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Based on observation, interview and record review the facility's Governing Body failed to ensure the QAPI program reflected all of the hospitals services when:

a.) The facility's laboratory was not using and storing Chemical Testing Reagents according to the manufacturer's instructions;

b.) the facility's dietary department failed to maintain a clean and sanitary food production environment; and

c.) the facility's pharmacy failed to control and distribute drugs and biologicals in a safe manner.

Findings Include:

a.) Observations made during a tour of the facility's laboratory on the morning of 5/17/16 revealed the Chemistry ultra-low freezer had excessive ice buildup; preventing air flow to all areas of the freezer. The temperature probe was incased in ice; preventing an accurate representation of the internal freezer temperature. (3) Glass ampules of, immediate use, CHEM II diagnostic product were open and stored in the refrigerator; and (4) bottles of diluted D-Dimer quality control agents were not labeled; the time when they were reconstituted/opened was not recorded and every time it was taken out of the refrigerator was not being tracked, as the facility procedure required.
b.) Observations made during a tour of the facility's Dietary Department on the afternoon of 5/16/16, the revealed; Four (4) large buckets of sugar, flour, cornmeal, and rice had a Styrofoam bowel sitting in the raw food product; the wares washing room had two (2) opened mouse traps sitting on the floor, with dirt and food debris noted on the floor, under the counters and dish machine; two (2) knives, with plastic handles, contained cuts and were not able to be cleaned; the food slicer blade had been cleaned and was ready for use; there was food debris left on the blade; the microwave's inner roof was covered with old food splatters; the can opener had dried food on the blade and on the can opener holster; an air vent, above the food production area, had extensive dirt and dust residue; and a can of soup was dented on the rim, compromising the integrity of the interior contents.

c. ) Observations made during a tour of the patient examination rooms and the Operating rooms, on the morning of 5/17/16 revealed: Nine (9) unlabeled syringes, filled with a clear liquid, two (2) brown bottles labeled Phenol, two (2) Ethyl Chloride bottles, and two (2) bottles labeled Cartharidin Plus were stored unsecured in patient exam rooms. (2) Bottles of Mannitol, used for intracranial pressure emergencies, were in the Colonoscopy holding room crash cart; the bottles were crystalized and available for immediate use. Two (2) Ophthalmic solutions, (1) Sensorcaine, (1) Xylocaine, (1) Xylociane with Epinephrine and (1) Alumium with Chloride bottles were in Operating Room #2; each was opened and had no opened date or expiration date.

Review of the facility provided document Risk Management Plan (dated 3/20/14) reflected: " ...creates and maintains a well-defined, organized program that identifies, analyzes and corrects situations that may jeopardize the safety of customers and staff members ....enhances the quality of patient care ... assure that ongoing, (daily, weekly, monthly) generic monitors and the resultant problems and studies undertaken for review and analysis are objectively assessed ...To identify patterns or trends ...The Quality Management Department will have the responsibility to develop, implement and coordinate a systemic organization-wide program ..."

During an interview on 5/17/16 at 1:40 p.m., in the conference room, Staff #8, Quality Manager stated, "In 2016, I started handing out the monitoring forms to the department managers to do the monitoring." "We Plan, Do, Check, Act. We try to correct the concerns immediately." "Do we put it in writing? No." "Do we know we have a problem? Yes."
During an interview on morning of 5/18/16, in the conference room, Staff #8, QM confirmed the findings.

Based on record review and interview the facility failed to ensure the Patient's Conscious Sedation Record contained the medications administered and the physician's signature as the facility's policy required. (Patients #2, 3, and 5)

Findings Include:

Review of the facility provided document Rules and Regulations for the Medical Staff (undated) reflected: " ...Medical Records ...The attending practitioner shall be responsible for the complete and legible medical record for each patient ....This record shall include ...medical or surgical treatment ..." "... reports shall be...promptly signed by the surgeon..."

Review of Patient #2's Conscious Sedation Record dated 4/01/16 reflected a 76 year old female admitted for an Esophagogastroduodenoscopy (EGD) and Colonoscopy procedure. The record did not reflect the medications administered and the physician did not sign the record.

Review of Patient #3's Conscious Sedation Record dated 4/27/16 reflected an 82 year old female admitted for a removal Hypertrophic (abnormal enlargement) bone from L Hallux (inner toe). The record did not reflect the medications administered and the physician did not sign the record.

Review of Patient #5's Conscious Sedation Record dated 6/10/15 reflected a 51 year old male admitted for an EGD and Colonoscopy procedure. The record did not reflect the medications administered and the physician did not sign the record.

During an interview on 5/18/16, in the conference room, Staff #9, CNO confirmed the findings.

Based on observation, record review and interview the facility failed to control and distribute drugs and biologicals in a safe manner when:

a.) Nine (9) unlabeled syringes, filled with a clear liquid, two (2) brown bottles labeled Phenol(an extremely poisonous compound, used in dilute solution as an antimicrobial, anesthetic), two (2) Ethyl Chloride (a topical anesthetic) bottles, and two (2) bottles labeled Cartharidin Plus, (used for removing warts) were stored unsecured in patient exam rooms.

b.) Two (2) bottles of Mannitol, used for intracranial pressure emergencies, were in the Colonoscopy holding room crash cart; the bottles were crystalized and available for immediate use.

c.) Two (2) Ophthalmic solutions, (1) Sensorcaine, (1) Xylocaine, (1) Xylociane with Epinephrine and (1) Alumium with Chloride bottles were in Operating Room #2; each was opened and had no opened date or expiration date.

Findings Include:

Review of the facility provided document, Risk Management Plan Policy #88-04 (dated 3/20/14) reflected: "The missions of the Risk Management Program... ...is to achieve and maintain high quality healthcare services responsive to the values and needs of our customers in a safe, secure environment ...."

a.) Observations made during a tour of patient examination rooms, on 5/17/16 at 9:30 a.m. revealed two patient's examination rooms contained plastic storage boxes in the closets. The boxes contained Two (2) brown bottles labeled Phenol, two (2) Ethyl Chloride bottles, and two (2) bottles labeled Cartharidin Plus and Nine (9) 3ml syringes with a clear liquid. The syringes did not have identifying labels, the initials of who prepared the syringes, or the date it was prepared.

During an interview on 5/17/16 at 9:30 a.m., in the patient examination room, Staff #9, CNO stated, "The medications are brought in by a podiatrist; the facility does not provide the medications." "The rooms are not locked. I didn't know the medications were in the rooms."

b.) Observations made during a tour of the Colonoscopy post-procedural holding room revealed Two (2) bottles of Mannitol, used for intracranial pressure emergencies, were in the crash cart; the bottles were crystalized and available for immediate use.

During an interview on 5/17/16 at 10:00 a.m. Staff # 8, Quality Manager and Staff #9, Chief Nursing Officer, were unable to explain the process for using the Mannitol. The Pharmacy manager was brought in. Staff # 15, the Pharmacy manager stated, "The Mannitol must be warmed before it can be used."

c.) Observations made during a tour of the #2 Operating room on 5/17/16 at 10:00 a.m. revealed Two (2) Ophthalmic solutions, (1) Sensorcaine, (1) Xylocaine, (1) Xylociane with Epinephrine and (1) Alumium with Chloride bottles were in Operating Room #2; each was opened and had no opened date or expiration date.

The facility was unable to provide a policy for the safe storage of medications, proper labeling of medications, and the use of the Mannitol.

During an interview on 5/17/16, in the afternoon, in the conference room, Staff #8. Quality Manager confirmed the findings.

Based on observation, record review and interview the facility's laboratory failed to provide laboratory services according to the hospital policy when the clinical chemistry control reagents were not used and stored according to the manufacturer's instructions when:

a.) (3) glass ampules of, immediate use, CHEM II diagnostic product were open and stored in the refrigerator;

b.) (4) bottles of diluted D-Dimer quality control agents were not labeled and the time when they were reconstituted/opened; and were not being tracked every time it was taken out of the refrigerator as the facility's procedure required;


Findings Include:

a.) Review of the facility provided document Manufactures instructions (undated) reflected: " ... CHEM II is an in vitro diagnostic product to be used to calibrate the ...chemistry system for the magnesium, phosphorus, and triglyceride ..." " ...Stability ...Opened Product: Opened ampules should be used immediately and any portion not used should be discarded.

Observation during a tour of the facility's laboratory on the morning of 5/17/16 revealed
Three (3) Chem II calibration glass ampules had been cracked open and were covered with a paraffin wrap and placed in a refrigerator. The ampules did not have an opened date or opened time.

During an interview on the morning of 5/17/16 in the facility's laboratory, Staff #28, Medical Technologist stated, "We save the opened ampules in case we get an error." When asked how long they save them, Staff #28 stated, "We save them for 24 hours."

b.) Review of the facility provided memo D-Dimer QC Reagent Preparation reflected: " ... Each tray of Innovance Reagents is stable for 4 weeks once reconstituted/opened.
To stretch the reagents we have to split the reconstituted reagents into 2 parts ....It is necessary to mark or tick the tray everytime it is taken out of the fridge because after 7 times of being taken in/out it has to be discarded.
Additional Memo: " ...in order to conserve D-Dimer reagent it was recommended by technical support to set that test up on a different group..."

Observation during a tour of the facility's laboratory on the morning of 5/17/16 revealed (4) bottles of diluted D-Dimer quality control agents were not labeled with the time and dated they were reconstituted/opened and were not being tracked every time it was taken out of the refrigerator.

The surveyor requested the facility's policy for handling the reagents, the facility did not have a policy.

During a telephone interview on the afternoon of 5/17/16, in the conference room, Staff #11, Laboratory Director stated, "I don't know about the ticking of the trays, we don't follow that." When asked if the Laboratory Director had written a policy for the handling of the Reagents, Staff #11 stated, "No."

During an interview on 5/18/16, in the afternoon, in the conference room, Staff #29, CEO confirmed the finding.

Based on observation, interview, and record review the facility's dietary department failed to maintain a clean and sanitary food production environment.

Findings Include:

Observations made during a tour of the facility's Dietary Department on the afternoon of 5/16/16, the revealed:

- Four (4) large buckets of sugar, flour, cornmeal, and rice had a Styrofoam bowel sitting in the raw food product.

- The facility's ware washing room had two (2) opened mouse traps sitting on the floor, with dirt and food debris noted on the floor, under the counters and dish machine.

- Two (2) knives, with plastic handles, contained cuts and were not able to be cleaned.

-The food slicer blade had been cleaned and was ready for use; there was food debris left on the blade.

-The microwave's inner roof was covered with old food splatters.

-The can opener had dried food on the blade and on the can opener holster.

-An air vent, above the food production area, had extensive dirt and dust residue.

-A can of soup was dented on the rim, compromising the integrity of the interior contents.

-Review of the facility outtakes refrigerator log dated May 2015 reflected:
5/2/15, no temperatures recorded for the am and the pm shift
5/9/15, no temperatures recorded for the am and the pm shift.
5/10/15, no temperature recorded for the pm shift.
5/11/15, no temperatures recorded for the am and the pm shift.

Review of the facility provided documents Cleaning Schedule (dated 10/2013) reflected: "After each use ...", " ...d. SLICER: The slicer is taken apart, cleaned with a solution of hot soapy water ..." " ...e. MICROWAVE OVERN: The turn table is taken out, cleaned ..."

The policies do not reflect the cleaning and proper storing for all deficient areas.

During an interview on the morning of 5/17/16, in the facility's Dietary Department, Staff #10, Dietary Manager confirmed the findings.

Based on observation, interview and document review the facility failed to maintain the physical plant in a manner which assured the well-being and safety of patients. This deficient practice could have affected the safety of multiple patients.

Findings were:

A tour of the hospital on the afternoon of 5/16/16 and the morning of 5/17/16 with the Chief Nursing Officer and OR Manager revealed the following:

Kitchen
· An approximate 12" long area under the external door through which daylight could be observed. This allowed entry for pests directly into the kitchen.
· Two traditional-style mouse traps in the entry area off the hall with dirt and debris surrounding them.
· Two dirty air filters over the food preparation area.

Multiple Patient Rooms
· Throughout the facility there were patient rooms containing old chests of drawers which had broken laminate and broken drawers. The chipped laminate made thorough cleaning impossible and the broken drawers fell out of the chests easily, thus posing a danger to patients, staff and visitors using the items.

OR Suite
· An approximate 3" strip between two external doors opening into the OR suite corridor through which daylight could be observed. This allowed entry for pests directly into the sterile OR suite.
· A blue supply cart, identified by the OR Manager during the tour on the morning of 5/17/16 as an "anesthesia cart," which had large patches of rust on the corners, a broken handle on the side of the cart which had a large glob of tape wrapped around it, as well as an American flag sticker on the front. These items made thorough cleaning of the cart impossible and jeopardized the sterility of the OR.
· A supply cart, identified by the OR Manager during the same tour as an "ortho cart" in the sterile OR corridor which contained a thick layer of dust and many white particles of debris.

Patient Clinic
· Under a sink in a patient Exam Room #4 were packaged sterile instruments, two bags of saline, and various other patient supplies all available for patient use. Items stored under sinks are at risk for contamination by moisture, mold and pests.

Physical Therapy
· Approximately 16 patient packs were hanging above the hydrocollator. When asked how the packs were cleaned, Staff #15, the Physical Therapy Manager stated, "We take them home to wash them." When asked if she knew whether the home washers reached the appropriate temperature for proper cleaning, she stated, "I'm not sure about that."

The above findings were confirmed with the Chief Nursing Officer and OR Manager during the tours of the facility on the afternoon of 5/16/16 and the morning of 5/17/16.

Facility policy #36-29, entitled Environmental Sanitation, effective date 1/20/14, included the following:
"1. Purpose
1.1 To provide a clean environment fell [sic] from dust and debris for the surgical patient and personnel...
1. Provides a routine, which assures all areas of the OR are cleaned on a consistent basis..."

These findings were again confirmed in a final interview with the hospital Chief Executive Officer and other administrative staff on the morning of 5/18/16 in the facility meeting room.

Based on a review of facility documentation, observation and staff interviews, the facility failed to have an active, complete program for the surveillance of infections as the hospital did not:

A. Conduct surveillance of surgical site infections;
B. Maintain a current policy and procedure for Notifiable State Reporting Requirements regarding communicable diseases identified in the State of Texas as delineated in Chapter 97, Title 25 of the Texas Administrative Code;
C. Perform preventive maintenance on the facility sterilizer according to manufacturer's recommendations, thus jeopardizing the thorough sterilization of surgical instruments;
D. Separate clean area from dirty area in the operating room high-level disinfection room as disinfected endoscopes were uncovered and hanging only a few feet from where the dirty ones were cleaned. This failed practice had the potential to spread infection to multiple patients; and,
E. Terminally clean the hospital ORs at the end of each surgical/procedural day. This faciled practice had the potential to spread infection to multiple patients.

Findings were:

A. The facility failed to conduct surveillance of surgical site infections.

In an interview with the Infection Control Director on the afternoon of 5/17/16, she was asked how the facility was monitoring surgical site infections. She stated "They do that in the doctors' offices. We don't do open surgeries here." She went on to state the facility performed only endoscopies and cataract surgeries. When asked if they followed up with the physicians to determine whether they had surgical site infections to report, she said the hospital did not.

Facility policy #36-81, entitled OR Surgical Site, last revised 3/1/16, included the following:
"The Infection Control Department shall conduct surveillance of surgical sites to aid in identifying possible hospital acquired infections manifesting after discharge...
2. All surveillance will be tracked, trended and reported to the Professional Activities."

A publication by the CDC entitled Surgical Site Infection Surveillance (SSI) Event, last modified April, 2015, included the following: "Surveillance of SSI with feedback of appropriate data to surgeons has been shown to be an important component of strategies to reduce SSI risks. A successful surveillance program includes the use of epidemiologically-sound infection definitions and effective surveillance methods, stratification of SSI rates according to risk factors associated with SSI development, and data feedback ...Post-discharge and ante-discharge surveillance methods should be used to detect SSIs following inpatient and outpatient operative procedures. These methods include, 1) direct examination of patients' wounds during follow-up visits to either surgery clinics or physicians' offices, 2) review of medical records or surgery clinic patient records, 3) surgeon surveys by mail or telephone, and 4) patient surveys by mail or telephone (though patients may have a difficult time assessing their infections). Any combination of these methods is acceptable for use...Infection occurs within 30 or 90 days after the ...operative procedure (where day 1 = the procedure date)..."

B. The facility failed to maintain a current policy and procedure for Notifiable State Reporting Requirements regarding communicable diseases identified in the State of Texas.

Review of the policies and procedures provided by the facility on 5/17/16 revealed no documented evidence provided of a current list of "Notifiable Conditions" for the State of Texas. The facility had a list which had expired 1/2013. The current list was last revised 12/2015 by the Texas Department of State Health Services and can be found at http://www.dshs.state.tx.us/idcu/. Health care providers, hospitals, laboratories, schools, and others are required to report patients who are suspected of having a notifiable condition (Chapter 97, Title 25, Texas Administrative Code).

Facility policy #88-12, entitled Notifiable Disease Reporting, last revised 4/15, included the following: "The SMH (Stephens Memorial Hospital) will follow the guidelines and instructions of the Texas Department of State Health Services...and yearly will be...supplied with materials packet for correctly formatting our reporting to them..."

C. The facility failed to perform preventive maintenance on the facility sterilizer according to manufacturer's recommendations, thus jeopardizing the thorough sterilization of surgical instruments.

On a tour of the OR suite on the morning of 5/17/16 with the Chief Nursing Office and OR Manager, the preventive maintenance records for the Steris Amsco V-116 sterilizer were requested. The OR Manager stated they had no documented preventive maintenance other than what was done by contract maintenance "maybe twice a year."

A review of the manual for the Amsco sterilizer revealed periodic maintenance tasks which were required daily, weekly and bi-monthly according to the manufacturer's recommendations.

Facility policy #36-32, entitled Sterilization of Instruments and Supplies, effective date 1/20/14, included the following:
"5.7 Sterile Supply will follow manufacturer's recommendations for use of steam sterilizers..."

D. The facility failed to separate clean area from dirty area in the operating room high-level disinfection room as disinfected endoscopes were uncovered and hanging only a few feet from where the dirty ones were cleaned. This failed practice had the potential to spread infection to multiple patients.

Observation on 5/17/16 at the facility revealed a high-level disinfection room used for the cleaning, disinfection and storage of endoscopes. The endoscopes were manually cleaned and disinfected at a sink/cleaning area which was approximately three feet away from an open standing cabinet in which disinfected endoscopes were hung. In addition, the room also contained clean patient supplies. This violated standard infection control practices of separating soiled or contaminated supplies and equipment from clean and disinfected patient supplies.

During an interview with the OR Manager during the tour of the OR suite on the morning of 5/17/16, she speculated how the facility might separate these items and agreed the facility failed to provide adequate space to effectively separate clean instruments and supplies from dirty areas.

E. The facility failed to terminally clean the ORs at the end of each surgical/procedural day.

In an interview with the OR Manager during a tour of the OR suite on the morning of 5/17/16 she stated the two hospital ORs were used on Wednesdays and Fridays. When asked how often terminal cleaning was performed on the ORs, she stated, "We do that every Wednesday. We clean at the end of the day, but we do terminal cleaning each Wednesday."

A review of facility policy #36-29, entitled Environmental Sanitation, effective 1/20/14, revealed the following:
"Terminal cleaning is completed each OR Suite on Wednesdays..."

A review of facility policy 82-41, entitled Housekeeping, last revised 3/24/14, included the following:
"The Environmental Services personnel will clean the Surgery Department daily as recommended by AORN position statement originally approved by the House of Delegates Washington, D.C. March 2006 and revised February 2011..."

Surgical center cleaning standards using AORN Recommended Practices, available at www.AORN.org, revealed the following:
"Recommended Practice III: Surgical procedure rooms and scrub/utility areas should be terminally cleaned daily ...Operating rooms, in which procedures may be performed ...should be terminally cleaned once during each 24-hour period during the regular work week. A clean surgical environment will reduce the number of microbial flora present. Terminal cleaning in the surgical practice setting reduces the number of microorganisms, dust, and organic debris present in the surgical environment ... " This standard implies terminal cleaning of an OR shall be completed each day the OR is in use.

These findings were confirmed during the tour of the OR suite with the OR manager on the morning of 5/17/16.

The above findings were confirmed a final time in an interview with the facility Chief Executive Officer and other administrative staff on the morning of 5/18/16 in the hospital conference room.

Based on a review of facility documentation and staff interviews, the facility failed to consistently implement its medical record policy which required that each patient have a history and physical in his/her medical records prior to surgery or a procedure in 1 of 5 patient surgery records reviewed (Patient #1).

Findings were:

A review of the Rules & Regulations for the Medical Staff of Stephens Memorial Hospital, no effective date noted, revealed the following:
"Section 2. Medical Records
A. The attending practitioner shall be responsible for the preparation of a complete and legible medical record for each patient. Its contents shall be pertinent and current. This record shall include ...personal history; family history; social history; history of present illness; physical examination; ...
C. A complete history and physical examination shall be performed prior to the performance of surgery. When the history and physical are not recorded before an operation or any potentially hazardous diagnostic procedure, the procedures shall be cancelled, unless the attending practitioner states in writing that such delay would be detrimental to the patient..."

A review of patient surgical records on the afternoon of 5/18/16 revealed Patient #1 underwent a procedure on 1/4/16 at Stephens Memorial Hospital. A history and physical examination dated 12/24/15 was included in the medical record, but with a fax received date of 2/8/16. An additional copy of the history and physical in the record included a fax received date of 5/18/16.

The above findings were confirmed with the Chief Nursing Officer and Quality Assurance Director on the morning of 5/18/16 in an interview in the facility conference room.

Based on record review and interview the facility failed to ensure the procedures and policies for emergency medical services are monitored and enforced when two (2) out of three (3) patients, reviewed for emergency services, arrived at the facility's designated Level 4 trauma, Emergency Room with an acute trauma and the staff did not call a trauma alert. (Patients #20 and 22)

Findings Include:

Review of the facility provided document Trauma Care (dated 5/10/11) reflected:
"1. Purpose
1.1 To provide consistent guidelines for identifying patients who require Trauma Team Activation
2. Policy
2.1 The Trauma Team will be activated on all injured patients meeting any of the following Criteria: ...2.1.1 The following patients will be determined "A TRAUMA ALERT" based on the EMS report.
Review of the EMS report reflected: " ...All penetrating injuries to head, torso, abdomen, extremities ...>55 years old with co-morbidity factors ..."

Review of Patient #20's medical records reflected a 40 year old female arrived at the emergency room with a " ...self-inflicted gunshot wound to the right leg ....there is no exit wound .... " ... Is this a trauma case: Yes ..."

Review of Patient #22's medical record reflected a 55 year old male arrived at the emergency room with " ...right hip pain following a ground level fall ... " ... Is this a trauma case: Yes..."
Further record review reflected co-morbidity of hypertension, and Acute Kidney disease. Patient #22 was subsequently transferred to a higher level of care, with a right hip, non-displaced hip fracture.

Review of the facility provided document Trauma Registry 2016 reflected Patient #20 and #22 Trauma Activation, "N" is marked.

During an interview on 5/18/16, in the morning, in the conference room, Staff #9, CNO former trauma coordinator stated, "The trauma alerts were not activated." Staff #9 confirmed patients #20 and #22 met the criteria for the trauma alert activation.

Based on observation and interview the facility failed to post conspicuous signage, in the patient's waiting for examination or treatment areas, displaying whether or not the hospital participates in the Medicaid program.

Findings Include:

Observations made during a tour of the facility waiting areas, on the morning of 5/16/18 and 5/17/18, revealed no required posting in the Main lobby, surgical/procedural waiting area, and the emergency waiting room.

During an interview on the morning of 5/17/16, in the conference room, Staff #8, Quality Manager confirmed the findings.