HospitalInspections.org

Based on observation, interview, policy and procedure review, and document review, it was determined that the governing body failed to exercise sufficient oversight of practices that have the potential for harm of patients.

Findings include:

An Immediate Jeopardy situation was identified on 3/4/15 at 10:45 AM in the Condition of Infection Control. Cross reference to Tag #A747.

An Immediate Jeopardy situation was identified on 3/6/15 at 10:00 AM in the Conditions of Participation for Infection Control and Surgical Services. Cross reference to Tags #A747 and A940.

Based on interview, medical record review, and observation, the hospital does not provide the patient the right to make informed decisions regarding his or her care as related to the lack of disclosure to the patient that there is no doctor of medicine or osteopathy present in the hospital 24 hours per day, seven days per week.

Findings include:

Interview on 3/2/15 at 9:30 AM with CEO Staff #1 and Director of Patient Care Services Staff #2 revealed that the hospital stopped having 24 hours per day, seven days per week coverage by physicians in May 2014.

Medical record review on 3/3/15 and 3/5/15 revealed that the records for inpatient Patients #7, 9 and 20 did not contain written notice that an MD/DO is not present at all times at the hospital and how the hospital will meet the medical needs of any patient who develops an emergency medical condition at a time when no physician is present at the hospital, with signed acknowledgement from the patient stating their understanding that a physician may not be present at all times services are furnished to him/her.

Observation on 3/5/15 at 10:15 AM in the emergency department revealed no evidence the hospital had posted a notice conspicuously, in a place or places likely to be noticed by all individuals entering the dedicated emergency department, stating that the hospital does not have a doctor of medicine or a doctor of osteopathy present in the hospital 24 hours per day, 7 days per week, and how the hospital will meet the medical needs of any patient with an emergency medical condition at a time when there is no doctor of medicine or doctor of osteopathy present in the hospital.

During interview on 3/3/15 at 10:15 AM, Director of Patient Care Services Staff #2 stated that the hospital does not have policies regarding this issue, and does not inform patients of this by having signage in the emergency department for emergency patients, or provide written notice with signed acknowledgement to inpatients, or outpatients who are under observation or having surgery or any other procedure using anesthesia.

During interview on 3/5/15 at 9:30 AM, ED Nurse Manager Staff #17 confirmed that there is currently no system to notify patients who present to the ED that a physician or doctor of osteopathy is not available 24 hours a day to provide medical care for patients that present via the ED.

Based on observation, interview and policy and procedure review, the hospital does not ensure safe nursing care related to infection prevention measures regarding multi-use lancet holders available for use to obtain fingerstick blood glucose samples, along with single-use glucometers, in the Primary Care Clinic.

Findings include:

During tour of the Primary Care Center on 3/4/15 at 10:15 AM, the DOH surveyor requested to inspect the glucometers used in the clinic. Registered Nurse Nurse Manager Staff #13 provided the surveyor with zippered cases containing single-patient glucometers (Accu-Chek Aviva and Accu-Chek Nano) and multi-use lancet holders (pen-type) with lancets. There were no manufacturer's directions for use; there was no information available from staff regarding performance of controls or calibrations.

During interview at that time, Staff #13 confirmed that the glucometers are for "single patient use" and not used that frequently, but they are used at times when providers ask for a stat fingerstick for a glucose level. She added that the glucometers are given to the clinic by drug representatives, and they are given to patients as needed. She also stated, "Some of them belonged to patients and we just hang onto them." The surveyor clarified the use of glucometers by inquiring, "Is this the glucometer that staff uses in the clinic if a provider requests a stat glucose?" Staff #13 and Licensed Practical Nurse Staff #12 verified that these were the glucometers used for a stat fingerstick blood glucose level performed in the Primary Care Center.

During continued interview at that time, Staff #12 revealed the glucometers are cleaned with alcohol after use, but the surveyor was unable to investigate appropriate cleaning methods per accepted infection control standards, as no manufacturer's directions for use were available.

Inspection on 3/4/15 at 10:20 AM of glucometer cases revealed they contained pen-style lancet holders (open, not in packaging), with two open packages (and one sealed package) of lancets contained therein and available for potential patient use. There were also multiple loose lancets, not in packaging. Direct questioning of staff if the lancet pens were used on patients revealed that they could have been used, but self-contained self-retracting single use lancets were also available in the same cupboard that housed the glucometers with the cases.

Policies regarding glucometers were requested from facility staff on 3/4/15. The "ACCU-CHEK Inform II Glucose Monitoring System" (dated 6/27/14) was the only policy provided, and discussion with Infection Preventionist Staff #4 at 11:15 AM revealed that this is the only policy approved by the operator for fingerstick blood glucose testing (used for the multi-patient system in use in the facility). No other policy was located for the single-patient use glucometers that were being utilized in the Primary Care Clinic.

These findings were discussed with CEO Staff #1, RN Director of Patient Care Services Staff #2, Staff #4 and Staff #13 at 11:00 AM on 3/4/15.

Based on observation and interview, the hospital does not ensure the confidentiality of patient records, specifically, potential unauthorized access to radiology records.

Findings include:

Observation on 3/2/15 at 12:45 PM revealed the door was open to a medical records room, across from the main elevator on the ground floor (used by visitors and staff to travel to the cafeteria and physical therapy department). There was signage on the door that stated to keep the door closed at all times. A DOH surveyor walked into the room along racks of shelving containing patient medical records and turned and left the room, without hospital staff being present to notice or speak to the surveyor.

Interview on 3/6/15 at 9:15 AM with Director of Patient Care Services Staff #2 and Imaging Department Manager Staff #7 revealed the radiology records were being culled by a staff member at that time on 3/2/15, and it was unknown why the door was open, as it should have been closed.

Based on interview, the hospital does not ensure that a policy/procedure is developed for the receipt and transportation of tissue specimens that are received from the surgical unit.

Findings include:

During interview on 3/5/15 at 3:30 PM, Operating Room Nurse Manager Staff #29 revealed that when surgical specimens are taken to the laboratory, documentation is not maintained regarding the staff who transported the specimen to the laboratory or the staff who received the specimen in the laboratory. Staff #29 indicated that the requisition is kept with the specimen, and they are placed in a designated container in the laboratory.

During interview on 3/6/15 at 11:30 AM, Phlebotomist Staff #16 and Medical Technician Staff #41 verified that a log does not exist for documentation of receipt of tissue specimens from the surgical unit. Staff #16 indicated that surgical staff transport the tissue specimens to the laboratory, time stamp the requisition and place the specimen in the designated container to await pickup by the contracted laboratory (ACM). Staff #16 indicated that prior to pick up by ACM Laboratories, the laboratory staff log the tissue specimens into a log book. Staff #16 and #41 also indicated that documentation is not maintained when ACM retrieves the specimen from the designated location in the laboratory and transports the specimen to ACM Laboratories.

During interview of Staff #29 on 3/5/15, and of Staff #16 and 41 on 3/6/15, it was revealed that they were not aware of any policy/procedure for the receipt, transport and disposition of surgical specimens.

Based on observation and interview, the hospital does not ensure that piped medical gases are utilized for patient use only.

Findings include:

During tour of the endoscopy reprocessing area on 3/6/15 at 9:30 AM, it was observed in procedure room #2 that an oxygen outlet was utilized by Certified SPD Technician Staff #40 to dry the endoscope.

During interview on 3/6/15 at 9:35 AM, Staff #40 stated that this outlet is utilized to "blow out" the scopes after the endoscopes have completed the reprocessing procedure and 70% isopropyl alcohol has been purged through the scope. Staff #40 also indicated that this gas is utilized to enhance the scope drying process prior to the scopes being stored in the ventilated cabinets.

Based on observation and interview, the facility does not ensure that the soiled utility room in the emergency department is adequately labeled and secured.

Findings include:

During tour on 3/4/15 at 2:30 PM of the emergency department, it was observed that regulated medical waste (RMW) was stored in the soiled utility room. It was noted that the door entering this area was not secured to avoid unauthorized entry, and did not have a label to indicate that RMW was stored at this location.

This finding was verified with Maintenance Manager Staff #5 at the time of observation.

Based on interview, the hospital does not ensure that maintenance is performed on the reverse osmosis (RO) system.

Findings include:

During interview on 3/6/15 at 9:00 AM, Certified SPD Technician Staff #40 revealed that the facility utilizes RO water for rinsing endoscopes after initial cleaning and after the scope has been removed from the high level disinfectant. Staff #40 also revealed that RO water is not always available when staff arrive and begin the endoscope reprocessing procedure.

During interview on 3/6/15 at 9:50 AM, Maintenance Manager Staff #5 stated that the RO system consists of one membrane that is followed by deionization tanks. Staff #5 revealed that maintenance has not performed on the RO system to ensure its proper operation, and the hospital has not developed a policy/procedure to ensure that staff receive adequate training to maintain the RO unit.

Based on document review and interview, the hospital does not ensure that the humidity and temperature in 2 of 2 operating rooms is maintained within facility established parameters, as evidenced for 6 of 6 months. (Operating Room (OR) #1 for 9/2014 - 2/2015, and OR #2 for 1/2015 - 2/2015)

Findings include:

Review on 3/5/15 at 10:15 AM of the SURGERY DEPARTMENT TEMPERATURE AND HUMIDITY LOG revealed that the temperature and humidity in the operating rooms were not within the facility established parameters of temperature at 68-73 degrees Fahrenheit and humidity at 30-60%, as follows:

OR #1:
- For February 2015:
---The temperature was not within the established parameters on 5 of 18 days;
---The humidity was not within the established parameters on 6 of 18 days.
- For January 2015:
---The humidity was not obtained on 7 of 9 days.
- For December 2014:
---The temperature was not within the established parameters on 3 of 3 days;
---The humidity was not within the established parameters on 3 of 3 days.
- For November 2014:
---The temperature was not within the established parameters on 13 of 16 days;
---The humidity was not within the established parameters on 14 of 16 days.
- For October 2014:
---The temperature was not within the established parameters on 15 of 20 days;
---The humidity was not within the established parameters on 3 of 20 days.
- For September 2014:
---The temperature was not within the established parameters on 16 of 20 days;
---The humidity was not within the established parameters on 2 of 20 days.

OR #2 (not operational from 12/2013 - 1/1215)
- For February 2015:
---The temperature was not within the established parameters on 2 of 18 days;
---The humidity was not within the established parameters on 7 of 18 days.
- For January 2015:
---The temperature was not within the established parameters on 1 of 9 days;
---The humidity was not obtained on 7 of 9 days, and was not within established parameters on 1 of 9 days.

Review of the log also revealed the following:
- Maintenance had been contacted 5 of 18 days in February 2015;
- Maintenance had been contacted 1 of 9 days in January 2015;
- Maintenance had been contacted 2 of 3 days in December 2014;
- Maintenance had been contacted 10 of 16 days in November 2014;
- Maintenance had been contacted 4 of 20 days in October 2014;
- Maintenance was not contacted in September 2014.
The log did not indicate that maintenance staff had responded to notifications that the operating room temperatures and/or humidity readings were not within the established parameters, or that the readings had been corrected prior to the start of surgical procedures.

These findings were verified with OR Nurse Manager Staff #29 on 3/5/15 at 10:30 AM.

THIS IS A REPEAT DEFICIENCY FROM THE SURVEYS COMPLETED 9/20/06 AND 4/7/11.

Based on observation, interview, policy and procure review, and document review, the hospital does not protect the patients from potential infection risk related to problems identified with cleaning/high level disinfection of video endoscopes, fingerstick blood glucose monitoring, surgical staff attire during surgical procedures, maintenance of endoscope reprocessing equipment, protection of clean linen and sterilized surgical supplies, and autoclave processing.

See findings under Tags #A748, A749 and A951.

Based on observation, policy and procedure review and interview, the hospital does not ensure that approved policies/procedures are followed for cleaning and high level disinfection of the video endoscopes.

Findings include:

During observation on 3/6/15 at 8:30 AM of the endoscopy reprocessing by Certified SPD Technician Staff #40, it was observed that after Staff #40 had performed the cleaning process on an individual endoscope, the endoscope was then placed in the high level disinfectant, Rapicide, for 10 minutes.

Review on 3/5/15 of policy/procedure, "Endoscopy.1A" (approved 3/2015) revealed that the endoscope must be completely immersed in the Rapicide OPA/28 solution for 20 minutes.

During interview on 3/6/15 at 9:30 AM, Staff #40 revealed that her training, utilizing the Rapicide OPA/28 solution, included immersion of the endoscope in the high level disinfectant for a minimum of 10 minutes.

This finding was verified with Operating Room Nurse Manager Staff #29 on 3/10/15 at 10:00 AM.

Based on observation, interview, policy and procedure review, and document review, the hospital has not developed an effective infection control system; specifically:
1) Multi-use lancet holders were available for use to obtain fingerstick blood glucose samples, along with single-use glucometers, in the Primary Care Clinic.
2) Surgical staff do not wear appropriate surgical attire in the operating room (OR).
3) The hospital does not ensure proper protection of the clean linen carts in 2 of 2 areas. (emergency department (ED) and surgical suite)
4) The hospital does not ensure that maintenance is performed on 2 of 2 Scope Buddies that are located in the endoscope reprocessing room for 5 of 5 months. (October 2014 - February 2015)
5) The hospital does not ensure that aseptic techniques are maintained when sterilizing instruments and materials that are utilized in the operating rooms.

Findings include:

Finding #1:
During tour of the Primary Care Center on 3/4/15 at 10:15 AM, the DOH surveyor requested to inspect the glucometers used in the clinic. Registered Nurse Nurse Manager Staff #13 provided the surveyor with zippered cases containing single-patient glucometers (Accu-Chek Aviva and Accu-Chek Nano) and multi-use lancet holders (pen-type) with lancets. There were no manufacturer's directions for use; there was no information available from staff regarding performance of controls or calibrations.

During interview at that time, Staff #13 confirmed that the glucometers are for "single patient use" and not used that frequently, but they are used at times when providers ask for a stat fingerstick for a glucose level. She added that the glucometers are given to the clinic by drug representatives, and they are given to patients as needed. She also stated, "Some of them belonged to patients and we just hang onto them." The surveyor clarified the use of glucometers by inquiring, "Is this the glucometer that staff uses in the clinic if a provider requests a stat glucose?" Staff #13 and Licensed Practical Nurse Staff #12 verified that these were the glucometers used for a stat fingerstick blood glucose level performed in the Primary Care Center.

During continued interview at that time, Staff #12 revealed the glucometers are cleaned with alcohol after use, but the surveyor was unable to investigate appropriate cleaning methods per accepted infection control standards, as no manufacturer's directions for use were available.

Inspection on 3/4/15 at 10:20 AM of glucometer cases revealed they contained pen-style lancet holders (open, not in packaging), with two open packages (and one sealed package) of lancets contained therein and available for potential patient use. There were also multiple loose lancets, not in packaging. Direct questioning of staff if the lancet pens were used on patients revealed that they could have been used, but self-contained self-retracting single use lancets were also available in the same cupboard that housed the glucometers with the cases.

Policies regarding glucometers were requested from facility staff on 3/4/15. The "ACCU-CHEK Inform II Glucose Monitoring System" (dated 6/27/14) was the only policy provided, and discussion with Infection Preventionist Staff #4 at 11:15 AM revealed that this is the only policy approved by the operator for fingerstick blood glucose testing (used for the multi-patient system in use in the facility). No other policy was located for the single-patient use glucometers that were being utilized in the Primary Care Clinic.

These findings were discussed with CEO Staff #1, RN Director of Patient Care Services Staff #2, Staff #4 and Staff #13 at 11:00 AM on 3/4/15.

Finding #2:
During tour of the operating room areas on 3/6/15 at 9:20 AM, Patient #21 was observed to be undergoing open abdominal surgery. Staff #30, the surgeon, was wearing his own fabric "skull cap" head covering, with exposed hair over the sterile field. Scrub Nurse Staff #31 was wearing dangling earrings over the sterile field. Certified Registered Nurse Anesthetist #33 was also to have on dangling earrings near the sterile field. Circulating Nurse Staff #32 had some of her hair loose from her bonnet.

Interview on 3/6/15 at 9:30 AM with OR Nurse Manager Staff #29 revealed that the hospital does not professionally launder any personal head coverings. Staff #29 stated that any staff who wear their own garments launder them at home. In addition, she stated that earrings are not permitted in the OR and that all hair is supposed to be covered.

Review on 3/6/15 of policy "#Surgery.72 - Operating Room Attire" (reviewed 3/2014) revealed that jewelry is prohibited in the OR, except a simple wedding band, and all hair is to be completely confined within the head cover. All rings must be removed by staff if scrubbing into a surgery.

These findings were discussed with CEO Staff #1, RN Director of Patient Care Services Staff #2 and Staff #29 at 10:00 AM on 3/6/15.

Finding #3:
During the tour of the ED on 3/4/15 at 3:30 PM, and tour of the surgical suite on 3/6/15 at 11:00 AM, it was observed that the carts containing clean linen were not adequately protected from dust and soil. The plastic sheet covering, provided on the carts to protect the clean linen, had been placed over the top of the cart, exposing the clean linen.

Interviews with ED RN Staff #43 on 3/4/15 at 3:45 PM, and with Certified SPD Technician Staff #40 on 3/6/15 at 11:00 AM, revealed that they were aware of the requirement to protect the clean linen on these carts.

Finding #4:
Review on 3/5/15 at 10:00 AM of the ENDOSCOPE CLEANING AND DISINFECTING LOG for the months from October 2014 through February 2015 revealed that maintenance was not performed daily on the hospital's two Scope Buddies, which are used for endoscope reprocessing. Review of this log revealed the following:
- In February 2015:
---Maintenance was not performed at the beginning of endoscope reprocessing on 8 of 16 days;
---Maintenance was not performed at the end of endoscope reprocessing on 14 of 16 days.
- In January 2015:
---Maintenance was not performed at the beginning of endoscope reprocessing on 6 of 14 days;
--- Maintenance was not performed at the end of endoscope reprocessing on 10 of 14 days.
- In December 2014:
---Maintenance was not performed at the beginning of endoscope reprocessing on 6 of 18 days;
---Maintenance was not performed at the end of endoscope reprocessing on 15 of 18 days.
- In November 2014:
---Maintenance was not performed at the beginning of endoscope reprocessing on 4 of 13 days;
---Maintenance was not performed at the end of endoscope reprocessing on 9 of 13 days.
- In October 2014:
---Maintenance was not performed at the beginning of endoscope reprocessing on 10 of 16 days;
---Maintenance was not performed at the end of endoscope reprocessing on 12 of 16 days.

Review on 3/10/15 of policy "Endoscopy.12 and Endoscopy.13" (reviewed 3/2013) revealed that maintenance must be conducted at the beginning of each work day to verify that the Scope Buddies are operating properly and delivering the correct amount of fluid (minimum of 100 ml), and maintenance must be conducted at the end of each work day to ensure that the Scope Buddies and attachments are adequately decontaminated.

During interview on 3/6/15 at 8:45 AM, Staff #40 verified that Scope Buddy maintenance must be conducted twice daily.

Finding #5:
During tour of the operating rooms on 3/5/15 at 1:30 PM, it was observed that a surgical towel had been placed in a blue wrap prior to sterilization. During interview at that time, Sterilization Technician Staff #18 and OR Nurse Manager Staff #29 could not verify if the blue wrap was waterproof. Staff #29 wetted the blue wrap to determine if the material was waterproof. Observation of the material after it had been wetted revealed that the material is not waterproof. It was also noted that it is not possible to determine if the blue wrap had previously been wetted after the wrap had dried.

During continued interview, Staff #18 and 29 stated that the facility does not put a shelf life on sterilized instruments, but considers the packaged instruments and materials to be sterile indefinitely unless the package integrity has been jeopardized or compromised. The staff indicated that if the package integrity has been jeopardized or compromised, the instrument or material would be repacked and sterilized prior to use.

Based on document review, policy and procedure review, medical record review and interview, the hospital does not ensure that information regarding potential organ donors who had cardiac deaths are reported to the OPO within the time frame established by the OPO and the hospital, nor does the hospital include this activity in its QAPI activities, as evidenced for 2 of 3 cardiac deaths. (Patients #1 and 3)

Findings include:

Review on 3/2/15 of the "Memorandum of Agreement Between Bertrand Chaffee Hospital and Upstate New York Transplant Services, Inc. (UNYTS)" (signed by the hospital on 4/15/10, and UNYTS on 4/21/10) revealed that it is the responsibility of the hospital to notify UNYTS of all cardiac deaths within one hour of death.

Review on 3/2/15 of hospital policy Nursing.127 "Organ, Tissue, Eye Donation" (last reviewed 5/12) revealed that nursing staff must notify the nurse manager whenever a patient dies, and the nurse manager must then notify UNYTS. However, the policy does not have a time frame for the notification of cardiac deaths to UNYTS. The policy also states that the hospital will monitor the timeliness of hospital responsibility functions.

Medical record review on 3/2/15 revealed that the "Routine Referral For Potential Donors" forms in 2 of 3 records reviewed did not show that the hospital notified UNYTS within one hour of the cardiac deaths:
- Patient #1 expired on 1/2/15 at 3:45 AM. UNYTS was notified on 1/2/15 at 5:08 AM.
- Patient #3 expired on 1/29/15 at 2:30 AM. UNYTS was notified on 1/29/15, but no time was documented.

Review of the "UNYTS Hospital Development Plan 2015" (signed by UNYTS and the hospital on 2/25/15) revealed that the number of cardiac deaths referred by the hospital to UNYTS was at 100% compliance for every month of 2014. However, although the rates of timely versus un-timely notification of imminent deaths to UNYTS is measured and tracked, there is no measurement/tracking of timeliness of UNYTS notification of cardiac deaths.

These findings were confirmed with Director of Patient Care Services Staff #2 on 3/2/15 at 3:30 PM.

Based on observation, interview, policy and procedure review and document review, the hospital does not provide surgical services in accordance with acceptable standards of practice related to staff surgical attire during performance of surgical procedures, and autoclave processing.

See findings under Tag #A951.

Based on observation, interview, policy and procedure review and document review, the operator failed to maintain high standards of surgical practice related to appropriate infection prevention measures; specifically:
1) Surgical staff do not wear appropriate surgical attire in the operating room.
2) The hospital does not have a policy/procedure for utilizing the SPS biological spore testing for the autoclaves.

Findings include:

Finding #1:
Refer to Tag #A749.

Finding #2:
Interview with Staff #29 on 3/5/15 at 1:15 PM revealed that the facility has been using SPS biological spore testing for the autoclaves since 8/2014.

Policy and procedure review on 3/5/15 revealed policy CS.10A "Biological Tesing of Sterilizers" (last reviewed 3/2013) was for a process using the type of biological spore test that was previously utilized by the hospital. There was no evidence of a policy/procedure for the product in current use for autoclave testing at the hospital.

Review on 3/5/15 of the manufacturer's recommendations for the SPS biological spore testing product indicates that the biological organism (Geobacillus Stearothermophilus) is not killed unless the organism has been exposed for a minimum of 7.5 minutes at a temperature of 270 degrees Fahrenheit.

Review of 3/5/15 of the biological spore test results conducted on 8/14/14 utilizing the SPS product for an immediate use cycle revealed that the biological sample was exposed to 270 degrees Fahrenheit for five minutes. Further review of the daily/weekly biological spore test results revealed that all biologicals are processed in the same manner.

These findings were verified with Staff #29 on 3/5/15 at 1:30 PM.