A) TECHNICAL REQUIREMENTS:
a. Personnel
Personnel competency is assessed in 4 categories which are, technical personnel, clinical personnel, management personnel and supervisory personnel.
A technical personnel that perform scientific and technical work of laboratory shall be accredited with Bachelor of Science or Biomedical Science Degree or Diploma in Medical Laboratory Technology with at least 6 months of supervised training in the suitable aspect and records of evaluation of competence in the duty given. Technical work may also be done by trainee technical personnel with direction and supervision of a technical personnel having the accreditation mentioned. For technical assistants that is not having the qualifications mentioned but possess suitable practical experience and specialized training, they are only to do job of repetitive nature that does not involve analysis of testing or result. Laboratories management are the one that behold accountability to entrust tasks in a way that guarantees result validity and laboratory safety when it comes to personnel with mental or physical challenges.
As for clinical personnel that deliver clinical interpretations for the aim of medical diagnosis or treatment, such professional judgement requires the clinical personnel to have qualifications, training and experience appropriate to the pathology category that they practice. In order to be accredited, laboratories must have suitable requirement for personnel with interpretive or consultative credentials. Clinical interpretations or consultations of laboratory test outcome must only be given by medically qualified pathologist specifically in the fields that they are qualified in. The qualification must be backed by post graduate qualification in pathology approved by Government of Malaysia, accompanied by at least 3 years of training or working experience before or after acquiring the post graduate qualification. Clinical interpretations can also be delivered by medical practitioners working in the laboratory following direction and supervision of medically qualified pathologist in the area.
In specific conditions, results interpretations might be given by technical personnel having the appropriate training and working experience. The interpretation however is only on prepared text or comment based on generally accepted aspects or algorithm but not on clinical diagnosis and management advice. These exceptions are stated within the Specific Technical Requirements (STRs). The person that provide clinical interpretations, being laboratory director or not, are of the power to make decisions on laboratory operations when it comes to clinical interpretations. Certain clinical personnel can also act as key personnel or designees of laboratory director.
To take on management and supervisory roles, some aspects must be considered. Firstly, the qualifications and experience that one have with management and supervisory. Next, the workload of laboratory and types of tests present and technical complexity and nature of the testing included. Contact that managers and supervisors have with subordinate staffs is also put into equation and lastly, the involvement of managers and supervisors in the improvement of methods and practice on new methods in the laboratory. Management team should be comprised of all laboratory directors and minimum one medically qualified pathologist that can be a visiting pathologist. There shall be a statement of sufficient authorities, skills and experience to train and supervise subordinate personnel for persons with supervisory roles.
Laboratory should ensure that a contracted personnel that will be used, meet the requirements for staff competence no matter the personnel will work on part-time or full-time basis. Records on the competency evaluation of personnel shall be kept. Training should be given where needed especially in the areas they will work on. Initially, they might need to be supervised directly to ensure their competence in carrying out their tasks.
Visiting pathologists are pathologist with medical qualification that visits laboratory periodically to perform tasks in areas no one else can carry out. The tasks might be supervisory or clinical interpretation of test result provision or other services. They shall have qualifications in field they are serving for and shall still comply with the requirements of clinical personnel competency. Between the laboratory director and the visiting pathologist, a written and formal arrangement shall be documented to ensure productive working relationship and the visiting pathologists instructions are acted upon appropriate timeframe. It is also to ensure prevalence and length of visits are suitable to the mass and area of task that is appointed to the visiting pathologist and might take into considerations the availability of electronic connections which still able a remote supervision of laboratory outcome. Besides, the functions, roles and practice of visiting pathologist should be defined transparently where records of each visits in details are kept and a proper mean of contacting the pathologist is set up. It must also be as effective of a system to give way to provision of clinical advice including signing of tests reports and the liabilities of the test outcome and intentions are clearly stated.
Competence assessment of personnel should be done at least in every two years. Personnel that have been absent from work for a long period also needs to be reassessed and retraining if necessary. Administration of training and competency accomplished must be done both trainer and trainee. A regular refresher training should be given in situation where personnel are to work in areas they don’t normally work in.
To maintain competence of clinical and technical personnel, continuing education and professional development is highly significant. External activities and use of suitable reference texts and journals can be considered as part of it. Examples of external activities includes attendance at professional conferences, seminars and lectures or educational attachment or field trips to other laboratories and to partake in training workshops and courses. On the other hand, internal activities that can be done, comprises of regular educational presentations, reviewing journal article, presenting cases, QAP educational material reviewing and unique case reviews.

b. Accommodation ; Environmental Conditions
The laboratory design shall guarantee comfortable and secure functional environment referring to WHO Laboratory Biosafety Manual, College of Pathologists, Academy of Medicine Malaysia guidelines; guidance documents from other accreditation bodies, Occupational Safety and Health (Regulation 2000 and 2013) and the Guidelines on Chemical Management in Health Care facilities Ministry of Health.
Safety wise, all practicable standards and guidelines that identifies to medical laboratories in Malaysia, and recognized best practice shall be administered. Any hazardous practices must be paid attention to. Safety manual listing policies and procedures in laboratory in relative to health and safety should be available at all time for staffs. Certain procedures should be separated to ensure workers’ safety and environment protection. For examples, procedures that may be hazardous towards other staffs, ones that are sensitive if not segregated and when silent, uninterrupted working environment is needed. “Clean” and “dirty” areas shall also be separated accordingly.

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c. Laboratory equipment, reagents, and consumables
Generally, when having to share specialized equipment that is not of a laboratory’s continuous control, there must be calibration and maintenance record of an equipment and its performance must be verified every time it is being used.
When it comes to equipment calibration and metrological traceability, test or calibration tools that can affect result must be calibrated according to Standards Malaysia accredited calibration laboratories and/or Standards Malaysia Mutual Recognition Agreement accredited calibration laboratories as it is laboratories’ accountability to provide transparent proof that its system of calibrating and maintenance brings assurance.
In aspect of reagents and consumables, they shall all be labeled at least minimum of name, prepared date and opened date as well as concentration, solvent and any specific hazards and/or precaution. Highly hazardous substances shall also be stored separately.

d. Pre-examination processes
Proper collection and transportation should be prioritized. Every three years, collection centers shall be accessed. Laboratory must ensure proper instruction and monitoring even if the laboratory personnel are not involved directly with sample collection. Samples must be identified uniquely while being matched to its accompanying request form. In case of more than one samples are requested, the sample must be able to be differentiated by the labels and request forms. Access of safety precautions instructions must be available for personnel responsible of sample collection. Collector shall positively identify patients and label the samples with the minimum of two unique identifiers, its type and date of collection.
Sample reception includes uniquely identifying samples throughout the testing, for example, by using unique laboratory numbers, the most practical option for differentiating specimens or by using at least two of patients’ identifiers. The best option are ones that can distinguish samples even after a long haul.

e. Examination processes
In general, each process must be endorsed, dated and documented by accountable key personnel. Inspection must be done for new batches for any procedural changes and inserted in the manual if any and relevance of products update must be reviewed. Measurement of uncertainty of measured quantity value is as stated in ISO 15189 and SAMM Policy 5.

f. Ensuring quality of examination results
As for quality control, person responsible for quality control activities shall be identified and conducted by including all analytical or analysis concentrations featured. All values control must be done daily or by batch of analysis and specifically for special stains, positive controls must be done and the control materials must be matrix matched. The controls must not be manufacturers’ products while means and standard deviation given by them must be verified. Appropriate material shall be used when doing calibration and acceptable spectrum must be outlined. Document any quality control that is outside acceptable range and action taken to it and also any internal QC done; acceptance or rejection criteria shall be established. Early detection of trends can be done by having graphical presentation of quantitative QC results. Long term monitoring of internal quality control results system must be possessed by laboratories for assessment purposes.
Interlaboratory Comparison (ILC) programs can give info of any uncertainties regarding patient samples, including personnel competence. Their participation records must be kept for the purpose of performance evaluation. ILC may also challenges personnel for professional development thus each laboratories must be subscribed to at least one current and sustained ILC program per test or per related group of tests. Risk based approach is best done to decide on suitable ILC frequencies.

g. Post-examination processes
Samples should be obtained in congruence to the national guidelines.

h. Reporting of results
Transcriptions of data or result are best to not be done manually or when there is no other option, there should be a way to check transcriptions accuracy and entries that is performed, by an independent operator.

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B) RECOMMENDED CALIBRATION AND/OR PERFORMANCE CHECK INTERVAL FOR MEDICAL TESTING LABORATORIES

Automatic burettes, dispensers and pipettors needs 3 monthly intermediate check in order to ensure accuracy of and repeatability at volumes in use. On the other hand, balances should be initially calibrated every time, such as every repair, moving of equipment. On each weighing, zero check must be done, while every month calibration is done by one point check procedure using a known mass close to balance capacity and every 6 months, calibration using traceable certified masses or using statistical process control (SPC) by using repeatability checks at the upper and lower ends of the scale. Masses should have initial calibration and 5 years recalibration by an accredited calibration laboratory. Biological Safety Cabinets, Laminar Flow and Fume Hood/Cabinet requires Yearly certification by a certified body or according to manufacturer’s instruction but Intermediate check or performance check must still be done. Centrifuges should be calibrated following manufacturer’s instruction by an accredited calibration laboratory.
Calibration equipment for centrifuges includes tachometer (mechanical, stroboscope or light cell type, or by other approved means) where operating speed is specified and calibration of the timing device and, where appropriate, the temperature measurement device will also be required. Sterilizers and autoclaves also requires initial calibration by an accredited calibration laboratory followed by 15 months calibration or as required by DOSH certification By Department of Safety and Health (DOSH). However, monthly intermediate check must be done with the use of biological indicator. After each use, use physical indicator to ensure device calibration. In the case of hot air sterilizing ovens it needs to be calibrated before use and after each use by an accredited laboratory using physical indicator. pH meter shall be calibrated using at least two appropriate standard buffers for intended purposes after each usage. Refrigerators, chillers, freezer and cold room need minimum of daily calibration and monitoring of temperature using calibrated thermometer.
Thermometers need 5 years, 6 months and initial checking by accredited calibration laboratory, by checking ice point and at points of use and by checking against reference thermometer or thermocouple across working range or at points of use respectively. Thermostatically controlled equipment such an incubator or water baths and oven requires initial calibration by an accredited calibration laboratory and working days checking to monitor temperature using calibrated thermometer. Volumetric glassware, for examples, flasks, pipettes and burettes only needs initial check using distilled water at critical graduations. For timing devices like stop watch, clock, and timers, 6 months check has to be done against Malaysia standard time by having 2 measurements separated by an appropriate interval.

A. Describe how you think the hotel’s management will Make sure that the way it manages the hotel is appropriate to the way it competes for business
From the case analysis above, The hotel management of Penang Mutiara has adopted various methods that have enabled them to be competitive, they have realized that it’s cheaper to maintain an existing customer than looking for an new ones. They have gone an extra mile to understand that once in a while guest will come in agitate probably due to their experiences with their flights for instance losing their luggage, their have made sure that so that the guest is not agitate further for repeat guest, by the time the guest is checking in all their details are ready, “staff avoid their having to repeat the information they gave on the previous visit. Reception staff simply check to see if guests have stayed before, retrieve the information and take them straight to their room without irritating delays”, this way, the customer feels much appreciated.
They have also gone an extra mile by ensuring that the customer demands are met without any delay, “A guest just should not be kept waiting. If a guest has a request, it has to be sorted out now” to do this they have to make sure that the staff are multi-skilled. The policy is making sure that restaurant staff can always do more than one job. It’s this kind of ?exibility which allows the hotel to maintain fast response to the customer.’
The Hotel has also ensure that they are Dependable, this is a a fundamental principle of a well-managed hotel. “We must always keep our promises”. For example, rooms are ready on time and accounts are also ready for presentation when a guest departs; this minimizes the long queues at both check in and out points.
The hotel also does planning in advance and anticipation of what could go wrong, their put up mechanism of how to cope with the problems or better still prevent them from occurring in the first place.
The Hotel is also flexible to the customer demand, “We never like to say NO” they ensure that what customer wants, even if they don’t have they have to go the extra mile and get it for him, if however they happen not to get it, they negotiate with the customer for an alternative.

Even though Penang Mutiara has managed to maintain their competitive advantage currently, they should do a SWOT analysis and understand how their can remain competitive in the long run. This should assist Penang Mutiara to understand the areas where their should put more effort
Their should also adopt new strategies, let Penang Mutiara look for mechanism to attract new customers over and above the existing one, they should have questionnaire’s and market survey initiatives to understand the new emerging markets.
Penang Mutiara should also introduce a loyalty programme for the frequent customers. Customers should be made to understand the benefits of the loyalty points.
Penang Mutiara should also have an online checking system where guests can be able to check-in in advance; in doing this the hotel should have a ready report that shows are the arrivals in a particular.

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a) Describe how you think the hotel’s management will Implement any change in strategy.

Penang Mutiara Should have branches in as many destinations as possible, this will enhance customer brand loyalty in most regions. Considering that “There are many luxurious hotels in the South-East Asia region but few can compare with the Penang Mutiara” this means that they are already are brand to recon on and therefore no much struggling with the advertising aspect.
The hotel should also conduct a market survey and determine what moves their customers, is it quality or cost? In so doing the hotel will be in a position to gauge their services and know what to put more focus on.
They should also have complementary airport transfer services for their client, this will ensure that the guest are not worried as to what means they will have to use to get to the hotel, in so doing guests security will definitely be enhanced.
The hotel should also adopt various cuisines, in doing so the guest will feel much appreciated. They will also being looking forward to see various cuisines that are available at any particular.
Describe how you think the hotel’s management will Develop its operation so that it drives the long-term strategy of the hotel
They should also ensure that they adopt a low cost supply chain, in doing so this will enhance the quality of purchases, fast delivery and right prices. With a proper supply chain process stock outs of major items will be significantly reduced
Penang Mutiara should have a hotel website. In it they should have as many facilities as possible, examples would warning the guest in advance of the current weather condition and the appropriate dress code for the weather, they can also highlight the uniques features available in the hotel, eg a kids club for the young ones., there also could be a feedback sections where guests can be able to air both their appreciations and complaints and probably give suggestions for improvement.
Penang Mutiara can also set aside a budget for advertising themselves in both the digital and print media; this will enhance awareness in the market.
They should also enhance the hotel with free wifi within the hotel premise and also ensure that all hotel rooms are fitted with sets of TV, Bibles, Quaran among others
The case describes how quality, speed, dependability, ?exibility and cost impact on the hotel’s external customers. Explain how each of these performance objectives might have internal bene?ts.
Quality- Penang Mutiara is conscious on the quality of service offered to its guests, they have ensured that being courteous, and being knowleagble in order to give appropriate responses to guests. In doing this guest will always be happy and also employees are happy at the end of the day.
The staff of Penang Mutiara are always anticipates guest needs and thinking ahead to identify what will delight or upset the guest. In so doing all the staff members are always enthusiastic and challenge all the time as their anticipate the next client and see what they can offer, this will uplift the morale of the staff.
They also help guest sort own problems, in this doing the employees feels that they have an extra mile and have a sense of accomplishment when a guest problem is sorted and the guest is happy.
In ensuring that guest get value for their money, they will keep on coming back to the same Hotel over and over again
Speed, This in terms of turnaround time to guest request, they don’t keep the customer waiting , in doing this it helps the hotel to have good revenues as there are no order cancelation since the customer’s request are responded to timely. In return the customer feels appreciated and looks forward to their next visit.
Dependability, This means that the guest always gets what the request, Penang Mutiara for example ensures rooms must be ready on time and accounts are ready for presentation when a guest departs; in getting this the guests have more trust in the hotel capability to deliver to them at any time. This build the customers trust. This leads to more effective operations.
?exibility, Penang Mutiara ensures flexibility by ensuring that their labour force consists of multi skilled employees, in doing so any one from any restaurant can be called upon to assist in any restaurant that is overwhelmed at any particular tine, In doing so employees feel appreciated and their skills are being fully utilized, customers on the hand have more confidence in the hotel services offered
Cost, the hotel is keen on looking at areas where cost can be minimized,( food ; beverages and energy) however this does not effect the quality of service offered to the customer. In giving the right service, the hotel is guaranteed a return back again of the customers. This ensures that they have full occupancy translating to more revenues.

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