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Based on interview and record review the facility failed to ensure that the State of Minnesota's requirement for criminal background checks were conducted prior to the start of employment for 4 of 32 (AA, AB, AC, AD) employee records reviewed. Findings include:

Employee AA was hired on 10/25/2004 and the criminal background study was completed on 11/12/2004.
Employee AB was hired on 1/13/2003 and the criminal background study was completed on 2/4/2003.
Employee AC was hired on 7/28/2003 and the criminal background study was completed on 8/17/2003.
Employee AD was hired on 5/7/2001 and the criminal background study was completed on 5/18/2001.

The facility's policy #HUM 0032 revised April 2009, specified: "Background studies will be conducted on all new employees, volunteers, physicians, interns, medical students (interns, RPAP) nursing students, other higher learning associated students, and high school students prior to having contact with patients and or residents."

In an interview with the Human Resource Director on 7/21/10 at 1:30 p.m. he stated that the above policy is in place and he was not able to confirm that these four employees did not have any contact with patients during the period of time between their hire date and when the criminal background studies were completed.

Based upon interview and policy review the Critical Access Hospital (CAH) was not in compliance with the Conditions of Participation for Physical Environment (CFR 485.623). Proper procedures were not followed related to the use of alcohol based skin preparation products in anesthetizing locations to reduce the risk of surgical fires. This practice was evident for every patient for whom surgeons used ChloroPrep or DuraPrep as surgical skin preparation prior to procedures. Findings include:

The CAH did develop policies and procedures to ensure compliance with applicable federal regulations and guidelines related to the use of alcohol based skin preparations in the Surgical Suite. The Centers for Medicare and Medicaid Services (CMS) issued a Survey and Certification Memo, dated 1/12/2007, addressing risk reduction techniques to permit safe use of alcohol based skin preparations in inpatient or outpatient anesthetizing locations in CAHs. The use of an alcohol based skin preparation in inpatient or outpatient anesthetizing locations is not considered safe, unless appropriate fire risk reduction measures are taken, preferably as part of a systematic approach by the CAH to prevent surgery related fires.

The surgical registered nurse (RN)-J, interviewed on 7/21/2010, at 10:00 a.m., stated DuraPrep and ChloraPrep (alcohol based products) were routinely used as a skin prep preoperatively. She stated that alcohol preps were routinely used as a preoperative skin prep for patients undergoing Caesarean section and an orthopedic surgeon also used them.

RN-J indicated there was a policy entitled "Preoperative Skin Antiseptic Agents: Handling, Storage & Disposal," however, the policy did not address the required documentation and had not been approved. RN-J verified that staff were not currently documenting when the alcohol based skin preparation was applied to the patient's skin or that the skin was dry before proceeding.

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the prevention of surgery related fires.

Based on observations and interview the facility failed to maintain the physical plant in a manner that ensured patient safety. Findings include:

During the physical plant tour on 722/10, at 7:30 a.m. the following observations were noted:

In patient rooms #214; 220; 222 and 226 the exterior door to the hallway were heavily gauged on the edge of the lower half of each door. This resulted in a rough and splintered surface.

Room 212 had an area of exposed plaster on the patient's wall which was approximately 3 feet by 4 feet. The wall had been patched but the plaster was exposed and had not been covered by any paint or wall covering.

In room #208 the window jam located less than 5 feet from patient's bed had an area of approximately 5 inches by 3 inches which had missing and flaking plaster. The cement board underneath the plaster was exposed.

During an interview with the director of plant operations on 7/22/10, at 8:00 a.m. he
stated these areas were in need of repair.

The tub room and shower room (no numbers on these rooms) located in the general patient care area on second floor, had two unsecured quart spray bottles of Quat #256 disinfectant solution. Quat #256 is listed on the Material Safety Data Sheet as a disinfectant that contained corrosive chemicals which could cause acute and chronic health hazards if not handle with appropriate precautions.

In an interview with the supervisor of environmental service on 7/22/10, at 11:10 a.m. she stated that there wasn't any specific policy regarding the securing of toxic cleaning chemicals, but she felt that all chemicals should be secured so as to ensure patient safety.

The following patient equipment did not have preventive maintenance labels on them which indicated if they had been checked for safety measures on a annually basis:
The SciFit Pro II recumbent bike in physical therapy.
Kendal -SCD Express machine
Bair Paws warmer which were located in Day surgery, rooms 1;3;5;6 and 7.

During an interview with the director of plant operations on 7/22/10, at 8:30 a.m. he stated there was an inadvertent error because this equipment was placed on a "manual audit" instead of an "annual audit". Due to this they were missed for annual inspection.

In review of the "Engineering Plan for Community Memorial Hospital" (undated) it identified the goal : "To implement a unified program of supplying essential utilities and maintaining a program of repair and maintenance for all equipment essential for operation of the facility and continuity of patient care."

Based on interview and policy review the facility failed to have representation of a mid level provider on the committee for policy development. Findings include:

During review of Clinical Services Policy ADM -3031 with a revision date of 5/2010, which addressed policy development, it specified it's purpose: "To ensure policy and procedures are current and meet facility standards and current standards of care: To maintain the safety of patients and provide direction to employees."

The members of the committee listed representation from: Nursing, physician, financial services, quality assurance, health information services and the administrator. The was no reference to any mid level care professional represented in the group of policy makers.

During an interview with the Director of Human resources on 7/21/10 at 3:30 p.m. he stated that at this time there isn't any representation from a mid-level professional.

Based on interview and policy review the facility failed to have a functioning group of professional personnel to advice the development of the Critical Access Hospital's (CAH) policies and failed to have representation of a mid level provider on the committee for policy development or a member that was not a member of CAH staff. Findings include:

The facility was unable to provide documentation that the group of professional personnel were meeting to advice the development of the CAH's policies. On 7/22/10, at 10 a.m. in an interview with the Administrator, he stated that the group had not been meeting to advice the development of policies and had not met for several years. He also verified that CAH utilized midlevels.

During review of Clinical Services Policy ADM -3031 with a revision date of 5/2010, which addressed policy development, it specified it's purpose: "To ensure policy and procedures are current and meet facility standards and current standards of care: To maintain the safety of patients and provide direction to employees." The members of the committee listed in the policy were representation from: Nursing, physician, financial services, quality assurance, health information services and the administrator. The was no reference to any mid level care professional represented in the group of policy makers or a member not part of the CAH staff or a member not a member of CAH staff.

During an interview with the Director of Human resources on 7/21/10, at 3:30 p.m. he stated that at this time there isn't any representation from a mid-level professional.

The CAH failed to ensure the surgeon (MD-I) was available for a scheduled procedure for 1 of 2 (P-8 ) patients who had their surgeries rescheduled. Findings include:

MD-I failed to appear for a scheduled procedure for P-8 on 3/23/2010.

P8 arrived in the day surgery area at approximately 9:30 a.m. on 3/23/2010, for surgical surgery of the right hand involving Drepreytren contracture to take place at 11:00 a.m. on 03/23/2010. The 11:12 a.m. nurses notes dated 3/23/10, indicated the preoperative checklist, consent, and intraoperative course was discussed with P8. It indicated the anesthesia preparation of the operation (preop) visit and surgeon or designee had completed a preop visit. (there is no documentation of this visit other than the check mark that it was done). The preop checklist also indicated P8 had nothing to eat since midnight. The same form indicated an intravenous (IV) of ringers lactated was started at 10:05 a.m. and the patient was taken in the the operating room (OR) at 11:06 a.m. It indicated at 12:05 PM P8 was removed from the OR and the intact IV was removed. At 12:15 p.m. P8 was discharged from the day surgery with out his surgery completed.

An "Unexpected Event Report" was completed on 03/23/10, indicated the "MD failed to show up for scheduled out pt (patient) procedure." It noted MD-I was unable to be reached. The CAH reached the MD-I Nurse at approximately 11:50 a.m. and the nurse said the surgery needed to be cancelled and rescheduled. The report indicated staff were educated not to bring the patients into the OR before the physician arrived there was no indication they determined why the physician did not arrived.

Interview with the Quality Improvement (QI) Director at approximately 11:00 a.m. on 07/22/10, indicated they had received this Unexpected Event Report dated 03/23/10, and had been reviewed by them and then given to the Director of Nursing to follow up on and to determine if further review was necessary. The QI Director indicated they did not follow up in peer review when surgery was cancelled without an explanation.

Interview with the DON at approximately 11:00 a.m. on 7/22/10, indicated she did not remember seeing this report and indicated her name was not on the report. She indicated if she would have received it she would asked the surgical manager to ask the surgeon why he had not cancelled the surgery or why he was not available as scheduled and would have then, followed up as needed.

Based on observations and interview the CAH failed to ensure medications in four Crash Carts and two anesthesia carts in the CAH were secure. Findings includes:

Two Crash Carts, and two anesthesia carts in the surgical areas were not secure. Both Crash Carts had red security tags with numbers present on the tags which were affixed to the carts. The presence of the tag was suppose to indicated the cart was intact and had not been opened. The anesthesia carts had keyed locks but were not kept locked. All of the carts contained medications that were to be secured from unlicensed personal and the public.

The Medication Security policy dated 9/25/05, indicated all medications stored in this hospital shall be accessible only to authorized personnel. Crash cart medications will be stored in containers closed with seals which allows the Pharmacist to determine if the package has been opened.

The two anesthesia carts which contained medications in the operating rooms I & II were not locked. While touring the surgical area with RN-K at approximately 11:35 a.m. on 07/20/10, the door to the Operating Room II (OR-II) was partly opened. RN-K and the surveyor went into OR-II pulled opened drawers to the Anesthesia cart which opened without difficulty exposing medications. The Anesthesia cart which contained medication was observed in the to be unsecured and OR-II had not been used that day, nor was there a plan to use OR-II on 7/20/10. This cart contained over 30 different medications. RN-K indicated the anesthesia cart should have been locked and confirmed they were not locked at this time. When asked if the housekeeping ever did cleaning alone in the OR's she indicated that they did they have their own housekeeper. She further indicated the janitors did the cleaning on week ends when needed without supervision. The surgical technicians would also have access to these areas without supervision. Interview with the certified nurse anesthetist CRNA-B on the morning of 07/21/10, indicated that he did not know the anesthesia carts should be kept locked. He indicated the anesthesia cart in OR I or OR II were normally not kept locked. He thought they were secure areas. He also confirmed house keeping and the janitor would have access to the unsecured carts.

Crash Carts had a hinged plate covering part of the drawers which was suppose to lock over the draws preventing the drawers from being opened. When this hinged plate was opened the red tab was supposed to break off, informing staff that someone had opened the cart.

A Crash Carts was observed while continuing the tour with RN-K in the surgical area's back hallway. The drawers in the cart were opened exposing medications and then closed. The red tab that was suppose to break off remained in placed even after the drawer was opened and then closed. The extra red tabs were observed to be kept in a Crash Cart drawer. If the red tab had been broken off when the drawers were opened or closed, it then could have been replaced by one of the red tabs from the code blue drawer. This system would not alert staff if unauthorized persons gained access to these medications. There were more than 30 medications found in these drawers. As we were standing by the Crash Cart a surgical technician who was orientating at the time walked through this area several time. Hospital staff coming into and leaving the surgical area would have access to this hall way with out being observed by licensed surgical staff. Interview with RN-K at approximately 11:45 a.m. on 07/20/10, confirm the surgical technician should not have access to the medications in the Crash Carts and confirmed that the housekeeper and the janitors working on week ends would have access to the Crash Carts and the two the OR's anesthesia carts.

A Crash Cart was observed by the nursing station and although this cart had less medications in it than the code blue cart in the back hall way the surveyor was able to open it several times when staff were not around. This area was not always under observations by licensed staff. Family members were observed in this area when staff could not be seen. The red tab system was the same on this cart as the Crash Cart in the back hall way. The cart could be opened and closed without breaking this red tab. The red tabs were observed to be kept in the drawer of this code blue cart. An unauthorized person could get in this cart and replace the tab or simply open and close the secure system slowly and the tab doesn't break and there would be no indication an unauthorized person had been in the cart.

Interview with the pharmacist director at 4:10 p.m. on 7/20/10, indicated that the nurses take care of the Crash Carts in surgery and through out the hospital. He did not know you could open the medications drawers without breaking the red tabs in the surgical Crash Carts.


13611

The Code Blue carts on the 2-East Nursing unit and in the Intensive Care Unit were observed on 7/21/2010 at 9:30 AM. Both carts had orange security tags with numbers present on the tags which were affixed to the carts. The presence of the tag indicated the cart was intact and had not been opened. Both of the Code Blue carts contained medications and other supplies.

Registered Nurse (RN-A), who served as the charge nurse on the nursing units, stated that a Registered Nurse removed the security tag weekly to check the medications for expiration dates. She stated the RN was to document on the monthly calendar the date the tag was removed, that the contents of the cart had been checked, and the cart had been resealed. She stated the only time medications were removed from the cart was in the event the cart had been used or if medication was expired and required replacement.

A review of the July 2010 calendar for the cart in the Intensive Care Unit indicated the cart had been checked and sealed on July 3, 2010 with security tag # 2071692. However, the next check of the cart was completed on July 4, 2010 and the security tag, which was affixed to the cart, now was numbered #2071695. There was no indication on the calendar why a different security tag had been affixed to the cart. Again, a notation on the calendar on July 19, 2010 indicated a different security tag with the #2031694 was now attached to the cart. There was no documentation why the cart had been entered and a new security tag had been applied. Again, on July 20, 2010, documentation on the calendar now indicated security tag #2071693 was affixed to the cart, however there was no indication why the previous tag had been removed and replaced. There was no further documentation the cart had been checked for integrity the rest of the month of July.

The Code Blue cart, which was located in the 2-East nursing unit, was observed on 7/23/2010 at 10:35 AM. An orange security tag which had a number present on the tag was affixed to the cart. A review of the May 2010 calendar, used to document when the cart had been checked for security and outdated medications, was reviewed. The calender indicated the cart was checked and sealed with security tag # 2071496 on May 14, 2010. The next entry indicted the cart now had security tag # 2071470 present but there was no indiction why the cart had been unsecured and why a new security tag had been applied.

RN-A stated the security tags for the code blue cart located on 2-East were located in an unlocked drawer in an unlocked room off the 2-East hallway. This location would allow unlicensed staff, as well as visitors and patients, access to the security tags.

The Director of Inpatient Care reviewed the calendars used to document the security of the tags on the carts and stated he was not able to determine why the carts had been opened and why the numbers on the tags did not always correspond with the previous tag number. He stated he thought all of the security tags were in a secure area and would not be accessible to unlicensed personnel or other persons.

During a tour of the emergency room on 7/20/10, at 3 p.m. the two Crash Carts were observed. They both were padlocked and also had a red numbered tag. In a review of the documentation for the checks of the Crash Cart Lock, there were inconsistencies with the tag replacement numbers. In interview with RN-E on 7/21/10, at 9:10 a.m. confirmed the inconsistencies.

The Critical Access Hospital (CAH) failed to ensure adequate disinfection of glucometers used for multiple patients on the inpatient nursing units for 2 of 2 (P33, P6) patients observed. Findings include:

On 7/20/2010, at 11:4:0 a.m. RN-H was observed to complete a blood glucose test with a Lifescan glucometer for P33. Following the procedure, RN-H was observed to take the glucometer out of the patient's room and return it to the the nursing station. RN-H was not observed to disinfect the glucometer.

RN-I then took this Lifescan glucometer and checked the blood glucose measurement of P6 on 7/20/2010, at 11:25 am. The glucometer was not disinfected prior to the use of the glucometer on P6. Following the procedure, the RN returned the glucometer to the nursing station and did not disinfect the glucometer.

RN-H and RN-I were interviewed immediately following the blood glucose monitoring procedure and stated the glucometers were not disinfected between patients. They stated glucometers were disinfected once a day.

RN-D was interviewed on 7/20/2010, at 11:30 am and stated the CAH had four glucometers available to check inpatient blood glucose levels. There were two glucometers available for patients on the Medical Surgical unit, one glucometer for patients in the Intensive Care Unit, and one glucometer available for any patient in the Obstetrics unit. In addition there was one glucometer in the emergency room.

The Infection Control Coordinator was interviewed on 7/21/2010, at 1:10 p.m. she stated the current CAH policy related to glucometer use directed staff to disinfect the glucometers once a day with the use of a Sani-Wipe. She stated a new policy had been developed which changed the way the glucometers would be disinfected, however the policy had not yet been approved nor implemented.

A review of the current CAH policy "Glucometer Use and Disinfection", dated November 13, 2009, directed staff to disinfect the glucometers using a Sani-wipe daily and the blue strip insert was cleansed with water only.

On 7/20/10, at 3 p.m., a review of the Lifescan glucometer manufacturer recommendations indicated that a 10 % (percent) bleach solution be used between uses and was verified by RN-E.

13611

Based upon interview, policy review, and interview, the Critical Access Hospital did not ensure that patient medical records included dated, timed and authenticated signatures of physicians and other healthcare professionals for 17 of 32 (P1, P2, P3, P4, P5, P6, P7, P33, P34, P9, P10, P22, P23, P24, P25, P26 and P27) patient records reviewed which included inpatients, outpatients and Emergency Department patients. Findings include:

Medical records lacked documentation of the authentication of entries which included date, time, signature of the physician or allied health professional for patient orders, progress notes, and preoperative evaluations.

P1's chart review indicated CRNA-A failed to indicate the time "Epidural Infusion Orders" were written, as well as the time the anesthesia preoperative note was written on 7/17/2010. Physician-C did not indicate the date or the time the "Pre-Op Cesarean Section Orders" were written. Physician-C also did not indicate what time "Intrapartum Admission Orders" and "Oxytocin Induction/Augmentation Physician Orders" had been written.

P2's chart review indicated Physician-D had not indicated the time "General Surgery pre-Op Orders" had been written. CRNA-A had not indicated the time the "PACU Order Set/ICU Wake Up" orders had been written nor the time the anesthesia preoperative note had been completed.

P3's chart review indicated Physician-A had not indicated the time "General Medical Admission Orders" had been written nor had Physician-A indicated the time progress notes had been written on 7/17/2010, 7/18/2010, 7/19/2010 and 7/20/2010.

P4's chart review indicated Physician-C had not indicated the time "Newborn Admission Orders" had been signed nor did progress notes, dated 7/17/2010, 7/18/2010, and 7/19/2010, indicate what time the notes had been written.

P5's chart review indicated Physician-L had not indicated the time "General Admission Orders" had been signed. Physician-A had not indicated the date nor the time that "Pneumonia Standing Orders" had been signed. Physician-A had not documented the time progress notes, dated 7/18/2010, 7/19/2010, 7/20/2010 and 7/21/2010 had been written. A courtesy note by Physician-J, dated/20/2010, did not indicate the time the note had been written.

P6's chart review indicated physician orders, dated 7/14/2010, did not include Physician-K's signature nor the time the orders had been written.

P7's chart review indicated Physician-H had not indicated the time physician orders had been written on 7/20/2010.

P33's chart review indicated Physician-G had not indicated the time "General Medical Admission Orders" and "Subcutaneous Insulin Orders" had been signed.

P34's chart review indicated Physician-G had not indicated the date nor the time "General Medical Admission Orders" had been signed nor the time "Cardiac Admission Orders" had been signed. Progress notes, dated 7/19/2010, and 7/20/2010, did not indicated what time Physician-G had written the progress notes.

P10's chart review indicated Physician-B Orthopaedic Surgery Pre-operative Orders had not indicated the time physician orders had been written on 3/29/2010. P10's chart review indicated Physician-A had not indicated the time physician orders had been written on 5/25/2010. P10's chart review indicated Physician-B had not indicated the time physician orders had been written on 5/30/2010.

P9's chart review indicated Physician-J had not indicated the time physician orders for a Modified Barium Swallow had been written on 6/28/2010.

P22's record review indicated Physician-N had not indicated the time physician orders for Emergency Department Physician Orders had been written on 4/14/2010 or Physician Orders dated 4/15/2010.

P23's emergency room record indicated that Physician-F had not indicated the time physician orders for Emergency Department Physician Orders had been written on 3/29/2010.

P24, P25, P26 and P27 were all seen by Physician-E in the emergency room on 7/19/2010. None of the Emergency Physician Records were dated and timed when the physician signed. Physician-E had not dated the Emergency Department Physician Orders for P24, P25 or P27.

A review of the CAH policy "Assembly and Analysis of the Medical Record", last reviewed August 2009, indicated all entries in the medical record should be timed, dated, and authenticated, and a method established to identify the author.

The Physician Liaison in the Information Systems Technology department was interviewed on 7/23/2010, at approximately 3:40 PM. She stated the CAH had identified a problem with some physicians not indicating the time orders had been written. She verified the current hospital policies require authentication of orders and progress notes with date, time and physician signature.

Based on interview, policy review, and a review of hospital contracts, the Critical Access Hospital (CAH) was found not to be in compliance with the Condition of Participation of Surgical Services. The CAH failed to ensure proper sterilization of surgical instruments for 16 of 16 outpatients (OPS 11-21, and 28-32) patients who underwent a cataract extraction with an intraocular lens implant by MD-M. This potentially could effect every patients who underwent this surgical procedure at the CAH. Findings include:

At approximately 10:15 a.m. interview with the RN-J in the surgical department on 7/21/2010 confirmed they used flash sterilization with planned eye surgery's. The surgical technician's (ST-A) indicated at 11:00 a.m. on 07/21/10 the surgical eye instruments were placed in the flash sterilizer in a tray (not wrapped). The RN-K stated the Operating Room policy indicated flash sterilization should only be used in an emergency situation. A review of the Flash sterilizer 3, record dated 6/17/2010, indicated eye instruments had been flash sterilized for six patients (OPS 17-21, and 28) of MD-M . The facility did not keep a log to why they were flashing instruments used for routine scheduled surgery. The Flashing Record for Flash sterilizer 3, dated 7/15/2010, indicated eye instruments had been flash sterilized for ten out patients (OPS 6-11) of MD-M.

A review of the "Surgical Services/Flash Sterilization" policy, last reviewed April 2008, indicated flash sterilization should be avoided whenever possible. The policy indicated flash sterilization could be utilized only in Emergency situations when no replacement instruments are available and the surgical suite is designed to incorporate flash sterilization. A review of the CAH policy "Surgical Services P&P\Cleaning/& Processing" of instruments last revised 11/02, was missing the review date. It indicated "All instruments should be sent for sterilization on CSR. Only instruments that have been dropped during the case or if no other sterilized tray is available are instruments to be flashed for use.

The OR/Register Nurse who is managing the flow of surgeries while the manager is on vacation stated the CAH had a contract with SightPath Medical who provided the CAH with staff to assist the ophthalmologist performing the cataract extractions as well as all instrumentation required. She was unsure how many instruments trays they provided each visit. She indicated MD-M was scheduled one day a month and would perform a number of eye procedures with each visit.

A review of the contract from SightPath Medical entitled "Agreement Mobile Cataract and Specialty Services", signed 03/23/2009, indicated SightPath Medical would provide two complete instrument trays with each contracted visit. The contract indicated additional instruments or instrument sets are the responsibility of the facility. The contract did not specify the number of instrument trays provided would be dependent upon the number of patients scheduled to undergo a cataract extraction when SightPath provided an onsite visit to the CAH.

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the proper sterilization of instruments used in surgery.

Based on interview, the facility failed on conduct annual review of the facilities health care policies. Findings include:

On 7/22/10, at 10 a.m. when the Administrator was interviewed, there was no evidence provided that the health care policies of the facility had been evaluated as part of the annual program evaluation. He indicated that each department is responsible for development of the policies, but the policies are not evaluated or reviewed as part the annual program evaluation.

Based on interview and review of quality assurance (QA) plans/programs the CAH failed to ensure, Medication Errors and Radiology had QA plans to improve their services. Findings include:

Review of the medication errors forms from October 2009 through June 2010 indicated the pharmacy did not have an QA to address medication errors. The pharmacy director, interviewed at approximately 4:00 p.m. on 7/21/2010, indicated they look at the medication individually. He confirmed they did not have a QA that evaluated the similarities of their medication errors. On review similarities were found. When the medication errors were reviewed with him three errors were found that when the nurses were waiting to get assistance from another hospital after hours. The QA Director, interviewed at 2:30 p.m. on 7/21/2010, confirmed she had not received a comprehensive medication errors QA from the pharmacy.

Review of the Radiology Quality Assurance (QA) minutes on 7/21/10, with the Director on Imagining indicated they were monitoring many things, however, they had not developed an area for a QA project to improve their service to the patients. The director of the Imagining was interviewed at 3:30 p.m. on 7/21/2010, and confirmed she currently was not working on any QA projects.