v25id8057

ORIGINAL RESEARCH

 

Standardization of nursing procedures in the autogenic infusion of hematopoietic stem cells

 

Fernanda Bion Jacques da CruzI; Ana Lúcia Colombo Ikeda II; Luciana Martins da RosaIII; Vera RadünzIV; Jane Cristina AndersV

I Nurse. Specialist in Gerontology and Oncology Nursing. Bone Marrow Transplantation Unit of the Santa Catarina State Health Department. Florianópolis, Santa Catarina, Brazil. E-mail: fernandabion@hotmail.com
II Nurse at the Bone Marrow Transplantation Unit of the Oncology Research Center. Florianópolis, Santa Catarina, Brazil. E-mail: naluikeda@hotmail.com
III Nurse. PhD. Professor at the Federal University of Santa Catarina. Florianópolis, Santa Catarina, Brazil. E-mail: luciana.m.rosa@ufsc.br
IV Nurse. PhD. Professor at the Federal University of Santa Catarina. Florianópolis, Santa Catarina, Brazil. E-mail: luciana.m.rosa@ufsc.br
V Nurse. PhD. Professor at the Federal University of Santa Catarina. Florianópolis, Santa Catarina, Brazil. E-mail:luciana.m.rosa@ufsc.br

DOI: http://dx.doi.org/10.12957/reuerj.2017.8057

 

 


ABSTRACT

Objective: to standardize nursing procedure in autogenic infusion of hematopoietic stem cells and stipulate the responsibilities to each member of the health care team. Method: Documentary research and bibliographic survey. Data were collected from September 2011 to March 2012, in textbooks of onco-hematology and documents that standardize the technique in four renowned oncological institutions in Brazil, to identify the steps that make up the procedure. Comparative analysis was performed between the data investigated and the routine adopted by an oncological institution in Santa Catarina, Brazil. Results: development of a standard operating procedure included the materials needed for cell infusion, description of procedures by professional category, and additional observations. Drafting of the procedure followed the guidelines of the Institutional Quality Program. Conclusion: technical standardization and definition of professional responsibilities are essential to providing competent care, and dissemination favors teaching and learning in nursing and in the health field.

Keywords: Bone marrow transplantation; nursing; medical oncology; education.


 

 

INTRODUCTION

Hematopoietic stem cell transplantation (HSCT) consists of replacing a diseased or deficient bone marrow with normal cells with the goal of reconstituting a new healthy marrow, i.e., hematopoietic stem cell (HSC) infusion through intravenous route1. Transplantation can be autogenic, allogenic and syngeneic2. This study addresses autogenic transplant, whose cells come from the patients themselves3.

In the State of Santa Catarina, autogenic HSCT is performed in a single Health Unit. This unit was inaugurated in 1999 and until 2011 did not yet have a standard operating procedure (SOP) formalized for autogenic HSC infusion. This was leading to doubts and risks related to the absence of technical standardization, according to a diagnosis reached by the nursing team in question.

Transplant success is totally linked to education and training of the team. Therefore, efficient and well-designed in-service education programs, including educational and clinical components, deserve constant attention. Technical standardization is essential for the success of this intervention, in order to ensure the quality of care to patients undergoing HSCT and decrease the possibility of iatrogenic events1.

In addition to the importance of technical standardization for the success of the procedure, the present study is also justified by the limited number of publications on HSCT at the national level. A study published in 2010, which identified scientific productions related to the subject indexed in the databases BDENF, LILACS, SciElo, CEPEn and CAPES Dissertations and Thesis Database, from 1997 to 2007, found 37 published papers that addressed nursing care, Bone Marrow Transplantation Services organization and management, quality of life, psychic suffering and knowledge production4. In these studies, there is no reference to specific nursing care during HSC infusion.

Thus, this study aims to standardize nursing procedures for HSC infusion and stipulate responsibilities that fit each one of the professionals of a health team during HSC infusion of an oncological institution in Santa Catarina/Brazil. This unit is a reference in the state for cancer care.

 

LITERATURE REVIEW

In order to support this study, the Quality Program guidelines established by the scenario where the study began, which define and guide the elaboration of standard operating procedures (SOPs), were followed.

The SOP is a detailed description of the steps required to carry out a procedure, a management tool that seeks excellence in service provision. This tool standardizes technical procedures and makes it possible to prevent and detect early complications or unintended consequences, preventing and/or favoring the correction of possible technical failures in the shortest time possible. The steps that define the SOP and its development must be completely understood and familiarized by the professionals who directly and/or indirectly participate in the execution of the procedure5.

The data considered essential for the elaboration of the SOP are title, date of issue and review, objective, performer, sector, material used, figures, description of procedure, complementary observations, registry control and name of those responsible for the elaboration, review and approval. This model was adopted by the study scenario.

 

METHODOLOGY

This is a documentary research and bibliographic survey carried out on HSCT for an oncology institution in the state of Santa Catarina between September 2011 and March 2012.

In the bibliographic survey, 13 publications were included, including six textbooks referring to HSCT, two Resolutions of the Federal Nursing Council (COFEN), two publications of the Sanitary Surveillance Agency and three articles published in indexed journals1-3,6-15. These publications were chosen because they were references in the oncology-hematology area and because they provided technical and legal support to the procedure investigated. These bibliographies also supported the analysis performed on the findings.

In order to perform data collection for the documentary research, the SOP for HSC infusion in autogenic transplantation adopted by theHospital das Clínicas of the Federal University of Paraná, the Hospital Israelita Albert Einstein, the Hematology and Hemotherapy Center of Santa Catarina (HEMOSC, in Portuguese) and the National Cancer Institute (INCA, in Portuguese) was requested for the Nursing Coordination Staffs by these institutions. These documents were received and included in the study16-19. As an ethical measure, authorization was requested in written form, making official the use of the documents as data source for this study. These institutions were chosen for their experience in the oncology-hematology area.

Data collection, in the documents and bibliographies, covered the search for the steps that make up the procedure for HSC infusion. The steps found were recorded in a Microsoft Word Program file, following the sequence of the investigated procedure. The findings were compared to the routine adopted by the nursing team in the setting where this study was started. The different steps were identified and recorded by comparative analysis.

The findings were presented to the nursing team and other professionals who make up the HSCT team. Then, a scientific analysis of the different findings was made. This occurred in two previously scheduled meetings. For the professionals who could not be present at these meetings, the findings were made available in printed form. The suggestions of these professionals were recorded in an instrument created for this purpose. After the analysis and consensus of the team, the SOP for HSC infusion was elaborated.

In order to validate the final document, a new meeting was scheduled with the nursing team. After this stage, the professionals were trained to develop the procedure established as institutional SOP.

 

RESULTS AND DISCUSSION

Bibliographic bases for the construction of the SOP

The consulted studies evidenced scarcity of published research specifically describing nursing care performed during the HSC infusion. Only one of the studies investigated describes the nursing routine1, however, all collaborated to the findings analysis.

The different findings found in the comparative analysis were:

The SOP provided by HEMOSC18 highlights the definition of maximum thawing time (5 minutes), infusion time of each HSC bag (5 minutes), ideal temperature for thawing of HSCs in a waterbath (between 37 and 40° C) and checking routine by biochemist and physician.

Thawing at 37-40° C ensures cell viability and grafting capacity. Cells are relatively sensitive to the so-called osmotic stress, so that the addition and removal of hypertonic solutions containing cryoprotective agents should be done carefully14. Two other publications also support cell thawing at 37-40 ° C to ensure cell viability1,13.

The SOP sent by the Hospital das Clínicas of the Federal University of Paraná16 does not encompass the object of this study. However, the description of infusion of fresh cells in the exclusive catheter route, without any concomitant medication, was important information for standardization, which reinforced the need for an exclusive route to avoid risks of extravasation by excess volume infused. Infusion by exclusive route was mentioned in all SOPs included in this study.

One of the publications used in this study states that HSC infusion should be done through a central venous catheter for two basic reasons: to effectively ensure cell infusion into the circulatory system and to avoid pain and phlebitis caused by peripheral vein infusion, since cell suspension with 10% dimethylsufoxide (DMSO) has high osmolarity 14.

The SOP made available by the Hospital Israelita Albert Einstein 17 highlighted the importance of describing orientations given to patient/family before and after the procedure, clarifying the signs and symptoms of possible complications related to HSCT.

The complexity of HSCT can produce deep psychological effects on the patient, the family and the professionals, and ignoring such factors, taking into account only the technical aspects of the procedure, can bring serious consequences for these individuals. During the HSCT, the patient and his/her family undergo changes in their psychosocial structures, and nurses have an important role in this adaptation so that the best quality of life is achieved20.

In the SOP of the Hospital Israelita Albert Einstein17 the physician is described as the professional responsible for HSC infusion, differing from the other institutions involved in this investigation, including the scenario of this study, that make the nurse responsible for HSC infusion.

In view of the complexity of the care provided to these patients, the COFEN instituted Resolution 200/1997, which deals with nurses' competences in HSCT, one of which is to perform specific technical procedures related to aspiration and infusion of bone marrow, umbilical cord and peripheral blood hematopoietic precursors, as well as to plan and implement actions aimed at reducing risks and enhancing treatment outcomes. Later, with the revision and updating of this Resolution, Resolution 306/2006 was published, which regulates the nurse's role in hemotherapy11,12.

The Hospital Israelita Albert Einstein procedure17 does not mention the origin of the water used in the water bath. Thus, contact was made with the Nursing Coordinator for clarification, which informed that the unit has a filtration and water heating system with bactericidal and fungicidal effect. The routines of the study scenario and other investigated institutions indicate the use of sterile distilled water in the water bath filling for thawing HSC. Considering that the study scenario does not have filtration or water heating system, we decided to maintain the use of sterile distilled water. It should be noted that this standardization was agreed upon from the technical guidelines of the Infection Control Commission that oversees the Unit.

The study scenario conduct determines checking only by the physician and the biochemist. The nurse does not participate in the examination of the bags as mentioned in the SOP of the Hospital Israelita Albert Einstein 17. The nurses of the study scenario evaluated that this professional should be part of the bag examination since they are responsible for HSC aspiration and infusion.

The SOP made available by INCA19 describes the need to maintain water balance up to 6 hours after the procedure in order to detect signs of renal failure such as oliguria, anuria and hematuria. Such conduct was also found in investigated studies1,7. The routine of the study's scenario ended balance one hour after the procedure.

Analyzing the asepsis techniques used by the institutions involved in the research, it was verified that all of them use 70% alcohol as an aseptic, differing from the study scenario, which routinely used 0.5% chlorhexidine gluconate in the asepsis of HSC bag, equipment and connections.

70% alcohol is the first choice antiseptic for this purpose, with chlorohexidine gluconate 0.5% being an alternative1,7,21. The National Sanitary Surveillance Agency (ANVISA, in Portuguese) describes that the disinfection of connections must be performed with alcoholic solution by means of vigorous friction with at least three rotational movements using clean gauze or sache10.

In view of the findings and associated with the considerations obtained with the Hospital Infection Commission of the study scenario, the nursing team decided to adopt the use of 70% alcohol, which is justified by the technical indication of patient safety as well as by reduced spending.

The other steps that make up the SOP for HSC infusion are similar between the institutions investigated in this study, so they were not described.

Procedures and responsibilities of the team in the HSC infusion

With the development of the method defined for this study, the SOP was established for the study scenario, named: Autogenic Infusion of Hematopoietic Stem Cells.

The responsibilities of physicians and biochemists were also included in the SOP as a request from the multidisciplinary team during the study development.

We present below the materials required to carry out the procedure, responsibilities by professional category and additional comments.

Materials needed for HSC infusion

A face towel; bags to pack HSC bags in thawing (one unit for each bag); large garbage bag; bags for vomiting; candies; infusion set for blood products with filter (one unit for each bag); 60 ml syringe with thread (one unit for every two bags of HSC); 20 ml syringe filled with 0.9% saline solution (SS); sterile caps; (one unit for every two bags of HSC); a sterile oral hygiene package; an enclosed environment and a sterile open field; 70% alcohol; three pairs of sterile gloves; apron; cap; mask; water bath equipment; thermometer for water bath; two stopwatches; bottles of sterile distilled water; vital signs monitor; electrodes; dressing trolley or Mayo stand.

Description of procedure and responsibilities by professional category

The nurse's responsibilities are:

To contact the HEMOSC (hemocenter) biochemist to schedule the HSC infusion;

To guide the patient and family about the procedure and schedule of infusion;

To communicate to physician on duty about the start of the procedure;

To start infusion of pre-medications and hydration as prescribed: ondanzentron 8 mg, mannitol 150 ml, solumedrol 125 mg, diphenhydramine 50 mg and 0.9% SS 1000 ml, 1 hour and 30 minutes before the start of the transplant. Medications should be taken in a tray into the patient's room next to two 20 ml syringes with 0.9% SS, sterile caps, one pair of sterile gloves, one sterile gauze pack and 70% alcohol. The fluid therapy adapted to the deep venous catheter should be removed and a new closed system must be adapted in a medial caliber route;

To keep track of water balance in the medical record from the moment the medications and SS are started;

To control urine output, schedule, in the first six hours;

To place the emergency vehicle next to the patient's bed, and the car must be checked and sealed;

To stimulate the patient to urinate fifteen minutes before the scheduled time for the beginning of the HSC infusion and, after return to bed, to install the vital sign monitor.

To wash hands or use alcohol gel at the care point;

To put apron, mask and cap;

To put on the sterile environment 60 ml syringe, saline lock, caps, set, fenestrated sterile environment and oral hygiene package, pouring 70% alcohol in the round basin;

To put on the sterile gloves;

To place the fenestrated sterile environment under the path to be used;

To wait for release of HSC bag by the cryobiology biochemist and the responsible physician;

To receive the HSC bag taken from the water bath by the cryobiology biochemist;

To remove the bag from the plastic bag and contrast it with the light, checking for clots or irregularities, together with the cryobiology biochemist/HEMOSC;

After verification, the bag is placed in a sterile environment, where the equipment will be adapted;

To hang the bag on a saline stand and to adapt the equipment and the saline lock to the extensor with 2 routes;

To use gauze soaked in 70% alcohol in the adaptation for cleaning and disinfection;

To couple syringe 60 ml in the lock;

To close the route in which 0.9% SS runs;

To aspirate the bag content with 60ml syringe and open the lock towards the syringe and route of the central catheter;

To inform the nursing technician about infusion start, who will control infusion time;

To perform slow infusion, maximum infusion time of 10 minutes for each bag;

To pay attention to changes in vital signs. In the case of more than one bag, if the patient does not present reactions and maintains stable vital signs at the end of the first bag and after the doctor's recommendation, the thawing process of the second bag should be started;

To pay attention to anaphylactic reaction caused by lysis of red blood cells that can cause hemoglobinuria, low urine output, increased serum creatinine and bilirubins;

To pay attention to hypersensitive reaction to DMSO: chills, tremors, fever, cough, nausea, vomiting, dyspnea and glottal edema;

To pay attention to respiratory changes such as dry cough, dyspnea, throat clearing, and chest pain;

To pay attention to signs of kidney failure such as oliguria, anuria, hematuria, pain and laboratory abnormalities;

To communicate to the physician any changes identified during HSC infusion;

If the patient experiences nausea and vomiting during the procedure, the nursing technician or nurse should administer anti-emetic medication, according to medical prescription;

To wash the catheter route with 20 ml 0.9% SS after the end of the infusion and adapt medications and solutions according to the daily prescription;

To dispose of materials in an appropriate place;

To end water balance and attach it to the medical chart;

To record changes during the evolving nursing procedure;

To release patient from cardiac monitor one hour after procedure.

The nursing technician's responsibilities are:

To wash hands;

To prepare pre-HSCT medications with aseptic technique in laminar flow hood;

To disinfect the material (water bath, thermometer and dressing trolley) with 70% alcohol before and after use;

To place the water bath equipment for thawing HSC in the patient's room;

To place sterile distilled water in the water bath at the ideal temperature for thawing, that is, at 37 to 40° C;

To empty the diuresis storage tub for precise control of eliminations when initiating pre-HSCT medications and hydration;

To position the bed in semi-Fowler position;

To offer candies to the patient before and during the HSC infusion and guiding them to order another one as soon as it is finished. Candies make the unpleasant taste caused by DMSO milder.

To use stopwatch to control HSC infusion time performed by the nurse;

To write down in the water balance record sheet the volume and time of infusion of each bag of HSC;

To dispose of the material used in a suitable place;

To provide support in case of complications.

The cryobiology biochemist's responsibilities are:

To bring the HSC bags, still frozen, into the canister in a box with dry ice;

To perform positive patient identification and to check medical records;

To record verified data;

To check the water bath temperature, which should be between 37 and 40° C;

To take the canister from the thermal box after authorization from the physician;

To open the canister and ask the physician to perform the verification of the patient's data in the identification set in the HSC bag;

To condition the bag in plastic bag and to start the process of thawing the bag in a water bath;

To use timer to control the bag defrosting time, which should not exceed 5 minutes;

To remove the HSC bag from the water bath;

To give the HSC bag to the nurse;

The physician's responsibilities are:

To check the data on the patient's chart and positive identification;

To sign the authorization for the infusion;

To remain in the patient's room until the end of the infusion.

Additional comments

Prior to hospitalization for HSC infusion, the assistant manager of the unit must make contact with the HEMOSC (hemocenter) to verify the viability and release of HSC bags, stored in a freezer at 150º C.

Day zero is the day of the HSC infusion itself. After termination of the chemotherapy conditioning regimen, a range of 24 to 72 hours should be adhered to before cell infusion due to the half-life of cytotoxic drugs. After this period, the hematopoietic stem cells must be infused, and the nurse is responsible for performing the technique of this procedure.

Infusion takes place through a calibrous central venous catheter, using blood transfusion equipment (with filter).

Hydration should be initiated prior to HSC infusion, as prescribed, and should be maintained after HSC infusion within the following 24 hours, according to daily prescription. Hydration avoids nephrotoxicity caused by toxicity of DMSO or by hemoglobinuria, which is the product of cell lysis during cryopreservation and thawing.

Previously, a central venous catheter dressing should be performed to evaluate, clean and check for airway permeability;

Usual adverse reactions that may occur during and immediately after infusion are related to volume overload, hypertension, weight gain and headache.

Hypersensitivity reactions to DMSO are: chills, tremors, fever, cough, nausea, vomiting, dyspnea and glottal edema; to pay attention to signs of kidney failure such as oliguria, anuria, hematuria, pain and laboratory abnormalities.

The HSC infusion standardization aimed to reduce the variability of the work processes without harming its flexibility. In addition, it met an institutional need and the desire of professionals in the study scenario.

The systematization of procedures is fundamental for achieving total quality, since it is through this systematization that one reaches predictability and maintenance of results. A standardized process leads to stability of results and decreases dispersions. Standardization is also the basis for training professionals22-25. Also, the use of standard operating procedures evidences the quality of care and competence of professionals, prioritizing patient safety 26.

 

CONCLUSION

The development of this study resulted in establishing the standard operating procedure for HSC infusion. Establishing a routine and standardizing it generated a useful product for nursing care, resulting in the effectiveness of the adopted behaviors.

The research work was complemented by the work of the HSCT team. This shared doing favored the description of the procedure from different opinions and experiences.

The dissemination of HSC infusion procedures becomes a source of information for other professionals who work or are interested in this subject, and the development of this study benefited the scenario in which this study began and especially the patient in HSCT.

The quality of the standardized content is due to the method established for this study and to the partnership with the Nursing Coordination Staffs of experienced and renowned institutions in oncology-hematological care.

A limitation of the study was the non-inclusion of operational procedures from international institutions.

 

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