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Based on interviews, record reviews and policy review the facility failed to designate only one Chief Executive Officer (CEO) responsible to manage the facility. This had the potential to affect all departments in the facility and the coordination and continuity of care to all patients. The facility census was 84.

Findings included:

1. Record review of the facility's organizational chart showed two CEO's, Staff A and Staff KKKK. Staff A's official title is President and CEO. Staff KKKK's official title is CEO responsible for another campus location with an Emergency Department and Psychiatric/Rehabilitation Units.

During an interview on 10/30/14 at 1:38 PM, Staff A stated that there were two CEO's for the facility, himself (Staff A) and at another location Staff KKKK. He stated that two CEO's had been over the facility for 20 years. He stated that Staff KKKK did not supervise any personnel but had different responsibilities that affected the patients and staff.

2. Record review of the position descriptions for Staff A and Staff KKKK were identical in Position Specific Accountabilities for the following:
- Teamwork;
- Quality/Excellence;
- Customer Focus;
- Learning & Innovation;
- Stewardship.

During an interview on 10/30/14 at 2:15 PM, Staff JJJJ, Chairman of the Board, stated that the facility's other campus location's CEO was Staff KKKK and that he operated the facility jointly with Staff A. He stated that Staff KKKK's largest role was community relations and that he was very effective working with Staff A for 20 years.

Based on interview and record review the facility's governing body failed to ensure that 21 of 21 clinical contracted services were included in the facilities annual Quality Assessment Performance Improvement (QAPI) Plan or Program to assess and monitor the clinical services provided to their patients. This had the potential to affect all patients by failing to identify quality and performance problems, implement appropriate corrective or improvement activities, and to ensure the monitoring and sustainability of those corrective or improvement activities. The facility census was 84.

Findings included:

Record review of the facility's document titled, "Performance Improvement Plan," dated 12/13, made no reference to the 21 contracted clinical services providing care to their patients or how the services were integrated into the facility-wide QAPI Program. The Quality Report was approved by the Board of Directors as presented by Staff F, Director Quality and Risk Management,

During an interview on 10/29/14 at 9:47 AM, Staff F provided evidence of nine clinical contracted services and later provided a more complete list for a total of 21 contracted clinical services. She stated that some of the contracted services provide the facility with QAPI data but the data was not analyzed and the quality of care was not monitored by the facility's QAPI Committee.

Based on interviews, record reviews, and policy reviews the facility failed to have systemic practices in place for the Quality Assessment Performance Improvement (QAPI) Program. The facility failed to:
- Have policies and procedures formulated with input from the Chief Executive Officer (CEO) and medical staff leadership and approved by the Governing Body. (A0309 and A273)
- Provide evidence that each quality indicator selected was related to improved health outcomes for all departments of the facility (A-0273).
- Provide evidence that the scope of data collection was appropriate to the indicator for Dietary, Maintenance, Radiology and all of the facility's 21 contracted services (A-0273).
- Provide evidence of the method and frequency of data collection for the Maintenance Department and all of the facility's 21 contracted services (A-0273).
- Analyze the collected data for Dietary, Maintenance and Radiology departments (A-0273).
- Provide evidence that the data collected was compared to performance benchmarks established by nationally recognized organizations for Dietary, Maintenance and Radiology (A-0273).
- Identify by data analysis what departments or contracted services needed improvement and failed to implement interventions (A-0283).
- Provide evidence that improvement activities focused on areas of high risk, high volume or problem prone areas (A-0283).
- Provide evidence of performance improvement projects for any department and/or any of the 21 of 21 contracted clinical services providing patient care. (A-0297).
- Provide evidence of written policies and procedures to implement the facility wide QAPI Program (A-0309).
- Hold the Chief Executive Officer (CEO) responsible for an effective facility-wide QAPI Program (A-0309).
- Provide evidence that all patient care services were monitored for performance improvement opportunities and sustained compliance (A-0273).
The facility census was 84.

The cumulative effect of these failed systemic practices resulted in the facility being out of compliance with the Condition of Participation: Quality Assessment Performance Improvement and resulted in an ineffective facility-wide QAPI Program.

Based on interview and record review the facility failed to ensure that the Quality Assessment Performance Improvement (QAPI) program met the following requirements:
-That each quality indicator selected was related to improved health outcomes for all departments of the hospital.
-That the scope of data collection was appropriate to the QAPI indicator for Dietary, Maintenance and Radiology
-That all contracted clinical services provided QAPI data to the facility.
-That the collected data for Dietary, Dialysis, Maintenance and Radiology was analyzed or compared to performance benchmarks established by nationally recognized organizations for Dietary, Maintenance and Radiology. The facility census was 84.

Findings included:

1. Record review of the QAPI scorecards (a written analysis of collected data) for the facility did not reflect improved health outcomes for the Dietary or Radiology Departments. The dietary department provided data collected on food temperature monitoring and refrigerator temperature logs but this data was not part of a formal written QAPI program which showed the method and frequency of data collection. The data was not analyzed for performance improvement opportunities and did not show improved health outcomes. The nutritional services (dietary) QAPI data was reviewed but the facility could not provide evidence for data analysis or improved patient care since 2011.

During an interview on 10/27/14 at 1:50 PM, Staff B, Chief Nursing Officer, stated that no formalized written QAPI was performed by Dietary.

The Radiology Department is a contracted clinical service by agreement. The department could not provide evidence that the QAPI data collected and submitted to the facility was evaluated or contributed to improved patient care. The department could not provide evidence that the data was presented to the facility's Governing Board as part of the facility-wide QAPI Program.

2. Record review of the Maintenance Department could not provide evidence that there was any formal QAPI data collection, analysis or performance improvement projects.

3. Record review of the data collection for contracted dialysis (the artificial process of eliminating waste and unwanted water from the blood) service showed that the contracted dialysis service submitted data to the facility for water culture competencies, infection control and laboratory values. This data was not analyzed or monitored by the facility to determine the quality of care or performance problems to their patients. The submitted data was compared to their other contracted dialysis services in facilities and was not based on performance benchmarks established by independent nationally recognized organizations.

4. The facility could not provide any of the required QAPI data on the following contracted clinical services:
- Retinopathy of prematurity services (abnormal growth of blood vessels in an infant's eye normally seen in premature babies);
- Pediatric electrocardiogram (a test that checks for problems with electrical activity of the heart) services;
- Acute care renal services (dialysis, the artificial process of eliminating waste and unwanted water from the blood);
- Two different agencies providing temporary medical staffing;
- Emergency medical services and medical director at each facility;
- Perinatal (period immediately before and after birth) inpatient services;
- Management/Staffing for facilities management;
- Neonatology and Pediatric services;
- Pathology services (the science of the causes and effects of diseases, especially the branch of medicine that deals with the laboratory examination of samples of body tissue for diagnostic or forensic purposes);
- Two different services providing Radiation Oncology (the use of radiation to treat cancer) Services;
- Radiologic interpretations (written explanation of x-rays used for diagnosis);
- Neonate Assessment (pertaining to newborn children);
- Radiology (imaging used to diagnose and treat disease);
- Anesthesia and Pain Management Services;
- Pulmonary (lung) Consultants;
- Organ Donation Services;
- Urology (area of medicine concerned with the parts of the body that produce and carry urine) consult to hospital patients;
- Eye surgery equipment; and
- OB (Obstetrics is the care of women before, during and after pregnancy) and GYN (Gynecology is the health maintenance of diseases of women especially the reproductive organs) emergency care services.

Based on interviews and record review the facility failed to analyze Quality Assessment Performance Improvement (QAPI) data that focused on areas of high risk, high volume or problem prone areas for two of 21 contracted clinical services (Radiology, medical specialty that uses imaging to diagnose and treat disease seen within the body and Dialysis, the artificial process of eliminating waste and unwanted water from the blood) and identify areas needing improvement or institute interventions to address problems. This had the potential to affect all patients' quality of care for the clinical services provided. The facility census was 84.

Findings included:

1. Record review of the facility's document titled, "Radiology Process Scorecard," dated 2012-2014, showed QAPI data collected for three key measures:
- Overreads (consultation service the radiologist provides to the treating physician);
- Average turnaround time from patient check in until radiology report is available; and
- Tech (radiology technician) peer review (would not be an appropriate project for patient care quality improvement).
The report showed data for the first and second quarters of 2014 but only one data entry for third quarter of 2014.

During an interview on 10/29/14 at 2:30 PM, Staff NNN, Director of Radiology, stated that the data is not submitted to the Board of Directors and the improvement to patient care had not been evaluated. The department could not provide evidence of any action plans for patient care improvements.

2. Record review of the facility's document titled, "[contracted] Dialysis Services, Acute Quality Improvement," dated 10/13/14, showed the Quality and Safety Monthly Audit dated 09/14 as 93% with a goal of 100%. No plan of action for improvement was noted.

During an interview on 10/29/14 at 2:15 PM, Staff F, Director Quality and Risk Management, stated that the facility accepts the data submitted by contracted dialysis service, and does not analyze the data, monitor the care, or formulate action plans for improved patient care.









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Based on interview and record review the facility failed to have any Quality Assessment Performance Improvement (QAPI) projects, which should be proportional to the scope and complexity of the hospital's services and contracted clinical services. This had the potential to affect all patients' health and quality of care for the services provided. The facility census was 84.

Findings included:

Record review of the facility's scope and complexity of services to patients included two distinct facility locations with two Emergency Departments and the following:
- Athletic Heart Clinic;
- Brain & Spine;
- Breast Care;
- Cancer Care;
- Care Van (provides patient transportation);
- Diabetes (Diabetes mellitus (DM), also known as simply diabetes, is a group of metabolic diseases in which there are high blood sugar levels over a prolonged period) & Endocrinology (a branch of biology and medicine dealing with the endocrine system, its diseases, and its specific secretions called hormones);
- Ear, Nose, and Throat;
- Gastroenterology (study of the normal function and diseases of the esophagus, colon, rectum, pancreas, gallbladder, bile ducts and liver);
- Heart & Vascular Care;
- Hip & Knee Center;
- Imaging (Radiology);
- Intensive Care (ICU);
- Lab - Outpatient;
- Mammography Digital;
- Maternity & NICU (neonatal intensive care unit caring for newborn babies);
- Orthopedics (the branch of surgery involved with the skeleton or bones);
- Pain Management;
- Palliative Care (a holistic, multi-disciplinary approach that includes specialized medical care for people with serious illnesses);
- Outpatient Pharmacy;
- Sleep Disorders;
- Surgical Services;
- Women's Health;
- Wound Care and
- Inpatient Rehabilitation and Psychiatric Units.

During an interview on 10/29/14 at 10:17 AM, Staff F, Director Quality and Risk Management, stated that she could not provide evidence of any QAPI projects conducted by the hospital departments.

Based on interview and record review the facility failed to ensure that it had written policies and procedures to guide and support the Quality Assessment Performance Improvement (QAPI) Program. The facility CEO failed to ensure that QAPI projects were conducted by any of the facility departments, which should focus on areas of high risk, high volume or problem prone issues. These failures of an ineffective facility-wide QAPI Program had the potential to affect all of the facility's patients' health outcomes and quality of care. The facility census was 84.

Findings included:

1. Record review of the documents provided by the facility did not include any policies or procedures for QAPI.

During an interview on 10/29/14 at 10:47 AM, Staff F, Director Quality and Risk Management, stated that there were no written policies and procedures for QAPI. She stated that there was only a written annual Performance Improvement Plan.

2. Record review of the facility's document titled, "Administrative Structure Standards" revised 10/14, showed the "Delegation of Board of Directors Functions: The Board holds the President/CEO and Executive council accountable for design, implementation and evaluation of an effective QI/PI [Quality Improvement/Performance Improvement] program, planning of the hospital services and implementation and monitoring of the operating and capital budgets."

3. Record review of the QAPI Facility-wide Program showed:
- Two hospital departments, Dietary and Maintenance were not included in the facility-wide QAPI Program.
- Radiology was included in the program but the facility could not provide data analysis or show implementation of performance improvement.
- Twenty-one contracted clinical services were not included in the facility's annual Performance Improvement Plan.
- If the facility collected or received QAPI data from the contracted services, the facility could not provide evidence that the data was analyzed or compared to performance benchmarks established by nationally recognized organizations.

4. During an interview on 10/29/14 at 10:17 AM, Staff F, Director Quality and Risk Management, stated that she could not provide evidence of any QAPI projects conducted by the hospital departments or by any of the 21 contracted clinical services.

Based on observation, interview and record review the facility failed to have a policy and procedure in place defining authorized personnel and naming authorized personnel by title that have access to locked areas where drugs and biological's are stored - specifically Controlled Substances (drugs and drug products divided into five schedules based primarily upon their abuse and dependence potential Schedule II, III, IV and V). The facility also failed to have a policy and procedure in place specifying how it prevents unauthorized personnel (ancillary staff, maintenance, housekeeping, etc.) from gaining access to locked areas where drugs and biological's are stored. This had the potential to affect all patients in the facility by securing the safety and control of medications intended for patient administration. The facility census was 84.

Findings included:

1. Record review of the facility's policy and procedure titled, "Controlled Substance Management in Pharmacy," revised 12/10, stated "to store all controlled substances within the narcotic [controlled substances] vault."

Record review of the facility's policy and procedure titled, "Medication: Storage" revised 08/14, stated that "The Pharmacy department will abide by all state and federal regulations involving the distribution of a medication. The Pharmacy department will maintain procedures for the appropriate storage."

The current policies and procedures did not define authorized personnel or procedures to prevent unauthorized personnel from accessing locked areas where drugs and biological's are stored.

2. Observation on 10/28/14 at 3:15 PM in the Pharmacy showed a large gray cabinet secured with a pad lock.

During an interview on 10/28/14 at 3:20 PM, Staff AAA, Registered Pharmacist, stated that the Class II through Class V (narcotic) medications were stored in that cabinet.

During an interview on 10/28/14 at 3:45 PM, Staff CCC, Certified Pharmacy Technician, stated that the keys to the narcotic cabinet were kept in the drawer marked, "keys". She walked over to the unlocked drawer, removed the keys and unlocked the narcotic cabinet. She stated that she had sole access to the keys and could open the cabinet and prepare narcotic medication. Staff CCC stated that she had always had total access to the narcotics and orders them, checks the orders in from delivery, puts them in the storage cabinet and fills the Pyxis (automated medication management system) for patient administration.

During an interview on 10/28/14 at 4:00 PM, Staff BBB, Director of Pharmacy, stated that the she wasn't aware that policy and procedure needed to define authorized personnel to access locked areas or that the policy must state the procedures to prevent unauthorized personnel from access to locked areas where drugs are stored.

Based on observation, interview and record review facility staff failed to ensure the facility menus, served to all patients, met the nutritional needs of each individual patient. This failure especially affected five younger Adolescent Psychiatry Unit (APU) patients (#14, #24, #28, #45, and #47) of six current patients. This deficient practice had the potential to under feed some younger patients; inadequately feed some and/or allow poorly accepted foods to be served to patients. The facility census was 84 with six of those on the APU.

Findings included:

1. During an interview on 10/27/14 at 2:05 PM, Staff C, Nutrition Manager, stated the approved diet manual for the facility was the Nutrition Care Manual from the American Dietetic Association (ADA).

2. Record review of the nutritional care recommendations for adolescents in the Nutrition Care Manual showed the following very specific directions for staff:
- Because of the amount of growth that occurs during adolescence, nutrient and energy needs are increased as compared to earlier childhood.
- During peak growth periods, nutrient needs may be twice as high as other times in adolescence.
- After the onset of puberty and changes in body composition and the menarche (start of menstrual periods), there are sex-specific nutrition recommendations.

3. During an interview on 10/30/14 at 9:02 AM, Staff C, stated the following:
- The facility menus were written to meet the needs of the adult patient population.
- The facility menus were not altered (no special changes in foods served) for the adolescent population in the APU.
- The Registered Dietitians (RDs, staff trained in providing foods that contain the nutrients needed to address specific nutritional needs) do not routinely assess the nutrient needs or the food intake of any of the APU patients.
- If an APU patient does not like the menus/foods served, they can voluntarily see a Dietary Technician during the technician's once a day visit to the unit.
- The Diet Technicians were dietary staff with on the job training (no formalized nutrition or diet therapy training).

During an interview on 10/28/14 at 1:07 PM, Staff JJ, RD, stated the following:
- She does not routinely assess any of the APU patients.
- She had not provided nutritional assessment for any of the current patients on the APU;
- Based on nutrition screening results from the nurse admission assessment, nursing staff should send the dietitian a consult for in depth, focused nutrition assessment;
- The brief nutrition screening tool, used to identify patients at nutritional risk (who would require nutritional assessment by the RD) only contained questions regarding weight loss; eating disorders and diabetes as indicators that they were at nutritional risk;
- The RD agreed the currently used nutrition screening tool would not identify a patient who required additional iron in the diet for blood losses due to menses.
- The RD agreed that an adolescent female may need menu adjustment to meet the nutritional needs of blood losses (menses).
- The Diet Technician was the dietary staff person that the patients talked to for any changes in food service (request different foods if they were served foods they did not want/like) or if they had any dietary questions.

4. Record review of Patient #14's admission Psychiatrist's Evaluation showed the 12 year old female patient was admitted on 10/27/14 with history of recently decreased appetite and the psychiatrist planned an increase in a medication that had possible side effects of gastrointestinal (GI or digestive system) upset (may affect eating). Review of the patient's plan of care dated 10/28/14 showed the RD failed to provide adjustments to the patient's menus to meet the patient's increased nutrient needs and the additional problems of possible GI upset.

5. Record review of Patient #24's admission Psychiatrist's Evaluation showed the 17 year old male patient was admitted on 10/27/14 with complaints including low energy and decreased appetite. The psychiatrist planned for a medication change including a medication that may cause GI upset. Review of the patient's plan of care dated 10/28/14 showed the RD failed to provide adjustments to the patient's menus to meet the adolescent's increased energy needs and additional problems of possible GI upset.

6. Record review of Patient #45's admission Psychiatrist's Evaluation showed admission on 10/27/14 with past medical history of 100 pound weight loss due to cosmetic surgery; surgical removal of excess skin; liposuction and complaints including eating disorders; binge eating and attempts to lose more body weight (felt she needed to lose 20 more pounds). The patient admitted to daily calorie counting. The psychiatrist planned to adjust the patient's current medications and add a medication that may cause GI upset. The patient's care plan dated 10/28/14 included notation that she requested a low carbohydrate diet with more fruits and vegetables and notation to pass the information on to Dietary. The RD failed to document interventions to change the patient's menus to meet the nutritional needs of the patient who may be attempting to decrease her food intake during adolescence when increased nutrient needs were evident.

7. Record review of Patient #47's admission Psychiatrist's Evaluation showed the patient was admitted on 10/28/14 with complaints of depression and decreased appetite. The psychiatrist planned for medication adjustment including one with possible side effect of GI upset (may interfere with eating). Further review of the patient's admission history and physical dated 10/28/14 showed the physician assessed an additional problem of mild anemia due to normal menses. Review of the patient's plan of care dated 10/28/14 showed the RD failed to provide adjustments to the patient's meal service/menus to address the mild anemia.

8. Record review of Patient #28's admission Psychiatrist's Evaluation showed the 14 year old patient was admitted on 10/23/14 with diagnoses including depression, suicidal ideation, anxiety, mood swings and illicit drug use.

Observation on 10/28/14 at 12:16 PM in the APU dining area showed
- All six patients received similar tray service (same types and amounts of foods);
- Patient #28 opened a bowl on her tray and stated that she did not know what (food) it was and said, "Yuck, I'm not eating that!"
- A staff nurse consulted the printed menu on the patient's tray and identified the bowl of food as potato soup.
- Even after the nurse identified the food, the patient pushed the bowl to the opposite end of the tray and refused to eat it.
- The staff nurse failed to offer an alternate food to replace the food rejected by the patient.

Based on interviews and record review the facility failed to ensure the facility diet manual was available to all staff for use as a diet reference. This deficient practice had the potential to permit diets that were not approved by the dietitian and the Medical Staff to be served to patients. The facility census was 84.

Findings included:

1. Record review of the facility's diet manual approval page, dated 07/21/14, showed the facility used the Nutrition Care Manual from the American Dietetic Association (ADA).

2. During an interview on 10/27/14 at 2:05 PM, Staff C, Nutrition Manager, confirmed that the facility used the Nutrition Care Manual as the approved diet manual and that the manual was available on-line through the intranet for all staff to use as a reference source.

During an interview on 10/28/14 at 2:20 PM, on the third floor Psychiatry Unit, Staff II, Registered Nurse (RN); Staff MM, Licensed Practice Nurse (LPN) and Staff HH, Mental Health Technician, all stated that they did not know where the facility diet manual was maintained.

During an interview on 10/29/14 at 10:48 AM, Staff KKK, Surgical Nurse, stated the facility diet manual was in the unit classroom on a bookshelf however, we could not see it because a class was being held at the time.

During an interview on 10/29/14 at 11:08 AM through 11:12 AM, on a Medical/Surgical Unit:
- Staff RRR, Information Assistant, stated that the unit did not have a diet manual.
- Staff QQQ, RN, stated she often worked on this unit and was not aware of the location of a facility diet manual.
- Staff SSS, RN Unit Manager, stated he did not know the location of the approved facility diet manual.

Based on observation, interviews and record reviews the facility failed to:
- Adequately monitor the temperature of cold foods, served to patients, that were stored on the nursing units;
- Store cold foods in clean refrigerators on the nursing units;
- Store refrigerated and dry foods in the facility kitchen in clean conditions to protect against cross contamination of foods;
- Clean and maintain food service equipment in a manner to protect against cross contamination of foods prepared in the facility kitchen.
The facility census was 84.

Findings included:

1. Record review of the facility's policy titled, "Refrigerator Temperatures for Patient Food and Medication," dated 08/15/14, directed nursing staff to monitor and record the temperatures of each unit refrigerator and /or freezer located in the nourishment area of each nursing unit.

2. During an interview on 10/28/14 at 10:36 AM, Staff OO, Registered Nurse (RN) on the Adult Psychiatry Unit (APU), stated the following:
- Refrigerated foods for patients were stored in the small refrigerator;
- Frozen patient foods could not be stored in the small refrigerator due to the accumulation of ice that caked the freezer compartment;
- Staff stored frozen patient foods in the staff refrigerator (a separate refrigerator).

Observation on 10/28/14 at 10:35 AM, in the APU nourishment room showed staff maintained patient foods in a soiled, small refrigeration unit with an ice caked (over an inch thick) freezer compartment.

Observation and concurrent interview on 10/28/14 at 10:38 AM in the same APU nourishment room, showed staff stored patient frozen foods on one shelf (of a two shelf freezer) of a home sized refrigerator. Staff failed to place a thermometer in the freezer compartment where patient foods were kept. Further observation showed a thermometer was located in the staff refrigeration section and not in the patient freezer section. Staff OO confirmed that the small patient food refrigerator needed to be cleaned and defrosted and confirmed that the thermometer should be in the freezer where the patient food was kept (not in the refrigerator where staff foods were stored) to adequately monitor the temperature of the freezer.

3. Observation and concurrent interview on 10/28/14 at 10:50 AM on the Adolescent Psychiatry Unit, showed staff stored two partially consumed 16 ounce bottles of water in the patient food refrigerator. Staff NN, Mental Health Technician (MHT), confirmed the two partial bottles were probably partially consumed by a patient then, placed in the patient food refrigerator with unopened foods. Staff NN further stated the patient's initials should be on the bottle; he did not see any initials on the bottles and the opened, partially consumed bottles of water should not be in the refrigerator with unopened foods used for patients.

4. Observation and concurrent interviews on 10/28/14 at 11:00 AM on an adult psychiatry unit, showed staff failed to clean and maintain a small refrigeration unit used to store patient foods. Staff HH, MHT; Staff AA Licensed Practical Nurse (LPN) and Staff LL, RN, all confirmed the small refrigerator needed to be wiped and cleaned and night shift staff was responsible for cleaning the refrigerator.

5. Record review of the US Department of Health and Human Services (DHHS), Public Health Service (PHS), Food and Drug Administration (FDA), 2013 Food Code directed the following in Chapter 3-302.12 Food or food ingredients that were removed from their original packages shall be identified with the common name of the food and in Chapter 3-305.11 Food shall be stored to protect from contamination by storing in a clean dry location; not exposed to splash, dust, or other contamination and at least six inches above the floor level.

6. After three requests (10/27/14 at 3:05 PM; 10/28/14 at 10:19 AM and 10/30/14 at 8:55 AM) for any facility policies directing food storage and equipment cleaning, Staff C, Nutrition Manager, provided (on 10/30/14) a blank, undated facility document titled, "Nutrition Checklist," that showed direction for staff to make observation including "Environment: Items not on the floor; Environment: No litter on the floor; and Food Storage: No outdated foods."

During an interview on 10/30/14 at 8:55 AM, Staff C, stated the following:
- She did not have policies and procedures directing staff to clean equipment;
- She did not have policies and procedures directing staff on safe food storage;
- The blank Nutrition Checklist provided was part of a monthly checklist/monitoring system;
- She guessed the revision date for the Nutrition Checklist was 2013 (however, she did not provide completed copies of the Nutrition Checklist).

Observation on 10/27/14 from 2:30 PM through 3:05 PM, in the Barry Road facility kitchen showed the following:
- Staff stored cases of ketchup, tortilla chips; soda concentrates, food storage bags and individual packages of breakfast cereal on the floor of the dry food storeroom;
- Opened, (undated when opened) partial packages of pasta; a five pound partial package of cocoa powder and a partial package of noodles all stored on shelves in the dry food storeroom;
- A gallon sized zip-lock plastic bag of dried beans stored with several two inch crumpled balls of aluminum foil (intermingled with the beans), on a shelf in the dry food store room;
- A bag of bulgur wheat dated "03/13/2012" stored on a shelf in the dry food storeroom;
- Unlabeled, undated, soiled bulk food containers of black beans and rice stored in the kitchen.

During concurrent interview on 10/27/14 from 2:30 PM through 3:05 PM in the Barry Road facility kitchen, Staff C, confirmed the following:
- Cases of foods should not be stored on the floor of the dry food storeroom;
- The undated opened packages of pasta, cocoa powder and noodles should be labeled and dated;
- She did not know why the plastic bag of dried beans was stored with crumpled aluminum foil balls mixed in with the beans;
- The bulgur wheat should have been discarded a while ago;
- The bulk storage bins should be cleaned, labeled and dated.

7. Record review of the US Department of Health and Human Services (DHHS), Public Health Service (PHS), Food and Drug Administration (FDA), 2013 Food Code directed the following:
- Chapter 3-305.14 During preparation, food shall be protected from environmental sources of contamination:
- Chapter 4-202.15 Cutting or piercing parts of can openers shall be readily removable for cleaning and replacement;
- Chapter 5-501.113 Receptacles and waste handling units for refuse shall be kept covered.

8. Record review of a blank copy of the facility document titled, "Nutrition Checklist," provided by Staff C, showed direction for staff to make observation including the following;
- Environment: Items not on the floor;
- Environment: No litter on the floor;
- Overall-Cleanliness: Can openers, cleaned and not [no] metal shavings on blade.

Observation on 10/27/14 from 2:30 PM through 3:05 PM, in the Barry Road facility kitchen showed the following:
- Two dust and debris covered nine level can racks with gritty, blackened soil along the rails of each level (lip of canned foods would come in direct contact with the soil);
- Litter and debris on the unswept floor of a walk-in freezer;
- Five uncovered partially filled trash containers in the cook's area; in the cold food preparation area; and in the dish washing area;
- A table mounted can opener with congealed red colored food stuck on the blade.

Observation on 10/28/14 from approximately 10:00 AM through 10:20 AM, in the Smithville facility kitchen, showed the following:
- Food spills and paper litter on the floor of a walk-in refrigerator;
- Two food soiled table mounted can openers;
- Partially filled, uncovered trash containers.

Based on observation, interview, record review and policy review the facility failed to:
-Follow their policy for hand hygiene (wash hands with hand sanitizer or with soap and water) for eight patients (#3, #5, #7, #10, #22, #34, #38 and #65) of 11 patients observed;
-Follow their policy for glove usage for five patients (#5, #7, #10, #37 and #38) of five patients observed.
-Ensure that male urinal bottles (hand held plastic containers used to hold urine) were not placed on the bedside table in order to avoid cross contamination with clean surfaces for two patients (#16 and #18) of three patients observed.
-Ensure a negative pressure airflow from two of two soiled linen rooms, (Barry Road facility and Smithville facility).
These failed practices increased the risk of infection and cross contamination and placed all patients and personnel at risk for hospital acquired infections (HAI) and contracting communicable diseases. The facility census was 84.

Findings included:

1. Record review of the facility's policy titled, "Hand Hygiene" dated 03/19/14, showed:
-All employees will perform hand hygiene with either soap and water or alcohol-based hand rub for routine decontaminating of hands;
-Before and after direct contact with patients or their environment;
-After removing gloves;
-When moving from a contaminated body site to a clean body site during patient care.
-Wear gloves when contact with blood or other potentially infectious materials, mucous membranes, and non intact skin could occur;

Record review of the facility's policy titled, "Standard/Transmission Precautions," dated 05/2014, showed that Standard Precautions apply to any situation in which a healthcare worker might have contact with any body fluids, secretions and excretions.

2. Observation on 10/27/14 at 2:15 PM showed Staff L, Registered Nurse (RN), entered the room of Patient #3 to administer an oral medication. She did not perform hand hygiene when she entered the room and typed on the computer, talked with the patient about his pain medication and proceeded to put the medication in a cup and hand it to the patient with a cup of water. She typed on the computer and left the room without performing hand hygiene.

During an interview on 10/27/14 at 2:55 PM, Staff L was asked about her lack of hand hygiene and stated, "Oh, I know I should have [washed my hands]".

3. Observation on 10/27/14 at 2:30 PM showed Staff P, RN, cleansed the left and right leg and left breast wounds of Patient #10 who was diagnosed with Vancomycin Resistant Enterocci (VRE is a bacteria which are resistant to the antibiotic Vancomycin). She then proceeded to apply clean dressings to these wounds. She did not change her gloves between the dirty and clean procedures or perform hand hygiene.

During an interview on 10/27/14 at 2:45 PM, Staff P, stated that she knew she didn't change her gloves between cleaning the wounds and applying clean dressings and should have.

4. Observation on 10/27/14 at 2:50 PM showed Staff M, RN, entered the room of Patient #7 to administer influenza vaccine by injection. She did not perform hand hygiene when she entered the room but put on gloves. She typed on the computer, prepared the medication and administered the medication wearing the same gloves. Staff M removed her gloves after medication administration but did not perform hand hygiene.

5. Observation on 10/27/14 at 3:22 PM showed Staff N, RN, entered the room of Patient #5 to administer a subcutaneous (under the skin) medication injection. She performed hand hygiene when she entered the room but did not put on gloves. She wiped the top of the medication vial to insert the needle but dropped it on the floor. She picked the vial up off of the floor and inserted the needle to draw the medication into the syringe without re-cleaning the vial or performing hand hygiene. Staff N did not put on gloves for the medication injection which made her at risk for contact with bodily fluids.

During concurrent interviews on 10/30/14 at 2:25 PM, Staff HHH, Infection Control Practitioner (ICP), and Staff B, Chief Nursing Officer (CNO), stated that they would have worn gloves to administer a medication injection to the patient.

6. Observation on 10/28/14 at 1:30 PM showed Staff HH, Psych Tech, entered Patient #22's room to take his blood pressure. She did not perform hand hygiene before entering or when leaving the room.

During an interview on 10/28/14 at 1:40 PM, Staff HH, stated that she usually washed her hands at the nursing station before entering the room because there is no soap or hand sanitizer near the patient's rooms.

During an interview on 10/28/14 at 1:45 PM Staff II, Charge Nurse, stated that there is no soap or hand sanitizer in the patient rooms due to safety concerns (patients drinking the contents or tearing the container from the walls) but there are small bottles of hand sanitizer that the staff can carry with them.

7. Observation on 10/29/14 at 1:30 PM showed Staff MMM, RN, entered the room of Patient #65 in the out-patient pre-operative room without performing hand hygiene. She proceeded to put gloves on and inserted an intravenous (a catheter placed within the vein for administering fluids) in the patient's right arm.

During an interview on 10/29/14 at 1:45, Staff MMM, stated that she had used hand sanitizer before she put on her gloves.

During a concurrent interview on 10/29/14 at 1:45 PM, Staff HHH, ICP, stated that Staff MMM had used hand sanitizer when leaving the room but not when she reentered the room and applied gloves.

8. Record review of the facility's procedure titled, "Lippincott Procedures-Nebulizer Therapy (drug delivery device used to administer medication in the form of mist inhaled into the lungs), Small Volume," revised 10/03/14, showed the following direction for staff:
- Standard precautions for body fluid isolation should be used for all patients receiving nebulizer therapy.
- Equipment: Gloves.
- Perform hand hygiene.
- Put on gloves and other personal protective equipment, as needed,
to comply with standard precautions.
- After the aerosol treatment (breathing treatment administered by a
nebulizer), remove and discard your gloves and other personal
protective equipment if worn.
- Perform hand hygiene.

9. Observation on 10/29/14 at 10:10 AM showed the following:
- Patient #34 rested on a stretcher bed in the Emergency Department (ED).
- Staff DDD, ED RN, entered the patient's room to administer Lasix (medication used to remove excess fluid from the body) 80 milligrams (mg) intravenous (IV-medication administered into a vein).
- Staff DDD put on gloves and scanned the medication, removed the gloves but did not perform hand hygiene after removal of the gloves.
- Staff DDD put on another pair of gloves but did not perform hand hygiene before putting on a new pair of gloves and prepared Nitro (medication in ointment form applied to the skin to provide relief from chest pain) paste.
- Staff DDD removed the gloves, did not perform hand hygiene, put on another pair of gloves and placed the Nitro paste onto the patient's chest.
- Staff DDD then drew up Lasix into a syringe, removed the gloves but did not perform hand hygiene, put on another pair of gloves and administered Lasix into the patient's IV.

During an interview on 10/29/14 at 10:25 AM, Staff Z, ED Clinical Nurse Manager, stated that she expected staff to either use soap and water or hand sanitizer after removal of gloves.

10. Record review of Patient #37's History and Physical dated 10/21/14 showed that the patient had been admitted to the facility with complaints of Influenza (flu) A and pneumonia.

Observation on 10/29/14 at 11:28 AM, showed Patient #37's room had a sign posted on the door that instructed staff and visitors to wear a mask because the patient was in respiratory isolation.

Observation on 10/29/14 at 11:30 AM showed Staff VVVV, Respiratory Therapist (RT), administered an aerosol treatment to Patient #37. Staff VVVV did not wear gloves during the procedure or when she rinsed the aerosol chamber (compartment where medication is placed) and mouth piece after the patient finished the treatment (the patient placed her mouth on the mouth piece to receive the misted medication to inhale into her lungs).

During an interview on 10/29/14 at 11:45 AM, Staff EEE, Respiratory Therapy Manager, stated that she did not expect RT staff to wear gloves when they administer aerosol treatments to patients. Staff EEE stated that she had never thought about if staff needed to wear gloves when they rinsed aerosol chambers and mouth pieces after a patient had finished a treatment.

11. Observation on 10/29/14 at 12:00 PM showed Staff WWWW, RT, entered Patient #38's room to suction him and administer an aerosol treatment per ventilator. Staff WWWW put on gloves and suctioned the patient. Staff WWWW removed the gloves but did not perform hand hygiene before she put on another pair of gloves when she administered the aerosol treatment.

During an interview on 10/29/14 at 12:20 PM, Staff EEE, RT Manager, stated that she expected staff to either use hand sanitizer or wash with soap and water after removal of gloves.

During an interview on 10/30/14 at 9:30 AM, Staff HHH, ICP, stated that staff should cleanse their hands between glove changes and wear gloves when giving aerosol treatments and when cleaning or rinsing anything which had touched a patient's mouth.

12. Observation on 10/29/14 at 9:10 AM showed a urinal (container used to collect urine) sitting on the overbed table of Patient #16. The urinal was sitting next to the patient's drinking water.
Observation on 10/29/14 at 9:30 AM showed a urinal sitting on the overbed table of Patient #18. The urinal was sitting between the patient's drinking water, a package of saltine crackers and a container of ice.

During an interview on 10/28/14 at 1:10 PM, Staff XX, RN, stated that a urinal should not be sitting on the tables next to a patient's drinking water and food because of the risk of contamination.

13. Record review of the document, "Center for Disease Control's Morbidity and Mortality Weekly Report," dated 06/06/03 recommended rooms used for holding or processing soiled linen be maintained with continuous negative air pressure in relation to the air pressure in the corridor and recommended monitoring air pressure periodically, preferably daily. The purpose of this recommendation was to ensure that potential airborne contaminants were exhausted outdoors or at a minimum through an air filter before being released back into the facility environment.

14. Observation on 10/28/14 at 11:00 PM, in the soiled utility room at the Smithville facility, showed air flow out of the room into the corridor rather than from the corridor into the room. The air flow from the soiled utility room into the corridor potentially exposed all patients, staff and visitors to airborne particulates released during transfer of soiled linen.

During an interview on 10/28/14, Staff TT, Director of Maintenance (Smithville), confirmed the observation and stated that he would check the vents and operation of the overhead vent fan.

15. Observation on 10/30/14 at 8:58 AM, in the soiled utility room at the Barry Road facility showed the door was propped open with a trash container. The corridor door of the room was connected to a self closing device to ensure air pressure in the room remained at a negative airflow between the room and the corridor.

During an interview, on 10/30/14 at 9:00 AM, Staff XXXX, Director of Maintenance, (Barry Road) confirmed the finding and stated that the door should not be propped open.



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04467

Based on interview and record review, the facility's Surgical Services staff failed to assure that the practitioner(s) responsible for the surgery obtained informed consent from patients consistent with the hospital's policies and failed to ensure the consent was completed and placed in the medical record prior to surgery for one current patient (#58) and one discharged patient (#53) of nine patients records reviewed. This deficient practice had the potential to place all surgical patients at risk for surgical errors. The facility performs an average of 10-12 surgeries per day and approximately 4000 surgeries per year. The facility census was 84.

Findings included:

1. Record review of the facility's "Medical Staff Rules and Regulations," dated 09/13, showed an informed consent will be obtained prior to all operative procedures or other invasive procedures except in emergency situations.

Record review of the facility's policy titled, "Consent -General and Informed," dated 05/10, showed the physician is responsible for explaining the nature, benefits, alternative and risks of the proposed procedure, intervention or treatment to the patient as well as documenting this discussion on the pre-admission dictated history and physical or by his/her signature on the Consent to Operation.

2. Record review of the surgical chart for current Patient #58 on 10/30/14 at 10:50 AM in OR #7 showed a surgical consent for Debridement (removal of dead, damaged, or infected tissue) of Abdominal wall and removal of infected mesh (device that is used to provide additional support when repairing weakened or damaged tissue) if present. There was no evidence of informed consent for surgery in the record and the surgical consent had not been signed by the surgeon prior to start of the surgical procedure.

3. Record review of the surgical charts for discharged Patient #53, showed a procedure consent for an Esophagogastroduodenoscopy (EGD, test to examine the lining of the esophagus, stomach, and first part of the small intestine) and Colonoscopy (test to look at the interior lining of the rectum and colon) performed on 06/20/14. The consent showed an electronic signature by the physician dated 09/11/14. Further review of the surgical chart showed a second surgical consent for Exploratory Laparotomy (large incision into the abdomen to determine information not available thru diagnostic studies) with possible bowel resection (removal of part of the intestine) performed on 06/21/14. The consent showed an electronic signature by the operating physician dated 09/15/14.

During an interview on 10/30/14 10/30/14 at 1:35 PM, Staff SSS, Chairman of the Department of Surgery, stated that the consent for surgery should be signed by the surgeon before the patient goes to surgery.

During an interview on 10/30/14 at 2:15 PM, Staff U, Director of Surgical Services, stated that her expectation was that the patient not be transported to the OR until the surgical consent was signed by the physician.