0, 2, and 6. There was no clear indication on the grid of the number of sterilizations. Staff #10 was asked to explain the grid marks on linens. Staff #10 stated, "I asked the same questions about 3 years ago during a tour of the offsite laundry. I have not been given a clear answer." Review of the manufacturer IFU (Instructions for Use) titled, "Wrap Pel Surgical Wrappers Instruction for use" revealed the following: "Each wrapper comes with a QCM grid that is to be used to track the usage of the product. Each time the product is processed, placed a mark in one of the unmarked squares on the grid. When all 75 squares are filled, remove the product from service." Review of the manufacturer IFU (Instructions for Use) titled, "PerVal Surgical Towels Instructions for Use" revealed the following: "OR towels are reusable through 50 wash, dry, and sterilization cycles." Review of the manufacturer IFU (Instructions for Use) titled, "ComPel Surgical Gowns Instructions for Use revealed the following: "The ComPel Surgical gowns are reusable through 75 wash, dry, and sterilization cycles." B. TRANSPORT OF STERILE SURGICAL LINEN PACKS During an interview with Staff #277 on August 15, 2019, at 9:00 a.m., the following infection control issues were revealed: Staff #277 reported the sterile surgical packs were transported from an offsite facility. Staff #277 stated, "The surgical linen packs are brought into the facility through materials management. The surgical linen packs are picked up in the morning by surgery and transported to the sterile/clean linen room. The portable linen racks have a shrink wrap around them and a cover on top of that." Observations on August 15, 2019, after 9:00 a.m. in the sterile/clean area showed one of the portable wire racks used to transport the sterile linen packs from the outside truck to the surgery department had shrink wrap that was torn and did not cover the cart completely. The linen was exposed to outside contaminates (dust, dirt, insects, and microorganisms) when unloaded from the transport truck. During an observation on August 15, 2019 after 12:45 p.m. the following was noted: A truck was parked at the loading dock outside materials management area to unload linen. The truck had clean linen in plastic carts with a plastic covering. There was no sterile linen on the truck. Staff #143, was asked if the same type of truck was used to transport sterile linen packs for the operating room. Staff #143 stated, "yes." Staff #143 was asked if the truck used to transport sterile linen packs had the same wooden floor as the truck used to transport clean linen. Staff #143 said "yes." Staff #143 was asked if the truck used to transport sterile linen packs for the operating room had any type of environmental controls (temperature and humidity). Staff #143 said "no." Staff #9 and Staff #10 confirmed the observations of the conditions of the transport truck. Review of the ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities revealed the following: "11.3 Transport of sterile packaged items 11.3.1 General considerations Sterile items should be transported in a manner that will protect the items from puncture and from contamination by moisture, excessive humidity, condensation caused by exposure to temperature extremes, insects, vermin, dust and dirt, excessive air pressures, and microorganisms." C. STERILIZATION/TRANSPORT OF STERILE LINEN MONITORING During an interview on August 15, 2019, after 12:45 p.m., Staff #10 and Staff #9 were asked what monitoring was in place for the sterile linen contract. Staff #10 and Staff #9 confirmed the facility did not have a process to monitor the sterilization and transport for the sterile linen packs. Staff #10 stated," I toured the offsite facility 3 years ago and asked several questions about sterilization. I have not been given any answers." Staff #10 and Staff #9 were asked if they were knowledgeable of the process for transportation of the sterile linen packs from the offsite facility to the surgical department. Staff #10 and Staff #9 confirmed they were not. D. TRANSPORT OF STERILE SURGICAL INSTRUMENTS TO OFF SITE FACILITY During a tour of the sterile processing department on August 20, 2019, after 1:00 p.m. the following observations were made: Staff #27 was asked if the sterile processing department transported any instruments to off-site facilities. Staff #27 stated, "yes, we transport to Mohs Surgery Center". Staff #27 was asked what mode (vehicle) the facility used to transport the sterile instruments. Staff #27 stated, "I don't know. We decontaminate and sterilize the instruments but I do not know how they are transported. Staff #27 was asked who was responsible to monitor that. Staff #27 said that Staff #143 was. An interview with Staff #143 on August 21, 2019 after 8:30 a.m. revealed the following: Staff #143 was asked what mode (vehicle) was used to transport sterile instrument sets to the Mohs Surgery Center. Staff #143 stated, they were transported in instrument carts in one of the facility transport trucks. Staff #143 stated, the staff made sure the truck was clean and then proceeded with the transport. Staff #143 was asked if the transport truck was the same type of truck used to transport linen. Staff #143 stated, "yes". Staff #143 was asked if the truck used to transport sterile surgical instrument sets had wood floors. Staff #143 stated, "yes". Staff #143 was asked how the truck was decontaminated after each transport. Staff #143 stated, "we do a visual inspection and sweep the truck out if necessary." Staff #143 was asked if the truck was washed/decontaminated in-between transports. Staff #143 stated, "no we just sweep it if necessary". Staff #143 was asked if the truck used to transport dirty/contaminated instruments would be the same truck to transport clean/sterile instruments. Staff #143 stated, "quite possibly yes." Staff #143 was asked if the temperature and humidity was monitored during transport of the sterile instruments. Staff #143 stated, "no". Review of the transportation logs for sterile surgical instruments transported to and from Mohs Surgery Center from main sterile processing department revealed the following: The sterile processing tracking form titled, "Mohs clinic" revealed 117 dirty/contaminated instrument trays were transported to MD Anderson sterile processing department at the main building from 8-1-2019 to 8-22-2019. The sterile processing tracking form titled, "Department Mohs" revealed 316 sterile instruments/instrument trays were transported to Mohs Surgery Center from the main sterile processing department from 8-1-2019 to 8-21-2019. Review of the facility policy titled, "Instrument and Equipment: Cleaning, Disinfection & Sterilization Policy" dated 7/30/2019 revealed the following: " ...J All transport vehicles (manual or motorized) should be constructed of materials that allow for proper decontamination processes ... ...Appropriate cleaning and disinfection of carts, tables, and transport vehicles should be performed per AAMI recommendations ..." Review of the ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities revealed the following: "11.3 Transport of sterile packaged items 11.3.1 General considerations Sterile items should be transported in a manner that will protect the items from puncture and from contamination by moisture, excessive humidity, condensation caused by exposure to temperature extremes, insects, vermin, dust and dirt, excessive air pressures, and microorganisms." Review of the ANSI/AAMI S179:2017 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities revealed the following: " ...11.3.5 Off-site transportation C. The design and materials used in the construction of all transport vehicles (motorized or manual) should allow for appropriate decontamination, especially if the vehicles are to be used alternately for the transport of sterile/clean items and soiled items. Vehicles used to transport sterile packages between health care facilities should a) provide for the complete separation of clean and sterile items from contaminated items; b) have a storage compartment that is completely enclosed; and c) allow for ease of loading and unloading. Carts containing sterile packages should be secured within the vehicle to prevent damage or contamination. NOTE-All external shipping cartons are considered contaminated, even if they contain packaged sterile items. When vehicles are used, environmental conditions should be assessed while the vehicle is in motion and when it is not in motion. In geographical areas where high humidity is the norm, testing should be performed to determine the potential for absorbent items to become contaminated and for the contents of sterile packages to become Wet from the condensate that can occur on metal or plastic surfaces. Vehicles that are loaded and ready for transport should not be left unattended in unsecured areas ..." E. STERILIZATION OF SURGICAL IMPLANT SETS Review of the Pod B Main autoclave log for 5-20-2019 to 8-20- revealed the following: A sterilization autoclave entry on 6-21-2019 revealed a sterilization load for plates brought in from an outside representative. The plates were sterilized using One tray. Review of the sterilizer load detail on 6-21-2019 for the sterilization of the above plates for Patient #328 revealed the plates were ran on a short cycle IUSS (immediate use sterilization) of 10 minutes exposure time at 270 degrees. There was no dry time indicated on the load detail. In an interview on 8-22-2019, after 4:00 p.m., Staff #27 was asked if the facility normally ran implant sets on IUSS cycles. Staff #27 stated, "No". Staff #27 was asked why this set was ran on an IUSS short cycle sterilization. Staff #27 stated, "Well it is my understanding the representative was late delivering the set and the patient was on the table". Review of the manufacturer (Biomet) instruction on sterilization revealed the following: "Sterilization Flash (immediate use) sterilization is not recommended. The hospital is responsible for an in-house procedure for the reassembly, inspection, and packaging of the implants after they are thoroughly cleaned in a manner that will ensure steam sterilant penetration and adequate drying. Provisions for protection of any sharp or potentially dangerous areas of the implants should also be recommended by the hospital. Steam sterilizer manufacturer recommendations should always be followed .... Table 3 U.S. Pre-Vacuum - Exposure Time - 4 minutes. Minimum Dry time 30 minutes." Review of the facility policy titled, "Vendor provided (Loaner) instrumentation and sterile implants dated 1-9-2013 revealed the following: " ...3.0 Delivery/Pick Up of Sterile Implants Sterile implants should be delivered one business day (24 hours) prior to the scheduled procedure (unless otherwise communicated) to the Nurse in charge located in the OR control room. Staff #27 confirmed the findings on the sterilization of the implant sets on IUSS sterilization cycle. F. COMPETENCIES Review of personnel records on August 22, 2019 after 8:30 a.m. revealed the following: Staff #84 was working as a surgical scrub technician at the ACB OR. There were competencies documented on 5-8-19 for precleaning procedural Instruments including scopes, probes, and instruments. There were competencies documented on 11-28-2018 for point of use precleaning, specimen management, and malignant hypothermia. There were no competencies documented in the personnel file for job specific competencies of a surgical scrub technician. Staff #267 was working as a Pre-Operative and Post-Operative nurse at the outpatient endoscopy center in the main building. There was a job description in the personnel file signed on 4-30-2019 by the manager. Staff #267 had not signed/acknowledged it. There were endoscopy competency skills in the folder dated 11-14-2012; almost 7 years ago. There were no current competencies. Staff #273 was working as a RN circulator at the ACB OR. There were competencies documented on 5-8-19 for precleaning procedural Instruments including scopes, probes, and instruments. There were competencies documented on 12-5-2018 for point of use precleaning, specimen management, and malignant hypothermia. There were no competencies documented in the personnel file for job specific competencies of a RN circulator. Staff #288 was working as a surgical scrub technician at the ACB OR. There were competencies documented on 5-10-19 for precleaning procedural Instruments including scopes, probes, and instruments. There were competencies documented on 12-6-2018 for point of use precleaning, specimen management, and [DIAGNOSES REDACTED]. There were no competencies documented in the personnel file for job specific competencies of a surgical scrub technician. Staff #'s 370 & 371 confirmed the above findings in the personnel files. G. SANITARY ENVIRONMENT MAYS ASC During a tour on August 13, 2019, at 9:50 a.m. the following observations were made: PRE-OP SUPPLY CART There was a wire rack in the room where supplies were stored. Sterile supplies (Foley catheter kits) were stored on the same shelf as non-sterile items (Urinals). There were Sani-cloths (Germicidal cleaning wipes) stored above sterile supplies. There was a bin that stored sterile yankauer suction tips and non-sterile suction tubing in the same bin. There was a rolling plastic cart in the middle of the room that linen was stored on. The linen had a cloth linen covering on in that did not cover all the linen. Sheet and blanket on one of the shelves were hanging out and exposed to dust, dirt, and contaminates. ANESTHESIA SUPPLY ROOM There was a container sitting on the floor that was full of clean anesthesia circuits used to monitor patients during surgical procedures. OPERATING ROOM 3 Outside of operating room 3 next to the scrub sinks, the linoleum floor had separated from the wall and exposed the sheetrock. There were scrapes and missing chips of paint above the same area. During a tour on August 14, 2019 the following observations were made: CATH LAB/INTERVENTIONAL RADIOLOGY PACU PACU SUPPLY CLOSET There were sterile supplies (Fem Stop kit - Used for compression after removal of arterial sheaths to achieve hemostasis) stored on the same shelf as patient pillows in a plastic bag and operating room bouffant caps and patient socks. There was a package of Styrofoam patient cups stored on same shelf with sterile steri-strips (Skin closure strips used to secure and close small wounds) and Salem Sump nasogastric tube. EMERGENCY SUPPLY CART Sterile supply packs (Paracentesis and Drapes) were stored in the same drawer with non-sterile items (Fluid collection bottles, masks, and biohazard bags). There was a sterile chest tube insertion kit that expired 3-1-2019; over 5 months ago in a drawer and ready for patient use. NURSES DESK At the nurse's desk around the sink, the laminate was worn and had a hole towards the back. There was no way to properly sanitize it. CATH LAB SUPPLY CLOSET(G3.3445) There were sterile/non-sterile supplies stored in a stack of bins that was on the floor. The bins contained syringes, gloves, and gowns. There was a corrugated cardboard box full of surgical tape. There was a cardboard box that had sterile arterial sheaths used in cardiac catheterization procedures stored in it. There were two boxes of sterile right heart kits stored in corrugated boxes. There was a stack of unused biohazard bins stored on the floor. CATH LAB SUPPLY CLOSET (G3.3473) The room was in disarray. There were sterile packs that contained sterile bowls on the floor. There was so much equipment stored in the room, it was pushed up against a cart containing sterile supplies. One of the Medtronic carts had sterile Medtronic cables used in cardiac procedures stored in corrugated boxes. The back wall had bins of sterile and non-sterile supplies stored together. There was a corrugated cardboard box that contained a regulatory accessory cable stored in it. There were patient positioner pads stored next to sterile packs. There was a Medtronic pacemaker generator stored in the closet and ready for patient use. The serial number was PKK 8R. There was no Biomed sticker on the generator. ENDOSCOPY CENTER PROCEDURE ROOM 7 During a patient tracer on August 16, 2019 the following observations were made: There was a wedge patient positioner that had tears in the vinyl. There was a corner behind the door that was in disarray. There was a Patient warmer (Bair Hugger) on the floor. There was a portable ultrasound machine and a mobile computer station that was covered in dust. There was a vinyl pad stored behind them on the floor. The pad was covered in dust. PROCEDURE ROOM 6 The room had two trash cans full of trash from previous patients and a linen hamper with dirty linen in it. Staff #269 was asked if the room had been cleaned. Staff #269 confirmed it had been cleaned. The wheel coverings on the anesthesia machine were coated in dust, dirt, and debris. The wheel casters on the supply cart were coated in rust. The air conditioning vent had been pushed into the wall and was coated in dust, dirt, and debris. There was a metal cart in the room that contained supplies for Gastrointestinal procedures. The plastic bins inside were coated in dust, dirt, and debris. There was a plastic cup that had irrigation needles in it. Observation of a manufacturer packet revealed the irrigation needles came in a package with a lot number and an expiration date. The irrigation needles were not being stored in the manufacturer package. There were biopsy forceps in a cabinet drawer that were stored in corrugated cardboard boxes. There were sterile Medivator Amplifeye devices stored in a cabinet drawer tightly wrapped with a rubber band. There was endoscopy equipment stored in the same drawer. The was a drawer that had clean linen bags stored on top of sterile endoscopy supplies. In the same drawer, there was sterile irrigation bottles and a container of decontamination wipes. There was a drawer that contained polyp traps used to collect polyps during endoscopy cases stored with office supplies (copy paper, staples, and paper rolls). There was a drawer that had sterile supplies (small bore pressure infusion extension set) stored with tattooing ink and date stamp. There was a cabinet that had an opened container of alcohol, tattoo ink, pathology slides, and sterile endoscopy supplies stored on the same shelf. MAIN OR During a tour on August 19, 2019, after 8:30 a.m. the following observations were made: SUPPLY CORE A The baseboard outside the entry door was separated from the wall exposing sheetrock. There was a build-up of dust, dirt, and debris in the base of plastic bins storing sterile supplies/instruments. In the equipment room storage, there was a ConMed Bipolar machine (used to control bleeding in surgical procedures) that the BioMed sticker expired 6/2019; over 2 months prior to the survey. The Bipolar machine was stored in an equipment room ready for patient use. There was a build-up of dust, dirt, and debris along the baseboards and corners of the floor in the room. In the anesthesia storage room Pod A, the cabinet had missing chips and pieces of laminate on the cabinets and drawers. There was no way to properly sanitize them. The walls had peeling paint, scrapes, and chunks of the wall missing that exposed the sheet rock. There was a build-up of dust, dirt, and debris along the baseboards and corners. There were patient supplies (Oxygen nasal cannula) on the floor. There was a tool box stored on the same shelf and next to sterile supplies (Bougie endotracheal tube introducer). There was an anesthesia doppler with the battery covered and secured by sponges and tape. There was no way to sanitize the doppler. The doppler was stored and ready for patient use. There was a locked cabinet that contained anesthesia gases. The base of the cabinet was coated in dust, dirt, and debris. The gases were stored next to white paper bags that were used to carry the gases into the operating room for surgical cases. The white bags were laying on the base of the cabinet that was covered in dust, dirt, and debris. Staff #366 confirmed the findings in the anesthesia storage room. STERILE CORE B Outside Operating room 24 on the core side, the plastic bumper guard was cracked and missing pieces of the end cap. There was a tear in the linoleum floor. There was an autoclave labeled, "IUSS Autoclave #1" in the core that had a build-up of rust. Staff #27 was asked when the last time the autoclave was cleaned. Staff #27 stated, "I don't know since it is outside of my area." Staff #9 later confirmed the autoclave had not been cleaned previously that she was aware of. Staff #9 stated, "We don't have a contract for cleaning on the core autoclaves. We do have a contract for PM's, but it does not involve cleaning". There was a plastic storage container with wheels, that had several sterile supplies (surgical drapes, drill bits, and sutures) stored in the drawers. The container was sitting on the floor. In one of the drawers, there was packages of sterile hooks. The packages had a rubber band tightly woven around them. Physical damage to the package, such as holes and tears can be caused by compression of the package. OPERATING ROOM 1 Outside operating room 1 on the Core Side, the caulking in the linoleum floor had several areas that were cracked and disintegrated. There was a metal strip underneath the plastic bumper guard that had separated from the wall exposing sheetrock. There was rust on the wheel casters of metal racks storing sterile instruments. There was a metal rack with several bins storing sterile instruments that were full. The bins contained peel packs (Sterilization packs) stacked up and packed tightly in the bins. The packages were stored in a manner that would allow crush, bend, and puncture of the package compromising the sterility of the item. OPERATING ROOM 16 The caulking in the linoleum floor had several areas that were cracked and disintegrated. OPERATING ROOM 21 The Bair Hugger (Patient warmer unit) was stored on the floor. There was an IV (Intravenous) pole in the room that had a plastic plate attached to the base. There was tape and tape residue on the plastic. Underneath the plastic plate, at the point where the plate attached to the IV pole, there was a build-up of dust, dirt, and debris. There was rust on the wheel caster of a metal table in the room. On the base of the anesthesia machine there was a plastic film coating that had rips and tears in it. There was a build-up of dust, dirt, and debris under the plastic film coating. There was a LUXTEC headlamp that had a crack in the plastic. There was no way to properly sanitize the machine. There were several areas in the room that had cracked and disintegrating caulking in the floor. OPERATING ROOM 22 Outside of Operating Room 22 entry door on the core side, the baseboard had separated from the wall exposing sheetrock. PRE-OPERATIVE AREA, Room P503 The mattress on the stretcher had multiple cracks and tears in the mattress. There was no way to sanitize it properly. MAIN OR PAVILLION TOWER There were storage bins on a metal rack in the core. The bins contained sterile items (tube holder, steri-drapes, Ioban drapes). The base of those bins was coated in dust, dirt, debris, and hair. There were sterile wrapped items (urethral instruments, cotton rolls) stored in a bin. The external tape sterilization indicator (External tape sterilization indicators provide at-a glance visual assurance that the package has been exposed to the steam sterilization process) was faded making it difficult to determine sterility. The bins storing these items were coated in dust, dirt, and debris. Staff #12 confirmed the above sanitary environment findings. INTERVENTIONAL RADIOLOGY: During a tour of room #3 of the Interventional Radiology Area on 8/13/2019, at 1:10 PM, the following infection control issues were observed: Observed a patient having a Renal biopsy with CT scan, there was a metal rolling cart in the procedure room approximately 2 feet from the patient. The metal cart was loaded with sterile packs and there was no protective covering to protect the sterile packs from contamination from the patient that was having a procedure. Also, in room #3, observed dust and lint on the air conditioner return vent. An interview with Staff #11 on 8/13/2019 at 1:30 PM confirmed the above findings. CATH LAB: During a tour of the Cath lab room on 8/14/2019, at 10:00 AM, observed the following infection control issues: 1. The wall base was pulled apart from the wall allowing dust and dirt to collect in the crack. 2. Plaster was missing from the wall underneath the hand sanitizer dispenser. 3. The paint was chipped along the trim of the glass protector window between the control room and the Cath lab procedure room. 4. In a drawer in the Cath Lab procedure room there was a blue plastic container that had brownish spillage in the container and there was sterile tegaderm being stored in the container. 5. The air conditioner return vent x 2 was covered in dust and lint. 6. In the drawer of the Cath Lab, found 2 purple top blood tubes that had expired 7/31/2019. Surveyor observed Staff #113, #131, and #272 cleaning the Cath Lab procedure room after the Right Heart Cath procedure had been completed. The surveyor showed Staff # 16 Nurse Manager that there was blood on the C-Arm, blood on the ceiling, and blood left on the counter where staff had completed blood sample testing. An interview with Staff # 16 Nurse Manager on 8/14/2019, at 10:40 AM, confirmed that there was blood found on the C-Arm, blood on the ceiling, and blood left on the counter. ENDOSCOPY UNIT: During the tour of the Motility procedure room on 8/16/2019, it was observed that after the motility probe (ManoScan high resolution Manometry) was cleaned, it was taken from the container and stored in the original case. There was no process in place on how the protective case was cleaned prior to placing the high level disinfected ManoScan high resolution Manometry in the protective case. An interview with Staff # 268 on 8/16/2019, at 10:00 AM, confirmed there was no process in place for cleaning the protective case. While observing the endoscopy suite and in the preoperative area there were 2 carts observed. In one of the carts surveyor found pink colored blood tubes that had expired 3/31/2019. An interview with Staff # 269 on 8/16/2019, at 10:30 AM, confirmed the pink colored tubes had expired on [DATE]. STORAGE ROOM: (located in the main surgical area outside the main Surgical area) During a tour on 8/15/2019, at 8:53 AM, entered a storage room that contained numerous supplies, linen, and equipment. The following infection control issues were observed: 1. Upon entering the room there was a distinct musty odor to the room. 2. The ceiling tile had a large brown circular substance that appeared to be where water had leaked. The ceiling tile was above the equipment and supplies. 3. There were stacks of equipment and furniture piled upon each other and underneath the equipment was wooden pallets. Mixed among the supplies and equipment was numerous open card board boxes. The surveyor was unable to see what was in the boxes due to the boxes were piled high on the equipment. 4. There was a large clear plastic bag full of supplies that was above the red fire line. The red line signifies items that should not be above the fire line. The surveyor was unable to see the supplies due to the bag being piled so high and in the corner of the room with numerous pieces of furniture and equipment in front of the plastic bag of supplies. 5. There were patient cleaning supplies stored with facility cleaning supplies in a cabinet. On the top shelf of the cabinet was packages of "Whole Earth" sugar sweetener. 6. There was a metal cart that had closed and open card board boxes. The open card board box contained a box with breast implant sizer. 7. On another lar |
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| VIOLATION: OUTPATIENT POST-ANESTHESIA EVALUATION | Tag No: A1005 | |
| ANESTHESIA POST EVALUATION Based on record review, and interview, the facility failed to ensure that the post anesthesia assessments were completed prior to the patient sufficiently recovering from anesthesia in 5 of 15 patients reviewed. This deficient practice had the likelihood to cause harm in all patients receiving anesthesia at the facility. Findings include: PATIENT #105 Patient #105 underwent a MRI with/without contrast and anesthesia on 8-14-2019. The patient was admitted to the PACU (Post anesthesia care unit) at 10:12 a.m. Patient #105 met the discharge criteria for PACU at 11:15 a.m. Patient #105 was discharged from PACU at 11:35 a.m. Review of the post-anesthesia assessment revealed the assessment was completed at 10:27 a.m., 45 minutes prior to the patient meeting the discharge criteria for PACU. PATIENT #236 Patient # 236 underwent a MRI Cervical Thoracic Lumbar Spine with/without contrast on 8-12-2019. The patient was admitted to the PACU at 11:28 a.m. Patient #105 met the discharge criteria at 12:05 p.m. Patient #105 was discharged from PACU at 12:10 p.m. Review of the post-anesthesia assessment revealed the assessment was completed at 11:30 a.m., 2 minutes after the patient was admitted to the PACU and 35 minutes prior to the patient meeting discharge criteria for PACU. PATIENT #238 Patient #238 underwent a flexible colonoscopy on 8-16-2019. The patient was admitted to PACU at 11:11 a.m. Patient # 238 met discharge criteria for PACU at 12:20 p.m. and was discharged from PACU at 12:53 p.m. Review of the post-anesthesia assessment revealed the assessment was completed at 11:25 a.m., 14 minutes after the patient was admitted to PACU and almost 1 hour prior to the patient meeting discharge criteria for PACU. PATIENT #239 Patient #239 underwent a colonoscopy on 8-16-2019. The patient was admitted to PACU at 8:28 a.m. Patient #239 met discharge criteria from PACU at 9:15 a.m. Patient #239 was discharged from PACU at 9:30 a.m. Review of the post-anesthesia assessment revealed the assessment was completed at 9:08 a.m. The vital signs used on the post anesthesia assessment were from 8:50 a.m. Interview with Staff #267 on August 16, 2019 after 10:00 a.m. revealed the following: Staff #267 was asked when anesthesia was notified that the PACU patients were ready for post-anesthesia assessment/discharge. Staff #267 stated, "I just look in computer and see if the anesthesia post evaluation is complete." Staff #267 was asked if the anesthesia provider came to the bedside to evaluate the patient. Staff #267 stated, "I don't really know. I look in computer and if the evaluation is there, I discharge patient. I don't know if they come to the bedside or not." PATIENT #242 Patient #267 underwent an exchange of right breast tissue expander for implant possible capsulorrhaphy and left breast augmentation with implant and mastopexy for symmetry on 8-19-2019. Patient #242 met discharge criteria for PACU at 1:45 p.m. Patient #242 was discharged from PACU at 2:02 p.m. Review of the PACU nursing notes revealed that Patient #242 was admitted to PACU at 10:04 a.m. Vital signs at 10:04 a.m. were temperature 98.8, respiration rate of 16. Vital signs at 10:15 a.m. were documented as SpO2 95% on nasal cannula 2 liters per minute, pulse 72, blood pressure was 128/62. Vital signs documented at 10:30 revealed respirations at 8, blood pressure 113/56, pulse 70. There was no respiration rate noted until 10:55 a.m. Vital signs at 10:55 a.m. were respiration rate 8, pulse 70, blood pressure 113/56. There was no documentation in the nurses notes that addressed the change in condition. There was a nurse note at 11:06 a.m. that encouraged deep breathing. Respiration rate at 10:35 a.m. was 11. Respiration rate at 1050 a.m. was 11. Respiration rate at 1130 a.m. was 11. Respiration rate at 1145 a.m. was 7. Oxygen saturation at 12:15 p.m. was 92% and respiration rate was 6. Pulse oximetry at 1:00 p.m. was 92%, no respiration rate was noted. There was no documentation in the nurses notes that the patient change in condition was addressed or reported to anesthesia or the physician. Review of the post-anesthesia assessment revealed it was completed at 12:45 a.m., one hour prior to the patient meeting discharge criteria for PACU. The vital signs used in the post-anesthesia assessment were from 11:30 a.m., 2 hours prior to the patient being discharged from PACU. The vital signs showed the patient was discharged with a respiratory rate of 9. An interview with Staff #378 on 8-20-2019 after 8:30 a.m. revealed the following: Staff #378 confirmed the findings for patient #242. Staff #378 was asked if staff was required to document a change in a patient's condition and report to the anesthesia staff/physician. Staff #378 confirmed they were. Staff #378 was asked if a patient would normally be discharged with a respiration of 9. Staff #378 confirmed they would not normally be discharged with a low respiration rate. Staff #378 was asked if anesthesia had a policy on post anesthesia evaluations in the PACU area. Staff #378 stated, "No we do not currently have a policy on post-anesthesia evaluations but have identified that as an issue and will be working on it." Staff # 13 confirmed the above findings on post-anesthesia evaluations. |
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| VIOLATION: OUTPATIENT SERVICES | Tag No: A1076 | |
| Based on observation, review of documentation, and interview, it was determined that the hospital failed to ensure that outpatient services were provided in a safe manner. Findings: Outpatient services were not provided in a safe manner as multiple issues were found to include: Outpatients were receiving Ketamine infusions (Ketamine is a powerful drug which can be used for chronic pain control as well as anesthesia) without proper monitoring from nursing staff, and there were no competencies for the nursing staff administering the Ketamine. There were no policies or procedures for the administration of Ketamine in an outpatient setting. This increased the likelihood of an adverse patient outcome. Cross refer to CFR 482.13(c)(2), A0144, Patient Rights: Care In Safe Setting The hospital failed to ensure that emergency equipment (crash carts) were at all the outpatient locations, this increased the likelihood of an adverse patient outcome in the event of an emergency medical situation. Cross refer to CFR 482.12(f)(3), A0094, Off-Campus Emergency Policies and Procedures The hospital failed to protect the confidentially of patient medical records from the potential of unauthorized access. Cross refer to CFR 482.13(d), A0146, Patient Rights: Confidentiality Of Records The hospital failed to ensure that staff monitored patient care supplies for expiration dates. Cross refer to CFR 482.41(d)(2), A0724, Facilities, Supplies, Equipment Maintenance The hospital failed to ensure that the physical environment was monitored for infection control issues and that worn patient care equipment (mattresses) were promptly replaced. Cross refer to CFR 482.42(a)(1), A0749, Infection Control Program The hospital failed to ensure that nursing staff monitored patient vital signs during blood and chemotherapy infusions. Cross refer to CFR 482.23(b), A0392, Staffing and Delivery of Care The hospital failed to ensure that outpatient services were integrated with inpatient services. Cross refer to CFR 482.54(a), A1077, Integration of Outpatient Services The hospital failed to ensure that there was documentation of the completion of identified quality improvement initiatives. Cross refer to CFR 482.21(b)(2)(ii),(c)(1),(c)(3), A0283, Quality Improvement Activities |
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| VIOLATION: INTEGRATION OF OUTPATIENT SERVICES | Tag No: A1077 | |
| Based on interview and document review, the facility failed to ensure that there was an organized outpatient program integrated with inpatient services in the Ambulatory Treatment Center (ATC); located at 1515 Holcombe Blvd, 2nd Floor. An interview was conducted on 8/14/2019, after 9:00 AM, with Staff #129. Staff #129 was asked how the ATC ensured their services were well organized and integrated with the inpatient services. Staff #129 said, "many of the patients that are discharged are seen in this clinic for outpatient services. The inpatients are scheduled upon discharge for services such as, infusions, transfusions, injections, and pump (a device connected to a patient via intravenous line that continuously infuses chemotherapy) changes." Staff #129 said, "we were informed of some problems in the last couple of weeks regarding scheduling a discharged patient for outpatient services." Staff #129 was asked, how was the problem identified and what corrective action was in place. Staff #129 said, "there has been a few patients that were discharged from inpatient services that were scheduled to have a pump changed at a specific time after discharge. The inpatient unit scheduled the outpatient appointment once the discharge order was written by the medical provider. If the patient was delayed being discharged no one rescheduled the outpatient appointment and the patients were arriving several hours before their appointment and we could not safely change their pump. These patients were having to wait extended hours in the waiting area until their scheduled appointment time." Staff #129 was asked if there was a process in place to ensure the scheduling process was streamlined and corrected. Staff #129 said, "we had a meeting and discussed a corrective action plan last week." A review of the documentation titled, "CADD and Eclipse Home Infusion Pumps" revealed patient screening and education information. On page two of this document, there was a one-line sentence that read, "Need consistency in contact information for patients". Further review of this document revealed, there was no corrective action plan mentioned in the document. No further documentation was provided for review. An interview was conducted with Staff #129 on 8/15/2019 after 9:00 AM. Staff #129 was asked what corrective action plan was in place to ensure the outpatient and inpatient services were well organized to ensure continuity of care. Staff #129 presented a document titled, "Proposal for inpatient to outpatient coordination of care with home infusion." This document was labeled as a "DRAFT" and had not been reviewed or approved by any committee or department leadership. The facility failed to have a well-organized scheduling process between their inpatient and outpatient services to ensure patient continuity. Staff #129 confirmed the findings. |
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