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Tag No.: C0204
Based on observation, interview, and policy review, the provider failed to ensure emergency room (ER) supplies and sterile packages were not outdated. Findings include:
1. Observation on 6/6/11 at 2:55 p.m. and on 6/7/11 from 8:57 a.m. through 10:00 a.m. in the ER revealed the following supplies and sterile packages were outdated and available for use in the ER:
*In the Broselow/Hinkle PES (pediatric emergency system) color-coded cart:
-Pink/red drawer:
*Intravenous (IV) module - July 2008.
*Intubation module (airway into the trachea) (opened package) - August 2009.
*Intraosseous module (IO, within the bone) (opened package) - March 2011.
-Red drawer:
*Intubation module - December 2005.
*Oxygen delivery module - December 2005.
-Purple drawer:
*Complete PES module - February 2007.
*IV module - June 2008.
*IO module - April 2011.
-Yellow drawer:
*Complete PES module - November 2004.
*IV module - July 2008.
*Intubation module - August 2009.
*IO module - April 2011.
-White drawer:
*Complete PES module - November 2006.
*Intubation module - July 2009.
*IO module - April 2011.
-Blue drawer:
*Complete PES module - November 2004.
*Intubation module - July 2009.
*IO module - April 2011.
-Orange drawer:
*Complete PES module - November 2004.
*IV module - June 2008.
*Intubation module - July 2009.
*IO module - November 2001.
-Green drawer:
*Complete PES module - November 2004.
*IV module - July 2008.
*Intubation module - July 2009.
*IO module - April 2011.
*Sterile packages and supplies:
-Enucleation kit - April 2010.
-Three towel clips - May 2011.
-Two finger drapes - May 2011.
-Emergency tracheotomy (trach) set - March 2011.
-Emergency trach probe set - March 2011.
-Low pressure trach tube - September 2010.
-Two Groshong PICC (peripherally inserted central catheter (IV access) procedure trays - August 2010.
-Large bore central venous line catheter procedure tray - September 2010.
-Neonatal (newborn) trach tube - September 2010.
-Childbirth delivery tray - February 2011.
-Circumcision tray - January 2009.
-Ringed forceps - August 2010.
-Spring retractor - May 2011.
-Specimen container - May 2011.
-Bone marrow needle (taped to the wall) - February 2011.
*Sutures:
-Ten 6.0 Ethilon - July 2009.
-Sixteen 7.0 Ethilon - January 2011.
-Four 6.0 Chromic gut - January 2010.
Interview on 6/7/11 at 10:15 a.m. with the acute care coordinator responsible for the ER confirmed the above supplies and sterile packages were outdated. She further revealed:
*The night nurses were responsible for checking all the supplies and medications in the ER monthly for outdates.
*The above expired PES supplies and sterile packages were not used "very often" or "probably never."
*The bone marrow needle was used in a knee or shoulder if they could not start an IV in a vein. They only had one. It was kept taped to the wall, so it would have been readily available if it was needed. The provider had only used one of those needles in the "last six years."
*She thought the ER policies and procedures manual was in her office.
Interview on 6/8/11 at 11:10 a.m. and again at 11:30 a.m. with the director of nursing revealed:
*The ER policy and procedure manual had been last reviewed in 1992.
*She kept the manual in her office, because she had needed to update the policies and procedures for ER.
*Any other ER policies and procedures they had would have been included with the nursing policies and procedures.
Review of the nursing policies and procedures reviewed in March 2009 revealed there were no policies included for the monitoring of supplies and sterile packages in the ER.
Tag No.: C0241
Based on record review, medical staff and governing board minutes review, and interview, the provider failed to ensure five of five sampled physicians (A, B, E, G, and H) and three of three sample allied health professionals (C, D, and F) had been credentialed according to the provider's By-Laws Rules and Regulations. Findings include:
1. Review of physicians A, B, G, and H credentialing files revealed:
*No current professional liability insurance information for all of those physicians.
*No current National Practitioner Data Bank query for all of those physicians.
*Physician G had an application dated 9/8/09 for appointment. There were no medical staff or governing board signatures noted.
*No current Drug Enforcement Administration (DEA) registration for all of those physicians.
*There was no South Dakota Department of Health Controlled Substance certificate.
2. Review of physician E's credentialing file contained only a copy of his current medical license.
3. Review of allied health professionals C, D, and F's credentialing files revealed:
*Physician assistant-certified (PA-C) C had an application for credentialing present. The application had not been signed that PA-C had been approved by the medical staff or governing board.
*PA-C D's last application for credentialing was 1/20/06.
*PA-C F had no application for credentialing in her file.
*No current professional liability insurance information for all PA-Cs.
4. Review of the quarterly medical staff minutes from 6/12/08 to 6/2/11 revealed:
*12/10/09 - "Medical staff credentialing committee-staff reviewed, motion made to reappoint all current medical staff as requested."
*6/10/10 - "Medical staff credentialing committee-motion made to reappoint all current medical staff as requested."
*12/9/10 - "PA-C C reviewed. Motion made to approve as requested."
Review of the monthly governing board minutes from 5/28/10 to 4/29/11 revealed no indication of medical staff appointments or reappointment's.
Review of the provider's 2/23/82 By-Laws Rules and Regulations on page 3, Article IV, Categories of the medical staff revealed:
*Initial appointments and reappointment to the medical staff shall be made by the governing body.
*The governing body shall act on appointments, reappointment only after there had been a recommendation from the executive committee as provided in those by-laws.
*Initial appointments shall be for a period of six months.
*Reappointment shall be for a period of not more than two medical staff years.
*The medical staff shall be divided into honorary, active, courtesy, consulting, and provisional categories.
Review of the provider's By-Laws Rules and Regulations on pages 4 through 6, Article V, Procedure for Appointment and Reappointment revealed detailed instructions for the:
*Application for Appointment.
*Appointment Process.
*Reappointment Process.
*Appointments Provisional.
*Temporary Privileges.
Review of the provider's By-Laws Rules and Regulations on page 14, Article IX, Section 6, Duties of Officers revealed the chief of staff would be responsible for the enforcement of medical staff by-laws, rules, and regulations.
Review of the provider's By-Laws Rules and Regulations on pages 14 and 15, Article XI, Section 1, Executive Committee revealed the purpose was to:
*"Review the credentials of all applicants and to make recommendations for staff membership, assignments to services, and delineation of privileges.
*Review periodically all information available regarding the performance and clinical competence of staff members and other practitioners with clinical privileges and, as a result of such review, to make recommendations for reappointment, and renewal of changes in clinical privileges."
Review of Amendment III to the by-laws revealed on 3/24/89 the governing body adopted the following regarding appointments:
*Appointments to the medical staff would be made by the governing body following recommendations from the staff after all credentialing procedures had been done. Initial appointment would be provisional for six months.
*Reappointment to the medial staff would be made by the governing body following recommendations of the full medical staff after evaluations and verifications had been completed. Reappointment would be for a period of no longer than two years and would coincide with the medical staff.
*At the time of each appointment or reappointment the governing body would approve the privileges of each individual appointment.
Interview on 6/7/11 at 10:45 a.m. with the human resource director revealed:
*She had been in her current position for approximately one year.
*She was in charge of maintaining the credentialing files.
*She was not sure what was involved for the credentialing process.
*The credentialing files and current physician licenses had not been kept current.
Interview on 6/7/11 at 2:00 p.m. with the administrator revealed:
*He was not aware the credentialing process had not been completed.
*He agreed the plan of correction from the 6/11/08 survey had not been completed or followed.
*He agreed he was to have been responsible for the monitoring of the credentialing process.
Tag No.: C0276
Based on observation, policy review, and interview, the provider failed to ensure:
*Access to high-alert medications was limited according to the provider's policy.
*A system was in place for the pharmacist to determine if medications removed from the pharmacy in the absence of the pharmacist were accurately removed.
*Medications were removed from the pharmacy in the absence of the pharmacist according to the provider's policy.
*The pharmacy department participated in the quality assurance and performance improvement (QAPI) program.
*Outdated drugs and biologicals were not used in one of three sampled areas (emergency room) where drugs and biologicals were stored.
Findings include:
1. Observation on 6/7/11 at 10:45 a.m. revealed there were five vials of potassium chloride (KCl) 20 milliequivalent (mEq) injection present in a drawer at the nurses station. The vials were included with a variety of other injectable medications.
Observation on 6/7/11 at 11:45 a.m. revealed patient 29 was receiving a 1000 milliter solution with 40 mEq of KCl added.
Review of an undated policy titled high-alert (high-risk) medications located in the pharmacy policy book revealed:
*Undiluted KCl was listed as a high-alert medication.
*High-alert medications were not to be stocked at the nurses station.
*High-alert medications were to be stored only in the pharmacy and mixed only in the pharmacy if practical.
*The pharmacy department was to dedicate a designated shelving area in the pharmacy and refrigerator for high-risk medications.
*The list of medications designated as high-risk medication was to be assessed at least annually by the pharmacy and therapeutics committee for any additions or deletions.
*Physician orders written for high-risk medications were to be reviewed by a pharmacist prior to administration to a patient.
*Physician orders written when the pharmacy was closed required a phone call to the pharmacist for verbal review of the order.
Review of the Institute for Safe Medication Practices (ISMP) List of High-Alert Medications, Revised 2008, revealed:
*A list of 13 specific medications was considered high-alert.
*There were 19 classes of medications considered to be high-alert.
*High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients.
*The list could be used to determine which medications require special safeguards to reduce the risk of errors.
*Strategies to prevent medication errors with high-alert medications included:
- Improving access to information about those drugs.
- Limiting access to high-alert medications.
- Using auxiliary labels and automated alerts.
- Standardizing the ordering, storage, preparation, and administration of these products.
- Employing redundancies such as automated or independent double checks when necessary.
Interview on 6/7/11 at 11:15 a.m. with the director of nursing revealed:
*She was not aware of the above policy.
*The pharmacist would know of the origin of the policy.
*There was no nursing service policy for high-alert medications.
Interview on 6/8/11 at 9:15 a.m. with the acute care coordinator (ACC) confirmed the KCl was present in a drawer at the nurses station. The ACC stated the nurses prepared the solutions when KCl was added. She was not aware of any policy for high-alert medications.
Interview on 6/8/11 with the pharmacist revealed:
*He was aware of the above policy but did not know where it had originated.
*He was aware nurses removed KCl from the pharmacy to be stocked at the nurses station.
*The pharmacy department did not have a designated shelving area in the pharmacy and refrigerator for high-risk medications.
*He was not called when KCl was ordered and added to solutions.
*The list of medications designated as high-risk in the policy was not assessed at least annually by the pharmacy and therapeutics committee for any additions or deletions.
*The above policy should have been followed or revised to meet the needs of the provider.
2. Observation on 6/7/11 at 8:05 a.m. of the pharmacy after hours entry log revealed six medications had been signed out from the pharmacy by nursing personnel between the hours of 4:00 a.m. and 5:00 a.m. Of those items all were listed as replacement of floor stock. There were no packages of the medications by the after hours entry log so the pharmacist could determine if the entry on the log reflected the actual medication removed.
Interview at the above time with the pharmacist revealed nursing personnel removing medications from the pharmacy should have left a comparative package, so he could determine if the proper medication was removed. He stated there were times when the package was left but often it was not. The pharmacist did not inspect the individual patient medication drawers or stock medication supplies at the nurses station to determine if the proper medication had been removed.
3. Review of the pharmacy after hours log for 6/6/11 through 6/8/11 revealed nursing service personnel removed twenty-two medications from the pharmacy. The entries for those medications revealed:
*Five were the smallest package size that could be removed.
*Seven were boxes of injectable medications with multiple vials in each box.
*Nine were unit-dose packages of oral medications with the quantities of each ranging between four and twenty doses.
*One was for six vials of injectable KCl.
Review of the provider's policy for access to the pharmacy reviewed June 2010 revealed:
*Access to the pharmacy department was to be limited as much as possible.
*Medications were to be removed only in quantities sufficient to complete the present shift of duty.
Interview on 6/8/11 at 11:40 a.m. with the pharmacist revealed:
*He came to the hospital and nursing home multiple times daily.
*He did not have a set schedule where he restocked the nursing station floor stock or patient medication carts.
*Nursing staff members removed medications from the pharmacy in quantities greater than the amount needed to complete the present shift.
4. Interview on 6/7/11 at 8:05 a.m. with the pharmacist revealed he was not sure if the pharmacy department had any QAPI projects related to the pharmacy operation or medication errors. He stated he did not attend QAPI meetings.
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5. Observation on 6/7/11 from 8:57 a.m. through 10:00 a.m. of the emergency room (ER)revealed the following expired biologicals available for use:
*One bottle of hydrogen peroxide had expired January 2009.
*Two bottles of Enfamil sterile water had a use by date of October 2008.
*One bottle of Enfamil 5% glucose in water had a use by date of November 2008.
*One bottle of Curity plain packing strips had an open date of January 20, 2011 and an expiration date of February 2009.
*One opened 250 milliliter (ml) bottle of 0.9% sodium chloride irrigation solution had an open date of May 20th.
*One opened 1000 ml bottle of 0.9% sodium chloride irrigation solution had an open date of November 27, 2010.
*Two opened 1000 ml bottles of sterile water for irrigation had no open date noted on them.
Review of the labels on the above irrigation solution bottles revealed any unused portion of the bottles should have been discarded.
Interview on 6/7/11 at 10:15 a.m. with the acute care coordinator responsible for the ER confirmed the above items were outdated. She further revealed:
*The night nurses were responsible for checking all the supplies and medications in the ER monthly for outdates.
*She was not aware the above irrigation solutions should have been discarded after one use.
*She thought the ER policies and procedures manual was in her office.
Interview with the director of nursing on 6/8/11 at 11:10 a.m. and again at 11:30 a.m. revealed:
*The ER policy and procedure manual had been last reviewed in 1992.
*She kept the manual in her office, because she had needed to update the policies and procedures for ER.
*Any other ER policies and procedures they had would have been included with the nursing policies and procedures.
Review of the nursing policies and procedures reviewed in March 2009 revealed there were no policies included for the monitoring of biologicals in the ER.
Tag No.: C0277
Based on observation, record review, policy review, and interview, the provider failed to ensure:
*The notification of physician information was completed for 13 of 41 sampled medication error reports.
*Medication error reports were analyzed to determine if there were common types of errors, potential corrective actions were identified, and incorporated into the provider's quality assessment and performance improvement (QAPI) program.
Findings include:
1. Review of 41 medication error reports prepared between 7/1/10 and 6/8/11 revealed 13 of the reports did not have physician notification information completed.
Review of the provider's policy for medication errors revised June 2010 revealed when a medication error was recognized:
*The charge nurse was to notify the patient's physician immediately after the error was discovered.
*A medication error form was to be completed and forwarded to the director of nursing.
Interview on 6/7/11 at 4:00 p.m. with the director of nursing revealed:
*There was an area on the provider's medication error reporting form for the nurse to indicate if and when the physician had been notified.
*It was the nurse's responsibility to complete that information.
*There may have been times when the physician was notified, but the nurse did not complete the form properly.
2. Review of 41 medication error reports, medical staff meeting minutes, and QAPI meeting minutes prepared between 7/1/10 and 6/8/11 revealed:
*There was no compilation, summary of the types of errors reported, or suggestions for corrective action to be taken related to the above 41 medication error reports.
*Medication errors were reviewed at one of four quarterly medical staff meetings held during the above time period.
*There was no reference to medication errors during the four QAPI meetings held during the above time.
Review of the National Coordinating Council for Medication Error Reporting and Prevention statement on medication error reporting reviewed 6/24/08 revealed:
*The goal of every health care organization should be to continually improve systems to prevent harm to patients due to medication errors.
*Health care organizations should monitor actual and potential medication errors that occurred within their organization, and investigate the root cause of errors with the goal of identifying ways to improve the medication use system to prevent future errors, and potential patient harm.
*The value of medication error reports and other data gathering strategies is to provide the information that allows an organization to identify weaknesses in its medication use system and to apply lessons learned to improve the system.
Interview on 6/7/11 at 4:00 p.m. with the director of nursing revealed:
*Medication errors were reviewed by the medical staff, but there was no current program to compile data.
*She had done root cause analysis of medication errors in the past.
*Many of the medication errors were handled individually with the party that was involved with the error.
*The medication error reports were not a part of the QAPI program.
Tag No.: C0278
A. Based on record review, policy review, and interview, the provider failed to ensure the infection prevention and control program:
*Provided adequate training for the infection prevention and control coordinator to accomplish her required tasks.
*Utilized an effective surveillance system to monitor current infections.
*Incorporated infection prevention and control data into a quality assessment and performance improvement (QAPI) program.
Findings include:
1. Interview beginning at 8:50 a.m. on 6/8/11 with the infection prevention and control (IPC) nurse revealed she had not received any formal training in the areas of infection prevention and control. She stated she relied on internet websites and resource books for information related to infections. She stated she also consulted with local physicians and other IPC nurses in the surrounding area.
2. Review of the provider's infection control sheet revealed it contained information about:
*A patient's personal demographic information.
*Any symptoms associated with the infection.
*The body system or part affected by the infection.
*The source of the infection.
*The need for isolation.
*The results of culture and sensitivity laboratory reports.
*The type of antibiotic the patient was taking.
Interview with the IPC nurse at the above time revealed she reviewed the information on the infection control sheets monthly. Compilation of data on that monthly sheet included:
*The numbers of infections that were either community or hospital acquired.
*Information related to the site of the infection.
*Mapping of the infection related to hospital rooms.
She stated she did not compile data related to the infectious organism or potential source of the infection. She further stated she primarily reviewed a patient's history related to an infection. She acknowledged it would have been important to know if there were multiple infections from the same organism at the time of occurrence. With that information she could have made any necessary changes in patient care processes or techniques. She stated she was not informed by laboratory personnel regarding culture results. She stated that information would have been shared with the nurses providing patient care.
Review of the provider's June 2010 infection control and surveillance policy revealed:
*The purpose of infection surveillance was to track and record all infections in the health care setting.
*An infection control sheet was to have been completed on every patient with a suspected or confirmed infection.
*All infection control sheets would have been kept in the infection control log book.
*Upon completion of antibiotic therapy, patient death, or discharge, the infection control sheet would have been provided to the infection control nurse.
*Infection control rates would be tabulated monthly.
The policy did not address the need regarding the type of data analysis needed for an ongoing IPC program.
3. Interview with the IPC nurse at the above time revealed she did not report IPC information to the QAPI program. Information from the IPC program was shared with medical staff on a quarterly basis. Refer to C337.
20031
B. Based on observation, testing, interview, and policy review, the provider failed to:
- Ensure the cleanliness and sterility of cotton tipped applicators.
- Maintain the cleanliness/integrity of the fingernail and toenail clippers and heavy duty nail nippers in the tub room.
- Properly clean and disinfect the electric razor on the sink counter.
- Use a durable/cleanable attachment for the end of the call cord for the tub.
- Maintain the integrity/cleanability for one of two fracture pans used for the tub seat.
- Maintain the integrity/cleanliness of the metal clean supply cabinet in the tub room.
- Maintain the cleanability of the base of the shower chair in the shower of the tub room.
- Maintain the cleanliness/integrity of the caulk around the base of the shower stall and the vinyl floor around the floor drain.
- Create a distinct whirlpool policy and training for the disinfection of the tub after patient use.
- Use durable/cleanable containers for clean supplies in the sterilization cabinet.
- Maintain the integrity/cleanability for two of two weight bags in radiology.
- Cover a foam rubber head rest on the x-ray table with an impermeable cover.
- Maintain the integrity/cleanliness for two of two cloth chairs in the physical therapy gym.
Findings include:
1. Observation and testing at 3:35 p.m. on 6/6/11 revealed the following in the tub room:
- An opened package of cotton tipped applicators sat on the sink counter with the cotton ends exposed (photo 2).
- Two fingernail clippers, two toenail clippers, and two heavy duty nail nippers were rusted and encrusted with debris that could be scraped off with a fingernail.
- The electric razor on the sink counter had beard tailings and debris under the razors.
- A roll of used tape was attached to the end of the call cord for the tub (photo 1).
- A fracture pan was broken and had a chipped edge approximately three inches long that created a rough surface that was sharp to the touch (photo 14).
- The metal clean supply cabinet drawers were littered with discarded alcohol pad and band aid wrappers (photo 8). The drawers were dirty and in disarray (photo 7), and the shelves were rusted (photo 5). The pull handle for the left door was missing (photo 6).
- The metal base of the tub/shower chair had large areas of chipped paint the size of quarters and dimes (photo 4).
- The caulking around the shower base had separated from the base, was missing in some areas, and was dirty (photos 3 and 11). The vinyl floor around the floor drain was separated from the floor and drain cover (photo 12).
Interview on 6/8/11 at 10:30 a.m. with the acute care coordinator (ACC) confirmed the above observations and testing. She stated she was not aware of the condition of the tub room and its fixtures but revealed it was not to be kept in that manner. She confirmed the electric razor was not clean. The ACC stated she had hoped the certified nurse assistants (CNA) would let her know when equipment was in need of attention or when repairs were needed.
2. Observation at 9:30 a.m. on 6/7/11 revealed CNA K had just finished giving a patient a whirlpool bath. Interview with CNA K at that time revealed she had been taught to just use the "glug, glug, glug" method to add disinfectant to the whirlpool water until it was a light green. She was not aware if there was a policy of instructions for cleaning and disinfecting the tub. That was the way she had been taught when she had started approximately one year ago.
3. Observation on 6/6/11 at 4:00 p.m. revealed a well used cardboard box and wooden box with chipped paint (photo 13) were used to hold clean supplies for sterilization. Interview with the ACC at 10:40 a.m. on 6/8/11 revealed she was not aware the staff were reusing cardboard boxes for clean supplies. She also agreed the chipped painted wooden box needed to be repainted or resealed to be cleanable.
4. Observation on 6/7/11 at 2:30 p.m. revealed two Naugahyde covered weight bags on the floor in the radiology closet. Those bags had been taped with several layers of duct tape (photos 15 and 16). Interview with x-ray technician J at the time of the observation confirmed that finding. She agreed those bags were no longer cleanable and needed to be recovered or discarded.
Additional observation at that same time revealed a large long red foam rubber triangle shaped cushion on the exam table in the x-ray room. That red foam rubber cushion had pieces of missing foam rubber the size of dollar bills (photo 17). Interview with x-ray technician J at the time of that observation confirmed that finding. She stated they used the cushion as a head rest for x-rays. She stated they used only a cloth pillow case to cover that cushion and did not use an impermeable cover that could be disinfected between each patient.
5. Observation on 6/6/11 at 3:30 p.m. revealed two cloth chairs in the physical therapy gym. Those two chairs were thread bare on the top cushions that exposed the foam rubber padding beneath the cloth (photos 21 and 22). Interview with the director of nursing at 4:00 p.m. on 6/8/11 confirmed those findings and agreed those chairs needed to be repaired or discarded.
6. Review of the 3/09 policy titled Cleaning of Electric Razors revealed all whiskers must be removed with a brush after each use. It also stated that the razor should be completely disassembled and disinfected weekly. The ACC agreed the policy should state the electric razors should be completely cleaned, disassembled, and disinfected after each use.
Review of the 6/10 policy titled Cleaning Shower, tubs, and bathing equipment revealed the instructions were to use the recommended disinfectant, wait 10 minutes, and rinse clean. The procedures also included the following: "5. Spray entire inside of tub with disinfectant solution and can leave this on." Review of the whirlpool cleaner and disinfectant revealed a potable rinse must be used after disinfection to ensure all surfaces were free of the chemical.
Tag No.: C0279
Based on observation, testing, record review, and interview, the provider failed to comply with proper food handling practices, maintain the cleanliness of non-food contact surfaces, and maintain the walls in a durable/cleanable condition. Findings include:
1. Observation on 6/7/11 from 10:50 a.m. through 11:45 a.m. revealed the following in the kitchen and on a patient tray:
a. The salad bar had an assortment of fresh fruits and salads. Temperature testing of certain foods revealed the following:
- The corn relish was 43 degrees Fahrenheit (F).
- The broccoli salad was 52 degrees F.
- The grape salad was 53 degrees F.
- The macaroni salad was 62 degrees F.
The pea salad on the serving line was 45-62 degrees F. Those above items had no date and according to dietary supervisor (DS) M the homemade salads had been made that morning. The salad bar had a layer of ice in the bottom of the holding tray. None of the salad bar food containers were in contact with that ice.
Continued interview with DS M at the time of the above observations and testing confirmed the above findings. He stated dietary aide (DA) L had made all the homemade salads this morning. He stated he had not taken a temperature or recorded a temperature of the food before it was placed on the salad bar or on the serving line. DS M revealed DA L might not know the temperature of cold foods, as she had just started making salads about two weeks ago. Interview with DA L at the time of the observation revealed she had not been trained about the proper food handling temperatures. She said she had wondered if they were cold enough when she had placed them on the salad bar but had not checked with anyone.
Additional observation and testing at 11:45 a.m. on that same day revealed the last tray to be served to a patient had the following temperatures: pea salad was 71 degrees F., Philly Cheesesteak was 130 F., and the carton of milk that was refused by the patient tested at 52 degrees F.
b. The back door to the storage room was propped open from 9:00 a.m. to 4:00 p.m. That door did not have a screen or air curtain to keep insects and rodents out of the kitchen area.
c. The food storage room was found at 93 degrees F. Interview with DS M at the time of the testing confirmed that condition. He revealed the food storage room had averaged between 95 and 105 degrees F. over the last three days. DS M stated the provider was working on the heating and cooling units for the facility. The food storage room did not have any air at this time. He stated he was aware food storage rooms must be kept at 70 degrees F or lower.
d. Several cups, glasses, bottles, and cans of pop were noted on a cart by the desk in the kitchen preparation area. Employees were noted to take drinks from the bottles and cans of pop, not wash their hands, and return to their food service duties. Interview with DS M at the time of the observations confirmed those findings. He stated he was not aware bottles and cans of pop could not be used as beverage containers in the food preparations and service areas. And they could contaminate the hands when handled.
e. The wall under the table on the soiled side of the dishwashing room next to the dishwasher had large chunks of plaster the size of coffee cups that had fallen to the floor (photos 18 and 19). The wall was eroded around water pipes and had started to crack (photo 20). Interview with DS M at the time of the observation confirmed that finding. He stated the wall had been in that condition for over a year.
f. The utensil storage drawers were in need of cleaning and had crumbs and layers of dried liquid and solid debris in the bottom. Interview with DA L at the time of the observation confirmed that finding. She agreed the drawers needed to be cleaned.
2. Observation on 6/8/11 at 9:00 a.m. revealed the food and utensil storage drawers in the kitchenette by the nurses station needed to be cleaned and organized. Those drawers were in disarray and had layers of crumbs and layers of dried and liquid food debris in the bottom. Interview at 4:00 p.m. on 6/8/11 with the acute care coordinator revealed she was not aware that kitchenette needed to be cleaned and organized.
Tag No.: C0280
Based on record review and interview, the provider failed to ensure all of the provider's patient care policies were reviewed annually. Findings include:
1. Review of the radiology service policy book revealed the last date of any review of the radiology policies had been 5/24/02. The review had been signed by the radiology director, administrator, and chief of medical staff. The review had been signed by the president of the governing board on 6/28/02.
Interview on 6/8/11 at 10:05 a.m. with radiology technician I revealed she was not aware of any annual review of the radiology policies.
2. Review of the pharmacy policy manual revealed it had been last reviewed in 2008.
Interview on 6/8/11 at 11:40 a.m. with the pharmacist revealed he did not review the pharmacy policies annually. He stated it would be a good idea to conduct an annual review.
3. Review of the medical staff meeting minutes from 6/10/10 through 6/2/11 revealed there was no discussion of patient care policies.
4. Review of nursing staff policies revealed they had been reviewed by the director of nursing in June 2010.
Interview on 6/8/11 at 4:30 p.m. with the director of nursing revealed the medical staff was aware of the review of policies. She stated the provider did not have an organized system for the medical staff to review the policies and document that review.
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5. Interview with the director of nursing on 6/8/11 at 11:10 a.m. and again at 11:30 a.m. revealed:
*The emergency room (ER) policy and procedure manual had last been reviewed in 1992.
*She kept it in her office, because she had needed to update the policies and procedures for ER.
*Any other ER policies and procedures the provider had would have been included with the nursing policies and procedures.
Review of the nursing policies and procedures reviewed in March 2009 revealed there were no policies included for the monitoring of sterile supplies or biologicals in the ER.
Tag No.: C0294
Based on record review, interview, and policy review, the provider failed to ensure professional standards were maintained:
*In the provision of services for two of eight sampled swing bed residents (10 and 13).
*For the administration of blood to one of three sampled patients (25) receiving blood transfusions.
Findings include:
1. Review of resident 13's undated nursing care plan revealed she was:
*At risk for fluid imbalance and edema.
*At risk for dehydration due to lack of fluid intake and use of a diuretic (medication that promotes fluid loss).
*To have oral fluids encouraged.
*To have intravenous (IV) fluids monitored.
*To have her intake and output strictly monitored.
Review of resident 13's April and May 2011 daily care records revealed her oral intake and output had been recorded each shift. Neither of those daily care records contained any information about her IV intake. Those daily records also did not contain documented 24 hour totals of her intake and output for ongoing monitoring.
Review of the provider's March 2009 intake and output policy revealed the objective was to maintain an accurate record of a patient's intake and output. That policy also stated only 8 hour totals were to have been maintained. That policy did not mention any need to measure IV intake.
Interview at 1:00 p.m. on 6/8/11 with the director of nursing (DON) revealed it was her expectation any accurate monitoring of intake and output would include calculations of the IV intake. She confirmed without that information an accurate picture of a patient's fluid balance could not be obtained.
2. Review of resident 10's 4/2/11 nurses' notes revealed his blood sugar level at midnight on that day was at 52 mg/dl (milligrams of sugar per deciliter of blood volume). He was given something to eat and his blood sugar was rechecked four minutes later. At that time his blood sugar was 36. Again he was given something to eat. His next blood sugar was not checked until 4:40 a.m. The blood sugar measured 60 at that time. There was no documentation the physician had been notified regarding those low blood sugars.
Review of the resident's 4/28/11 nurses' notes revealed his blood sugar was 45 mg/dlat 4:30 a.m. He was given something to eat at that time. His blood sugar was rechecked 45 minutes later and was measured at 57. There was no documentation the physician had been notified regarding those low blood sugars.
Review of resident 10's March, April, and May 2011 blood sugar checks recorded four times daily revealed his blood sugar normally measured from a low of 80 to a high of 372.
Review of the resident's undated care plan revealed he was to have his blood sugar monitored and abnormal values reported to the physician.
Review of the provider's April 2010 blood glucose monitoring policy revealed when the glucose (sugar) monitoring result from an adult patient was less than 50 mg/dl the nurse should have repeated the procedure and reported those results to the provider.
Interview beginning at 1:00 p.m. on 6/8/11 with the DON revealed it was her expectation the provider should have been notified of resident 10's low blood sugar levels. She stated the physician should have been called no matter the time of the occurrence.
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3. Review of patient 25's 10/27/10 outpatient blood transfusion record revealed:
*Her first unit of blood had been started at 1:10 p.m. and was completed at 4:10 p.m.
*The blood had been transfused at a rate of 125 milliliters (ml) per hour.
*A second unit of blood had been started at 4:30 p.m. and was completed at 9:50 p.m.
*The blood had been transfused at a rate of 100 ml per hour.
*The second unit of blood transfused had taken 5 hours and 20 minutes.
Review of the provider's revised March 2010 blood transfusion policy revealed:*Administer each unit of blood slowly at 75 ml per hour for the first 10 to 15 minutes.
*Blood was to infuse in no less than 2 hours and no more than 4 hours
Interview on 6/8/11 at 11:00 a.m. with the DON revealed:*Nurses were to review the blood transfusion policy and procedure before each transfusion.
*She agreed the second unit of blood given to resident 15 had been given over too long of a time period.
*She agreed the flow rate was too high when it had been administered.
Tag No.: C0297
Based on record review, interview, and policy review the provider failed to ensure:
*Seventy-one of ninety-six verbal orders had been authenticated by the physician with a date, time, and signature.
*Physician's orders for medications were signed for 4 of 6 patients (18, 19, 22, and 23) closed emergency room records.
Findings include:
1. Review of the provider's 12/17/81 medical staff by-laws medical records policy revealed all entries in the patient record would be dated and authenticated. There was no mention of timing in that policy.
Interview on 6/7/11 at 11:45 a.m. with physician A revealed he was aware that verbal orders were to be authenticated by the physician. He agreed that process was not always completed.
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2. Review of four of six (18, 19, 22, and 23) closed emergency room records revealed physician's orders for medications had not been signed by the physician.
Review of the provider's physician services policy revised July 2010 revealed:
*Physicians must sign and date all orders.
*All medical orders should have been signed by the physician or the physician extender.
Tag No.: C0304
Based on record review, policy review, and interview, the provider failed to ensure informed consent forms were properly executed for:
*One of three sampled open, closed, and outpatient (25) records reviewed for blood transfusions.
*Two of two procedures for one of one patient (15).
Findings include:
1. Review of patient 25's closed outpatient record revealed:
*She had received two units of packed red blood cells on 10/27/10.
*The consent for transfusion form had "patient unable to sign" in the patient signature area.
*Two professional nurses had signed the witness area.
Review of a 10/26/10 physician's progress note revealed resident 25 had diagnoses that included high degree of dementia.
Review of a 10/28/10 physician's follow-up blood transfusion progress note revealed "The patient had a transfusion for anemia yesterday." "Her family recommends no aggressive type therapy. They did agree to the transfusion of 2 units yesterday."
Review of patient 25's nursing facility interdisciplinary progress notes provided by the director of nursing (DON) revealed a 10/27/10 at 8:30 a.m. note "Events explained to resident but not sure of comprehension."
Interview on 6/8/11 at 10:15 a.m. with the DON revealed:
*A signed consent form should have been obtained from patient 25's responsible party or power of attorney.
*She was unsure if a verbal consent had been obtained by physician assistant D from resident 25's responsible party or power of attorney.
*The two professional nurses should have obtained a written or verbal consent from patient 25's responsible party or power of attorney before the blood transfusion had been started.
Review of the provider's revised March 2010 blood transfusion policy revealed:
*The patient or patient's agent would sign the transfusion consent form when an order was received by a physician.
*The patient would have been educated regarding the possible risks and reactions from receiving blood transfusions.
2. Review of patient 15's 5/27/11 at 7:10 p.m. nurse's notes revealed she had been brought to the emergency department for a thoracentesis to her left lung.
Review of patient 15's 5/29/11 at 5:00 p.m. nurse's notes revealed "Patient prepped for thoracentesis."
Further review of patient 15's medical record revealed no consents for the thoracentesis on 5/27/11 or 5/29/11.
Interview on 6/7/11 at 4:00 p.m. with the DON revealed she agreed a consent form should have been completed for each thoracentesis procedure.
Review of the provider's last reviewed March 2009 consent form policy revealed the consent would include the identity of the patient, the date, the procedure or treatment to be performed, and a witness signature.
Review of the 12/17/81 medical staff by-laws medical records policy revealed consent forms would be signed for all treatment of all patients. The consent form would be obtained and signed by the physician.
Tag No.: C0306
Based on record review, interview, and policy review, the provider failed to ensure complete and accurate documentation was maintained to monitor the clinical status for six of eight sampled swing bed residents (6, 9, 10, 11, 12, and 13). Findings include:
1. Review of resident 6's 5/1/11 nurses' notes revealed she had fallen on that day. She complained of pain to her elbow with bending. No displacement or bruising of the elbow was noted. The next entry in those nurses' notes was on 5/3/11. That entry stated resident 6's right arm remained in a splint with a sling. There was no documentation between those two entries indicating why that arm was placed in a splint.
Review of resident 6's 5/2/11 X-ray report revealed she had a fracture of the ulna (the forearm bone) through the base of the olecranon (the elbow).
Continued review of those nurses' notes revealed the next entry for resident 6 was on 5/9/11. There was no documentation in those notes regarding the status of her fractured arm/elbow.
Review of the 5/24/11 nurses' notes revealed an entry stating resident 6 had a fracture of her humerus (the upper arm bone). No physician's verification or X-ray report was found validating that fracture.
2. Review of resident 9's nurses' notes revealed he had been admitted to the facility on 3/20/11. He complained of stiffness, numbness, and tingling in the right shoulder and arm. He also complained of feeling dizzy when he sat on his right hip. The next entry in those nurses' notes was 3/31/11. That entry stated he was being evaluated for a special treatment by physical therapy. There was nothing in those nurses' notes about an assessment of the above complaints. No further entries were made in those nurses' notes until 5/9/11. At that time resident 9 complained of increased stiffness and dizziness.
3. Review of resident 10's 4/15/11 nurses' notes revealed he had accidentally poured a hot cup of coffee on his lap. He had bright pink spots on both inner thighs and blisters were forming. The next entry in those nurses' notes was on 4/22/11. That entry revealed resident 10 had two blisters "2 x 4, 1 x 3 - fluid and dark old blood filled." There was no indication as to what the above numbers meant. No other assessment documentation was found within that one week time frame.
4. Review of resident 11's 1/10/11 nurses' notes revealed she had a red spot on the first joint of both of her great toes. Those notes stated "nursing will assess again at bedtime and again in the morning." The next entry in those nurses notes was dated 1/21/11. Those nurses' notes revealed she had complained of nausea and diarrhea. She had refused to eat anything for fear of vomiting. That entry was followed by one dated 2/10/11. No further documentation of assessment was found regarding the redness in the toes or the complaints of nausea.
5. Review of resident 12's 4/20/11 nurses' notes revealed she had complained of arthritis in her legs. The next entry in her nurses' notes was on 6/4/11 indicating a family member would transport her to an eye doctor appointment. There was no further documentation regarding an assessment for her complaints of arthritic pain.
6. Review of resident 13's 5/2/11 physician's orders revealed an order for a rapid strep (streptococcus) test on her throat to be done on 5/3/11. Another verbal order on that same day revealed an order for resident 13 to have "swish and swallow magic mouth wash as needed for complaints of pain." Review of her nurses' notes revealed entries on 5/1/11 and 5/3/11. Neither of those entries had any assessment regarding why a strep test or the "Swish and swallow" had been ordered. The next entry in those nurses' notes was 5/13/11. There was no documentation in those nurses' notes regarding resolution of concerns regarding her mouth or throat.
7. Review of the provider's revised June 2010 medical records policy revealed the purpose of a medical record was to:
*Serve as a basis for planning and for continuity of patient care.
*Provide a means of communication among the physicians and professionals contributing to the patient's care.
*Furnish documentary evidence of the course of the patient's illness and treatment during their hospital stay.
*Serve as a basis for review, study, and evaluation of the care provided to the patient.
*Include all significant detailed clinical information pertaining to the patient.
Review of the provider's revised March 2009 charting duties policy revealed nurse's charting must have been accurate, concise, and clear. That charting must have contained accurate observations and explicit statements in order to contribute to the continuity of patient care.
Review of the provider's revised July 2010 documentation policy revealed:
*The record was to describe patient/resident care.
*The following guidelines were to have been used to include all appropriate information:
-Record anything "abnormal or out of the ordinary."
-Document follow-up action to nursing observations.
-Document response to medications or treatments.
*The medical record was to have been maintained and kept up-to-date at all times.
Interview with the director of nursing at 1:00 p.m. on 6/8/11 revealed nurses primarily documented "by exception" for all swing bed residents. She stated that meant documentation would only reflect any changes that occurred in the resident's condition or status. She stated it would have been her expectation documentation was included to clarify and follow-up on any concerns. She confirmed the above stated areas did not reflect accurate and complete documentation on those residents' concerns.
Tag No.: C0307
Based on record review, interview, and policy review, the provider failed to ensure all sampled medical record entries from different patient service areas were authenticated with signatures, dates, and/or times. Findings include:
1. Review of 64 written physicians' orders during review of medical records on all patient care areas revealed 5 were not signed, 21 were not dated, and 64 were not timed.
2. Review of 96 telephone or verbal physicians' orders during review of medical records on all patient care areas revealed 50 were not signed, 7 were not dated, and 36 were not timed.
3. Review of 35 physicians' progress notes during review of medical records on all patient care areas revealed 3 were not signed and 35 were not timed.
4. Review of 29 miscellaneous forms regarding physician or staff contact with the patient during review of medical records on all patient care areas revealed 13 were not signed, 21 were not dated, and 26 were not timed.
5. Interview on 6/7/11 at 11:45 a.m. with physician A revealed he was aware that all entries were to be signed, dated, and timed.
Interview on 6/8/11 at 5:00 p.m. with the medical record director revealed:
*She was aware insurance companies were requiring proof of dating, timing, and signing of medical records.
*No tracking of signing, timing, and dating of medical records had been done.
*She had not presented any information to the medical staff on the requirement of dating, timing, and signing medical records.
Review of the provider's 12/17/81 medical staff by-laws medical records policy revealed all entries in the patient record would be dated and authenticated. There was no mention of timing in that policy.
Tag No.: C0337
Based on record review, policy review, and interview, the provider failed to implement a quality assessment and performance improvement (QAPI) program to evaluate all patient care services. Findings include:
1. Review of the minutes of the QAPI committee for the period between 6/10/10 and 6/2/11 revealed the committee met quarterly. The minutes mentioned status of the following hospital related projects:
*7/15/10 - Emergency room, medical records, business office, and laboratory.
*10/21/10 - Maintenance, laboratory, radiology, and physical therapy. The minutes consisted of a table showing the department, monitored activities, and summarized results. There was no documentation of discussion or actions taken in response to that table.
*1/20/11 - Hospital survey items completed (from 6/11/08 survey), maintenance, laboratory, radiology, and physical therapy. The minutes consisted of a table showing the department, monitored activities, and summarized results. There was no documentation of discussion or actions taken in response to that table.
*4/21/11 - Hospital survey items completed (from 6/11/08 survey), maintenance, laboratory, and physical therapy. The minutes consisted of a table showing the department, monitored activities, and summarized results. There was no documentation of discussion or actions taken in response to that table.
2. Review of the minutes of the medical staff for the period between 6/10/10 and 6/2/11 revealed the medical staff met five times. QAPI activities were mentioned at two meetings:
*6/10/10 - QAPI reports were passed and discussed. Records were on file in administration. There was no documentation of the discussion or if any action was taken.
*9/9/10 - QAPI reports were passed and discussed. Records were on file in administration. There was no documentation of the discussion or if any action was taken.
3. Review of the minutes of the governing board for the period between 6/10/10 and 6/2/11 revealed the governing board held eleven regular meetings. QAPI activities were mentioned at two meetings.
*8/27/10 - The marketing manager presented results of an employee focus group and patient satisfaction survey. The satisfaction survey dealt primarily with the activities of the rural health clinic. The board identified action points and determined it was appropriate to move forward with improvements that were practical. (There was no documentation the process for the employee focus group and patient satisfaction survey were included in the QAPI program.)
*4/21/11 - The summary performance improvement report was distributed. It was documented the report had been presented to and approved by the medical staff. A motion was passed to accept the report and approve the process. The summary report attached to the minutes revealed it was the minutes of the 10/21/10 QAPI meeting signed by the chief of staff on 3/10/11.
4. Review of three medical records chart review reports submitted between 6/1/10 and 3/30/11 revealed a sample of medical records was reviewed each quarter to evaluate the completion rate of the selected records. The reports did not provide any cumulative data or track any trends in completion of the records. There was no record that the reports were included in the QAPI program.
Interview on 6/8/11 at 4:15 p.m. with the medical records director revealed:
*The reports were prepared by the consultant pathologist as a part of his medical records review.
*The pathologist presented the results to the medical staff meetings.
*The director of nursing (DON) was involved with the medical staff and nurses to inform them of the results.
*The reports were a part of the utilization review process for the hospital and could also be considered quality improvement.
5. Interview on 6/7/11 at 8:05 a.m. with the pharmacist revealed he was not aware if the pharmacy had any QAPI programs involving the operation of the pharmacy or medication errors. Refer to C276, finding 4.
6. Interview on 6/7/11 at 4:00 p.m. with the DON revealed medication error reports were not a part of the QAPI program. Refer to C277.
7. Review of a quality improvement program for the hospital, rural health clinic, nursing home, and assisted living center last reviewed on 12/16/03 revealed:
*The governing board was to receive a report of the results of the QAPI committee on a quarterly basis.
*Administration would prepare an annual review of the services and financial activities of the hospital and report to the governing board.
*The medical staff were to oversee and support the maintenance of the QAPI by reviewing committee activities on a regular basis.
*A medical staff member was to be appointed to the QAPI committee. (Review of the quarterly minutes of the QAPI committee for the period between 6/10/10 and 6/2/11 revealed no member of the medical staff had attended any meeting.)
*Each department manager was responsible for implementing and maintaining a system for evaluating the quality and appropriateness of care/service as defined in the unit plan.
*The quality improvement coordinator was to ensure the development and continual change in the QAPI program.
*The QAPI committee was to meet quarterly to evaluate the effect of QAPI activities from all departments.
*Findings of the QAPI committee were to be reported to the medical staff and governing board.
*The structure, functions, and methods of the QAPI program were to be reappraised at least annually to ensure the program was achieving its objectives, was demonstrating impact, was cost-efficient, and was consistent.
8. Interview on 6/7/11 at 4:00 p.m. with the DON revealed she acted along with the administrator to direct the activities of the QAPI program. She stated she was not aware of an annual QAPI plan for the hospital.
Interview on 6/7/11 at 4:45 p.m. with the administrator revealed:
*The administrator was responsible for taking the QAPI program information to the medical staff and governing board.
*The QAPI committee minutes with the table showing the department, monitored activities, and summarized results served as a hospital QAPI plan.
*Medication errors were not included in the QAPI program.
Interview on 6/8/11 at 4:45 p.m. with the DON revealed:
*She had updated a QAPI plan for each department on 3/2/09.
*It was the responsibility of each department head to implement the plan.
*Not all departments implemented the plans she had updated.
*The QAPI plans for each department were not incorporated into a hospital-wide program.
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9. Interview with the infection prevention and control coordinator at 8:50 a.m. on 6/8/11 revealed she did not report infection prevention and control information to the QAPI program.
10. Interview with the DON at 1:00 p.m. on 6/8/11 revealed she did not report any information related specifically to services provided for swing bed residents to the QAPI program.