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Based on interview, record review, and policy review, the provider failed to ensure all patient care related contracted services were evaluated to ensure the needs of the patients were met. Findings include:

1. Review of the provider's continuous quality improvement (CQI) monitoring data revealed contracted services had not been included in the monitoring process. There was no data available determining if contracted services were provided or had met the needs of the patient and had complied with the hospital conditions of participation.

Interview on 1/23/13 at 2:30 p.m. with the CQI coordinator revealed the provider did not monitor any patient care related contracted services.

Based on record review, interview, and policy review, the provider failed to:
*Develop a plan for monitoring four of four revised therapeutic menus (1200, 1500, 1800, and 2000 calorie count) received from the contracted dietary service.
*Develop benchmarking for quality indicators for three of three monitored patient care services (nursing, anesthesia, and dietary).
Findings include:

1. Review of the continuous quality improvement (CQI) monitoring data revealed:
*The registered dietitian had identified menus that needed to be updated with new menu items from the contracted dietary service.
*Physicians had been ordering 1800 and 2000 calorie diets, and the menus had needed updating to increase the calorie count.
*They did not have a documented plan to ensure the contracted dietary service provided meals in accordance with the revised therapeutic menus.
*The CQI process did not monitor if patients were provided the appropriate therapeutic menus as ordered by the physician for meal choices.

2. Review of the narcotic CQI quarterly review for nursing revealed the following indicators were monitored:
*Medication given, order present for medication given, waste, medication signed out, two signatures on waste record, and documentation the medication was administered to the patient.
*The overall compliance rate was 80 percent (%) in October 2012, November 2012, and had declined to 70% in December 2012.
*There was no threshold/benchmarking to compare the facility's data to determine if goals were met.
*There was no documentation of an action plan when the narcotic rate had declined to 70%, or whether or not an action plan was required.

3. Review of the narcotic CQI quarterly review for anesthesia revealed the following indicators were monitored:
*The administering practitioner, medications used, medication waste, two signatures on the "blue" record, medications signed out, two signatures on the waste record, and the medication amounts matched up on the records.
*The overall compliance rate was 80% in October 2012, 90% in November 2012, and 80% in December 2012.
*There was no threshold/benchmarking to compare the facility's data to determine if goals were met.
*There was no documentation of an action plan when the narcotic rate had declined to 80%, or whether or not an action plan was required.
*Yes and no answers were required for documentation of amount wasted, two signatures on the
'blue" record, medication sign-out record, two signatures on the waste record, and the amounts matched up on records. When a "No" or "?" (question mark) had been documented there was no explanation/reason for the answer. There was no documented action taken for "No" or questionable answers.

4. Interview on 1/23/13 at 2:30 p.m. with the CQI coordinator revealed:
*She did not have a monitoring plan to ensure compliance with the revised therapeutic menus.
*The nursing and anesthesia indicators monitored did not include threshold/benchmarking criteria.

Review of the provider's CQI policy dated August 2010 revealed:
*If questions were raised during the evaluation process there would be further evaluation to provide an understanding of the problem, a method of correction, and follow-up of corrective action taken.
*The CQI processes were designed to measure positive and negative outcomes through monitoring and evaluation of the quality and appropriateness of patient services provided.
*Problem correction and monitoring methods should have been developed to ensure unacceptable practices had not occurred.
*A quality outcome measurement system should have been implemented to evaluate the effectiveness of particular interventions or interactions.
*Contracted services should have been part of the CQI process.
*The CQI program followed the APIE (Assessment, Plan, Intervention, Evaluation) methodology for monitoring issues at the facility.
*Plan for improvement involved:
-Assessment of the project to identify the problem, data collection, and establishing standards to meet.
-Planning the improvement by identification of opportunities for improvement, and determining indicated corrective action.
-Implementing improvement by making changes, developing strategies to maintain improvement, and staff education/policy changes/practice changes.
-Evaluating the improvement by measuring the impact of the change, examining data to determine if changes led to expected improvements, and determine whether or not to continue working on the process.

Based on review of medical staff rules, interview, and Centers for Medicare and Medicaid Services regulation review, the provider failed to ensure the medical staff developed and adopted rules related to autopsies. Findings include:

1. Review of the provider's current medical staff rules revealed no rules existed related to autopsies.

Interview, review of medical staff rules, and Centers for Medicare and Medicaid Services regulation review on 1/24/13 at 11:43 a.m. with the chief executive officer revealed she:
*Confirmed no medical staff rules had been developed or adopted by the medical staff related to autopsies.
*Agreed the Centers for Medicare and Medicaid Services regulation related to the medical staff rules on autopsies had not been followed.

A. Based on observation, interview, and policy review, the provider failed to ensure medications were administered by physicians, registered nurses, and the certified nurse anesthetist for one of one sampled patient (27) who received oxygen therapy. Findings include:

1. Observation on 1/22/13 between 2:15 p.m. and 2:30 p.m. of patient 27's physical therapy session revealed:
*Physical therapist (PT) F checked the patient's oxygen saturation several times during the session.
*When the patient's oxygen saturation went below 90 percent (%) on room air the therapist had applied oxygen via nasal cannula at two liters per minute.

Interview on 1/22/23 at 2:30 p.m. with PT F regarding patient 27 confirmed:
*She had applied oxygen at two liters per minute via nasal cannula when the patient's oxygen saturation was below 90%, and the patient was experiencing shortness of breath.
*She had checked physician orders, nursing notes, and past physical therapy notes prior to initiating the patient's physical therapy session.
*A review of the physician's order for oxygen administration revealed the patient should have had oxygen on to maintain an oxygen saturation of 93%.

Interview on 1/22/13 at 4:30 p.m. with the director of nursing (DON) regarding patient 27 revealed:
*PT F should not have administered the patient oxygen.
*PT F should have requested the assistance of a registered nurse. The application of oxygen should have been administered by a registered nurse.
*The physician's order dated 1/21/13 for patient 27 revealed "Oxygen by nasal cannula to keep sats (saturation) above 93%."

Review of the provider's undated guidelines for administration of medications policy revealed:
*"Purpose: To ensure medications only be administered pursuant to an order prescribed by a physician on the Medical Staff of the Hospital, within the scope of their license classification."
*"Policy: Medications may be administered by the following professional groups:
1. Registered Nurse (RN)
2. Physicians on Medical Staff of the Hospital.
3. Certified Nurse Anesthetist (C.R.N.A.)"
*"Drugs for administration shall be those drugs directly applied, whether by injection, inhalation, ingestion, or any other means to the body of a patient for his or her immediate needs."

B. Based on observation, interview, and policy review, the provider failed to ensure medications brought from home were secured at the nursing station as indicated by facility policy for one of one sampled patient (27). Findings include:

1. Review of the medical record for patient 27 revealed she had been admitted on 1/21/13 for a left hip arthroplasty.

Observation on 1/22/13 at 2:00 p.m. in patient 27's room revealed two inhalers were on the overbed table.

Review of patient 27's medication administration record revealed:
*The Alvesco inhaler had been scheduled for administration one puff twice a day at 8:00 a.m. and at 8:00 p.m. The Alvesco inhaler had been administered as ordered on 1/21/13 and 1/23/13.
*The Pro-Air inhaler was scheduled as needed for a maximum of twelve puffs per day. There was no indication of administration documented for the Pro-Air inhaler.

Review of the 1/21/13 physician's orders for patient 27 revealed:
*There was no order for self-administration of medications.
*A physician order "May use own home inhaler/eye drops."
*The medications had been verified with pharmacy.
*The medications had been verified with the patient/family.

Interview on 1/22/13 at 3:00 p.m. with registered nurse E confirmed:
*The patient's inhalers were maintained at the bedside.
*No assessments had been documented evaluating the patient's ability to self-administer medications.
*Patients were allowed to have medication brought from home.

Review of the provider's undated medications brought from home policy revealed:
*"Patients may not keep medications on their person or in their room without a physician's order allowing self-administration."
*"Any home medications that are used in the facility will be locked up in the nurses station."

Based on interview and policy review, the provider failed to ensure blood products were always verified by two registered nurses prior to administration. Findings include:

1. Interview on 1/23/13 at 8:00 a.m. with the interim laboratory manager regarding blood administration revealed:
*Blood products were received from another provider across town, and then checked into and stored in a refrigerator on the patient care unit.
*Blood products were often verified by a patient care technician (PCT) and a registered nurse (RN) during the night. That was due to the fact the patient care unit was frequently staffed at night with one PCT and one RN.
*Blood products were not signed out of the blood storage refrigerator by the person who removed it.

Interview and policy review on 1/23/13 at 11:10 a.m. with the director of nursing related to blood administration revealed:
*Blood products were being verified prior to administration with an RN and a PCT during the evenings and nights when one RN and one PCT were on duty.
*She confirmed the provider's April 2002 blood and blood products transfusion policy called for two RNs or an RN and a physician to verify the blood product prior to administering it. She further confirmed that policy had not been followed.

Based on observation, interview, and pharmacy label review, the provider failed to ensure medications obtained from the contracted pharmacy were labeled with expiration dates for three of three patients (27, 32, and 33) who received stock medications from the contracted pharmacy. Findings include:

1. Observation on 1/22/13 at 12:30 p.m. in the locked medication storage cabinet at the nurses station revealed the medications stored for patients 27, 32, and 33 did not have expiration dates on the medication bottles. Interview at the time of the observation with the director of nursing (DON) confirmed the medication bottles did not have expiration dates. The DON stated those patients' medications had come from their contract pharmacy. She did not know why the expiration dates had not been on the pharmacy labels. The DON revealed checking the expiration date would be a nursing responsibility prior to medication administration.

Interview on 1/23/13 at 10:00 a.m. with pharmacist D revealed the medication labels should have had an expiration date, it would be part of the nurse's check prior to medication administration. The missing expiration dates were an oversight.

Based on interview and Centers for Medicare and Medicaid Services regulation review, the provider failed to:
*Have twenty-four hour, seven day a week laboratory services available onsite.
*Ensure emergency onsite laboratory (lab) services had been outlined and established by the medical staff to address patients' emergency laboratory needs.
Findings include:

1. Interview and Centers for Medicare and Medicaid Services regulation review on 1/23/13 at 8:00 a.m. with the interim lab manager revealed:
*Laboratory services were currently supplied onsite Monday through Friday from 6:00 a.m. through 6:00 p.m. On the weekends the laboratory hours were Saturday 8:00 a.m. through noon, and Sunday the laboratory was closed.
*Laboratory staff were not on-call Monday through Friday.
*Currently any laboratory tests needed after hours were sent to another provider across town. Those laboratory tests were transported by a patient care technician (PCT) from the patient care area.
*No emergency onsite laboratory services had been outlined and established by the medical staff to address patients' emergency laboratory needs.
*She confirmed the Centers for Medicare and Medicaid Services regulation related to twenty-four hour, seven day a week laboratory services, and emergency laboratory services had not been followed.

Interview and Centers for Medicare and Medicaid Services regulation review on 1/23/13 at 11:10 a.m. with the director of nursing revealed:
*She confirmed and agreed with the information received from the interim laboratory manager.
*The patient care area was frequently staffed with one nurse and one PCT during the night leaving only one nurse on duty while the PCT delivered laboratory tests across town.
*No nursing policies had been established related to emergency laboratory services.

Based on menu review and interview, the provider failed to ensure one of one patient (31) on therapeutic diet received that diet. Findings include:

1. Interview on 1/24/13 at 10:51 a.m. with patient care technician A who was responsible for overseeing the dietary department revealed:
*There was no monitoring policy or procedure for verifying residents on a therapeutic diet had received a therapeutic diet.
*Staff were to provide the specific therapeutic diet menu to the patient. The patient would then order from that menu. The staff who took the order would send the order to the contracted dietary service to be filled. The provider would prepare the cereal or toast for the patient if that had been selected. The patient's menu would be saved to verify what the patient had ordered.

Review of the saved patient's menus revealed:
*On 12/19/12 patient 31 was on an 1800 calorie diet.
*The menu that his order had been placed on was not reflective of an 1800 calorie diet.
*The patient had ordered a bagel and cream cheese with orange juice for breakfast; a chicken wrap, potato salad, and diet coke for lunch; and a cheeseburger and lettuce with water for supper.

Review of the 1800 calorie menu revealed bagel and cream cheese, chicken wrap, potato salad, and cheeseburger were not on the list of items to order.

Interview on 1/24/13 at 11:15 a.m. with patient care technician A revealed:
*Staff should have been checking what residents ordered and verifyed what they ordered was compliant with the therapeutic diet.
*The menus had been recently updated to compensate for some menu items that were no longer available with the contracted service provider.
*The items ordered by patient 31 would not have been available on the 1800 calorie diet menu.

Interview on 1/24/13 at 1:50 p.m. with the director of nursing revealed:
*The nursing staff was responsible for ensuring the patient received the correct diet.
*The patient care technicians delivered the menus to the rooms and took the patient orders.
*The nurses did not review the patient menu or orders received by the patient care technicians. The only time the patient orders were reviewed was if a patient care technician questioned what the patient ordered.
*She agreed patient 31 had received items that were not compliant with the 1800 calorie diet menu.

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Based on observation and interview, the provider failed to:
*Store blood products in a manner that ensured the safety of the product.
*Ensure the hot water supply was operating at a safe temperature below the maximum allowed temperature of 125 degrees Fahrenheit (F).
*Store three boxes of 0.9 percent sodium chloride irrigation solution in a safe manner.
*Mix the sanitizer in the kitchen at an appropriate strength.
Findings include:

1. Random observations on 1/22/13 and 1/23/13 of the blood storage area and the refrigerator revealed:
*Blood was stored in the laboratory (lab), in the patient care area across from the visitor waiting room.
*The door to the laboratory was always open, and the blood storage refrigerator was unlocked.
*Staff were not able to ensure visitors, patients, and unauthorized staff did not have access to the laboratory or refrigerator where blood was stored.

Interview on 1/23/13 at 8:00 a.m. with the interim laboratory manager regarding the security of the laboratory and the blood storage refrigerator revealed:
*The provider had no policies related to laboratory security.
*She agreed leaving the laboratory open to the public and the blood storage refrigerator unlocked left the blood and anything else stored in that laboratory open to theft and potential tampering with it.

Interview on 1/23/13 at 11:10 a.m. with the director of nursing regarding the security of the laboratory and the blood storage refrigerator revealed:
*No nursing policies addressed the security of the lab or the blood products in it.
*She agreed the blood products had not been stored in a manner to ensure the safety of the products.

2. Testing of the hot water temperature on 1/22/13 at 1:40 p.m. in patient rooms 6, and 7, and in the lab revealed the hot water temperatures were 135 degrees F.

Interview and observation at 2:00 p.m. in the mechanical room with the maintenance person revealed:
*He was not aware the hot water temperatures in the above rooms were 135 degrees F.
*He checked the water temperature on the recirculating loop in the boiler room on a daily basis. The temperature was about 120 degrees F when he had checked it today.
*The temperature on the recirculating loop was 122 degrees F when checked by this surveyor.
*He had the hot water heaters set to run at 120 degrees F and showed this surveyor the setting.
*We tested the hot water in patient room 7 with a facility thermometer and this surveyor ' s thermometer. Both thermometers read 135 degrees F.
*He could not explain what had happened with the water temperatures but would adjust the hot water heaters down. He would monitor the hot water supply until it was below 125 F.

Testing on 1/23/13 at 10:45 a.m. revealed the hot water temperature in the lab and patient room 7 was 110 degrees F.

3. Observation and interview on 1/22/13 at 1:50 p.m. with patient care technician A in the report room revealed:
*Three boxes of 0.9 percent sodium chloride irrigation solution were stored on the floor within six feet of a floor drain.
*It was the extra supply that would not fit in the store room.
*She agreed it should not have been stored on the floor.

4. Observation, testing, label review, and interview on 1/22/13 at 1:30 p.m. with patient care technician A in the kitchen revealed:
*The quaternary ammonia sanitizer in the kitchen read more than 400 parts per million when tested.
*The dispenser for the sanitizer had been set-up by the chemical supply company.
*She was not aware at what strength the sanitizer should have been mixed at.
*The T10 sanitizer label stated it should have been mixed to equal 200 parts per million for a sanitizer.

Interview on 1/22/13 at 3:45 p.m. with the chemical supply company representative revealed:
*The dispenser was set-up to mix the sanitizer solution.
*He was not for sure why it was mixing too strong.
*He would supply the facility with a premixed ready-to-use sanitizer.

Based on record review, interview, and policy review, the provider failed to ensure infection control training was provided to one of one sampled infection control officer (G). Findings include:

1. Interview on 1/24/13 at 8:20 a.m. with the director of nursing (DON) revealed:
*She had taken over the facility's infection control program in 2010.
*She had not had specialized training in infection control, had not attended infection control conferences, and had not had any infection control training since assuming control of the program in 2010.
*She had been taught about infection control monitoring by a previous co-worker.
*The Infection Control Manual for Hospitals revised 2004 was her current infection control manual. She did not know if it had been revised since that date.
*She knew what the provider's infection control rate was but did not have an industry standard to compare that rate with. She assumed because her infection control rates were less than 1% the facility was doing good.

Review of the infection control officer's official transcript for 2012 revealed eleven minutes of computer training had been spent on infection control training.

Review of the provider's infection control policy dated January 2009 did not include educational requirements of the infection control officer.

Based on observation, label review, policy review, and interview, the provider failed to follow:
*Their policy and procedure in regards to flash sterilization.
*Manufacture's instructions for mixing enzymatic detergent used in the washing of scopes prior to high level disinfection.
*Manufacture's instructions for rinsing procedures while manually processing scopes after high level disinfection.
Findings include:

1. Interview on 1/22/13 at 3:30 p.m. with certified surgical technician B revealed:
*The provider had two sets of eye instruments.
*The provider did six to eight eye cases per day.
*It took ten minutes to do the eye procedure, and ten minutes to clean up and turn over the procedure room. The full length sterilization cycle took thirty minutes.
*The eye instruments were flash sterilized on a short cycle to match the twenty minute time frame.
*She agreed the eye instruments were flash sterilized for convenience and time.
*She was not for sure if the manufacture of the eye instruments had approved them for flash sterilization.
*No documentation was available to prove the eye instruments could be flash sterilized safely.

Interview on 1/23/13 at 11:00 a.m. with the director of nursing revealed:
*The flash sterilization of eye instruments had been a process that had been put into place before she had taken the director of nursing position.
*She agreed the eye instruments were flashed for convenience and time.
*She agreed flash sterilization did not ensure the same level of safety that normal sterilization did.
*She agreed flash sterilization of eye instruments did not follow the provider's policy and procedure in regards to flash sterilization.

Review of the provider's undated policy and procedure for flash sterilization revealed "Flash sterilization is used to quickly sterilize surgical instruments. Flash sterilization is used in surgical cases to allow quick sterilization of a 'one-of-a-kind' device that has been dropped."

Review of the 2011 Association for the Advancement of Medical Instrumentation standard, section 8.6.2.5 Flash cycles with sealed containment devices revealed "It is important to follow the containment device manufacturer's written IFU (instruction for use) regarding the types of instruments that were suitable for this type of cycle, because in some cases instruments with lumens, power equipment, and porous items cannot be processed by this method (because of potential difficulties with air removal and steam penetration)."

2. Interview and testing on 1/22/13 at 4:00 p.m. with certified surgical technician B revealed:
*Scopes were cleaned in the soiled utility room of the procedure room.
*When they were cleaned the sink was filled, and one squirt of enzymatic detergent was added.
*She was unable to tell this surveyor how much water was in the sink or how much enzymatic detergent was dispensed with one squirt. She estimated one to two gallons of water was in the sink.
*The instruction for use on the enzymatic detergent indicated the solution should have been mixed between one quarter and one half of an ounce per gallon of water.
*One squirt of detergent was equal to one quarter of an ounce.
*She agreed that without knowing how much water was in the sink she could not accurately mix the solution of enzymatic detergent.

Review of the provider's undated Cleaning, disinfection, and sterilization policy revealed "Cleaning: The removal of all soiled material from surfaces. This can be accomplished by the use of water with detergents. Thorough cleaning is necessary before proceeding to high-level disinfection and sterilization."

Review of the provider's April 2011 Steris System 1E policy revealed "Wash instruments with instrument cleaner thoroughly according to department specification and/or manual instructions."

3. Interview and label review on 1/23/13 at 12:55 p.m. with surgical technician C revealed:
*The provider used Cidex OPA as a high level disinfection when manually processing scopes.
*When manually processing scopes the scope was rinsed in one large volume of water.
*They did not follow the manufacture's instruction for the rinsing procedure for manual processing. Specifically, repeating the rinsing procedure two more additional times for a total of three rinses, with large volumes of fresh water to remove Cidex OPA solution residue.
*She was not aware of the manufacture's instructions for the rinsing procedure while manually processing.

Interview and label review on 1/23/13 at 1:50 p.m. with the director of nursing revealed she agreed they were not following the manufacture's instructions for the rinsing procedure while manually processing scopes.

Review of the provider's undated Endoscopes policy revealed "Procedure: Strict guidelines will be followed to ensure the safety of flexible endoscopes coming into contact with critical sterile body sites and semi critical areas of the body."

Based on interview and policy review, the provider failed to ensure designated requesters received training from a course offered or approved by an organ procurement organization (OPO) for all physicians and nursing staff who performed designated requestor duties. Findings include:

1. Interview and review on 1/24/13 at 8:20 a.m. with the director of nursing (DON) of the provider's organ procurement policy dated 1/14/10 revealed the physicians were designated requestors. If the physicians were not available then the nursing staff acted as the designated requestor. The DON confirmed the physicians nor the nursing staff had received training on the duties and responsibilities of a designated requestor. The DON revealed the provider had contracts with LifeSource and the South Dakota Lions Eye Bank.

Review of the provider's organ, eye, and tissue procurement review policy dated 1/4/10 revealed:
*"The individual designated by the hospital to initiate the request to the family must be an organ procurement representative or a designated requestor."
*The designated requestor was an individual that had completed a course offered or approved by the OPO and in conjunction with the tissue eye bank in the methodology for approaching potential donor families and requesting organ or tissue donation.
*"Nursing staff at all levels of licensure will receive education and training on the requirements of the designated organ procurement organization serving the hospital."

Review of the LifeSource contract dated 10/5/09 revealed one of the hospital responsibilities included working cooperatively with "LifeSource in educating all appropriate Hospital staff on donation issues, including the authorization (consent) process by donor designation or family authorization, the importance of discretion and sensitivity, and the role of the Designated Requester."

Based on interview and policy review, the provider failed to ensure all hospital physicians and all nursing staff received education on donation issues. Findings include:

1. Interview and review on 1/24/13 at 8:20 a.m. with the director of nursing (DON) on the provider's organ procurement policy revealed the provider did not have documentation the physicians and nursing staff had been educated on donation issues. The DON stated LifeSource had provided an in-service in 2011. At that time the meeting contents were not documented. That meeting was basically a meet and greet type affair. LifeSource had not provided education on donation issues during that meeting.

Review of the South Dakota Lions Eye Bank contract dated 2/1/02 revealed "The South Dakota Lions Eye Bank will provide as requested by the Hospital, professional education to Hospital personnel consistent with regulatory requirements and industry standards."

Review of the LifeSource contract dated 10/5/09 revealed one of the hospital responsibilities included working cooperatively with "LifeSource in educating all appropriate Hospital staff on donation issues, including the authorization (consent) process by donor designation or family authorization, the importance of discretion and sensitivity, and the role of the Designated Requester."

Based on record review, interview, policy review, and contract review, the provider failed to work cooperatively with a designated organ procurement organization (OPO) to review all facility death records. Findings include:

1. Interview on 1/24/13 at 8:20 a.m. with the director of nursing (DON) revealed:
*The death records in the facility had not been reviewed by an OPO.
*She was not aware of that requirement.

Review of the provider's organ donation policy dated 1/14/10 revealed the provider should have been "Reviewing death records to improve identification of potential donors."

Review of the Organ Recovery Agreement dated 10/5/09 between the provider and LifeSource revealed both parties should have been working cooperatively in "Reviewing death records in order to determine the Hospital's donor potential, improve identification of potential donors, develop strategies for improving donation rates and identifying areas where both LifeSource and Hospital staff performance might be improved."