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Based on observations, review of records, and staff interviews, the governing body failed to establish an effective monitoring mechanism to ensure the adequate oversight of the hospital, as evidenced by the Chief Executive Officer's failure to:


A. Establish a mechanism to ensure that the Quality Assurance and Performance Improvement program measured, analyzed, and tracked quality indicators which assessed processes of care, hospital services, and operations (See A-0057-A);


B. Establish an efficient mechanism for setting quality priorities to ensure performance improvement activities address problem-prone areas (See A-0057-B);


C. Ensure that nursing services are provided by a licensed registered nurse, in the District of Columbia (See A-0057-C);


D. Establish a mechanism to ensure the nursing staff developed and kept current nursing plans for the patient's identified needs (See A- 0057-D);


E. Establish a mechanism to ensure a registered nurse, with the specialized qualifications and competence, is assigned to manage the care of patients with endotracheal tubes (See A-0057-E);


F. Establish a mechanism to ensure that the nursing staff administered drugs and biologicals, in accordance with orders, and accepted standards of practice (See A-0057-F);


G. Establish a mechanism to ensure that one (1) of the nine (9) tests performed by the medical staff, at the point of care, is certified by Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) (See A-0057-G);


H. Establish a mechanism to maintain the physical plant and the overall environment in a safe and sanitary manner, to include ensuring the refrigerator temperatures are within the specified range, to ensure that the safety and well-being of patients (See A-0057-H);


I. Establish a mechanism to ensure that tissue products were stored at the appropriate temperature, outdated supplies were not stored and available for patient use, and preventative maintenance (PM) for life-sustaining equipment and medical devices were completed, in accordance with manufacturer guidelines (See A-0057-I);


J. Establish a mechanism to ensure adequate numbers of respiratory therapists were available to meet the needs of patients (See A-0057-J);


K. Establish a mechanism to ensure respiratory services were delivered, in accordance with medical staff directives (See A-0057-K);


L. Establish a mechanism to ensure all respiratory care services orders were documented, in the patient's medical record, in accordance with the requirements (See A-0057-L);


M. Establish a mechanism to ensure documentation of the administration, wasting, or handling of controlled substances (See A-0057-M);


N. Establish a mechanism to ensure verification of the patient's current Methadone dose with the Substance Abuse Clinic treating the patient (See A-0057-N);


O. Establish a mechanism to ensure labeling of medications, which require expiration date, such as Succinylcholine (See A-0057-O);


P. Establish a mechanism to ensure that all radiologic equipment was inspected and corrected, promptly, as evidenced by the failure to report a malfunctioning ultrasound machine, when a problem was identified (See A-0057-P);


Q. Establish a mechanism to ensure the hospital staff performed hand hygiene, in accordance with hospital policy and acceptable standards of practice, to prevent the spread of infection (See A-0057-Q);


R. Establish a mechanism to ensure ongoing reassessments are performed to ensure the implementation of the discharge plan, according to the patient's needs (See A-0057-R);


S. Establish a mechanism to provide appropriate personnel necessary to furnish the cardiovascular services offered (See A-0057-S);


T. Establish a mechanism to provide interventional cardiac/surgical services, consistent with patients' needs and medical resources (See A-0057-T);


U. Establish a mechanism to to establish an effective system to schedule, coordinate care and/or follow up with patients receiving services, in the Cardiac Catheterization Lab (See A-0057-U).


V. Establish a mechanism to ensure policies and procedures were developed for the management of altered skin integrity for patients in the Neonatal Intensive Care Unit (See A-0057-V).


The cumulative effect of these systemic deficient practices resulted in the governing body failure to comply with the conditions of participation for the Governing Body.

A. Based on data review, committee meeting minutes, and staff interview, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established a mechanism to ensure that the Quality Assurance and Performance Improvement program measure, analyze, and track quality indicators, which assessed processes of care, hospital services, and operations. (Cross-reference to A-0267).


B. Based on quality program review and staff interviews, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established an efficient mechanism for setting quality priorities to ensure performance improvement activities address problem-prone areas (Cross-reference to A-0285).


C. Based on record review, policy review, and staff interviews, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established a well-organized nursing service, which has a plan of administrative authority and delineation of responsibilities by a licensed registered nurse, as evidenced by the Chief Nursing Officer failure to possess a current license as a registered nurse, in the District of Columbia (Cross-reference to A-0386).


D. Based on record review, policy review, and staff interviews, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established a mechanism to ensure the nursing staff developed and kept current nursing plans for the patient's identified needs (Cross-referenced to A-0396).


E. Based on record review, policy review, and staff interviews, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established and implemented a mechanism to ensure that nursing services assigned a registered nurse to determine the appropriate nursing staff, with the specialized qualifications and competence, to meet the patient's care needs (Cross-referenced to A-0397).


F. Based on record review, policy review, and staff interviews, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established and implemented a mechanism to ensure that the nursing staff administered drugs and biologicals, in accordance with Federal and State laws, and accepted standards of practice (Cross-referenced to A-0405).


G. Based on record review, policy review, and staff interviews, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established and implemented a mechanism to ensure that one (1) of the nine (9) tests performed by the medical staff, at the point of care is certified by Clinical Laboratory Improvement Amendments of 1988 (CLIA'88), in accordance with section 353 of the Public Health Service Act 42 U.S.C. §263a (Cross-reference to A-0582).


H. Based on record review, policy review, and staff interviews, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established and implemented a mechanism to maintain the physical plant and the overall environment in a safe and sanitary manner, to include ensuring the refrigerator temperatures were within the specified range, to ensure that the safety and well-being of patients (Cross-reference to A-0701).


I. Based on record review, policy review, and staff interviews, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established and implemented a mechanism to ensure that tissue product are stored at the appropriate temperature, outdated supplies were not stored and available for patient use, and preventative maintenance (PM) for life-sustaining equipment and medical devices were completed, in accordance with manufacturer guidelines (Cross-reference to A-0724).


J. Based on record review, policy review, and staff interviews, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established and implemented a mechanism to ensure adequate numbers of respiratory therapists were available to meet the needs of patients (Cross-reference to A-1154).


K. Based on record review, policy review, and staff interviews, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established and implemented a mechanism to ensure respiratory services were delivered, in accordance with medical staff directives (Cross-reference to A-1160).


L. Based on record review, policy review, and staff interviews, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established and implemented a mechanism to ensure all respiratory care services orders were documented, in the patient's medical record, in accordance with the requirements (Cross-referenced A-1164).


M. Based on record review, policy review, and staff interviews, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established and implemented a mechanism to ensure documentation of the administration, wasting, or handling of controlled substances (Cross-reference to A-0494).


N. Based on record review, policy review, and staff interviews, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established and implemented a mechanism to ensure verification of the patient's current Methadone dose with the Substance Abuse Clinic treating the patient (Cross-reference to A-0500).


O. Based on record review, policy review, and staff interviews, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established and implemented a mechanism to ensure labeling of medications, which require expiration date, such as Succinylcholine (Cross-reference to A-0505).


P. Based on record review, policy review, and staff interviews, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established and implemented a mechanism to ensure that all radiologic equipment was inspected and corrected, promptly, as evidenced by the failure to report a malfunctioning ultrasound machine, when a problem was identified (Cross-reference to A-0537).


Q. Based on record review, policy review, and staff interviews, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established and implemented a mechanism to ensure the hospital staff performed hand hygiene, in accordance with hospital policy and acceptable standards of practice, to prevent the spread of infection (Cross-reference to A-0749).


R. Based on record review, policy review, and staff interviews, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established and implemented a mechanism to ensure ongoing reassessments are performed to ensure the implementation of the discharge plan, according to the patient's needs (Cross-reference to A-0843).


S. Based on record review, policy review, and staff interviews, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established and implemented a mechanism to provide appropriate personnel needed to furnish the cardiovascular services offered (Cross-reference to A-0941).


T. Based on record review, policy review, and staff interviews, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established and implemented a mechanism to provide interventional cardiac/surgical services, consistent with patients' needs and medical resources (Cross-reference to A-0951).


U. Based on record review, policy review, and staff interviews, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established and implemented an effective system to schedule, coordinate care and/or follow up with patients receiving services, in the Cardiac Catheterization Lab (Cross-reference to A-0951).


V. Based on record review, policy review, and staff interviews, it was determined the governing body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer established and implemented policies and procedures for the management of altered skin integrity for patients in the Neonatal Intensive Care Unit (Cross-reference to A-0396).



The numerous complaint survey findings are representative of the governing body's failure to ensure the Chief Executive Officer managed the hospital's services to ensure the quality of care.


A face to face interview was conducted on April 12, 2017, at approximately 3:00 PM with Employee #4. The findings were reviewed, discussed, and acknowledged.

Based on observation, policy review and staff confirmation, it was determined that staff failed to maintain the personal privacy of the patient, whose door and curtain was left open during physical examination, in one (1) of 10 observations (Patient #16).


The findings include:


The Howard University Hospital [HUH] Policy Number PTR-004-14, titled, 'Patient Rights and Responsibilities,' last revised April, 2014, stipulates, "...POLICY: 1. HUH's Responsibilities to Our Patients ...j. To provide patients with care in a safe setting and an environment that preserves their dignity and contributes to a positive self-image ...n. To respect patients' need for confidentiality and privacy.


Patient #16 was admitted with diagnoses to include Sepsis.


On April 11, 2017, at approximately 12:10 PM, a tour of the 5 North unit was conducted. Employee #49 was observed performing a physical examination on Patient #16, with the room door and curtain open, exposing the patient to passersby. The observation was made in the presence of Employee #40, who closed the curtain.


The practice failed to provide evidence that ensured the patient's physical privacy.


Employees #40 and 53 confirmed the findings.

Based on observation, policy review and staff interviews, it was determined that staff failed to maintain the privacy and confidentiality of patients' sensitive information, whose health information and/or electronic medical records (EMR) were left open and unattended, in two (2) of 10 observations.


The findings include:


The Howard University Hospital [HUH] Policy Number PTR-004-14, titled, 'Patient Rights and Responsibilities,' last revised April, 2014, stipulates, "...POLICY: 1. HUH's Responsibilities to Our Patients ... o. To ensure the confidentiality of patients' clinical records ..."
The Howard University Hospital [HUH] Policy Number MIS-007-14, titled, 'Security and Confidentiality', last reviewed April, 2014, stipulates, "... PROCEDURES: 2. Confidentiality of Patient Data and Information... All employees of HUH who have access to patient data and information must regard such data and information as private and confidential ..."


A. On April 10, 2017, at approximately 12:40 PM, during a tour in the Emergency Department, the computer located in the nursing station was observed unattended and the Emergency Department Tracking Board was left open, displaying personal identifiers to include patient's name, patients' complaint, and age. Employee #86 was logged into the computer. The observation was made in the presence of Employee #38.


The practice failed to provide evidence that ensured the privacy and confidentiality of patients' medical/health information.


On April 10, 2017, at approximately 12:45 PM, a face-to-face interview was conducted with Employee #86, regarding the open EMR. S/he explained that the EMR should have been closed and s/he should have logged off, prior to leaving the computer.


Employees #38 and 86 acknowledged the findings.


B. On April 10, 2017, at approximately 12:54 PM, during a tour in the Emergency Department, the computer located in the nursing station was observed unattended and the Emergency Department Tracking Board was left open, displaying personal identifiers to include patient's name, patients' complaint, and age. Employee #56 was logged into the computer. The observation was made in the presence of Employee #38.


The practice failed to provide evidence that ensured the privacy and confidentiality of patients' medical/health information.


On April 10, 2017, at approximately 1:00 PM, a face-to-face interview was conducted with Employee #56, regarding the open EMR. S/he explained the hospital policy adding, "I should have logged off."


Employees #38 and 56 acknowledged the findings.

Based on quality program review, record review, and staff interview, it was determined the hospital failed to measure, analyze, and track quality indicators to include aspects of performance that assess processes of care, services, and operations (A-267); and failed to set priorities for its performance improvement activities that focus on problem-prone areas and affect health outcomes, patient safety, and quality of care (A-0285).


The cumulative effect of these systemic practices resulted in the hospital's failure to comply with conditions of participation in Quality Assessment and Performance Improvement Program.

Based on data review, committee meeting minutes, and staff interview, it was determined the hospital failed to measure, analyze, and track quality indicators which assess processes of care, hospital services, and operations related to nursing services, respiratory services, surgical services, and physical environment.


The findings include:


During the complaint survey from April 10- 13, 2017, the following concerns were identified:



1. Failure to develop and keep current an individualized nursing care plan to address identified needs Cross reference CFR §482.23(b)(4), A-0396

2. Failure to ensure the chief nursing officer possessed a current license as a registered nurse, in the District of Columbia Cross reference CFR §482.23(a), A-0386

3. Failure to ensure nursing personnel had qualifications and competence to care for a ventilator dependent patient with an endotracheal tube Cross reference CFR §482.23(b)(5), A-0397

4. Failure to administer drugs and biologics, in accordance with the physician orders related insulin, wound treatments, respiratory medications, and pain medications Cross reference CFR §482.23(c), A-0405

5. Failure to document all information to describe the patient's progress and response to medications and services Cross reference CFR §482.24(c), A-0449

6. Failure to ensure that all entries are complete, dated and timed, in the medical record Cross reference CFR §482.24(c)(1), A-0450

7. Failure to ensure the hospital maintained a current and accurate record for the receipt and distribution of all scheduled drugs Cross reference CFR §482.25(a)(3), A-0494

8. Failure to verify the patient's current Methadone dose with the substance abuse clinic treating the patient cross-reference to CFR §482.25(b), A-0500

9. Failure to ensure the Succinylcholine was correctly labeled with an expiration date Cross reference CFR §482.25(b)(3), A-0505

10. Failure to ensure that all radiologic equipment was inspected and hazards identified with prompt correction Cross reference CFR §482.26(b)(2), A-0537

11. Failure to ensure that test performed at the point of care is certified by Clinical Laboratory Improvement Amendment of 1988 (CLIA '88), in accordance with section 353 of the Public Health Service Act of 42 U.S.C. §263a Cross reference to CFR §482.27(a), A-0582

12. Failure to maintain the physical plant and environment in a safe and sanitary manner, to include the maintenance of the Operating Room refrigerator, cross-reference to CFR §482.41(a), A-0701

13. Failure to ensure tissue products are stored at the appropriate temperature, in accordance with the manufacturer's instructions; and failed to ensure outdated supplies were not stored and available for use, cross-reference to CFR §482.41(c)(2), A-0724

14. Failure to ensure the social work staff perform ongoing reassessments to ensure the implementation of the discharge plan, according to the patient's needs, cross-reference to CFR §482.43(e), A-0843

15. Failure to ensure the hospital had adequate respiratory staff to meet the respiratory needs of patients, cross-reference to 482.57(a)(2), A-1154

16. Failure to administer respiratory treatment, in accordance with physician orders, cross-reference to CFR §482.57(b). A-1160

17. Failure to obtain an order from a qualified and licensed practitioner for the administration of oxygen cross-reference to CFR §482.57(b)(4), A-1164


On April 12, 2017, at approximately 3:00 PM, a face-to-face interview with Employee #4 was conducted to review quality program and concerns identified during the complaint survey. Employee #4 explained that the hospital's quality structure uses a rotating port structure with each department reporting three (3) times per year. The department's heads have been provided a template for use to identify required reporting information such as "Core Measure, Population Measure, and Regulatory Findings." Once the department report is submitted, the "Standing Members" meet separately to discuss issues, assist with processes, and identify resources needed and ways to remove the barrier." Employee #4 further shared; a workgroup was established in March 2016 to meet daily to monitor action steps taken to address deficiencies identified by the local health department. The workgroup focuses on monitoring over time. According to the employee, most of the deficiencies cited required behavior changes, and the changes are "numerous" taking about 18 months to change. S/he further added, "My assessment is that it will be three to five years before a change is seen."


The findings were reviewed, discussed, and acknowledged by Employee #4.

Based on quality program review and staff interviews, it was determined the hospital failed to implement an efficient mechanism for setting quality priorities to ensure performance improvement activities address problem-prone areas.


The findings include:


Review of the Quality Assurance and Performance Improvement data for January 2016 through March 2017, on April 12, 2017 at approximately 11:30 AM revealed the hospital was monitoring data and processes focuses on four domains to meet core measures, as identified by various accrediting organizations and systems, such as the Joint Commission and Centers for Medicare and Medicaid Services (CMS) Quality and Patient Safety Indicators, Structural Measures, and Disease -Specific Certifications. The quality program's core team consistent of representation from the medical staff, nursing, quality management, health information management and care coordination, focus on falls with injury, pressure injuries, readmission rates, and emergency department wait times. However, the hospital failed to recognize, monitor, measure and track problem-prone areas and issues identified during the complaint survey such assessments, expired supplies, management of hyperglycemia, respiratory service and administration of medication, to ensure care delivery and process improvement.


The Quality Management Committee, under the oversight of the Chief Medical Officer, developed the "Quality and Patient Safety Plan" to determine the Quality Assurance and Performance Improvement activities of the hospital. The "National Quality Strategy" is the framework that the hospital uses to focus its priorities.


The quality and patient safety plan lacked documented evidence of structural, procedural or process changes to achieve sustainable remediation of chronic deficient practices and care delivery issues. In addition, the action plan lacked documented evidence of priorities and process improvement activities related to hospital-specific problem areas.


The problem-prone areas identified by the surveyors include:


1. Failure to develop and keep current an individualized nursing care plan to address identified needs Cross reference CFR §482.23(b)(4), A-0396


2. Failure to administer drugs and biologics, in accordance with the physician orders related insulin, wound treatments, respiratory medications, and pain medications Cross reference CFR §482.23(c), A-0405


3. Failure to document all information to describe the patient's progress and response to medications and services Cross reference CFR §482.24(c), A-0449


4. Failure to ensure that all entries are complete, dated and timed in the medical record Cross reference CFR §482.24(c)(1), A-0450


5. Failure to ensure the hospital maintained a current and accurate record for the receipt and distribution of all scheduled drugs Cross reference CFR §482.25(a)(3), A-0494


6. Failure to verify patient's current Methadone dose with the substance abuse clinic treating the patient, cross-reference to CFR §482.25(b), A-0500


7. Failure to ensure that dietary services were adequate to ensure that foods were served in a safe and sanitary manner, to include ensuring dietary staff covered hair during food preparation Cross reference CFR §482.28(a), A-0619


8. Failure to maintain the physical plant and environment in a safe and sanitary manner, to include the maintenance of the Operating Room refrigerator, cross-reference to CFR §482.41(a), A-0701


9. Failure to tissue products are stored at the appropriate temperature, in accordance with the manufacturer's instructions; and failed to ensure outdated supplies were not stored and available for use, cross-reference to CFR §482.41(c)(2), A-0724


10. Failure to ensure the hospital staff follow hand hygiene practices to prevent the spread of infection, cross-reference to CFR §482.42(a)(1), A-0749


11. Failure to ensure the social work staff perform ongoing reassessments to ensure the implementation of the discharge plan, according to the patient's needs, cross-reference to CFR §482.43(e), A-0843


12. Failure to ensure the Chief Nursing Officer possessed a current license as a registered nurse, in the District of Columbia Cross reference, CFR §482.23(a), A-0386


13. Failure to ensure preventative maintenance (PM) for life-sustaining equipment and medical devices were complete, in accordance with manufacturer's instructions, cross-reference to CFR §482.41(c)(2), A-0724


On April 12, 2017, at approximately 3:00 PM, a face-to-face interview with Employee #4 was conducted to review the quality program and concerns identified during the complaint survey. The findings were reviewed, discussed, and acknowledged by Employee #4.

Based on record review, policy review, and staff interviews, it was determined the hospital failed to have a well-organized nursing service, with a plan of administrative authority and delineation of responsibilities by a licensed registered nurse (A-0386); failed to ensure the nursing staff develops and keeps current nursing plans for the patient's identified needs (A-0396); failed to ensure that a registered nurse assigns the nursing care of patient, in accordance with the specialized qualifications and competence of the available nursing staff (A-0397); and failed to ensure that drugs and biologicals are administered, in accordance with Federal and State laws, and accepted standards of practice (A-0405).


The cumulative effect of these systemic practices resulted in the hospital failure to comply with conditions of participation for Nursing Services.

Based on the review of hospital organizational chart, position description, and staff interview, it was determined the hospital failed to ensure the chief nursing officer possessed a current license as a registered nurse, in the District of Columbia, in one (1) of one (1) personnel record reviewed (Employee
#3).


On April 10, 2017, at 12:56 PM, the surveyor reviewed the hospital organizational chart, which indicated that Employee #3 was the Chief Nursing Officer. According to the organizational chart, the nursing directors for the Emergency Department, Cardiology, Trauma Services, Perioperative Services, Perinatal Services, Diabetes Treatment Center, Medical and Surgical Intensive Care Units, and Staff Development, report to Employee #3.


The surveyor team requested the personnel record for Employee #3 on April 11, 2017. The personnel record review revealed that Employee #3's District of Columbia registered nurse license was in the "pending" status. The hospital's position description for the Chief Nursing Officer requires a "current license as a registered nurse in the District of Columbia."


On April 11, 2017, at 3:30 PM, a face to face interview was conducted with Employee #3. According to Employee #3, s/he has submitted the application; however, the endorsement from California is pending. Also, s/he contacted the nursing boards in California to determine the expected completion day. Employee #3 provided the surveyor with a screen shot from the "California Board of Nursing website, which indicated the board of nursing is approximately 10- 12 weeks from completing an application for endorsement, on April 11, 2017, at 6:21 PM.


Furthermore, Employee #3 was queried about his/her job description. S/he stated that his/her current role is primarily administrative. S/he has no clinical involvement. Employee #3 acknowledged that the facility failed to ensure the hospital's nursing services were supervised by a licensed registered nurse on April 11, 2017. The finding is consistent with the same deficiency identified during the March 6, 2017, annual licensure survey.


On April 12, 2017, at approximately 9:19 AM, Employee #3 provided the survey team a revised hospital organizational chart, which indicated a change in his/her position with the hospital. S/he was listed as "Nurse Consultant" with no supervisor oversight of the nursing staff. In addition, at approximately 10:28 AM, Employee #3 submitted a copy of a temporary District of Columbia registered nurse license, with an issue date of April 12, 2017.

1. Based on a review of records and staff interview for one (1) of three (3) Neonatal Intensive Care [NICU] patients reviewed; it was determined that nursing staff failed to consistently and comprehensively assess the status of altered skin integrity for Patient #12.


The findings include:


On February 27, 2017 Patient #12 was born, diagnosed with Respiratory Distress Syndrome and admitted to the Neonatal Intensive Care Unit [NICU].


According to the IV [intravenous] Care Flow Sheet, Patient #12 received TPN [total parenteral nutrition], D10W [10% dextrose and water] with electrolytes at 6.7 cc/hr. [cubic centimeters/hours] intravenously.


On March 16, 2017 at 5:00 PM, according to a nurse's entry; Patient #12 was assessed with an intravenous (IV) infiltrate at the right inner leg that resulted in an alteration in skin integrity recorded as follows: "IV D/C'd [discontinued] blister noted on right inner ankle, doctor [named] notified, continue to elevate and monitor."


A nurse's entry dated March 17, 2017 at 8:00 AM read as follows: "...IV burn to right inner leg close to ankle...blister, drying up..."


An entry recorded by the Plastic Surgeon on March 17, 2017 at 8:55 AM read as follows: "...Neonate seen in incubator ...R [right] leg with 1.5 x 1.5 centimeter (cm) eschar noted to medial aspect of R leg with surrounding edema and erythema. Appears tender to touch. Assessment - Deep partial thickness burn in premature neonate; Plan- Non-surgical management. We will review with further detailed recommendations today."


A review of the "Skin Condition" forms completed by nurses for the period of March 16 - April 10, 2017 lacked evidence of consistency in the assessment of Patient #6's altered skin integrity. The documentation lacked consistent assessment of the wounds' size, color, tissue type (e.g. eschar) and/or presence of drainage.


An assessment documented by the Plastic Surgeon on March 31, 2017 at 1:07 PM revealed the Patient #12's wound was improved; "...Baby doing well, base of the burn is pink and there is no discharge, swelling or edema... encroaching granulation..."


A face-to-face interview was conducted on April 11, 2017 at approximately 3:30 PM with Employee #96. S/he acknowledged inconsistencies in the assessments of Patient #6's altered skin. In response to a request to review the NICU skin/wound management policy, s/he stated an unawareness of a policy. Employee #4 confirmed that there was no policy for monitoring the skin integrity for infants. The record was reviewed on April 11, 2017.


2. Based on medical record review, policy review and staff interview, it was determined that the nursing staff failed to perform pain assessment and/or re- assessment for the administration of intravenous pain medication, in accordance to the plan of care, in two (2) of five (5) records reviewed (Patients #4 and 5).


The findings include:


The Howard University Hospital (HUH) Policy Number NUR -020-14, ASP, last revised January 2014, titled, 'PAIN MANAGEMENT,' stipulates, " ...POLICY: Howard University Hospital recognizes that all patients have a right to comprehensive pain assessment and management ...Assessment/Management ...Pain will be assessed using one of the following pain scales: 0-10 scale ...Happy Face/Sad Face ...NV[Non-verbal] 1 ...NV2 ...The licensed nurse will assess and document pain management as follows ...within 30 minutes of giving an IV [intravenous] analgesic ..."


The Howard University Hospital (HUH) Policy Number 1, last revised September 2012, titled, 'Documentation In The Medical Record,' stipulates " ...I. Documentation of the Nursing Process F. Reassessment - Reassessment is the process of re-evaluation of the patient's needs for care ...3 ...Patients are required to be reassessed at the following times ...c. on discharge; d. at any time that there is a change in the patient's condition ..."


A. Patient #4 was seen in the Emergency Department for diagnoses to include Headache.


On April 10, 2017, at approximately 12:40 PM, a review of the medical record revealed a physician's order for Toradol 30 milligrams, one (1) dose, intravenously, for pain. Nursing staff administered Toradol to the patient on April 10, 2017 at 8:48 AM for head and abdominal pain; however, the record lacked documented evidence of the performance of a pain assessment to include a pain scale or characteristics. Further review revealed there was no pain re-assessment 30 minutes after the administration of intravenous medications to determine the effectiveness of the intervention.


The record lacked documented evidence that staff implemented the plan of care to include pain assessment and reassessment to address the patient's need for pain management.


On April 10, 2017, at approximately 12:50 PM, a face-to-face interview was conducted with Employees #56, in the presence of Employee #38. S/he was queried regarding the performance of pain assessment and reassessment. Employee #56 could provide no insight, but acknowledged the findings.


B. Patient #5 was seen in the Emergency Department for diagnoses to include Upper Abdominal Pain.


On April 10, 2017, at approximately 12:30 PM, a review of the medical record revealed a physician's order for Morphine one (1) milligram, every six hours, intravenously for pain, if needed. Nursing staff administered Morphine to the patient on April 10, 2017 at 9:24 AM for pain; however, the record lacked documented evidence of the performance of a pain assessment to include a pain scale or characteristics. Further review revealed there was no pain re-assessment 30 minutes after the administration of intravenous medications to determine the effectiveness of the intervention.


The record lacked documented evidence that staff implemented the plan of care to include pain assessment and reassessment.


On April 10, 2017, at approximately 12:35 PM, a face-to-face interview was conducted with Employees #56, in the presence of Employee #38. S/he was queried regarding the performance of pain assessment and reassessment. Employee #56 could provide no insight, but acknowledged the findings.


3. Based on medical record review, policy review and staff interview, it was determined that the nursing staff failed to perform a wound care evaluation, in accordance with the order and plan of care, and hospital policy, in one (1) of five patient records reviewed (Patient #11).


The findings include:


The Howard University Hospital (HUH) Policy Number NUR-027-14-ASP, last revised January 2017, titled, 'PRESSURE INJURY PREVENTION AND TREATMENT,' stipulates "POLICY The Howard University Hospital (HUH) shall have a system in place that assures assessments are timely and appropriate, interventions are implemented, monitored and revised as appropriate; and changes in condition are recognized, evaluated ..."


Patient #11 was admitted with diagnoses to include Transient Ischemic Attack, rule out Stroke, and Pneumonia.


On April 10, 2017 at approximately 3:40 PM, a review of the medical record revealed a computer entry order for "Wound Care Evaluation" consult dated March 22, 2017 at 6:43 PM.


Further review of the medical record revealed the presence of a wound care consult completed on March 27, 2017 (five days later).


On April 10, 2017, at approximately 4:00 PM, a face-to-face interview was conducted with the Employee #62, in the presence of Employee #38. S/he was queried regarding the timeliness of the performance of wound consultations. Employee #38 explained that the consults are typically performed within 24-48 hours by the night supervisor, who is the dedicated wound care nurse at present. S/he shared that two wound care nurses have recently been hired.


The medical record lacked documented evidence that the wound care consult was completed with timeliness, as per plan of care to manage the patient's wound care needs.


Employees #38 and 62 acknowledged the findings.


4. Based on medical record review, policy review and staff interview, it was determined that the nursing staff failed to accurately assessed and consistently reassessed wounds to include all relevant characteristics and information to determine wound progression and/or treatment relative to the plan of care, in two (2) of 10 records reviewed (Patients #11 and 15).


The findings include:


The Howard University Hospital (HUH) Policy Number NUR-027-14-ASP, last revised January 2017, titled, 'PRESSURE INJURY PREVENTION AND TREATMENT,' stipulates "POLICY The Howard University Hospital (HUH) shall have a system in place that assures assessments are timely and appropriate, interventions are implemented, monitored and revised as appropriate; and changes in condition are recognized, evaluated ...PROCEDURE ...Nursing Staff shall ...Assess, reassess and document the ulcer's characteristics ...Daily Monitoring of Pressure Ulcer (Injury) Shall Include: Evaluate the ulcer (injury) if no dressing is present, evaluate the dressing if present; dressing intact, drainage present, evaluate the area surrounding the pressure ulcer (injury) ...With each dressing change, or at least weekly, the pressure ulcer (injury) wound shall be assessed and documented by certified wound care specialist or registered nurse: date, location of ulcer and staging, size ...depth, presence, location and extent of any undermining or tunneling ...presence of exudates ... color or type of tissue/character ...description of wound edges and surrounding tissue ..."


A. Patient #11 was admitted with diagnoses to include Transient Ischemic Attack, rule out Stroke, and Pneumonia.


On April 10, 2017 at approximately 3:40 PM, review of the nursing "Integumentary Assessment' revealed the presence of a Stage 1 pressure injury (ulcer) measuring [size in centimeters (length x width x depth)] 0.5 x 0.5 on the sacrum, with no other listed characteristics, first identified on April 3, 2017. On April 4-6, 2017, documentation revealed ulceration on the sacrum, with no measurements or characteristics. On April 7, 2017, documentation on the nursing care flow sheet revealed a Stage 2 Sacral ulcer that measured 6.5 x 9, with slough and red area. On April 8-9, 2017, the same presence of the wound was documented.


On April 9, 2017, a wound care consult was ordered for the sacral decubitus ulcer. On April 10, 2017 at 12:00 PM, photographic wound documentation performed by the registered nurse, Employee #62, revealed a Stage 2 Pressure Ulcer to the Sacrum, measuring 8x8x0.5, with scant bloody exudate, eschar on the wound bed, wound edges with peripheral tissue edema and no tunneling, undermining, or granulation. The areas for documentation of the "date first observed" and "Surrounding Skin Color" were left blank.


Inconsistent with the prior wound care assessment, that same day at 10:30 PM, photographic wound documentation performed by the wound care nurse, Employee #88, revealed a Sacrococcygeal Unstageable Pressure Ulcer, measuring 10x10x0, with 30% granulation, scant serosanguinous exudate, eschar on the wound bed, pink surrounding tissue, wound edges with peripheral tissue edema, and no tunneling or undermining. The area for documentation of the "date first observed" was left blank.


The record lacked documented evidence that nursing staff followed the hospital's policy to ensure the patient's pressure injury (ulcer) was accurately assessed and consistently reassessed, as per plan, to include all relevant characteristics and information to determine wound progression and/or treatment.


On April 10, 2017 at approximately 4:00 PM, a face-to-face interview was conducted with the Employee #62, in the presence of Employee #38. S/he was queried regarding the inconsistent, incomplete, and conflicting wound assessments, as well as the lack of documentation relative to the patient's wound care needs. Both employees acknowledged the findings and Employee #38 shared that two wound care nurses have recently been hired.


B. Patient #15 was admitted with diagnoses to include Sepsis and Acute Respiratory Failure; and developed Stage 2 Pressure Injury to the Sacrum, during the course of hospitalization.


On April 11, 2017 at approximately 10:48 AM, a review of the nursing "Integumentary Assessment,' photographic wound documentation, and nursing progress notes from March 18, 2017 to April 10, 2017 revealed that wound assessments to include characteristics were not consistently performed at least weekly from March 20-31, 2017, as per hospital policy.


The record lacked documented evidence that nursing staff followed the hospital's policy to ensure the patient's pressure injury (ulcer) was consistently reassessed to include all relevant characteristics and information to determine wound progression and/or treatment and plan of care.


On April 11, 2017 at approximately 11:00 AM, a face-to-face interview was conducted with Employees #53 and 69, regarding the reassessment of wounds. Employees #53 acknowledged the findings.


5. Based on record and policy review, and staff interview for one (1) of one (1) patient reviewed for psychiatric services, it was determined that nursing staff failed to comprehensively assess Patient #38 at the time of admission, per policy and plan of care.


The findings include:


According to Hospital Policy #Nur-037-14, ASP "Management of Patients at Risk for Harming Self or Others" last revised January 2014; "Initial Assessment [Nurse] - the patient's risk for suicide/violence is assessed by completing the Suicide Risk Assessment Tool..."


Patient #38 was admitted April 10, 2017 at 8:10 PM with diagnoses that included rule out Bipolar disorder, Schizoaffective disorder and Suicidal Ideation.


The admission orders included Suicidal precaution with every 15-minute observation for unpredictable behavior.


A review of the "Psychiatric Admission Database" revealed the nurse who admitted Patient #38 documented an admission time of 23:37 (11:37 PM on 4/10/17). There was no evidence that the nurse conducted an assessment of the patient's suicidal risk at the time of admission/initial assessment, as stipulated in the aforementioned policy and according to the plan of care for the patient. The medical record revealed the nurse conducted the "Suicidal Self Harm Assessment" at 5:00 AM on April 11, 2017, approximately eight (8) hours post admission.


A face-to-face interview was conducted with Employee #97 on April 11, 2017 at approximately 10:00 AM. In response to a query regarding the admission process for patients identified as possible risk for self-harm; s/he stated "Suicidal Self Harm Assessment" is to be completed at the time of admission. S/he added that it was late [when the patient was admitted] and the patient may have been sleepy. S/he acknowledged the findings. The record was reviewed April 11, 2017.





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5. Based on medical record review, policy review, and staff interview, it was determined the nursing staff failed to develop, and keep current, an individualized nursing care plan to address the patient's identified needs, in five (5) of seven (7) records reviewed (Patients #9, 10, 19, 38 and 73).


The findings include:


A. Patient #9 was admitted with Abdominal Pain. Subsequently, s/he underwent an exploratory laparotomy.


A review of the medical record conducted on April 10, 2017 at approximately 3:30 PM revealed that Patient #9 was intubated and on a ventilator. A review of the care plan did not address an alteration in respiratory function.


A review of a physician note dated April 9, 2017 at 5:00 AM revealed " ...Episode of hypoglycemia ..." A review of the point of care (POC) testing results for Fingerstick Blood Glucose (FSBG) revealed that on April 8, 2017 at 7:51 AM Patient #9 had a FSBG value of 37 milligrams per deciliter (mg/dl); on April 8, 2017 at 11:57 AM, the value was 44 mg/dl; on April 9, 2017 at 6:42 AM, the value was 30 mg/dl, and on April 9, 2017 at 8:56 AM the value was 44 mg/dl. The plan of care did not address Hypoglycemia for Patient #9.


Further review of the medical record revealed a physician order dated April 4, 2017 at 7:43 AM for Total Parenteral Nutrition (TPN). The plan of care did not address an alteration in nutrition.


Review of the nursing care plan did not identify alteration in respiratory function, Hypoglycemia, or an alteration in nutrition.


The nursing staff failed to maintain a care plan with interventions and measurable goals to address the needs of Patient #9.


A face to face interview was conducted on April 10, 2017, at approximately 4:00 PM with Employee #64 in the presence of Employees #5 and 39 regarding the care plan. S/he acknowledged the findings.


B. Patient #10 was admitted after an exploratory laparotomy for a Small Bowel Obstruction.


A review of the medical record conducted on April 10, 2017 at approximately 12:00PM revealed a nursing note dated April 6, 2016 at 1:52 PM documenting that the patient was intubated and on a ventilator.


Review of the nursing care plan did not identify an alteration in respiratory function.


The nursing staff failed to establish and maintain a current nursing care plan with goals and interventions to meet the needs of Patient #10.


A face to face interview was conducted on April 10, 2017, at approximately 12:30 PM, with Employee #64 in the presence of Employees #5 and 39 regarding the care plan. Employee #64 acknowledged the findings.


C. Patient #19 was admitted with Acute Encephalopathy secondary to Anoxic Brain Injury.


A review of the medical record conducted on April 11, 2017 at approximately 9:25 AM revealed a History and Physical conducted on March 4, 2017 which noted that Patient #19 was intubated and on a ventilator.


A review of the respiratory nursing assessments from March 16 - 18, 2017 lacked documented evidence of breath sound assessments and endotracheal tube (ETT) position for all shifts. Further review of nursing respiratory assessments revealed there were no breath sound assessments documented and no documentation of the ETT position documented from April 4 - 11, 2017.


Review of the nursing care plan initiated on March 9, 2017 did not address Patient #19's alteration in respiratory function.


The nursing staff failed to assess respiratory status and maintain a care plan with interventions and measurable goals to address the needs of Patient #19.


Further review of the record revealed interventions documented that did not meet the needs of the patient. The intervention "Assist with Ambulation Once per shift" was documented as completed by nursing staff April 3 - 11, 2017. Patient #19 is unable to ambulate related to his/her diagnosis, and unresponsiveness.


A face to face interview was conducted on April 11, 2017 at approximately 10: 00 AM with Employee #54 in the presence of Employees #8 and 39, regarding the individualization of the care plan. Employee #54 acknowledged the findings and said that the alteration in respiration should have been addressed. Employee #39 acknowledged that the interventions documented did not meet the needs of the patient.


D. Patient #38 was admitted April 10, 2017 with diagnoses that included rule out Bipolar disorder, Schizoaffective disorder and Suicidal Ideation.


On April 11, 2017 at approximately 9:45 AM, A review of the medical record revealed Patient #38 had a past psychiatric history of Bipolar Disorder who presented to the emergency department with worsening of auditory hallucinations and feeling suicidal.


A review of the care plan for Patient #38 included but was not limited to "in hospital suicide precautions; suicide prevention and disease process" with outcomes that included "absence of self-harm and effective coping." However, the care plan lacked evidence of measurable goals and approaches, inclusive of intermediate interventions to meet Patient 38's needs.


A face-to-face interview was conducted with Employee #97 on April 11, 2017 at approximately 10:00 AM regarding the care plan. S/he acknowledged the findings.



E. Patient #73 was admitted with Shortness of Breath, Lower Back Pain for two (2) days, with a medical history of B-cell Lymphoma with lung metastasis.


The medical record view conducted on April 10, 2017, at approximately 4:28 PM revealed Patient #73 entered the hospital through the Emergency Department, with a pain score of nine out of ten (9/10) in the back and abdomen. At 10:30 PM on October 1, 2016, the patient described the pain as aching; no further descriptors were documented.


Consequently, the medical staff entered orders for Hydromorphone 0.5 milligrams 11:45 PM on October 1, 2016; administered at 11:45 PM. Further review of the medical record revealed a lack of documented evidence to demonstrate the nursing staff completed a pain re-assessment to evaluate the pain medication effectiveness. Additionally, at 12:35 AM, the nursing documentation in the "Vital Signs" section of the electronic medical record revealed the nursing staff documented "back" as the "Pain Location"; however, the section lacked documentation of further detail related to the back pain to include quality or rate.


The nursing staff transferred Patient #73 to the Medical Intensive Care Unit (MICU) at 5:00 AM on October 2, 2016. According to the nursing admission database, Patient #73 was able to state the reason for admission to the unit secondary to being intubated with an oral endotracheal tube (device used to facilitate mechanical ventilation) and oxygen delivery of four (4) liter of oxygen, via nasal cannula. The "Respiratory" section of the admission database indicated that Patient #73's respiratory status was "WDL [Within Desire Limits] except as noted below." The documented exception related to respiratory status was recorded as tachypnea. The sections available for the documentation of "oxygen" and "ventilator" were left blank.


The documented respiratory assessment, in the admission database, is inconsistent with the documented condition of the patient recorded, in other sections of the admission database; "General Admission Info"[Information].


The nursing staff failed to perform a comprehensive admission assessment to accurately determine the patient needs and establish an individualized nursing plan of care.


Other areas of inconsistent nursing assessment are related to pain. On October 2, 2016, at 5:00 AM, the nursing staff documented the presence of abdominal tenderness, without any further descriptors. Review of the Medication Administration Record revealed Patient #73 received Hydromorphone one (1) milligram at 10:00 AM, approximately five (5) hours after the assessment of abdominal tenderness.


The medical record lacked documented evidence the nursing staff performed pain assessment with sufficient details to develop an appropriate plan of care to address Patient #73's pain.


The nursing staff failed to accurately and consistently assess and reassess Patient #73's pain and respiratory status to ensure the development of an individualized plan of care to address his/her needs.


During a face to face interview on April 10, 2017, at approximately 4:45 PM, Employee #62 acknowledged and confirmed the findings. S/he was unable to provide any further insight into the discrepancies noted in the medical record related to pain and respiratory.






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Based on observation, medical record review, and staff interview, it was determined the facility failed to ensure nursing personnel had the qualifications and competence to care for a ventilator dependent patient with an endotracheal tube, in one (1) of one (1) patient records reviewed (Patient #19).


The findings include:


Patient #19 was admitted with Acute Encephalopathy, secondary to Anoxic Brain Injury and was intubated on arrival to the Emergency Department. S/he remained intubated with an endotracheal tube for the duration of the admission.


A review of the medical record conducted on April 11, 2017, at approximately 9:25 AM revealed Patient #19 was transferred from the Intensive Care Unit (ICU) to a lower level of care, Medical Surgical (MedSurg) Unit 5 East, on March 16, 2017. Review of a nursing note dated March 18, 2017, at 8:19 PM revealed, " ...Patient #19's oxygen saturation dropped to 80 - 85%...Patient for transfer to [Medical Intensive care unit] ..." A review of the respiratory nursing assessments from March 16-18, 2017 lacked documented evidence of breath sound assessments and endotracheal tube (ETT) position, for all shifts, prior to transfer to a higher level of care. On March 21, 2017, the patient was transferred back to Unit 5East, after resolution of Respiratory Distress.


Further review of nursing respiratory assessments revealed there were no breath sounds assessments documented and no documentation of the ETT position from April 4-11, 2017.


A face to face interview was conducted on April 11, 2017, at approximately 10:00 AM with Employee #8, regarding respiratory assessment expectations for staff. S/he explained that the breath sounds and ETT placement should be assessed during all shifts. When queried about the competency of the nursing staff assigned to care for patients with an ETT, on a ventilator, s/he explained that only the charge nurse is assigned to care for Patient #19 and s/he assumed that they had been trained.


A face to face interview was conducted on April 11, 2017, at approximately 10:10 AM with Employee #39, regarding education and competency provided to nurses on the MedSurg units to care for patients with an ETT on a ventilator. S/he explained that the facility had not provided education related to ventilator care, or ETT's for MedSurg staff, in "a couple of years", but stated that it was on the schedule for 2017.


A review of employee records for nursing staff assigned to the care of Patient #19 was conducted on April 11, 2017, at approximately 4:00 PM. The findings revealed there was no ventilator education or competency found on Employees #68, 69, 70, 71, 72, 73, 75, 76,77,78,79, 80, 81, and 82. Further review revealed Employee #74 last completed ventilator education and training in 2008.


The facility failed to ensure that nursing staff assigned to care for Patient #19, received the specialized training necessary to meet the patient's needs.


A face to face interview was conducted on April 12, 2017, at approximately 3:00 PM with Employee #4, regarding the education of the nursing staff. S/he acknowledged the aforementioned findings.

Based on medical record and policy review, review of facility documents, and staff interview and confirmation, it was determined that staff failed to properly administer medications and to administer medication, in accordance with physician orders and acceptable standards of practice, for five (5) of 29 patients (Patients #15, 19, 36, 71 and 75).


The findings include:


A. Patient #15 was admitted with diagnoses to include Sepsis and Acute Respiratory Failure; and developed Stage 2 Pressure Injury to the Sacrum, during the course of hospitalization.


The Howard University Hospital (HUH) Policy Number NUR-027-14-ASP, last revised January 2017, titled, 'PRESSURE INJURY PREVENTION AND TREATMENT,' stipulates " ...PROCEDURE ...Nursing Staff shall ...Follow practitioner's orders for treatment of the pressure ulcer (injury) ..."


On April 11, 2017, at approximately 10:48 AM, a review of the record revealed a physician order dated April 1, 2017 at 7:43 AM for wound care to the right gluteal wound, with Normal Saline and Xeroform, every day and as needed.


Further review of the record from April 1- 10, 2017, revealed no evidence to indicate nursing staff followed the order to perform daily wound care with Normal Saline and Xeroform on April 1-7, 2017.


The record lacked evidence that staff followed the physician's order.


On April 11, 2017, at approximately 11:00 AM, a face-to-face interview was conducted with Employees #53 and 69, regarding the doctor's order. Employee #53 reviewed the medication administration record and nursing progress notes; however, explained that there was no indication that wound care was performed on the days in question.


Employees #53 acknowledged the findings.


B. Patient #19 was admitted with Acute Encephalopathy secondary to Anoxic Brain Injury, and was intubated on arrival to the Emergency Department. S/he remained intubated with an endotracheal tube for the duration of the admission.


A review of the medical record conducted on April 11, 2017 at approximately 9:25 AM revealed a physician order dated March 26, 2017 for fingerstick blood glucose (FSBG) monitoring every six (6) hours; and for low dose sliding scale insulin to be given as follows: From 180 - 199 milliliters per deciliter (mg/dl), give one unit; for 200 - 249 mg/dl, give two (2) units; 250 - 299 mg/dl, give 3 units; 300 - 349 mg/dl give 4 units; and for a value of 350 - 399 mg/dl, give 5 units.


Review of FSBG results revealed that on April 8, 2017 at 11:52 PM, the result was 191 mg/dl; April 9, 2017 at 12:44 PM, the result was 197 mg/dl; April 10, 2017 at 12:12 AM, the result was 197 mg/dl; and April 10, 2017, at 7:05 AM, the result was 200 mg/dl.


A review of the Electronic Medication Administration Record (EMAR) for as needed (PRN) medications revealed that no sliding scale insulin coverage was administered for those values.


The practice lacked evidence that the nursing staff administered insulin, as ordered by the physician.


A face to face interview was conducted on April 11, 2017 at approximately 10: 00 AM with Employee #54, in the presence of Employees #8 and 39 regarding the administration of sliding scale insulin, in accordance with physician orders, for Patient #19. All employees acknowledged and confirmed the findings.


C. Patient #36 arrived at the Emergency Department with complaints of "feeling weak and constipation" and a history of Hypertension and Coronary Artery Disease.


The medical record review conducted on April 10, 2017, at 12:59 PM revealed Patient #36 experienced a Myocardial Infarct (heart attack where the blood circulation to the heart is depleted) and required a cardiac catheterization (a procedure used to see inside of the arteries of the heart).


At 4:33 PM on October 1, 2016, medical staff entered orders for Atropine Sulfate one (1) milligram, Plavix 600 milligrams; and Eptifibatide 10.5 and 30 milligrams at 8:07 PM and 8:16 PM, respectively. Atropine, Plavix, and Eptifibatide are medications used to treat a patient with suspected heart attack.


Review of the Medication Administration Record lacked documented evidence the nursing staff administered the previously mentioned medications, as ordered by the medical staff. The nursing staff failed to administer medication to support the plan of care for the treatment of a patient experiencing a heart attack.


A face to face interview conducted with Employees #89 and 91 on April 10, 2017, at approximately 1:30 PM confirmed the findings.


D. On April 10, 2017, and April 11, 2017, a seventy-two (72) hour or twenty-four (24) hour report was generated by the facility's ADM for controlled substances, schedule II-V. The 72-hour reports were printed for Patient Care Units 6S-1, 6S-2, and Surgical Intensive Care Unit (SICU). The 24-hour report was printed for Patient Care Unit units, Main Emergency Department (ED), Fast Track. All patients were randomly selected for this audit. The survey of records was started on April 10, 2017, at approximately 11:00 and was completed on April 11, 2017, at approximately 16:30.


In the presence of Employee #87, the physician order and MAR or Electronic Medication Administration Record (eMAR) were reviewed for accuracy, withdrawals from the ADM were compared with administration times and the dispositioning of controlled substances.


On March 20, 2017, Patient #71 was admitted to 6 S-1. On April 9, 2017, the patient was ordered Hydromorphone 1mg (milligram), intravenously every four (4) hours. On April 9, 2017, nursing documentation on the notes in the eMAR revealed the 02:00 and 06:00 doses were not available from pharmacy. The inspector verified the ADM records to discover that Hydromorphone 2mg/ml (milliliter) was available for administration for these two doses. On April 9, 2017, at 07:22, Hydromorphone 2mg/ml was removed from the ADM and administered to patient at 07:25. Documentation on the eMAR revealed that Hydromorphone was administered at 06:00, when it was not (notes show that it was documented for the scheduled time, not actual time of administration).


The findings were reviewed, discussed, and acknowledged by Employee #87.


E. Patient #75 was admitted with diagnoses to include Chronic Obstructive Pulmonary Disease Exacerbation and Congestive Heart Failure.


The surveyor conducted a medical record review on April 11, 2017, at approximately 10:14 AM which revealed a physician order for blood glucose monitoring, via fingerstick before meals and at bedtime dated May 25, 2016, at 7:04 PM. In addition, the medical staff ordered low dose Insulin Aspart sliding scale subcutaneous before meals and at bedtime as needed for elevated blood glucose level as ordered: 180- 199 milligrams per deciliter (mg/dL) give one (1) unit; 200- 249 mg/dL give two (2) units; 250- 299 mg/dL give three (3) units; 300- 349 mg/dL give four (4) units; and 350-399 mg/dL give five (5) units. Also, if the blood glucose level is greater than 300- notify the physician.


Patient #75's blood glucose levels were documented as 187 mg/dL and 227 mg/dL on May 25, 2016 at 7:01 PM and 10:14 PM, respectively.


The medical record lacked documented evidence the nursing staff administered the Aspart insulin, in accordance with the correctional sliding scale for the episodes of elevated blood glucose levels documented on May 25, 2016, at 7:01 PM and 10:14 PM.


On May 26, 2016 at 7:16 AM, the medical staff changed the order for the correctional dose Insulin Aspart sliding scale to a medium dose algorithm as follows: 180- 199 milligrams per deciliter (mg/dL) give one (1) unit; 200- 249 mg/dL give three (3) units; 250- 299 mg/dL give five (5) units; 300- 349 mg/dL give seven (7) units; and 350-399 mg/dL give eight (8) units. Also, if the blood glucose level is equal to or greater than 350 mg/dL- notify the physician.


Further review of the blood glucose testing results revealed Patient #75's experienced elevated blood glucose levels on the following date and time, without the administration of the appropriate dose of Aspart insulin as follows: May 27, 2016 at 12:56 AM- 360 mg/dL; May 27, 2016 at 1:57 PM- 375 mg/dL; May 27, 2016 at 2:56 PM- 329 mg/dl; May 27, 2016 at 11:34 PM- 304 mg/dL; May 28, 2016 at 11:36 AM- 337 mg/dL; May 28, 2016 at 9:15 PM; and May 29, 2016 at 7:18 AM- 227 mg/dL.


Review of the Medication Administration Record and the nursing documentation lacked documented evidence the nursing staff administered the Aspart insulin, in accordance with the correctional sliding scale for episodes of elevated blood glucose levels. In addition, the medical record lacked documented evidence the nursing staff notified the medical staff for results greater than 350 mg/dL or obtained an order to omit the dose.


The surveyor queried Employee #90 on April 11, 2017, at approximately 11:30 AM about the insulin administration. S/he explained that it is the expectation of the hospital that all medications are administered as ordered. The findings were reviewed and acknowledged.





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Based on record review and staff interview for one (1) of two (2) patients reviewed for Hemodialysis services, it was determined facility staff failed to ensure that information was accurately written, as evidenced by variations of the patient's name documented, in the medical record (Patient #32).


Patient #32 was admitted April 10, 2017. A review of the patient's medical record on April 12, 2017 at 10:45 AM revealed a variation [different spelling; different name] in the patient's first name, throughout the medical record.


The medical record lacked evidence that staff accurately documented the patient's name in the record, consistently.


A face-to-face interview was conducted with Employee #4 on April 12, 2017 at approximately 9:30 AM. In response to a query regarding the inconsistency in the patient's first name, s/he stated that one name was obtained in the emergency department (ED) and the other name was obtained during admission. There is a difference because no insurance information is obtained in the ED, but it is during admission. The patient uses a different name for insurance. The record was reviewed April 12, 2017. Employee #4 acknowledged the findings.

Based on medical record review, policy review, and staff interview, it was determined the hospital failed to ensure that all medical record contained information to justify and support hospitalizations; describe the patient's progress and response to medications, care, and treatment, in seven (7) of 13 patient records reviewed (Patients #4, 5, 10, 11, 15, 19 and 36).


The findings include:


A. Patient #4 was seen in the Emergency Department for diagnoses to include Headache.


The Howard University Hospital (HUH) Policy Number NUR -020-14, ASP, last revised January 2014, titled, 'PAIN MANAGEMENT,' stipulates, " ...POLICY: Howard University Hospital recognizes that all patients have a right to comprehensive pain assessment and management ...Assessment/Management ...Pain will be assessed using one of the following pain scales: 0-10 scale ...Happy Face/Sad Face ...NV[Non-verbal] 1 ...NV2 ...The licensed nurse will assess and document pain management as follows ...within 30 minutes of giving an IV [intravenous] analgesic ..."

The Howard University Hospital (HUH) Policy Number 1, last revised September 2012, titled, 'Documentation In The Medical Record,' stipulates " ...I. Documentation of the Nursing Process F. Reassessment - Reassessment is the process of re-evaluation of the patient's needs for care ...3 ...Patients are required to be reassessed at the following times ...c. on discharge; d. at any time that there is a change in the patient's condition ..."


On April 10, 2017, at approximately 12:40 PM, a review of the medical record revealed a physician's order for Toradol 30 milligrams, one (1) dose, intravenously, for pain. Nursing staff administered Toradol to the patient on April 10, 2017 at 8:48 AM for head and abdominal pain; however, the record lacked documented evidence of the performance of a pain assessment to include a pain scale or characteristics. Further review revealed there was no documented evidence of pain re-assessment, 30 minutes after the administration of intravenous medications to determine the effectiveness of the intervention.


The record lacked evidence that staff documented necessary care and treatment to include pain assessment and reassessment.


On April 10, 2017, at approximately 12:50 PM, a face-to-face interview was conducted with Employees #56, in the presence of Employee #38. S/he was queried regarding the documentation of pain assessment and reassessment. Employee #56 could provide no insight, but acknowledged the findings.


B. Patient #5 was seen in the Emergency Department for diagnoses to include Upper Abdominal Pain.


On April 10, 2017, at approximately 12:30 PM, a review of the medical record revealed a physician's order for Morphine one (1) milligram, every six hours, intravenously for pain, if needed. Nursing staff administered Morphine to the patient on April 10, 2017 at 9:24 AM for pain; however, the record lacked evidence that staff documented the performance of a pain assessment to include a pain scale or characteristics. Further review revealed there was no documented evidence of pain re-assessment, 30 minutes after the administration of intravenous medications to determine the effectiveness of the intervention.


The record lacked evidence that staff documented necessary care and treatment to include pain assessment and reassessment.


On April 10, 2017, at approximately 12:35 PM, a face-to-face interview was conducted with Employees #56, in the presence of Employee #38. S/he was queried regarding the documentation of pain assessment and reassessment. Employee #56 could provide no insight, but acknowledged the findings.


C. Patient #10 was admitted after an exploratory laparotomy for a Small Bowel Obstruction.


A review of the medical record conducted on April 10, 2017, at approximately 12:00 PM revealed a physician order dated April 5, 2017, at 1:11 PM for Atrovent and Albuterol nebulizer every four (4) hours, as needed (PRN) for wheezing. A review of the nursing assessment at the same time revealed Patient #10 was on a non-rebreather mask at the time.


Further review of the respiratory therapy assessment and treatment record revealed that there were no pre-treatment assessments documented when the medication was administered, on the following dates at the following times: April 5, 2017, at 10:00 PM; April 6, 2017, 2:00 AM and 3:00 PM; April 7, 2017, at 11:00 AM, 2:00 PM, and 10:00 PM; April 8, 2017, at 2:00 AM, 6:00 AM, 2:00 PM, 6:00 PM, and 11:00 PM; April 9, 2017, at 2:00 AM, 5:00 AM, 3:00 PM, and 10:00 PM; April 10, 2017, at 2:00 AM, 5:00 AM, and 10:00 AM.


The medical record lacked evidence that respiratory assessments were documented by respiratory staff to justify the administration of medication.


A face to face interview was conducted on April 10, 2017, at approximately 1:45 PM with Employee #85, regarding documentation of assessments, prior to administering the medication. S/he acknowledged the findings.


D. Patient #11 was admitted with diagnoses to include Transient Ischemic Attack, rule out Stroke, and Pneumonia.


The Howard University Hospital (HUH) Policy Number NUR-027-14-ASP, last revised January 2017, titled, 'PRESSURE INJURY PREVENTION AND TREATMENT,' stipulates "...POLICY The Howard University Hospital (HUH) shall have a system in place that assures assessments are timely and appropriate, interventions are implemented, monitored and revised as appropriate; and changes in condition are recognized, evaluated ...Nursing Staff shall ...Assess, reassess and document the ulcer's characteristics ...Daily Monitoring of Pressure Ulcer (Injury) Shall Include: Evaluate the ulcer (injury) if no dressing is present, evaluate the dressing if present; dressing intact, drainage present, evaluate the area surrounding the pressure ulcer (injury) ...With each dressing change, or at least weekly, the pressure ulcer (injury) wound shall be assessed and documented by certified wound care specialist or registered nurse: date, location of ulcer and staging, size ...depth, presence, location and extent of any undermining or tunneling ...presence of exudates ... color or type of tissue/character ...description of wound edges and surrounding tissue ..."


On April 10, 2017 at approximately 3:40 PM, a review of the medical record revealed a computer entry order for "Wound Care Evaluation" consult dated March 22, 2017 at 6:43 PM. Further review of the record revealed a wound care consult completed on March 27, 2017 (five days later).


The medical record lacked evidence of a wound care consult documented with timeliness.


Additionally, a review of the nursing "Integumentary Assessment' revealed the presence of a Stage 1 pressure injury (ulcer) measuring [size in centimeters (length x width x depth)] 0.5 x 0.5 on the sacrum, with no other listed characteristics, first identified on April 3, 2017. On April 4-6, 2017, documentation revealed ulceration on the sacrum, with no measurements or characteristics. On April 7, 2017, documentation on the nursing care flow sheet revealed a Stage 2 Sacral ulcer that measured 6.5 x 9, with slough and red area. On April 8-9, 2017, the same presence of the wound was documented.


On April 9, 2017, a wound care consult was ordered for the sacral decubitus ulcer. On April 10, 2017 at 12:00 PM, photographic wound documentation performed by the registered nurse, Employee #62, revealed a Stage 2 Pressure Ulcer to the Sacrum, measuring 8x8x0.5, with scant bloody exudate, eschar on the wound bed, wound edges with peripheral tissue edema and no tunneling, undermining, or granulation. The areas for documentation of the "date first observed" and "Surrounding Skin Color" were left blank.


Inconsistent with the prior wound care assessment, that same day at 10:30 PM, photographic wound documentation performed by the wound care nurse, Employee #88, revealed a Sacrococcygeal Unstageable Pressure Ulcer, measuring 10x10x0, with 30% granulation, scant serosanguinous exudate, eschar on the wound bed, pink surrounding tissue, wound edges with peripheral tissue edema, and no tunneling or undermining. The area for documentation of the "date first observed" was left blank.


The record lacked evidence that nursing staff documented the accurate and complete assessment of the patient's pressure injury (ulcer), to include all relevant characteristics and information to determine wound progression and/or treatment.


On April 10, 2017, at approximately 4:00 PM, a face-to-face interview was conducted with the Employee #62, in the presence of Employee #38. S/he was queried regarding the documentation and timeliness of the performance of wound consultations and the lack of documentation, relative to the patient's wound care needs. Employee #38 explained that the consults should be accurately documented within 24-48 hours by the night supervisor, who is the dedicated wound care nurse at present, and nursing staff is responsible for accurate documentation of wound assessments. S/he shared that two wound care nurses have recently been hired. Both employees acknowledged the findings.


E. Patient #15 was admitted with diagnoses to include Sepsis and Acute Respiratory Failure; and developed Stage 2 Pressure Injury to the Sacrum, during the course of hospitalization.


The Howard University Hospital (HUH) Policy Number NUR-027-14-ASP, last revised January 2017, titled, 'PRESSURE INJURY PREVENTION AND TREATMENT,' stipulates "...With each dressing change, or at least weekly, the pressure ulcer (injury) wound shall be assessed and documented by certified wound care specialist or registered nurse: date, location of ulcer and staging, size ...depth, presence, location and extent of any undermining or tunneling ...presence of exudates ... color or type of tissue/character ...description of wound edges and surrounding tissue ..."


On April 11, 2017 at approximately 10:48 AM, a review of the nursing "Integumentary Assessment,' photographic wound documentation, and nursing progress notes from March 18, 2017 to April 10, 2017 revealed that wound assessments to include characteristics were not consistently documented, at least weekly from March 20-31, 2017, as per hospital policy.


The record lacked evidence that nursing staff accurately and consistently documented the patient's pressure injury (ulcer) to include all relevant characteristics and information to determine wound progression and/or treatment, as per hospital policy.



On April 11, 2017 at approximately 11:00 AM, a face-to-face interview was conducted with Employees #53 and 69, regarding the documentation of wounds. Employees #53 acknowledged the findings.


F. Patient #19 was admitted with Acute Encephalopathy secondary to an Anoxic Brain Injury and was intubated on arrival to the Emergency Department. S/he remained intubated with an endotracheal tube for the duration of the admission.


A review of the medical record conducted on April 11, 2017, at approximately 9:25 AM revealed a physician order for an Albuterol nebulizer to be administered for wheezing, every six (6) hours, as needed (PRN).


Further review of the medical record revealed a respiratory assessment on April 4, 2017, at 6:35 PM, the medication was administered. "Pre-Treatment breath sounds not assessed at this time ...Post-treatment breath sounds not assessed at this time" was documented, under the breath sound assessment area.


The medical record lacked evidence that respiratory assessments were documented by respiratory staff to justify the administration of medication.


A face to face interview was conducted on April 11, 2017, at approximately 10:15 AM with Employee #84, regarding the lack of documentation of an indication for the administration of medication. S/he could offer no further insight. Employees #8, 39, and 85 acknowledged the findings.


G. Patient #36 arrived at the Emergency Department with complaints of "feeling weak and constipation" and a history of Hypertension and Coronary Artery Disease.


The medical record review conducted on April 10, 2017, at 12:59 PM revealed Patient #36 experienced a Myocardial Infarct (heart attack where the blood circulation to the heart is depleted) and required a cardiac catheterization (a procedure used to see inside of the arteries of the heart).


At 4:00 PM on October 1, 2016, Patient #36 entered the Catheterization Lab for a cardiac catheterization. The hospital staff aborted the procedure, as the patient was found to have a complete heart block. Consequently, the medical staff documented the plan of care to include a transfer to an outside hospital for re-vascularization. The medical staff assigned Patient #36 to the Medical Intensive Care Unit (MICU) at 7:02 PM. Patient #36 remained on the MICU, until his/her death on October 2, 2016, at 3:30 AM.


The nursing staff documented a call to the outside hospital at 10:30 PM, indicating patient report was given to the receiving nurse. Also, the nursing note for October 1, 2016, at 10:30 PM stated the patient vital signs were "stable with current pressors."


The medical record lacked documented evidence of the rationale for transferring the patient to the MICU, instead of the outside hospital for a higher level of care. In addition, the medical record lacked documentation to provide an explanation or rationale for the delay in transfer from 7:02 PM to 11:05 PM, when Patient #36 experienced the first of three (3) episodes of Pulseless Electrical Activity (PEA) and asystole (absent heartbeat) requiring cardiopulmonary resuscitation.


A face to face interview with Employee #89 and 91 conducted on April 10, 2017, at 1:30 PM revealed the nursing, and medical staff failed to document all information to describe the patient's progress and response to care, and treatment to support continued hospitalization, without receiving cardiac revascularization. The findings were reviewed, discussed, and acknowledged during the interview.








34093






35226

Based on a review of facility documents, Omnicell [Automated Dispensing Machine (ADM)] -Schedule II, III, IV, and V Controlled Substances Transactions by Patient report, physicians' orders, and Medication Administration Record [MAR] (in the presence of Employee #87), it was determined that hospital staff did not properly document the time the order was written, in one (1) of 24 patients (Patients #60).


The findings include:


On April 10, 2017, and April 11, 2017, a seventy-two (72) hour or twenty-four (24) hour report was generated by the facility's ADM for controlled substances, schedule II-V. The 72-hour reports were printed for Patient Care Units 6S-1, 6S-2, and Surgical Intensive Care Unit (SICU). The 24-hour report was printed for Patient Care Unit Main Emergency Department (ED) and Fast Track. All Patients were randomly selected for this audit. The survey of records was started on April 10, 2017, at approximately 11:00 AM and was completed on April 11, 2017, at approximately 4:30 PM.


In the presence of Employee #8, physician orders were reviewed for accuracy of documentation.


On April 9, 2017, Patient #60 was admitted to SICU. On April 9, 2017, an order was written to discontinue Tylenol, Percocet, and Morphine and to begin Dilaudid 2mg intravenously, every three (3) hours, as needed for pain. The time that the order was written was not on the order.


The findings were reviewed, discussed, and acknowledged by Employee #87.

Based on observation, record review and staff interview for one (1) of two (2) patients reviewed for Hemodialysis services, it was determined that staff failed to ensure that the medical record contained all necessary information to monitor care and treatment (Patient #37).


The findings include:


During a tour of the Acute Hemodialysis Division on April 10, 2017 at approximately 11:00 AM, Patient #37 was observed alert and responsive, resting in bed, receiving hemodialysis treatment.


During a follow up visit to the Acute Hemodialysis Division on April 12, 2017 at approximately 10:30 AM, Patient #37 was observed receiving hemodialysis treatment. In response to a request to review Patient #37s treatment record for the dialysis services that were provided on Monday, April 10, 2017; staff were unable to locate the records.


There was no evidence that staff located the dialysis treatment record of April 10, 2017 to justify the dialysis treatment or describe Patient #37s progress and response to treatment.


Employee #98, who observed the staff's inability to locate the treatment record presented the dialysis schedule from April 10, 2017 and stated, "yes, [s/he] was treated, [patient] was on the schedule." S/he stated that they would present the treatment record, once it was located. There was no evidence that staff located the dialysis treatment record of April 10, 2017 for Patient #37. Employee #98 acknowledged the findings.

Based on a review of facility documents, Omnicell [Automated Dispensing Machine (ADM)] -Schedule II, III, IV, and V Controlled Substances Transactions by Patient report, physicians' orders, and Medication Administration Record [MAR] (in the presence of Employee #87), it was determined that hospital staff did not properly document the administration, wasting, or handling of controlled substances, for four (4) of 24 patients (Patients #53, 56, 58, and 71).


The findings include:


On April 10, 2017, and April 11, 2017, a seventy-two (72) hour or twenty-four (24) hour report was generated by the facility's ADM for controlled substances, schedule II-V. The 72-hour reports were printed for Patient Care Units 6S-1, 6S-2, and Surgical Intensive Care Unit (SICU). The 24-hour report was printed for Patient Care Unit units, Main Emergency Department (ED), Fast Track. All patients were randomly selected for this audit. The survey of records was started on April 10, 2017, at approximately 11:00 and was completed on April 11, 2017, at approximately 16:30.


A. On April 9, 2017, Patient #53 was admitted to ED. The patient was ordered Morphine 4mg, intravenously, one time dose. On April 9, 2017, at 06:30, two Morphine 2mg doses were removed from the ADM, but were not administered until 07:11.


B. On April 7, 2017, Patient #56 was admitted to SICU. On April 7, 2017 at 22:20, the patient was ordered Serax 10mg, by mouth, every four hours, until calm. On April 8, 2017, at 14:15, Serax 10mg was removed from the ADM. The e-MAR showed the medication was administered to the patient at 14:00 (15 minutes before it was removed from the ADM).


C. On April 8, 2017, Patient #58 was admitted to the SICU. On April 8, 2017, no time was recorded when the order was written; however, the patient was ordered two (2) tablets of Percocet 5/325 by mouth every 6 hours, as needed for pain. On April 9, 2017, at 01:41, two (2) tablets of Percocet 5/325 were removed from the ADM, but were not administered to the patient until 05:00 (almost 4 hours later).



D. On March 20, 2017, Patient #71 was admitted to 6 S-1. On April 9, 2017, the patient was ordered Hydromorphone 1mg intravenously, every 4 hours. On April 9, 2017, at 07:22, Hydromorphone 2mg/ml was removed from the ADM and administered to the patient at 07:25. Documentation on the eMAR revealed Hydromorphone was administered at 06:00, the record revealed it was documented for the scheduled time, not the actual time of administration).


The findings were reviewed, discussed, and acknowledged by Employee #87.

Based on medical record review, and policy review and staff confirmation, it was determined that the clinical staff failed to verify the patient's current Methadone dose with the Substance Abuse Clinic treating the patient, for one (1) of 24 patients (Patient #16).


The finding include:


The Code of Federal Regulations Title 21 § 1306.07, Administering or dispensing of narcotic drugs stipulates, "(a) A practitioner may administer or dispense directly (but not prescribe) a narcotic drug listed in any schedule to a narcotic dependent person for the purpose of maintenance or detoxification treatment if the practitioner meets both of the following conditions: (1) The practitioner is separately registered with DEA as a narcotic treatment program. (2) The practitioner is in compliance with DEA regulations regarding treatment qualifications, security, records, and unsupervised use of the drugs pursuant to the Act ..."


Howard University Hospital Policy #PHA-15-16, titled, 'Inpatient Methadone Maintenance,' stipulates, "...1. On admission of a methadone maintenance patient as a hospital inpatient, the hospital staff should notify the patient's treatment program and confirm the individual's enrollment in the treatment program, methadone dose, and time and date of last dose ..."


On April 12, 2017 at 12:06, in the presence of Employee #87, it was discovered that a patient admitted was prescribed Methadone for Substance Abuse. The hospital staff failed to contact the clinic/prescriber to verify the dose, treatment plan, and time and date of last dose.


On April 7, 2017, Patient #16 was admitted to Unit 5 N. Patient's initial history and physical revealed, "[S/he] used to abuse cocaine and heroin and [s/he] is on methadone for last 10 years". It was also documented, "History of Substance abuse. The patient was on methadone 60 mg oral daily. Last dose was today, so we will resume the patient's methadone 60 mg and consult substance abuse specialist in the morning." There is no documentation that this was done.


The findings were reviewed, discussed, and acknowledged by Employee #87.

Based on observation of anesthesia carts in the Operating Rooms, in the presence of Employee #87, it was determined that the Succinylcholine was not labeled correctly with the expiration date.


The findings include:


According to standards for succinylcholine injection labeling(www.accessdata.fda.gov/drugsatfda_docs/label/2010/008453s027lbl.pdf), "The multi-dose vials are stable for up to 14 days at room temperature..."


On April 11, 2017 at approximately 13:00, an observation survey of anesthesia carts, in operating rooms (OR) 3, 4, 6, 9, as well as the storage room for anesthesia medications and refilled carts was conducted for outdated or mislabeled medications.


Succinylcholine was found in eight (8) of eight (8) anesthesia carts, unrefrigerated, and were without documentation of an expiration date of 14 days, when stored outside refrigeration.


The findings were reviewed, discussed, and acknowledged by Employee #87.

Based on observations, equipment maintenance logs, policy and medical record review, and staff interview, it was determined the hospital failed to ensure that all radiologic equipment was inspected and that all identified problems were corrected, in a timely manner, as evidenced by the failure to report a malfunctioning ultrasound machine.


The findings include:


The Howard University Hospital policy number BES-032, entitled, "Overview of Medical Equipment Maintenance Services How to request service from Biomedical Equipment Services", reviewed May 2015, stipulates, "Procedure: Medical Equipment Emergencies ...II. If medical equipment fails: Call Biomedical Equipment Services ...2. Know how you can obtain alternate equipment ...3.Have a plan of action when waiting for alternate equipment ..."

Facility staff failed to notify the Biomedical Engineering department, immediately, when it was determined that diagnostic equipment was not functioning properly; and failed to properly notify physicians, to prevent delay in treatment.


A review of Patient #9's medical record conducted on April 10, 2017, at approximately 3:30 PM revealed a physician order dated April 2, 2017, at 7:30 PM for a duplex venous ultrasound of the bilateral lower extremities, to rule out Deep Vein Thrombosis. The order was discontinued in the Electronic Medical Record (EMR) on April 4, 2017, at 9:37 AM, by Employee #37. On April 4, 2017, at 9:00 AM, a physician order was written for another duplex ultrasound of the bilateral lower extremities for Deep Vein Thrombosis screening. The order was discontinued on April 10, 2017, at 8:37 AM, by Employee #37.


Further review of the medical record revealed that the ultrasound was not performed for Patient #9, and no physician ordered to cancel the ultrasound exams.


A face to face interview was conducted on April 12, 2017, at approximately 12:00 PM with Employee #37, in the presence of Employee #11, regarding the cancellation of the diagnostic exams without a physician order. S/he explained that on April 4, s/he noticed the screen flickering on the ultrasound machine, s/he "turned it off and put it away." Employee #37 was asked who was notified about the flickering screen, s/he responded "no one." When asked what the contingency plan was to prevent a delay in care for the patient, s/he stated that usually, she puts a note in the EMR; however, this time s/he did not. When a note is placed in the system, the physician knows to re-order the exam through Radiology. Employee #11 explained that the vascular lab was working on a system to prevent a delay in care due to faulty equipment. Both Employees #11 and 37 were asked, when the equipment was reported to the Biomedical Engineering department? Employee #37 stated that s/he couldn't remember exactly; Employee #11 said that it was on April 10, 2017.


A face to face interview was conducted on April 12, 2017, with Employee #26, regarding when the ultrasound machine was reported as malfunctioning. S/he stated that s/he received the report about the equipment on April 6, 2017.



During a subsequent face to face interview conducted on April 12, 2017, at approximately 4:00 PM with Employee #11, s/he explained that the orders for ultrasound should not have been canceled, and that the physician should have been notified. S/he confirmed the findings.

The hospital failed to ensure that one (1) of the nine (9) tests performed at point of care is certified by Clinical Laboratory Improvement Amendments of 1988 (CLIA'88), in accordance with section 353 of the Public Health Service Act 42 U.S.C. §263a (See A-0582).


The hospital's failure to ensure that all tests are performed under a CLIA certificate results in the hospital's inability to provide patients with laboratory services that is performed in a certified laboratory.

Based on observation, review of the hospital's main laboratory test menu, and confirmation by interview with Employees #30, 31 and 32, the hospital failed to ensure that one (1) of the nine (9) tests performed at point of care is certified by Clinical Laboratory Improvement Amendments of 1988 (CLIA'88), in accordance with section 353 of the Public Health Service Act 42 U.S.C. §263a (Fern test performed in the hospital Labor and Delivery unit).


The findings included:


1. According to CLIA'88,"section §353 of the Public Health Service Act (42 U.S.C. §263a) is amended to extend jurisdiction of the Department of Health and Human Services (HHS) to regulate all laboratories that test human specimens for the purpose of providing information for diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of, the health of human beings."


2. There was no evidence that the hospital implemented policies and procedures to ensure that the Fern test (a test performed by Labor and Delivery physicians on cervical mucus to detect amniotic fluid leakage) is performed, under a CLIA certificate in accordance with the aforementioned regulation.


3. An interview with Employees #30 and 31 on April 10, 2017 at approximately 11:30 AM revealed that the Fern test performed in the hospital's Labor and Delivery (L&D) unit is not under the main laboratory's CLIA certificate and is not on the main laboratory's test menu. In addition, Employees #30, 31 and 32 were unaware of an existing separate CLIA certificate of Provider Performed Microscopic Procedures (PPMP) for the Fern test, performed in L&D.


4. A subsequent inspection of the L&D unit of the hospital, on April 10, 2017 at approximately 12:00 Noon, revealed a microscope, Potassium Hydroxide (KOH) reagent and slides. Interview with Employee #32 at the time of inspection confirmed that physicians use the microscope to perform Fern testing.

1. Based on observations during the survey, it was determined that dietary services were not adequate to ensure that foods are served in a safe and sanitary manner. The findings were observed and acknowledged, in the presence of Employee #18.


The findings include:


A. The interior surfaces of convection ovens, in the cook's preparation area, were soiled with food spillages, in two (2) of four (4) observations at 11:20 AM on April 10, 2017.


B. Floor surfaces, in the rear of convection ovens, were soiled with food spillages, in one (1) of one (1) observation at 11:45 AM on April 10, 2017.


C. A vertical stainless steel panel, near the hand sink, in the cook's preparation area was soiled and stained, in one (1) of one (1) observation, at 11:50 AM on April 10, 2017.


D. Wall and ceiling surfaces were damaged, soiled and stained in the Ice Machine Room, in one (1) of one (1) observation at 12:05 PM on April 10, 2017.



2. Based on observation during the survey, policy review, and staff confirmation it was determined that dietary staff failed to cover hair, during food preparation to prevent contamination, in one (1) of two (2) observations. The findings were observed and acknowledged, in the presence of Employee #18.


The findings include:


According to Howard University Hospital Policy #1.1.4 "HACCP (Hazard Analysis Critical Control Point)/Food Safety Standards and Requirements", reviewed August 2017 stipulates, " ...3.Employees must wear approved hair restraints, beard restraints ...Hair restraints (hairnets, hats or caps) must cover hair sufficiently to effectively keep hair from contacting exposed food ..."


April 10, 2017 at 11:05 AM, an observation of the Main Kitchen was conducted. Dietary staff was observed working in the vegetable area, without a hair net, hat, or cap. The practice failed to support that staff followed policy to prevent contamination of foods. The findings were observed and confirmed by Employee #18.

Based on observations, record review, policy review, and staff interviews, it was determined the hospital staff failed to maintain the physical plant and the overall environment in a safe and sanitary manner to ensure that the safety and well-being of patients and have a mechanism to in place to ensure the refrigerator temperatures were within the specified range (A-0701); and failed to ensure that tissue products are stored at the appropriate temperature, and outdated supplies were not stored and available for patient use (A-0724).


The cumulative effect of these systemic practices resulted in the hospital failure to comply with conditions of participation for Physical Environment.

Based on observations during environmental survey, it was determined that staff failed to maintain the physical plant and the overall environment in a safe and sanitary manner to insure that the safety and well-being of patients. The findings were observed and acknowledged, in the presence of Employees #18 and 21.


The findings include:


A. The following findings were observed during a tour of the kitchen, in the presence of Employee #18 at approximately 12:20 PM on April 10, 2017.


1. Door surfaces were soiled, stained, and failed to close; and floors were soiled at the entrance to the Men's Bathroom, in four (4) of four (4) observations at 12:15 PM on April 10, 2017.


2. Floor surfaces were soiled around the perimeter near the entrance; the ceiling lamp lacked a cover; and the seat and backrest surfaces of chairs were worn and damaged in the Ladies Restroom, in three (3) of three (3) observations on April 10, 2017 at 12:20 PM.



B. The following findings were observed during a tour of the Surgical Intensive Care Unit, beginning at 9:45 AM on April 11, 2017.


1. Wall guards were marred and damaged; bed frames were soiled; and counter top surfaces, near the sink were damaged and soiled in Room 1, in two (2) of two (2) observations.


2. The lower headwall surfaces were soiled and stained; the horizontal surfaces of the bed frame were soiled with dust; the base surfaces of the Intravenous Venous Pole were soiled and stained; and the middle sliding glass door made contact with floor surfaces and failed to open, in four (4) of four (4) observations, in Room 3.


3. Counter surfaces were soiled and damaged, in the rear of faucets; window blinds were soiled with dust; and headwall surfaces were soiled and dusty, in three (3) of three (3) observations, in Room 6.


4. The slat surfaces of venetian blinds and the horizontal surfaces of the bed frame were soiled with dust; counter top surfaces and the backsplash areas of the sink were damaged, in three (3) of three (3) observations, in Room 7.


5. The interior and bottom shelf surfaces of the Omni Cell were soiled with dust in the Supply Area.


6. Walls were marred and damaged; the counter tops were soiled near the sink; headwall surfaces, behind the bed, were soiled with dust and other debris; the sliding glass door failed to latch when tested; and the hot water supply was 94 degrees Fahrenheit, which is below the minimum temperature requirement of 105-degree Fahrenheit, in Room 1.


7. The lower surfaces of the headwall behind the bed were soiled with dust and splatters; the backsplash areas of the sink were damaged; the horizontal surfaces of the bed frame were soiled with dust; the middle sliding door made contact with floor and was difficult to open and close when examined, in three (3) of three (3) observations, in Room 3.


8. Counter top surfaces in the rear of faucets were damaged; intravenous pole surfaces were soiled with spillages; the sequential compressor was improperly stored on the floor; window blinds were soiled with dust; and headwall surfaces were soiled and stained in, Room 6.


9. The horizontal surfaces of venetian blind slats were soiled with dust; headwall surfaces were soiled with spillages; dust was observed on bed frame surfaces; the monitor was soiled with dust on the top surfaces; and the counter top backsplash was damaged, in Room 7.


C. The following findings were observed during a tour of the Emergency Department, between 11:43 AM and 3:25 PM on April 11, 2017.


1. Bed frame surfaces and the top surface of monitors were soiled with dust; the top and hinge surfaces of the trash receptacle were soiled with rust; bed frame surfaces were soiled; the lower surfaces of the stainless steel cabinet were damaged, in three (3) of three (3) observations, in Room 10.


2. Ceiling surfaces were soiled and stained and trash receptacle hinges were rusty, in the Emergency Medical Technicians Room.


3. Floor surfaces were soiled and marred; the top surfaces of the trash receptacle and hinges were marred, in the Decontamination Room.


4. Emergency boards stored on the exterior of the facility near the entrance were marred and soiled; and the exterior grounds, surroundings the Emergency Room entrance were cluttered with paper products, in two (2) of two (2) observations.


5. The lower and top shelf surfaces in the Omni Cell cabinet were soiled with dust; the exterior glass door surfaces were splattered and soiled; the top surfaces of examination lamps were dusty; and door surfaces were marred, in four (4) of four observations, in Trauma Room 3.


6. Ceiling tile surfaces were soiled and stained, in the Rapid Evaluation Area.


7. Wall surfaces were marred and damaged, in the rear of chairs, in the Rapid Evaluation Unit.


8. The frontal and interior areas of the Omni Cell were soiled with dust; wall surfaces were marred behind the chair; and the frontal exterior glass surfaces were soiled, in three (3) of three (3) observations, in Room 13.


9. Ceiling tiles were soiled and stained, in the Nutrition Room.


10. Exhaust vents were soiled; the top surfaces of monitors were soiled with dust; caulking around the lower walls and floors were soiled and damaged; and privacy curtain hooks were detached, in three (3) of three (3) observations in Room 15.


11. Chairs were worn and damaged on the seat and armrest surfaces, in the Waiting Area, in seven (7) of seven (7) observations.


12. Exhaust vent louvers were soiled on the interior surfaces; ceiling tile grids were soiled and rusty; and floors were soiled, in three (3) of three (3) observations, in the Men's and Ladies Restrooms.


13. The horizontal surfaces of the bed frame were soiled with dust, and the hinges and top surfaces of the trash receptacle were damaged, with rust formation, in two (2) of two (2) observations, in Room 10.


14. Floor surfaces were soiled and the trash receptacle lid and hinges were rusty, in two (2) of two (2) observations, in the Decontamination Room.


15. Emergency Room transport boards, stored on the exterior of the Emergency Room entrance were marred in one (1) of one (1) observation.


16. The lower shelf surfaces of two (2) Omni Cells were soiled with dust; the top surfaces of examination lamps were dusty; and door surfaces were marred, in four (4) of four (4) observations, in Trauma Room 2.


17. The top surfaces of lamps and the Oxygen, Air and Vacuum gas supply lines, in the Resuscitation Room were soiled with dust.


18. Wall guards near the Emergency Room entrance doors were marred and stained.


19. The top surfaces of the monitor were soiled; the horizontal surfaces of the stretcher were marred and dusty; privacy curtain mesh surfaces were torn; the frontal surfaces of the door were marred; hot water temperatures were measured at 85 degrees Fahrenheit, which is below the minimum requirement of 105 degrees Fahrenheit; and window surfaces were soiled, in four (4) of four (4) observations, in Room 5.


20. The top surfaces of a computer monitor and the overhead lamps arms were soiled with dust, in Room 6.


D. The following findings were observed, during a tour of the Operating Suite, between 9:55 AM and 10:45 AM on April 11, 2017.


1. The lower interior shelf surfaces of the Omni Cell were soiled with dust and debris.


2. The plastic lamp cover was cracked and damaged, in the Storage Room.


3. Residual adhesive tape and debris were on floor surfaces, in the Storage Area.


4. Oxygen canisters were not secured to prevent a potential hazard, in the Storage Room, in seven (7) of 28 observations.


5. Floor surfaces were soiled and stained with debris; penetrations were observed in the ceiling; and exhaust vents were dusty, in three (3) of three (3) observations, in the Decontamination Room.


E. The following findings were observed during a tour of the Post-Partum Unit, between 3:55 PM and 4:15 PM on April 11, 2017.


1. The horizontal surfaces of bed frames were soiled with dust; privacy curtain hooks were not secured; and the interior and exterior surfaces of exhaust vents were soiled with dust, in three (3) of three (3) observations, in Room 3W66.


2. Wall surfaces in the rear of the headboard were damaged; floor surfaces were soiled along walls; the toilet rooms entrance door lacked a threshold; and wall surfaces were marred near the entrance door, in four (4) of four (4) observations, in Room 3W68.


3. Counter surfaces were soiled and exhaust vent louver surfaces were soiled, in two (2) of two (2) observations, in Room 3A05.


4. Chair seat surfaces were worn and damaged; venetian blinds and the television arm were dusty; threshold surfaces at the entrance to the bathroom were soiled, in three (3) of three (3) observations, in Room 3W74.


5. The top surfaces of the over bed lamp were soiled with dust; the horizontal surfaces of the bed frame was soiled with dust; caulking at the threshold was soiled; and the hot water temperature at the sink was 101 degrees Fahrenheit which is below the minimu required temperature of 105 degree farenheit, in three (3) of three (3) observations, in Room 3W77.


F. The following findings were observed, during a tour of the Transitional Nursery Unit at 4:18 PM on April 11, 2017.


1. The Heating Ventilation and Air Conditioner (HVAC) Unit cover was damaged and soiled and corner guard surfaces were rusty and damaged, in two (2) of two (2) observations, in Room 1.


2. Venetian blinds slats were soiled with dust, in Area 2 and the Break Area, in two (2) of two (2) observations.


3. Wall surfaces were marred and damaged, in Area 12.


4. Door and door jamb surfaces were marred, in Room 3A44.


5. The bottom shelf surfaces and the frontal exterior glass areas of the Omni Cell were soiled and stained; floor surfaces were damaged; ceiling tiles were soiled and damaged; and door jamb surfaces were marred, near the rear exit door within Area 8 of the Transitional Care Unit, in four (4) of four (4) observations.


G. The following findings were observed, during a tour of the Labor and Delivery Unit on April 10, 2017 beginning at 4:38 PM.


1. Venetian blind slats and frontal areas of monitors were soiled; the frontal surfaces of cabinets were marred and scarred; wall surfaces were marred and damaged; bed frame surfaces were soiled with dust on the horizontal surfaces; and the top surfaces of tiles, in the Toilet Room were dusty, in seven (7) of seven (7) observations, in Room 58.


2. The frontal areas of the cabinet, near the bed were damaged; privacy curtain hooks were detached; the thermostat cover in the bathroom was missing; window sill surfaces were marred; hot water temperature measured at 102 degrees Fahrenheit which is below the required minimum temperature of 105 degrees Farenheit; the supply cart near the bed was marred, on the top and splintered on the edge surfaces, in six (6) of six (6) observations, in Room 66.


H. The following findings were observed, during a tour of the Cardiac Catheterization Laboratory on April 12, 2017 at beginning at 1:55 PM.


1. Wall surfaces were marred; ceiling tile surfaces were soiled; and privacy curtains were detached from ceiling tracks, in three (3) of three (3) observations, in the Echocardiograph Area.


2. The top surfaces of the treadmill were soiled with dust; privacy curtain hooks were detached from ceiling tracks, in two (2) of two (2) observations in the Stress Lab.


3. Exhaust vents were soiled, on the exterior and interior surfaces, in the Bathroom near the Stress Laboratory.


4. The exterior surfaces of an oxygen canister was soiled and rust formation was observe on the exterior surface; and floor surfaces were soiled, under the Information Management System, in the Pre-Operative Area.


5. The ice machines water and ice chutes were soiled with mineral deposits, on the interior surfaces.


6. The bottom shelf surfaces of the Omni Cell were soiled and the exterior doors surfaces were soiled and stained, in the Pre-Operative Holding Area.


7. The top surfaces of equipment were soiled with dust and privacy curtains mesh surfaces were torn, in Room 3.


8. The horizontal surfaces of the stretcher and equipment, on the base of the stretcher were soiled, in Cauterization Laboratory 1 and 2 in, two (2) of two (2) observations.



2. Based on observation, record review, and staff confirmation, it was determined that Operating Room staff failed to have a mechanism to in place to ensure the refrigerator temperatures were within the specified range.


The findings include:


On April 11, 2017 at 10:15 AM, a tour was conducted in the Operating Room, in the presence of Employee #10. A review of the 'Specimen Refrigerator Temperature Log' lacked information to specify the normal temperature range and instructions directing staff as to what action to take, when temperatures were outside of the normal range.


Employee #10 confirmed the findings.

1. Based on observation, review of records (policies and procedures manual, temperature charts, tissue manufacturer's instructions), and confirmation by interview with Employee #10 and a representative from the tissue manufacturer, it was determined that the hospital failed to ensure that tissue products are stored at the appropriate temperature, and in accordance with the manufacturer's instructions, for one (1) of the two (2) types of tissue products observed stored (Patellar Tendon).


The findings included:


1. Observation of the tissue storage area in the hospital's Operating Room (OR) freezer on April 11, 2017 at approximately 3:30 PM revealed that the freezer temperature was set between -25 and -75°C (degrees Celsius).


2. Review of RTI Biologics (the manufacturer of the Patellar Tendon) revealed instructions to store the Patellar Tendon at -40°C or colder until expiration.


3. Review of the hospital's policy (OR Clinic #6) with a revision date of September 30, 2014 revealed instructions to store tissues long-term at -75°C or lower.


In addition, although there was no tissue product stored in the short-term tissue freezer, the temperature range was not appropriate for storing tissues, such as Patellar Tendon. According to the temperature chart posted on the short-term tissue freezer, the acceptable temperature range was from 0-32°F, which is not appropriate to store tissue products that require -40°C or colder.


4. Review of the temperature log for the long term tissue freezer revealed that on numerous days, the recorded temperature was warmer than -40°C as detailed below:

(a) One (1) day in April, 2016 (4/30);

(b) Three (3) days in May 2016 (5/20, 5/22, 5/24, and 5/26);

(c) Twenty-eight (28) days in June 2016 (6/1-6/13 and 6/15-6/20);

(d) Twenty-nine (29) days in July, 2016 (7/1 and 7/4-7/31);

(e) Twenty-eight (28) days in August, 2016 (8/1-8/13 and 8/17-8/31);

(f) Thirty (30) days in September, 2016 (9/1-9/30);

(g) Thirty-one (31) days in October, 2016 (10/1-10/31);

(h) Thirty (30) days in November, 2016 (11/1-11/30);

(i) Thirty-one (31) days in December, 2016 (12/1-12/31);

(j) Thirty-one (31) days in January, 2017 (1/1-1/31);

(k) Twenty-eight (28) days in February, 2017 (2/1-2/28);

(l) Thirty-one (31) days in March, 2017 (3/1-3/31); and

(m) Six (6) out of eleven (11) days in April, 2017 (4/2, 4/4, 4/5, 4/6, 4/9, 4/11).


5. Interview with a representative from RTI Biologics, via telephone, on April 11, 2017 at approximately 3:30 PM, confirmed the need to store Patellar tendons at -40°C or colder.


6. Interview with Employee #10 confirmed that the temperature setting on the long- term freezer was inaccurate. In addition, according to Employee #10, the staff documented in error. However, there was no documented evidence that staff reviewed and addressed the erroneous temperature records.






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2. Based on observations, policy review, and staff interview, it was determined the hospital failed to ensure outdated supplies were not stored and available for patient use, in four (4) of four (4) observations.


The findings include:


A. On April 10, 2017 at approximately 12:00 PM, a tour was conducted in Labor and Delivery, in the presence of Employee #32. A bottle of Potassium Hydroxide (KOH), lot #03184 that expired on September 18, 2014 was observed on a counter in the room, next to a microscope. Employee #32 confirmed the finding at the time of observation.


B. On April 11, 2017 at approximately 11:00 AM, a tour of the Radiology Department was conducted. A visual inspection of medical supplies, stored in a three-cell Omnicell Automated Dispensary System revealed the following:


1. 36 Mini-Bore Extension Set with Slide Clamp and Luer Lock Connects of which 24 expired January 2017, and 12 expired October of 2016


2. One (1) 1000 milliliter (mL) bag of 5% Dextrose in 0.9% Sodium Chloride Injection with expiration date of March 2017


3. Two (2) Tegaderm Films with expiration dates of 2015


4. Four (4) Secondary Set Luer Lock Connectors of which two (2) expired March 2015, one (1) expired August 2016, and one (1) expired March 2017


The practice failed to support that hospital staff ensured outdated supplies were not stored and available for use.


On April 12, 2017 at approximately 11:10 AM, a face-to-face interview was conducted with Employees #19 and 20, from the Central Supply Department. Both employees explained the process of restocking the Omnicells, and stated that all supplies within the Omnicell are counted and checked for expiration dates daily. Employee #24 reviewed, discussed and acknowledged the findings.


C. At approximately 3:15 PM, a second visual inspection of the same Omnicell in the Radiology Department was conducted, in the presence of Employees #14 and 24, that revealed the following:


1.10 Stepped 5-in-1 connectors with expiration dates of July 2016


2. One (1) Petroleum Gauze Overwrap with expiration date of December 2014


3. Two (2) 20mL bottles of Sterile Water for Injection with expiration dates of February 2017


4. Eight (8) 500 mL bags of .45% Sodium Chloride Injection of which five (5) expired in August 2016, one (1) in September of 2016, and two (2) in November 2016


An "expired/destock" touch button feature was observed on the screen of the Omnicell Automated Dispensary System; however, Employee #24 stated that feature was inoperable on that specific Omicell.


On April 12, 2017, at approximately 10:40 AM, a face-to-face interview was conducted with Employees #24 and 25, regarding the expired supplies. Employee #24 stated there were no current policies in place governing the destocking of expired medical supplies. A memo addressing the Central Supply/Distribution Staff, dated July 24, 2012, with the subject heading, "Outdated stock items," depicts how to restock supplies and discard expired materials; however, there were no approved policies regarding the process.


On April 12, 2017 at approximately 11:10 AM, a face-to-face interview was conducted with Employees #19 and 20, from the Central Supply Department. Both employees explained the process of restocking the Omnicells, and stated that all supplies within the Omnicell are counted and checked for expiration dates daily.


The practice failed to support that hospital staff ensured outdated supplies were not stored and available for use.


The findings were reviewed, discussed, and acknowledged by Employee #24 on April 12, 2017 at approximately 2:45 PM.


D. On April 11, 2017, at approximately 9:25 AM a tour of unit 5 East was conducted, in the presence of Employees #8, 39, and 54. The findings revealed 180 blue top blood collection tubes that expired March 31, 2017.


A face to face interview was conducted with Employee #8, regarding the expired supplies. S/he acknowledged the findings and discarded the items.




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3. Based on observations, record review, policy review, and staff confirmation, it was determined the hospital staff failed to ensure preventative maintenance (PM) for life-sustaining equipment and medical devices were completed, in accordance with manufacturer guidelines, in 18 of 50 devices reviewed.


The findings include:


Howard University Hospital Policy Number BES-001 titled "Scope of Service" last reviewed July 2013, stipulates, "SCOPE: ... Preventive maintenance and safety inspections will be completed on all equipment included in the program.


During the tour of the Operating Room area, on April 10, 2017, at approximately 11:15 AM, the surveyor observed equipment containing labels which stipulated "still use." The preventative maintenance stickers affixed to the devices were outdated. Consequently, a list of all life-sustaining equipment and telemetry devices, to include last PM and next PM due date, were requested on April 10, 2017, at approximately 3:30 PM.


On April 11, 2017, at 3:47 PM, the hospital staff provided a list of the life-sustaining equipment. The review of the PM list revealed multiple devices with outdated PMs. In addition, the hospital staff provided the "Unscheduled PM Work Order" for each of the devices, indicating the work completed on April 11, 2017.


The outdated equipment was as follows:


1. Zoll Medical Corp Defibrillator, Pacemaker, External, Asset Number 7556, Last Completed August 26, 2017

2. Zoll Medical Corp Defibrillator, Pacemaker, External, Asset Number 432782, Last Completed, September 22, 2016

3. Zoll Medical Corp Defibrillator, Pacemaker, External, Asset Number 432770, Last Completed September 26, 2016

4. Zoll Medical Corp Defibrillator, Pacemaker, External, Asset Number 7519, Last Completed September 26, 2016

5. Zoll Medical Corp Defibrillator, Pacemaker, External, Asset Number 5399, Last Completed September 27, 2016

6. Zoll Medical Corp Defibrillator, Pacemaker, External, Asset Number 5408, Last Completed September 27, 2016

7. Zoll Medical Corp Defibrillator, Pacemaker, External, Asset Number 7743, Last Completed September 27, 2016

8. Terumo Medical Corp, Heart-Lung Bypass Units, Asset Number 433365, Last Completed September 28, 2016

9. Zoll Medical Corp Defibrillator, Pacemaker, External, Asset Number 5463, Last Completed September 30, 2016

10. Zoll Medical Corp Defibrillator, Pacemaker, External, Asset Number 9679, Last Completed September 30, 2016

11. Zoll Medical Corp Defibrillator, Pacemaker, External, Asset Number 7787, Last Completed September 30, 2016

12. Zoll Medical Corp Defibrillator, Pacemaker, External, Asset Number 433138, Last Completed September 30, 2016

13. Zoll Medical Corp Defibrillator, Pacemaker, External, Asset Number 9678, Last Completed September 30, 2016

14. Artherex Continuous Wave III, Arthroscopy Pump, Asset Number 7379, Last Completed January 2016

15. High Def Camera System, Asset Number 7353, Last completed January 2016

16. Storz Endoscope, Asset Number 7360, Last Completed January 2016

17. Zeiss Microscope, Asset Number 5234, Last Completed January 2015

18. C-arm, Asset Number 0885, Last Completed January 2014


A face to face interview was conducted on April 11, 2017, at 4:30 PM with Employee #4. The findings were reviewed, discussed, and acknowledged.





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Based on observation, policy review and staff interviews, it was determined that the staff failed to follow the hospital hand hygiene policy to prevent the spread of infection, in two (2) of 10 observations (Patients #11 and 25).


The findings include:


The Howard University Hospital (HUH) Policy Number ASPM-NFC-022-14, last revised March 2014, titled, 'HAND HYGIENE,' stipulates, " ...INDICATIONS FOR HANDWASHING ... After removing Personal Protective Equipment (Gowns, Gloves, Masks, Booties, Buffoon Caps ...HANDWASHING PROCEDURE (Soap and running water) ... Rub hands together vigorously for at least 15-20 seconds covering all areas of the hands and fingers with the soap ..."

The Howard University Hospital (HUH) Infection Surveillance Prevention and Control Manual dated 201- 2016 stipulates, " ...Personal Protective Equipment (PPE) ...Isolation gowns and protective apparel are removed and discarded at the point of use. Hands are to be washed after removing PPE ..."


A. Patient #11 was admitted with diagnoses to include Sepsis and received wound care treatment for a Stage 2 Sacral Ulcer.


On April 11, 2017, at approximately 8:50 AM, during a wound care observation, Employee #61 was observed performing wound care to the patient's sacral ulcer, with the assistance of Employee #51. During the procedure, both Employees failed to sanitize, after removing gloves, to obtain other necessary items, and prior to providing patient care. Additionally, when Employee #61 washed his/her hands on two occasions, s/he sanitized for only four seconds, which is less than the 15-20 seconds required, in the hand hygiene policy.



The practices failed to provide evidence to support that the nurses followed the hospital policy relative to practices to prevent the spread of infection.


On April 11, 2017, at approximately 9:10 AM, a face-to-face interview was conducted with Employees #51 and 61, regarding the findings. Both employees acknowledged the findings.



Employees #5 acknowledged the findings.


B. Patient #25 was admitted with diagnoses to include Pulmonary Edema and Respiratory Failure.


On April 11, 2017 at approximately 4:00 PM, during a tour on the 5 East unit, Employee #46 was observed exiting Patient 25's room, without first sanitizing, after providing direct patient care.


On April 11, 2017 at approximately 4:05 PM, a face-to-face interview was conducted with Employee #45, regarding the findings. S/he stated, "I should have washed my hands."


The practice failed to provide evidence to support that the medical staff followed the hospital policy relative to the practice of hand hygiene to prevent the spread of infection.


Employee #45 acknowledged the findings.






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Based on observation and staff interview, it was determined that hospital staff failed to ensure that supplies for patient use were stored in a sanitary manner, to prevent the spread of infection.


The findings include:


On April 10, 2017 at approximately 11:00 AM a tour of the Post Anesthesia Care Unit (PACU) was conducted, in the presence of Employees #10, 39, and 52. A stack of unwrapped gauze was observed, in an empty alcohol swab box in a supply cabinet, in PACU room 1. As the drawer was opened and closed, the unwrapped gauze was observed touching the interior of the cabinet. Further observations revealed unwrapped gauze were located in PACU rooms 3, 4, 6, 7, 8, and 9.


A face to face interview was conducted on April 10, 2017 at approximately 11:15 AM with Employee #52, regarding the use for the unwrapped gauze. S/he explained that the gauze is used, when removing intravenous lines from patients post-operatively. When asked how staff ensured the gauze was clean, s/he explained that the drawer and the alcohol swab box were cleaned daily, before the gauze is placed in the drawer.


A face to face interview was conducted on April 10, 2017 at approximately 11:30 AM with Employee #10. S/he explained that the unwrapped gauze were clean because the only staff going in and out of those drawers, were PACU nurses.


The practice of placing unwrapped gauze, in an open cardboard box, failed to demonstrate that staff stored items, for patient use, in a sanitary manner.


A face to face interview was conducted on April 12, 2017 at 10:45 AM with Employee #28, regarding the practice of gauze storage in the PACU. S/he acknowledged the findings.

Based on a review of records and staff interview for two (2) of five (5) patients reviewed for interventional cardiology services (cardiac catheterization laboratory); it was determined that the facility failed to provide appropriate personnel necessary to furnish the surgical services offered, as evidenced by a lack of surgical staff to accommodate cardiovascular interventions (Patients #34 and 36).


The findings include:


A. Patient #34 reported to the facility on April 5, 2017 at 12:10 PM. S/he was scheduled for a Coronary Angiogram [also known as heart (cardiac) catheterization - a procedure that uses X-ray imaging to check for blocked or narrowed blood vessels in your heart] on April 5, 2017 to manage a diagnosis of Unstable Angina. The procedure was initiated; however, cancelled secondary to a lack of "surgical backup."


According to the facility's form "Day of Surgery Nursing Assessment - Pre Op Meds Given" dated April 5, 2017 at 12:50 PM, an intravenous (IV) line was initiated and diagnostic blood work was obtained from Patient #15. At 1:15 PM, 500 milliliters (ml) of Normal Saline was initiated via IV at a rate at 50 ml/hour. According to the "Procedure Log," the patient arrived in the Cath Lab [procedure room] at 3:00 PM. The physician arrived at 3:04 PM and the procedure was "aborted" at 3:24 PM "due to no surgical backup" as recorded on the Procedure Log.


A face-to-face interview was conducted with Employee #33 on April 11, 2017 at 11:00 AM. In response to a query regarding why the procedure was aborted, s/he stated that the cardiologist made the call to abort the procedure. In response to a query regarding the availability of surgical support, s/he stated that there was on "on-call" schedule; however, the surgeons aren't always available as needed. S/he was not able to specify the reason for the cancellation of the procedure for Patient #34.


The facility failed to ensure the availability of surgical support to accommodate interventional cardiovascular services for Patient #34. The record was reviewed April 11, 2017.


B. Patient #36 underwent a cardiac angiogram on October 1, 2016. The interventional cardiologist determined that cardiothoracic surgical intervention was necessary to meet the patient's needs. There was no evidence that the hospital had resources to support the surgical needs of Patient #36 as evidenced by the cardiologist's note dated October 2, 2016 at 12:08 AM, "patient with STEMI (ST-Segment Elevation Myocardial Infarction) was found to have complete occlusion of right coronary artery S/P (status post) cardiac catheterization. Was not amenable to angioplasty. [In] the process to transfer to [local hospital named] for CABG (Coronary Artery Bypass Graft) because of multivessel coronary artery disease."


A review of the medical record for Patient #36 revealed the patient presented to the Emergency Care Area (ECA) with chief complaint of "Lethargy." The initial EKG (electrocardiogram) showed changes consistent with inferior wall MI (Myocardial Infarction). STEMI code was called and the patient was treated per protocol and immediately transferred to the Cardiac Catheterization lab within "20 minutes". Patient #36 was found to have "Multivessel CAD (Coronary Artery Disease - presence of greater than or equal to 75% stenosis in two or more major arteries)." An attempt was made to place a stent proximal to the RCA (Right Circumflex Artery). During this time patient went into V-tach/V-fib (Ventricular Tachycardia/Ventricular Fibrillation- heart beats are so fast and irregular that the heart stops pumping blood.) Patient received resuscitative measures and the procedure was aborted. The interventional cardiologist determined the patient needed to be transferred to a higher level of care for "surgical revascularization/CABG."


A face-to-face interview was conducted with Employee #33 on April 11:15 AM. In response to a query regarding why the patient would require transfer to another hospital, s/he stated that the cardiologist makes that determination. [Cardiologist named] wanted the patient moved to a higher level of care. In response to a query regarding the availability of cardiothoracic surgical support in this facility, s/he stated that there was "on-call" schedule; but it was the weekend [Saturday, 10/1/16] and sometimes the surgeons or the OR [operating room] staff aren't always available.


The facility failed to provide surgical services consistent with patients' needs and medical resources.

Based on a review of the procedure log, interventional cardiology schedule and through staff interview; it was determined that the hospital failed to establish an effective system to schedule, coordinate care and/or follow up with patients who received services, in the Cardiac Catheterization [Cath] Lab. The sample included three (3) of 11 patients that were scheduled for procedures during the period of April 3 - 7, 2017 and four (4) of five (5) patient records reviewed (Patients #24, 34, 35, and 36).


The findings include:


A. A review of the Cath Lab appointment schedule for April 2017 revealed Patient #35 was scheduled to undergo a "Left Heart Cath" on April 10, 2017. A notation that the procedure was cancelled was observed recorded in the appointment book.


A face-to-face interview was conducted with Employee #33 on April 11, 2017 at 12:10 PM. In response to a query as to why the procedure was cancelled, s/he stated that the doctor decided to take vacation, he is off for the week [April 10-14, 2017] ... 'we' were told on Friday, April 7, 2017 [one (1) business day prior to the scheduled procedure].


There was no evidence that the procedure schedule was coordinated in a fashion that would allow for consistency of appointments. The physician's elective leave [vacation] was not incorporated into the schedule so as not to negatively impact patient services.



B. Patient #34 reported to the hospital on April 5, 2017 at 12:10 PM. S/he was scheduled for a Coronary Angiogram [also known as heart (cardiac) catheterization - a procedure that uses X-ray imaging to check for blocked or narrowed blood vessels in your heart] on April 5, 2017 to manage a diagnosis of Unstable Angina. The procedure was initiated; however, cancelled secondary to a lack of "surgical backup."


A face-to-face interview was conducted with Employee #33 on April 11, 2017 at 11:00 AM. In response to a query regarding whether or not the patient subsequently underwent the coronary angiogram procedure, s/he responded that [he/she] was not certain and pointed out documentation in the patient's medical record, "follow up as an outpatient"; a physician's entry on April 5, 2017 after aborting the procedure. Employee #33 stated that a registered nurse managed the scheduling process in the Cath Lab. However, there was no evidence of a process/system to determine the dispositions of patients receiving services in the Cath Lab. There was no evidence that staff initiated provisions for follow- up care after the unanticipated cancellation Patient #34's cardiac procedure. The record was reviewed April 11, 2017.


C. A review of the Cath Lab appointment schedule for April 2017 revealed Patient #24 was scheduled to undergo a Port-a-Cath placement (Port-a-Cath, an implantable Venous Access System designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids, and nutritional solutions and for the sampling of venous blood) on April 6, 2017. A recorded notation on the schedule read "cancelled."


Patient #24's diagnoses included B-cell Lymphoma and a surgical consent form dated April 5, 2017 for Port-a-Cath placement was signed by Patient #24.


There was no additional documentation in the Cath Lab schedule to identify the reason for the cancellation and/or evidence of follow-up regarding the patient's disposition as it relates to placement of the Porta-cath.


A face-to-face interview was conducted with Employee #33 on April 11, 2017 at 1:00 PM regarding the reason for the cancellation of the Port-a-Cath procedure and whether or not the procedure was subsequently performed. Employee #33 stated that s/he was uncertain and inquired with nursing staff present in the Cath Lab who responded, "I think [patient] went somewhere else, another facility maybe, but not sure ..."


The hospital failed to establish an effective system for scheduling patients in the Cath Lab.


D. A review of the medical record for Patient #36 revealed the patient presented to the Emergency Care Area (ECA) with chief complaint of "Lethargy" on October 1, 2016. The initial EKG (electrocardiogram) showed changes consistent with inferior wall MI (Myocardial Infarction) and a STEMI code was called and the patient was transferred to the Cardiac Catheterization lab wherein s/he underwent a cardiac catheterization. During the procedure, the patient was found to have "Multivessel CAD (Coronary Artery Disease- presence of greater than or equal to 75% stenosis in two or more major arteries)." The interventional cardiologist determined that the patient needed transfer to [hospital named] a local hospital for emergent "surgical revascularization/CABG [coronary artery bypass graft]." The physician's procedure summary revealed the receiving physician at the local hospital agreed to accept Patient #36.


A review of Cath Lab progress notes revealed and isolated entry recorded by Employee #33 [nurse manager] on October 1, 2016 at 1902 (7:02 PM); "Pt [patient] transferred to MICU [medical intensive care unit] #11. Pt on Dopamine 5 mcg/Kg [micrograms per kilogram]. IABP [intra-aortic balloon pump - a mechanical device that helps the heart pump blood] in place to rt. [right] femoral (50cc). Intubated with 7.5 ETT [endotracheal tube] ...[illegible] ...Report given off to MICU RN [registered nurse].


The medical record lacked evidence that the Cath (catheterization) Lab nursing staff implemented measures to facilitate Patient #36's transfer to another acute hospital for emergent surgical intervention. There was no documentation to support that coordination was initiated between the Cath Lab and the staff of the receiving hospital. Additionally, there was no standardized process and/or policy to address transitions of care between facilities for emergent procedures/surgery.


A face-to-face interview was conducted with Employee #33 on April 11, 2017 at approximately 11:15 AM. In response to a query regarding the role of Cath Lab staff in the facilitation of transfer to another facility; s/he stated that the doctor does that. In response to a query regarding the lack of nursing documentation regarding the patient's need for transfer and emergency surgery as communicated to the receiving MICU staff; s/he acknowledged that it was not documented but said [s/he] told the nurse.


The facility failed to establish an effective system to facilitate an emergent transfer to another hospital for Patient #36.


A review of the hospital's method to manage patients receiving services in the Cardiac Cath Lab lacked evidence of a systematic, organized approach to identify, track and coordinate services for patients. A registered nurse was assigned to manage the schedule of appointments. The schedule was maintained in a bound ledger style book wherein patient names and dates were recorded. There was no evidence of a system to determine dispositions for patients whose procedures were cancelled and/or aborted. There was no evidence of a system to determine the availability of surgical support for interventional cardiac procedures as evidenced by one (1) procedure that was cancelled due to lack of surgical support and one (1) patient who was determined to require transfer to another hospital of equal level of care [e.g. Level I Trauma Center] following an interventional cardiac procedure. The ledger book lacked evidence of unique patient identification such as date of birth, medical record number and/or reason for procedure. There was a lack of an effective system to manage patients receiving services in the Cath Lab.

Based on observations, medical record and policy review, and staff interviews, it was determined that the hospital failed to ensure adequate numbers of respiratory therapists were available to meet the needs of patients (1154); failed to ensure respiratory services were delivered, in accordance with medical staff directives (1160); and failed to ensure all respiratory care services orders were documented, in the patient's medical record, in accordance with the requirements (1164).


The cumulative effect of these systemic practices resulted in the hospital's failure to comply with conditions of participation for Respiratory Services.

Based on observations, respiratory staff assignments and schedules, policy review, and staff interview, it was determined the hospital failed to ensure adequate numbers of respiratory therapy personnel was available to meet the respiratory needs, for one (1) of three (3) records reviewed (Patient #19).


The findings include:


The Howard University policy #104, for Respiratory Care Services, entitled "Distribution of Work Assignment" effective September 2016 stipulates, "Policy: Hours of work are to be assigned by the Supervisor or Charge Therapist in order to facility prioritization of work during critical situations. Procedure: 1. Calculate number of work hours relative to the total number of procedures ...2. Divide the work hours by the number of staff personnel ...3. Distribute work equally among staff. Consideration should be given to prevent the distribution of three (3) floors to any one therapist ..."


The Howard University policy #604, for Respiratory Care Services, entitled "Patient-Ventilator Maintenance/Monitoring-Recommended Parameter" effective September 2016 stipulates, " ...Patient-ventilator maintenance/monitoring must include patient information and observations indicative of the ventilator's settings at the time of the check. Observations should include but are not limited to: ...Breath sounds ...chest motion ...A patient-ventilator maintenance /monitoring must be performed on a scheduled basis (every two hours during the first 24 hours and every 3 hours thereafter) for any patient requiring mechanical ventilation for life support.


Patient #19 was admitted with Acute Encephalopathy secondary to Anoxic Brain Injury and was intubated on arrival to the Emergency Department. S/he remained intubated with an endotracheal tube for the duration of the admission.


A review of the medical record conducted on April 11, 2017, at approximately 9:25 AM revealed a physician order for an Albuterol nebulizer to be administered for wheezing, every six (6) hours, as needed (PRN).


A review of the respiratory therapy assessment dated April 5, 2017, revealed that a "Ventilator Patient Assessment" was completed at 9:09 AM, the next ventilator check was completed at 5:11 PM, which was eight (8) hours later. Additionally, at 2:00 PM the therapist documented that the "Small Volume Nebulizer treatment not administered ..." the reason listed is " ...Therapy prioritized ..."


A review of the respiratory therapy "Daily Assignment Sheet" for April 5, 2017, during the 7:30 AM to 3:30 PM shift revealed three (3) therapists worked during that shift. According to the "Workload Estimate for Shift" for April 5, 2017, 7:30 AM to 3:30 PM, 5.3 therapists were calculated as staff needed to cover the respiratory patient load during the shift.


Further review of respiratory therapy assessments revealed that between April 9, 2017, at 2:00 AM and April 10, 2017, at 2:00 AM, there were no respiratory lung field assessments performed by respiratory staff. Additionally, on April 9, 2017, respiratory tasks were "canceled" and not performed. These tasks included a Mechanical Ventilator treatment at 7:32 AM, the reason was documented as "cancelled"; Suctioning of the artificial airway tube at 7:32 AM, the reason was documented as "cancelled", nebulizer treatment at 8:00 AM, the reason was documented as "cancelled"; and a nebulizer treatment at 2:00 PM, reason documented as "Patient assessed and no treatment needed;" however, there was no documented assessment at that time.


A review of the respiratory therapy "Daily Assignment Sheet" for April 9, 2017, during the 7:30 AM to 3:30 PM, revealed four (4) therapists worked during that shift. According to the "Workload Estimate for Shift" for April 9, 2017, 7:30 AM to 3:30 PM, 4.5 therapists were calculated as staff needed to cover the respiratory patient load during the shift.


A face to face interview was conducted on April 11, 2017, at approximately 4:00 PM with Employee #83, regarding the missing and canceled tasks to be completed. S/he explained that because of staffing, the therapist prioritizes care, and are unable sometimes to complete all tasks, if there is an emergency with another patient.

1. Based on record review and staff interview for one (1) of four (4) patients reviewed for respiratory services, it was determined that respiratory staff failed to perform a respiratory assessment, when it was determined that Patient #7's nebulizer treatment was not warranted.


The findings include:


Patient #7 was admitted April 8, 2017 with diagnoses that included Acute on Chronic Respiratory Failure, Sickle Cell Disease, Hypertension and Acute Kidney Injury.


A physician's order dated April 10, 2017 at 5:20 PM directed DuoNeb [bronchodilator medication] every 6 hours as needed (prn) for shortness of breath.


A review of the medication administration record [MAR] revealed that respiratory staff documented the following entry on April 11, 2017 at 8:00 PM: "Small volume nebulizer treatment not administered; reason - patient assessed and no treatment needed."


There was no evidence in medical record [Electronic Health Record (EHR) or other chart], of an assessment of the patient's respiratory status; inclusive of breath sounds, lung field assessment and respiratory rate to correlate with the respiratory staff's decision that the Nebulizer treatment was not warranted.


A face-to-face interview was conducted with Employee #84 on April 12, 2017 at 11:00 AM. S/he acknowledged that the record lacked evidence of an assessment when it was determined the Nebulizer treatment was "not needed."





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2. Based on record review, policy review, and staff interview, it was determined the respiratory therapy staff failed to administer nebulization treatment, in accordance with physician's order, in two (2) of three (3) patients reviewed (Patients #10 and 19).


The findings include:

Howard University Hospital Policy number QUA-001-14 entitled "Organizational-Wide Assessment of Patients", last reviewed July, 2014 stipulates, " ...1. Respiratory Care Services a. An assessment of patients receiving respiratory therapy modalities will be performed as appropriate. The assessment will be documented in the medical record in the Respiratory Care progress notes, treatment sheet or other appropriate documents. Clinical documentation for services performed is outlined in the respiratory manual within Respiratory Care. 2. Procedures/Services a. Spontaneous Nebulization ...Technique Method: ...Auscultation ..."


A. Patient #10 was admitted after an exploratory laparotomy for a Small Bowel Obstruction.


A review of the medical record conducted on April 10, 2017 at approximately 12:00PM revealed a physician order dated April 5, 2017 at 1:11 PM for Atrovent and Albuterol nebulizer, every four (4) hours, as needed (PRN) for wheezing. A review of the nursing assessment at the same time revealed that Patient #10 was on a non-rebreather mask at that time.


Review of the respiratory therapy assessment and treatment record revealed that the medication was administered, on the following dates at the following times: April 5, 2017, at 5:00 PM; April 6, 2017 at 5:00 PM, and 8:00 PM; April 7, 2017 at 1:00 AM, 4:00 AM, and 5:00 PM; April 8, 2017 at 9:00 AM and 8:00 PM; and April 9, 2017 at 9:00 AM. However, the assessments were documented as coarse, rales, or diminished breath sounds. There were no assessments of wheezing documented at the time of nebulizer administration.


Further review of the respiratory therapy assessment and treatment record revealed that there were no breath sound assessments documented, when the medication was administered, on the following dates at the following times: April 5, 2017 at 10:00 PM; April 6, 2017 at 2:00 AM and 3:00 PM; April 7, 2017 at 11:00 AM, 2:00 PM, and 10:00 PM; April 8, 2017 at 2:00 AM, 6:00 AM, 2:00 PM, 6:00 PM, and 11:00 PM; April 9, 2017 at 2:00 AM, 5:00 AM, 3:00 PM, and 10:00 PM; and April 10, 2017 at 2:00 AM, 5:00 AM, and 10:00 AM.


The medical record lacked documented evidence of an indication to administer the nebulizer treatment, to Patient
#10, as ordered by the physician for wheezing. Additionally, the record lacked evidence that respiratory assessments were performed prior to medication administration.


Further review of nursing and respiratory therapy assessments revealed that Patient #10 was switched from a nasal cannula at six (6) liters (l) of oxygen on April 5, 2017 at 12:00 PM to a non-rebreather mask at 1 PM. At 2:00 AM on April 6, 2017, a nebulizer treatment was administered by respiratory therapy with no pre or post treatment assessment documented.


A face to face interview was conducted on April 10, 2017 at approximately1:45 PM with Employee #85, regarding the performance of respiratory assessment to determine the need for nebulizer treatment for wheezing, in accordance to the doctors order. S/he stated that the assessments should be done to determine if the patient requires the medication and the medication should not be given with no indication.


A face to face interview was conducted on April 12, 2017 at approximately 3:30 PM with Employee #9, regarding respiratory assessments prior to administration of medication. S/he stated that assessments should be done before and after treatments are administered. Both employees acknowledged the findings.


B. Patient #19 was admitted with Acute Encephalopathy, secondary to Anoxic Brain injury, and was intubated on arrival to the Emergency Department. S/he remained intubated with an endotracheal tube for the duration of the admission.


A review of the medical record conducted on April 11, 2017, at approximately 9:25 AM, revealed a physician order for an Albuterol nebulizer to be administered for wheezing, every six (6) hours, as needed (PRN).


Review of the respiratory therapy assessment and treatment record revealed that the medication was administered, on the following dates at the following times: April 9, 2017 at 2:10 AM, 9:00 AM, and 2:00 PM; April 5, 2017 at 9:09 AM and at 8:50 PM; April 6, 2017 at 2:50 AM; April 7, 2017 at 9:00 PM; April 8, 2017 at 5:00 AM, and 2:30 PM; and April 9, 2017 at 2:00 AM. However, the assessments were documented as coarse rhonchi. There were no assessments of wheezing documented at the time of nebulizer administration.


Respiratory assessments revealed that on April 4, 2017 at 6:35 PM, the medication was administered. "Pre Treatment breath sounds not assessed at this time ...Post treatment breath sounds not assessed at this time," was documented in the respiratory assessment area.


The medical record lacked documented evidence of an indication to administer the nebulizer treatment, to Patient #19, as ordered by the physician for wheezing. Additionally, the record lacked evidence that respiratory assessments were performed prior to medication administration.


A face to face interview was conducted on April 12, 2017 at approximately 3:30 PM with Employee #9, regarding respiratory assessments prior to administration of medication. S/he stated that assessments should be done before and after treatments are administered. Both employees acknowledged the findings.


3. Based on observation, record review, and staff interview, it was determined the respiratory therapy staff failed to perform chest physiotherapy, as ordered by the physician, in one (1) of one (1) patient record reviewed (Patient #10).


The findings include:


Patient #10 was admitted after an exploratory laparotomy for a Small Bowel Obstruction.


A review of the medical record conducted on April 10, 2017 at approximately 12:00PM revealed a physician order dated April 5, 2017 at 9:19 AM for chest physiotherapy.


Review of respiratory therapy assessments revealed that Patient #10 was changed from a nasal Cannula at six (6) liters (l) of oxygen on April 5, 2017 at 12:00 PM to a non-rebreather mask at 1:00 PM. There was no documentation related to the performance of chest physiotherapy; and no additional respiratory assessments documented until 9:00 AM, when Patient #10 was intubated and placed on a ventilator.


The record lacked documented evidence that chest physiotherapy was performed, as ordered by the physician.


A face to face interview was conducted on April 10, 2017 at approximately 1:45 PM with Employee #85, regarding the order for chest physiotherapy. S/he stated that there is a module on the patient's bed that performs the therapy.


An observation of the Patient #10's room on April 10, 2017 at approximately 2:00 PM failed to reveal evidence that the patient's bed could be programmed to provide chest physiotherapy.


A face to face interview was conducted on April 12, 2017 at approximately 3:30 PM with Employee #9. When queried regarding how chest physiotherapy orders are carried out, s/he explained that either the nurse carries out the order, if the patient has a bed programmed to perform chest physiotherapy, or respiratory therapy performs the physical task. When asked how it is ensured that the patient receives the therapy, s/he could offer no further insight.

Based on observation, record review and staff interviews, it was determined that the respiratory staff failed to document the initiation of oxygen therapy, in (1) of 10 patient records reviewed (Patient #16).


The findings include:


Patient #16 was admitted with diagnoses to include Sepsis.


On April 11, 2017 at approximately 11:45 AM, review of the medical record revealed nursing staff documented the patient received 2 liters oxygen, via nasal cannula, on April 10-11, 2017. Additionally, nursing documentation on April 10, 2017 at 4:23 AM revealed that the patient's oxygen saturation was 92% on room air at 2:52 AM. The patient received a nebulizer treatment and was placed on two liters of oxygen, by the respiratory therapist and the physician was informed. Further review of the record revealed respiratory therapy staff documentation that confirmed a nebulizer treatment was administered at 2:59 AM; however, the record lacked evidence of documentation for oxygen administration, by respiratory staff.


The practice lacked evidence that respiratory staff documented the administration of oxygen for Patient #16.


On April 11, 2017 at approximately 12:05 PM, a face to face interview was conducted with Employee #9, who was queried regarding the practice. S/he explained that it is the practice to document all treatment provided to patients. S/he acknowledged the findings.